From pharmaceuticals to dietary supplements, preemption to public health, New York state and federal courts issued decisions in 2021, 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 years ahead.
In the New York Medical and Life Sciences: Year in Review 2021, Judi Abbott Curry reviews, analyzes and shares potential implications for future life science cases, based on several key judicial holdings in New York in 2021 pertaining to:
- Pharmaceuticals - FRCP 12(b)(6) and plausible pleadings
- Federal Preemption - major drug labeling change; PMA devices
- Medical Devices - design defect and failure to warn claims
- Public Health - agency immunities
- Consumer Fraud Class Action - NYBCL violation premised upon an FDA action
PHARMACEUTICALS
Frei v. Taro Pharmaceutical U.S.A., Inc., 844 F. Appx. 444 (2d Cir. 2021) cert. denied No. 21-654 2022 U.S. LEXIS 12 (U.S. Jan. 10, 2022)
Plaintiffs appealed from the FRCP 12(b)(6) dismissal of their first amended complaint alleging they suffered injuries from taking Amiodarone, a generic drug manufactured by Taro Pharmaceutical, for the off label treatment of atrial fibrillation. The Second Circuit affirmed the dismissal because none of the claims were plausibly pled, and as such did not reach the questions of whether certain claims were preempted or barred by the learned intermediary doctrine.
Plaintiffs alleged that Taro concealed information regarding adverse events that had occurred from the use of the drug to treat atrial fibrillation. The court found this allegation was not plausible, as it was based upon a broad statistical allegation, and one not specifically tied to Taro's conduct. Plaintiffs complained that Taro failed to make medication guides available to patients. The Second Circuit found that simply because plaintiffs did not receive medication guides did not mean Taro had committed any wrongdoing. Plaintiffs also allege that Taro failed to ensure the accuracy of prescribing information relied on by physicians, such as in the PDR, but the complaint did not explain how Taro, as a generic manufacturer, contributed to the inaccuracy or had authority to correct such reference materials. Thus, these failure to warn claims were not plausibly pled.
Gioia v. Janssen Pharmaceuticals, No. 19-CV-05377 (JMA)(SIL), 2021 U.S. Dist. LEXIS 29013 (E.D.N.Y. February 16, 2021)
Manufacturer of the schizophrenia drug Invega moved to dismiss complaint alleging pro se plaintiff suffered numerous side effects, including hypertension, diabetes, and stroke, which led to the end of her career as a primary care physician. While a court is required to read a plaintiff's pro se complaint liberally and interpret it as raising the strongest arguments it suggests, a pro se plaintiff must still plead enough facts to state a claim for relief that is plausible on its face.
Plaintiff claimed that defendant failed to “provide proper informed consent about [the] ultimate outcome as well as important side effects from taking their medicine Invega” but plaintiff's lack of informed consent claim against a manufacturer is non-cognizable under New York law, and was dismissed with prejudice. As the drug's manufacturer, Janssen had no duty to warn plaintiff directly of the potential side effects or risks of taking Invega—that was the responsibility of plaintiff's physician, the learned intermediary. In her failure to warn claim, plaintiff's complaint provided only conclusory allegations and failed to allege any facts to suggest that her treating physician was not informed of the risks associated with Invega. Defendant offered, and plaintiff did not dispute, Invega's FDA-approved package insert as evidence of Invega's warnings of possible side effects including, among others, hyperglycemia, diabetes, hypertension, stroke and tardive dyskinesia. The Court took judicial notice of the FDA-approved package insert, as labels can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned. Under New York law, prescription medicine warnings are adequate when as occurred here, information regarding “the precise malady incurred” was communicated in the prescribing information. Therefore, plaintiff's conclusory allegations coupled with plaintiff's allegations of suffering from the very side effects of which defendant warns, required dismissal of plaintiff's warning claim.
Pharmaceuticals- Potential implication for future cases:
Claims of failure to warn must be plausibly pled, which does not include only broad allegations of inadequate labeling or undisclosed adverse events. In a pre-answer motion to dismiss, the drug's IFU can be submitted as an Exhibit to show the warnings conveyed to the prescriber, as the IFU is factual information of which courts can take Judicial Notice.
FEDERAL PREEMPTION
Ignacuinos v. Boehringer Ingelheim Pharms., 8 F.4th 98 (2d Cir. 2021)
Plaintiffs were prescribed Combivent Respimat, a branded metered-dose inhaler for chronic obstructive pulmonary disease. Plaintiffs alleged that while the inhaler was labeled to deliver 120 doses, it actually delivered substantially fewer doses, and they were physically and economically injured as a result. The federal district court dismissed the claims based on federal preemption and this appeal followed to the Second Circuit.
