Product Liability 2021 Year in Review

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Massachusetts federal and state courts issued several important product liability decisions in 2021. Nutter’s Product Liability practice group reviewed these cases and report on their significant holdings as follows.

1. UNITED STATES FIRST CIRCUIT COURT OF APPEALS

Carrozza v. CVS Pharmacy, Inc.
992 F.3d 44 (1st Cir. Mar. 31, 2021)

Significant Holding: As a matter of first impression under Massachusetts law, the First Circuit held that a pharmacist’s dispensation of prescribed medication was predominantly provision of services, and not sale of goods.

The plaintiff sued after an allergic reaction to a prescribed drug, Levaquin (the quinolone antibiotic levofloxacin). Neither the plaintiff nor his physician were aware of any allergies to quinolones, but while filling the prescription, the CVS pharmacist received a “hard stop” warning suggesting that the plaintiff was allergic to quinolones. At the same time, CVS’s Patient Profile included statements by the plaintiff that he in fact had no quinolone allergy and had received prior prescriptions of Levaquin. Given the conflicting information, the pharmacist exercised his individual judgment and dispensed the Levaquin.

The District Court issued various rulings on the admissibility of testimony by the treating ophthalmologist and the plaintiff’s expert, which the First Circuit affirmed. Without an expert opinion on the standard of care and the causation of his injuries, the District Court properly granted summary judgment on the plaintiff’s negligence claims. Notably, regarding the plaintiff’s strict liability claims resting on breach of implied warranty under the Uniform Commercial Code, the First Circuit agreed that under Massachusetts law a pharmacist’s dispensation of prescribed medication is predominately the rendition of services, not sale of goods. Thus, the warranty claim could not survive because the UCC does not apply to agreements for provision of services.

2. UNITED STATES DISTRICT COURT

Ducat v. Ethicon, Inc.
534 F. Supp. 3d 152 (D. Mass. April 14, 2021)

Significant Holding:  Under Massachusetts law, the plaintiffs must allege the existence of a safer or reasonable alternative design to state a claim for negligent design and breach of implied warranty of merchantability.

The plaintiffs brought suit for injuries from a pelvic mesh medical implant alleging design defect and breach of implied warranty of merchantability. The defendants moved for judgment on the pleadings, arguing that the plaintiffs’ design defect claims should be dismissed for various reasons, including failure to plead the existence of a safer alternative design.

The District Court began by noting ambiguity in Massachusetts law on whether, to prevail on a defective design claim, a plaintiff must follow the “consumer expectations” or “risk-utility” test — which requires proof of the existence of a reasonable alternative design. This ambiguity stems from two decisions of the Massachusetts Supreme Judicial Court that remain in conflict – one involving cigarettes (requiring a technologically feasible and practical alternative design) and the other involving a snowmobile (accepting a consumer’s reasonable expectation as proof of design defect when the danger fell within the average juror’s knowledge).

Ultimately, relying on the First Circuit’s decision in Tersigni v. Wyeth, 817 F.3d 364 (1st Cir. 2016), the District Court found that the plaintiffs here do need to allege the existence of a safer or reasonable alternative design, citing favorably the guidelines set forth in the Restatement (Third) of Torts, §2, and rejecting the reasoning of Taupier v. Davol, Inc., 490 F. Supp. 3d 430 (D. Mass. 2020). The District Court did, however, grant the plaintiffs leave to amend their complaint to comply with this standard.

In re Zofran (Ondansetron) Prods. Liab. Litig.
MDL No. 1:15-md-2657-FDS 2021 WL 2209871 (D.Mass. June 1, 2021)

Significant Holding:  The plaintiffs’ failure to warn claims are preempted by federal law when there is “clear evidence” that the U.S. FDA did not approve changing the prescription drug’s label to include a warning that the plaintiffs contend was required by state law.

In this federal multi-district litigation, the plaintiffs who were prescribed the drug Zofran off-label to prevent nausea and vomiting while pregnant brought failure to warn claims, alleging that the product manufacturer failed to disclose material evidence to the U.S. Food and Drug Administration about Zofran’s adverse fetal effects. The defendant manufacturer moved for summary judgment, arguing that the plaintiffs’ state law claims were preempted by federal law because the FDA approved the product’s label and expressly rejected later proposed changes.

