A number of important announcements from the Food and Drug Administration (FDA) in 2018, as well as a variety of court decisions, will undoubtedly have an impact on future drug and device products liability claims. These announcements and cases include changes to medical device certification, future changes to post-market surveillance of devices and a number of developments regarding pharmaceutical drug preemption cases.
- Medical Device De Novo Classification Process: On Dec. 7, 2018, the FDA published the proposed Medical Device De Novo Classification Process.1 The idea behind the rule is to modernize the pathway for the review of new, low- to moderate-risk medical devices for which there are no legally marketed predicate devices. If finalized, the proposed rule will establish certain procedures and criteria used in the de novo classification process, providing market applicants with a better understanding of how to navigate the certification process. Additionally, the proposed rule would establish a 12-day review period.
- Official Statements by the FDA: On Nov. 20, following the release of its Medical Device Safety Action Plan, the FDA announced its continuing efforts to overhaul the post-market surveillance system from the current passive system, which relies on reports from device users, to a more active system, which will rely on “real-world evidence and timely receipt of robust safety information.”2 The active surveillance system will result in more real-world data that can be promptly analyzed by the FDA and the medical technology industry to improve the effectiveness and safety of medical devices. At present, the FDA has only initiated pilot programs of the active surveillance system, most recently focusing on devices for women’s health.
- On Dec. 13, the FDA withdrew a controversial rule that would have allowed generic drug manufacturers to unilaterally change their drug labels to warn of new safety developments. The rule would have likely removed the preemption protections by the Supreme Court’s opinion in PLIVA v. Mensing,4 as well as exposing generic drug companies to direct liability for broader warnings-based claims. The FDA stated that it was withdrawing the proposed rule, in part, due to the perceived risk that the rule could increase industry costs that might be shifted to patients.
- Daubert Standards & FDA Warnings: The consolidated litigation of In re: Accutane Litigation from the New Jersey Supreme Court produced two favorable decisions for future defendants. The first, handed down in August 2018,5 ended more than 2,000 cases alleging Accutane causes gastrointestinal problems. In its ruling, the New Jersey Supreme County held that courts must assess the scientific reliability of evidence before it goes in front of a jury. The second decision, handed down in October,6 ended an additional 500 cases alleging that a healthcare company didn’t adequately warn of possible gastrointestinal side effects from its acne drug. In its decision, the high court said that since the warnings were approved by the FDA, the plaintiffs had not overcome the state’s rebuttable presumption of adequacy under New Jersey’s Products Liability Act. That presumption of adequacy affords pharmaceutical companies greater protection from products liability claims in New Jersey than in other jurisdictions.
- Preemption: The past year has been marked by a changing field of pharmaceutical drug preemption cases, with several set for significant developments in 2018.7
- “Newly Acquired Information”: In August, the Seventh Circuit vacated a $3 million judgment in favor of a plaintiff in an Illinois innovator liability case.8 The case involved ingestion of a generic form of the anti-depressant Paxil. In reversing the judgment from the trial court, the Seventh Circuit held (1) “clear evidence” established that the plaintiff’s proposed warnings had been rejected by the FDA in 2007 and (2) the plaintiff failed to offer evidence that the pharmaceutical company acquired new information after 2007 that would justify a change in the label. The Seventh Circuit noted that the FDA had studied the risk at issue, the pharmaceutical company had made the labeling change and provided the FDA with complete data supporting the change, and that each of the four requests made were rejected by the FDA.
- Innovator Liability: The Supreme Judicial Court of Massachusetts reached an important decision recognizing innovator liability in certain circumstances.9 The court found that while plaintiffs injured using a generic drug could not bring a standard negligence claim against the brand name manufacturer for failure to warn, a viable claim against brand manufacturers exists where the plaintiff establishes that the brand manufacturer’s conduct was “reckless” in failing to warn of “an unreasonable risk of death or grave bodily injury.”
- Generic Drugs: The Sixth Circuit found that a plaintiff’s failure to warn claim against a generic manufacturer for failure to provide a medication guide was impliedly preempted.10 The Sixth Circuit affirmed the dismissal of the failure to warn claims with prejudice, holding that they were impliedly preempted under the Federal Food, Drug, and Cosmetic Act. The plaintiff failed to cite any state law duty paralleling the federal duty to provide a medication guide, so the claims would not exist without the Act.
- Case to Watch: The U.S. Supreme Court heard oral argument on the closely watched In re Fosamax Prods. Liab. Litig. on Jan. 7, 2019.11 In Fosamax, plaintiffs claim that a label should have included a warning, while the pharmaceutical company argues that it was prevented from doing so by the FDA. While the trial court found the plaintiffs’ claims were preempted, the Third Circuit reversed, finding that “clear evidence” meant “clear and convincing” evidence and that preemption is a question of fact for a jury. Both issues will be decided by the Supreme Court and could have a huge impact on the pharmaceutical industry in the years to come.
These announcements and cases mark changes not only to how companies will handle device approval and compliance with the FDA, but also potential changes to defenses and strategies involved in innovator liability cases. For more information about these changes or how they might affect your company or organization, please contact Peter French or Tristan Fretwell.
183 Fed. Reg. 63127 (Dec. 7, 2018).
4564 U.S. 604 (2011).
5191 A.3d 560 (N.J. 2018).
6194 A.3d 503 (N.J. 2018).
8Dolin v. GlaxoSmithKline LLC, 901 F.3d 803 (7th Cir. 2018).
9Rafferty v. Merck & Co., 479 Mass. 141, 157 (2018).
10McDaniel v. Upsher-Smith Laboratories Inc., 893 F.3d 941 (6th Cir. 2018).
11852 F.3d 268 (3d. Cir. 2017).