Important Preemption Decision

Last week the Sixth Circuit issued a significant opinion in Yates v. Ortho-McNeil-Janssen Pharmaceuticals Inc., No. 15-3104, 2015 WL 8538119 (6th Cir. Dec. 11, 2015), upholding impossibility preemption of design defect claims against brand-name drug manufacturers.

Yates alleged she experienced a stroke while using the ORTHO EVRA® birth control patch, and sued the manufacturers of the patch.  Yates alleged five causes of action against defendants: (1) strict liability in tort—failure to warn; (2) strict liability in tort—manufacturing defect; (3) negligence; (4) breach of implied warranty; and (5) breach of express warranty.  The district court granted summary judgment as to Yates's failure to warn claim. 2014 WL 1369466 (N.D.Ohio Apr. 7, 2014). Thereafter, the district court granted summary judgment as to Yates's remaining claims and entered final judgment dismissing the case. 76 F.Supp.3d 680 (N.D.Ohio 2015). Yates timely appealed the district court's dismissal of all five of her causes of action.  The Sixth Circuit affirmed.

Failure to warn.

To establish a claim against a drug manufacturer for failure to warn under New York law, a plaintiff must demonstrate that the warning was inadequate and that the failure to adequately warn of the dangers of the drug was a proximate cause of his or her injuries. Krasnopolsky v. Warner–Lambert Co., 799 F.Supp. 1342, 1346 (E.D.N.Y.1992) (quoting Glucksman v. Halsey Drug Co., 160 A.D.2d 305, 553 N.Y.S.2d 724, 726 (1990)). The manufacturer's duty to warn extends to the treating physician, and not directly to the patient. Glucksman, 553 N.Y.S.2d at 726. It has long been the law in New York that prescription medicine warnings are adequate when information regarding the precise malady incurred was communicated in the prescribing information. Alston v. Caraco Pharm., Inc., 670 F.Supp.2d 279, 284 (S.D.N.Y.2009) (quoting Wolfgruber v. Upjohn Co., 72 A.D.2d 59, 423 N.Y.S.2d 95, 96–97 (1979)).  In this case, the “precise malady incurred” was a stroke, and the risk of stroke was communicated in the prescribing information. Defendants mentioned the risk of stroke several times in the package inserts. The label specifically stated there was an increased risk of several serious conditions including stroke. Thus, there was no genuine issue of material fact for a jury on the issue of whether defendants failed to adequately warn Yates, through her prescribing medical provider, of the risk of stroke associated with the product. 

Preemption

Readers know that state law claims can be preempted expressly in a federal statute or regulation, or impliedly, where congressional intent to preempt state law is inferred.  Congress may intend federal law to occupy the field,  or state law may conflict with a federal statute.  Conflict preemption exists where it is impossible for a private party to comply with both state and federal law, or when the state law is an obstacle to the accomplishment and execution of the full purposes and objectives of Congress. A court needs to ascertain whether federal law expressly prohibits the defendant from complying with state law, or there is sufficient, sometimes termed clear evidence, that the FDA would have prohibited the defendant from taking the necessary steps under state law.

The next issue in this case was whether defendants could have complied with their alleged duty under New York law to have designed a safer drug, given FDA approvals of the design. The court reviewed Supreme Court guidance in three recent opinions on federal preemption in pharmaceutical products liability suits: LevineMensing, and  Bartlett, in which plaintiff argued that the manufacturers could comply with both federal and state law by choosing not to make the drug at all. The Supreme Court reversed, holding that impossibility preemption barred the plaintiff's claims. As for drug redesign, the Court found that was impossible for two reasons: (1) the FDCA requires generic drugs to have the same active ingredients, route of administration, dosage form, strength, and labeling as the brand-name drug on which it is based; and thus the drug was “chemically incapable” of being redesigned. 

New York law provides that a product is defectively designed if  the product, as designed, was not reasonably safe because there was a substantial likelihood of harm and it was feasible to design the product in a safer manner. Doomes v. Best Transit Corp., 17 N.Y.3d 594, 608, 935 N.Y.S.2d 268, 958 N.E.2d 1183 (2011). New York follows a “risk-utility” approach to determining whether a product is not reasonably safe, which calls for consideration of several factors: (1) the utility of the product to the public as a whole and to the individual user; (2) the nature of the product—that is, the likelihood that it will cause injury; (3) the availability of a safer design; (4) the potential for designing and manufacturing the product so that it is safer but remains functional and reasonably priced; (5) the ability of the plaintiff to have avoided injury by careful use of the product; (6) the degree of awareness of the potential danger of the product which reasonably can be attributed to the plaintiff; and (7) the manufacturer's ability to spread any cost related to improving the safety of the design.

The court concluded that Yates's post-approval design defect claim was clearly preempted by federal law. FDA regulations provide that once a drug, whether generic or brand-name, is approved, the manufacturer is prohibited from making any major changes to the qualitative or quantitative formulation of the drug product, including inactive ingredients, or in the specifications provided in the approved application. 21 C.F.R. § 314.70(b)(2)(i). Moderate changes must be reported to the FDA at least 30 days prior to distribution of the drug product made using the change. Id. § 314.70(c).  Based on the plain meaning of the regulation,  defendants could not have altered the dosage of estrogen without submission to the FDA and the agency's approval prior to distribution of the product made using the change. Changing the dosage level of the active ingredient of ORTHO EVRA® constituted a “major change."  Quite simply, federal law prohibited defendants from decreasing the dosage of estrogen post-approval.

Readers should note the Sixth Circuit going out of its way to state that the FDA pre-approval requirement for design changes applied to all prescription drugs, with a reference to “branded or generic” drugs.  The court also rejected plaintiff's contention that there is no federal law that would have prohibited defendants from designing a different drug in the first instance, as opposed to altering an approved design. Yates's argument regarding defendants' pre-approval duty was too attenuated. To imagine such a pre-approval duty exists, a court would have to speculate that had defendants designed ORTHO EVRA® differently, the FDA would have approved the alternate design. Next, the court would have to assume that Yates would have selected this method of birth control from all the choices, and in the face of whatever warnings were on the label. Further the court would have to suppose that this alternate design would not have caused Yates to suffer a stroke. "This is several steps too far".  The argument was contingent upon whether the FDA would approve the alternate design in the first place, and this “never start selling” claim was also preempted because it mirrored the “stop selling” claim rejected in Bartlett.   

The Sixth Circuit affirmed the district court’s grant of summary judgment on all claims ( the others on fact-specific issues we won't get into here).

 

Preemption Found in Another Drug MDL

Implied preemption makes complete sense when it is evident that the FDA would not have permitted label changes that plaintiffs in private litigation say are required by state law. The latest example comes in the MDL litigation accusing various drug companies of failing to warn patients of alleged pancreas problems from Type 2 diabetes drugs; the California federal court recognized the FDA would have rejected the types of warnings plaintiffs demanded. See In re Incretin-Based Therapies Prods. Liab. Litig., No. 3:13-md-2452, 2015 WL 6912689 (S.D. Cal. Nov. 9, 2015).  The court concluded that defendants’ preemption defense was not only viable, but also dispositive of plaintiffs’ failure to warn claims. The record established that the FDA had specifically considered pancreatic cancer risk, commented publicly on the adequacy of drug labeling, and maintained its position that scientific evidence of a causal association between incretin mimetics and pancreatic cancer was indeterminate. Because an indeterminate causal association falls well below the federal regulatory standards required for labeling changes, clear evidence existed that the FDA would have rejected a reference to pancreatic cancer in product labeling.

This litigation involves claims that defendants failed to warn that four prescription drugs used to treat type 2 diabetes cause or increase the risk of pancreatic cancer. Plaintiffs are individuals with type 2 diabetes who were prescribed and consumed one or more of the prescription drugs in this group. The court first discussed Levine v. Wyeth, and its comment  that “absent clear evidence that the FDA would not have approved a change to Phenergan’s label” the Supreme Court would “not conclude that it was impossible for Wyeth to comply with both federal and state requirements.”  The court read Levine as providing the relevant conflict preemption standard (although there is an argument that the "clear evidence" notion arises from the unique procedural posture of the case, not as an evidentiary standard applicable in all preemption cases), but the case did not define what constitutes clear evidence. As such, application of the standard is necessarily fact-specific, said the court.  See Koho v. Forest Labs., Inc., 17 F. Supp. 3d 1109, 1118 (W.D. Wash. 2014) (“[T]he clear evidence standard is a fact based inquiry that depends on the express type of warning at issue and the particular facts of each case.”); Dobbs, 797 F. Supp. 2d at 1270 (explaining that ascertaining conflict preemption is “necessarily fact specific”).

Defendants cited multiple instances where the FDA had taken a position regarding pancreatic safety, including: (1) issuance of the FDA’s February 2014 assessment of pancreatic safety in the New England Journal of Medicine; (2) the FDA’s rejection of a citizen petition requesting the withdrawal of Victoza; (3) the FDA’s September 2014 conclusion that a causal association between incretin mimetics and pancreatic cancer is indeterminate; and (4) the subsequent approval of other incretin-based therapies without any reference to pancreatic cancer in the product labeling. Defendants argued that each instance represents the FDA’s opinion regarding pancreatic safety and its conclusion that current data does not support a pancreatic cancer label reference.
Plaintiffs argued that the evidence established the FDA has been aware of a pancreatic cancer safety "signal" for several years, and actively investigated the existence of a possible causal relationship between the drugs and pancreatic cancer.

It is worth noting, particularly, that in 2014, the FDA formally responded to a 2012 Victoza citizen petition. In doing so, the FDA again rejected adverse event data as evidence of a causal association between Victoza and pancreatic cancer. The FDA also concluded that any causal association between exposure to Victoza and pancreatic cancer is indeterminate at this time. Based on these conclusions, the FDA made no labeling change recommendations specific to pancreatic cancer. In September 2014, the FDA again reviewed pancreatic safety concerns in considering the safety of a higher dose of Victoza, marketed for weight loss. As part of a briefing document, the FDA acknowledged that pancreatic cancer had been “hypothesized but not proven” as a risk associated with incretin mimetics, and that “animal observations and clinical trial data reviewed by the FDA to date have not supported a causal association.” The FDA also reiterated its earlier conclusion that studies were “inconclusive” as to a causal association between incretin mimetics and pancreatic cancer.


These facts established that  the FDA has considered pancreatic cancer risk, the specific issue that plaintiffs allege defendants should have warned of or otherwise referenced in their product labeling. In addition to considering the specific issue raised by plaintiffs, the FDA had also  consistently concluded that a causal association between the drugs and pancreatic cancer was indeterminate. This falls below the science-based regulatory standards that govern what
must be included in product labeling. See 21 C.F.R. § 201.57(c)(6) (requiring reasonable evidence of a causal association); id. § 201.57(c)(7) (requiring sufficient basis to believe there is a causal association).  The FDA had also not required any of the defendants to add a pancreatic cancer warning, or required the inclusion of a warning in newly approved incretin-based therapies. That FDA inaction was "highly persuasive given the FDA’s comprehensive review of pancreatic safety and ability to mandate a labeling change if it concluded the regulatory standards were satisfied.

The court also rejected the standard plaintiff position that a defendant cannot establish preemption absent express rejection by the agency of a proposed labeling change it made. "Plaintiffs overstate the burden imposed by Levine."  While a CBE rejection would readily meet the clear evidence standard, it is not the only means by which a manufacturer can establish conflict preemption. The Supreme Court stated a manufacturer must demonstrate the FDA would have rejected a label change, not that the FDA did reject the labeling change.  Also, plaintiffs cannot establish the FDA’s substantial review of pancreatic safety in this posture was materially different from what the FDA would have done in response to a CBE, had one been submitted.  In fact, instead of reviewing data submitted by an individual manufacturer, the FDA considered a variety of data sources related to the entire class of incretin mimetics. Thus, "the facts of this matter are different in form only."

Notably, responding to citizen petitions is just as much within the FDA’s regulatory authority. The Victoza citizen petition rejection was written by the Director of the FDA’s Center for Drug Evaluation and Research, and constitutes the FDA’s official response to the request to withdraw Victoza from the market. Other courts to address conflict preemption have considered citizen petition responses as indicative of whether the FDA would reject a proposed labeling change. See, e.g., Mason, 596 F.3d at 395 (considering citizen petitions in clear evidence analysis); Koho, 17 F. Supp. 3d at 1117 (same); Dorsett, 699 F. Supp. 2d at 1157 (same).

The existence of an alleged "open safety signal" and the FDA’s ongoing review of pancreatic safety did not undermine the FDA’s previously articulated conclusions. The existence of a safety signal is not, without more, indicative of a causal association. FDA Guidance for Industry recognizes that signal generation is only the first step in pharmacovigilance and merely indicates the need for further investigation before any conclusions are drawn. Further investigation may or may not lead to the conclusion that the product caused the event. The existence of a hypothetical causal association is insufficient to satisfy the CBE standard. See Robinson, 615 F.3d at 869 (noting a label describing every serious disease that might or even arguably be caused by a drug would result in “information overload” making “label warnings worthless to consumers”); Mason, 596 F.3d at 392 (“While it is important for a manufacturer to warn of potential side effects, it is equally important that it not over-warn because over-warning can deter potentially beneficial uses of the drug by making it seem riskier than warranted and can dilute the effectiveness of valid warnings.”).

Thus, the FDA’s ongoing review of pancreatic safety, indeed any drug, is more indicative of the nature of drug surveillance than of the existence of a causal association. FDA continuously monitors every medication for new or evolving information as long as a drug is on the market. The potential for the FDA to reach a different conclusion in the future in light of new, future, scientific evidence or developments does not preclude a finding of preemption now. 

Sound analysis.

Proposed Class Action Stayed Pending FDA Guidance

A California recently indicated he would stay a putative class action raising allegations  about labeling of “evaporated cane juice” pending a decision from the U.S. Food and Drug Administration on sweetener labeling.  See Jennifer Shaouli v. Reed’s Inc., No.BC534738 (Sup. Ct. Los Angeles, Cal.).  The 2014 complaint can be found at 2014 WL 533701, and alleges various juice products, including defendant's  Hibiscus Ginger Grapefruit, Cranberry Ginger, Lemon Ginger Raspberry, Pomegranate Ginger, Coconut Water Lime, Passion Mango Ginger, and Cabernet Grape, were labeled misleadingly because they allegedly list “organic evaporated cane juice” as an ingredient. 

The Food and Drug Administration reopened the comment period on its draft guidance for industry on declaring "evaporated cane juice" as an ingredient on food labels. The agency originally published the draft guidance in October of 2009 and accepted comments through early December of that year. FDA reopened the comment period to obtain additional data and information to better understand the basic nature and characterizing properties of the ingredient, the methods of producing it, and the differences between this ingredient and other sweeteners.

The FDA is still mulling the new comments. And the court wisely decided it made little sense to proceed with the proposed class action until hearing from the FDA. Among the issues FDA is considering is whether the name “evaporated cane juice” adequately conveys the basic nature of the food and its characterizing properties or ingredients. 

Local Fracking Ban Struck Down

We typically focus on state court class actions when they reach the appellate level, but wanted to note an interesting decision at the trial court level.  An Ohio court has rejected a proposed class action by a group seeking to ban hydraulic fracturing in their community.  See Mothers Against Drilling in Our Neighborhood v. Ohio, No. CV-14-836899 (Ohio Ct. Com. Pl., 7/1/15).

Last December, community activists filed the class action against the state, the governor, and some fracking defendants, with the far-reaching argument that the portion of state law (Ohio Rev. Code § 1509) that gives the state Department of Natural Resources exclusive authority to permit, locate, space and regulate oil and gas wells, somehow violates plaintiffs' state constitutional right to local self-governance.  Plaintiffs' community had voted in favor of a city ordinance that bans fracking within the boundaries of their city.

The court granted defendants' motion for summary judgment, relying in large measure on a recent Ohio Supreme Court ruling in State v. Beck Energy Corp., Ohio, No. 2013-465, 2015 WL 687475 (Ohio, 2/17/15).  The ban on fracking was an invalid exercise of the city's home rule authority as it was preempted by Ohio Rev.C. 1509 as a matter of law.  In Beck, the state supreme court had noted that Chapter 1509 regulates oil and gas wells and production operations in Ohio. While it preserves certain limited powers for local governments, it gives the state government “sole and exclusive authority” to regulate the permitting, location, and spacing of oil and gas wells and production operations within the state.The supreme court held that the Home Rule Amendment to the Ohio Constitution did not grant to a city the power to enforce its own permitting scheme atop the state system. 

More background on this local regulation debate can be found at Knight & Gullman, The Power Of State Interest: Preemption Of Local Fracking Ordinances In Home-Rule Cities, 28 Tul. Envtl. L.J. 297 (Summer, 2015).

Tea Class Action Dumped Overboard

A federal court rejected a putative class action against tea maker Twinings North America, Inc. over antioxidant labeling.  See Craig v. Twinings N. Am., Inc., No. 5:14-CV-05214 (W.D. Ark., 2/5/15).

Craig allegedly purchased Twinings Irish Breakfast Tea and other varieties, and then alleged that defendant had misbranded its products.  Craig contended that Twinings mislabeled its tea as a “natural source of antioxidants” in order to charge a premium for the products. Plaintiff alleged that the “teas do not meet the minimum nutrient level threshold to make such a claim which is 10% or more of the Reference Daily Intake (‘RDI’) or the Daily Reference Value (‘DRV’) of a nutrient with a recognized RDI per reference amount customarily consumed.”  According to Craig, tea that has been labeled this way cannot be legally sold or possessed, and misbranded food has no economic value. She further contended that had she known that the misbranded teas were illegal to sell or possess, she would not have purchased the teas. Craig brought  five claims, based upon violations of the Arkansas Food, Drug, and Cosmetic Act (“AFDCA”), Ark. Code Ann. § 20-56-201, et seq.: (1)
violations of the Arkansas Deceptive Trade Practices Act (“ADTPA”), Ark. Code Ann. § 4-88-101, et seq.; (2) unjust enrichment; (3) breach of implied warranty of merchantability;  (4) breach of express warranty; and (5) negligence.

Twining moved to dismiss, arguing Craig's Complaint was preempted by the FDCA as amended by
the Nutrition Labeling and Education Act (“NLEA”). The Supreme Court has long recognized that state laws that conflict with federal law are “without effect.” Maryland v. Louisiana, 451 U.S. 725, 746 (1981).  That is, Congress has the power to preempt state laws. Fid. Fed. Sav. & Loan Ass'n v. de la Cuesta, 458 U.S. 141, 152–53 (1982). Federal preemption occurs when: (1) Congress enacts a statute that explicitly preempts state law; (2) state law actually conflicts with federal law; or (3) federal law occupies a legislative field to such an extent that it is reasonable to conclude that Congress left no room for state regulation in that field.” See generally In re Aurora Dairy Corp. Organic Milk Mktg. & Sales Practices Litig., 621 F. 3d 781, 791-94 (8th Cir. 2010). In the instant case, only express preemption was at issue.

The FDCA grants the FDA the responsibility to protect public health by ensuring that “foods are safe, wholesome, sanitary, and properly labeled.” 21 U.S.C. § 393(b)(2). There is no private right of action under the FDCA. 21 U.S.C. § 337(a). In 1990 Congress passed the NLEA, amending the FDCA, to specifically address labeling requirements for certain food and beverage products. Pub. L. No. 101–535, 104 Stat. 2353 (1990). The NLEA provides for national uniform nutrition labeling and expressly preempts state law that is inconsistent with its requirements. 21 U.S.C. § 343–1(a).


Twinings argued that Craig was making an end-run around the private action bar by indirectly bringing a claim to obtain redress for an alleged violation of the FDA labeling regulations. While the NLEA expressly preempts state labeling laws that cover certain described foods, 21 U.S.C. § 343–1, it does not preempt requirements imposed by state law that effectively parallel the NLEA. See, e.g., N. Y. State Rest. Ass'n, 556 F.3d 114, 123 (2nd Cir. 2009); In re Simply Orange Juice Mktg. & Sales Practices Litig., 2013 WL 781785, at *3 (W.D. Mo. Mar. 1, 2013); Chavez v. Blue Sky Natural Beverage Co., 268 F.R.D. 365, 370 (N.D. Cal. 2010). The purpose of the NLEA is not to preclude all state regulation of nutritional labeling, but to prevent states from adopting inconsistent requirements with respect to the labeling of nutrients. Astiana v. Ben & Jerry's Homemade, Inc., 2011 WL 2111796, at *9 (N.D. Cal. May 26, 2011); Pub. L. No. 101–535, 104 Stat. 2353, 2364 (1990). Thus, the preemption issue here was whether the label violations on which Craig based her claim impose a requirement pursuant to state law that differs from the FDCA. 

Craig’s claims were ostensibly based on the AFDCA, which impliedly adopts the federal provisions as its own. See e.g. Ark. Code Ann. 20-56-209(7) (declaring food to be “misbranded” if it falls
short of standards prescribed by the FDCA). Craig contended that any labeling violation of
the AFDCA is also a violation of the ADTPA and drives her remaining state law claims.

A claim that expressly or implicitly characterizes the level of a nutrient of the type required to be in nutrition labeling may not be made on the label or in labeling of foods unless the claim is made in accordance with federal regulation. 21 C.F.R. § 101.13(b).  The labels attached to the Complaint attest that the tea is a “natural source of antioxidants,” but did not characterize the level of the antioxidants, and thus were not nutrient-content claims as defined in the regs.  “Natural” does not modify the word “source” to indicate the level of the ingredient.. The generic phrase “natural source of antioxidants” did not appear to the court to be either an express or implied nutrient-content claim. Express claims are those that make a direct statement about the level (or range) of a nutrient in the food, and implied nutrient-content claims are those that describe a food or an ingredient in a manner that suggests that a nutrient is absent or present in a certain amount (e.g., “high in oat bran”).  Here, the challenged statement did not fall under either category, as it did not make an
explicit claim or statement regarding antioxidants.

