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CCL has long been involved in efforts to protect the rights of plaintiffs injured by prescription drugs to pursue state tort remedies for their injuries and has aggressively opposed efforts by drug manufacturers to invoke federal preemption to shield them from such liability. In Pliva, Inc. v. Mensing, a case argued by CCL Senior Litigation Counsel Louis Bograd, the Supreme Court ruled, 5-4, that generic drug companies were largely immune from state failure-to-warn liability, because federal law prohibited them from adding new or strengthened warnings about their drugs without prior FDA approval. Now, after prolonged efforts by CCL, the American Association for Justice, and other advocates for injured plaintiffs, the FDA stands ready to overturn Mensing, at least prospectively, and effectively to restore plaintiffs’ rights. In a notice of proposed rulemaking published last week, FDA proposed revised regulations that would permit generic drug manufacturers to add new or strengthened warnings to their labels—and to send Dear Doctor letters about those changes—without prior agency approval, so long as the company simultaneously submits a supplemental application to the FDA seeking approval for the change. As the FDA notes, the proposed regulations would achieve “parity” between manufacturers of brand-name and generic drugs and thereby subject generic manufacturers to tort liability on the same basis as brand-name manufacturers. CCL will be working closely with AAJ and others to submit comments to FDA in support of the proposed regulations.

The Sixth Circuit today denied defendants’ petitions for leave to appeal remand orders under CAFA in seven separate Darvon cases. Plaintiffs had filed these cases in California and had named a drug distributor based in California as one of the defendants to prevent removal based on diversity. Defendants nevertheless removed these cases to federal court, asserting among other things that the cases were subject to federal jurisdiction under the mass action provision of the Class Action Fairness Act. Defendants moved to transfer the cases to the Darvon MDL and the JPML decided that the remand issue could properly be resolved by that court after transfer (even though, if federal jurisdiction were based solely on CAFA, transfer would be prohibited). The MDL judge then granted remand, rejecting defendants’ three separate arguments for federal jurisdiction.

Defendants sought leave to appeal to the Sixth Circuit. Although remand orders are not generally appealable, a provision in CAFA authorizes petitions for expedited appeal of remand orders rejecting federal jurisdiction under that act. CCL Senior Counsel Lou Bograd was retained to oppose the petitions. Today, a motions panel of the court entered an order denying leave to appeal in all seven cases, which will now all be remanded to California state court.

The Supreme Court of Georgia has held that a railroad may be liable under the Federal Employers Liability Act (FELA) to injured crew members for failure to provide safety training regarding grade crossing collisions. Norfolk Southern Railway Co.v. Zeagler, ___ S.E.2d ___ (Ga., Sept. 23, 2013). CCL Senior Counsel Jeffrey White argued in an amicus curiae brief filed on behalf of the American Association for Justice that the FELA action was neither preempted nor precluded by Federal Railroad Safety Act regulations.

Freight conductor Zeagler was riding in the locomotive cab when a logging truck pulled onto the tracks at a grade crossing. Although the engineer pulled the emergency brake, it was clear the train could not stop in time. As Zeagler was scrambling to exit the locomotive, he fell and injured his back. He brought suit under the FELA, alleging that the railroad negligently failed to instruct workers to brace in place when a collision is imminent, rather than try to escape from the locomotive. The trial judge granted Norfolk Southern’s motion for summary judgment on the ground that that it had no duty under federal law to provide such training. The court of appeals reversed.

The Georgia Supreme Court upheld the appellate court’s determination that injury to trainmen is clearly foreseeable and that the railroad owed a duty “to provide Zeagler with whatever training is reasonably appropriate to protect him from injury in such accidents.” The court rejected the railroad’s contention that Federal Railroad Safety Act regulations, which do not specifically require such collision training, preempt Zeagler’s FELA cause of action. The court made clear at the outset that preemption doctrine, based on the constitutional supremacy of federal law over state law, does not apply to a potential conflict between federal laws. Nor do the FSRA regulations preclude the FELA claim. The court did not reach the narrow scope of preclusion advocated by the AAJ brief. In this case, where FSRA regulations do not prescribe any particular safety instructions, there was nothing that could preclude plaintiff’s FELA lawsuit under even a relaxed standard. The court also rejected Norfolk Southern’s argument that precluding the cause of action would serve the goal of national uniformity for railroad requirements. Instead, the court held that “any ‘national uniformity’ in this area will occur through the recognition of a standard of care in cases brought under FELA.”

On Wednesday, September 04, 2013, the Alabama Supreme Court heard oral argument on rehearing in the case of Wyeth v. Weeks. The case involves the issue of whether the manufacturer of a brand-name drug may be held liable for injuries caused by its misrepresentations about the drug to a plaintiff who was injured as a result of his doctor’s reliance on the manufacturer’s representations, even though the plaintiff’s prescription was filled with a generic equivalent of the branded drug. Last January, the Alabama Court decided 8-1 that the manufacturer may be held liable for misrepresentation under these circumstances. Wyeth petitioned for rehearing, leading to this week’s argument.

