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 Re: Mirena IUS Levonorgestrel-Related Products Liability Litigation (No. II), 982 F.3d 113 (2d Cir. 2020)
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.
Montero v. Teva Pharmaceuticals USA Inc. et al., No. 19 Civ. 9304, 2020 WL 1862593 (S.D.N.Y. April 14, 2020)
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.”
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 opposed to the mere presence of the mesh itself. Finally, the expert’s opinions about alleged future complications were speculative and unreliable, as not consistent with Daubert’s methodology requirements.
Arruda v. C.R. Bard, No. 6:19-cv-1523, 2020 WL 4569436 (N.D.N.Y. Aug. 6, 2020)
In a product liability matter involving Align, a 510K device, defendant contended that plaintiff could not prevail on a design defect claim unless she also demonstrated a failure to warn. Defendant argued that a medical device that is implanted and requires a prescription is a Comment K unavoidably unsafe product to which strict products liability would not normally apply. Defendant, however, largely relied on cases that involved prescription drugs, not devices. The court noted the Second Circuit would assess the viability of a design defect claim under the legal standard for such claims in New York– a utility/risk analysis–rather than by applying the unavoidably unsafe products exception. The court thus did not require plaintiff to show a failure to warn in order to maintain a design defect claim. Defendant’s attempt to have the court adopt a categorical approach to the exception stated in Comment K, finding that any medical device implanted pursuant to a prescription is unavoidably unsafe, was rejected. Among other things, the court denied defendant’s motion for summary judgment on design defect and failure to warn claims.
Dunham v. Covidien, 19-cv-2855, 2020 WL 5995102 (S.D.N.Y. Oct. 9, 2020) and Krulewich v Covidien, No. 19-cv-2857, 2020 WL 5995103 (S.D.N.Y. Oct. 9, 2020)
In a Covidien mesh action, defendant moved to dismiss claims for common law strict products liability (manufacturing defect, design defect, and failure to warn), negligence, breach of warranty (express and implied), negligent and fraudulent misrepresentation, unconscionable commercial practices under New York General Business Law Sections 349 and 350, unjust enrichment, and punitive damages, which was granted. Dunham v. Covidien. On the same day, the same court dismissed claims for common law strict products liability (manufacturing defect, design defect, and failure to warn), negligence, breach of warranty (express and implied), negligent and fraudulent misrepresentation, unconscionable commercial practices under New York General Business Law Sections 349 and 350, unjust enrichment, punitive damages, and loss of consortium. Krulewich v Covidien. In both cases, plaintiffs’ proposed alternative design was to use polypropylene instead of polyester. Plaintiffs did not adequately plead that the use of polyester was a substantial factor in causing the injuries. The plaintiffs thus failed to allege adequately a design defect claim. The court also found deficiencies in the plaintiffs’ failure to warn claims because the allegations did not identify how the warnings given were insufficient to warn physicians and the plaintiffs of the potential dangers of using the mesh. The warnings provided noted the risks of the complications that plaintiff actually experienced, namely, chronic pain, adhesion, and hernia recurrence.
Potential implication for future cases: Surgical mesh plaintiffs must adequately plead their design defect and warning claims under traditional New York concepts of product liability. New York approaches design defect for a medical device under a risk – utility balancing approach, not as an unavoidably unsafe product. Plaintiffs must specify the design defect through expert witness opinion evidence.
DRUGS AND DEVICES
Gayle v. Pfizer, Inc., 452 F. Supp.3d 78 (S.D.N.Y. 2020).