Further, tea and coffee are exempt from certain labeling requirements if they contain insignificant amounts of all of the nutrients and food components required to be included in the declaration of nutrition information.  Antioxidants are not listed in the nutrients required to be on the label.

The court concluded that Craig’s suit could not continue, as the very crux of her argument was that the term “natural source of antioxidants” is a misbranding of Twinings’ teas, and is therefore illegal.
Even if Twinings’ labels contain nutrient-content claims, the product labels do not violate the FDA’s labeling requirements because they do not characterize the level of antioxidants.  Because Craig’s allegations did not violate the FDCA, any related state law claims arising from the same facts were preempted. If allowed to proceed, the state law claims would impose liability inconsistent with the FDCA.

Turning to Craig’s false representation claim, the Court observed that while Craig alleged that “natural source of antioxidants” is a false representation affirmatively made to her by Twinings, and she relied on this representation in making the decision to purchase the teas, Craig has not suffered actual damages as contemplated by the statute.  Craig’s alleged damages were based solely upon Twinings’ alleged violation of the FDA’s general nutrient content labeling regulations. In the instant case, Craig paid for tea and received tea. The Court could not find, therefore, that this product was “not at all what defendant represented.”

 

Mouthwash Class Action Washed Out

A federal judge earlier this month granted defendant's motion to dismiss a putative class action lawsuit accusing it of using misleading labeling on its market mouthwash.  See Suzanna Bowling v. Johnson & Johnson et al., No. 1:14-cv-03727 (S.D.N.Y., 11/4/14).

The issue here was preemption.  Plaintiff Bowling filed this action on behalf of herself and others similarly situated, alleging that the defendant violated (1) numerous state statutes, as well as (2) the Magnuson-Moss Warranty Act ("MMWA"), when it sold Listerine Total Care ("LTC"), a line of
mouthwashes. Defendant moved to dismiss on the grounds that the state law claims were preempted by the Food Drug and Cosmetics Act ("FDCA"). (Put the MMWA issue aside for today.)

Plaintiffs alleged that purported claims that the mouthwash can help with tooth enamel issues were false. But FDA had trod on this ground in "monographs" that set out labeling regulations for over-the-counter ("OTC") dental hygiene products.  First, in 1980, the FDA published a proposed
monograph ("1980 Monograph"), which found, inter alia, that "[t]he deposition of fluoride in dental enamel has been shown to increase resistance to enamel solubility and therefore dental decay" - or in plain English, flouride is good for preserving enamel. Second, in 1995, the FDA published a final monograph ("1995 Monograph"), which permits manufacturers of OTC drugs containing sodium
fluoride (such as LTC) to market the product as "aid[ing] the prevention of dental .. . decay,"'  along with "other truthful and nonmisleading statements [further] describing [this] use."  In other words, pursuant to the 1995 Monograph, manufacturers of OTC drugs containing sodium fluoride are allowed (1) to represent that such drugs prevent tooth decay and (2) to provide further labeling to explain how decay is prevented.  Furthermore, on multiple occasions, the FDA has sent letters to manufacturers of OTC drugs containing sodium fluoride to clarify the parameters of the Monographs.  In each of these letters, the FDA has objected to certain labeling practices - for example, certain representation that sodium fluoride "fights plaque"- but it has expressed no concern about the label "Restores Enamel."

Defendant moved to dismiss. In the context of OTC drugs, the FDCA expressly preempts state law labeling requirements that are "different from," "addition[ al] to," or "otherwise not identical with" federal labeling requirements. Under this standard, said the court, preemption is certainly appropriate when a state law prohibits labeling that is permitted under federal law. But it is also appropriate when a state law prohibits labeling that is not prohibited under federal law. The standard, in other words, is not only whether a state law actively undermines federal law. It is whether state law diverges from federal law at all.

That means, found the court, that plaintiffs would need to plead facts suggesting that the FDA has
affirmatively prohibited the challenged label language. Otherwise, plaintiffs' state law causes of action would be, in effect, imposing a labeling requirement that is "not identical with" labeling requirements under federal law. "Plaintiffs cannot meet this burden." If the FDA had prohibited the
"Restores Enamel" kind of label, there would obviously have been a regulation saying so. But there was no such regulation. As it stands, observed the court, the FDA has issued a monograph directly on point but declined to indicate either in the monograph itself or in advisory interpretations of the monograph that a phrase like "Restores Enamel" is misleading. If successful, this litigation would thus do exactly what Congress sought to forbid: using state law causes of action to bootstrap labeling requirements that are "not identical with" federal regulation.

Motion granted, 

Energy Drink Case Subject to Primary Jurisdiction

We have posted before about the important doctrine of primary jurisdiction.  Last week, a defendant obtained dismissal of a proposed class action over its energy drinks under this theory. See Fisher v. Monster Beverage Corp., No. 12-2188 (C.D. Cal. 11/12/13).

Plaintiffs sued individually and as putative class representatives for  allegedly "unfair and deceptive business and trade practices on behalf of anyone who purchased for personal consumption any of the Monster-branded energy drinks sold under the Monster Rehab® brand name and the original Monster Energy®."  Plaintiffs alleged various misrepresentations on the labels of the Original Monster and Rehab Varieties cans, including language that the drink "quenches thirst, hydrates like a sports drink, and brings you back after a hard day's night", that it would "RE-FRESH, RE-HYDRATE, REVIVE," and is "the ideal combo of the right ingredients in the right proportion to deliver the big bad buzz that only Monster can."  Plaintiffs alleged these statements were  misrepresentations because the cans do not hydrate like a sports drink, and allegedly cause dehydration; because "it is not the ideal combo of the right ingredients in the right proportion" and because the statement omits the potential health risks associated with such drinks.  Plaintiffs also alleged claims related to Monster's advertising "strategy."  Plaintiffs alleged that Monster specifically "targets" youth despite the caffeine levels in Monster Drinks.

The court tackled a number of challenges, including standing, preemption (some claims were preempted by the Nutrition Labeling and Education Act), and the absence of particularity in many of the fraud allegations.  But our focus here is on primary jurisdiction.  The primary jurisdiction doctrine allows courts to stay proceedings or to dismiss a complaint without prejudice pending the resolution of an issue within the special competence of an administrative agency; it is most often invoked if a claim involves an issue of first impression or a particularly complicated issue Congress has committed to a regulatory agency.  The courts traditionally weigh four factors in deciding whether to apply the primary jurisdiction doctrine: (1) the need to resolve an issue that (2) has been placed by Congress within the jurisdiction of an administrative body having regulatory authority (3) pursuant to a statute that subjects an industry or activity to a comprehensive regulatory authority that (4) requires expertise or uniformity in administration.  The court determines that an otherwise cognizable claim implicates technical and policy questions that should be addressed in the first instance by the agency with regulatory authority over the relevant industry rather than by the judicial branch.

Defendants argued that the FDA has jurisdiction over issues involving food safety and labeling, and the FDA has specialized expertise in the "technical and policy" questions involved here; the FDA has commenced a science-based evaluation of the safety of caffeine-containing food products, including energy drinks. They also argued that the FDA has primary jurisdiction because the agency has special competence over the matters involving the alleged inadequate warnings and failure to warn issues in this case.  The court agreed that the matters at issue here have been placed by Congress within the jurisdiction of the FDA pursuant to statute and regulations that require the FDA's expertise. The FDA has regulatory authority over food labeling. The FDCA establishes a uniform federal scheme of food regulation to ensure that food is labeled in a manner that does not mislead consumers. Second, plaintiffs' claims ultimately involve "technical and policy claims" about the effects of caffeine and whether Monster should be allowed to advertise and label their products in a way that appeals to a younger demographic. Plaintiffs cited to studies examining the effects of "energy drinks" in general, demonstrating that issues raised in the complaint may affect an entire industry. 

Third, the FDA has taken an interest in investigating and resolving whether energy drinks, including Monster, contain proper levels of caffeine. The FDA's interest in regulating the safety of caffeine weighed in favor of exercising the primary jurisdiction doctrine.  Thus, the Court found that plaintiffs' claims were covered under the Primary  Jurisdiction Doctrine.  

 

 

Supreme Court Issues Important Preemption Ruling

The Supreme Court last week reversed the First Circuit decision in Mutual Pharmaceutical Co. v. Bartlett, No. 12-142 (U.S., 6/24/13).

Readers will recall that in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), the Supreme Court held that state tort law claims against generic drug manufacturers based on the alleged inadequacy of the drug labeling are preempted; under the Hatch-Waxman Amendments to the Food, Drug and Cosmetic Act, generic drug labeling must be the same as the labeling of the reference-listed drug. Because generic drug manufacturers cannot independently change the labeling, state law failure to warn claims are preempted.

Plaintiffs proceeded to hunt for exceptions, ways around the ruling.  One of the strategies was to resurrect design defect theories, which traditionally were not a major aspect of most drug plaintiff claims. This case was tried on a design defect theory of liability after the plaintiff’s failure to warn claims were dismissed prior to trial and the district court rejected the generic manufacturer’s preemption defense on the design claim.  The jury found for plaintiff, and defendant appealed, arguing that just as the manufacturer cannot alter the label, once a drug—whether generic or brand-name—is approved, the manufacturer is prohibited from making any major changes to the qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved new drug application.  In Bartlett, the First Circuit held that the plaintiff’s state law theory of liability could nevertheless be reconciled with federal law because, although the generic manufacturer could change neither the design nor the labeling, it could avoid liability if it stopped selling the drug entirely within the state.

The Supreme Court reversed.

New Hampshire imposes design defect liability where the design of the product created a defective condition unreasonably dangerous to the user. To determine whether a product is “unreasonably dangerous,” the New Hampshire Supreme Court employs a risk/utility approach under which a product is defective as designed if the magnitude of the danger outweighs the utility of the product. The New Hampshire Supreme Court has repeatedly identified three factors as germane to the risk-utility inquiry: the usefulness and desirability of the product to the public as a whole, whether the risk of danger could have been reduced without significantly affecting either the product’s effectiveness or manufacturing cost, and the presence and efficacy of a warning to avoid an unreasonable risk of harm from hidden dangers or from foreseeable uses.  

In the drug context, either increasing the “usefulness” of a product or reducing its “risk of danger” would require redesigning the drug: a drug’s usefulness and its risk of danger are both direct results of its chemical design and, most saliently, its active ingredients. Here, said the Supreme Court, redesign was not possible, as the FDCA requires a generic drug to have the same active ingredients, route of administration, dosage form, strength, as the brand-name drug on which it is based. Given the impossibility of redesigning the drug, the only way for the defendant to ameliorate the drug’s “risk-utility” profile—and thus to escape liability—was to strengthen the presence and efficacy of the warning in such a way that the warning avoided an unreasonable risk of harm from hidden dangers or from foreseeable uses.

That was, of course, preempted.  When federal law forbids an action that state law requires, the state law is “without effect.” Because it is impossible for generic manufacturers to comply with both state and federal law, New Hampshire’s warning-infused design defect cause of action was pre-empted with respect to FDA-approved drugs sold in interstate commerce.

The Supreme Court rejected the argument that a defendant could satisfy both laws by paying tort judgments or refraining from selling its product in that particular state. And rejected the “stop-selling” rationale as incompatible with its pre-emption jurisprudence. The Court's pre-emption cases presume that an actor seeking to satisfy both his federal and state law obligations is not required to cease acting altogether in order to avoid liability. Indeed, if the option of ceasing to act defeated a claim of impossibility, impossibility pre-emption would be all but meaningless. The incoherence of the stop-selling theory becomes plain when viewed through the lens of the previous cases. In every instance in which the Court has found impossibility pre-emption, the direct conflict between federal and state law duties could easily have been avoided if the regulated actor had simply ceased acting.

Interestingly, there is nothing in the Court's rejection of “stop-selling” limiting it to generic drugs; the rejection seems applicable to all federally regulated products because it's not based on the FDCA but is an argument “incompatible with our pre-emption jurisprudence.”

 

Another Federal Court Applies Mensing

A federal court in Ohio recently ruled that a plaintiff who used only the generic form of the drug  metoclopramide has no cause of action under the Ohio Product Liability Act against makers of the brand-name drug. Hogue v. Pfizer Inc., No. 10-805 (S.D. Ohio, 9/27/12).

In late 2000, Ms. Hogue's physician prescribed Reglan® to treat plaintiff''s abdominal pain and digestive problems. Ms. Hogue then began to take generic metoclopramide and continued to do so until about August 2009. The parties stipulate she ingested only the generic version of metoclopramide, which the Brand Defendants did not manufacture. She later allegedly suffered side effects and sued both the branded and the generic manufacturers for an alleged failure to warn. And so  we have two rulings to reflect the status of each kind of defendant.

The generic defendants filed a motion to dismiss, arguing that the United States Supreme Court held in PLIVA, Inc. v. Mensing that such state law tort claims against generic drug manufacturers are preempted by federal law. Generic defendants pointed out that the Mensing case involved the same generic medication at issue in this case, the same alleged injuries, some of the same generic drug manufacturer defendants, the same claims, etc.  Plaintiff argued that nonetheless the Mensing holding was somehow more limited.  The court agreed with the defendants: First, the Supreme Court rejected the theories that generic drug manufacturers could use the "changes-being-effected" ("CBE") process to change their labels to satisfy the state law. The FDA interprets the CBE process to allow generic manufacturers to change generic drug labels only to match an updated brand-name label or to follow the FDA's instructions. Any unilateral change to labels by generic drug manufacturers would violate the federal requirement that generic drugs be identical to brand name drugs in both substance and labeling.

Second, the court noted that  the Supreme Court has considered and rejected the plaintiff's argument that the generic drug manufacturers could have sent "Dear Doctor" letters as additional
warnings. Dear Doctor letters qualify as "labeling" and therefore must be consistent with, and not
contrary to, the rest of the drug's approved labeling.  Any Dear Doctor letter containing substantially new warnings would not conform to the approved labeling. Moreover, if generic drug
manufacturers, but not the brand-name manufacturer, sent such letters, that would inaccurately imply a therapeutic difference between the branded and generic drugs and thus could be impermissibly misleading.

Third, the Supreme Court already considered whether the generic drug  manufacturers could have complied with the state laws by proposing stronger warning labels to the FDA. Even assuming such a duty exists on the part of generics, which is not clear, fulfillment of that duty would not have satisfied the state law requirements. Because it was impossible to comply with both federal law and state law, the plaintiff's state law claims were preempted.

Plaintiff further argued that Mensing didn't apply when the FDA has designated a defendant's drug as a reference listed drug ("RLD"). But the designation of a drug as an RLD does not change the manufacturer's status as an Amended New Drug Application ("ANDA'') holder,  the RLD designation does nothing to alter an ANDA holder's duties concerning labeling changes.

On the legal side, even if a failure to warn was preempted, plaintiff argued that several of her legal claims were not based on a theory of failure to warn. For example, plaintiff stated her breach of warranty claims did not conflict with any federal requirement regarding labeling and thus were not preempted. But the required analysis here is to focus not on the label or caption of the count, but the substance of the claim; and the other claims such as breach of warranty were in fact predicated on the failure to provide adequate warnings and were preempted. See also Smith v. Wyeth, 657 F.3d 420, 423 (6th Cir. 2011 ), cert. denied 132 S. Ct. 2103.

Brand defendants moved for summary judgment, arguing that Ohio law requires a plaintiff to prove the defendant manufactured the product that caused her injuries. Because they did not manufacture the metoclopramide Ms. Hogue ingested, her claims against them should fail as a matter of law.

The court noted that under Ohio law the defendant must have sold the actual product that was the cause of harm for which the claimant seeks to recover compensatory damages, and proof that a manufacturer designed or sold the type of product in question is not proof that the manufacturer did so for the actual defective product in the product liability claim. The Ohio Product Liability Act displaced plaintiff's common law claims, and required plaintiff to prove the defendant manufactured the product that caused her injuries.  They did not, so summary judgment was warranted.

(Note SHB works for the defense in part of this litigation.)
 

 

 

Supreme Court Declines to Review Medical Device Case

Earlier this week, the Supreme Court declined to hear plaintiff's challenge to the Fourth Circuit's decision on an important aspect of medical device law in Walker v. Medtronic Inc., No. 11-1418 (U.S. 10/1/12). 

The Court denied the petition for a writ of certiorari from plaintiff Walker, who appealed a Fourth Circuit decision that held that the 1976 Medical Device Amendments to the Federal Food, Drug and Cosmetic Act preempted her suit alleging that defendant's medical device caused her husband's death.  The denial may help to clarify the standard set forth in Riegel v. Medtronic, which held that state law requirements are generally preempted by the MDA.  More specifically, the case relates to the so-called “parallel violation claim” exception to the general rule of medical device preemption.  Readers may recall that some dicta in Riegel noted a theoretical possible exception for when a claim of a violation was "parallel" to and not different than the FDA's actual requirements.

The court of appeals, 2012 WL 206036, slip op. (4th Cir. Jan. 25, 2012), offered a very narrow view of this exception, a good thing for manufacturers.  Walker alleged he had used a Class III device designed to infuse a preset amount of  medicine into the fluid that surrounded his spinal cord.  Plaintiff passed away, and a claim was filed alleging that the device was defective, leading to a fatal overdose.  Plaintiff's attempt to evade the reach of preemption turned on language in the product literature that the device would give the specified dosages ±15%, language plaintiff said was a “guarantee of performance,” creating an un-preempted “parallel” violation claim. 

The court held the parallel exception is quite narrow. The FDA has performance standards, under which a manufacturer must guarantee a particular level functioning or performance.  The FDA may condition its grant of premarket approval upon such performance standards if it determines that a performance standard is necessary to provide reasonable assurance of the safety and effectiveness of the device. See 21 U.S.C. §360d(a)(1).  But the establishment of a performance standard is a highly formal process, requiring notice, findings of fact on risks, and comments from interested stakeholders.  

So, when a plaintiff asserts that a statement or representation or feature that hasn’t gone through the formal FDA procedure is a “performance standard,”  that is in fact asserting something different from or in addition to the FDA standards for the product within the meaning of the Act’s preemption clause. Thus, it is preempted.  The court of appeals concluded that the only mechanism for creating a binding, ongoing performance requirement is the creation of a performance standard. And the plus or minus 15 percent specification was not a performance standard.

That makes complete sense because the device in question was manufactured in full compliance with what the FDA required.   Expectations that may have been generated by literature surrounding the product are not the same thing as FDA standards. The device was not required to always dispense medication within the range of the plus or minus 15 percent.  And for plaintiff to try to sue over this feature would be to seek to impose a more demanding standard than that of the FDA, rather than just a parallel one.

Walker appears to be one of the first appellate court decisions to reject this type of claim on the basis that a mere device malfunction that does not relate to a formal performance standard is not going to be enough to establish a “parallel” violation claim. And the Supreme Court leaves it in place.

Consumer Fraud Claim on "All Natural" Beverage Rejected

One trend we are keeping an eye on here at MassTortDefense is plaintiffs' aggressive and excessive use of consumer fraud act claims, micro-analyzing every ad, turning traditional puffing into some kind of nefarious marketing scheme.  Class certification in such cases can trigger the need to think about "blackmail settlements."

So all victories are worth noting, and last week South Beach Beverage Co. Inc., maker of SoBe drinks, garnered dismissal of a California putative class action alleging false claims about their "0 Calories Lifewater" drinks. See Charles Hairston v. South Beach Beverage Co. Inc,. et al., No. 2:12-cv-01429 (C.D. Cal. 5/18/12).

SoBe manufactures a diverse range of beverages, including teas and enhanced waters, that are characterized by exotic flavor combinations and added vitamins. In his First Amended Complaint, plaintiff alleged that during the last three to four years, he regularly purchased SoBe 0 Calorie Lifewater beverages (“Lifewater”), which are no-calorie, vitamin-enhanced, flavored water drinks. Plaintiff raised three challenges to Lifewater’s labeling, which he claimed he “read and relied on.” First, plaintiff alleged that the “all natural” label was potentially deceptive because Lifewater contains “deceptively labeled ingredients” that are “synthetic or created via chemical processing.” Second, plaintiff alleged that Lifewater’s labels are potentially misleading because the names of various fruits are used to describe the different flavors of Lifewater even though Lifewater allegedly does not contain any actual fruit or fruit juice. Third, plaintiff alleged that the use of the common vitamin name (e.g., B12) on the product labels is misleading because the vitamins added to Lifewater are "synthetic" or created via chemical processing.

As is typical, plaintiffs alleged causes of action including for: (1) California Consumers Legal Remedies Act – California Civil Code §§ 1750, et seq. (“CLRA”); (2) California False Advertising Law – California Business & Professions Code §§ 17500, et seq. (“FAL”); (3) California Unfair Competition Law – California Business & Professions Code §§ 17200, et seq. (“UCL”).

Defendants argued first that the claims alleged related to the use of fruit names to describe the various flavors of Lifewater and their use of common vitamin names were preempted by the express preemption provisions in the Federal Food, Drug, and Cosmetic Act (“FDCA”) and by the specific labeling regulations promulgated by the Food and Drug Administration (“FDA”). The court concluded that plaintiff’s claims related to defendants’ use of the names of various fruits to describe the different flavors of Lifewater were indeed preempted. See, e.g., Dvora v.
General Mills, Inc., 2011 WL 1897349 (C.D. Cal. May 6, 2011) (holding that CLRA and UCL claims
were preempted where the plaintiff was challenging the use of the words “Blueberry Pomegranate”
in labeling a cereal not containing any blueberries or pomegranates because FDA regulations
explicitly permit manufacturers “to use the name and images of a fruit on a product’s packaging to
describe the characterizing flavor of the product even where the product does not contain any of
that fruit, or contains no fruit at all”); McKinnis v. General Mills, Inc., 2007 WL 4762172 (C.D. Cal.
Sept. 18, 2007) (holding that use of “Strawberry Kiwi” to designate the flavor of yogurt containing
no fruit ingredients was “permissible to demonstrate the ‘characterizing flavor’ of the product”).

