Drug and Medical Device Law Update 2012

Transcription

1 Drug and Medical Device Law Update 2012 Laura E. De Santos Gordon & Rees LLP 1900 West Loop South, Suite 1000 Houston, TX (713)

2 Laura E. De Santos is a partner in the Houston office of Gordon & Rees. She has extensive experience representing corporate clients in state and federal courts throughout the United States. Ms. De Santos concentrates her practice on product liability, commercial litigation, and employment law litigation. She has represented pharmaceutical and medical device manufacturers and has tried numerous cases of serious injury to verdict. She has been involved in all aspects of tort litigation management and handling, including discovery, document management, settlement evaluation and negotiation, and expert witness development. Ms. De Santos is a member of the DRI and the International Association of Defense Counsel, where she currently serves on the Board of Directors for the Foundation of the IADC. Ms. De Santos would like to thank Andrew Hutton and Rebecca Wardell for their assistance with this article.

3 Drug and Medical Device Law Update 2012 Table of Contents I. Introduction II. Drug Preemption A. Mensing and Its Aftermath Mensing Lofton v. McNeil Consumer & Specialty Pharms B. Innovator Liability Foster and Generic Liability Post-Mensing In re Darvocet, Darvon & Propoxyphene Prods. Liab. Litig Weeks v. Wyeth, Inc O Neil and the future of Conte in California III. Medical Device Preemption Walker v. Medtronic Inc Bass v. Stryker Corp IV. Proof of Causation V. Statute of Limitations A. Kendall v. Hoffman-La Roche B. Gazal v. Boehringer Ingelheim Pharmaceuticals, Inc., C. Rick v. Wyeth, Inc D. Casey v. Merck & Co VI. Conclusion Endnotes Drug and Medical Device Law Update 2012 De Santos 269

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5 Drug and Medical Device Law Update 2012 I. Introduction Without question, the most significant drug and device ruling of the past year was the U.S. Supreme Court s decision in PLIVA, Inc. v. Mensing, 131 S. Ct (2011), which established a barrier for plaintiffs seeking to recover damages for failure to warn from generic drug manufacturers. The Court held that federal regulations prevent generic manufacturers from unilaterally changing warning labels and state-law duties requiring these manufactures to update warning labels with new risk information are preempted by federal law. Mensing and the questions it raised have been central to drug and medical device litigation in the past year. Aside from negotiating the outer-most boundaries of Mensing, other prominent issues from the past year have been the extra-jurisdictional impact of final judgments on the statute of limitations, intersections between scientific evidence and the statute of limitations and the application of state and federal standards for admissibility of scientific evidence at trial. II. Drug Preemption This year rapidly is shaping up to be the year of Mensing, although the decision itself is almost a year old. How the lower courts ultimately interpret and apply Mensing will have a far-reaching impact on the future of drug and device law, and for federal preemption law more generally. Mensing held that federal regulations prevent generic manufacturers from unilaterally changing their drugs warning labels and thus that any state-law obligation requiring a generic manufacturer to provide different risk information is preempted by federal law. The plaintiffs in Mensing claimed that they suffered neurological injuries as a result of taking metoclopramide, which is also sold under the brand name Reglan. Plaintiffs sued the manufacturers of the generic drugs they used, alleging that those companies failed to adequately warn about their product s neurological side effects. The generic defendants argued that federal law preempted these claims, because the FDA requires generic labels to use the same language as the brandequivalent drug, making it impossible for them to comply with both federal and state law. The Supreme Court agreed that the claims were preempted. Mensing called into question the presumption against preemption that was so pivotal three years ago in Wyeth v. Levine, 129 S. Ct. 1187, 1191 (2009), where the Court held that state tort claims against branded drug manufacturers were not preempted. That presumption was not even mentioned in the Mensing majority s opinion, despite the difference in outcome. The holding in Mensing also may also lead to further litigation over the issue of innovator liability, since plaintiffs who find their claims barred against generic drug manufacturers may turn their sights on brand-name manufacturers who drafted the initial labeling. For instance, many plaintiffs have argued unsuccessfully that Mensing undermines the Fourth Circuit s seminal decision rejecting innovator liability in Foster v. Am. Home Prods. Corp., 29 F.3d 165, 170 (4th Cir. 1994). Below we discuss case law developments since Mensing and its impact on the presumption against preemption. A. Mensing and Its Aftermath 1. Mensing Mensing arose out of decisions from the Fifth and Eighth Circuit U.S. Courts of Appeal, which had determined that federal law did not preempt failure-to-warn claims against the manufacturers of generic Drug and Medical Device Law Update 2012 De Santos 271

