Medical and Life Sciences law: Year in review

From drugs to aid in weight loss or to quit smoking to medical devices for spinal surgery, New York state and federal courts issued decisions the past 12 months that further shaped the legal landscape in the medical and life sciences arena.

To prepare the best product liability defense strategies for pharmaceuticals, medical devices, personal care and other FDA regulated products, it is often helpful to step back and review holdings that affected the industry and may shape the years ahead.

In this article, we review, analyze and share potential implications for future life science cases based on several key judicial holdings in New York in 2022 pertaining to pharmaceuticals and medical devices.

Pharmaceuticals

Vardouniotis v. Pfizer, 2022 N.Y. Misc. LEXIS 75*; 2022 N.Y. Slip Op. 30040(U) (N.Y. Cnty. Jan. 10, 2022)

Plaintiff alleged her use of Chantix to quit smoking caused various injuries, including chronic pain, muscle spasm, arthritic changes in the neck, cervical injuries, exhaustion, depression and anxiety, among others.

Plaintiff alleged Pfizer never attempted to include all her claimed side effects in the Chantix labeling. However, Pfizer did add a boxed warning to the Chantix label about the risk of changes in mood and behavior before plaintiff used the drug.

After reviewing a large clinical trial, FDA determined the risks of serious neuropsychiatric events were lower than previously suspected and concluded the benefits of stopping smoking outweigh the risks.

Pfizer moved to dismiss the amended complaint based on failure to state a cause of action and based on documentary evidence to refute plaintiff’s factual allegations. New York’s Supreme Court, New York County found that Plaintiff sufficiently buttressed the failure to warn claim with articles and information pertaining to newly acquired information that could have permitted a change of the Chantix label under the CBE (changes being affected) regulation; therefore, the failure to warn claims were not preempted.

Additionally, the informed intermediary doctrine was not sufficient to require the wholesale dismissal of the failure to warn claims, as the complaint alleged the physician did not receive adequate warnings. However, the failure to warn claim was dismissed to the extent it was premised on a failure to warn plaintiff and the public, as opposed to the prescribing physician. The Court declined to dismiss the warranty and unjust enrichment claims at this pleading stage but dismissed the plaintiff’s request for punitive damages, as nothing in the complaint alleged that Pfizer engaged in any morally culpable conduct.

Reynolds-Sitzer v. Eisai, 586 F. Supp.3d 123 (N.D.N.Y. 2022)

Plaintiff alleged the first-in-class oral selective serotonin 5HT2c receptor agonist weight loss drug Belviq caused her to develop thyroid cancer.

Upon a motion to dismiss pursuant to FRCP 12(b)(6), the Court evaluated plaintiff’s claims under the products liability theories of negligence, strict liability, express warranty and implied warranty.

Plaintiff also asserted fraudulent misrepresentation and concealment. For the defective design claim, defendants’ motion argued plaintiff’s complaint did not identify a particular problem in the design of the drug or plead facts alleging the existence of a feasible alternative design.

Plaintiff claimed that since Belviq was designed as a serotonin receptor agonist for weight loss, this posed a substantial likelihood of harm and a safer alternative was a drug that did not affect the serotonin pathway.

Although plaintiff did not posit an alternate design, the Court ruled that requiring plaintiff to do so at the pleading stage would require technical or scientific knowledge that goes beyond Rule 8’s notice pleading requirement. As such, the design defect claim was plausibly pled to withstand a motion to dismiss.

As for the failure to warn claim, defendants sought dismissal only to the extent the allegations were premised upon on duty to warn plaintiff directly or, for that matter, anyone other than the prescribing physician.

The Court found that defendants were getting ahead of themselves and a motion premised upon the learned intermediary doctrine would be more appropriate after discovery. The breach of warranty claims were not time barred due to the New York Executive Order 202.8 “COVID-19 toll.” Further, under New York law, where a product is for retail sale or intended for human consumption, there is no requirement for pre-suit notice under the New York Uniform Commercial Code. Lastly, the Court found the allegations of fraud did not meet the particularity requirements of Rule 9 and therefore were dismissed.

