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.


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.

5th Circuit Clarifies Heeding Presumption in Learned Intermediary Case

In a previous post, MassTortDefense began analysis of the 5th Circuit's decision in Ackermann v. Wyeth Pharmaceuticals, 2008 WL 1821379 (5th Cir, April 24, 2008), in which the Fifth Circuit addressed a couple of very important issues affecting the learned intermediary doctrine. The Court emphasized that the prescriber testified that he reviewed the plaintiff’s proposed “fuller” warning, concluding that if the proposed warning had been communicated to him effectively and in a prominent manner before he prescribed Effexor to plaintiff, he would have considered it, but it would not have changed his prescription decision. What about the heeding presumption?

Heeding Presumption 

Appellant also contended that, regardless of Dr. Sonn’s testimony, Texas law created a presumption supporting a causal link between Wyeth’s inadequate warning and her husband’s death. The Court rejected that broad argument: Texas law creates no such presumption. In general, when a manufacturer fails to give adequate warnings or instructions, a rebuttable presumption arises that the product user would have read and heeded such warnings or instructions (the “read and heed” presumption). This presumption’s effect is to shift the burden of producing evidence to the party against whom it operates. But, significantly, the Court found that neither Texas nor federal courts applying Texas law have applied the read-and-heed presumption to pharmaceutical cases involving learned intermediaries. In fact, Texas has explicitly rejected the Restatement (Second) of Torts  § 402A, Comment j’s “read-and-heed” presumption for policy reasons, and because it has been superseded by the Third Restatement  § 2. See Uniroyal Goodrich Tire Co. v. Martinez, 977 S.W.2d 328, 336–37 (Tex. 1998). 2008 WL 1821379 *6. [Indeed the comment 1 to Section 2 calls the prior language “unfortunate.”]

Further, the Fifth Circuit doubted that the Texas Supreme Court would apply such a presumption here, when it would not serve its intended purposes. The read-and heed presumption has been justified because it excuses plaintiff from the necessity of making self-serving assertions that he would have followed adequate instructions, simply to put the issue of causation in sufficient dispute to avoid summary judgment or directed verdict, and it assists plaintiffs in cases where the person injured has died and evidence of what he would have done is unavailable for that reason. In the learned-intermediary context, however, it is the prescribing physician, not plaintiff, who has to testify about his or her decision to prescribe. 2008 WL 1821379 *7.

Moreover, MassTortDefense would point out that applying the read and heed presumption to prescription product contexts confuses two very different warnings: unavoidable risk warnings, and preventable risk warnings. The latter describe risks that can be avoided by the consumer by using a product in certain manner. The former, however, associated with prescription products, can only be avoided if the consumer chooses not to use the product at all. Thus, the question becomes whether the potential benefit of the prescription product outweighs a potential risk. The choice is not between a safe, or less safe use, or unsafe use, of the product, but whether to use the product at all. With prescription products, the FDA has determined that for indicated populations, the risks do not outweigh the benefits. A good albeit older discussion of why the heeding presumption doesn't make sense in this context is found in Thomas v. Hoffman-LaRoche, 949 F.2d 806, 812-14 (5th Cir. 1992).

Further, even if the presumption applied, it arguably would not have changed the result here. It is a rebuttable presumption, and Dr. Sonn remained firm in stating that even if Ackermann’s proposed “black box” warning had been given to him, he would have considered it -- but it would not have changed his decision to prescribe Effexor. For all these reasons, the Fifth Circuit concluded that the district court properly granted summary judgment to Wyeth on appellant’s failure-to-warn and strict-liability claims because she failed to show that an inadequate warning was a producing cause of her husband’s death.

5th Circuit Clarifies Learned Intermediary Doctrine and Heeding Presumption

In Ackermann v. Wyeth Pharmaceuticals, 2008 WL 1821379 (5th Cir, April 24, 2008), the Fifth Circuit addressed a couple of very important issues affecting the learned intermediary doctrine. Readers of MassTortDefense recognize that the LI doctrine is an important exception to the rule that a manufacturer must warn the end user or consumer of its product. In the case of prescription drugs and medical devices, which a patient may receive through the advice and with the permission of a prescribing physician, the duty to warn extends to this learned intermediary, who in turn uses his or her expertise, judgment, and knowledge of the specific patient, to decide not only which product the patient should receive, but which aspects of the long and detailed warning information should be emphasized with the patient.

Background of Decision

In Ackermman, plaintiff’s decedent alleged that defendant Wyeth failed adequately to warn about the drug-induced risk of suicide from its drug Effexor, and this deficiency led to her husband’s suicide. Effexor is a member of the class of drugs referred to as “selective serotonin and norepinephrine reuptake inhibitors” (“SNRI”). SNRIs are used to treat major depressive disorder, obsessive-compulsive disorder, panic disorder, premenstrual dysphoric disorder, and social anxiety disorder. The FDA generally groups Effexor with the selective serotonin reuptake inhibitor (“SSRI”) class of antidepressants, which includes Celexa, Prozac, Paxil, and Zoloft.

Plaintiff apparently suffered from clinical depression brought on by severe business and family problems. Martin sought treatment from psychiatrist Dr. Thomas Sonn on January 4, 2002. Martin saw Dr. Sonn four times in the following eight days. During that time, Dr. Sonn changed Martin’s medication to Effexor. On January 12, Martin complained to Dr. Sonn of various side effects he attributed to Effexor, including anxiety. Martin announced he would no longer take the medication. Dr. Sonn changed Martin’s medication from Effexor to Celexa because of the apparent side effects. Plaintiff terminated his relationship with Dr. Sonn. Nevertheless, Martin continued to take Celexa for five days until January 17, 2002, when he apparently committed suicide with a revolver. At the time of his death, Martin had detectable levels of Celexa, but not Effexor, in his bloodstream. 2008 WL 1821379 *1.

Dr. Sonn testified at deposition that he believed the package insert for Effexor as it existed in January 2002 adequately warned him of the risks of suicide and that he would continue to prescribe the drug to depressed patients. Wyeth filed for summary judgment, which was granted by the district court on the basis of the learned intermediary doctrine.