6 metoclopramide. The Supreme Court by a 5-4 majority reversed, holding that because federal drug regulations prevent generic manufacturers from unilaterally changing their products labeling, federal law conflicts with and preempts contrary state-law duties requiring those manufacturers to update their warnings to account for new risk information. The Supreme Court explained that the 1984 Drug Price Competition and Patent Term Restoration Act commonly called the Hatch-Waxman Amendments permits manufacturers to gain FDA approval for generic drugs by showing equivalence to an already-approved reference listed drug without the need for duplicating clinical trials already performed on the brand-name product. That law further provides that generic drug labeling must be the same as that for the brand-name drug. The Court concluded that there was no regulatory mechanism available that would have permitted the generic manufacturers to unilaterally alter their labeling because such action would render the generic warnings out of step with the brand-equivalent product s warnings. The Supreme Court rejected three arguments raised by the plaintiffs that the federal scheme was broad enough to allow generic manufacturers to revise their products warnings. First, deferring to the FDA s interpretation of its regulations, the Court observed that manufacturers of generic drugs may not take advantage of the changes-being-effected (CBE) process, which otherwise allows brand-name manufacturers to add to or strengthen their labels without prior FDA approval. Mensing, 131 S. Ct. at According to the Court, generic manufacturers may only change their labels to match an updated brand-name label or in accordance with FDA instructions. Id. 2575; see 21 CFR (a)(8)(iv). Second, the Court concluded that generic defendants could not meet a state-imposed duty to warn by advising physicians of enhanced warnings via Dear Doctor letter. Such letters are a form of labeling under federal regulations, and a Dear Doctor letter may not promulgate information inconsistent with approved labeling. Mensing, 131 S. Ct. at 2576; see 21 CFR (d)(1). Third, the Court rejected the notion that a generic manufacturer could have complied with both its state and federal law obligations simply by proposing stronger warnings to the FDA, which the agency then could have made both to the branded and generic drug labels. The Mensing majority found that although generic manufacturers could have requested the FDA s help in strengthening the brand-name label, such action would not have satisfied their state-law duty to actually provide a different label to their customers. More significantly, the Court held that the generic manufacturers failure to take these steps did not vitiate their preemption defense on impossibility grounds. Mensing, 131 S. Ct. at Plaintiffs argument that such steps could have made a difference depended upon a series of assumptions that is, if the manufacturer had asked for the FDA s help in changing the label, and if the FDA had found there was sufficient supporting information for a label change, and if the FDA undertook negotiations with the brand manufacturer, and if adequate label changes were implemented, then the generic manufacturer s request might eventually have led to a better label. The Court declined to make federal preemption dependent upon what it characterized as a Mouse Trap game requiring a series of decisions by different actors. Id. at 2578 The Court instead found that the relevant question for preemption purposes is whether the private party could independently do under federal law what state law requires of it. Id. at The generic manufacturers could not facilitate a label change without the assistance and acquiescence both of the FDA and the brand manufacturer. The Court found that this was the key distinction from its 2009 decision in Levine, where it held that the brand manufacturer unilaterally could make changes to its drug labeling without the FDA s assistance or permission. In contrast, the Mensing majority wrote that when a party cannot satisfy its state duties without the Federal Government s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for preemption 272 Drug and Medical Device Seminar May 2012

7 purposes. Id. at Because the generic manufacturer could not have changed the label on its own, plaintiffs failure-to-warn claims were preempted. 2. Lofton v. McNeil Consumer & Specialty Pharms Among the questions raised by Mensing is the impact it will have on general conflict preemption principles and the presumption against preemption. In the Supreme Court s Levine decision, the presumption against preemption seemed to definitively tip the balance against preemption in the context of the brandname manufacturer s label. However, as the Fifth Circuit s recent decision in Lofton v. McNeil Consumer & Specialty Pharms., No , 2012 U.S. App. LEXIS 3496 (5th Cir. Feb. 22, 2012) noted, Mensing made no reference to the presumption with respect to its preemption finding, and thus the Fifth Circuit remarked that whatever value or relevance a presumption against preemption of state tort law should play is uncertain. Id. at *18. Another significant issue is the interplay between Mensing s holding and that of Buckman Co. v. Plaintiffs Legal Comm., 531 U.S. 341 (2001). Mensing characterized Buckman broadly as holding that federal drug and medical device laws pre-empted a state tort-law claim based on the failure to properly communicate with FDA, and cited the decision in support of the notion that the generic manufacturers could not be liable based on those companies failure to ask for the FDA s help in changing their labels. See Mensing, 131 S. Ct. at Lofton applied a similar construction of Buckman in finding preempted a Texas statute allowing plaintiffs to establish state-law failure-to-warn claims with proof that a drug manufacturer withheld or misrepresented information to the FDA. In so holding, the Fifth Circuit sided with the Sixth Circuit rather than with the Second Circuit in what has become known as the Garcia/Desiano divide. Compare Garcia v. Wyeth- Ayerst Labs., 385 F.3d 961 (6th Cir. 2004), with Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006), aff d by an equally divided court sub nom. Warner-Lambert Co., LLC v. Kent, 552 U.S. 440 (2008). The Lofton court agreed with the Sixth Circuit s holding that Buckman is implicated whenever a critical element of the plaintiff s state-law claim depends on proof that the drug manufacturer defrauded the FDA, and rejected the Second Circuit s approach which had limited Buckman s scope to stand-alone claims for fraud on the agency. 1 Mensing arguably tips the balance in favor of the Fifth and Sixth Circuit s construction of Buckman, and against the Second Circuit. Nevertheless, the Supreme Court likely will have a chance to clarify these issues should the plaintiff in Lofton decide to petition for certiorari review. Lofton thus remains a case to watch. B. Innovator Liability 1. Foster and Generic Liability Post-Mensing For nearly two decades, the overwhelming weight of authority in the United States has rejected plaintiffs attempts to hold brand-name drug manufacturers liable for personal injuries caused by other companies generic drug products. Scores of decisions applying the laws of more than 20 jurisdictions including opinions from three federal courts of appeal have recognized that such claims are subject to standard product liability requirements of product identification, and that brand-name manufacturers have no duty to warn consumers of another manufacturer s generic drugs. See, e.g., Smith v. Wyeth, Inc., 657 F.3d 420, 424 (6th Cir. 2011); Mensing v. Wyeth, Inc., 588 F.3d 603, (8th Cir. 2009), rev d on other grounds sub nom., PLIVA, Inc. v. Mensing, 131 S. Ct (2011); Foster v. Am. Home Prods. Corp., 29 F.3d 165, 170 (4th Cir. 1994). These holdings apply regardless of whether plaintiffs characterize their claims as sounding in negligence, misrepresentation, or fraud. With the exception of two outlier decisions from California and Vermont that have departed from this consensus view, this rule seemed fairly settled. Drug and Medical Device Law Update 2012 De Santos 273