Defendant argued that plaintiffs' product liability design and manufacturing defect claims were impliedly preempted because 21 C.F.R. § 314.70(b) prevented it from changing the inhaler's design or manufacturing methods without prior FDA approval. The Second Circuit considered the question of when a drug manufacturer needs FDA approval to make a labeling change, and when it can act unilaterally without approval, noting the difference between making a “major” versus “moderate” or “minor” change. Plaintiffs argued that a “major” change is one that would have substantial potential to have an adverse effect and this was not that sort of change.
The Second Circuit disagreed, concluding that the manufacturer could not unilaterally change the design of the inhaler to release a different amount of medication per puff. FDA considers the design and operation of these types of container closure systems to be critical to ensuring that the patient receives the correct dose. Consequently, changes to such a drug delivery system would categorically have a substantial potential to adversely affect the safety or effectiveness of the drug product, and therefore would qualify as a major change. Any state law claim premised upon a duty to make the suggested change to the design of the Combivent inhaler was therefore preempted by federal law.
Arnold v. Lanier, 2021 NY Slip Op 06666 (2d Dept. December 1, 2021)
Plaintiff's product liability and breach of warranty claims related to decedent's cardiac Left Ventricular Assist System, were dismissed upon defendants' pre-answer motion to dismiss pursuant to CPLR 3211(a) based upon federal preemption. Plaintiff appealed only two causes of action, those based upon negligent acts or omissions in replacing the lead by engineers employed by defendant Abbott. Plaintiff conceded that the products liability and breach of warranty causes of action were properly dismissed based upon express preemption, as the device at issue was a Class III device subject to premarket approval (PMA) under the rigorous regime of the Medical Device Amendments to the FDCA. Common law causes of action which challenge the safety and effectiveness of a medical device and seek to impose requirements that are “different from, or in addition to” federal requirements, such as those sounding in products liability and breach of warranty, are preempted. New York's Appellate Division, Second Department reversed the trial court's dismissal of the negligence claims premised upon the work of the engineers, as those claims do not challenge the safety and effectiveness of the medical device and they seek to impose requirements different or additional to federal law. Accordingly, they are not preempted.
Barone v. Bausch & Lomb, Inc., 191 A.D.3d 1365, 141 N.Y.S.3d 808 (4th Dept. 2021)
In a medical device product liability action premised upon plaintiff's allegations that he sustained injuries from implantation of an FDA approved PMA medical device, Crystalens, indicated to treat cataracts and presbyopia, the court reversed the trial court and dismissed the foreign corporate defendant, because plaintiff did not show a regular flow of the corporation's goods into New York, advertising directed at New York, the delivery of the corporation's goods into the stream of commerce with the expectation of purchase in New York, or any other facts that arguably established jurisdiction. The claims against the second defendant, a device distributor, were expressly preempted, as they were based on defendant's alleged failure to provide adequate warnings to plaintiff and his eye doctor. Plaintiff's warning claims were not “parallel” to the federal requirements. While plaintiff pointed to FDA regulations requiring a manufacturer to report known incidents to FDA (even assuming that regulation applies to a distributor), the claims in the complaint were not premised on any alleged failure to report incidents, but rather on typical claims that defendant failed to provide adequate warnings. Thus, the Appellate Division reversed the trial court and dismissed the amended complaint against both defendants.
Preemption- Potential implication for future cases:
Changes to a drug delivery system that have substantial potential to adversely affect the safety or effectiveness of the drug product, qualify as a “major” change to the label. State law claims premised upon a duty to unilaterally make the suggested major change to the design are impliedly preempted. Typical product claims that defendant failed to provide adequate warnings of a PMA medical device are expressly preempted. But negligence claims premised upon the work of engineers, which do not challenge the safety and effectiveness of the medical device, are not preempted.