The Learned Intermdiary Doctrine

The Fifth Circuit noted that under the doctrine, a patient-purchaser’s doctor stands between the patient and the manufacturer, professionally evaluating the patient’s needs, assessing the risks and benefits of available drugs, prescribing one, and supervising its use. If the doctor is properly warned of the possibility of a side effect and is advised of the symptoms normally accompanying the side effect, it is anticipated that injury to the patient will be avoided. Accordingly, the doctrine excuses a drug manufacturer “from warning each patient who receives the product when the manufacturer properly warns the prescribing physician of the product’s dangers.” Porterfield v. Ethicon, Inc., 183 F.3d 464, 467–68 (5th Cir. 1999). Under Texas law, the learned-intermediary doctrine is not an affirmative defense, but it delineates to whom a defendant owes the duty to warn. 2008 WL 1821379 *2-3.

To recover for failure to warn under this doctrine, a plaintiff typically must show that (1) the warning was defective, and (2) the failure to warn was a producing cause of the injury. In other words, under Texas law, a plaintiff who complains that a prescription drug warning is inadequate must also show that the alleged inadequacy caused her doctor to prescribe the drug for her. If the physician was aware of the possible risks involved in the use of the product but decided to use it anyway, the adequacy of the warning is not a producing cause of the injury and the plaintiff’s recovery must be denied. And even if the physician is not aware of a risk, the plaintiff must show that a proper warning would have changed the decision of the treating physician, i.e., that but for the inadequate warning, the treating physician would have not used or prescribed the product. 2008 WL 1821379 *3.

Application To The Facts

Applying that review to the facts here, the Fifth Circuit noted that the January 2002 package insert warning mentions the risk for suicide twice, cautions that close supervision of high-risk patients should accompany initial drug therapy, and identifies the frequencies of suicidal behavior observed in patients taking Effexor. Even if not as explicit as plaintiff demanded post hoc, taken all together, the insert’s discussions of suicide establish that at least some risk of suicide exists when a patient takes Effexor.

The Court allowed the possibility that some issue of fact could be made out about whether the defendant’s characterization of the infrequent risks, was within a requisite degree of accuracy or was misleading. 2008 WL 1821379 *4.

However, the appeal could be resolved on the second prong of the analysis, namely, whether any defect in the Effexor warning was a substantial cause of Martin’s death. There must be a genuine issue of material fact whether the physician, here Dr. Sonn, would have prescribed Effexor even had the warning been “adequate” in plaintiff's terms. Here the court had to look at Dr. Sonn’s testimony about the certainty of his decision to prescribe Effexor, and alternatively, at the so-called “read-and-heed” presumption presuming that when an adequate warning is given by the manufacturer, it is heeded by the learned intermediary. 

Prescriber Testimony Key

Dr. Sonn testified that he reviewed the plaintiff’s proposed “fuller” warning, concluding that if the [proposed] warning had been communicated to him effectively and in a prominent manner before he prescribed Effexor to plaintiff, he would have considered it “but it would not have changed my decision to prescribe Effexor XR to Martin Ackermann to treat his depression, beginning with low-dose pills. It also would have not changed my decision to monitor and observe Martin Ackermann closely for suicide-related risks as I did… and as I did with Martin Ackermann, I would address the suicide-related risks reflected in that warning by close monitoring and observation, rather than through discussions with the patient expressly mentioning the risk of suicide or drug-triggered suicide.” 2008 WL 1821379 *5.

The Court rejected plaintiff’s argument that this was somehow contradictory testimony; his testimony was unequivocal. That he said he would have read it and heeded it did not mean anything other than he would have considered it, would have included it in his decision-making calculus. In his deposition and in his later declaration, Dr. Sonn affirmed that he would have prescribed Effexor to Martin and adhered to the treatment regimen he used regardless whether he had received the proposed stronger warning. In December 2005, he testified that he would not have warned Martin about the possibility of an increased risk of suicide primarily based on his belief that the suggestion would either plant seeds in the patient’s mind that suicide was an option or would discourage the patient from pursuing pharmacological treatment. And that, MassTortDefense readers, is a crucial notion. Any argument from the plaintiff that the prescriber was or would be legally required to pore over all the details of the warnings with a sick patient [and thus scare plaintiff into not taking the drug] is fundamentally inconsistent with the ethical duties of the physician.

Dr. Sonn was also asked to review the warning label accompanying Effexor that was in effect at the time of his deposition in December 2005, which included a “black box” warning for potential increased suicide in children and adolescents. When asked a follow-up question about a proposed similar warning for adults, Dr. Sonn reiterated his prior testimony and confirmed that it would not have changed his decision to prescribe Effexor XR to Martin Ackermann to treat his depression.

Because she construed this as a “no warnings” case, plaintiff's decedent argued that Wyeth completely sabotaged the intermediary, who, in turn, failed to warn of the risk of suicide. For this reason, she viewed Dr. Sonn’s testimony that he would have given a required warning to mean, “if Wyeth had given me a better warning, I would have warned.” This interpretation, however, is incompatible with Dr. Sonn’s testimony that his treatment protocol would not have changed and he still would have prescribed Effexor regardless of the warning given by the manufacturer.

This part of the decision is consistent with some other useful cases out there, including Motus v. Pfizer Inc., 358 F.3d 659 (9th Cir. 2004)(Zoloft); Porter v. Eli Lilly & Co., 2008 WL 544739 (N.D. Ga. Feb. 25, 2008)(Prozac); Longs ex rel. Estate of Buchanan v. Wyeth, 536 F.Supp.2d 843 (N.D. Ohio 2008)(Redux); Allgood v. Glaxosmithkline Plc, 2008 WL 483574 (E.D. La. Feb.20, 2008)(Paxil); Vanderwerf v. SmithKlineBeecham Corp., 529 F. Supp.2d 1294 (D. Kans. 2008)(Paxil).

In our next post, MassTortDefense will switch focus to the 5th Circuit's handling of the heeding presumption.

