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).

 

Coffee's On: Claims Dismissed in Single-Cup Brewing Class Litigation

A federal court last week dismissed the claims in a case accusing Green Mountain Coffee Roasters of misrepresenting the performance quality of its single-cup brewing systems. See Green v. Green Mountain Coffee Roasters Inc., et al., 2011 WL 6372617 (12/20/12 D.N.J.).

Your humble blogger is in the minority, not being a coffee drinker. Nearly 60% of adults drink coffee daily. The average American drinks 3.1 cups of coffee each day. This contributes to an $18 billion U.S. coffee market. One of the tremendous innovations (speaking from experience, having given these as holiday gifts) in the market is the single cup brewing machine for the home, allowing coffee lovers to make less than a full pot, and to choose from among hundreds of flavors and brands of coffee-related beverages.

Defendants are in the specialty coffee and coffee maker businesses. They manufacture single-cup brewers, accessories and coffee, tea, cocoa and other beverages in "K–Cup portion packs.” Plaintiff Green maintained that his machine failed to brew the programmed amounts of K–Cup coffee within a few weeks of use. Plaintiff asserted that the machines had defective components, including defective pumps. As a result, the machines allegedly failed and brewed less than the specified amount. Furthemore, this defect allegedly caused consumers to use additional K–Cups to brew a single beverage. 

Plaintiff maintained that defendants' actions were in violation of the New Jersey Consumer Fraud Act (“CFA”), N.J. Stat. Ann. § 56:8–1, et seq., and constituted a breach of implied warranty. 

Defendants moved to dismiss.  The court noted that threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice under Ashcroft v. Iqbal, 556 U.S. 662 (2009), and Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007).  If the well-pleaded facts do not permit the court to infer more than the mere possibility of misconduct, the complaint should be dismissed for failing to show that the pleader is entitled to relief. A plaintiff's obligation to provide the grounds of his entitlement to relief requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do. 

The motion challenged plaintiffs' standing. To have standing, the plaintiff must have suffered an injury in fact—an invasion of a legally protected interest which is (a) concrete and particularized, and (b) actual or imminent, not conjectural or hypothetical. Second, there must be a causal connection between the injury and the conduct complained of—the injury has to be fairly traceable to the challenged action of the defendant, and not the result of the independent action of some third party not before the court. Third, it must be likely, as opposed to merely speculative, that the injury will be redressed by a favorable decision.  The injury-in-fact element is often determinative.

The injury must affect the plaintiff in a personal and individual way.  Here, Green alleged that he purchased and used the Keurig Platinum Brewing System (model series B70).  Nevertheless, he sought to represent all individuals in New Jersey who “purchased or received”  a variety of Keurig Brewing Systems. Plaintiff did not have standing to pursue a claim that products he neither purchased nor used did not work as advertised.

Regarding that model series B70, plaintiff contended in his complaint that, because of defective components, the coffee machines at issue brew a lesser amount of coffee than the companies represented, compromising the quality of the beverage. Consumers are then forced to use additional K-Cups, which are a portion pack for the systems, according to the complaint. Defendants maintained that even if their alleged conduct was unlawful, plaintiff had not sufficiently pled ascertainable loss.  In a misrepresentation case, a plaintiff generally may show ascertainable loss by either out-of-pocket loss or a demonstration of loss in value.  In this case, Green did not allege that he made a claim for warranty repair or replacement of his machine.  The warranty provided as part of the contract of sale is part of the benefit of the bargain between the parties. Any defects that arise and are addressed by warranty, at no cost to the consumer, do not provide the predicate loss that the CFA expressly requires for a private claim.  Because plaintiff had not availed himself of defendants' warranty, he could not allege that the warranty does not address the defect in his machine.

Furthermore, the court found unpersuasive plaintiff's argument that the warranty did not address the defects in the brewers because other consumers allegedly reported that their replaced or repaired brewers were equally defective.  Allegations regarding the experience of absent members of the putative class, in general, cannot fulfill the requirement of pleading injury with adequate specificity.

Similarly, plaintiff did not sufficiently plead loss in value.   Plaintiff broadly asserted that he suffered a loss because each brewer failed to perform its advertised purpose and caused purchasers to suffer a loss of value of the product. But Green failed to allege how much he paid for his brewer and how much other comparable brewers manufactured by competitors cost at the time of purchase. Furthermore, Green had not suffered a diminution in value because the defective brewer could have been repaired or replaced with a new brewer which would have had its own one-year warranty.