24 plaintiffs claimed the cholesterol drug Lipitor caused their type II diabetes. Pfizer moved for judgment on the pleadings under FRCP 12(c) on the basis that if the claims arose after the 2012 Lipitor label change, they were preempted and if the claims arose before April 2016 they were time-barred. The court found the claims preempted, even though plaintiffs theorized 6,000 adverse event reports relating to diabetes from Pfizer to the FDA constituted “newly acquired information” which would enable the manufacturer to change the label under the FDA’s Changes Being Effected (CBE) regulations. In order to qualify as “newly acquired information,” the information must demonstrate “reasonable evidence of a causal association with a drug” 21 C.F.R. § 201.57. But the fact that a user of a drug has suffered an adverse event, standing alone, does not mean that the drug caused that event. Additionally, while plaintiffs did not allege when their claims accrued, to the extent they accrued before April 2016, they were deemed untimely. Applying New York’s borrowing statute CPLR 202 (which applies the shorter of the New York or other state statute of limitations) the court found the claims untimely. Plaintiffs could not take advantage of New York’s discovery rule allowing plaintiffs to bring a claim one year after discovery of the cause of the injuries, because plaintiffs “would still be caught in the preemption trap.” Plaintiffs did not plead that technical, scientific or medical knowledge and information sufficient to ascertain the cause of their injury had not been discovered. Nor did plaintiffs plead with particularity that Pfizer fraudulently concealed the information, to equitably toll the statute of limitations.
Potential implication for future cases: Adverse event reports are not evidence of causation, and do not enable plaintiffs to do an end-run around preemption.
Vardouniotis v. Pfizer, 2020 NY Slip Op 32233(U) (Sup. Ct., NY County 2020)
In a state court action involving Chantix, a smoking cessation medication manufactured by Pfizer, defendant moved, pursuant to CPLR 3211(a)(7), to dismiss the verified complaint. The court dismissed the negligence, gross negligence, and willful, wanton and malicious conduct claims insofar as those causes of action were based upon failure to warn allegations, as well as the breach of express warranty, fraudulent misrepresentation, fraudulent concealment, reckless and/or negligent misrepresentation and concealment claims, and the plaintiff’s request for punitive damages. Plaintiff argued that the label for Chantix did not include warnings for dystonia, muscular spasm, movement disorders and abnormal posture, which are typically due to neurological disease or a side effect of drug therapy. According to the plaintiff, Pfizer knew or should have known of these side effects, citing newspaper articles and scientific journal publications identifying adverse effects, especially those experienced by the plaintiff, not identified in the Chantix label. Although plaintiff cited newspaper articles and journal articles in her memorandum of law, these articles were not annexed to the complaint or her opposition to Pfizer’s motion to dismiss. The court declined to take Judicial Notice of facts alluded to, as that is reserved for “matter[s] of common and general knowledge, well-established and authoritatively settled.” Prince, Richardson on Evidence § 2-201 (Farrell 11th ed). There was no showing that these websites were “of sufficient authenticity and reliability.” Plaintiff also alleged negligence, gross negligence and that Pfizer was “wanton and malicious in its actions, misrepresentations, and omissions” as a result of Pfizer’s failure to adequately test Chantix and failure to conduct post-marketing surveillance. Pfizer’s motion seeking dismissal of these claims was denied. Breach of express warranty was dismissed as no express warranties were pled or presented but the plaintiff adequately alleged that Pfizer breached the implied warranties of merchantability and fitness by holding Chantix out as reasonably fit and suitable when it was allegedly unreasonably dangerous. Unjust enrichment was not duplicative of any other claim, given that plaintiff sought disgorgement of Pfizer’s profits and monetary benefits. It is well-settled that conduct warranting an award of punitive damages “need not be intentionally harmful but may consist of actions which constitute willful or wanton negligence or recklessness.” Home Ins. Co. v American Home Prods. Corp., 75 NY2d 196, 204 (1990). Here, the complaint failed to allege that Pfizer engaged in any morally culpable conduct and plaintiffs’ request for punitive damages was denied.
Potential implication for future cases: New York State courts require that plaintiffs plead their complaints with particularity or be subject to early dismissal of claims not supported. AERs are not facts of which courts will take as Judicial Notice.