Two Recent Consumer Fraud Class Action Decisions

Two recent decisions are worth noting in the emerging battleground that is “consumer fraud” litigation. Plaintiffs have turned increasingly to the state unfair and deceptive trade practices acts and consumer fraud statutes that exist in virtually every jurisdiction. Not only do these statutes potentially give plaintiff attorneys access to a wider group of product liability claimants – those with no traditional injury from a product – they also hold out the theoretical promise of class certification because of the interpretation of the reliance and causation elements of the statutory claims. Plaintiffs frequently assert that these elements do not present the predominating individual issues that cut against class certification in a traditional mass tort or complex product liability context.  Many consumer fraud statutes authorize multiple/treble damages, attorney fees and costs. Plaintiff attorneys have resorted to asserting that the law of one state (the most pro-plaintiff consumer fraud statute) should apply to plaintiffs from various other jurisdictions in a multi-state class action.  The American Tort Reform Association has a good report on this phenomenon.

First, the Supreme Court of Missouri decertified a class defined as all individuals who purchased fountain Diet Coke in the state after March 24, 1999. See Coca-Cola Co. v. Nixon, 2008 WL 1724177 (Mo. April 15, 2008). According to the opinion, since 1984, fountain Diet Coke has been sweetened with a blend of aspartame and saccharin while bottled Diet Coke has been sweetened exclusively with aspartame. Plaintiff contended that she and many other consumers would not have purchased fountain Diet Coke if they had known it contained saccharin. She further contended that the deception, itself, resulted in irreparable harm. The trial court certified the class, and defendant appealed.

Class Definition Key

The court began its analysis by noting that while the state class action rule does not explicitly mention a proper class definition, such a requirement clearly underlies each of the mandatory elements for certification. Moreover, a properly defined class is necessary to realize both the protections and benefits for which the class action device was created. A class definition that encompasses more than a relatively small number of uninjured putative members is overly broad and improper. Likewise, a proposed class definition may be improper because the putative class is indefinite. The primary concern underlying the requirement of a class capable of definition, the Court said, is that the proposed class not be amorphous, vague, or indeterminate. 2008 WL 1724177 at *4. The class definition must be sufficiently definite so that it is administratively feasible to identify members of the class, which means, first, that class membership cannot depend on individual merit determinations. Class definitions requiring merit determinations are inappropriate in that the members of the class could not be presently ascertainable; such determinations could not be made until the case is concluded. Second, class membership must be based on objective, rather than subjective, criteria.

Plaintiff's proposed class included an extremely large number of uninjured class members, that is, those who did not care if the Diet Coke they purchased contained saccharin. Many consumers had no choice of the brand of fountain diet cola they purchased at any given location, let alone the particular type of sweetener used in one brand, Diet Coke. Plaintiff's own expert witness indicated that only twenty percent of those who currently consume fountain Diet Coke would not continue to do so if they knew it contained saccharin. In other words, eighty percent of the putative class suffered no injury, even under plaintiff’s theory of damages. Because of the presumably large number of individuals who purchased fountain Diet Coke in Missouri, proposed class “could include millions who [were not injured] and thus have no grievance.” Id.

The Court also rejected proposed modifications of the class definition. If class membership was limited to those who were allegedly injured by Coca-Cola, the class definition would contain an impermissible merit determination. The circuit court would not be able to determine whether an individual is, or is not, a class member until after the completion of the litigation. If the class definition were modified to be based on an individual's dislike of saccharin, membership would depend on an individual's subjective preference. Such a modification would result in innumerable “mini-trials” to determine class membership. Id. at *5. The opinion is thus a useful reminder of the importance of a careful analysis of the class definition.

A second recent CFA decision highlights the tactical decisions associated with attempts to have CFA claims dismissed at an early stage, particularly in light of Bell Atlantic Corp. v. Twombly, 127 S.Ct. 1955, 1974 (2007), which instructed that a district court should grant a motion to dismiss if plaintiffs have not pled enough facts to state a claim to relief that is plausible on its face. “Factual allegations must be enough to raise a right to relief above the speculative level.” Id. at 1965.

In Williams ex rel. Tabiu v. Gerber Products Co., 2008 WL 1776522 (9th Cir. April 21, 2008), the Ninth Circuit reversed the trial court’s decision dismissing a putative class action alleging various tort claims and violations of California’s Unfair Competition Law, Cal. Bus. & Prof. Code § 17200 et seq., and California’s Consumer Legal Remedies Act, Cal. Civil Code § 1750 et seq. The plaintiffs challenged several aspects of the marketing of Fruit Juice Snacks sold as part of Gerber’s “Graduates for Toddlers.”

  • First, they challenged the use of the words “Fruit Juice” juxtaposed alongside images of fruits such as oranges, peaches, strawberries, and cherries, contending that this juxtaposition was deceptive because the product did not contain fruit juice from all of the fruits pictured on the packaging;
  • Second, they challenged a statement on the side panel of the packaging describing the product as made “with real fruit juice and other all natural ingredients,” even though the two most prominent ingredients were corn syrup and sugar.
  • Third, plaintiffs challenged a separate statement on the side panel; namely, that Snacks was “one of a variety of nutritious Gerber Graduates foods and juices.”
  • Fourth, they challenged Gerber’s decision to label the product a “snack” instead of a “candy,” “sweet,” or a “treat.”


Lower Court's Sensible Approach

Gerber filed a Rule 12(b)(6) motion, which the district court granted. 439 F.Supp.2d 1112 (S.D. Cal. 2006). Plaintiffs must allege that Defendants' statements are likely to deceive a reasonable consumer. The term “likely” means probable, not just possible. If the alleged misrepresentation would not mislead a reasonable consumer, then the allegation may be dismissed on a motion to dismiss. In determining whether a statement is misleading “the primary evidence in a false advertising case in the advertising itself.” Id. at 1115. The trial court noted that the mere depiction of fruit, or fruit like substances, is not a specific affirmative representation that the product contains those fruits. Viewing the packaging as a whole, the inescapable conclusion was that no reasonable consumer upon review of the package would conclude that the Snacks contain the juice from the actual and fruit-like substances displayed on the packaging particularly where the ingredients are specifically identified. “Where a consumer can readily and accurately determine the nutritional value and ingredients of a product, and the product packaging does not affirmatively mislead the consumer by means of specific representations, no reasonable consumer would be misled” by the words “Fruit Juice Snack” or deceived by depictions of fruit and fruit-like substances on the primary packaging label. Id. at 1116.

