From contraceptives to mesh implants, shampoos to pasta, New York state and federal courts issued decisions in 2020 which further shaped the landscape in the medical and life sciences legal world. To prepare the best product liability and class action defense strategies for pharmaceuticals, medical devices and other FDA regulated products, it is often helpful to step back and review holdings that have affected the industry and may shape the year ahead.
In the New York Medical and Life Sciences: Year in Review 2020, we review, analyze and share potential implications for future life science cases, based on several key judicial holdings in New York in 2020 pertaining to:
- Contraceptives: general causation, expert witness opinions, preemption
- Surgical Mesh: specific causation, design defect, failure to warn
- Drugs and Devices: adverse event reports, choice of law, preemption
- Class Actions: injunctive relief, reasonable consumer, expert opinion, ingredient list
In an appeal from a judgment of the United States District Court for the Southern District of New York granting summary judgment in favor of Bayer dismissing mass tort plaintiffs' products liability Mirena claims after preclusion of the opinions of all of plaintiffs’ expert witnesses on general causation, the Second Circuit affirmed. Plaintiffs argued that the district court abused its discretion by (1) focusing on plaintiffs' experts' conclusions rather than their methodologies, (2) requiring the experts to back their opinions with published studies that definitively supported their conclusions, and (3) taking a "hard look" at the experts' methodology. The Second Circuit held that plaintiffs may challenge whether the district court’s reliability analysis was correct, but plaintiffs had no basis to argue that the district court did not engage in a detailed analysis of their experts' methodologies. An expert need not back his/her opinion with published studies that support his/her conclusion if he/she has utilized reliable scientific methods to reach that conclusion. But here, because the district court found that plaintiffs' experts did not otherwise reliably utilize scientific methods and the conclusions were not supported by other studies, the experts' reports were properly excluded. Not only was it appropriate for the district court to take a hard look at plaintiffs' experts' reports, the court was required to do so to ensure reliability. Plaintiffs also argued that the district court erred in precluding differential-diagnosis evidence, which they argued would have shown general causation. While the Second Circuit declined to adopt a bright-line rule that "a differential diagnosis may never provide a sufficient basis for an opinion as to general causation," they explained that the district judge had broad discretion in determining whether in a given case a differential diagnosis is enough by itself to support such an opinion. And here it was not.
English v Bayer, 468 F. Supp.3d 573 (W.D.N.Y. 2020)
Plaintiffs, three former users of Essure, a Class III medical device contraceptive implant, subject to Pre-Market Approval procedures, and granted PMA by the FDA, asserted causes of action for negligent training of physicians, breach of express warranty and negligent misrepresentation (advertising concerning safety and effectiveness at preventing pregnancy, and qualifications of implanting physicians), negligent risk management (failing to report adverse events to the FDA), and negligent failure to warn. Defendants moved pre-Answer to dismiss under FRCP 12(b)(6) on the basis that plaintiffs’ claims were entirely preempted by the Medical Device Amendments to the federal Food Drug and Cosmetic Act. The court found plaintiffs did not plausibly allege that the FDA-approved training requirements placed any duty on defendants to do so. To the extent that plaintiffs claimed that defendants did deviate from FDA-approved training requirements by failing to ensure that implanting physicians completed preceptoring requirements, read and understood the Physician Training Manual, and successfully completed simulator training, those claims did not seek to impose obligations beyond those mandated by the FDA, and thus arguably were not expressly preempted. However, they were nonetheless impliedly preempted since plaintiffs did not plead any parallel state law cause of action that supported their negligent training claims, nor did their opposition identify any New York law establishing liability on the part of a non-employer for injuries to third parties arising out of alleged negligent training. With respect to plaintiffs’ “failure to report adverse events to the FDA” claims, even if they were characterized as a failure to warn, they were expressly preempted: plaintiffs could not maintain a claim that defendants were required to issue additional warnings beyond what the FDA prescribed and approved. Furthermore, as a standalone claim, “failure to report adverse events to the FDA” is not a cognizable cause of action under New York law.
Plaintiff alleged that she developed blood-clots, resulting in a pulmonary embolism, as a result of using an oral contraceptive, marketed as a generic drug. The complaint asserted causes of action for negligence, strict liability, breach of warranty, fraud and negligent misrepresentation. On a FRCP 12(c) motion for judgment on the pleadings, the court dismissed the warning and design claims as preempted, citing Supreme Court precedents (PLIVA, Inc. v. Mensing 564 U.S. 604 (2011) and Mut. Pharm. Co. v. Bartlett, 570 U.S. 472 (2013)). Moreover, plaintiff could not proceed on her other claims, including a failure to test theory, a theory premised on the suggestion that such testing would have shown that the oral contraceptive “was too dangerous for the market.” That argument is inconsistent with Bartlett, which held that the “stop-selling rationale” that products should be pulled from the market is incompatible with “preemption jurisprudence because preemption cases presume that an actor seeking to satisfy both his federal and state law obligations is not required to cease acting altogether in order to avoid liability.”
Contraceptives
Potential implication for future cases: In contraceptive product liability actions, whether the product is regulated as a drug or a device, preemption remains a first line of defense. Even non-traditional theories, such as failure to test, train or report AERs, are vulnerable to dismissal. New York continues to be wary of admitting differential diagnosis expert opinion on issues of general causation.
Balura v Ethicon, No. 3:19-CV-1372, 2020 WL 819293 (N.D.N.Y. Feb. 19, 2020)
In a “massive products liability multi-district litigation” involving transvaginal surgical mesh used primarily to treat pelvic organ prolapse and stress urinary incontinence, defendants moved to exclude a specific causation expert alleging differential diagnosis, as the opinion was replete with factual errors, which prohibited him from forming a proper foundation for his opinions. The court ruled that the differential diagnosis opinion was suitable in a specific causation analysis. However, the opinion that plaintiff’s pelvic injuries were caused by a defective device without specifying any design defect was insufficient under New York law. The court ruled the expert failed to describe or explain how a defect in the mesh caused plaintiff’s injuries, as...