8 However, faced with the generic manufacturers use of Mensing as a shield against liability, plaintiffs have attempted to turn that decision into a cudgel against brand-name manufacturers. They have argued that Mensing undermines the reasoning of the Fourth Circuit s seminal 1994 decision in Foster v. Am. Home Prods., which rejected an innovator liability theory under Maryland law while seemingly presuming that plaintiffs remedies for their injuries would lay in a claim against the generic drug manufacturer. According to the plaintiffs, this was a fundamental error in the Foster court s analysis that impugns its ultimate holding. They further have made an equitable argument that, if generic manufacturers are not liable for injuries caused by their products, plaintiffs should be allowed to pursue recovery from other manufacturers in the marketplace. These arguments so far have been rejected by the courts. Post-Mensing decisions have recognized that Mensing considered only federal preemption issues and did not and could not change the underlying state-law principles that foreclose liability against brand-name manufacturers. See, e.g., Metz v. Wyeth LLC, F. Supp. 2d, No. 8:10-cv-02658, 2011 U.S. Dist. LEXIS , at *7 (M.D. Fla. Nov. 18, 2011). As one court explained in discussing Foster s continued vitality, [t]he Supreme Court s holding in Mensing neither created nor abrogated any duty under [state] law with regard to brand-name-manufacturers.... Gross v. Pfizer, Inc., No. 8:10-cv AW, 2011 WL , *2 (D. Md. Sept. 7, 2011). Moreover, Mensing may not foreclose all claims against generic drug manufacturers. Courts may find generic manufacturers subject to liability unrelated to state-imposed duties to strengthen drug warning labels. For instance, one court has suggested liability exists where a generic defendant fails to send a Dear Doctor letter informing a plaintiff s doctor about a recent label change. See Brasley-Thrash v. Teva Pharm., USA, cv kd-n, 2011 U.S. Dist. LEXIS , at *3 (S.D. Ala. Sept. 12, 2011). In Brasley-Thrash, the court rejected the defendant s argument that FDA regulations prohibited it from sending Dear Doctor letters consistent with (and not contrary to) the drug s approved labeling. Id. Generic defendants also may be subject to liability for failing to timely change their labels to include FDA-approved warnings. See Fisher v. Pelstring, 4:09-cv-00252, 2011 U.S. Dist LEXIS , at *12 (D.S.C. Sept. 30, 2011) reconsideration granted in part, denied in part, 2012 U.S. Dist. LEXIS (D.S.C., Jan. 11, 2012). 2. In re Darvocet, Darvon & Propoxyphene Prods. Liab. Litig In March, the federal district court overseeing the Davocet/Darvon MDL proceedings in Kentucky strongly endorsed the national consensus rejecting innovator liability. See In re Darvocet, Darvon & Propoxyphene Prods. Liab. Litig., No. 2:11-md-2226-DCR, slip op. (E.D. Ky. Mar. 5, 2012). In that litigation, Xanodyne Pharmaceuticals filed motions to dismiss plaintiffs claims against it in cases arising from 18 different states where those plaintiffs complaints failed adequately to allege that they consumed Xanodyne s brand-name products. The court granted the motion, holding that each state s laws required plaintiffs to meet the threshold requirement of showing that the defendant s product caused their injuries. Slip op. at 5-6. The court further observed that the plaintiffs could not evade that requirement by couching their allegations as misrepresentation claims, finding that Xanodyne owed no duty to consumers of other manufacturers generic drugs. Id. at 9. The court also definitively rejected plaintiff s argument that a federal court sitting in diversity should recognize plaintiff s proposed expansion of product liability principles to reach brand-name manufacturers. It held that in the absence of any binding authority that would dictate the application of the rule proffered by the plaintiffs, this Court concludes that Xanodyne cannot be held liable to plaintiffs who consumed other manufacturers drugs. Id. at Weeks v. Wyeth, Inc. The Alabama Supreme Court is poised to be the first state high court to directly address the issue of innovator liability. In Weeks v. Wyeth, Inc., the plaintiff initially filed suit in the Middle District of Alabama 274 Drug and Medical Device Seminar May 2012