CCL Senior Litigation Counsel Lou Bograd filed an amicus brief on behalf of the American Association for Justice in support of the Court’s earlier ruling. Bograd was also quoted in a Reuters article, “Brand drugmaker liability in the spotlight at Alabama high court,” setting the stage for the argument. ”The defendants want to characterize this as the sky falling and the world ending,” said Bograd in the article. “Misrepresentation resulting in physical injury is a well-recognized tort.”

The American Tort Reform Association (ATRA) filed a petition in the U.S. Court of Appeals for the D.C. Circuit challenging the Occupational Safety and Health Agency’s (OSHA’s) edits to preemption language in the Hazard Communication Standard. The federal Standard establishes minimum labeling requirements for hazardous chemicals. ATRA argues that the preemption language in effect prior to these edits in 2012 suggested that the federal Standard preempted common-law duties and liabilities, such as for failure to warn.  OSHA’s edits, according to ATRA, foreclose preemption. These changes, ATRA maintains, were made without notice or opportunity for comment, and thus are ultra vires.

CCL has now filed an amicus curiae brief for the American Association for Justice (AAJ) in this case. The brief, written by CCL’s Andre M. Mura, and filed in support of OSHA, expresses AAJ’s concern that if tort remedies against chemical manufacturers are limited through improper application of preemption principles, injured workers will be left without compensation and chemical manufacturers will not have adequate incentive to conduct a thorough hazardous material review, or to update labeling when new hazards emerge. The brief takes issue with ATRA’s preemption arguments, contending instead that the federal Standard has never been understood to preempt common-law duties and liabilities. The brief further argues, not only did OSHA not intend to preempt common-law duties in this federal Standard, it has no authority to do so, because Congress, in enacting the OSH Act, never authorized preemption of common-law duties on the scale imagined by ATRA.

In an important preemption case, Fulgenzi v. Pliva, Inc., the 6th Circuit unanimously ruled today that a generic drug manufacturer may be sued under state law where it failed to provide all of the warnings approved by the FDA for the equivalent brand-name drug.

The court rejected the argument that plaintiff’s claim was preempted on grounds of impossibility under the U.S. Supreme Court’s 2011 ruling in Pliva, Inc. v. Mensing, stating: “not only could PLIVA have independently updated its labeling to match that of the branded manufacturer through the CBE process, but it had a federal duty to do so. As a result, compliance with federal and state duties was not just possible; it was required. Impossibility preemption is inappropriate in such a case.”

The court also rejected defendant’s argument that Ms. Fulgenzi’s claim was preempted under Buckman v. Plaintiffs Legal Comm. (2001), as an attempt to privately enforce federal law: “Here, Fulgenzi’s suit is not even premised on violation of federal law, but rather on an independent state duty. The alleged breach arises from the same act, but the legal basis is different. This is simply not grounds for preemption.”

The Fulgenzi decision represents a significant limitation on the reach of the Supreme Court’s generic drug preemption ruling in Mensing. The decision takes on added significance in light of a recent study which found that more than 2/3 of generic drug labels lack warnings found on the labels of the equivalent branded drugs. Consistency in the safety labeling of bioequivalent medications, Pharmacoepidemiology and Drug Safety (2012).

The appeal in Fulgenzi was briefed and argued by CCL Senior Litigation Counsel Louis Bograd.  Find news coverage here.

In Mutual Pharmaceutical Co. v. Bartlett, No. 12-142, the Supreme Court of the United States will consider whether the Federal Food, Drug, and Cosmetic Act supersedes state-law claims against manufacturers of generic prescription drugs for design defects. CCL has filed two amicus curiae briefs in support of the injured plaintiff, Karen Bartlett, whose adverse reaction to the generic pain medication ‘sulindac’ included burns, disfigurement, and blindness.

An amicus brief written by CCL’s Andre M. Mura, and filed on behalf of the American Association for Justice, a voluntary national bar association, and Public Justice, PC, a national public interest law firm, argued that Congress did not intend to deprive persons injured by unreasonably dangerous drugs of long available compensation. Responding to the generic drug manufacturer’s argument that it was impossible for it to comply with both state tort law and federal drug-safety law, the brief explained that even a state-law prohibition against the sale of an unreasonably dangerous drug would not impose an impossibility conflict with federal law because federal law does not require drug manufacturers to sell drug products. Lastly, the brief criticized the United States’ position on preemption, which favors the generic manufacturer in this case, for failing either to acknowledge the Food and Drug Administration’s (FDA’s) shortcomings, which hamper its ability to monitor the safety and efficacy of prescription drugs, or to credit product-liability litigation for providing a critical layer of consumer protection.

CCL filed a separate amicus brief on behalf of persons injured by the prescription drug propoxyphene, which is alleged to have caused serious cardiac injuries or death to thousands, and which has now been withdrawn from the market. The brief, written by CCL’s Louis M. Bograd, argued that state-law design-defect claims are entirely consistent with and complementary to the FDA’s regulatory system. Further, the brief explained that the Supreme Court’s recent decision in Pliva, Inc.  v. Mensing, 131 S. Ct. 2567 (2011), which held that failure-to-warn claims against the manufacturers of generic prescription drugs were preempted by federal law, is not controlling here because design-defect liability differs in important ways from liability for failure to warn.