MEDICAL DEVICES
Green v. Covidien LP, No. 18 Civ. 2939, 2021 U.S. Dist. LEXIS 61250 (S.D.N.Y March 30, 2021)
After dismissal of plaintiff's amended complaint, hernia mesh manufacturer moved, again, pursuant to Fed. R. Civ. P. 12(b)(6) to dismiss second amended complaint (SAC) which asserted strict products liability (in design, manufacture, failure to warn), negligence, breach of implied warranty, negligent and fraudulent misrepresentation, unjust enrichment, consumer fraud and punitive damages causes of action. The defective design claim made only a generic statement of causation and did not even endeavor to explain why the mesh was a more likely, let alone proximate cause of plaintiff's injury. Once again, plaintiff did not plead facts showing manufacturing defect, such as some mishap in the mesh's manufacturing process, improper workmanship, or because defective materials were used in its construction and as such, the manufacturing defect claim was dismissed. The failure to warn claim was dismissed as the injuries that plaintiff allegedly suffered were included in defendant's instructions for use, which defendant attached to its motion to dismiss. While documents outside a complaint generally are not considered on a FRCP 12(b)(6) motion, the court may consider documents incorporated by reference in the complaint. Here, the court considered the instructions for use in connection with the dismissal motion because it was the very document that gives doctors the warnings that the SAC claims were insufficient, and therefore was integral to the complaint. Plaintiff also claimed the mesh brochure and website did not contain warnings, but cited no case law suggesting that product warnings must be included in informational or marketing brochures or websites associated with such products.
Plaintiff's breach of implied warranty claim was dismissed, as it relied on the design allegations for the claim that the mesh was not reasonably fit for its intended use. Plaintiff's fraud claim attempted to add the requisite FRCP 9 (b) particularity but plaintiff did not show the statements were false or that defendant intended to defraud plaintiff. Plaintiff used her own injuries as the predicate for her fraud claims, but those injuries were part of defendant's warnings. The unjust enrichment claim once again was based on the same allegations as those set forth in support of her other claims, including fraud. The consumer fraud New York General Business Law §349 claim failed for the same reasons that her fraud and negligent misrepresentation claims failed. Although the court previously ruled that a claim for punitive damages is not a separate cause of action, plaintiff again pled a separate cause of action for punitive damages. Punitive damages are a remedy and not a cause of action. Accordingly, since the other causes of action were dismissed, so was the cause of action for punitive damages. With all of these shortcomings, multiple failures to cure the pleading deficiencies, despite detailed explanations from the court, plaintiff's contradictory pleadings, and the undue prejudice yet another amendment to the complaint would cause to defendant, the court gave no further leave for plaintiff to file another amended complaint and the matter was dismissed.
Cosh v. Atrium Med. Corp., No. 1:18-cv-08335 (ALC), 2021 U.S. Dist. LEXIS 59649 (SDNY April 2, 2021)
Hernia mesh plaintiffs, after dismissal of complaint, refiled amended complaint and defendant moved again for FRCP 12 (b)(6) dismissal. Plaintiffs alleged design defect, manufacturing defect and failure to warn theories of liability. With respect to design defect, plaintiffs alleged that the defendant could have used a different type of mesh (for example, the use of hemp instead of a synthetic mesh, heavyweight small-pore mesh instead of midweight mesh, or non-woven mesh instead of a knitted or woven mesh). However, plaintiffs failed to allege facts showing this would be technically and economically feasible and would result in a safer design. Importantly, “alleging that the product should not be used at all, is insufficient to satisfy the feasible alternative design element”.
In the original complaint, plaintiffs did not allege what specific component of the device was defective to show a manufacturing defect. Plaintiffs could not use the alleged injuries as circumstantial evidence to establish a manufacturing defect because the injuries were consistent with common injuries and were known side effects caused by hernia repair surgeries using mesh products. In the amended complaint, plaintiff claimed that an FDA complaint and warning letter involving the factory where the hernia mesh was made was proof of a manufacturing defect. Numerous violations and a consent decree where the facility was ordered to shut down did not cure the manufacturing defect pleading deficiencies, as they did not suffice to plead a deviation from the manufacturing process, improper workmanship, or defective materials for the specific unit of the mesh, implanted into the plaintiff.
The failure to warn claim was dismissed as it merely alleged defendant represented its product was safe and effective, but pointed to no specific statements and that claim “merely reframe[ed] Plaintiffs' design and manufacturing defect allegations.” Plaintiffs' negligent misrepresentation claim was not saved when plaintiff added an allegation that the defendant had failed to investigate hundreds adverse events, as plaintiff failed to adequately allege that she and her physician relied upon them. Without providing plaintiffs with the further opportunity to amend the complaint, the action was dismissed in its entirety.
Rouviere v. DePuy Orthopaedics, Inc., No. 18-cv-4814 (LJL), 2021 U.S. Dist. LEXIS 17753 (S.D.N.Y. September 17, 2021), recons. denied 2021 U.S. Dist. LEXIS 237051 (S.D.N.Y. Dec. 9, 2021)
During hip replacement surgery, plaintiff's surgeon implanted a device that combined components made by two companies. Plaintiff alleged that some of these components impinged on others, releasing toxic metal debris into her body. DePuy moved for summary judgment to dismiss plaintiff's product-liability claims under theories of negligence, strict liability, and breach of express and implied warranties. Although plaintiff's objection to the Magistrate's exclusion of certain engineering expert's opinions against DePuy was untimely, the district court reviewed the objection but overruled it on the merits, as a replacement expert report expressed opinions well beyond those expressed in a previous, disqualified expert's report, and the Magistrate's denial of the Rouvieres' request to reopen expert discovery was not erroneous or contrary to the law.