Relying on prior U.S. Supreme Court decisions, including Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668, 203 L. Ed. 2d 822 (2019), the District Court noted that failure to warn claims are not preempted unless there is “clear evidence” that the drug manufacturer fully informed the FDA of the justifications for the warning required by state law, and the FDA, in turn, informed the drug manufacturer that it would not approve the change. Here, the original manufacturer sold its rights to the drug, and the current owner applied to the FDA for labeling changes in 2020. These changes included warnings related to pregnancy use and birth defects. The plaintiffs argued that the original manufacturer withheld or mischaracterized scientific studies and adverse event data at the time of original approval, but the District Court held that, even if it did, the current owner presented all such information about the drug’s safety to the FDA by the time of the requested labeling change in 2020. Based on this information, the FDA rejected the proposed changes, and approved a label that did not include warnings about use during pregnancy.

As a result, “clear evidence” exists that the FDA was fully informed of potential justifications for changing the drug’s warning label, and had rejected prior submissions for pregnancy enhanced warnings three separate times (in 2013, 2015, and 2021) after considering the very evidence that the plaintiffs contend required an enhanced warning. Furthermore, the fact that the current owner rather than the manufacturer requested the labeling change did not alter the outcome. Preemption analysis does not depend on whether the original manufacturer requests a label change, or to whom the FDA explicitly communicates its rejection of the proposed change. The District Court therefore granted the manufacturer’s motion for summary judgment, and disposed of the entire MDL.  

Plourde v. Sorin Grp. USA, Inc., et al.
517 F. Supp. 3d 76 (D. Mass. Feb. 5, 2021)

Significant Holding:  The plaintiffs’ state law claims that the defendants had a duty to report or warn the FDA of adverse events about a medical device are preempted by federal law.

The plaintiffs filed this claim on behalf of their adult daughter who was fatally injured during a heart valve replacement procedure. They alleged that the defendants knew of an increased risk of harm to patients under 30 years old, but failed to notify the FDA. The defendants countered that such claims were preempted by federal law, because the plaintiffs failed to establish that they had a duty to report to the FDA under a Massachusetts law parallel to federal law. The District Court agreed, and also held that a duty to warn doctors under the learned intermediary doctrine does not correspondingly impose a duty to report to the FDA. Furthermore, the plaintiffs’ breach of express warranty claim failed because the valve’s Instructions For Use contained explicit warnings about the use of the valve in younger individuals. The plaintiffs did not identify any specific statements that the defendant made that could be understood as a guarantee or warranty of the valve’s suitability in patients under 30 years old. The District Court therefore granted summary judgment.

3. SUPREME JUDICIAL COURT

Dunn v. Genzyme Corp.
486 Mass. 713 (Jan. 29, 2021)

Significant Holding: The plaintiffs asserting state law claims about medical devices regulated by the FDA are not required to plead specific facts to meet the Commonwealth’s notice-pleading standard.

After experiencing severe side effects, the plaintiff brought personal injury and product liability claims against the defendant manufacturer of Synvisc-One, a Class III medical device subject to premarket approval under the Medical Device Amendments of the U.S. Food, Drug, and Cosmetics Act. The defendant moved to dismiss, asserting that the allegations were preempted by federal regulations and failed to meet the applicable state law pleading standards. The Superior Court denied the motion, and, on transfer from the Appeals Court on interlocutory review, the SJC reversed. 

First, the SJC held that the plaintiff’s claims under Massachusetts law could be interpreted as coextensive with the comprehensive federal requirements imposed on the defendant rather than adding to them, and therefore satisfied the preemption standard established by the U.S. Supreme Court in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). Second, the SJC held that the plaintiffs asserting parallel state law claims were not required to plead the precise federal regulations purportedly violated to meet the ordinary notice-pleading standard established by the SJC in Iannacchino v. Ford Motor Co., 451 Mass. 623 (2008). Despite these legal statements, however, the SJC concluded that this plaintiff’s complaint provided no factual allegations to establish causality between the defendant’s activities and the plaintiff’s injuries sufficient to survive a motion to dismiss.