Regarding the implied warranty claim, the general purpose of the brewers is to brew beverages. Even if defendants may have advertised that the machines would brew a specific amount of beverage, that alone did not transform the “general” purpose.  Green did not allege that his machine would not brew coffee or that it was inoperable.  The complaint was also devoid of any allegation that plaintiff can no longer use his brewer. Therefore, Green had not sufficiently alleged that his brewer was unfit for its ordinary purpose of brewing beverages at the time of purchase.

Defendants also contended that the class allegations should be dismissed. Plaintiff argued that the Court should deny the motion because it was premature. Nevertheless, a court may strike class action allegations in those cases where the complaint itself demonstrates that the requirements for maintaining a class action cannot be met.  Here, the court concluded that the plaintiff could not  meet the predominance requirement set forth in Fed.R.Civ.P. 23(b).

The complaint did not allege that all individuals in New Jersey who purchased the Keurig Brewing Systems had experienced the defect. Plaintiff acknowledged that there were members in the putative class who had not yet suffered the alleged pump failure. Consequently, the putative class included individuals who do not presently have a claim against defendants. Proving that defendants breached the implied warranty of merchantability would also require an individualized inquiry. Not every member of the putative class experienced a defect with the model series B70. Even if the purported defect had manifested in all of the brewers purchased within the class period, the court would have to make individual inquiries as to the cause and extent of the defect.  Motion granted. 

 

Strict Liability Does Not Apply to Medical Devices

Another court has recognized that strict liability or breach of implied warranty claims do not lie against medical device makers. Horsmon v. Zimmer Holdings Inc., No. 11-1050 (W.D. Pa., 11/10/11).

Plaintiff had a total hip replacement whereby her right hip joint was replaced with implant components designed, manufactured, and sold by defendants. Ms. Horsmon alleeged she later began to experience pain in her right hip, which eventually required further surgery. She alleged this was due to a defect in the original liner that was used during the hip replacement.  She sued, and defendants moved to dismiss.

Defendants asserted that plaintiff‟s claim for strict liability was barred by Pennsylvania law. The Supreme Court of Pennsylvania in Hahn v. Richter, 673 A.2d 888 (Pa. 1996), held that strict liability claims cannot be brought against prescription drug manufacturers. The court relied on Comment k to the Restatement (Second) of Torts § 402A, regarding unavoidably unsafe products. The Superior Court of Pennsylvania and several United States District Courts applying Pennsylvania law have extended Hahn to bar strict liability claims against medical device manufacturers. E.g., Creazzo v. Medtronic, Inc., 903 A.2d 24, 31 (Pa. Super. Ct. 2006).  This court agreed that the reasoning of Hahn extends to medical devices.

Defendants further asserted that plaintiff's breach of implied warranties claim was also barred by Pennsylvania law. In a claim for breach of implied warranty of merchantability, the essence of the warranty of merchantability is that the item sold is fit for the ordinary purposes for which such goods are used. Under Pennsylvania law, the very nature of prescription drugs precludes the imposition of a warranty of fitness for ordinary purposes, as each individual for whom they are prescribed is a unique organism who must be examined by a physician who is aware of the nature of the patient's condition as well as the medical history of the patient. Breach of implied warranty of merchantability claims, therefore, are precluded for prescription drugs. Again, several courts have extended this reasoning to preclude claims against medical device manufacturers for breach of implied warranties of merchantability and fitness for a particular purpose.  And the district court here agreed; there was no compelling reason to distinguish between prescription drugs and medical devices.

The court then turned to the express warranty claim. Under Pennsylvania law, any affirmation of fact or promise made by the seller to the buyer which relates to the goods and becomes part of the basis of the bargain creates an express warranty that the goods shall conform to the affirmation or promise.  Here, plaintiff alleged that defendants expressly warranted in written literature, advertisements and representations of representatives and agents that the systems, bone screws, liners and other related components were safe, effective, fit, and proper for the use for which they were intended. But plaintiff did not allege any particular affirmation of fact or promise, as required under federal pleading rules, that would give rise to a reasonable inference that defendants expressly warranted that its products were safe, effective, fit, and proper for the use for which they were intended. Plaintiff failed to allege that any particular affirmation of fact or promise was made in any of those sources.  Plaintiff's allegations also did not support a reasonable inference that any affirmation of fact or promise by defendants became part of the basis of the bargain in plaintiff's purchase. (Of course, plaintiff could not allege that any particular affirmation of fact or promise became “part of the basis of the bargain” without alleging any particular affirmation of fact or promise.)  Thus, plaintiff failed to state a plausible claim for breach of express warranties under Pennsylvania law. (However, the court gave Horsmon another chance to amend and replead her breach of express warranty claim.)

 

Choice of Law Defeats Another Proposed Nationwide Consumer Fraud Class

A federal court recently ruled that a suit over alleged defects in an MP3 player's display screen could not proceed as a nationwide class action. See Maloney et al. v. Microsoft Corp., No. 3:09-cv-02047 (D.N.J.).