The lack of expert testimony doomed the plaintiff's defective-design claims and she abandoned the claims for defective design, defective manufacture, and breach of express or implied warranties, thus leaving the failure to warn claim. DePuy and Stryker both had a duty to warn, as where the combination of one sound product with another sound product creates a dangerous condition, the manufacturer of each product has a duty to warn. Thus, even if DePuy had no duty to warn about Stryker's products, it still had a duty to warn of latent dangers resulting from foreseeable uses of its products.
While there was a genuine dispute about the adequacy of DePuy's warnings, DePuy was entitled to summary judgment because DePuy's insufficient warnings did not proximately caused the injury. The plaintiff could proffer no evidence to support the premise that, had the surgeon been given additional warnings about impingement, he would have chosen different components or recommended against the surgery. To the contrary the surgeon testified that he planned to continue using the DePuy stem even knowing what he knows now. Moreover additional warnings from DePuy would not have resulted in a different conversation between the surgeon and the plaintiff concerning the risks of impingement, as he testified additional knowledge would not have affected his choice of components or his choice of warnings.
Medical Devices- Potential implication for future cases:
Where the components of two different manufacturers of medical devices may be used together, each manufacturer has a duty to warn of latent dangers resulting from foreseeable uses of its products. Since the combination of one sound product with another sound product could create a dangerous condition, the manufacturer of each product has a duty to warn about its own product, but not a duty to warn of the other's product. General allegations of an FDA complaint, warning letter and consent decree involving the factory where a medical device was made is not proof of a manufacturing defect. To plead a manufacturing defect, there must be an allegation of a deviation from the manufacturing process, improper workmanship, or defective materials for the specific unit of the device implanted into the plaintiff. In a pre-answer motion to dismiss, the medical device's IFU can be submitted as an Exhibit to show the warnings conveyed to the surgeon, since those warnings were incorporated by reference in the complaint. To oppose a summary judgment motion, plaintiffs must specify the design defect through expert witness opinion evidence.
PUBLIC HEALTH
Kling et. al. v. The World Health Organization, 532 F. Supp. 3d 141 (S.D.N.Y 2021)
Plaintiffs commenced an action against the World Health Organization (WHO), a specialized agency of the United Nations responsible for international public health, alleging negligence in responding to the COVID-19 pandemic. In December 2019, the first patients exhibiting symptoms of the coronavirus were hospitalized in Wuhan, China. WHO claims it received its first notice of the existence of this virus on December 31, 2019 from the Wuhan Municipal Health Commission website. On January 5, 2020, WHO released a statement on its own website that there was no evidence of significant human-to-human transmission. Plaintiffs alleged that WHO had actual or constructive notice that China was denying or downplaying that risk. A WHO delegation visited Wuhan on January 20, 2020, and on January 22, they issued a statement that there was evidence of human-to-human transmission. WHO traveled to Beijing on January 28. On January 30, WHO declared that COVID-19 was a public health emergency of international concern, but they did not recommend any travel or trade restrictions. On March 11, 2020 WHO concluded COVID-19 can be characterized as a pandemic. Plaintiffs alleged that WHO's response to the pandemic between December 2019 and March 2020 was negligent and reckless. WHO moved to dismiss under FRCP 12(b)(1) for lack of subject matter jurisdiction as the court lacked statutory or constitutional power to adjudicate the action. WHO's immunity defense implicated the court's subject matter jurisdiction, and was properly addressed under FRCP 12(b)(1). The court found that WHO is independently immune from suit under the International Organization Immunities Act and did not expressly waive it, or impliedly waive its immunity under the Foreign Sovereign Immunities Act.
Public Health - Potential implications for future cases: Multiple bases for immunity exist for claims against international public health agency, providing subject matter jurisdictional defense to lawsuits based on their response to public health crises.