9 against five current and former manufacturers of the prescription drug metoclopramide. The plaintiff conceded that he never consumed the brand-name version of the drug, but nevertheless named the brand manufacturers as defendants. The federal district court later submitted and the Alabama Supreme Court accepted the following certified question: Under Alabama law, may a drug company be held liable for fraud or misrepresentation (by misstatement or omission), based on statements it made in connection with the manufacture or distribution of a brand-name drug, by a plaintiff claiming physical injury from a generic drug manufactured and distributed by a different company? Weeks v. Wyeth, Inc., 2011 U.S. Dist. LEXIS (M.D. Ala. Aug. 25, 2011). Briefing before the Alabama Supreme Court is now complete in Weeks and a decision is expected sometime in the coming year. 4. O Neil and the future of Conte in California In Conte v. Wyeth, 85 Cal. Rptr. 3d 299 (2008), the California Court of Appeals rejected the consensus view on innovator liability and held that a brand-name drug manufacturer could be liable under a negligent misrepresentation theory for injuries allegedly caused by other companies generic-equivalent products. The court reasoned that the brand-name drug manufacturer owed the plaintiff a duty of care because it was foreseeable that her prescribing physicians would rely on the brand-name drug s labeling in issuing the prescription. The California Supreme Court recently cast doubt on Conte s continued viability, however, by rejecting the idea that one manufacturer owed consumers of other manufacturers products a duty of care based on the foreseeability of potential harm. O Neil v. Crane Co., 266 P.3d 987 (Cal. 2012). In O Neil, the plaintiffs filed strict liability and negligence claims against the manufacturers of certain asbestos-containing valves and pumps used by the U.S. Navy on its warships during World War II. Over the years, the external insulation and internal gaskets and packing for these pumps and valves were replaced by parts manufactured by other companies. Patrick O Neil was a seaman who was exposed to airborne asbestos fibers from the replacement parts. He later died of mesothelioma and his family brought a wrongful death claim against the defendants. It was undisputed that defendants did not manufacture the asbestos-containing products that O Neil was exposed to. Plaintiffs argued that the original manufacturing defendants bore responsibility for the decedent s injuries because: (1) their products included asbestos-containing components or required the addition of asbestos insulation from other sources, (2) it was foreseeable that those parts would wear and be replaced with other asbestos-containing products, and (3) it was foreseeable that these repair and maintenance procedures would release harmful asbestos dust. The trial court granted nonsuit in favor of the original manufacturers, but the Court of Appeal reversed. The California Supreme Court then reinstated the trial court s holding, noting that O Neil was not exposed to any asbestos from a product made by the defendants. Id. at On review, the California Supreme Court found in contrast to Conte s holding that the defendants had no duty to warn of risks arising from other manufacturers products. The court unanimously determined that foreseeability does not supplant the fundamental requirements of product liability law, whether the plaintiff s claims were brought in negligence or strict liability: An interpretation of [the law] that would require a manufacturer to warn about all potentially hazardous conditions surrounding the use of a product, even when those hazards arise entirely from the product of another manufacturer, reaches too far. There is no precedent in California law for such a broad expansion of a product manufacturer s duty. Id. at Moreover, [t]he foreseeability of harm, standing alone, is not a sufficient basis for imposing strict liability on the manufacturer of a nondefective product, or one whose arguably defective product does not actually cause the harm. Id. at Drug and Medical Device Law Update 2012 De Santos 275

10 The same was true for the plaintiffs claims based in negligence, where an analysis is required on the legal duty of care. To recognize a legal duty, the Court said, there must be a consideration of the foreseeability of the risk and a weighing of policy considerations for and against imposition of liability. The O Neil court held that the policy considerations at issue in the case dictated against imposing a legal duty of care regarding other companies products: [E]xpansion of the duty of care as urged here would impose an obligation to compensate on those whose products caused the plaintiff no harm. To do so would exceed the boundaries established over decades of product liability law. [S]ocial policy must at some point intervene to delimit liability even for foreseeable injury. The same policy considerations that militate against imposing strict liability in this situation apply with equal force in the context of negligence. Id. at 1007 (internal citations omitted). Accordingly, the court found that the original manufacturing defendants were properly dismissed as a matter of law. III. Medical Device Preemption This year, two appellate decisions were published examining the reach of federal law preemption to claims involving FDA-approved medical devices. On January 25, 2012, the Fourth Circuit issued its opinion in Walker v. Medtronic, which clarified the standard articulated in Riegel v. Medtronic, Inc. concerning the preemption of parallel claims that exceed federal requirements. Just a few days later, the Fifth Circuit ruled in Bass v. Stryker Corp. that claims premised on manufacturing defects resulting from violations of the manufacturer s processes approved by the FDA or the FDA s manufacturing practices were parallel to the federal requirements and, therefore, not preempted. 1. Walker v. Medtronic Inc. Plaintiff Sherry Walker filed suit against Medtronic, Inc. when her husband died while being infused with a pain medication delivered through Medtronic s SynchroMed pump. Walker v. Medtronic Inc., 2012 U.S. App. LEXIS 1334 (4 th Cir. 2012). The district court dismissed her suit after finding her claims were preempted by the Medical Device Amendments of 1976 (MDA), as interpreted by Riegel v. Medtronic, Inc. 552 U.S. 312 (2008). On appeal, Walker argued that because the pain pump failed to operate in accordance with the terms of its premarket approval, her claims were parallel to federal requirements and should escape preemption. Walker, 2012 U.S. App. LEXIS at *1. However, because Walker conceded that the pump was designed, manufactured, and distributed in compliance with its FDA premarket approval, her common law claims would impose requirements that exceed or differ from, rather than parallel, federal requirements. Accordingly, her claims for negligence, strict liability, and breach of warranty were preempted. Central to the Court s decision was a finding that a performance standard associated with the pump -- that an implanted pain pump should maintain its flow accuracy between plus or minus 15 percent -- was not a formal performance standard approved by the FDA and, therefore, treating that specification as a requirement would impose a heightened standard beyond what the FDA required. Id. at *21. According to the Court, accepting Walker s invitation to transform a design specification, which the FDA recognizes the device will not always function in accordance with, into an actionable guarantee, would impose an additional requirement precluded under Riegel. Id. at * The Court further noted that the consensus of federal court decisions post-riegel support their conclusion. Numerous district courts, the Court stated, have held that common law tort claims based on the 276 Drug and Medical Device Seminar May 2012