The motion to dismiss raises the intersection of federal pleading rules and the state law underlying the elements of the claim being alleged. The Ninth Circuit engaged in no balancing or careful melding, but rather disposed of the federal pleading requirement as clarified in Twombly by noting that “California courts, however, have recognized that whether a business practice is deceptive will usually be a question of fact not appropriate for decision on demurrer.” 2008 WL 1776522 at *3. The facts of this case, the panel thought, do not amount to the “rare situation” in which granting a motion to dismiss is proper. Id. at *4. The Court simply substituted its view of the potential impact of the packaging for the trial court’s view: The packaging pictures a number of different fruits, “potentially suggesting (falsely) that those fruits or their juices are contained in the product.” Id. Further, the statement that Fruit Juice Snacks was made with “fruit juice and other all natural ingredients” could “easily” be interpreted by consumers as a claim that all the ingredients in the product were natural, “which appears to be false.” Id. [That’s the good news/bad news about a de novo review standard.]

The Ninth Circuit also disagreed with the trial court’s view that reasonable consumers might be expected to look beyond the front of the box to discover the ingredient list on the side of the box.

“We do not, however, think that a busy parent walking through the aisles of a grocery store should be expected to verify that the representations on the front of the box are confirmed in the ingredient list. Instead, reasonable consumers expect that the ingredient list contains more detailed information about the product that confirms other representations on the packaging.” Id.

That view – as unsupported by evidence as any the trial court relied on – is apparently designed to substitute the appellate court’s view of consumers in that specific environment, for an objective analysis of the packaging in a calm, or reflective atmosphere. It seems potentially inconsistent with the court’s holding that claims under these California CFA statutes are governed by a “reasonable consumer” test, unless the advertisement targets a particular disadvantaged or vulnerable group. Apparently, shoppers in grocery stores – if they are parents – are too disadvantaged and vulnerable to be expected to read the ingredients on the food they are buying for their children. What a tremendous policy decision! Sure to encourage more informed decisions by consumers. Apparently, reasonable consumers don’t read the label.

FDA Role

It is curious also in light of the treatment of the issue of the role of the FDA in this case. The trial court noted that “the FDA authorizes the manner in which Gerber labels Snacks…. The depictions of the fruit suggest that the product is fruit flavored and, as indicated on the packaging label, Snacks is a naturally flavored drink containing grape juice and natural flavors, along with corn syrup, sugar, Vitamin C, and other listed ingredients.” 439 F.Supp.2d at 1112. The Ninth Circuit rejected Gerber’s assertion that the district court concluded as an “alternate holding” that the product complied with FDA guidelines. This supposedly was not an alternate holding but simply support for the conclusion that the product was not deceptive. (The Court put off as not yet ripe any preemption challenge.)

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. 

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.

California Supreme Court Recognizes "Sophisticated User" Doctrine

The California Supreme Court recently expanded potential defenses for manufacturers who are alleged to have failed to warn about risks associated with their products. In Johnson v. American Standard, 179 P.3d 905, 74 Cal.Rptr.3d 108 (Cal. 4/3/08), the Court adopted the so-called “sophisticated user” doctrine, holding that a manufacturer has no duty to provide warnings to plaintiffs who should already be aware of product hazards because of their professional training or expertise.

Part of the analysis of a duty to warn claim is the identity of the person to whom a duty to warn may be owed. A second part of the analysis, assuming a duty exists, is whether a failure to warn can be the legal cause of the injury alleged. Two important doctrines affect this analysis.

  • One is the so-called bulk supplier doctrine. In many contexts, a chain of commerce exists in which the manufacturer may not be in privity with end users or consumers. As explored in Section 388 of the Second Restatement of Torts, comment n, does a supplier exercise due care by fully warning his immediate customer, and entrusting the communication of the necessary information to users farther down the chain? Courts have generally focused on a number of factors in deciding whether the upstream supplier is reasonable in so doing. First, what are the burdens involved in requiring the manufacturer or ultimate supplier to directly warn the end users? Second, how reliable is the intermediate, the employer, the intermediate purchaser, as a conduit for the necessary information to the downstream user? And third, what is the magnitude of the risks involved, balanced against those burdens?

    In a number of product contexts, it is very difficult for the supplier to reach the end user directly. The manufacturer may not know who the end users are. The supplier may not have a practical means of reaching the end users with warning information because of the nature of the product and how it is shipped. Thus, a number of cases in this area are “bulk supplier” cases in which he chemical or other product is sold or delivered in bulk and then repackaged in other containers by the intermediate users; the original containers which might have warning information never reach the end users. The product might be combined with other products sold by others. The product might be unloaded, conveyed or stored in a manner such as to defeat any original warnings. The nature of the warning may be such that only the end user can take appropriate precautions for safe use. The existence of numerous suppliers may potentially confuse the information flow. Safety may not be enhanced by requiring the manufacturer to do more than warn the immediate customer. Purvis v. PPG Industries, 502 So.2d 714 (Ala. 1987); Adams v. Union Carbide, 737 F.2d 1453 (6th Cir. 1984). Many courts apply the same notion to strict liability warnings cases. E.g., Smith v. Walter C. Best, Inc., 927 F.2d 736 (3d Cir. 1990). Of course, is some product contexts, regulations impact the duty, such as the Material Safety Data Sheet (MSDS) that must accompany certain hazardous chemicals, and must be made available by employers to employees potentially exposed to those chemicals in the workplace.


  • The second related notion arises when those downstream users are themselves expert in the safe handling and use of the product, perhaps even as knowledgeable as the original manufacturer. This raises the sophisticated user doctrine.