The court also concluded that plaintiff’s claims related to defendants’ use of the common names
of vitamins were preempted. See, e.g., 21 C.F.R. § 101.9(c)(8)(v) (recognizing that “Vitamin C” and
“Ascorbic acid” are “synonym[s]” that may be used in the alternative in a product’s nutritional
information labeling); 21 C.F.R. § 101.9(k)(4) (stating that the FDA will consider a food
“misbranded” if its “label or labeling represents, suggests, or implies” that “a natural vitamin in food is superior to an added or synthetic vitamin”).

Significantly, the court concluded that plaintiff could not avoid preemption of these claims by arguing that his claim related solely to defendants’ “all natural” representations and that he included his fruit name and vitamin name claims only as support for his “all natural” claim. Such an argument would effectively allow a plaintiff to always avoid preemption of those claims, and would undermine the purpose of the federal labeling standards which includes avoiding
a patchwork of different state standards.  These claims were dismissed with prejudice.

Plaintiff also alleged that the “all natural” labeling on defendants’ products was potentially deceptive because the product contains “deceptively labeled ingredients” that are
“synthetic or created via chemical processing.” However, plaintiff could not state a claim under the
CLRA, FAL, or UCL regarding defendants’ allegedly deceptive “all natural” labeling because once
the preempted statements regarding fruit names and vitamin labeling were removed, plaintiff’s claim is based on a single out-of-context phrase found in one component of Lifewater’s label.

The court concluded that plaintiff’s selective interpretation of individual words or phrases from a product’s labeling could not support a CLRA, FAL, or UCL claim. See, e.g., Carrea v. Dreyer’s Grand Ice Cream, 2012 WL 1131526 (9th Cir. Apr. 5, 2012).  Lifewater’s label did not simply state that it is “all natural” without elaboration or explanation. Instead, the “all natural” language was immediately followed by additional statements, like “with vitamins” or “with B vitamins.”  Lifewater did not use the “all natural” language in a vacuum. Thus, it was impossible for plaintiff to allege how the “all natural” language would be deceptive without relying on the preempted statements regarding fruit names and vitamins.

In addition, the court concluded that no reasonable consumer would read the “all natural”
language as modifying the “with vitamins” language and somehow believe that the added vitamins are suppose to be “all natural vitamins.”  Moreover, to the extent there was any ambiguity, it was  clarified by the detailed information contained in the ingredient list, which explained the exact contents of Lifewater. In this case, the ingredient list was consistent with the front label statement of “all natural with vitamins.”

The court concluded that the challenge to the “all natural” language on Lifewater was not deceptive as a matter of law.

 

Class Action Complaint on 100% Natural Oil Dismissed

A federal court recently dismissed a proposed class action accusing a food company of misleadingly labeling cooking oils as 100% natural when they allegedly were made from genetically modified plants. Robert Briseno, et al. v. ConAgra Foods Inc., No. 2:11-cv-05379 (C.D. Calif.).

Quick research reveals that 88-94% of the nation’s crops of corn, soy and canola are grown from seeds that are the product of bioengineering.  There is no credible science that there are serious health issues with these products, and multiple peer reviewed studies on "GM" crops worldwide show farmers in underdeveloped countries have seen an increase in yield of about 29% from using them, along with decreased use of insecticide applications.

Plaintiff alleged that he regularly purchased Wesson Canola Oil, bearing labels that state the product is “100% Natural.” Plaintiff contended that contrary to these representations, ConAgra used plants grown from genetically modified organism seeds that have been engineered to allow for greater yield, and to be pest-resistant, to make Wesson-branded oils. He asserted that the genetically modified organisms are somehow not “100% natural,” and thus the labels and advertising are deceptive. Plaintiff filed a complaint seeking to represent a class of all persons in the United States who have purchased Wesson Oils from 2007 on. As is typical, he alleged
violation of California’s false advertising law (“FAL”), California’s unfair competition law (“UCL”), and California’s Consumer Legal Remedies Act (“CLRA”).

Defendant moved to dismiss. The first issue was preemption of the state law causes of action, based on FDA guidance regarding food labels. Federal preemption occurs, generally, when: (1) Congress enacts a statute that explicitly pre-empts state law; (2) state law actually conflicts with federal law; or (3) federal law occupies a legislative field to such an extent that it is reasonable to conclude that Congress left no room for state regulation in that field. Specifically, ConAgra argued that Briseno’s claims were preempted because the FDA has repeatedly concluded that bioengineered foods are not meaningfully different from foods developed by traditional plant breeding, and thus that the fact that a food product is derived from bioengineered plants need not be reflected on a product’s label. Plaintiff responded that he was not arguing that ConAgra was required to state whether its products were made from genetically modified plants. Rather, he contended that the decision to label its products “100% Natural” was misleading.

Courts have split on food preemption issues. Compare Dvora v. General Mills, Inc., 2011 WL 1897349 (C.D. Cal. May 16, 2011)(cereal-yes); Turek v. General Mills, Inc., 754 F.Supp.2d 956 (N.D. Ill. 2010)(snack bars-yes); Yumul v. Smart Balance, Inc., 2011 WL 1045555 (C.D. Cal. Mar. 14, 2011)(yes), with Lockwood v. Conagra Foods, Inc., 597 F.Supp.2d 1028 (N.D. Cal. Feb. 3, 2009)(pasta-no); Wright v. General Mills, Inc., 2009 WL 3247148 (S.D. Cal. Sept. 30, 2009)(granola bars-no).

Here, the court found no preemption on most of the complaint. The bulk of the complaint, said the court, alleged that use of the phrase “100% Natural” is misleading, and did not contend that additional information must be added to Wesson Oil labels. Regulations requiring that each product list its ingredients by their “common or usual name,” together with the regulations requiring that vegetable oils be denominated “ oil,” were inapplicable since plaintiff’s central argument was not that ConAgra cannot use the common or usual names of canola oil, vegetable oil or corn oil.

The FDA has expressed that it has no basis for concluding that bioengineered foods differ from other foods in any meaningful or uniform way, or that, as a class, foods developed by the new techniques present any different or greater safety concern than foods developed by traditional plant breeding. So, plaintiff, in essence, sought to create a distinction – between “natural” oils and those made from bioengineered plants when the FDA has determined that no such distinction exists. The court rejected this argument, refusing to read the FDA guidance as formal enough or clear enough on the issue.

Plaintiff did also seek an order requiring defendant to adopt and enforce a policy that requires appropriate disclosure of GM ingredients. Entering an order of this type would impose a
requirement that is not identical to federal law, and thus this particular prayer for such relief was preempted.

Rule 9(b) requires that in all averments of fraud or mistake, the circumstances constituting fraud or mistake shall be stated with particularity. The pleading must identify the circumstances constituting fraud so that a defendant can prepare an adequate answer to the allegations. While statements of the time, place and nature of the alleged fraudulent activities are often sufficient, mere conclusory allegations of fraud are insufficient. Even if fraud is not a necessary element of a claim under the CLRA and UCL, when a plaintiff alleges fraudulent conduct then the claim can be said to be grounded in fraud or to sound in fraud.

Plaintiff alleged that he regularly purchased Wesson Canola Oil for his own and his family’s consumption. But his complaint contained no allegations as to whether he became aware of the
representation through advertising, or labeling, or otherwise. He provided no information about how often he was exposed to the allegedly misleading statement. He did not allege how
frequently he purchased the product and over what period of time, whether he relied on
statements on canola oil labels, on a website, in advertisements, or all of the above,
whether the statements remained the same throughout the class period, or, if they did not, on
which label(s), advertisement(s) or statement(s) he relied.

Thus, this complaint did not afford ConAgra adequate opportunity to respond. Consequently, defendant's motion to dismiss was granted (without prejudice).


 

Chew on This: Consumer Fraud Claim on Snack Bars Preempted

The Seventh Circuit ruled earlier this month that federal food labeling law expressly preempts state law claims seeking certain additional health-related disclosures on chewy bars. Turek v. General Mills Inc., No. 10-3267 (7th Cir. 10/17/11).

The bars have been around since at least the early 1980's, but have grown into a nearly $2 billion segment of the food industry.  Consumers love their portability, and relatively low calorie count.

Plaintiffs brought a diversity class action suit under the Illinois Consumer Fraud and Deceptive Business Practices Act, and the Illinois Uniform Deceptive Trade Practices Act, alleging that the label of certain "chewy bars" was misleading regarding fiber content.  Specifically, the complaint alleged that the principal fiber, by weight, in the bars was inulin extracted from chicory root. The complaint describes inulin so extracted as a processed, "non-natural” fiber which was not as beneficial to consumer health as other fiber.

Those state law claims ran smack into a provision of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 343-1(a)(5), added by the Nutrition Labeling and Education Act of 1990, which forbids states to impose “any requirement respecting any claim of the type described in section 343(r)(1)
[of the Food, Drug, and Cosmetic Act] . . . made in the label or labeling of food that is not identical to the requirement of section 343(r).”  A state thus can impose the identical requirement or requirements, and by doing so be enabled, because of the narrow scope of the preemption provision in the Nutrition Labeling and Education Act, to enforce a violation of the Act as a violation of state law. See also In re Pepsico, Inc. Bottled Water Marketing and Sales Practices Litigation, 588 F. Supp. 2d 527, 532 (S.D.N.Y. 2008); “Beverages: Bottled Water,” 60 Fed. Reg. 57076, 57120 (Final Rule, Nov. 13, 1995). This is important because the Food, Drug, and Cosmetic Act does not create a private right of action. Medtronic, Inc. v. Lohr, 518 U.S. 470, 487 (1996).

The question thus became what requirements the federal law imposes on the labeling of dietary fiber. Section 343(q)(1) of the Act contains a requirement that the “label or labeling” of food products intended for human consumption state “the amount of . . . dietary fiber . . . contained in each serving size or other unit of measure.” Other requirements for labeling claims relating to dietary fiber are set forth in implementing regulations.  

The labeling of the products challenged by the plaintiff was compliant with these regulations relating to health claims for dietary fiber. See, e.g., 21 C.F.R. § 101.76. All the FDA’s requirements relating to labeling dietary fiber are requirements to which any labeling disclosures required by a state must be identical.  But the disclaimers that the plaintiff wants added to the labeling of the defendants’ inulin-containing chewy bars were not identical to the labeling requirements imposed on such products by federal law, and so they were barred, held the court of appeals. The information required by federal law does not include disclosing that the fiber in the product includes inulin or that a product containing inulin allegedly produces fewer health benefits than a product that contains only product that contains only “natural” fiber, for example. 

Even if the disclaimers that the plaintiff wants added would be "consistent" with the requirements imposed, importantly, consistency is not the test. Identity is, said the court.

The Seventh Circuit thus affirmed dismissal of the case. But clarified, procedurally, that when a state law claim is expressly preempted under section 403A of the Federal Food, Drug, and Cosmetic Act,” a dismissal on the merits is the proper outcome, with prejudice like other merits judgments, not dismissal for want of federal jurisdiction, as the district court had ordered.

This is a victory for consumers when one considers why Congress did not want to allow states to impose disclosure requirements of their own on packaged food products, most of which are sold nationwide. Manufacturers might have to print 50 different labels, driving consumers who buy the food products crazy. A granola bar you buy in California ought to look just like the one you buy in Maine.

 

Class Action Claims Against Labeling of Snack Food Preempted

Last week, a federal district court held that federal food labeling law does preempt state law claims attacking the use of phrases such as “0 Grams of Trans Fat” on snack food packaging. See Peviani v. Hostess Brands Inc., No. 2:10-cv-02303 (C.D. Cal., 11/3/10).

 In this putative class action, plaintiffs alleged that the defendant used misleading and deceptive statements to market the "Hostess 100 Calorie Packs" baked goods. In particular, plaintiffs alleged that the label noting "0 Grams of Trans Fat" was inconsistent with the products containing partially hydrogenated oils (PVHO).  Plaintiffs alleged that PVHO is linked to various health problems, and therefore is supposedly a "dangerous trans fat."

Plaintiffs alleged they purchased the 100 Calorie Pack foods relying on the no trans fat claim.  They asserted false advertising under the Lanham Act, violations of the California Unfair Competition Law, the California False Advertising Law, and the Consumer Legal Remedies Act. The two classes proposed were a restitution and damages nationwide class of those that purchased the foods, and an injunctive relief class of those who commonly purchase such foods.

Defendants filed a motion to dismiss, arguing that the claims were preempted by federal law.  The  court noted that the FDCA sets forth a comprehensive federal scheme for the regulation of food. In 1990, Congress passed the Nutrition Labeling and Education Act, 21 U.S.C. 341, which clarified FDA's authority to require and regulate nutrition labeling on food.  Two provisions directly apply to use of phrases like "0 Grams of Trans Fat."  One provision requires the labeling in the Nutrition Facts Panel to include the amount of saturated fat and total fat in each serving; and this regulation requires that if a serving contains less than 0.5 grams of trans fat, the amount "shall be expressed as zero."  Second, a regulation permits certain nutrient claims outside the Facts Panel about the level or range of a nutrient in the food, such as sodium, or calories or fat.  The NLEA permits such a statement as long as it is not false or misleading. 21 U.S.C. §§ 343(q) and (r).

The court noted that laws regulating the proper marketing of food are within the states' historic police powers, and thus subject to a presumption against preemption.  Nevertheless, consumer protection laws, such as those invoked here, are nonetheless preempted if they seek to impose requirements (through their use in litigation) that contravene the provisions of the federal law.  The NLEA contains an express preemption clause relating to any requirement  in state law that is not identical to the federal provisions.  But the court noted that implied preemption can accompany express preemption, as the essential inquiry always remains the substance and scope of Congress' intent to displace state law.

Plaintiffs alleged that the trans fat label outside of the Nutrition Facts Panel was an express nutrient content claim, and was false and misleading.  But the court noted that the FDA has declined to promulgate any regulation as to whether actual values must be used in labeling or rounded values may be used. In fact, the FDA has said that the difference between actual and rounded values are nutritionally insignificant, and thus either value relays the same basic information.  Here, since the phrase "0 grams of Trans Fat" is not false or misleading when used in the Nutrition Facts Panel, defendant's use of the exact same phrase elsewhere on the product label cannot be found false or misleading. If 0 and less than 0.5 grams mean, nutritionally, the same thing in the important Panel section, use of the exact same claim could not be misleading elsewhere on the label.

In essence, plaintiffs were trying, under state law, to enjoin on the label the use of the very phrase that federal law permits on another part of the label.  Plaintiffs' claims failed because they would impose a state law obligation for trans-fat disclosure that is not required by federal law.  (The plaintiffs' federal claim, for false advertising under the Lanham Act, failed for lack of standing,.)

The decision echoed Chacanaca v. Quaker Oats Co.,  No. 5:10-cv-00502 (N.D. Cal., Oct. 14, 2010), which dismissed similar claims over the phrase “0 Grams Trans Fat” on preemption grounds.

These types of claims illustrate the lengths to which plaintiffs are going to attack the food and beverage industries.  No one was sick from the snacks, which were labeled in exact accordance with explicit federal requirements.  Yet, a multi-count claim is brought in state court, with the legal theory that, in essence, federally approved language in one part of a food label is false and misleading under state law when it appears in another part of the same label. This is not about helping consumers.  How could it benefit consumers and clarify the information they have to make their own free and individual purchase decisions (with all the factors that go into what we decide to buy and eat) if the FDA-approved language in the Nutrient Facts Panel is allowed to be called false and misleading by a state court jury in California?


 

Gulf Oil Spill Litigation

More than 100 federal and state court actions have been filed against BP PLC, Transocean Ltd., and other companies in connection with the Deepwater Horizon drilling rig accident in the Gulf of Mexico.  (The API has a Q&A on the accident, and the Unified Command on the incident offers updates.)  Like many mass accident scenarios, the spill has generated a variety of kinds of actions. The claims so far fall into several main categories, including personal injury/wrongful death, maritime torts, property damage/lost profits, shareholder claims, and environmental law actions.

The wrongful death actions arise from the 11 workers missing and presumed dead in the accident.  These cases were filed in federal and state courts in Louisiana and Texas.  Gulf-front property owners, fishermen, shrimpers, harvesters, seafood processors, and restaurants in Louisiana, Alabama, Mississippi and Florida are among the entities suing over alleged harm to their businesses and their economic livelihoods. Many of these suits are class actions with overlapping class definitions.  The plaintiffs typically allege that defendants knew of the dangers associated with deepwater drilling and failed to take appropriate safety measures to prevent damage to marine or coastal environments, where they work and earn their income.

These claims potentially implicate caps on damages under the Limitation of Liability Act, and the Oil Pollution Act, which currently caps certain oil spill liability at approximately $75 million.  Plaintiffs have asserted that there are various exemptions from this reach of the Oil Pollution Act, for gross negligence and certain cleanup costs.  Also, the Obama administration and Democrats in Congress have advocated raising the caps retroactively. Bills S. 3305  (the so-called Big Oil Bailout Prevention Liability Act of 2010) and H.R. 5214 would raise the liability for economic damages to $10 billion per spill from the current $75 million. In a Senate hearing, Interior Secretary Ken Salazar warned that raising the trust fund's liability cap to $10 billion would prevent smaller and mid-sized energy companies from operating offshore. Perhaps most importantly, there is some case law suggesting that the Oil Pollution Act will not preempt state common law tort liability.

The administration is also proposing a tax increase, to support the Oil Spill Liability Trust Fund, of a further 1 cent per barrel on petroleum. It is interesting that the administration has been criticized for the slowness of some of its responses to the spill, but is very quick to propose tax hikes, without an opportunity for all stakeholders to be heard and without careful consideration of the availability of the fund for future incidents. A White House summary of its proposals for legislation on oil spill response is available.

Some plaintiffs have proposed that the federal cases be coordinated in an MDL proceeding in the Eastern District of Louisiana.  In Re Oil Spill by the Oil Rig Deepwater Horizon in the Gulf of Mexico on April 20, 2010, MDL No. 2179 (filed 4/30/10). Certain defendants have suggested instead that the Southern District of Texas host the MDL. A large group of plaintiffs' attorneys had met in New Orleans early in the month to plot out litigation strategy.  Interestingly, the Mississippi Bar issued a statement advising potentially affected parties of the risk of improper solicitation by plaintiff attorneys.It will be fascinating to see if the defendants can remain similarly coordinated and avoid unnecessary finger-pointing.  The testimony of various executives for BP Plc, Transocean Ltd., and Halliburton in front of the Senate Energy and Natural Resources Committee and the Senate Environment and Public Works Committee that pointed out the responsibilities of the other companies, raises this issue. 

Another type of pending action is by various shareholders alleging securities fraud in a class action that asserts that defendants made false and misleading statements about their safety procedures. Allegedly as a result of the statements and the company's supposed failure to disclose prior safety issues, the stock prices had been inflated, tumbling after the accident.  Several shareholder derivative lawsuits were also filed against certain officers and directors of the defendants, claiming that they breached their fiduciary duties by supposedly ignoring critical safety issues. The suits also allege that defendants lobbied governmental authorities to reduce the extent of safety  regulation of the companies' gulf operations. (one would think that was protected speech)

Some litigation has named Interior Secretary Salazar and the U.S. Department of the Interior for their oversight of off-shore drilling operations. These case point to the rules regulating the oil companies' blowout and worst-case oil spill preparations.  Some have gone so far as to seek a halt to BP's operations at other oil drilling platforms.  Still others have focused on the oil companies' environmental impact statement posture as in violation of  the National Environmental Policy Act, and their seismic surveys and drilling operations as in violation of the Marine Mammal Protection Act and the Endangered Species Act.

Democratic Senators are pressuring the Justice Department to to open a criminal probe into the accident, and BP's statements to the federal government regarding its ability to respond to oil spills. Earlier this month, Florida Gov. Crist appointed two former Florida state attorneys general to head a newly formed legal team that will represent the state on issues related to the spill.

 

Supreme Court Grants Cert. In Vaccine Case

A case to watch:  earlier this month the Supreme Court granted certiorari in Bruesewitz v. Wyeth, 2010 WL 757696, which raises important issues under the National Childhood Vaccine Injury Act of 1986 (“Vaccine Act”) , 42 U.S.C. §§ 300aa-1 et seq.  The Act expressly preempts state law claims against vaccine manufacturers if the injury or death giving rise to such a claim results from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warning. 

But the lower courts have split on the meaning of that provision. Does the Vaccine Act preempt all design defect claims against vaccine manufacturers, or must the preemption of particular design claims be decided on a case-by-case basis?

In this case, the 3rd Circuit correctly held that the Vaccine Act preempts all design defect claims,  including negligence and strict liability design claims. 561 F.3d 233 (3d Cir. 2009). The Georgia Supreme Court, by contrast, is  one court that had previously held that a design defect claim is not preempted unless the manufacturer demonstrates, on case-by-case basis, that there was no safer design that could have avoided the injury giving rise to the claim. Am. Home Prods. Corp. v. Ferrari, 668 S.E.2d 236 (Ga.2008).

One of the many ways that the Ferrari court's construction is contrary to the structure of the Act and intent of Congress is that it does not necessarily bar any design defect claims. If the court interpret the Vaccine Act to allow case-by-case analysis of whether particular vaccine side effects are avoidable, then every design defect claim is subject to evaluation by a court, and theoretically every one of them could be found not-preempted by the state courts around the country. That clearly is not what Congress meant. 
 