This dispute arose out of the sale of portable MP3 players, the 30 gb model Zune. Plaintiffs alleged that the 30gb-model Zune was defective because of alleged cracks on the liquid crystal display (LCD) screen. (News flash: if you drop an electronic device, it may crack.)

Plaintiffs moved for class certification, pursuant to Fed. R. Civ. P. 23(b)(3), of a national class of purchasers. The court concluded that each state‘s common law and consumer protection laws would apply, and therefore a nation-wide class could not properly be certified.

Attempts to structure and certify nation-wide classes involving plaintiffs in all fifty states often turn on whether the law of a single state or multiple states should be applied.  If all 50 states‘ laws apply to a class-action claim, the moving party must provide an extensive analysis of state law variances showing that class certification does not present insuperable obstacles. Plaintiffs bear this burden at the class certification stage, and rarely (we'd say never) can meet it.  Many courts have recognized that state implied warranty laws differ in significant and material ways. For example, states differ on: (1) application of the parole evidence rule; (2) burdens of proof; (3) statute of limitations; (4) whether plaintiffs must demonstrate reliance; (5) whether plaintiffs must provide notice of breach; (6) whether there must be privity of contract; (7) whether plaintiffs can recover for unmanifested defects; (8) whether merchantability may be presumed; and (9) whether warranty protections extend to used goods.

New Jersey courts have adopted the most significant relationship test of the Restatement (Second) of Conflicts of Law. Before applying the Restatement test, plaintiffs here contended that a choice-of-law clause contained in the limited warranty accompanying the product should apply to all of the claims. However, the court determined that the choice-of-law provision did not apply to any of plaintiffs‘ claims. First, the implied warranty claims asserted by the plaintiffs were not governed by the choice-of-law provision in the express warranty. As a plain reading of the text of the express warranty made clear, the choice-of-law provision applies only to the limited warranty, i.e., the express warranty.

To evade this plain reading of the express warranty, plaintiffs then attempted to shoehorn their implied warranty claims into the choice-of-law clause by conflating their implied warranty and Magnoson-Moss (MMWA) claims. Plaintiffs‘ argument was untenable because ultimately plaintiffs‘ MMWA claims rely on their implied-warranty claims, not violations of federal law. State warranty law lies at the base of all warranty claims under Magnuson-Moss. Plaintiffs wrongfully confused substantive MMWA violations and the right to recover under the MMWA.

Although federal substantive law—and not state law—prevents a seller from disclaiming implied warranties, plaintiffs‘ ultimate right to recover on their MMWA claims still depended on state law. When a defendant improperly disclaims an implied warranty, the MMWA provides a statutory remedy: such disclaimer would be void and plaintiffs would be able to proceed against defendant on breach of implied warranties claims, under state law.  Similarly, the choice-of-law provision contained in the limited warranty did not apply to plaintiffs‘ consumer-fraud claims.

Having determined that the choice-of-law provision in the limited warranty did not apply to any of the plaintiffs‘ claims, the court then applied  the choice-of-law rules of the State of New Jersey.  Considering all of the Restatement factors, the court concluded that the state with the most significant relationship to the implied warranty claims was each class member‘s home state.
First, the place of contracting occurred wherever each class member purchased their 30gb Zune, which was presumably in their home state. Second, there was no negotiation of the implied warranties. Third, the place of performance also occurred wherever each class member purchased their 30gb Zune. Fourth, the location of the subject matter of the implied warranties is wherever the Zune was physically located, also presumably in each class member‘s home state. Finally, the domicile of the plaintiffs varies between each class member. Weighing these considerations, the state with the most significant relationship to the implied warranty claims—and consequently, the MMWA claims— was each class members‘ home state.

Plaintiffs‘ consumer-fraud claims would also be governed by the laws of each class member‘s home state.  In this case, the place, or places, where the plaintiff acted in reliance upon the defendant‘s supposed representations; the place where the plaintiff received the alleged representations; the place where a tangible thing which is the subject of the transaction between the parties was situated at the time; and the place where the plaintiff is to render performance under a contract which he has been induced to enter by the alleged false representations of the defendant—all weighed in favor of applying the consumer fraud laws of each class member‘s home state.

In light of the court‘s determination that the laws of all 50 states apply to the claims, and because plaintiffs suggested no workable means by which to conduct a manageable trial—let alone the extensive analysis required of them—class certification was denied on a nation-wide basis. (The court reserved decision as to whether or not a New Jersey-wide class might be certified, subject to further briefing by the parties; clearly additional individual issues will predominate in that context as well, we predict at MassTortDefense.)


 

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?