Background of the Decision

The California opinion involved a suit brought by an air conditioning technician who suffered from lung disease (pulmonary fibrosis) allegedly caused by exposure to phosgene gas. Plaintiff Johnson alleged the defendant knew that phosgene gas can cause a potentially fatal lung disease, and would be released when evaporators were serviced. The defendant allegedly failed to provide adequate warnings about the hazard. Plaintiff was a certified HVAC technician who alleged he was exposed to phosgene gas while welding in the course of repairing an air conditioning unit made by the defendant. Phosgene gas is formed when R-22, a hydrochlorofluorocarbon refrigerant, is exposed to flame or high heat. The plaintiff had gone to trade school where he was allegedly trained in the risks of toxic exposure during welding, received a study guide for a certification exam offered by the EPA that addressed those risks, and passed a five-part test to obtain the EPA’s highest level of certification. That certification was mandatory for any technician to work on commercial air conditioning systems. Whenever the plaintiff purchased refrigerant for those systems, he was supposed to have received an MSDS advising of the risk, and his employer was also required to provide him with job training addressing those risks.

In addition, expert testimony established that the specific health risks associated with inhaling heated refrigerant were widely known in the profession.  American Standard also argued that it was widely known by industry technicians that R-22, when heated, can decompose into toxic byproducts including phosgene. The Environmental Protection Agency requires HVAC professionals to understand decomposition products of refrigerants at high temperatures, the defendant argued. 74 Cal.Rptr.3d at 112-113.

Plaintiff's Version

Johnson testified that although he read material data safety sheets every time he purchased the refrigerant, he did not understand that he should avoid heating it. In deposition, Johnson testified that he did not learn in training that phosgene gas could be created when refrigerant lines were brazed, or that phosgene could cause lung damage. He said he never heard of phosgene until he got sick. Although he read the MSDS for R-22, Johnson said he understood the warning about hot metal as a caution against heating metal, not against heating R-22. 74 Cal.Rptr.3d at 114, 122.

Sophisticated User Doctrine

The air conditioning equipment maker (other defendants had reportedly settled or been dismissed) raised the defense, arguing that the sophisticated user doctrine is specifically applied to plaintiffs who knew or should have known of a product's hazards, and it acts as an exception to manufacturers' general duty to warn consumers. That is, manufacturers generally have a duty to warn consumers about any dangers inherent in their products that the consumers would not know about, so that the consumers can either decide not to use the product or use it in ways that would avoid the stated dangers. The sophisticated user defense is an exception to this general rule, as users sufficiently familiar with the product already know or should know about the dangers that would be announced in any warning. Because these sophisticated users are charged with knowing the particular product's dangers, the failure to warn about those dangers is not the legal cause of any harm that product may cause.

The trial court granted summary judgment on the basis of the doctrine, and the court of appeals affirmed. The state Supreme Court noted that the doctrine in most jurisdictions is treated as an affirmative defense to negate the manufacturer’s duty to warn, under the theory that sophisticated users need not be warned about dangers on which they are already aware or should be aware. Because the user is presumed to know the risk, the failure to warn of the danger cannot be the legal cause of the harm. The Court noted that the doctrine is a natural extension of the notion that there is no duty to warn of known risks or obvious dangers. For those individuals or members of professions who do or should know about the product’s potential dangers, those risks should be obvious. 74 Cal.Rptr.3d at 114-115.

In discussing the policy issues raised by the doctrine, the Court noted that “Not all warnings . . . promote user safety. Requiring manufacturers to warn their products' users in all instances would place an onerous burden on them and would invite mass consumer disregard and ultimate contempt for the warning process.” 74 Cal.Rptr.3d at 119. The doctrine thus helps ensure that warnings will be heeded.

Clarification of the Doctrine

The opinion offers clarity on a number of features of the doctrine, which would apply “equally to strict liability and negligent failure to warn cases.”

  • First, Johnson makes clear that the test is an objective one that depends not on what the plaintiff subjectively knew about the risks, but rather what is generally known or should have been known to the relevant class of sophisticated users. It is virtually impossible for a manufacturer to predict – and of course warnings are by their very nature based on predictions about users – whether any given member of a trained and sophisticated group has actual knowledge of the dangers. A manufacturer’s liability does not depend on the potentially “infinite number of user idiosyncrasies” that may result in a particular user being unaware of the risk, such as users who “may have misread their training manuals, failed to study the information in those manuals, or simply forgotten what they were taught.” 74 Cal.Rptr.3d at 120. However, if individuals hold themselves out as having training or having professional knowledge and skill associated with that class of users, that they might not actually possess all that knowledge and skill does not give rise to liability on the part of the manufacturer.


  • Second, the Court found that user sophistication is measured from the time of the plaintiff’s injury, rather than from the date the product was manufactured or sold. This is consistent with the rule’s focus on the knowledge of the general population of sophisticated users rather than that of the manufacturer, and “conforms to the defense’s purpose to eliminate any duty to warn when the expected user population is generally aware of the risk at issue.” 74 Cal.Rptr.3d at 122.

    Although the case involved a trained, sophisticated plaintiff, the Court discussed with approval two cases which applied the doctrine to a context in which the manufacturer warned a sophisticated intermediary, which then sold the product to the plaintiff end user. In Fierro v. International Harvester Co., (1982) 127 Cal.App.3d 862, the plaintiff sued the defendant because it manufactured the truck her husband was driving when he crashed and died. The plaintiff’s husband was driving the truck in the course and scope of his employment when the truck overturned after blowing a tire, crashed, skidded for a distance, spilled fuel, and caught fire. The plaintiff alleged that the defendant had a duty to warn not her husband, but the purchaser (his employer), that attaching power cables from the refrigerator unit to the truck’s battery could create a fire hazard. The court found that the defendant was not liable for failing to warn the employer, explaining in dicta that the employer was a “sophisticated organization” that “does not have to be told” of the risks. Similarly, In re Related Asbestos Cases, 543 F.Supp. 1142 (N.D.Cal. 1982), applied the so-called “sophisticated intermediary” doctrine to the US Navy, which was a sophisticated user of asbestos products, and which then distributed them to employees for use.

    Finally, the opinion reserved for future decision the issue of whether a plaintiff will be able to negate the application of the sophisticated user defense by showing that the sophisticated user’s misuse of the product was foreseeable.

    The Product Liability Advisory Council Inc.’s amicus brief was quoted in the opinion. PLAC does great work on these important appeals.

EPA Revises Chemical Risk Information System

Readers of MassTortDefense who have an interest in toxic torts may wish to take note that the Environmental Protection Agency’s (EPA) Office of Research and Development recently announced revisions to the Integrated Risk Information System (IRIS).