BPA Litigation Update- Part I

In the BPA MDL, Judge Ortrie D. Smith granted in part and denied in part defendants’ motions to dismiss various claims. In re: Bispehnol-A Polycarbonate Plastic Products Liability Litigation, MDL No. 1967 (W.D. Mo.).

Readers of MassTortDefense will recall that last year the Judicial Panel on Multidistrict Litigation centralized fourteen cases; since then, the Panel has continued to transfer cases from around the country, so now about thirty-eight cases have been transferred. In addition, approximately ten cases have been filed in the MDL District and have become part of the consolidation. Defendants roughly fall into two categories: the Bottle Defendants and the Formula Defendants. Generally, the Bottle Defendants make baby bottles, sippy cups and similar products for infants and toddlers, and/or sport bottles. The Formula Defendants sell infant formula packaged in metal cans.

Most of the complaints assert, on behalf of consumers, various causes of action including: (1) violation of state consumer protection laws, (2) breach of express warranty, (3) breach of the implied warranties of merchantability and fitness for a particular purpose, (4) intentional misrepresentation, (5) negligent misrepresentation, and (6) unjust enrichment.

In one Order the court began by addressing the motions to dismiss claims for fraud, misrepresentation and breach of express warranties. The MDL court had previously, mindful of Rule 9, required plaintiffs to identify defendants’ alleged statements that form the basis for their claims of fraud, misrepresentation, and breach of express warranties. Plaintiffs’ continued failure to do so was, said the court, now fatal to these claims. Likely because they were unable to comply, and perhaps because they recognized what compliance would do to their already slim chances for class certification (because of the individual issues that a response would highlight), plaintiffs responded to the aforementioned requirement by saying that they had not identified any advertisements or other media because the allegations are not based on any particular representations. A misrepresentation claim not based on any misrepresentation. Rather, plaintiffs’ allegations are based on defendants’ supposed “overall course of conduct” in marketing and selling the products at issue. Taken as a whole, defendants’ alleged “overall course of conduct” somehow deceptively conveyed the impression or message that the products at issue are safe and healthy for use by infants and children.

By disclaiming reference to any particular fraudulent act, plaintiffs had disclaimed one of the essential elements of a fraud or misrepresentation claim. All states require proof of reliance and causation. For a statement to be relied upon and thus cause a purchaser’s injury, the statement must have been heard by the purchaser. Plaintiffs’ theory – that the placement of a product in a stream of commerce alone somehow conveys a sufficient representation about the product’s safety that can serve as grounds for fraud liability – is a rule that has not been demonstrated to exist in any of the fifty states.

Allowing the mere sale of products to convey an affirmative representation regarding safety would eviscerate the law of warranty and be contrary to the rationale supporting the limited circumstances in which actions constitute representations, noted the court.  Plaintiffs’ failure to identify any expressions made by defendants to them about their products precludes any claim that an express warranty was made, let alone violated. Given the absence of any “affirmation of fact or promise,” (see UCC Article 2-313), plaintiffs cannot allege an express warranty was made. The Supreme Court’s decision in Iqbal requires a plaintiff to identify the basis for, if not the content of, the alleged warranty. And, in a related issue, plaintiffs’ were thus unable to allege how the supposed, non-existent, warranties became “part of the basis of the bargain.”  A representation cannot be part of the “bargain” if the other party to the bargain did not know the representation was made! Merely alleging a representation became part of the bargain does not satisfy Iqbal. If one party (here, the buyer) is not aware of the statement, that party cannot claim the statement became a part of the parties’ bargain.

The court declined to dismiss the claims for fraudulent omissions, based on what it called a “common-sense” view of Rule 9 under which it was unnecessary to require plaintiffs to specifically identify who failed to disclose information and each occasion upon which they failed to disclose it. Rule 9 is satisfied, said the court, with respect to a claim of fraudulent omissions if the omitted information is identified and “how or when” the concealment occurred.

The claim for breach of implied warranty of fitness for a particular purpose was dismissed because while the ordinary purpose for baby bottles can be described as to allow babies and toddlers to drink liquids, a plaintiff cannot rely on this ordinary purpose to support a claim that there was a warranty of fitness for a particular purpose; they must point to some other purpose that is not “ordinary” in order to support their claim.

The court put off ruling on the claims for breach of the implied warranty of merchantability because defendants’ arguments (including lack of privity, untimeliness, and failure to provide notice), seemed premised on the unique characteristics of various states’ laws. Thus, they seemed more amenable to analysis at the time of any class certification decision, which will inevitably raise choice of law issues. A similar deferral was applied to dismissal of all unjust enrichment claims. Many of defendants’ arguments seemed to depend on unique aspects of various states’ laws, found the court.

Defendants also made a strong argument that the claims, at bottom, were improper “no injury” claims. The court agreed as to the category of plaintiffs who disposed of or used up the products before learning about BPA. They received all the benefits they desired and were unaffected by defendants’ alleged concealment. Importantly, the court recognized that while they may contend they would not have purchased the goods had they known more about BPA, these plaintiffs received 100% use (and benefit) from the products and have no quantifiable damages. In this instance, plaintiffs’ position “leads to absurd results.”  These buyers obtained the full anticipated benefit of the bargain. While they may not have paid the asking price, had they allegedly known, offset against this is the fact that they received the full benefits paid for – leaving them with no damages. Plaintiffs here may allege they would not have purchased those products had they supposedly known the true facts, but, again, they obtained full use of those products before learning the truth: the formula was consumed or the children grew to an age where they did not use bottles and sippy cups, so they were discarded. These consumers thus obtained full value from their purchase and have not suffered any damage. These plaintiffs are relegated to the unjust enrichment claim.

The court distinguished, however, those plaintiffs who learned about BPA’s presence and potential effects and either still have the goods or subsequently replaced or disposed of them. Defendants’ argument does not apply to this category, found the court.

That left before the court only plaintiffs’ claims that defendants made fraudulent omissions, violated various state consumer protection statutes, breached the implied warranty of merchantability, and that defendants were unjustly enriched. With these remaining claims pending, the court, in a second order, granted in part defendants’ motion to dismiss on the basis of preemption and denied their motion to dismiss on the ground of primary jurisdiction.

Defendants’ preemption and primary jurisdiction arguments were generally alike in that they both contend their use of BPA should only be subject to regulation by the FDA. Indeed, FDA has issued regulations prescribing the conditions for “safe” use of resinous and polymeric coatings, allowing the coatings to be formulated from “optional substances” that may include “[e]poxy resins” containing BPA. Thus, BPA’s presence in some resinous and polymeric coatings and in polycarbonate resins is subject to regulation by the FDA. It is also a fair reading of FDA’s regulations authorizing BPA’s use that the FDA thinks that food additives containing BPA could be used safely without labeling requirements.

The doctrine of primary jurisdiction applies when enforcement of a claim that is originally cognizable in the courts requires the resolution of issues which, under a regulatory scheme, have been placed within the special competence of an administrative body. The FDA clearly has specialized expertise and experience to determine whether BPA is “safe.” However, said the court, the ultimate issues in these cases, as alleged by plaintiffs, are whether defendants failed to disclose material facts to plaintiffs and thus, for example, whether defendants breached the implied warranty of merchantability through the sale of products containing BPA. FDA’s decision that BPA is “safe” is not determinative of any of those issues, said the court. This conclusion seemed to give insufficient attention, in our view, to the argument that plaintiffs have predicated their claims on proof that BPA is allegedly unsafe: the undisclosed facts are not material unless BPA is not safe. The products are not unmerchantable unless BPA is unsafe, Since plaintiffs base their claims on such evidence, the claims seemed to fall within the primary jurisdiction of the FDA.  The MDL court did not agree.

Turning to the preemption issue, the court first rejected the claim of implied preemption. While noting that FDA has approved BPA use in food additives and noting the agency’s decision not to require labeling, the court concluded that the FDA’s approval of BPA as safe without labeling requirements establishes only a regulatory minimum; nothing in these regulations either required or prohibited defendants from providing the disclosures sought. The court cited Wyeth v. Levine for the proposition that that there is no preemption when federal law did not prevent the drug manufacturer from strengthening its drug label as necessary to comply with the standard to be imposed by state law.

However, the Formula Defendants also raised express preemption; they asserted that the FDA regulations exempt Formula Defendants from having to disclose the presence of BPA in their products. Express preemption exists when a federal law explicitly prohibits state regulation in a particular field. With respect to food labeling, federal law generally prohibits states from establishing any differing requirements for the labeling of food. Thus, plaintiffs’ claims are expressly preempted because they would impose disclosure requirements concerning BPA, the exact opposite of the exemption. Now, here is the interesting twist: plaintiffs asserted that Congress also provided an exception to express preemption under the law for “any requirement respecting a statement in the labeling of food that provides for a warning concerning the safety of the food or component of the food.”  But, the court noted, plaintiffs cannot have it both ways.  If their claims are based on warnings about the safety of food, then their claims would have been subject to dismissal under the primary jurisdiction doctrine because the determination whether BPA is “safe” is solely the province of the FDA, and the FDA has concluded that the use of BPA in epoxy liners is “safe” so long as the manufacturer abides by the FDA’s prescribed conditions. See 21 C.F.R. § 175.300 (2009).  If the claims against the Formula Defendants are not subject to primary jurisdiction, as plaintiffs argued, then they are subject to express preemption analysis.

It may seem clear to readers of MassTortDefense that even with respect to those claims the court concluded should not be dismissed on the pleadings, the court's analysis highlights several issues that may make it difficult for the plaintiffs to proceed as a viable class action. 

 

Senate Holds Hearing On Medical Device Safety Bill

The Senate Health, Education, Labor, and Pensions Committee last week held a hearing on the Medical Device Safety Act of 2009 (S. 540), which if enacted would overturn the Supreme Court's interpretation of the Medical Device Amendments (MDA) to the Federal Food, Drug, and Cosmetic Act in Reigel v. Medtronic.  The Supreme Court ruled that the MDA bars state law product liability claims against medical device companies based on alleged defects in products that had received approval through FDA's stringent premarket approval (PMA) process. The PMA process is used only in class III devices—devices FDA deems to be “high risk,” like pacemakers. The devices that are marketed as PMAs represent cutting edge science and are critical to public health.
 

We have posted on this legislation before here at MassTort Defense.  In addition to ignoring the important benefits of a uniform federal standard and the chaos of allowing devices to be regulated by litigation, the bill would would stifle innovation in the medical device industry and result in lost jobs, especially at smaller device companies. Obviously the bill is favored by overzealous trial lawyers and the legislators they support.

Testifying at the hearing were a variety of supporters of the bill, including academics who argued that preemption deprives victims of their right to compensation from the wrongdoers who injured them -- without convincingly responding to the concerns that would be raised by the new regime which allow juries throughout the country not only to impose requirements that are inconsistent with FDA determination, but that differ from one state court to another. The witness panel had no representative from the device industry.

The legislation would take away primary responsibility for device safety from the FDA and put it in the hands of lay jurors who have little to no understanding to the science involved, and who will listen to plaintiff's lawyers arguing about a single alleged injury without regard to the many of patients potentially safely aided by the device. Democratic supporters argued that no matter how diligently and effectively the FDA does its job, it simply cannot "guarantee that no defective, dangerous, and deadly medical device will reach consumers." The notion that any regulatory regime can "guarantee" defect-free products is misguided.  And to think that lay juries will do a better job of balancing product risks and benefits is foolish. Risk is inherent in all medical devices, and small numbers of patient injuries does not mean a device is defective.
 

The Advanced Medical Technology Association (AdvaMed) has urged Congress to reject the legislation, noting it would increase health care costs and decrease patient access to life-saving medical technology.  As the debate is ongoing about health care reform, legislation that will create more litigation, increase health care costs, and render it harder for medical device manufacturers to invest in promising new technology, hardly seems wise.

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Presidential Memo On Preemption Sends A Warning

Along with my partner Andy Gaddes, I taught a recent CLE seminar on products liability issues.  One of the topics the attendees -- in-house counsel from a variety of industries -- were most interested in was President Obama's May, 2009 memorandum to federal agencies reversing the Bush administration's well-reasoned preemption policy.
 
The new policy is contained in a memo, not a formal executive order, but it clearly expresses a new view of preemption. Cloaked somewhat ironically in the guise of "state's rights", the policy comes from an administration that apparently has no trouble expanding the role of the federal government in unprecedented ways, taking over the auto companies, banks, and others.
 
The memo provides that heads of departments and agencies should not include in regulatory preambles statements that the department or agency intends to preempt State law through the regulation except where preemption provisions are also included in the codified regulation.  Heads of departments and agencies should not include preemption provisions in codified regulations except where such provisions would be justified under the Administration's new interpretation of the legal principles governing preemption.  Finally, heads of departments and agencies should review regulations issued within the past 10 years that contain statements in regulatory preambles or codified provisions intended by the department or agency to preempt State law, in order to decide whether such statements or provisions are justified under the new interpretation of the applicable legal principles governing preemption.
 
The legal basis of the doctrine is not really that malleable. Federal preemption is derived from the supremacy clause of the Constitution that says federal law is the supreme law of the land and any conflicting state law or regulation is without effect.  The policy basis of the doctrine is equally clear: allowing each state to set diverse and individual safety standards can undercut needed uniformity and can subject manufacturers to expensive, unfair, and confusing requirements. It forces product sellers to potentially navigate a confusing, often contradictory patchwork quilt of up to 50 sets of laws and regulations.  Of course, the preemption issue affects more than traditional administrative regulation by the states: companies may become subject to regulation by litigation at the hands of the plaintiffs' bar. 
 
The new policy has the potential to create a real chilling effect in agencies that should be clear about the preemptive intent and reach of their regulations.  While the Obama administration claims its approach breaks no new ground, it may well fundamentally weaken the federal government's ability to address problems on a national level and thus may have untended consequences by allowing states to interfere with parts of the Obama administration's domestic agenda. Regulations for health care and climate change, for example, arguably cannot work absent preemption.
 
Preemption has been applied to drugs and medical devices, vehicular roof crush standards issued by the National Highway Traffic Safety Administration, mattress flammability standards issued by the Consumer Product Safety Commission, pesticides regulated by the EPA and a variety of other products.  A majority of the regulations containing preemptive language were issued by the FDA and NHTSA.   
 

 

FEMA Trailer MDL Decision on Preemption

The federal court overseeing the MDL involving trailers issued by the U.S. government following Hurricane Katrina has dismissed some of the plaintiffs' state law claims against mobile home manufacturer defendants, on the basis of the federal preemption doctrine. In Re: FEMA Trailer Formaldehyde Products Liability Litigation, MDL No. 1873 (E.D. La.)

As readers of MassTort Defense know, Hurricane Katrina impacted much of the Gulf Coast in August 2005, and Hurricane Rita followed in September 2005, causing extensive damage along the Louisiana and Texas coasts. In the wake of the hurricanes, many individuals whose homes were lost or damaged moved into temporary housing provided by FEMA. Plaintiffs allege that these trailers exposed residents to high levels of the chemical formaldehyde, about which they were not warned. The Judicial Panel on Multidistrict Litigation consolidated a number of suits against defendants, including the federal government and several trailer manufacturers, over the alleged formaldehyde exposure in 2007.

Judge Kurt Engelhardt of the U.S. District Court for the Eastern District of Louisiana last week granted the manufacturer defendants' motion to dismiss certain state law claims. The defendants asserted that the construction of these mobile homes was regulated by the Manufactured Home Construction and Safety Standards Act, 42 U.S.C. § 5401 et seq., (“the MHA”) and the regulations promulgated by the United States Department of Housing and Urban Development (“HUD”), pursuant to 24 C.F.R. § 3280 and § 3282 (“the HUD Code”). Pursuant to the MHA, HUD established the Manufactured Home Construction and Safety Standards (“MHCSS”), 24 C.F.R § 3208 et seq., which govern the standards for formaldehyde emissions from materials used in manufactured homes. This regulation expressly and specifically dictates the maximum level of formaldehyde gas that component products in mobile homes can emit. The regulations also specify that a health notice on formaldehyde emissions shall be temporarily displayed in the kitchen of each manufactured home.Accordingly, the defendants asserted that the federal statutes and regulation in the MHA and the HUD Code explicitly and impliedly preempt plaintiffs’ state law claims against them.

As several courts have previously noted, the MHA does not explicitly preempt state causes of action. Turning to implied preemption, the court noted that implied preemption exists when state law regulates conduct in a field Congress intended the Federal Government to occupy exclusively (also referred to as “field preemption”), or when state law actually conflicts with federal law (also referred to as “conflict preemption”). Conflict preemption exists in two scenarios: (1) when compliance with both a state and federal law is impossible, and/or (2) when the state law conflicts with the federal law such that it stands as an obstacle to the achievement of the federal law’s purposes and objectives.

After analyzing the statute and regulations, the MDL court concluded that if plaintiffs in the instant case were allowed to go forward with their state product liability claims raising the ambient air standard, then defendants in the mobile home industry would essentially be required to deviate (in ways variable from state to state) from those federal standards so carefully and thoroughly crafted by HUD. The MHA clearly states that if states want to regulate safety matters that federal law already covers (like formaldehyde emissions), those regulations must be “identical.” 42 U.S.C. § 5403(d). Furthermore, it was noteworthy that the plaintiffs contend that the moving defendants should have adhered to the ambient air standard, which differs from the HUD-accepted component products standard. Thus, cases that present situations where the plaintiffs are not arguing that the defendants should have adhered to a standard higher than, or different from what the MHA imposes, are inapplicable.

The court concluded similarly that any such claims relating to inadequate warnings of exposure
to purportedly high levels of formaldehyde contained in the units, that require more than the federal
label standards, should be dismissed. However, any of plaintiffs’ state law claims that advance non-compliance with federal formaldehyde regulations (to the extent that such claims exist) are considered to be parallel claims, are not preempted and, thus, are not dismissed. See Riegel v. Medtronic, Inc., 128 S.Ct 999, 1011 (2008).

Administration Releases Memorandum On Preemption

The Democratic assault on the preemption doctrine has taken its next step with the release last week by the White House of a Presidential memorandum which restricts federal agency statements on preemption and directs those agencies to review preemption pronouncements made in the past decade under the Bush Administration.


Ironically, the directive ostensibly rests on the grounds of States rights: noting State law and national law often operate concurrently to provide independent safeguards for the public, and that throughout our history, State and local governments have frequently protected health, safety, and the environment more aggressively than has the national government.  “An understanding of the important role of State governments in our Federal system is reflected in longstanding practices by executive departments and agencies, which have shown respect for the traditional prerogatives of the States,” argues the memorandum.

The memorandum comes two months after the Supreme Court’s ruling on preemption in the context of drugs in Wyeth v. Levine, and concurrently with democratic efforts in Congress to overturn Medtronic v. Riegel in the medical device context.


The memorandum sets for the general policy of the new Administration that preemption of State law by executive departments and agencies should be undertaken only with full consideration of the “legitimate prerogatives of the States and with a sufficient legal basis for preemption.” Specifically, it orders that agencies should not include in regulatory preambles statements that the department intends to preempt State law through the regulation except where preemption provisions are also included in the codified regulation. Also, agencies should not include preemption provisions in codified regulations except where such provisions would be justified under the (presumably re-assessed) legal principles governing preemption.

Finally, departments should review regulations issued within the past 10 years that contain statements in regulatory preambles or codified provisions intended by the agency to preempt State law, in order to decide whether such statements or provisions are justified under (again, re-interpreted) applicable legal principles governing preemption. Where the head of a department or agency determines that a regulatory statement of preemption or codified regulatory provision cannot be so justified, the head of that department or agency should initiate appropriate action, which may include amendment of the relevant regulation.


The memorandum is a political statement as much as a legal document, and is consistent with President’s Obama’s comments while a candidate. As it eventually evolves into specific agency statements and policy, it promises to create a hodge-podge regulatory quilt, under which business will struggle with product safety decisions which will comply with federal, national standards, be upheld in some state jurisdictions, but nevertheless be subject to review by lay juries in others.

 

White Paper Explains Detrimental Impact of Proposed Medical Device Anti-Preemption Bill

Much of the debate over the preemption doctrine, certainly in the media and even in many legal circles, has focused on the alleged inadequacy of the FDA to regulate drugs and devices, and the purported consequent  need to have state juries of lay people “police” the health industry. Comparatively little attention has been given to the other impacts of eliminating federal preemption.

A new white paper demonstrates that erasing this doctrine would decrease access to life-enhancing medical devices, increase health care costs, and reduce medical device industry employment. Congressional Democrats are seeking to do just this in the device context -- the Medical Device Safety Act of 2009 was crafted in response to the U.S. Supreme Court's 8-1 ruling in February, 2008 in Riegel v. Medtronic, upholding preemption for certain medical devices when the devices, and their warning labels, had been approved by the U.S. Food and Drug Administration.


The Economic Impact of Eliminating Federal Preemption for Medical Devices on Patients, Innovation and Jobs” was authored by Ernst Berndt, professor in applied economics at MIT's Sloan School of Management, and Mark Trusheim. They argue that among the effects of the bill would be:

 • Reduced patient access to products and the health benefits they provide

• Unreliable, variable patient access to products and the health benefits they provide as varying state regulations and tort liabilities discourage or eliminate products in some regions but not others

• Increased medical costs and lower net public health compared to what could be achieved with increased medical device innovation and product introductions

• Increased defensive medical practices by physicians to avoid possible litigation, raising health costs and exposing patients to greater risks from the added unnecessary procedures

• Reduction in the number of products being developed as manufacturers and their investors respond to greater uncertainty regarding product approval and economic sustainability

• Transfer of health regulatory decisions to untrained, non-expert juries who are exposed to only a biased fraction of the scientific fact base on which to base their decisions


The authors compare the bill to what happened with vaccines: from 1967 to 2004 the number of vaccine makers plummeted from 26 to 3, leading to reduced access, higher costs, no new products, shortages of existing products, a fragile vaccine supply chain, reduced employment and increases in preventable illness. Congress had to step in and take the vaccines out of the traditional tort system.