11 malfunction of a device designed, manufactured, and sold in accordance with the terms of their premarket approval are preempted under Riegel. Id. at * Bass v. Stryker Corp. Plaintiff Alton Bass sued Stryker Corporation (and Howmedica Osteonics Corporation, doing business as Stryker Orthopaedics) alleging that a hip replacement product malfunctioned and injured him. Bass v. Stryker Corp., et al., 2012 U.S. App. LEXIS 1789 (5 th Cir. 2012). Bass claims that after the Trident hip replacement system was implanted in his left hip, he experienced a loosening in the joint which required a surgical revision of his hip replacement. According to Bass, the looseness was caused by manufacturing residuals on the Shell which prevented bony ingrowth to the Shell. Id. at *3. He brought claims for strict liability, negligence, breach of warranty, and violation of the Texas Deceptive Trade Practices Act (DTPA). Id. at *3-4. Stryker moved to dismiss his claims under Federal Rule 12(b)(6) claiming Bass claims were preempted by the MDA. The district court granted the motion and dismissed the action on preemption grounds. On appeal, the Fifth Circuit affirmed the dismissal of Bass strict liability, design defect, negligence, and DTPA claims to the extent they were premised on failure to warn or marketing defect theories. Likewise, the court affirmed the dismissal of his breach of express warranty claims, but the Court reversed and remanded: (1) Bass strict liability and negligence claims, to the extent they were based on manufacturing defects arising from a violation of Stryker s manufacturing practices or those approved by the FDA; (2) his claim for breach of an implied warranty to the extent it relied on the failure to comply with the FDA s requirements; and (3) his DTPA claim, to the extent it relied on a breach of an implied warranty. Id. In so holding, the Court reiterated that the preemption provision of the MDA do not prevent a State from providing a damages remedy for claims premised on violation of the FDA regulations applicable to a medical device, as those duties run parallel rather than in addition to, the federal requirements. Id. at *11 (internal citations omitted). To assert a valid parallel claim, the plaintiff must plead sufficient facts (as opposed to conclusory allegations) to find that his injury plausibly resulted from a violation of FDA standards. Id. at *16. To be clear, the Court stated: We therefore hold that if a plaintiff pleads that a manufacturer of a Class III medical device failed to comply with either the specific processes and procedures that were approved by the FDA or the CGMPs [Current Good Manufacturing Practices] themselves and that this failure caused the injury, the plaintiff will have pleaded a parallel claim. Id. at *23 (emphasis in original). The Court s analysis of when a parallel claim is preempted is enlightening, but not surprising; but, as the Bass case was dismissed at the pleading stage, we thought the Court s opinion shed some much needed light on the pleading standard applicable to plaintiff s asserting parallel claims. District courts may look to Bass to determine whether a plaintiff has properly pleaded such a claim. IV. Proof of Causation Merck & Co., Inc. v. Garza The Texas Supreme Court in Merck & Co., Inc. v. Garza, 347 S.W.3d 256 (Tex. 2011) has reaffirmed and clarified the requirements imposed by state law for determining whether epidemiological evidence is sufficient to prove causation. Applying its seminal decision in Merrell Dow Pharm., Inc. v. Havner, 953 S.W.2d 706 (Tex. 1997), the court held that a plaintiff relying on epidemiological evidence regardless of whether the studies involved are observational, meta-analyses, or randomized clinical trials cannot meet her burden of Drug and Medical Device Law Update 2012 De Santos 277

12 proving general causation without presenting two or more properly-designed studies that show a doubling of the risk in question. Moreover, the plaintiff must demonstrate that his or her individual circumstances are substantially similar to the subjects in the cited studies and that other plausible causes of the injury or condition are excluded with reasonable certainty. In Garza, the court found that the plaintiffs had failed to meet these standards and reversed the jury s $32 million product liability verdict, rendering judgment instead for the defendant. The plaintiffs in the case had sued Merck, the manufacturer of the prescription drug Vioxx, claiming that use of the drug caused Leonel Garza s fatal heart attack. Garza, however, had a long history of heart problems prior to taking Vioxx and only took a limited amount of the drug for a relatively short period before his death. Merck repeatedly challenged the scientific reliability of plaintiffs evidence linking Garza s heart attack to Vioxx, but the trial court overruled those objections. The intermediate court of appeals likewise rejected Merck s argument that the plaintiffs failed to prove causation under Havner because they had not produced two statistically-significant epidemiological studies showing that Vioxx at the dose and for the duration taken by Garza more than doubles the risk of heart attack. The appellate court concluded that Havner did not establish such a bright-line test and instead held that sufficiency of the causation evidence should be determined from its totality. The Texas Supreme Court granted Merck s petition for review and reversed. In an opinion authored by Justice Hecht, and without dissent, the Texas Supreme Court agreed with Merck that Havner s requirements were fatal to plaintiffs claims. It rejected plaintiffs contention that Havner applied only to the specific type of observational studies at issue in that case, and did not extend to the more reliable, controlled clinical trials relied on by plaintiffs causation experts. Furthermore, the Garza court confirmed that Havner imposes a firm requirement demanding at least two studies that establish a doubling of the risk, and that the totality of the evidence only comes into play after a plaintiff meets this initial burden: Havner holds, and we reiterate, that when parties attempt to prove general causation using epidemiological evidence, a threshold requirement of reliability is that the evidence demonstrate a statistically significant doubling of the risk. In addition, Havner requires that a plaintiff show that he or she is similar to [the subjects] in the studies and that other plausible causes of the injury or condition that could be negated [are excluded] with reasonable certainty. Havner also requires that even if the studies meet the threshold requirements of reliability, sound methodology still necessitates that courts examine the design and execution of epidemiological studies using factors like the Bradford-Hill criteria to reveal any biases that might have skewed the results of the study, and to ensure that the standards of reliability are met in at least two properly designed studies. Thus, a plaintiff must first pass the primary reliability inquiry by meeting Havner s threshold requirements of general causation. Then, courts must conduct the secondary reliability inquiry that examines the soundness of a study s findings using the totality of the evidence test. Garza, 347 S.W.3d at (internal footnotes omitted, alterations in original). Applying these standards, the court concluded that the plaintiffs evidence was insufficient to prove general causation. For instance, the plaintiffs reliance on two studies that purportedly showed a doubling of the risk of heart attacks for Vioxx users was misplaced, as the conditions in those studies were not substantially similar to those surrounding Garza s Vioxx use. One study examined patients who used a much higher dose of the drug for a longer duration than Garza, while another involved a meta-analysis that combined a number of different studies, with differing dosages, durations and comparison drugs. Moreover, the court found that the plaintiffs had presented no reliable basis for extrapolating those studies results to Garza s drug 278 Drug and Medical Device Seminar May 2012