Crespo v Merck, No. 13-cv-2388, 2020 WL 5369045 (E.D.N.Y. Sep. 8, 2020), reconsideration denied 2020 U.S. Dist. LEXIS 188955 (E.D.N.Y., Oct. 12, 2020), appeal filed (Jan. 7, 2021)
Plaintiffs pro se brought this products liability action in the District of New Jersey. The Judicial Panel on Multidistrict Litigation transferred it to New York for coordinated pretrial proceedings, pursuant to 28 U.S.C. § 1407. Plaintiff alleged sexual dysfunction from use of Propecia, was diagnosed with erectile dysfunction in 2003, and was diagnosed with hypogonadism in Florida, in 2009. At some point in 2009, his doctors discussed the possibility that plaintiff’s use of Propecia had caused his sexual dysfunction. Merck moved for summary judgment on the basis of time bar, as plaintiffs filed the action on April 2, 2013. Generally, “[a] federal court sitting in diversity jurisdiction applies the choice of law rules of the forum state.” Forest Park Pictures v. Universal Television Network, Inc., 683 F.3d 424, 433 (2d Cir. 2012). When the JPML transfers a case, however, the “transferee court applies the substantive state law, including choice-of-law rules, of the jurisdiction in which the action was filed.” Menowitz v. Brown, 991 F.2d 36, 40 (2d Cir. 1993). The court applied New Jersey’s choice-of-law rules, not the rules in New York. Here, two states had a potential interest in this action. New Jersey was the state in which plaintiffs filed the action, and the state in which defendants were incorporated, had their principal place of business, and made decisions regarding the labeling and marketing of Propecia. Florida was the state in which plaintiff was prescribed, purchased, and took Propecia. Plaintiff choose to file suit in New Jersey and there were no exceptional circumstance to justify departing from the general rule that New Jersey’s statute of limitations applied, which barred plaintiffs’ claims.
Potential implication for future cases: In MDL cases, choice of law is not necessarily the law of the forum state, or the plaintiff’s residence. Plaintiff’s choice of forum may dictate choice of law.
Webb v Mentor, 453 F. Supp.3d 550 (N.D.N.Y. 2020)
MemoryGel silicone breast implants are Class III medical devices, approved by the FDA through the PMA process in 2006. Plaintiff sued in product liability (negligence based on failure to warn and manufacturing defect, negligence per se, strict liability in design and manufacturing defect, breach of express and implied warranty) and asserted claims related to the implants’ safety and effectiveness. Defendants moved to dismiss the complaint, asserting that plaintiff’s claims were preempted, pursuant to the Medical Device Amendments of 1976, 21 USC § 360c and, alternatively, that plaintiff failed to state any claims upon which relief may be granted, under FRCP 12(b)(6). To succeed in asserting a claim that fits through the narrow gap between express and implied preemption, plaintiff must identify a parallel law upon which she has based her state law claims. Plaintiff alleged that defendants did not comply with the FDA’s Quality System Regulations and Current Good Manufacturing Practices (CGMPs). However, plaintiff failed to identify specific regulations or explain how defendants violated the CGMPs. Plaintiff’s general allegations could not withstand preemption because she failed to establish the necessary link between defendants’ federal violations and her alleged causes of action. Plaintiff’s failure to warn and design defect claims were preempted because she sought to impose safety related requirements on the device or labeling beyond those imposed by the FDA. Plaintiff’s express and implied warranty claims were preempted; plaintiff did not identify specific representations of the manufacture which exceeded the scope of FDA approved labeling statements nor did she show defendants alleged federal violations caused the implants to have a deviated from their purpose, that they failed, or that they were unfit for patients.
Potential implication for future cases: PMA medical devices, including breast implants, continue to enjoy preemption in New York.
Berni v Barilla, 964 F.3d 141 (2d Cir. 2020)
Plaintiffs brought a class action against Barilla for deceptive packaging, alleging that Barilla intentionally sold its pasta in misleading boxes which concealed non-functional “slack-fill,” asserting claims under New York General Business Law section 349. The Second Circuit held future harm to pasta purchasers is not likely, and as a result, the injunctive relief sought would not provide a remedy for all members of the class. Pasta purchasers who alleged they were deceived were alleging past harm. Such past harm is of the kind that is commonly redressable at law through the award of damages, not injunctive relief. The district court did, in fact, err in certifying a Rule 23(b)(2) class because not all class members stand to benefit from injunctive relief, the kind of relief the settlement primarily provides. The Second Circuit held that past purchasers of a product—like the purchasers of Barilla pasta in this case—were not eligible for class certification under FRCP Rule 23(b)(2).