What Is IRIS?

IRIS is a compilation of electronic reports on specific substances found in the environment and their potential to cause human health effects. IRIS was initially developed for EPA staff in response to a growing demand for consistent information on substances for use in risk assessments, decision-making and regulatory activities. For each chemical contained in IRIS,  the database contains summary information on the studies evaluated, any uncertainties or assumptions made in the studies, a statement of the level of confidence that EPA has in the study, the names of EPA scientists to contact for more information, and complete bibliographic citations. See Report of the IRIS Quality Action Team on External Peer Review and Public Involvement at 5 (July 1994).

IRIS provides human health risk information describing the potential adverse health effects that may result from exposure to over 540 environmental contaminants. IRIS includes descriptions of hazard identification and dose-response information, quantitative risk estimates for chronic non-cancer and cancer effects, and access to searchable scientific documentation.

Not Just Regulatory

While EPA often will base regulatory rules on IRIS evaluations, this is not just a regulatory issue. IRIS is generally accepted as a reliable source of information on the potential hazardous effects of those chemicals that are included in IRIS. See National Oilseed Processors Ass'n v. Browner, 924 F.Supp. 1193 (D.D.C.,1996). Thus, proffered experts in the toxic tort branch of products litigation may refer to and seek to rely on IRIS. E.g., Avance v. Kerr-McGee Chemical, 2006 WL 39124272 (E.D. Texas 1/1//07); Allgood v. General Motors, 2006 WL 2669337 (S.D. Ind. 9/18/06). And this is true of class actions, e.g., Pohl v. NGK Metals Corp., 2003 WL 24207633 (Pa. Com. Pl. 7/9/03)(rejecting medical monitoring class action), and mass toxic torts. E.g., In re Welding Fume Products Liab. Litig., 2006 WL 4507859 (N.D. Ohio 8/8/06).

The upcoming changes are to the process for developing chemical assessments, and will include an expanded process for recommending a substance be assessed; the earlier involvement of other agencies and the public; hosting “listening sessions” to allow for the broader participation and engagement of interested parties; and an even more rigorous scientific peer review of IRIS assessments.

How It Works And How It Will Change

On an annual basis, the IRIS Program requests nominations for new or updated IRIS assessments from EPA Program Offices and Regions and from the public. The IRIS process has started with the development of a draft Toxicological Review for the chemical.  A health scientist, referred to as a Chemical Manager, is assigned to each substance. The Chemical Manager is responsible for developing the draft assessment and shepherding draft documents though the review process. Development of a draft assessment consists of a literature search and preparation of a draft Toxicological Review and an IRIS Summary. The Chemical Manager may work with a team of toxicologists, epidemiologists, and statisticians in reviewing and analyzing the available literature. EPA’s risk assessment guidelines form the basis for the analysis. This work is often supported by an EPA outside contractor.

The next stage includes internal and external scientific reviews of the draft document, conducted in accordance with Agency guidance on peer review. These may include internal (EPA) peer review, a review by a standing group of senior health scientists representing EPA’s Offices and Regions and by selected senior health scientists with scientific expertise relevant to the substance, review by other federal agencies, and external peer review, typically via a panel meeting. Final steps are the EPA response to review comments, and development and posting on the IRIS web site of an IRIS Summary and final Toxicological Review. www.epa.gov/iris

The new steps in the process include increased participation by other federal agencies and the public in the development of the Toxicological Review and greater opportunities for other federal agencies to conduct research to fill data gaps. Together, these changes to the IRIS process are supposed to help create a more predictable, streamlined, and transparent process for conducting IRIS assessments. A major stated goal of the Agency is to define the important role that public and inter-agency comments and interactions play in the process, and to foster greater communication and sharing of relevant scientific information between experts, interested parties, and EPA.

Effects on Readers?

The revised procedure is not without controversy, as environmental groups and Democratic legislators – ironically those often calling for more public input and participation – have argued that chemical risk assessments will become a “special-interest scrum.”  But for clients of readers of MassTortDefense, it may offer increased opportunities to ensure their voice is at least heard.

8th Circuit Decertifies Device Class With Consumer Fraud Allegations

Today, let’s continue mining the depths of the Eight Circuit’s recent decision, In re: St. Jude Medical, Inc., Silzone Heart Valve Products Liability Litigation, No. 06-3860, 2008 WL 942274, 522 F.3d 836
(8th Cir. April 9, 2008). The case offers a number of potential lessons for mass tort defendants, and not just those in the medical device arena. We already made some medical monitoring observations here.

CFA Claims Abound

Today’s focus is consumer fraud act (CFA) claims. Virtually every state has some version of an unfair or deceptive trade practice act, or some form of consumer-protection oriented fraud act. Often these statutes permit a private cause of action, in addition to possible enforcement by the state attorney general. Plaintiffs in the Silzone case relied on three Minnesota statutes, the False Advertising Act (MFAA), Minn. Stat. § 325F.67, the Consumer Fraud Act (MCFA), Minn. Stat. § 325F.69, and the Deceptive Trade Practices Act, Minn. Stat. § 325D.44.

Plaintiffs have been increasingly aggressive in recent years in seeking to apply such statutes to the traditional product liability world. Expanding the potential plaintiff group from those who actually suffered disease or personal injury as a result of a product, and beyond those who claim to be at increased risk of future personal injury (medical monitoring), such CFA claims seemingly permit anyone who used or purchased a product to seek economic damages (and sometimes punitives, and sometimes attorney fees, and sometimes treble or multiple damages). Thus, we now see CFA-type claims against drug and device makers, consumer product manufacturers, and a growing list of other industries.

Moreover, the elements of the CFA claims seem, superficially, more amenable to class action treatment. In particular, the courts’ treatment of the reliance element of CFA claims has been confused at times, shallow at others, and not always helpful to the defeat of class certification. Judge Colloton goes right to the heart of this issue: “This case exemplifies the difficulty with class treatment of cases alleging fraud or misrepresentation.” Id. at 838. In a typical common law fraud claim or negligent misrepresentation claim, a plaintiff must show he or she saw or heard the fraudulent statement and reasonably relied on it. Because proof virtually always varies among plaintiffs concerning what they saw and heard and the degree to which they relied, if at all, and the reasonableness of the reliance, such fraud claims generally shouldn’t be and don’t get certified as class actions.