13 dosage or duration of use. Accordingly, the plaintiffs failed to meet their burden of proof and Merck was entitled to judgment as a matter of law. Garza is a significant decision for companies defending against claims grounded in Texas law and based on epidemiological evidence that assert a drug caused a particular injury. The court s opinion makes clear that Havner s sufficiency standard applies regardless of the type of scientific studies relied upon, and that Havner will not permit plaintiffs to satisfy their burden by pointing only to the totality of the causation evidence where they otherwise lack proof of two different, well-designed studies showing a doubling of the risk. Garza also is the second Texas appellate court opinion in the Vioxx litigation to reverse a substantial plaintiffs verdict on causation grounds. The Houston Court of Appeals previously reversed and rendered judgment for Merck in the first Vioxx case tried in Texas. See Merck & Co., Inc. v. Ernst, 296 S.W.3d 81 (Tex. App. Houston [14th Dist.] 2009, pet filed). The Ernst court found that the plaintiff had not presented sufficient evidence to sustain her theory of specific causation, as there was no evidence that the decedent had a heart attack as a result of a Vioxx-induced blood clot. The plaintiff in Ernst has filed a petition for review that remains pending before the Texas Supreme Court. V. Statute of Limitations Statutes of limitations are intended to protect defendants from litigating against stale claims, where documents may no longer exist and witness memories (if witnesses still exist) may have faded. A plaintiff, therefore, must bring an action within a certain period of time prescribed by the state s statute of limitations, which in most states, begins when the plaintiff discovered or reasonably should have discovered his or her injury was a result of another s conduct. Plaintiffs have tried a number of ways to circumvent statutes of limitation, from asserting that putative class actions in foreign jurisdictions tolled their claims (as was done in Casey v. Merck) to relying upon causation standards to justify the delayed filing of their lawsuit (see Gazal v. Boehringer Ingelheim Pharmaceuticals, Inc.). Over the last year, Courts have considered whether a state law granting FDA-approved warnings the presumption of adequateness was dispositive in a statute of limitations analysis (Kendall v. Hoffman-La Roche) and affirmed the dismissal of a case involving plaintiffs forum shopping of time-barred claims (Rick v. Wyeth). A. Kendall v. Hoffman-La Roche The New Jersey Supreme Court ruled on February 27, 2012 that the New Jersey Products Liability Act s presumption that FDA-approved warnings are per se adequate is not dispositive in a statute of limitations analysis. Kendall v. Hoffman-La Roche, Inc., 2012 N.J. LEXIS 160, *12 (N.J. Feb. 27, 2012); see N.J. Stat. 2A:58C-4. 2 The defendant drug manufacturer in Kendall unsuccessfully argued that the presumption of adequacy of FDAapproved labeling should foreclose the application of the common law discovery rule for purposes of determining when a plaintiff knew or had reason to know that her injury was caused by defendant s product. Plaintiff Kamie Kendall filed suit against the drug manufacturer in December 2005 alleging her use of an acne drug caused her to develop ulcerative colitis. Kendall was first prescribed the drug in 1997, when she was 12 years old. Between , she underwent three courses of treatment, during which she experienced some side effects to the medication, including dry lips and eyes, bloody noses, and back and knee pain, but no gastrointestinal symptoms. Id. at * In April 1999, she was hospitalized with gastrointestinal effects and was diagnosed with ulcerative colitis, a gastrointestinal disease also known as irritable bowel disease (IBD). Id. at *21. Kendall was not taking the drug at the time of her diagnosis. Drug and Medical Device Law Update 2012 De Santos 279

14 Plaintiff returned to her dermatologist for acne treatment in December 2000, and after consulting with her gastroenterologist, who had no objection to Kendall resuming her acne drug treatment, Kendall underwent another course of drug treatment. Again, Kendall experienced no gastrointestinal side effects. Id. at * Three years later, Kendall returned to her dermatologist for acne treatment and from August 2003 through January 2004, Kendall took another course of the drug. This time, Plaintiff experienced increased gastrointestinal effects. Id. at *23. Since 1984, the drug s labeling has contained a warning related to inflammatory bowel disease. In 1994, before plaintiff began taking the medication, the company issued a brochure warning about serious side effects including, severe stomach pain, diarrhea and rectal bleeding, which could be early signs of more serious and possibly permanent side effects. Id. at In August 1998, the company issued a Dear Doctor letter to board certified dermatologists warning that patients should be monitored for serious adverse events including IBD. Id. at *17. In 2003, the patient labeling accompanying the drug warned about abdominal problems, including a warning to be alert for symptoms such as diarrhea and rectal bleeding. Id. at 19. Kendall acknowledged receipt of this 2003 warning, but said that she only skimmed it as she had taken the medication before. Kendall filed suit in December The company sought to dismiss the action based on the expiration of the statute of limitations, which the trial court denied. Id. at *24. The case went to trial and the jury returned a verdict for Kendall. Defendants appealed the verdict and the trial court s rulings regarding the statute of limitations. Id. at 26. The appellate court reversed the verdict and remanded based on an evidentiary issue, but rejected the manufacturer s challenge on the statute of limitations. Id. at * The New Jersey Supreme Court granted the company s petition for certification to review whether Kendall s claim was barred by limitations. Id. at *29. New Jersey has a two-year statute of limitations. See N.J.S.A. 2A:14-2(a). As in many states, the statute is subject to the discovery rule which may toll the period of limitations if the plaintiff did not know or have reason to know that a cause of action against an identifiable defendant existed until after the normal period of limitations expired. Id. at * The company argued that the presumption of adequacy in the PLA is dispositive in an analysis of the discovery rule. Kendall, on the other hand, contended the presumption does not apply to the discovery rule determinations. Id. at *41. Although the Court acknowledged that the legislative intent behind the PLA was to protect a manufacturer who provides an FDA-sanctioned warning and that intent should extend to protect the same manufacturer from an open-ended burden of defending belatedly-filed product liability lawsuits, it held that the presumption of adequacy is not a super presumption. Id. at *44. Instead, the Court ruled that the presumption of adequacy arising from an FDA approved label should be factored into the court s analysis of the discovery rule, but a plaintiff can overcome that presumption with evidence that a reasonable person in the same circumstance would not have been aware that the defendant s product caused her injury. Id. The Court concluded that a reasonable person in Kendall s position would not have been aware by December 2003 that defendant s product was related to her injury, holding that a reasonable person in the same situation would not have suspected her IBD was related to her use of the drug and therefore, the drug s warnings were not sufficient to serve as constructive notice. B. Gazal v. Boehringer Ingelheim Pharmaceuticals, Inc., The lack of scientifically reliable, epidemiological evidence does not, according to the Eighth Circuit, toll the Texas two-year statute of limitations. In Gazal v. Boehringer Ingelheim Pharms., Inc., 647 F.3d Drug and Medical Device Seminar May 2012