Under the bill, the authors note, state juries would be asked to render decisions regarding device safety and efficacy based on a limited range of information focused on individual risk versus broad benefit at a trial typically lasting at most several weeks. Allowing state tort suits to do this will place state juries in the position of replacing, by overriding, professionally trained federal regulators in evaluating and quantifying the risks of medical devices. And unlike federal regulators, state juries will not balance, perhaps not even consider, the benefits to those for whom the medical devices enhances health and quality of life -- who of course are not parties to the action.
 

Justice Souter To Resign -- A Mass Tort Perspective

Justice David Souter plans to retire from the Supreme Court when the current term ends in June. This announcement, and the inevitable speculation about the identity and judicial philosophy of his replacement, makes one wonder about the impact of the impending change on those of us in the mass tort and products liability field.

What jumps to mind? In the field of mass torts, Justice Souter authored the majority opinion in Ortiz v. Fibreboard Corp., 527 U.S. 815 (1999), the decision rejecting a Rule 23(b)(1)(B) limited fund settlement class action in the asbestos mass tort litigation. After Ortiz, non-opt-out settlement class actions became difficult as a potential mass tort settlement mechanism, particularly as a potential vehicle for resolving future claims in mass torts.

Justice Souter, writing for a 5-3 majority, also authored the landmark ruling limiting punitive damages in the long-running Exxon Valdez saga. The Supreme Court overturned a $2.5 billion punitive damages award assessed against Exxon for the 1989 Valdez oil spill, holding that the award was excessive under (maritime) common law. See Exxon Shipping Co. v. Baker, 128 S.Ct. 2605 (2008). Justice Souter stated that, under maritime law, the upper limit for punitive damages is a 1:1 ratio to compensatory damages. Although the Court’s ruling was limited to maritime cases, its reasoning was not.

According to Souter, punitive damage awards, along with runaway juries and a lack of legislative standards, have led to unpredictable outcomes and outlier awards. The Court found that the best way to cure the defect was to impose a 1:1 ratio of punitive to compensatory damages as the upper limit for punitive damages. His infamous footnote 17, however, referenced “a body of literature” that documented the unpredictability of punitive damages. But then, somewhat puzzlingly noted that: “Because this research was funded in part by Exxon, we decline to rely on it.”  Court observers have speculated on why he bothered to refer to the literature if he wasn't going to rely on it. Of course, there are times – particularly in long running mass torts -- when litigants pay for relevant empirical studies that are used in litigation, in part because often the litigants are the only ones with enough at stake to pay for expensive research studies.  And both sides do it.


In the area of preemption, Justice Souter joined the majority in Riegel v. Medtronic, Inc., 128 S.Ct. 999 (2008), holding that the preemption clause of the Medical Device Amendments of 1976 (21 U.S.C. § 360k(a)) bars common-law claims challenging the safety or efficacy of a medical device marketed in a form that has received pre-market approval from the FDA. However, he sided with the anti-preemption forces in Altria v. Good, 129 S.Ct. 538 (2008), to form a narrow 5-4 majority holding that federal law doesn't preempt cigarette makers from state law suits accusing them of deceiving consumers by marketing "light" or "low tar" cigarette brands. This despite extensive regulation of the “lights” area by the Federal Trade Commission, dating to the 1960’s, and the Congressional mandates on labeling in the Federal Cigarette Labeling and Advertising Act of 1965. Similarly, Justice Souter sided with the majority in the recent Levine v. Wyeth, 129 S.Ct.  1187 (2009) decision, finding that FDA actions had not preempted a state law claim concerning warnings about the side effects of the drug Phenergan.  The effects of that decision are yet to be felt, but the majority risked creating a hodge-podge of inconsistent state-based regulation of drugs (through jury verdicts) that need a consistent, national regulatory approach. 


 

Preemption Decision in Wake of Levine

Much attention has been focused on what aspects of the preemption doctrine were restricted by the U.S. Supreme Court's recent decision in Wyeth v. Levine. A recent decision holds that claims that a drug was “unreasonably dangerous” and that no warning would have been adequate, are preempted. Longs v. Wyeth, 2009 WL 754524 (N.D. Ohio, 3/20/09). Plaintiff sued Wyeth and asserted strict liability and negligence claims concerning the diet drug Redux. Wyeth argued that plaintiff's claim that Redux was an unreasonably dangerous drug, for which no warning would have been adequate, directly conflicts with the FDA's authority to determine which drugs are sufficiently safe and effective to be marketed. The court affirmed its grant of summary judgment, finding that the strict liability and negligence claims related to pre-FDA approval were preempted by federal law, and that the claims that were not preempted failed on their merits.

The Court rejected plaintiff’s claim that Wyeth v. Levine called for reconsideration. In Wyeth, the Court considered the narrow issue of whether the FDA's drug labeling judgments preempt certain state law product liability claims premised on the theory that different labeling judgments were necessary to make drugs reasonably safe for use. The court noted that the Supreme Court emphasized that it was Congress' intent to have state law complement federal drug regulation because manufacturers may have superior access to information about their drugs, especially in the postmarketing phase as new risks emerge.

The instant case was distinguishable from Wyeth v. Levine because it did not involve a failure to warn claim, and because Levine arose out of the actions of the manufacturer post-FDA approval. A post-FDA approval duty is distinguishable from a manufacturer's duty prior to approval by the FDA, a circumstance that the Supreme Court did not explicitly address. Whatever Wyeth v. Levine may stand for regarding whether post-FDA approval claims are preempted, it does not purport to hold anything for pre-FDA approval claims, held the court.
 

Supreme Court Decides Levine v. Wyeth

The Supreme Court has issued its decision in the much-anticipated Levine preemption case.

Readers of MassTortDefense will recall that Wyeth manufactures the anti-nausea drug Phenergan. After a clinician injected plaintiff Levine with Phenergan by the “IV push” method, whereby a drug is injected directly into a patient’s vein, the drug entered Levine’s artery, she developed gangrene, and doctors amputated her forearm. Levine brought a state law damages action, alleging, inter alia, that Wyeth had failed to provide an adequate warning about the significant risks of administering Phenergan by the IV-push method. The jury determined that Levine’s injury would not have occurred if Phenergan’s label included an adequate warning, and it awarded damages for her pain and suffering, substantial medical expenses, and loss of her livelihood as a musician. The trial court rejected Wyeth’s argument that Levine’s failure-to-warn claims were pre-empted by federal law because Phenergan’s labeling had been approved by FDA. The Vermont Supreme Court affirmed.


Today, the Supreme Court affirmed, 6-3, J. Stevens writing for the majority, holding that federal law does not pre-empt Levine’s claim that Phenergan’s label did not contain an adequate warning about the IV-push method of administration. The argument that Levine’s state law claims are pre-empted because it is impossible for Wyeth to comply with both the state law duties underlying those claims and its federal labeling duties was rejected. Although a manufacturer generally may change a drug label only after the FDA approves a supplemental application, the agency’s “changes being effected” (CBE) regulation permits certain preapproval labeling changes that add or strengthen a warning to improve drug safety. Pursuant to the CBE regulation, Wyeth could have unilaterally added a stronger warning about IV-push administration, said the Court, as there was no good evidence that the FDA would ultimately have rejected such a labeling change. Wyeth’s reading of the CBE regulation and its assertion that unilaterally changing the Phenergan label would have violated federal law governing unauthorized distribution and misbranding of drugs are based on the “fundamental misunderstanding” that the FDA, rather than the manufacturer, bears primary responsibility for drug labeling.

The Court also rejected Wyeth’s argument that requiring it to comply with a state law duty to provide a stronger warning would interfere with Congress’ purpose of entrusting an expert agency with drug labeling decisions, because it relies on an overbroad view of an agency’s power to preempt state law. The history of the FDCA shows that Congress did not intend to pre-empt state law failure to warn actions, said the majority. The preamble to the 2006 FDA regulation declaring that state law failure to warn claims threaten the FDA’s statutorily prescribed is merely an agency’s assertion that state law is an obstacle to achieving its statutory objectives. The weight the Court accords the agency’s explanation of state law’s impact on the federal scheme depends on its thoroughness, consistency, and persuasiveness. Skidmore v. Swift & Co., 323 U. S. 134. Under this standard, the FDA’s 2006 preamble did not merit much deference, said the Court. It was limited in light of the FDA’s failure to offer interested parties notice or opportunity for comment on the preemption question; it is at odds with the available evidence of Congress’ purposes; and it reverses the FDA’s own longstanding position that state law is a complementary form of drug regulation.

Quick reactions: The Court was able to get around some facts that made the case appear strong for Wyeth, noting the findings below that that a stronger warning would have made a factual difference (getting around the issues of possible medical malpractice), and that this was indeed a failure to warn and not a duty to contraindicate case. Second, it seems that congressional intent is the touchstone of not only express preemption, but also implied preemption. Third, the presumption against preemption, which some argued really applies only in express cases, also applies to implied preemption cases. Fourth, the Court recognized that some state-law claims might well frustrate the achievement of congressional objectives, but “this is not the case." Defendants will have to carefully explore that opening, develop a robust regulatory record, and see where that may take them.
 

Members of Congress to Re-introduce Medical Device "Safety" Bill

Democratic members of Congress are planning to re-introduce legislation that would overturn the February, 2008 Supreme Court decision in Reigel v. Medtronic, which held  that the Medical Device Act Amendments of 1976 specifically pre-empt product liability lawsuits against makers of FDA-approved class III medical devices. The FDA approval process for such devices is infamously labyrinthine, requiring years and tens of millions of dollars in investment to prove a device is safe and effective. The bills would permit lay juries to second-guess regulatory decisions of the FDA resulting from that process.

Sponsors of the planned legislation include Representatives Henry Waxman, chairman of the House Energy and Commerce Committee, and Frank Pallone, head of its health subcommittee, and Senators Edward M. Kennedy and Patrick J. Leahy.  The lawmakers claim that the Supreme Court’s decision has left patients legally powerless against what they criticize as incomplete oversight of products by the FDA. Of course, if there is concern about the FDA’s efficacy, the answer is to increase the agency's resources, as the FDA is the appropriate body to set nationwide safety standards; allowing juries to second-guess such decisions would stifle product innovation. Such a bill would also encourage the creation of a 50-state hodge-podge of tort-based rules impossible for a manufacturer to comply with. What the sponsors may really want is to restore the trial lawyer lotto that can net jackpot jury awards while wreaking havoc on national standards.
 

Similar legislation, the Medical Device Safety Act of 2008, was introduced last session to overturn the Supreme Court’s decision in Reigel v. Medtronic.  H.R. 6381 garnered 62 co-sponsors last time.  Officials for the "American Association for Justice" f/k/a ATLA,  recently released a legislative agenda for 2009 and cited as their top priority efforts to pass this pro-litigation legislation.

District Court Permits Consumer Fraud Putative Class Action to Proceed on "All Natural" Claims

A federal district court recently denied defendant’s motion to dismiss in a putative class action under California's Unfair Competition Law alleging that defendant engaged in misleading conduct by advertising its “Healthy Choice” pasta sauce as “all natural” even though it includes some “high fructose corn syrup.” Lockwood v. Conagra Foods, Inc., 2009 WL 250459 (N.D.Cal. Feb. 3, 2009).

Defendant moved to dismiss on several grounds: arguing plaintiffs' claims were expressly preempted by the Nutrition Labeling and Education Act; were impliedly preempted by comprehensive FDA regulations under the Federal Food and Drug Cosmetic Act; that the court should defer to the FDA under the “primary jurisdiction” doctrine. Finally, defendants asserted that the court should strike the class allegations because plaintiffs cannot prove reliance on a class-wide basis.

Regarding the field preemption argument, the court noted that the purpose of the NLEA was to clarify and to strengthen FDA's authority to require nutrition labeling on foods, and to establish the circumstances under which claims may be made about the nutrients in foods. Under the Act, states may impose labeling requirements for artificial favors, colors or preservatives only if such requirements are identical to those imposed by the FDCA; any differences are preempted. But, the court held, this provision does not apply to plaintiffs' complaint as currently pled. Plaintiffs did not allege that defendant's pasta sauce contains artificial flavoring, coloring or a chemical preservative; rather, they allege that the “high fructose corn syrup” is not produced by a natural process and therefore the pasta sauce is not “all natural.”  One wonders why the claims of not all "natural" due to the use of an "artificial" flavor isn't squarely in that ballpark.

Turing to implied field preemption, the court noted that NLEA's provisions suggest Congress did not intend to occupy the field of food and beverage labeling. The FDA's policy as to the word “natural” similarly suggested an intent not to occupy the field of food labeling. Under the policy, the agency has considered natural to mean merely that nothing artificial or synthetic (including colors regardless of source) is included in, or has been added to, the product that would not normally be there. Although the FDA acknowledges that some consumers may be misled by the use of the term “natural,” it has declined to adopt any regulations governing this term. This inaction is consistent with an intent not to occupy the field. This is especially so given that at the time the FDA declined to formally define “natural” it was aware of and had reviewed state regulation of the use of the term, yet it made no mention of the need for uniformity or a preemptive federal regulation.

On conflict preemption, the court found that the defendant had not proved as a matter of law that plaintiffs' claims, if successful, make compliance with federal law a physical impossibility. A manufacturer could comply, that is, not violate, the FDA's policy as to use of the term “natural” and still comply with state law as articulated by plaintiffs in this case, thought the court. Nor does California law stand as an obstacle to the accomplishment and execution of the objectives of the FDCA. Again, it seems questionable that this type of claim wouldn't risk imposing labeling requirements for "artificial" favors, directly in contrast to federal regulations.

Regarding primary jurisdiction, the court found application of the doctrine was not appropriate here. At a minimum, various parties have repeatedly asked the FDA to adopt formal rulemaking to define the word natural and the FDA has declined to do so because it is not a priority and the FDA has limited resources. Moreover, the court did not feel this was a technical area in which the FDA has greater technical expertise than the courts. Finally, plaintiffs' claims were based on state law and, thus, federal law would not dispose of plaintiffs' state law claims.

Finally, the court declined to strike the class allegations at this juncture, finding that if a misrepresentation is material an inference of class-wide reliance may be inferred under the California law. MassTortDefense has posted about the growing trend of plaintiffs to use consumer fraud act claims in place of traditional product theories. Plaintiffs continue to believe that claims based on unfair and deceptive trade practices acts are somehow easier to certify as class actions because of differing notions of reliance and causation.
 

Preemption Found In Medtronic MDL

The federal judge in the Medtronic Sprint Fidelis Leads MDL has ruled that all claims in the plaintiffs' master consolidated complaint are preempted. In Re: Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 2009 WL 35467 (D.Minn. 2009).

The Judicial Panel on Multidistrict Litigation transferred related cases involving Medtronic Inc.'s recalled Sprint Fidelis defibrillator leads to the District of Minnesota last February. The leads were recalled in late 2007, because of the potential for fracture, which can potentially cause unnecessary shocks or failure, possibly resulting in injury. 

Relying on the U.S. Supreme Court's decision in Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008), the MDL court noted that Congress has decided to limit medical-device manufacturers' liability in order to spur innovation. Plaintiffs' remedy, therefore, lies with Congress, and not with the courts. 

Every medical device intended for human use is placed into one of three categories by the FDA, based on the risks of injury or illness the device presents; each category is subjected to a different level of FDA scrutiny. Devices that either support or sustain human life or present a potential unreasonable risk of illness or injury” are categorized as “Class III” devices. Class III devices are subject to the greatest level of FDA scrutiny and “must complete a thorough review process with the FDA before they may be marketed.”  Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 344 (2001). Through this process, known as pre-market approval (“PMA”), a device maker must provide the FDA with “reasonable assurance” that its device is both safe and effective.

The PMA process is “a rigorous one.” Medtronic, Inc. v. Lohr, 518 U.S. 470, 477 (1996). Manufacturers must submit detailed information regarding the safety and efficacy of their devices, which the FDA then reviews, spending an average of 1,200 hours on each submission. When analyzing that information, the FDA weighs the probable benefit to health from the use of the device against any probable risk of injury or illness from such use. Accordingly, the FDA sometimes grants PMA to potentially life-threatening devices, if they offer great benefits in light of available alternatives. Riegel, 128 S.Ct. at 1004.

Here, the MDL court rejected arguments that a recall of the leads invalidated their premarket approval. Medtronic correctly noted that the PMA process is governed by a completely separate statutory and regulatory regime than that governing withdrawal of a PMA. Also, the PMA for the leads was in place at the time they were implanted, a crucial fact because liability under plaintiffs' various legal theories hinges upon whether the leads were defective at that time. More fundamentally, the federal interest that preemption is designed to protect is the PMA process, and preemption necessarily looks backward (to the time of PMA) rather than forward.

The court also rejected the plaintiffs' claims that they have asserted "parallel" claims and therefore preemption does not apply. For example, plaintiffs purported reliance on Good Manufacturing Practice or Quality Control guidance did not save the claims. In the absence of any specific requirement in the CGMPs/QSR that Medtronic weld the Sprint Fidelis leads in a certain fashion [that was plaintiffs' beef], holding Medtronic liable for such a welding “defect” would have imposed requirements “different from, or in addition to” those under federal law. This is equally true of plaintiffs' allegation that Medtronic used inadequate testing and quality-assurance methods. Plaintiffs simply could not identify any specific requirements in the CGMPs/QSR that were purportedly violated by Medtronic.

It is noteworthy that the court found dismissal with prejudice was appropriate. This complaint was filed after extensive preparation by the Plaintiffs' Steering Committee, which is made up of lawyers who are experienced in federal preemption litigation. In the MDL Court's estimation, if plaintiffs were aware of sufficient facts in order to avoid preemption, they would have already pleaded them.
 

New Article: Platitudes From Plaintiffs About Product Stewardship

A recent academic paper may be worth a look. Noah, Lars, “Platitudes about 'Product Stewardship' in Torts: Continuing Drug Research and Education,” 15 Michigan Telecommunications and Technology Law Review 2009.

This paper focuses on one emerging aspect of tort litigation against pharmaceutical manufacturers that, if it gained traction, might portend a dramatic (and potentially counterproductive, in the author’s view) expansion in the prescription drug industry's exposure to liability. A growing number of liberal commentators would seek to impose on pharmaceutical manufacturers a broader duty to test and educate (aspects of what they call an obligation of "product stewardship"). This paper explains some of  the serious flaws in such proposals.

The article is thus part of the overall debate about what role tort law may have to play in drug research and development. Does the threat of liability create important safety incentives (and make up for perceived, alleged failings in regulatory oversight), or, instead, does it unduly interfere with innovation and patient access to life-saving therapies? These and related questions have
inspired an active debate among commentators, the author notes;  courts and legislators have also made occasional forays into the area by constricting the scope of potential tort liability in particular circumstances. The Restatement (Third) of Torts: Products Liability, which ALI published a decade ago, included special provisions governing prescription drug cases, and the pitched battle over using implied preemption as a defense, which the United States Supreme Court may address in 2009, represents only the latest manifestation of these sharp disagreements.

Worth a read.
 

Opposition To Cert Petition In Colaccico: That Other Preemption Case

While much preemption focus has been on Levine v. Wyeth, including by posts here at MassTortDefense, other preemption decisions are winding there way through the federal appellate courts. Defendants Pfizer Inc., GlaxoSmithKline, and Apotex Inc. last week asked the U.S. Supreme Court to uphold a ruling by the U.S. Court of Appeals for the Third Circuit that failure to warn claims are impliedly preempted by federal law based on the regulatory history of the antidepressants at issue. Colacicco v. Apotex Inc., 521 F.3d 253 (3d Cir. 2008), Petition for Certiorari Filed, 77 USLW 3229 (Oct 02, 2008). 

Readers of MassTortDefense know that plaintiff Colacicco filed suit after his wife allegedly committed suicide while under treatment with a generic equivalent to Paxil. The district court for the E.D. of Pennsylvania found preemption. The appeal was consolidated with a contrasting preemption decision in the McNellis case out of the district court in New Jersey, involving Zoloft. The Third Circuit's decision was the first by a federal appeals court to address the preemptive effect of prescription drug law and regulation since the FDA had expanded on its guidance on the issue.

Plaintiffs sought certiorari, asking the Court to review the Third Circuit's decision; alternatively, they asked the court to hold the petition pending resolution of Levine, argued last month. But the Court should do neither, the manufacturers argued, and cert should just be denied.

Pfizer Brief

According to Pfizer's brief, the Third Circuit properly determined that plaintiff below McNellis sought a warning about suicidal behavior that conflicted with the federal warning requirements for Zoloft. For more than 15 years, the FDA had considered whether SSRIs were associated with an increased risk of suicidality in adult patients. The agency repeatedly determined that the scientific evidence did not support such a warning.

Pfizer notes there is no disagreement among appellate courts (a well-established basis for Supreme Court review) on preemption in SSRI litigation.  No other federal appeals court has ruled in a contrary way on the preemptive effect of the type of conflict at issue here. The 3d Circuit found preemption based on “the direct, real conflict” between plaintiff’s claim that New Jersey law required a warning about adult suicidality and the FDA's requirement—based on its repeated finding of no reasonable evidence of such an association—that only the FDA's approved warning be given. McNellis relied on the Court's decision in Sprietsma v. Mercury Marine, 537 U.S. 51 (2002) to argue that the FDA merely failed to act with respect to suicidality warnings, and that a federal agency's failure to act does not create a federal requirement triggering preemption. But the FDA “regulated with great specificity and care” in repeatedly finding no reasonable association between SSRIs and suicidality, and by requiring the manufacturer to provide the specified warnings.