Lower Court Got It Wrong

However, the District Court held that proof of individual reliance is unnecessary under the Minnesota consumer protection law (which the court was applying to all plaintiffs from 17 states). This conclusion was based on Group Health Plan Inc. v. Philip Morris Inc., 621 N.W.2d 2 (Minn. 2001), which stated that the state legislature had "eliminated the requirement of pleading and proving traditional common law reliance as an element of a statutory misrepresentation claim." The absence of any need to prove reliance, said the plaintiffs, eliminated this as an individual issue. And thus the allegedly common issue of the defendant’s fraudulent conduct predominated.

Unlike common law fraud, many consumer fraud statutes do not explicitly require a showing of reliance.  For this reason, plaintiffs have repeatedly argued that manufacturers can be held liable to
an entire class of plaintiffs for an alleged misrepresentation— even if most members of the
class never saw the misrepresentation, or saw it but purchased the item for some other, unrelated
reason. Consumer fraud defendants have fought back against this line of attack, with
varying degrees of success, by arguing that causation, which is required under most consumer
fraud statutes, cannot be proven in such situations.

8th Circuit Offers Deeper Analysis

The Court of Appeals, in a more nuanced analysis here, noted that while it was not necessary for plaintiffs to plead individual consumer reliance, and need not provide direct evidence of reliance by individual consumers as part of their burden of proof, that was not the end of the analysis. Plaintiffs must – and this is true generally beyond Minnesota – prove a causal nexus between the allegedly wrongful conduct of the defendant and the plaintiff’s damages. Thus, “reliance” evidence about the relationship between the claimed damages and the alleged conduct is relevant and probative of the causation issue – even when presented by the defendant.

The 8th Circuit believed that there was a “reliance component” to the causation element, at least where as a practical matter it is not possible that the damages could be caused by the alleged violation without some kind of reliance on the statements or conduct alleged to violate the statute.

But even if plaintiffs were not required to present any direct proof of individual reliance, this would not prevent a defendant from presenting direct evidence that an individual plaintiff, or his or her physician, did not rely on any representations from the company. "Whatever Group Health means about the need for these plaintiffs to present direct evidence of individual reliance, it does not eliminate the right of a defendant to present evidence negating a plaintiff's direct or circumstantial showing of causation and reliance.”  2008 WL 942274 at *3, 522 F.3d at 840.

Why This Matters?

This is a huge issue for defendants in many kinds of class action, including but not limited to CFA claims. Too often, courts addressing certification rely on an analysis of plaintiffs’ burden of proof and the elements of their claim. Sometimes, courts will look at affirmative defenses – but often relegating such to later phases of a bifurcated proceeding to give the impression that common issues dominate the first phase. More rarely, courts conduct the full analysis we see here: in addition to plaintiffs’ burden of proof, and formal affirmative defenses, defendant has a due process right to offer relevant, probative evidence tending to negate or defeat plaintiffs’ cause of action. If that evidence raises individual issues, if the nature of that evidence will require individual discovery and particularized assessment by the finder of fact, those individual issues are just as relevant to the class certification decision as individual or common issues raised by the elements of the cause of action itself.

The defendant here planned to present evidence of non-reliance by individual plaintiffs, and thus an absence of causation, and this made it clear to the appeals court that resolving the issue of the company's liability to each plaintiff under the Minnesota consumer fraud statutes would depend on individual issues of causation and reliance. Specifically, “St. Jude has presented evidence that a number of implant patients did not receive any material representation about the heart valve.” The doctors who prescribed the valves had “learned about St. Jude’s heart valve in different ways.” One doctor heard about the valve “from a senior partner, another discovered it at a cardiology conference, and a third learned about the valve from a St. Jude sales representative and a St. Jude advertisement.” (Two of the five named plaintiffs couldn’t remember hearing anything about the valve.)  Any trial thus would require a physician-by-physician inquiry into each doctor’s sources of information about the valve. “Given the showing by St. Jude that it will present evidence concerning the reliance or non-reliance of individual physicians and patients on representations made by St. Jude, it is clear that resolution of St. Jude’s potential liability to each plaintiff under the consumer fraud statutes will be dominated by individual issues of causation and reliance.”  Id.

The court recognized that there may be certain issues that are common to all plaintiffs, such as whether certain published representations about the valve were materially false. But without even reaching the issue of choice of law and the questionable application of one state’s law to plaintiffs from 17 jurisdictions, the court found it clear that the common issues do not predominate over the individual issues that must be litigated to resolve the plaintiffs' CFA claims. Increasingly, courts are being asked to certify sweeping consumer fraud class actions based on abstract and unproven economic injuries. St. Jude provides precedent for defendants’ right to present a defense based on lack of reliance/causation, and its impact on class certification.

8th Circuit Decertifies Medical Monitoring Class in Device Case

The Eight Circuit’s recent decision, In re: St. Jude Medical, Inc., Silzone Heart Valve Products Liability Litigation, No. 06-3860, 2008 WL 942274 (8th Cir. April 9, 2008), offers a number of potential lessons for mass tort defendants, and not just those in the medical device arena. (As always at MassTortDefense, we try to cross-pollinate from industry to industry and mass tort to mass tort those theories, rulings, etc. that can potentially assist a broad range of defendants.) So many lessons, in fact, that one posting can’t do them all justice. So let’s break it down into some sub-parts and see if we can’t gain some insights.

Today’s focus is medical monitoring, which of course is near and dear to MassTortDefense ever since having tried to a defense verdict a medical monitoring class action in West Virginia a few years back.

Some Background

As readers may know, before the 8th Circuit decertified a class of an estimated 11,000 plaintiffs who received one of St. Jude Medical Inc.’s allegedly defective Silzone heart valves, the case had a bit of an up and down history. The district court originally certified two subclasses of plaintiffs seeking damages and injunctive relief, respectively. Then in In re St. Jude Med., Inc., 425 F.3d 1116 (8th Cir. 2005), the appeals court reversed the district court’s certification of a subclass of plaintiffs seeking injunctive relief, which was described as a “medical monitoring class,” because the class presented “a myriad of individual issues making class certification improper.” Id. at 1122.