This critical preemption case is set for argument on March 19.  A decision is expected by end of the Court’s Term in June.

In Pliva, Inc.  v. Mensing, 131 S.Ct. 2567 (2011), the U.S. Supreme Court held that failure-to-warn claims against the manufacturers of generic prescription drugs were preempted by the Federal Food, Drug, and Cosmetic Act. In the wake of this decision, two courts recently issued opinions that permit plaintiffs injured after taking generic prescription drugs to pursue different claims against generic and brand-name prescription drug manufacturers.

In Wyeth, Inc. v. Weeks, the Alabama Supreme Court, answering a question certified to it by the U.S. District Court for the Middle District of Alabama, held that a brand-name drug manufacturer may be held liable for fraud or misrepresentation, based on statements it made in connection with the manufacture of a brand-name prescription drug, by a plaintiff who was physically injured by a generic version of that drug. The Alabama Supreme Court noted that the vast majority of the cases that came to the opposite conclusion preceded the U.S. Supreme Court’s decision in Mensing, and falsely presumed that generic manufacturers could be held responsible for the representations on their labels. Trial News, an electronic publication of the American Association for Justice, quoted CCL’s Louis Bograd on February 7, 2013, calling the Alabama decision “a lifeline to plaintiffs injured by inadequately labeled generic drugs.”  The Alabama Supreme Court also found that earlier cases had conflated strict products liability and tort law. The decision in Weeks is in line with the California Court of Appeals’ decision in Conte v. Wyeth, Inc., 168 Cal. App. 4th 89 (2008), which was argued by CCL’s Valerie M. Nannery.

In Arters v. Sandoz Inc., the U.S. District Court for the Southern District of Ohio allowed a man blinded by the generic drug amiodarone to pursue design defect claims against the manufacturer of the drug, while holding that his state law failure-to-warn claims were preempted by federal law. The court also allowed the plaintiff to move forward on claims sounding in negligence, breach of implied warranty and fraud for the manufacturer’s promotion of off-label use of the drug. While recognizing that under the Supreme Court’s ruling in Mensing, federal law requires generic drugs to have the same labels as their name-brand counterparts, the court noted that federal law does not require generic manufacturers to sell an unreasonably dangerous product in Ohio or to promote their drugs for off-label use. Thus, the court denied, in part, the manufacturer’s motion for judgment on the pleadings.

On March 19^th, the United States Supreme Court will hear arguments in Mutual Pharmaceutical Co. v. Bartlett, which presents the question of whether state law claims against manufacturers of generic prescription drugs for design defects are preempted by federal law. CCL’s Bograd, representing plaintiffs in the Darvon litigation, and CCL’s Andre Mura, representing AAJ, are preparing amicus curiae briefs in Bartlett.

On Wednesday, January 16, 2013, CCL Senior Litigation Counsel Louis Bograd appeared before a panel of the United States Court of Appeals for the Sixth Circuit to argue the case of Fulgenzi v. Pliva, Inc. Eleanor Fulgenzi developed tardive dyskinesia, a serious neurological disorder, as a result of her long-term use of the generic prescription drug metoclopramide manufactured by defendant Pliva. The FDA had only approved metoclopramide for short-term use of up to twelve weeks, but Pliva failed to include a warning that “metoclopramide use should not exceed 12 weeks in duration,” which the FDA had approved for the label of Reglan, the brand-name equivalent for metoclopramide. The central issue in this appeal is whether Pliva’s failure to include this FDA-mandated warning distinguishes this case from Pliva, Inc. v. Mensing, in which the Supreme Court held that most failure-to-warn claims against generic drug manufacturers are preempted on grounds of impossibility, because federal law prohibits generic drug companies from providing warnings that differ from those provided by the equivalent brand-name product. Fulgenzi is one of a number of post-Mensing appeals currently being considered by various federal circuits.

On December 5, 2012, CCL Senior Litigation Counsel Louis Bograd argued the case of Morris v. Teva et al., before the United States Court of Appeals for the Fifth Circuit. Plaintiff Penny Morris developed tardive dyskinesia, a serious neurological disorder, as a result of her long-term use of the generic prescription drug metoclopramide manufactured by the defendants. In July 2004, the FDA approved a change to the label of Reglan, the brand-name form of metoclopramide, to add a bold-faced warning that “metoclopramide use should not exceed 12 weeks in duration.” Yet no manufacturer of metoclopramide ever communicated this new warning to Ms. Morris’s doctor, either through a Dear Doctor letter announcing the change or by publishing the revised warning in the Physician’s Desk Reference. The central issue in the Morris appeal is whether this failure to communicate a warning approved by the FDA distinguishes this case from Pliva, Inc. v. Mensing, in which the Supreme Court held that most failure-to-warn claims against generic drug manufacturers are preempted on grounds of impossibility. Here, federal law did not prohibit the defendants from notifying doctors of the new FDA-approved warning. Morris is one of a number of post-Mensing appeals currently being considered by various federal circuits.