As to the claim that the manufacturers failed to disclose information to the FDA, defendants assert that the lower court correctly found that this claim should be presented to the FDA first. In addition, Buckman preemption likewise prevents plaintiffs from evading a definitive FDA regulatory record by arguing that the FDA was somehow defrauded; the appellate court found that the preemption doctrine of Buckman v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001), bars claims that the manufacturer withheld information from the FDA.

Direct Conflict

Arguing against even staying the petition until Levine is decided, Pfizer said the issues in the cases are distinct, asserting that the 3d Circuit's decision in this case is correct regardless of whether Levine is affirmed or reversed. Respondents point out what they see as distinct regulatory facts in that case, involving contraindication claims.

Brief for Apotex, GlaxoSmithKline

Apotex, a maker of generic Paxil, and GlaxoSmithKline, the maker of brand-name Paxil, also argued against review. Like Pfizer, they contended the 3d Circuit properly concluded that the FDA's repeated rejection of suicidality warnings preempts plaintiff Colacicco's claims.

The brief also argued that state law failure to warn claims challenging FDA-approved labeling should be preempted. To allow this sort of tort action to continue would place state-law juries in the position of second-guessing FDA decisions regarding the proper warnings for drugs. Lay juries should not be able to undermine the agency's expertise by second-guessing the agency's warning decisions. At its base, Colacicco's argument against preemption is the theory that a court, applying state law, has authority to decide whether GSK could have under federal law, and should have under state law, unilaterally added a suicidality warning to the Paxil labeling, despite FDA regulation.

Courts do not share concurrent jurisdiction with the FDA over drug labeling; there should be no preemption test that would require a court to delve deeply into internal FDA decision making. Specifically, the lower courts do not share jurisdiction with the FDA over the CBE regulation, which is the basis for the “could have, should have” argument, Apotex and GSK both wrote. FDA has made clear that CBE supplements fall squarely within its regulatory jurisdiction. Under Colacicco's theory, the lower court would be authorized to decide, without reference to the FDA, that a CBE supplement adding the putative warning could have been submitted, that the added warning would have been consistent with the FDCAct, and that FDA would have approved it. Thus, the lower courts would become “shadow” FDAs. That is not the scheme adopted by Congress for drug regulation.

 


 

Punitive Damages Claim Against Patch Maker Found Preempted

A federal court has found that federal law preempts a state law that allows plaintiffs to seek punitive damages from the makers of defective drug products if the drug company knowingly withheld information from the Food and Drug Administration. Grange v. Mylan Laboratories Inc., 2008 WL 4813311 (D.Utah 10/31/08).

Plaintiffs’ estate sued over an allegedly defective drug patch. Defendants sold the Fentanyl Patch, which is applied directly to the skin to deliver fentanyl, a strong pain medicine. Doctors prescribe the Fentanyl Patch to relieve chronic moderate to severe pain. The patch should be worn for seventy-two hours and is supposed to deliver the medicine at a regulated rate. Plaintiff alleged that due to a design and/or manufacturing defect, some Fentanyl Patches contain and deliver fentanyl in amounts far in excess of what is advertised. Plaintiff alleged that defendants knew that the Fentanyl Patch was defective, but did not warn of the potential risk of overdose.

Defendants moved to dismiss the claims for punitive damages. A Utah statute, Utah Code Ann. § 78B-8-203, completely bars punitive damages for harm caused by FDA approved drugs. But that statute has an exception for cases where a plaintiff can show that a defendant withheld information from the FDA. Plaintiffs, of course, alleged that the exception applied here. But defendants contended that this exception is preempted by federal law.

As the court noted, this statutory limitation on liability for punitive damages does not apply if it is shown by clear and convincing evidence that the drug manufacturer knowingly withheld or misrepresented information required to be submitted to the Federal Food and Drug Administration under its regulations, which information was material and relevant to the claimant's harm. Defendants contended that the statutory exception amounts to a de facto “fraud on the FDA” claim, which is preempted by federal law.

In support of this argument, defendants relied on Buckman Co. v. Plaintiff's Legal Comm'n., 531 U.S. 341, 348 (2000), which held that state law fraud-on-the-FDA claims conflict with, and are therefore impliedly preempted by, federal law. The Buckman Court gave two primary reasons for this holding. First, allowing state law claims of fraud on the FDA would interfere with the FDA's objectives and judgment. See id. at 350-51. Second, such claims could cause the FDA to face a deluge of unnecessary information in the approval process by drug companies attempting to avoid state law liability, jamming up the regulatory system.

The court decided that the decision in Buckman did not directly reach the issue presented here. In this case, unlike in Buckman, the state statute does not predicate liability on fraud on the FDA, but rather would allow certian damages based on such fraud. The question of whether this type of statute is preempted, said the court, has created a split of authority. Compare Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961 (6th Cir.2004)(extending Buckman's logic to a statute similar to Utah's), with Desiano v. Warner-Lambert & Co., 467 F.3d 85, 97 (2d Cir.2006)(same Michigan statute was not preempted by Buckman), affirmed sub nom, Warner-Lambert Co., LLC v. Kent, 128 S.Ct. 1168 (2008)(4-4 vote).

Despite a mention of the so-called presumption against preemption, the court found that the Sixth Circuit's decision in Garcia was more persuasive here. The chief problems that Buckman sought to counteract are present whenever a plaintiff, as a prerequisite to collecting damages, is required to put on evidence that there was what amounts to fraud on the FDA. When such evidence is considered, state courts are essentially second-guessing the FDA, and drug companies, nervous about state litigation, will have an incentive to flood the FDA with information. To the extent that the Utah law allows for an exception in cases where a plaintiff puts on his or her own independent evidence of information being withheld from the FDA, this statute was found to be preempted. There is no preemption, however, in a situation where a plaintiff invokes the Act to seek punitive damages in cases where the FDA itself has found that there was fraud in the application process.
 

PMA Device Preemption Recognized Despite "Parallel" Allegation

Those readers defending PMA medical device defendants should review Parker v. Stryker Corp., 2008 WL 4716879 (D. Colo. Oct. 22, 2008); the district court granted a preemption-based Rule 12(b)(6) motion to dismiss.

Plaintiff underwent a total hip arthroplasty during which she was implanted with the Trident Ceramic Acetabular System, an artificial hip implant device developed, manufactured, and sold by defendants. After the surgery, plaintiff claims she noticed an audible sound coming from the device. She alleges that she had experienced constant irritation and discomfort, as well as “additional and resultant bone loss,” and that she was at an increased risk for requiring a premature revision surgery. She sued under Colorado state law for failure to warn, manufacturing defect, design defect, breach of express and implied warranties, breach of implied warranty of fitness, breach of implied warranty of merchantability, and negligence. Defendants moved to dismiss, claiming that all of plaintiff's state law causes of action were preempted.

Resolution of the motion turned in part on the recent Supreme Court decision interpreting the preemptive scope of the 1976 Medical Device Amendments (“MDA”), 21 U.S.C. §§ 360c-360n, to the Federal Food, Drug and Cosmetic Act of 1938 (“FDCA”), 21 U.S.C. §§ 301-399a, Reigel v. Medtronic, Inc., 128 S.Ct. 999 (2008). In that case, the Court concluded that state claims that would impose on manufacturers requirements that are different from, or in addition to, those prescribed by the MDA are preempted. Id. at 1011.

Plaintiff, however, insisted that her claims were not preempted because they did not seek to impose different or additional requirements, but only those parallel to the federal requirements of the MDA. The court here noted first that a "parallel" violation claim is not stated by reference to provisions of the FDCA that govern the sale of adulterated and misbranded devices, because there is no private right of action under the FDCA.

The district court found, second,  that although so-called parallel claims may be recognized, plaintiff had not properly pled them here. Conclusory allegations or legal conclusions masquerading as factual conclusions will not suffice to prevent a motion to dismiss.  Fernandez-Montes v. Allied Pilots Association, 987 F.2d 278, 284 (5th Cir.1993); see also Ruiz v. McDonnell, 299 F.3d 1173, 1181 (10th Cir. 2002), cert. denied, 538 U.S. 999 (2003). Plaintiffs’ conclusory allegations standing alone were not sufficient to sustain plaintiff's burden of pleading under Bell Atlantic Corp. v. Twombly, 127 S.Ct. 1955, 1969, 1974 (2007). Specifically, under Twombly a plaintiff can't state a claim simply by alleging that the defendant violated FDA regulations without alleging sufficient facts to back up the claim. And citing FDA warning letters is not sufficient to state a claim without some facts tying the letters to the plaintiff's case.

The only claim not clearly preempted by Reigel was plaintiff's breach of express warranty claim. Federal courts are divided as to whether breach of express warranty claims are preempted. The Third and Seventh Circuits have held that such claims are not preempted because any “requirements” imposed by the warranty are voluntarily assumed by the warrantor, not imposed by the state. See Mitchell v. Collagen Corp., 126 F.3d 902, 915 (7th Cir.1997), cert. denied, 523 U.S. 1020, (1998); Michael v. Shiley, Inc., 46 F.3d 1316, 1327-28 (3rd Cir.), cert. denied, 516 U.S. 815 (1995), overruled on other grounds as stated in In re Orthopedic Bone Screw Products Liability Litigation, 159 F.3d 817, 825 (3rd Cir.1998). See also In re Medtronic, Inc. Implantable Defibrillators Litigation, 465 F.Supp.2d 886, 898 (D.Min.2006); Davenport v. Medtronic, Inc., 302 F.Supp.2d 419, 433 (E.D.Pa.2004); Steele v. Depuy Orthopaedics, Inc., 295 F.Supp.2d 439, 455-56 (D.N.J.2003). Other courts have found this reasoning unpersuasive given the comprehensive nature of the PMA process. Because all representations regarding the device in its labeling must be approved by the FDA as part of the PMA process, these courts have held that any claim that such representations are inadequate is preempted. See Enlow v. St. Jude Medical, Inc., 210 F.Supp.2d 853, 861-62 (W.D.Ky.2001) (citing Martin v. Telectronics Pacing Systems, Inc., 105 F.3d 1090, 1100 (6th Cir.1997), cert. denied, 522 U.S. 1075 (1998)).

None of these cases was decided with the benefit of the Supreme Court's decision in Reigel. In light of that decision, the district court decided that the better-reasoned approach would find plaintiff's breach of express warranty claims based on the labeling of the Trident System preempted. The FDA evaluates labeling as part of the PMA process, it noted. Moreover, once approved, labels cannot be changed without FDA approval. Parker's express warranty claim would contradict the FDA's determination that the representations made on the label were adequate and appropriate and, thus, impose requirements different from or in addition to the federal requirements.
 

Wyeth Files Reply Brief in Levine Preemption Case

Wyeth has filed its reply brief in the Levine case.

The reply stresses that this case is not a conventional failure to warn case, but an alleged failure to contraindicate case. Thus, plaintiff is directly challenging the FDA’s balancing of the risks and benefits of a labeled, warned-about indication. State law cannot obstruct federal regulation of pharmaceuticals by seeking to impose a different outcome to this balancing process than the one reached by the FDA.

When the FDA did address the risks and benefits of the particular method of drug delivery at issue, the agency told the defendant to use labeling which the state court jury held was inadequate under state law. 

Wyeth also stressed what the case was not: no allegations of concealment from the agency or of failure to make a label change in response to any new risk information. The FDA had all the important information, and made a regulatory decision, which plaintiffs told the jury they could, and should, simply reject.

Note also an interesting discussion of CBE issues, with the arguments that this was not a CBE case, especially where methods of use are at issue, and that the FDA's interpretation of the CBE is entitled to Auer- level deference. (As noted in a post by MassTortDefense, the CBE regulation was always intended to apply solely to new, emerging, significant information.) Finally the plaintiff’s argument that the defendant must prove that a CBE submission would have been unsuccessful before qualifying for preemption would create the untenable and frequently dis-approved situation in which juries are deciding hypothetical situations full of what-ifs.
 

FDA Finalizes CBE Rule, Reinforcing Preemption

The Food and Drug Administration has finalized the updated rule on using supplemental applications for changes to prescription drug, biologics, and medical device labels. The final rule, 73 Fed. Reg. 49603, allows manufacturers to submit a supplemental application to amend the labeling for an approved product to reflect newly acquired information. These supplements are commonly referred to as "changes being effected supplements" or "CBE supplements." The final rule becomes effective on Sept. 22, 2008. The final rule modifies 21 C.F.R. Sections 314, 601 and 814.

MassTortDefense would disagree with the media reports describing this as a “new” rule. In fact, the final rule affirms FDA’s longstanding position that a CBE supplement is appropriate to amend the labeling for an approved product only to reflect newly acquired information. But even though when it originally adopted this regulation FDA intended it as a limited, narrow, emergency exception to the general rule of Agency pre-approval of changes to prescription drug labeling, after preemption became a huge issue in prescription drug product liability litigation the regulation has been at times cited by courts as applying far more broadly than the FDA intended.

Plaintiffs argued that, since manufacturers are supposedly free to change their labels without prior FDA approval, there can be no conflict with state law holding them liable for not doing what the regulation supposedly allows. The plaintiffs thus have argued that the narrow exception swallows the rule that drug labeling changes are subject FDA pre-approval. Some courts have accepted this argument, and for example ruled that pharmaceutical defendants should have unilaterally strengthened suicide warnings for antidepressants – despite the FDA having evaluated the evidence of this alleged risk multiple times, concluding that there is no sufficient scientific basis for including a suicide warning. Compare McNellis v. Pfizer, Inc., 2006 WL 2819046 (D.N.J. Sept. 29, 2006) with Colacicco v. Apotex, Inc., 432 F. Supp.2d 514, 523, 527-28 (E.D. Pa. 2006). The Third Circuit's  take on this split is at Colacicco v. Apotex, 521 F.3d 253 (3d Cir. 2008).

FDA proposed the CBE procedure in 1982, making clear at the time that CBE supplements were intended to apply only if the sponsor became aware of newly discovered safety information that was appropriate for inclusion in the labeling for the product. Since then, the FDA has repeatedly tried, through amicus briefs, and in the 2006 preemption preamble, to inform courts of the limited scope of the regulation, with arguably mixed success. In briefs recently filed in the Supreme Court and in testimony before Congress, FDA has also stated a more generally applicable rule that is consistent with the examples of  cases finding preemption, and the principles set forth in the preamble to the 2006 Physician Labeling Rule,  that: (1) The labeling requirements are not a mere minimum safety standard, but rather strike a balance between risks and benefits, and (2) FDA's regulations permit changes in labeling without prior approval only in narrow circumstances. Specifically, FDA has explained that State law claims that "challenge labeling that FDA approved after being informed of the relevant risk" are preempted.

So now, the agency decided to change the regulation to say precisely what the agency has said it meant all along, with the hope that the lawyers and judges who have been ignoring it can’t do so any longer.

In January, several liberal Democrats in Congress wrote a letter to FDA questioning the basis for the proposed CBE rule, saying it appeared to be designed to shield pharmaceutical and medical device companies from liability sustained by consumers. But the rule does not alter the agency's current practices with respect to accepting or rejecting labeling changes proposed by a CBE supplement, reiterating the agency's longstanding view that the changes-being-effected mechanism is a narrow exception to the FDA's requirement of prior approval for labeling changes to approved products.

Under the rule, newly acquired information means data, analyses, or other information not previously submitted to the agency, which may include (but are not limited to) data derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data (e.g., meta-analyses) -- if the studies, events or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA. The final rule thus clarifies the meaning of "newly acquired information," such that the data, whether derived from new clinical studies, reports of adverse events, etc., needs to be new and different -- of a different type or greater severity or frequency than previously submitted to FDA. This limitation applies to data derived from new clinical studies, reports of adverse events, and new analyses of previously submitted data, alike. The final rule notes thus that there must be reasonable evidence of a causal association before a CBE supplement may be used to add or strengthen a contraindication, warning, precaution, or adverse reaction language.

The FDA rejected comments suggesting that a lower standard should be used under CBE for when a sponsor may warn, reiterating that it "interprets the Act to establish both a 'floor' and a 'ceiling', such that additional disclosures of risk information can expose a manufacturer to liability under the act if the additional statement is unsubstantiated or otherwise false or misleading." 

The new rule may be of some assistance in dealing with those courts that seem reluctant to recognize the longstanding view of the narrow scope of the CBE rule.  The rule limits the scenarios in which manufacturers of drugs, biologics, or medical devices can change a previously approved label in advance of the FDA’s formal review and approval mechanism. And the smaller the scope of things permitted in a CBE change, the greater the scope of conflict between FDA-approved labels and state court second-guessing of the warnings.  

More Amicus Briefing in Wyeth v. Levine

A number of entities have continued to weigh in as amici in the Wyeth v. Levine preemption case pending before the Supreme Court. In an amicus brief filed earlier this summer, BIO and PhRMA argued from a policy perspective that state law tort suits challenging the adequacy of FDA approved prescription drug labeling pose significant risks to public health. (BIO is the world's largest biotechnology organization, providing advocacy, business development and communications services for more than 1,150 members worldwide.) Those suits imperil FDA's ability to accomplish its mission because they allow state court juries to second guess FDA's balancing of the risks and benefits of a prescription medicine. State court verdicts inconsistent with FDA guidance will simply encourage manufacturers to warn physicians and patients about risks that are speculative and scientifically unsupported; this ultimately dilutes the impact of scientifically valid warnings and can discourage physicians from prescribing and patients from using beneficial drugs.

On the legal side, these amici argued that the Vermont Supreme Court's decision now on appeal was at odds with a core premise of the Supremacy Clause: that state law cannot require what federal law prohibits. Absent new scientific information, federal regulations prohibit a manufacturer from changing prescription drug labeling without prior FDA approval. In this case, FDA knew of and considered the relevant risk over a long period of time, and approved carefully crafted warnings and instructions designed to minimize those risks while still encouraging beneficial drug use.

The Latest

Last week, in what appears to be a first, the editors of the New England Journal of Medicine  weighed in on the preemption legal battle -- on the side of the plaintiff below, Levine. While the brief attacks the track record of the FDA, arguing that the agency lacks the resources to do its job, it does not answer the next question: whether experts at the FDA, even with allegedly inadequate funding, are more or less likely to decide difficult scientific questions correctly than are juries of lay people “educated” by trial lawyers. The NEJM spouts the rhetoric of juries "policing" the industry.  But a dramatic gulf separates the competence of the FDA from that of state jurors who, absent preemption, are called on to assess the safety of prescription drugs and second-guess federal regulators. Laypersons applying state law cannot substitute for the FDA, the expert agency congressionally delegated the role of meticulously balancing nuanced and sometimes competing nationwide goals. The FDA’s regulation of prescription drugs is governed by a sweeping network of federal law individually applied to each drug. A lay jury lacks the expertise and the broader perspective of the FDA, and thus cannot adequately adjudicate individual plaintiff/patient risks in the context of population benefits – quintessentially the kind of issue that the FDA must confront every day. Without preemption, however, state juries are asked to do just that.

Similarly, the NEJM brief bemoans the fact that FDA is reliant upon information gathered and produced by the drug company, but the fact is that no entity other than the drug company has any incentive or ability to study a not-yet-approved drug. And permitting after the fact tort suits to second-guess the FDA won’t change that. Moreover, how is the situation any different in a tort suit? If a new study comes out about the risks or benefits of a drug or device after a tort suit has been concluded, we don’t go back and start the case again. Would the NEJM advise unwinding the results in Bendectin litigation? Breast implants? The state of the art is by definition time-dependent.

And as pointed out in DRI’s amicus brief, there was an enhancement of the FDA’s powers by the recent FDAAA. This contrasts a one possible way (congressional action) and a clearly worse way (complaining in state court litigation) to deal with perceived deficiencies in FDA action.
 

Senate Bill Introduced To Overturn Riegel

Two liberal Senators have followed the lead of liberal Democratic House lawmakers and introduced a Senate counterpart to the proposed Medical Device Safety Act of 2008. The bill would overturn the Supreme Court’s decision in Reigel v. Medtronic, which properly confirmed preemption of state tort suits for FDA-approved medical devices. The bill would permit individuals to sue device makers under state tort laws, and permit state court juries to second-guess the expert decisions of federal regulators. The bill would also encourage the creation of a 50-state hodge-podge of tort-based rules impossible for a manufacturer to comply with.

Sens. Edward Kennedy (D-Mass.) and Patrick Leahy (D-Vt.) introduced the companion bill to H.R. 6381, which has 62 co-sponsors in the House, and which was introduced in the House in June by Reps. Frank Pallone (D-N.J.) and Henry Waxman (D-Calif.). The Senators’ introductory statement can be viewed here

MassTortDefense has posted on preemption, including here and here.

The Wall Street Journal weighed in on these issues in an editorial August 13th. Describing the Supreme Court's “sensible 8-1 ruling earlier this year” in Riegel v. Medtronic, the Journal noted how the FDA's authority to approve a drug or device pre-empts state product liability laws. “The Court's decision makes sense for many reasons, not least to avoid creating a sort of double-jeopardy for companies -- first having to run the FDA approval maze, then allowing a nationwide quilt of different laws and standards to second-guess that approval.” In 1976 Congress passed the Medical Device Amendments, establishing a national standard with express pre-emption language barring states from imposing their own requirements.

Democratic House member Henry Waxman said the decision "strips consumers of the rights they've had for decades." Who writes this stuff for Henry?, asks the WSJ. Far from representing a radical departure in the law, “the Court's reasoning upheld what had become a common opinion in the federal court system. In half a dozen holdings, federal circuit courts had already ruled in favor of pre-emption, covering states from Texas to Illinois to Pennsylvania.”