15 (8th Cir. 2011), the Court was presented with the question of whether a plaintiff may delay filing suit until scientific evidence of causation to satisfy the burden of proof standard in the relevant jurisdiction exists. The Eighth Circuit said, no. Plaintiff Nabil Gazal was an Australian citizen who received medical treatment in Texas for his Parkinson s disease. In 2002, his Texas physicians prescribed Mirapex to control the symptoms of his disease. Id. at 836. Mirapex did reduce Gazal s symptoms, but he suffered significant side-effects, including an increase in his gambling habits. After losing a substantial sum, he reported his increased gambling to his physicians in April Id. In July 2005, the Mayo Clinic published a study suggesting a link between Mirapex and compulsive gambling and Gazal admitted he became aware of this link in late Id. at 837. Gazal, however, continued to gamble. Then, in June 2008, the first large-scale study of Mirapex and impulse-control disorders was published (the Dominion Study ) concluding that Mirapex users had an increased risk of developing a gambling disorder. Id. Gazal filed suit against the Mirapex manufacturers in Texas state court in June Id. The action was removed to federal court based on diversity and transferred to Minnesota as part of the Mirapex Products Liability MDL. As the case was removed under federal diversity jurisdiction, Defendants moved for summary judgment under Texas two-year statute of limitations. Id. The district court found Gazal had become aware of a possible link between Mirapex and pathological gambling no later than 2005 and granted summary judgment in favor of defendants. Id. On appeal, Gazal argued that an injury is not legally cognizable unless its cause can be ascertained. More specifically, plaintiff claimed a cause of action does not accrue absent scientifically, reliable evidence of a causal connection. Id. In a products liability action such as this, Texas follows the causation standards articulated in Merrell Dow Pharmaceuticals, Inc. v. Havner, 953 S.W.2d 706, (Tex. 1997), which requires a plaintiff to meet their burden of general causation by presenting two or more properly-designed studies that show a doubling of the risk in question. Gazal contended that his cause of action would have failed as a matter of law until the Dominion Study was published, and therefore, his cause of action did not accrue until In short, he argued that his cause of action did not arise until there was evidence that met the Havner standard. The Eighth Circuit rejected this accrual argument because Havner relates to standards applicable to a plaintiff s burden of proof on general causation. Havner is irrelevant in determining the minimum notice a plaintiff must have before a particular claim accrues. Id. at Gazal, the Court held, was on notice of his injury and of its causal connection to his Mirapex prescription no later than 2005 and his claim was timebarred. C. Rick v. Wyeth, Inc. The Eighth Circuit, faced with an example of egregious forum shopping, ruled that where a defendant has obtained a final order of dismissal of a plaintiff s original action under the plaintiff s home state statute of limitations, that order also requires dismissal of a subsequent action filed in a State with a longer statute of limitations. Rick v. Wyeth, Inc., 662 F.3d 1067 (8th Cir. Minn. 2011). The appeal raised a single issue: whether dismissal of plaintiffs actions as time-barred under New York law precludes assertion of the same claims in a federal court diversity action in Minnesota where the claims would not be time-barred. Id. at The case, according to the Eighth Circuit, invoked three complex issues of law -- full faith and credit, diversity jurisdiction and claim preclusion (res judicata) -- but the court had no difficulty, based on the record, affirming the dismissal. Id. at In Rick, plaintiffs, who were citizens of New York, sued the defendant pharmaceutical companies in New York state court, claiming the defendants hormone replacement therapy drugs caused plaintiffs to Drug and Medical Device Law Update 2012 De Santos 281