Sibrian v Cento Fine Foods, Inc., No. 19-CV-0974, 2020 WL 3618953 (E.D.N.Y. July 2, 2020)
Plaintiffs alleged misleading labeling of canned tomato products from Italy labeled “Certified San Marzano” under New York General Business Law sections 349 and 350. The court dismissed these claims as conclusory and strained, as the “reasonable consumer” would not have an expectation that a San Marzano tomato must be certified by the Consortium of the San Marzano Tomato Protected Designation of Origin. Plaintiffs did not allege that Cento falsely claimed the product was certified by the Consortium, and Consortium-certified seals did not appear on the product labels. Rather, plaintiffs contended the labeling and packaging created the impression of that certification. While there might be a few consumers who expect a San Marzano tomato to be certified by the Consortium, drawing upon common sense and common experience, the vast majority of reasonable consumers expect no such thing.
Steele v Wegmans, No. 19 Civ. 9227, 2020 WL 3975461 (S.D.N.Y. July 14, 2020)
Plaintiffs claimed deceptive acts or practices in violation of federal, New York, and Pennsylvania statutes and standards, false advertising, common-law negligent misrepresentation, fraud, breach of warranty and unjust enrichment alleging they were deceived into believing Wegman’s ice cream was flavored with vanilla beans or extract. Upon a motion to dismiss, the court found the label on the ice cream container did not misrepresent the container’s contents and the plaintiffs’ elaborate gas chromatography-mass spectrometry analysis chemists performed failed to show there was fraudulently little vanilla bean extract in the ice cream. Similarly in a case involving vanilla almond milk the SDNY found the term “vanilla” by itself does not communicate to a reasonable consumer that the product was made exclusively with vanilla bean and a reasonable consumer would understand “vanilla” refers to a flavor, not an ingredient. Cosgrove et al. v. Blue Diamond Growers, No. 19-Civ-8993 (S.D.N.Y. December 7, 2020).
Price v L’Oréal, No. 17 Civ. 614, 2020 WL 4937464 (S.D.N.Y. Aug. 24, 2020)
After certification of two classes of New York and California consumer fraud plaintiffs who claimed they were deceived into purchasing Matrix Biolage Advanced line of Keratin shampoos and conditioners because they contained Keratin, defendants L’Oréal and Matrix moved to exclude plaintiffs’ experts and both sides moved for summary judgment. The motion to exclude plaintiffs’ marketing expert opinion on consumer perceptions was granted in part and the economic expert opinion on class-wide damages was excluded as unreliable. Except for the breach of contract claim dismissed under New York law, the summary judgment motions were denied.
Devane v. L’Oréal, No. 19 Civ. 4362, 2020 WL 5518484 (S.D.N.Y. Sept. 16, 2020)
Purported class action plaintiffs alleged L’Oréal deceptively marketed and labeled Eversleek Keratin Caring products to make consumers believe the shampoos and conditioners contained Keratin, even though the products were labeled as vegan and Keratin was not on the ingredient list. Upon a motion to dismiss fraud, warranty and consumer fraud statutory claims (Alabama, Florida and New York), the court analyzed the claims under the “reasonable consumer” standard. The Second Circuit has noted it is not reasonable to assume that a product contains an ingredient when it is not on the ingredient list. As the product label was clear that the shampoos and conditioners cared for Keratin already found in hair and Keratin was not a listed ingredient, the court dismissed the entire case as not plausible.
Potential implication for future cases: Federal courts in New York scrutinize purported class actions involving FDA-regulated products for plausibility and expert support. The reasonable consumer, drawing on common sense and common experience, does not assume a product contains an ingredient not listed on the label.
The developments of 2020 indicate that it is critical to remain informed about changes in the law in order to develop the strongest product liability defense of pharmaceuticals and medical devices. We know it takes an enormous investment to develop innovative pharmaceuticals and medical devices to improve life experiences. That’s why our attorneys, with a national reputation for aggressively defending some of the largest entities in the regulated pharmaceutical, medical device, cosmetics and nutritional supplement industries, leverage their combination of medical and legal credentials to protect your critical life sciences products.
Click below to learn more about our team:
Medical and Life Sciences Industry Team