With respect to the subclass seeking damages and described as a “consumer protection class,” the 8th Circuit held that the district court should have conducted a more thorough choice-of-law analysis before it determined to apply Minnesota law to the claim of every plaintiff. Id. at 1121. It remanded the case to the district court for further consideration. On remand, the district court determined that Minnesota law should apply to all claims in the nationwide class, and recertified the consumer protection class pursuant to Federal Rule of Civil Procedure 23(b)(3). In re St. Jude Medical, Inc., No. 01-1396, 2006 WL 2943154 (D. Minn. 2006). St. Jude’s appeal of this certification of the class led to the April decision we discuss here.

Medical Monitoring

Among the individual issues that would predominate over so-called common questions were several related to the "highly individualized remedy of medical monitoring.” 2008 WL 942274 at *4. Medical monitoring, generally defined, is periodic testing and/or examination to facilitate the diagnosis and treatment of a latent disease by early detection. It is not the diagnostic testing that accompanies symptoms, but rather testing of seemingly healthy, asymptomatic persons who have been exposed to a potentially harmful substance and are at risk of future disease or injury.

Medical monitoring is almost always seen as a potential class action claim, for several reasons:

  • First, the individual damages associated with periodic testing of a so-far healthy plaintiff may not be all that financially attractive to plaintiff attorneys.
  • Secondly, a number of the elements of the claim (or remedy) of medical monitoring seem, on the surface, amenable to “common” proof in the form of epidemiological evidence. For example, the increased risk that typically must be shown.

Plaintiffs’ attempts to certify medical monitoring classes have come under both Rule 23 (b)(2) and (b)(3). The 23(b)(2) claim typically alleges that the defendant has acted on grounds generally applicable to the class (for example, making a defective product or failing to warn of its hazards) and that injunctive relief for the class is appropriate in the form of a requirement that the defendant provide medical monitoring for the class. Claimants seeking certification under Rule 23(b)(2) often seek a court-established monitoring program, alleging it to be a claim for injunctive relief (see In re Sulzer HipProsthesis and Knee Prosthesis Liab. Litig., 455 F.Supp.2d 709 (N.D. Ohio 2006) ). Such a claim, however, may simply be an artful pleading of a simple pass-through mechanism in which claimants seek monetary damages for the payment of medical test bills for class members: essentially, a suit for damages. Thomas v FAG Bearings Corp., 846 F. Supp. 1400 ( W.D. Mo. 1994 ). The 23(b)(3) claim typically asserts that the defendant’s conduct, the significant exposure of class members, the hazardous nature of the product in question and the increased risk of future disease each class member faces, are common issues that predominate over any questions affecting only individual class members.

The 8th Circuit previously rejected certification of a medical monitoring class under Rule 23 (b)(2), saying in its 2005 opinion that whether an individual plaintiff will require additional monitoring "is an individualized inquiry depending on that patient's medical history, the condition of the patient's heart valves at the time of implantation, the patient's risk factors for heart valve complications, the patient's general health, the patient's personal choice, and other factors." Now, even if one assumed Minnesota law would apply to all the claims, the need for these detailed and individual factual inquires concerning the appropriate remedy weighed against a (b)(3) class certification as well. 2008 WL 942274 at *4-5.

This language is useful for defendants opposing (b)(2) or (b)(3) medical monitoring putative classes. While plaintiff’s proposed medical monitoring plan is typically a one-size fits all program, and hence seemingly a common issue, the court noted as a potential individual issue what the appropriate monitoring may be -- turning, as it does, on the class member’s medical history, condition, risk factors for complications, and general health. The court also noted that a class member who had been implanted with the device might already require future medical monitoring – some type of periodic follow-up medical checks – as an ordinary part of his or her follow-up care.

Whenever this is the case, plaintiffs will stumble on the typical medical monitoring element that the testing being sought would not be done as part of the ordinary standard of medical care. Often called the “over and above” element, most courts that have adopted some form of medical monitoring require that the testing that defendant is being asked to pay for is something that is needed because of the harmful exposure to the defendant’s product, and not something that plaintiff needed and would or should have gotten even in the absence of exposure to defendant’s product. Very often, whether the recipient of an implant, the taker of a prescription drug, the user of a consumer product, might or would or should have undergone the same periodic medical testing is provable, and at the least, is an individual inquiry that depends on the specific facts concerning each putative class member.

Same Notion Seen in HRT

This notion was also explored in Wyeth, Inc. v. Gottlieb, 930 So.2d 635 (Fla. 3d Dist. Ct. App. 2006),
review denied, 950 So.2d 413 (Fla. 2007). The Florida appellate court reversed the decision of the state trial court to certify a state-wide medical monitoring class of about 300,000 women who took Prempro. The court saw the proposed monitoring plan for the HRT class as nearly the same medical testing recommended for all post-menopausal women. A person seeking medical monitoring must show that, given her own unique medical and other exposure history, the exposure caused by the defendants significantly increased her risk and necessitated the monitoring recommended for her. The HRT schemes proposed by plaintiffs are not programs for at risk Prempro users, but for any woman who had any breast cancer risk factor, including age, family history, weight or alcohol use. As a jury issue, the over and above notion has worked well for the tobacco industry, which has been subjected to multiple putative class actions seeking medical monitoring.

Medical monitoring remains a potential threat. While the Mississippi Supreme Court rejected medical monitoring in Paz v. Brush Engineered Materials, Inc., 949 So.2d 1 (Miss. 2007), the Missouri Supreme Court recognized a medical monitoring remedy in Meyer ex rel. Coplin v. Fluor Corp., 220 S.W.3d 712 (Mo. 2007). And the American Law Institute (ALI) has released a “Council Draft” of a Restatement (Third) Torts: Economic Torts and Related Wrongs, which would recognize a “limited” form of medical monitoring claim. Clear and careful analysis like that of Judge Colloton and the 8th Circuit panel is useful in responding to the threat.