16 develop breast cancer. Id. After substantial discovery, defendants moved for summary judgment arguing plaintiffs claims were time-barred under New York s three-year statute of limitations. Id. While the New York litigation was pending, plaintiffs filed diversity actions in the District of Minnesota, asserting the same claims, and also sought a dismissal of their claims without prejudice in the New York court. Id. Minnesota has a six year statute of limitations and plaintiffs actions would not have been time-barred in that state. The New York court denied the plaintiff s motions to dismiss the actions without prejudice, noting plaintiffs had already filed their actions in Minnesota to get around New York s obviously shorter three year statute and holding that dismissal without prejudice would deprive the defendants of the right to judgment on the merits. Id. at The court then granted the defendants summary judgment motions and dismissed the claims as time-barred. Id. The Minnesota district court, in turn, granted defendants motion for summary judgment holding that the New York courts final judgment under New York law based on limitations is sufficiently close to the merits to have preclusive effects in Minnesota. Id. Plaintiffs appealed the district court ruling. The Eighth Circuit ruled that the preclusive effect of a prior state court judgment is determined by the Constitution s Full Faith and Credit Clause, Article IV, 1. Id. at Federal courts must give a statecourt judgment the same preclusive effect as the state issuing the judgment would give that judgment. Id. More to the point, where there has been a full evaluation of plaintiffs claims in light of New York s statute of limitations, a dismissal on statute of limitations grounds is considered a dismissal on the merits for res judicata purposes and bars a second action. Id. at D. Casey v. Merck & Co. The Virginia Supreme Court ruled on March 2, 2012, that the filing of a putative class action in another jurisdiction does not toll the State s statute of limitations. Casey v. Merck & Co., Inc., 2012 Va. LEXIS 48 (Va., Mar. 2, 2012). The Second Circuit Court of Appeals certified two questions to the Virginia Supreme Court to determine whether the pendency of a putative class action in another jurisdiction: (1) equitably tolled the statute of limitations; or (2) tolled the statute of limitations under Va. Code Ann (E)(1). In September 2005, a putative class action, Wolfe v. Merck, was filed in the Middle District of Tennessee. The class action purported to include all persons who consume or have consumed Fosomax and asserted claims for strict liability, negligence, and medical monitoring against Merck. The Wolfe putative class action was transferred to the U.S. District Court for the Southern District of New York (where the Fosomax MDL was pending). The MDL court dismissed the Wolfe action on January 28, Before the putative class action was dismissed, the four Casey plaintiffs filed suit against Merck in the MDL. It was undisputed that the Casey plaintiffs filed suit more than 2 years after the latest possible date of injury and that Virginia law applied to their claims. Merck moved for summary judgment in the MDL under the Virginia 2-year statute of limitations. The Casey plaintiffs contended their claims were tolled during the pendency of the Wolfe putative class action because they would have been members of that class action had certification been granted. The district court granted Merck s summary judgment motion and the plaintiffs appealed to the Second Circuit. The Second Circuit determined Virginia law would govern whether the putative class action equitably or statutorily tolled the Casey plaintiff s claims and certified the questions presented. The Supreme Court of Virginia disposed of the equitable argument quickly, and found that there was no authority in Virginia jurisprudence for the equitable tolling of a statute of limitations based upon the pendency of a putative class action. Casey, 2012 Va. LEXIS 48 at *6. It then turned to whether Va. Code Ann (E)(1) tolled plaintiff s claims. Code (E)(1) states: 282 Drug and Medical Device Seminar May 2012

17 [I]f any action is commenced within the prescribed limitation period and for any cause abates or is dismissed without determining the merits, the time such action is pending shall not be computed as part of the period within which such action may be brought, and another action may be brought within the remaining period. Plaintiffs argued this provision statutorily tolled their claims. The Virginia Supreme Court disagreed and held that for tolling to be permitted the subsequently filed action must be filed by the same party in interest on the same cause of action in the same right. Id. at *8 (internal citations omitted). In other words, Code (E)(1) will toll a subsequent action if the plaintiff who brought the original action is the same plaintiff who brought the later action and asserted the same cause of action. Since Virginia does not recognize putative class actions there is no identify of parties between the named plaintiff in a putative class action and the unnamed putative class member who files a subsequent action. Accordingly, a putative class action cannot toll the statutory period for unnamed putative class members who are not recognized under Virginia law as plaintiffs or represented plaintiffs in the original action. Id. at *9 VI. Conclusion If the year concludes, as we think it might, with more cases interpreting Mensing, then we think it s fair to say that Mensing has pushed open a door in pharmaceutical litigation that was only slightly ajar after Wyeth v. Levine. The implications of the FDA s different labeling requirements for brand name and generic manufacturers, therefore, will probably continue to impact preemption jurisprudence well into the future. Drug and Medical Device Law Update 2012 De Santos 283

18 Endnotes 1 The Sixth Circuit may soon again address the preemption issue when the court reviews a decision from the Western District of Michigan entered in four related cases last year. In Blair v. Genentech, Inc., 2011 U.S. Dist. LEXIS (W.D. Mich. Oct. 26, 2011) (and the related cases Tiefenthal v. Genentech, Inc., Marsh v. Genentech, Inc., and Muniz v. Genentech, Inc.), the district court held that the fraud-on-the-fda exception to Michigan s products liability statute, which protects manufacturers from liability for failure-to-warn claims based on FDA approved labeling, is impliedly preempted under Buckman. Blair v. Genentech, Inc., 2011 U.S. Dist. LEXIS at *15. Following Garcia, the district court held that federal law prohibits a plaintiff from invoking the exceptions on the basis of state court findings of fraud; but, the exception would still apply where a federal determination of fraud is made. Id. at *12. 2 N.J.S.A. 2A:58C-4 reads as follows (emphasis added): In any product liability action the manufacturer or seller shall not be liable for harm caused by a failure to warn if the product contains an adequate warning or instruction or, in the case of dangers a manufacturer or seller discovers or reasonably should discover after the product leaves its control, if the manufacturer or seller provides an adequate warning or instruction. An adequate product warning or instruction is one that a reasonably prudent person in the same or similar circumstances would have provided with respect to the danger and that communicates adequate information on the dangers and safe use of the product, taking into account the characteristics of, and the ordinary knowledge common to, the persons by whom the product is intended to be used, or in the case of prescription drugs, taking into account the characteristics of, and the ordinary knowledge common to, the prescribing physician. If the warning or instruction given in connection with a drug or device or food or food additive has been approved or prescribed by the federal Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act, 52 Stat. 1040, 21 U.S.C. 301 et seq. or the Public Health Service Act, 58 Stat. 682, 42 U.S.C. 201 et seq., a rebuttable presumption shall arise that the warning or instruction is adequate. 284 Drug and Medical Device Seminar May 2012