The Journal observed, “What Mr. Waxman really wants to restore is the trial lawyer bingo that can net jackpot jury awards while wreaking havoc on national standards. The FDA approval process is infamously labyrinthine, requiring years and tens of millions of dollars in investment to prove a device is safe and effective.” Of the 8-1 vote, the editorial mentioned, “You've got to love it when the tort bar and Democrats accuse those notorious right-wing Justices Stephen Breyer, Anthony Kennedy and David Souter -- who joined the majority opinion -- of being the greedy tools of business. Another liberal, John Paul Stevens, joined the majority with some caveats.”
 

Partial Summary Judgment Granted in Aredia MDL

Novartis Pharmaceuticals Corp. has prevailed in a motion to end certain failure-to-warn claims in cases in the MDL relating to its bone cancer drugs Aredia and Zometa. The U.S. District Court for the Middle District of Tennessee granted defendant’s motion for partial summary judgment, dismissing claims of eight Texas-based plaintiffs. In Re: Aredia and Zometa Products Liability Litigation, No. 06-md-01760 (M.D. Tenn.) Opinion found here.

The motion was based upon a Texas statute which protects a defendant from any products liability claims involving failure to provide adequate warnings if the drug at issue and accompanying warnings were approved by the FDA. The statute creates the presumption such warnings were adequate, and then specifically explains how a claimant can rebut this presumption:

(b) The claimant may rebut the presumption in Subsection (a) as to each defendant by establishing that: (1) the defendant, before or after pre-market approval or licensing of the product, withheld from or misrepresented to the United States Food and Drug Administration required information that was material and relevant to the performance of the product and was causally related to the claimant’s injury. Tex. Civ. Prac. & Rem. Code Ann. § 82.007(b)(1).

The court noted that plaintiffs were correct that the language of the Texas statute specifically creates a rebuttable presumption that a defendant is not liable for failure-to-warn claims if the warnings provided with the product were approved by the FDA. The Texas Legislature, however, went on to establish certain evidentiary standards for rebutting this presumption. The presumption of adequate warnings, therefore, is unrebuttable unless one of the specific statutory provisions applies.  Here, the only possible exception was the so-called fraud-on-the-FDA exception. However, in Buckman Co. v. Plaintiffs’ Legal Comm., 121 S.Ct. 1012 (2001), the Supreme Court found that the plaintiffs’ state law fraud-on-the-FDA claims conflicted with and were therefore impliedly preempted by the Federal Food, Drug and Cosmetic Act. Noting that policing fraud against federal agencies is hardly a “field which the States have traditionally occupied,” the Court held that it is the FDA’s exclusive responsibility to police fraud or wrongdoing in connection with approval of products before the FDA. Id. at 1017.   The Court stated that fraud-on-the-FDA claims would “inevitably conflict with the FDA’s responsibility to police fraud consistently with the Administration’s judgment and objectives.” Id. at 1018. In sum, the Court opined, this sort of litigation would exert an extraneous pull on the scheme established by Congress, and it is therefore preempted by that scheme. Id. at 1020.

Under the Texas law, in order to rebut the presumption plaintiffs must establish that defendant withheld or misrepresented “required information” to the FDA. The Court found that the task of determining whether certain information was “required” by the FDA would raise the federalism concerns expressed in Buckman.

Second, the Texas statute also requires that the information which was withheld or misrepresented be “material and relevant” to the performance of the product. Because subsection (b) concerns misrepresentations to the FDA, it is reasonable to infer that the information must be “material and relevant” to the FDA. Determining what information would have been important to the FDA would also create the federalism concerns noted by the Court in Buckman.

Finally, the information which was allegedly withheld or misrepresented must, under the Texas statute, be causally related to plaintiffs’ injuries. Unless the withheld information would have resulted in some definite change by the FDA, such as either non-approval of the drug or a labeling change, such withheld information could not be causally related to a plaintiff’s injury. Again, in order to establish that the FDA would have acted differently if defendant had submitted accurate information, plaintiffs would have to “go behind” the FDA processes, raising the concerns sought to be avoided in Buckman.

The Court thus found that the requisite showing under the Texas statute is analogous to and sufficiently equivalent to asserting a claim of fraud on the FDA that the fraud claim/presumption defense/statutory exception is itself preempted under Buckman. For all these reasons, Defendant’s Motion for Partial Summary Judgment was granted.

The ruling on the Texas claims follows the MDL court's April ruling dismissing claims by Michigan plaintiffs. The court had relied on Garcia v. Wyeth-Ayerst Laboratories, 385 F.3d 961 (6th Cir. 2004), for the proposition that the Michigan fraud exception was also preempted under the U.S. Supreme Court's decision in Buckman.

Recent Preemption Ruling: Wait For Levine

A recent trial court decision shows the state of flux in applying the preemption doctrine in pharmaceutical cases. In the Celexa/ Lexapro MDL, the court denied without prejudice the defendant’s preemption motion, to allow further discovery and expressly because the United States Supreme Court has granted certiorari in Levine v. Wyeth, 128 S.Ct. 1118 (2008), to consider the extent to which prescription drug labeling judgments imposed on manufacturers by the FDA, pursuant to FDA's comprehensive safety and efficacy authority under the Federal Food, Drug, and Cosmetic Act, preempt state law product liability claims premised on the theory that different labeling judgments were necessary to make drugs reasonably safe for use. See In re Celexa and Lexapro Products Liability Litigation, 2008 WL 2906713 (E.D.Mo. July 24, 2008), found here.

 

Federal Court Reverses Self On Drug Preemption

Judge David F. Hamilton of the U.S. District Court for the Southern District of Indiana has reversed a prior decision and reinstated a Paxil suicide case that had been dismissed – properly in the view of MassTortDefense --  on preemption grounds last year. See Tucker v. SmithKline Beecham Corp./d/b/a Glaxosmithkline, No. 04-1748, (S.D. Ind. 7/18/08). See opinion here.  In granting plaintiff’s motion for reconsideration, the court violated the rule “if it ain’t broke, don’t fix it.”

Plaintiff Debra Tucker sued GSK on behalf of her brother, Rick Tucker, alleging that her brother committed suicide in September 2002 as a result of taking Paxil for three weeks. The claim was that GSK breached a duty to warn of an alleged increased suicide risk among Paxil patients. (MassTortDefense notes that the scientific evidence actually does not establish that paroxetine (the active ingredient in Paxil) causes suicide, suicide attempts, self-harm or suicidal thinking. On the basis of research in tens of thousands of patients taking antidepressants, including Paxil, there is no significantly increased risk of suicidal thinking or behavior in people age 24 and older and, in fact, in patients older than 65, there was a reduction in risk in suicidal thoughts and behavior.)

The defendant sought summary judgment on preemption grounds. The court correctly determined in September, 2007, that her claims conflicted with the FDA's labeling requirements for Paxil. The court said it believed the record showed that the FDA had rejected the hypothesis that there is a causal link between Paxil and suicide.

In granting the plaintiff's motion for reconsideration, the court said it had "failed to appreciate the fact that the ongoing ability, authority, and responsibility to strengthen a label still rest squarely with the drug manufacturer." In its new decision, the court first noted that under 21 C.F.R. §201.80, a manufacturer must revise labeling "to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug; a causal relationship need not have been proved." Under 21 C.F.R. §314.70(c), a manufacturer may unilaterally add or strengthen a contraindication, warning, precaution or adverse reaction upon submission of a "changes being effected" [CBE] supplement. The court now thinks that the FDA's power to disapprove a label "does not make the manufacturer's voluntarily strengthened label a violation of federal law, which is what it would take to establish an actual conflict between state tort law and federal law.”  If the agency disapproves the revised label, the manufacturer simply stops distribution; there is no retroactive illegality.

The court’s new order rejected the FDA’s position that such failure to warn claims are preempted, calling the agency's position on preemption an "180-degree reversal" of its earlier stance. On reconsideration, the court thus gave "relatively little weight to the FDA's opinion on the preemptive effects of its regulations." In 2006, the FDA amended its regulations governing prescription drug labeling, clarifying the preemption of certain warning claims. The court adopted plaintiff’s argument that the 2006 Preamble was promulgated without notice-and-comment.

GSK argued that drug manufacturers will be forced to place scientifically unsubstantiated warnings on their drug products unless state law tort claims are preempted. But the causation requirements on plaintiffs will guard against this risk, the court said. In fact, thought the court, failure to warn litigation can reinforce the FDA's regulations, which already place the obligation to strengthen the warnings on a drug's label “squarely on the shoulders of the drug's manufacturer."  GSK's possible future risk of prosecution for distributing a misbranded drug would present a conflict only if GSK could say with absolute certainty that it will never have new evidence sufficient to trigger its regulatory obligations to revise its label to strengthen a warning with Paxil-specific language, but is forced to do so by state tort law, stated the new opinion.

Here’s why the new opinion got it wrong.
Regarding CBE, proposed changes in labeling typically are first submitted to the FDA for
approval. 21 C.F.R. § 314.70(a)-(d). A limited exception is with the use of a changes being effected supplement. 21 C.F.R. § 314.70(c). When a new safety issue emerges with a product, the pharmaceutical company may temporarily add to the product's labeling under this rule, which describes "changes that may be made before FDA approval." 21 C.F.R. § 314.70(c). Nonetheless, the FDA must still be notified and will subsequently review the modified labeling to ensure compliance with FDA regulations. In 1982, when the CBE procedure was proposed, the FDA stated, "these supplements would describe changes placed into effect to correct concerns about newly discovered risks from the use of the drug." 73 Fed. Reg. 2849 (Jan. 16, 2008) (quoting 47 Fed. Reg. 46622, 46623 (Oct. 19, 1982)). FDA’s longstanding position is that a CBE supplement “is appropriate to amend the labeling for an approved product only to reflect newly acquired information . . . to add or strengthen a contraindication, warning, precaution, or adverse reaction only if there is sufficient evidence of a causal association." 73 Fed. Reg. 2848 (Jan. 16, 2008). The FDA explicitly defines "newly acquired" as "data, analyses, or other information not previously submitted to the agency." Id. at 2850.

The holding of the court that any label change adding or strengthening warnings could always be made unilaterally, without FDA pre-approval, would lead to absurd and unreasonable results. If manufacturers were free to make unilateral changes to labeling the day after FDA’s approval based on information that was previously available to the agency, the approval process would be greatly undermined and the agency’s careful balancing of risks and benefits thwarted. And plaintiff’s proposed reading of the rule would require manufacturers to make the same CBE change over and over again – despite FDA rejection of the change – in order to avoid liability, because a jury would be free to say – despite the FDA decision – that the manufacturer was free to make the change anyway. It just doesn’t make any sense for the CBE process to permit (and thus obligate, under plaintiffs’ view), a manufacturer to ignore an FDA-mandated label by unilaterally changing the warning to something else. Plaintiffs' construction of the current CBE regulation would permit (and thus obligate) manufacturers to repeat such changes again and again, each time the FDA rejects the proposed change – all without any new scientific evidence to warrant any change at all. Plaintiffs could argue that the “weight” or “accumulation” of evidence required a label change, even as the FDA has rejected changes based on each individual “new” evidence. The only way to prevent the CBE exception from becoming a vehicle for ignoring FDA labeling decisions is to limit it to new information. Any changes to a drug’s labeling without prior FDA approval must be based on new information establishing that risks arising from use of the drug are of a different type or greater severity than the risks of which FDA had previously been made aware – not cumulative new information that does not add to the information that was previously available to the agency.

Second, since this part of the argument is about interpretation of the scope of the FDA’s own CBE regulation, government views concerning that regulation are entitled to substantial deference, not the little weight given. Judicial deference to administrative positions on preemption, typically expressed in amicus briefs, has more or less been the rule, rather than the exception.

Third, regarding the supposed “reinforcing” aspect of tort claims, the new decision in this case would allow a jury to determine whether an FDA-approved label adequately informs physicians about a medication's risks and benefits, as the label generally has to be found to be inadequate before the manufacturer can be held liable. This could result in a patchwork of labels/warning information that vary from state to state for no good reason – the science in Maine is the same in California, even if the juries are not. And this would place doctors and patients in an untenable position. Indeed, state common-law tort actions based on the manufacturers’ failure to warn present the pharmaceutical manufacturers with particular difficulties. State standards of care undoubtedly would differ from state to state. Absent a determination that the FDA-approved labeling and the FDA’s refusal to require the warnings suggested by plaintiffs in this case preempt state tort actions, the manufacturers may be subjected to considerable liability based on varying standards, with no benchmark that they should follow.

The FDA, rather than a jury, has the responsibility to determine whether the labels on medicines offered in the U.S. are appropriate. The FDA has actively monitored the possible association between SSRIs and suicide for nearly twenty years, and has concluded that the suicide warnings desired by plaintiffs are without sufficient scientific basis and would therefore be false and misleading. This claim of supposed harmony or reinforcement by tort law is belied by what the plaintiffs always ask for:  that state courts provide a check on agency power; that state juries be allowed to make their own judgment on whether the label was adequate; and that FDA approval of a label, or rejection of an alternate label, doesn’t mean anything to the company’s potential liability.

Finally, regarding misbranding, a pharmaceutical company that independently institutes a change in labeling may be subject to penalty or seizure if the drug is deemed misbranded by the FDA. See 21 U.S.C. § 333 (authorizing penalties); 21 U.S.C. § 334 (authorizing seizure); 21 C.F.R. § 7.45(a) (providing authority to request recall). And it has never been required, for a conflict to exist, to show how many times the federal law was applied, or how significant the sanctions were. That the federal agency has the legal power to enforce the federal rule is, and ought to be, sufficient.

In its next term, the U.S. Supreme Court will take up a preemption question in Wyeth v. Levine, and we may see if the court got it right the first time or the second time.

Preemption Decision In Toxic Tort Claims Under Railroad Safety Act

There has been significant discussion of preemption recently, particularly in the medical device and drug context. A recent decision under the Federal Railroad Safety Act offers some insight into potentially important aspects of the doctrine, and particularly when Congressional action may affect preemption.

In Lundeen v. Canadian Pac. Ry. Co., 2008 WL 2597958 (8th Cir. July 2, 2008), the Eighth Circuit confronted a situation in which a legislative amendment, which was retroactive to the date of the relevant incident, had the apparent effect of reinstating a suit which had been preempted.

In January, 2002, a freight train operated by Canadian Pacific Railway Co. derailed in North Dakota, releasing a cloud of anhydrous ammonia. Nearby residents sued in state court, alleging respiratory disease and eye damage. Defendants removed based on federal question jurisdiction, but plaintiffs amended their complaint to delete reference to federal law. The district court then ruled that the cases should be remanded to Minnesota state court. Canadian Pacific appealed the ruling, and the Eighth Circuit found that the claims were preempted under the Federal Railroad Safety Act. The cases were remanded to the district court, which dismissed on the merits.

Plaintiffs appealed, and while the appeal was pending, the Act was amended, retroactive to the date of the train derailment. The amendment stated that “nothing in this section shall be construed to preempt an action under State law seeking damages for personal injury, death, or property damage alleging that a party …has failed to comply with the Federal standard of care established by a regulation or order issued by the Secretary of Transportation (with respect to railroad safety matters), or … has failed to comply with a State law, regulation, or order that is not incompatible with [federal law].” This “clarifying” amendment reflected Congress's disagreement with the manner in which the courts, including the Eighth Circuit, had interpreted the Act to preempt state law causes of action whenever a federal regulation covered the same subject matter as the allegations of negligence in a state court lawsuit.

Defendants argued that applying the amendment here: 1) would violate the U.S. Constitution's separation of powers doctrine; 2) violate due process; 3) violate equal protection; and 4) violate the ex post facto clause.

The appeals court rejected the railroad's separation of powers argument, citing Plaut v. Spendthrift Farm, 514 U.S. 211 (1995), for the notion that the doctrine is violated only when Congress tries to apply new law to cases which have already reached a final judgment. Here, the amendment became effective while these cases were on appeal and had not reached final judgments. The Supreme Court has reiterated that Congress possesses the power to amend existing law even if the amendment affects the outcome of pending cases.

The court also denied the due process challenge. The railroad had the burden of showing there is no rational basis for the law. See FCC v. Beach Communications, Inc., 508 U.S. 307 (1993). Indeed, the court noted it reviews legislation regulating economic and business affairs under a “highly deferential rational basis” standard of review. The sufficient rational basis for the amendment, said the court, was to give railroad accident victims the right to seek recovery in state courts when they allege railroads violate safety standards. Prior to the amendment, the relevant section had been interpreted in such a way that an injured person’s state law claims were preempted. It was “rational” for Congress to clarify this result was not an intended purpose of the Act.

No equal rights violation was recognized despite the amendment imposing different standards on railroads that caused harm before and after the effective date. Every retroactive statute, by necessity, imposes different standards on parties affected by the statute, and those differences are directly tied to the statute's effective date.

Finally, the court said, the amendment does not violate the Ex Post Facto clause, because there is no proof that Congress intended the amendment as a criminal penalty. The Ex Post Facto clause applies only to criminal penalties, and clear proof is needed to support the argument that a civil remedy is so “punitive” in purpose or effect as to be in essence a criminal penalty.

In an interesting dissent, Judge Beam disagreed with the majority view of retroactivity. Because the case had already been up on appeal on an issue of federal jurisdiction there was a final decision that could not be undone by legislation.

Of more interest to readers of MassTortDefense is his argument that the court should have followed Riegel v. Medtronic, Inc., 128 S.Ct. 999 (2008) and its discussion of the preemption precedent established in Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992); Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996); and Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005).

“I concede that the MDA as discussed in Riegel deals with a product or service different from that of the FRSA. But, for preemption analysis, any differences are immaterial-the preemption language and the regulatory requirements are analogous. For federal preemption purposes, a medical device manufactured and marketed under a regime employing specific federal safety requirements is little different from a railroad service formulated and delivered under specific federal safety regulations. Thus, Riegel provides the precedent we must apply.”

And “Like the medical device in Riegel, the railroad service in Lundeen is entitled to be delivered free of state requirements that differ from the federal regime. And, when the amended statute is properly construed, the limited state cause of action authorized by FRSA II fits within that paradigm. So, with minor exceptions not applicable in Lundeen, all state railroad safety requirements that are in addition to or different from those established under FRSA II are preempted. Paraphrasing Justice Scalia's comment in Riegel, excluding North Dakota common law duties from the scope of the FRSA II preemption scheme would make little sense.”

Thus, the dissent argued that Congress had authorized the creation of a state cause of action, but at the same time carefully protected the concept of federal uniformity established by the Act. This cause of action is limited to allegations regarding the failure of a defendant to comply with the federal standards of care established by regulation or order issued by the Secretary of Transportation, or the failure to comply with a plan, rule or standard created pursuant to regulation or order of the Secretary. This limited claim for damages preserves the federal uniformity demanded by the FRSA. Accordingly, any state law cause of action permitting railroad liability based upon more expansive state-based requirements than those directly established by the Secretary's regulations, rules or orders, does not pass muster under the amended Act, said the dissent. 

Waxman Seeks Preemption Drafts From FDA

Preemption of state law claims, particularly in the area of medical devices and drugs, has been a hot topic lately. MassTortDefense has posted on it here and here, and there are numerous good posts on the topic at Drug and Device Law.

In the latest development, Congressman Henry A. Waxman (D-Calif.), Chair of the House Committee on Oversight and Government Reform recently sent a letter to Food and Drug Administration Commissioner Andrew C. von Eschenbach, requesting information about the agency's stance on federal preemption issues under the Bush administration.

The FDA believes, correctly, that state product liability lawsuits which challenge or undermine or invite conduct inconsistent with the federal agency's authority can have a detrimental effect on public health.  Waxman calls this a "reversal of FDA's long-standing position on preemption.”  Waxman’s view about the FDA’s position isn’t so firmly grounded, as seen in the back and forth between the majority and the dissent in Colacicco v. Apotex Inc., 2008 WL 927848 (3d Cir. Apr. 8, 2008), concerning whether the FDA has been “inconsistent” in its positions towards preemption. Going back to the Clinton era (Bill), for example, the FDA has repeatedly stated that FDA regulations may displace both state legislative requirements and state common law duties. In 2000, the FDA fretted that consumers in court would have to prove that harm was linked to the substance based on a standard that might vary by jurisdiction or at the “whim of a jury.” 65 Fed. Reg. 43269, 43278-79 (FDA July 13, 2000). And in an FDA final rule regarding FDA-mandated adverse event reports in state-law civil litigation, the agency stated that implied preemption was appropriate because state or local laws, rules, regulations, or other requirements would impede FDA’s ability to monitor product safety after approval to ensure that human drug products, biologics, and medical devices are safe and effective for their intended uses. “Thus, under principles of preemption law, congressional intent to preempt State law can be inferred.” 60 Fed. Reg. 16962, 16963 (FDA Apr. 3, 1995). See also 59 Fed. Reg. 3944, 3948 (FDA Jan. 27, 1994).

Nevertheless, Waxman is asking for numerous documents from the agency, including:

-all documents since Jan. 20, 2001, concerning communications between FDA and private individuals about preemption;
-all documents since that date, relating to internal FDA communications about preemption;
-all documents since Jan. 20, 2001, relating to communications between FDA officials and officials in the Department of HHS, the White House, and other federal agencies about preemption;
-all amicus briefs since Jan. 20, 2001, filed by FDA in product liability suits; and
-all drafts since that date of the final drug labeling rules issued Jan. 24, 2006.