Pharmaceuticals: Potential implication for future cases

The learned intermediary doctrine, known as the informed intermediary doctrine in New York, is an important tool to defend against warning claims for FDA regulated products. However, New York state and federal courts are unlikely to dismiss failure to warn claims at the pleading stage, where the extent of knowledge of the prescribing physician is not yet known.

The better course is to take discovery, including testimony from the prescriber, to show the physician assessed the risks and benefits of the drug, advised the patient of its possible risks and side effects and exercised appropriate independent medical judgment in prescribing the product.

Moreover, an early pre-answer dismissal motion of the design defect claims based upon the absence of a safer alternative feasible design may not result in outright dismissal, but rather provide plaintiff with the opportunity to replead; and in some cases, claim the technical or scientific knowledge to plead the precise type of alternative safer feasible design requires discovery from the manufacturer.

Medical devices

Redd v. Medtronic Inc., 21-CV-06448, 2022 U.S. Dist. LEXIS 223697, 2022 WL 17584377 (S.D.N.Y Dec. 12, 2022)

Plaintiff alleged medical screws inserted into his back during spinal surgery broke one year after surgery, necessitating a second surgery.

Defendant Medtronic moved to dismiss the complaint and plaintiff, proceeding pro se, did not submit an opposition.

The Court, while finding pro se complaints are held to less stringent standards than those drafted by lawyers, dismissed the constitutionally-based claims against Medtronic. Considering plaintiff’s complaint with the liberality required of pro se pleadings, the Court construed the complaint as asserting a product liability claim under New York law. However other than alleging the screws were broken, the complaint failed to speak to their design, manufacture or warnings, and the products liability claim was therefore dismissed.

Poulin v. Boston Sci. Corp., 22-CV-553, 2022 U.S. Dist. LEXIS 222564 (W.D.N.Y. Dec. 9, 2022)

Plaintiff alleged decedent’s death by cardiac arrest was due to a vena cava filter, a medical device implanted into a blood vessel to prevent blood clots from traveling into the lungs and maintain blood flow; this product liability action alleged failure to warn, design defect, breach of express and implied warranty, and consumer fraud.

Following removal to federal court based upon diversity jurisdiction, defendant moved to dismiss the amended complaint for failure to state a claim. Upon autopsy, the filter was found to be partially embedded into the vessel and focally perforating with a blood clot found to be near totally occluding the filter. To support the dismissal motion, defendant submitted the device’s instructions for use (IFU) containing warnings of both perforation of the vena cava and migration of the filter.

Because the plaintiff disputed the authenticity of the IFU, particularly that the version supplied to the Court was not in effect at the time of the implant, the Court did not consider the IFU and its warnings on the motion. Because plaintiff alleged an absence of any warning, as opposed to an inadequacy of a specific warning, plaintiff was not required to identify how the missing warning was inadequate and the Court permitted the failure to warn claim.

Plaintiff’s design defect claim was dismissed, as the pleading did not adequately allege a safer alternative feasible design, or one that would have prevented the injuries.

The breach of express warranty claim was dismissed because it was premised only upon marketing materials and the implied warranty claim was concededly time barred.

Plaintiff’s allegations of consumer fraud and deceptive trade practices premised upon New York General Business Law §349 were dismissed, as there were no allegations the alleged misrepresentations were directed to consumers, including physicians and their patients, and plaintiff did not allege reliance on the alleged materially misleading conduct.

Finally, the motion seeking dismissal of the punitive damages allegations was denied as premature, pending discovery.

Medical devices: Potential implication for future cases

The Court may dismiss a design defect claim upon a pre-answer motion to dismiss if the pleading does not even allege a safer alternative feasible design would have prevented the injuries.

Claims of consumer fraud and deceptive trade practices premised upon New York General Business Law are not typically claimed in personal injury product liability medical device cases and are subject to dismissal where there are no allegations, or reliance on, claims that the alleged misrepresentations were directed to consumers.

Judi Abbott Curry is a senior partner, Harris Beach PLLC Medical and Life Sciences Practice Group.