CONSUMER FRAUD CLASS ACTIONS
Price v. L'Oreal, No. 17 Civ. 614, 2021 U.S. Dist. LEXIS 187099 (S.D.N.Y. September 29, 2021), recons. denied 2021 U.S. Dist. LEXIS 237045 (S.D.N.Y. Dec. 10, 2021)
Defendants moved to decertify two New York and California previously certified consumer fraud classes, alleging misleading and fraudulent labeling of “Keratindose” haircare products Matrix Biolage Advanced. Plaintiffs could not provide a means of calculating class-wide damages consistent with the claimed injury that they paid a price premium because inclusion of the word keratin in the products' labeling would lead a consumer to believe that there was actual keratin in the product. Class certification was originally appropriate because plaintiffs' expert's methodology appeared to be capable of measuring class-wide damages. After discovery, however, plaintiffs did not adduce enough evidence to make the expert's formula work, as the survey that the consumers used to help calculate the damages they encountered was unreliable. Inasmuch as plaintiffs could not satisfy their burden to prove class-wide damages, the classes were decertified.
Borgese v. Baby Brezza Enterprises, LLC, No. 20 Civ. 1180 (VM), 2021 U.S. Dist. LEXIS 30216 (S.D.N.Y. February 18, 2021).
In a putative class action alleging baby formula machine mixed less formula than required for proper nutrition and caused children to receive poor nutrition and suffer complications and injuries such as weight loss, plaintiff filed the near identical complaint in both New York state and federal court, indistinguishable in every way except for the class definition. In federal court, plaintiff filed claims on behalf of all purchasers in the United States, and in state court filed claims on behalf of all purchasers in the state of New York. Defendant sought dismissal of the complaint as lacking in predominance, as the claims were highly individualized and unsuitable for class treatment, and also sought a stay under the “first filed” rule because the federal court action was duplicative of the state court case. While early motions to strike class action allegations are generally disfavored, the court was persuaded that the class allegations should be stricken here because it was clear from the pleadings that the certification requirements could not be met.
The court was unable to take the requisite “close look” to determine whether common legal questions predominate over individual ones because the complaint did not indicate where the other purchasers of the baby Brezza machine resided, where they purchased the machines, or where they may have suffered their injuries. The court was therefore unable to determine which states laws might apply, and in turn whether those laws materially differ. On its face, the complaint did not allege any common legal issues, let alone any issues more substantial than individualized ones. Moreover, plaintiff failed to identify a single member of the purported class other than himself or to conduct an investigation to determine if there were other class members before filing the action. Additionally, while the product defect claim could be subject to generalized resolution, the other claims involving fraud and negligence are not typically appropriate for class treatment because they require highly individualized inquiry to determine liability. While the first filed rule did not apply, because both actions were not filed in federal court, based upon the facts presented and application of the Colorado River factors (Colo. River Water Conservation Dist. v. United States, 424 U.S. 800 (1976)), the court concluded the exercise of federal jurisdiction should be postponed until after the state court litigation was completed. Therefore, the federal court action was stayed pending outcome of the state case.
Womack v. Evol Nutrition Assocs., No. 6:21-cv-00332 (BKS/TWD), 2021 U.S. Dist. LEXIS 238347 (N.D.N.Y. Dec. 14, 2021)
In a purported unfair and deceptive trade class action involving the marketing, distribution and sale of Sleepwalker and Red Dawn energy drinks/dietary supplements, plaintiff alleged the products contained Beta-phenyl-gamma-aminobutyric acid, also known as Phenibut or GABA. FDA had sent defendant a warning letter, that because Phenibut is not recognized under the FDCA as a dietary ingredient, the products were misbranded. Because Phenibut is not GRAS [generally recognized as safe] it would need premarket approval to be sold in the United States. Defendant moved to dismiss under FRCP 12(b)(6) and argued that plaintiff's action for consumer fraud under New York's General Business Law §349 improperly relied on the warning letter as meeting the “inherently deceptive” requirement. Although plaintiff alleged adverse health effects from ingesting the product with the unapproved ingredient, which is sufficient to allege injury under NYGBL §349, plaintiff did not meet the “inherently deceptive” requirement of the statute, since he essentially tried to re-characterize a statutory violation for the “deceptive” requirement. The federal district court held that the “FDCA does not provide a private cause of action, and that gap is not filled by the NYGBL.” FDA's warning letter did not warn of an allegedly dangerous and addictive nature of Phenibut, rather, it indicated that ingredient did not fit in any of the dietary ingredient categories under the FDCA and allegations of violations of the FDCA. Accordingly, the court concluded that plaintiff failed to state a plausible claim for relief under NYGBL §349.
Class actions - Potential implication for future cases:
Federal courts in New York scrutinize purported class actions involving FDA-regulated products to take a close look at whether common legal questions predominate over individual ones, especially if a physical injury is claimed. Even where the NYBCL violation is premised upon an FDA action, FDCA does not provide a private cause of action, and that gap is not filled by the NYGBL. Damages calculation in consumer fraud class actions must be supported by a valid expert methodology.