Liberal Democrats in Congress have been buzzing about the Supreme Court’s decision in Riegel v. Medtronic Inc., in which the Court held that federal law preempted state-law claims against the manufacturer of a medical device that went through the Food and Drug Administration's premarket approval process. And they introduced H.R. 6381 that would reverse the effects of Riegel in medical device lawsuits. Waxman’s letter also comes in anticipation of the Court’s consideration of the extent to which the Food, Drug and Cosmetic Act impliedly preempts state law claims against drug makers. See Wyeth v. Levine, U.S., No. 06-1249, review granted 1/18/08. Of course, DOJ/FDA filed an amicus brief arguing in favor of preemption in that case.

Summary Judgment Ruling In New Jersey HRT Litigation

On July 11, 2008, the mass tort judge handling hormone replacement cases in New Jersey granted summary judgment dismissing Bailey v. Wyeth, No. L-999-06 MT (N.J. Super.), ruling that the labels used by defendants Wyeth and Upjohn were adequate as a matter of law. The failure to warn claims were dismissed because the plaintiffs could not overcome the presumption of adequacy of FDA-approved labels created by the New Jersey Products Liability Act (NJ PLA). The claims for fraud, negligent misrepresentation, and consumer fraud likewise failed because they are subsumed by the NJ PLA and could not be asserted as independent causes of action.

Because our firm is involved in HRT litigation, and because of past and current client relationships, MassTortDefense policy is to not offer extensive commentary on such decisions.  Here, however, for interested readers is the actual opinion.

Summary Judgment Ruling In New Jersey HRT Litigation

On July 11, 2008, the mass tort judge handling hormone replacement cases in New Jersey granted summary judgment dismissing Bailey v. Wyeth, No. L-999-06 MT (N.J. Super.), ruling that the labels used by defendants Wyeth and Upjohn were adequate as a matter of law. The failure to warn claims were dismissed because the plaintiffs could not overcome the presumption of adequacy of FDA-approved labels created by the New Jersey Products Liability Act (NJ PLA). The claims for fraud, negligent misrepresentation, and consumer fraud likewise failed because they are subsumed by the NJ PLA and could not be asserted as independent causes of action.

Because our firm is involved in HRT litigation, and because of past and current client relationships, MassTortDefense policy is to not offer extensive commentary on such decisions.  Here, however, for interested readers is the actual opinion.

Senate Judiciary Committee Holds Hearing on Preemption

The Senate Committee on the Judiciary recently held a hearing entitled “Short-Change for Consumers and Short-Shrift for Congress? The Supreme Court’s Treatment of Laws that Protect Americans’ Health, Safety, Jobs and Retirement.”

On June 11, 2008, the Committee discussed recent preemption decisions by the Supreme Court, and heard from several witnesses including consumers, academics, a representative of the United States Chamber of Commerce, and attorneys. See details here.

Committee Chair Senator Leahy (D. Vt.) took up the cry of Democrats who have suggested that the Supreme Court has narrowly interpreted the laws designed to protect Americans who rely on medical devices to keep them alive. This Supreme Court interpretation has transformed the law, he said, into one that takes away protections from people by extinguishing long-standing state law remedies which hold corporations accountable when they are aware of potential dangers but hide them from consumers. As a result, Americans are allegedly not only deprived of a remedy under state law but are offered no replacement remedy under Federal law.

Sen. Orrin Hatch’s questioning brought out the U.S. Supreme Court's decision in Riegel v. Medtronic, preempting state law claims relating to FDA approval of certain medical devices, was correctly decided. FDA approval of a device pre-marketing-approval application constitutes approval of the physical aspects of a device and its labeling, which results from a comprehensive review of the scientific and medical information relevant to the effectiveness and safety of the particular device. It also reflects FDA’s detailed resolution of tensions between aspects of the device that confer therapeutic benefits and aspects that present risks to safety.

Where the FDA has weighed the advantages and disadvantages of, and has approved, the design and labeling of a particular product, decision-makers applying state law should not be permitted to second-guess FDA’s approval, or re-weigh benefits and risks, or revise trade-offs FDA has already found acceptable, by finding the product’s design or labeling inadequate, Hatch was told.

Hatch noted that it would be difficult to characterize the Supreme Court's 8-1 decision as a ruling by an "activist" court. The court's decision was foreshadowed by prior Supreme Court and federal appeals court rulings.

The hearing was cut off before all witnesses testified live due to procedural issues in the Senate. Clearly, however, certain members of Congress are paying attention to the preemption issues.

Government Files Amicus Brief in Levine v. Wyeth

For those readers of MassTortDefense following the Levine v. Wyeth matter, here is the BRIEF FOR THE UNITED STATES AS AMICUS CURIAE SUPPORTING PETITIONER.

The agency, via the Solicitor General, argues that the FDA’s decision to approve a drug and its labeling reflects the agency’s expert evaluation of the health risks and benefits the product can provide; respondent’s claims are preempted because they challenge labeling that FDA approved after being informed of the relevant facts. When federal regulation is designed to strike a balance between competing risk/benefit considerations, state laws that strike a different balance are impliedly preempted because they interfere with the federal balancing. The amicus brief also notes that FDA’s labeling requirements do not qualify as a mere minimum safety standard, or floor, upon which state laws could add more stringent requirements.

The SG also addresses the Vermont Supreme Court’s conclusion that the FDA’s regulations allow drug manufacturers to easily change drug labels unilaterally. “Petitioner was not free to disregard FDA’s judgment concerning previously known risks.” Brief at 21. The “limited exception” to the general rule requiring FDA to approve any label changes requires submission of a supplemental new drug application to, albeit not prior approval by, the agency. And substantive changes may be made without prior FDA approval only to correct concerns about newly discovered risks from the use of the drug. If manufacturers were free to make unilateral changes to labeling the day after FDA’s approval based on information that was previously available to the agency, the approval process would be greatly undermined and the agency’s careful balancing of risks and benefits thwarted.

Wyeth Files Supreme Court Brief in Levine Case

Wyeth filed its brief yesterday in the U.S. Supreme Court in the Levine case, the closely-watched, much-anticipated, case regarding FDA preemption. The drug at issue is the company’s anti-nausea drug, Phenergan. Levine claims that the drug's labeling should have foreclosed IV push injection of Phenergan because of the risk of injury. Wyeth has argued that the FDA's approval of the Phenergan labels/warnings preempted any such state-law claims over the product.

In October 2006, the Vermont Supreme Court upheld a $7 million judgment for Levine and ordered Wyeth to modify the drug's label to reflect the alleged risk, citing a “presumption against preemption.”

The Supreme Court granted cert in January, and in the brief, Wyeth notes that the FDCA prohibited it from modifying the drug's label in most cases without approval from the FDA. Vermont law, by contrast, imposed a tort-law requirement that Wyeth alter that labeling (to foreclose IV administration) regardless of FDA action.

In the FDCA, Congress established a drug-approval regime in which an expert scientific agency makes uniform, national judgments about the safety and effectiveness of prescription drugs by balancing therapeutic benefits against safety risks ex ante, taking into account the interests of all potential patients. Wyeth argues that FDA struck precisely that type of balance in approving IV administration of Phenergan and in determining what warnings and instructions were appropriate to manage its associated risks.

Plaintiff has until August 1 to file the reply brief.

Congressional Committee Holds Hearing on Preemption

The House Committee on Oversight and Government Reform held a hearing last week entitled, “Should FDA Drug and Medical Device Regulation Bar State Liability Claims?” Chairman Waxman’s opening statement opined that preemption was a "radical legal doctrine" being advocated by the pharmaceutical and device industries and the Food and Drug Administration (FDA). Patients allegedly injured by defective drugs and medical devices would no longer have the ability to seek compensation. “The result is that one of the most powerful incentives for safety - the threat of liability - would vanish.”  Waxman and other Democrats are of the view that FDA approval of drugs and medical devices before they are marketed “does not necessarily guarantee safety.”

Of course, the politicos' simplistic view ignores the fundamental reality that prescription products are typically unavoidably unsafe. Nothing guarantees complete safety.  They are complex products that carry risks, at least to some users. That is why the FDA weighs the risks and benefits for an indicated population, and a learned intermediary – doctor – is needed to obtain the product, someone who can balance the risks with the benefits for the particular patient.

The hearing follows on the Supreme Court decision in Riegel v. Medtronic,128 S. Ct. 999 (2008), and in anticipation of the Court’s decision in Levine v. Wyeth.


The witnesses included some leading opponents of preemption, from actor Dennis Quaid (who has a suit against Baxter), former FDA official David Kessler, and an editor from the New England Journal of Medicine (who editorializes against preemption). No one from the industry was scheduled to appear, apparently. The only two witnesses in favor of preemption were buried in later witness panels.  This led Congressman Christopher Shays (R-Conn.) to note that the hearing was more about plaintiff lawyers than public health. 


Most of the press coverage focused on Quaid (MassTortDefense liked him in “The Rookie”), who urged Congress on Wednesday to preserve patients' rights to sue drug makers for injuries, and recounted the story of his newborn twins’ medical scare – which apparently resulted from human error at the hospital and was unrelated to the safety and efficacy of Baxter's product. "I believe if preemption of lawsuits is allowed to prevail, it will basically make all of us, the public, uninformed and uncompensated lab rats," Quaid said.


The FDA currently and correctly believes that the important decisions it makes about the safety, efficacy and labeling of medical products should not be second-guessed by state court juries.  But should the Supreme Court recognize the role of preemption in the Levine case, this is yet another sign that some in Congress may seek to take action to overturn any ruling in favor of the doctrine.


 

Rehearing Rejected in Colacicco

Although coming as no big surprise, it is good to note that the 3d Circuit refused to revisit its recent decision that federal law preempts claims against antidepressant manufacturers for failing to warn of suicide-related risks (Colacicco v. Apotex Inc., 3d Cir., No. 06-3107, 5/5/08).


Readers of MassTortDefense know that plaintiff Colacicco filed suit after his wife allegedly committed suicide while under treatment with a generic equivalent to Paxil. The EDPA found preemption. However, the DNJ reached the opposite conclusion in a claim by plaintiff McNellis, whose father allegedly committed suicide while taking Zoloft. Both decisions were appealed, and the appeals were consolidated. The Third Circuit's decision was the first by a federal appeals court to address the preemptive effect of prescription drug law and regulation since the FDA’s clarified guidance on the issue.


Plaintiffs sought a rehearing. Only two judges on the panel, including Judge Thomas L. Ambro, who dissented from the panel’s preemption decision, would have granted the petition for rehearing en banc. (Judge Fisher also would have granted the petition for rehearing en banc.)

Many eyes turn now to Wyeth v. Levine, in the US Supreme Court, on the crucial issue of preemption. 

Texas Supreme Court Relies On Riegel Analysis For Preemption Decision Under CPSA

In a recent posting, here, MassTortDefense examined the less than happy reaction of some members of the Arkansas Supreme Court to medical device preemption as defined by the U.S. Supreme Court. In Despain v. Bradburn, No. 07-714 2008 WL 1067202, (Ark., April 10, 2008), notions of “federalism,” the asserted importance of the common law, and the desire to compensate injured plaintiffs, compelled members of the court to decry (even as they applied) the guidance of the Supreme Court, and to call for the legislative reversal of the Riegel v. Medtronic,128 S. Ct. 999 (2008), decision.

A week later, the Texas Supreme Court decided an interesting preemption case, and relied on the rationale of Riegel to apply preemption outside the medical device area. Obviously, the government regulates the design and hazard communications of numerous other non-medical products for important safety reasons. And one of the things we love to do at MassTortDefense is point out how successful ideas in one mass tort may help in another significant product litigation as well. In Bic Pen Corp. v. Carter, 2008 WL 1765550 (Tex. Apr. 18, 2008), the Texas Supreme Court considered a case involving a disposable lighter and federal standards for child-proofing them promulgated by the CPSC.

Background

A six-year-old was severely burned when her five-year-old brother allegedly set fire to her dress with a J-26 model BIC lighter. Plaintiff claimed the injuries resulted from manufacturing and design defects in the J-26 lighter. The jury found for Carter, awarding three million dollars in actual damages and two million dollars in exemplary damages. A variety of issues were raised on appeal including spoliation and causation. But we focus here on preemption. The Court concluded that plaintiff’s manufacturing defect claim was not preempted, which simply asserted that the particular lighter involved in the case deviated “in its construction or quality” from the manufacturer’s design specifications. 2008 WL 1765550 at *6. It did not depend on standards different from what the CPSC had promulgated for child-proof lighters, and thus did not require a state court jury to set a state-law design standard that differed from the federal standard.

Design Defect

More interesting, however, is the Court’s conclusion that plaintiff’s design defect claim was preempted by federal law. The CPSC is charged with protecting the public against unreasonable risks of injuries from consumer products in the 1972 Consumer Product Safety Act. Specifically, the J-26 lighter is subject to the federal standards for child-proof lighters and must be certified as compliant by the Consumer Product Safety Commission. CPSC evaluated data regarding disposable lighters and promulgated regulations for child-proofing them. The Commission adopted regulations requiring disposable lighters to be child-resistant and setting a protocol for testing a lighter's child resistance. The regulations set forth specific requirements for compliance, and required the manufacturer to submit a description of all child-resistant features. The J-26 lighter underwent qualification testing in 1994. Bic completed the other requirements for the disposable lighter at issue in the case, and received a certificate of compliance from the CPSC.

In the Consumer Product Safety Act, Congress included both a preemption clause and a savings clause. The preemption clause states that no State “shall have any authority either to establish or to continue in effect any provision of a safety standard or regulation which prescribes any requirements as to the ... design” if it is “designed to deal with the same risk of injury” that the CPSC addressed through its regulations. 2008 WL 1765550 at *3. The savings clause, however, specifically allowed some common law tort lawsuits. The Texas Supreme Court considered the interplay between saving clauses and express preemption provisions based on the guidance of Geier v. American Honda Motor Co., 529 U.S. 861, 869-73 (2000). The combination of express preemption and savings clauses do not bar the ordinary working of conflict preemption principles. If the state law claim conflicts with federal regulations, it is still preempted. Because Carter maintained that the J-26 lighter was unreasonably dangerous under common law because more effective child-resistant lighter designs were available, the issue for preemption purposes was whether Carter's claim of a need for a higher standard of child resistance under the common law is compatible with federal regulation under the CPSA.

The opinion noted that one other trial court had rejected implied preemption in a child-proof lighter case, Colon v. BIC USA, Inc., 136 F. Supp. 2d 196 (S.D.N.Y. 2000), with the reasoning that the goal of reducing injuries to children was best served by supplementing the federal minimum standard on a case-by-case basis, according to the stricter requirements, if any, imposed by state common law. See id. at 209.

Analysis of the Regulatory Scheme

However, the Texas Court found preemption. Analyzing the CPSC scheme, the Court noted that the Commission weighed several factors, including child resistance, overall safety, the realities of manufacturing, the variability and randomness of child testing, the product's utility, and the importance of consumer acceptance. Indeed, one of the CPSC's primary objectives was to create a standard that encouraged the manufacture of child-resistant lighters and yet did not discourage adults from using them. The Commission was concerned that if adults were unable or unwilling to use child-resistant lighters, they might switch to non-child-resistant lighters or matches, which could expose children to an even greater risk. 2008 WL 1765550 at *4. The Commission, moreover, was aware that greater child resistance might be achieved but specifically rejected imposing higher standards, finding that a higher standard would reduce the utility and convenience of the product and increase costs disproportionate to the benefits.

Thus, interpreting federal regulation in this area merely as a liability floor that may be enhanced by state law, as plaintiff argued, undercut the federal regulations and the Commission's conclusion that the chosen standard “strikes a reasonable balance between improved safety for a substantial majority of young children and other potential fire victims and the potential for adverse competitive effects and manufacturing disruption.” Id. at *4. As the Commission judged, a stricter design requirement might “on its face, appear to increase safety,”  but the practical effect would be otherwise. Id.

Riegel Analysis Relevant

Although Riegel addressed an express preemption provision, the Texas court found its policy analysis applicable here, id. at *6, in part because both cases involved a balancing of factors by the regulators that ensure the product meets carefully prescribed safety standards. Significantly, the Texas Court quoted the Supreme Court’s admonition that that tort law, applied by juries under a negligence or strict-liability standard, is less deserving of preservation that state regulation, because it does not include the cost-benefit analysis similar to that applied by the experts at the FDA. Instead, a jury sees only the cost of a more dangerous design, and is not concerned with its benefits. Id. at *5.

Particularly where a federal agency has balanced the relevant factors and rejected the idea of more stringent standards, this case is more support for the notion that under Riegel a common-law tort claim could impose duties that conflict with the federal regulatory scheme and therefore would stand as an obstacle to the accomplishment and execution of the full purpose and objections of Congress, even outside the medical device area.

Arkansas Supreme Court Reluctantly Applies Riegel

Much has been written about the U.S. Supreme Court decision in Riegel v. Medtronic Inc., 128 S.Ct. 999 (2008), in which the Court found preempted the design and warnings claims made by plaintiff concerning a medical device regulated by the FDA pursuant to the MDA. And MassTortDefense thought it might be interesting to also not how some lower courts are dealing with the decision.

In Despain v. Bradburn, No. 07-714, 2008 WL 1067202, (Ark., April 10, 2008), the Arkansas state supreme court revisited the attempt of plaintiff to recover damages allegedly suffered as the result of a defective hearing device. Despain alleged that the hearing device was defective because of the way it reacted to a strong magnetic field and that defendant failed to adequately warn Despain of this danger. “He does not allege that any particular part of the device should have been designed in any specific [other] manner.”

Previous Ruling

The Arkansas Court had just ruled in February that the lower court had erroneously granted summary judgment for defendant in plaintiff's state law tort suit. See 2008 WL 324356, Ark., February 07, 2008. The state supreme court expressly ruled that the Medical Device Amendments (MDA) to the federal Food, Drug and Cosmetic Act did not preempt Despain's claims. The state high court, noting a perceived presumption against preemption, asserted that the general state common-law requirements in this suit were not specifically developed “with respect to” medical devices. Accordingly, they are not the kinds of requirements that Congress and the FDA feared would impede the ability of federal regulators to implement and enforce specific federal requirements.

But Riegel

A few weeks later, the U.S. Supreme Court reached the opposite conclusion. Common law liability is premised on the existence of a legal duty, and thus a tort judgments establishes that the defendant has violated a state-law obligation. 128 S.Ct. at 1108. An award of damages can be, and is designed to be, a potent method of governing conduct and controlling policy. State law that requires a manufacturer to change a design, making the product safer but less effective than the design approved by the FDA disrupts the federal scheme, whether it be through tort judgments mandated by application of the common law or a specific state regulation. State juries, however, do not conduct an FDA-like risk-benefit analysis. A jury sees only the cost of the more dangerous design, and is not concerned with its benefits, as the patients who reaped the benefit of the existing demand are not before the court. Id. 

Rehearing
The defendant petitioned for rehearing in light of Riegel. The Arkansas high court, in an opinion by Justice Glaze, granted the petition. The earlier opinion had reasoned that the defendant had not provided evidence of any federal device-specific requirements related to the hearing device and nothing in the complaint would have required specific changes in the way the device was designed or manufactured. Those arguments had been rejected.
Chief Justice Hannah, joined by Justice Brown, concurred in the opinion granting the petition for rehearing, noting that the U.S. Supreme Court is, of course, "the court of last resort” on questions of whether United States Congressional acts preempt state law.


Now the more interesting part of the opinion…. C.J. Hannah, concurring, expressed "deep concern" with Riegel. While clearly the MDA preempts states from setting up regulatory systems that compete with the regulatory systems set up by the federal government under the MDA, the state's common law on tort is no such regulatory system. “It does not compete with the MDA,” according to the Chief Justice. He disagreed with the core premise underlying the Riegel decision that common-law tort damages constitute requirements preempted under the MDA because the award of damages may affect how medical devices are designed, manufactured, and sold. He though unfounded the “fear that changes made by medical device providers as a consequence of tort damage suits will be made based on what must be done to avoid future tort damages as opposed to increasing safety and effectiveness.” He disagreed with the Supreme Court’s belief “that the FDA is more reliable than juries in dealing with the issue of defective medical devices.”

He suggested the need for actual evidence to show that a state used its common-law tort damages as a means to set requirements for the safety and effectiveness of medical devices. “Arkansas does not use common-law tort damages as a means to set requirements for the safety and effectiveness of medical devices. Arkansas has no special tort law that applies only to medical devices. The tort law that applies to medical devices in Arkansas applies to any other causes of action in tort.”

The justice was “also compelled to express dismay at the summary abandonment of venerable principles of state common law that have been developed over many generations. By a conclusory and incomplete analysis, our law is dismissed. In the place of well-reasoned judicial decisions reaching back to the England of Blackstone, injured plaintiffs are told that instead of looking to their common law for redress they must look to a regulatory agency that has no power to grant them any redress.”

After extolling the virtues of the venerable common law, the opinion argues that preemption undermines “the MDA, which was enacted to protect the public against defective and unsafe medical devices through federal regulation.” He then deplores the “injury done to the ….principles of federalism [which] will not be so easily healed.”

The opinion concludes with a prediction that the United States Congress will step in to amend the MDA and “heal the injury caused in this case.” (Indeed, Senator Kennedy and Representative Waxman have already proposed that Congress reverse the decision. See Medical Device Safety Act of 2008.)

While the Arkansas court got the ultimate decision right, the language of the concurrence ought to be of continuing concern to product makers. MassTortDefense was once involved in a case in which a trial judge refused to grant a valid motion in limine because the preemption doctrine “boggles the mind and boils the blood.” The resistance to the notion that federal law is the supreme law of the land continues in many legal circles. Notions of “federalism” – read states’ rights-- the asserted importance of the common law, and the desire to compensate injured plaintiffs may compel many lower courts to resist the guidance of the Supreme Court, to narrow the scope of the such preemption rulings, to force defendants to fight for every application of the rule, and to look with skepticism at attempts to base preemption motions on the policies and reasoning of the Supreme Court decision.