Doull et al. v. Foster et al.
487 Mass. 1 (Feb. 26, 2021)

Significant Holding: Redefining the Massachusetts standard for factual causation in negligence cases involving multiple alleged causes of harm, the SJC adopts a “but-for” standard and abandons the “substantial contributing factor” test.

After a patient developed a pulmonary embolism and chronic thromboembolic pulmonary hypertension (“CTEPH”) which caused her death, the patient’s estate brought a medical malpractice action against her nurse practitioner and physician employer, alleging that the nurse practitioner failed to obtain informed consent as to the potential risks of pulmonary embolism associated with use of a progesterone cream for perimenopause-related symptoms, and that she failed to diagnose the patient’s pulmonary embolism. The defendants’ experts testified there was no evidence that the cream increased the risk of clotting, or that the patient’s CTEPH would have been preventable had she been diagnosed with it earlier. The jury returned a verdict for the defendants, finding no failure to obtain informed consent, and that, even though the nurse practitioner was negligent in failing to diagnose the pulmonary embolism and her employer was negligent in supervising her, neither defendant was the “sole/but-for” cause of the harms suffered by the patient.

On appeal, the plaintiffs argued that the trial judge had to instruct on a “substantial contributing factor” standard because there were several possible causes and multiple tortfeasors involved in the patient’s injuries and death. The SJC disagreed and affirmed, holding that in a majority of negligence cases, the jury should be instructed using the but-for standard. Causation is an essential element of any negligence claim and involves two components – factual and legal cause. Generally, a defendant is a factual cause of a harm if the harm would not have occurred “but for” the defendant’s negligent conduct. The SJC explained that in some cases – for example, toxic tort and asbestos cases involving multiple causes – the but-for standard can cause unjust results, and alternative causation standards like the substantial factor test could be more appropriate. The SJC distinguished the current malpractice action from a toxic tort or asbestos case in which it would be impossible for a plaintiff to determine which exposures were necessary to bring about the harm and which were not. Here, the SJC believed the jury could separate the conduct that did not affect the harm from the conduct that caused the harm.

Notably, the SJC supported the approach proposed by the Restatement (Third) of Torts, § 27, to supplement rather than abandon the but-for standard in cases involving multiple causes to avoid confusing terminology and eliminate the risk of a trial judge instructing the jury on the wrong standard. Furthermore, in a long footnote, the SJC stated that it would reconsider use of the substantial factor test in Massachusetts if an appropriate toxic tort case came before it in the future.

Laramie v. Philip Morris USA Inc.
488 Mass. 399 (Sept. 15, 2021)

Significant Holding: The doctrine of claim preclusion did not apply when a prior action by the Attorney General did not adequately represent the plaintiff’s personal interest in punitive damages.

The plaintiff, a widow of a cigarette smoker, sued pursuant to Massachusetts’ wrongful death statute, G.L. c. 229 § 2, claiming that the defendant caused her husband’s death by selling him defective and unreasonably dangerous cigarettes. The jury awarded her $11 million in compensatory damages and $10 million in punitive damages. The defendant appealed, arguing that the punitive damages were precluded by a 1998 master settlement agreement with the Massachusetts Attorney General. The agreement covered claims against the defendant alleging conspiracy to mislead the Commonwealth and its citizens about the health risks of smoking, and recovered the Commonwealth’s costs for providing smoking-related medical assistance to Massachusetts residents.

On appeal, the SJC affirmed, rejecting the defendants’ argument of claim preclusion. The master settlement agreement released the defendant from liability for punitive damages to persons acting as private attorney general seeking relief on behalf of the general public, but preserved claims for individual relief for separate and distinct injuries. The SJC held that this language explicitly stated the parties’ intention to preserve personal rights, including actions under the Commonwealth’s wrongful death act. As a result, the master settlement agreement did not preclude the plaintiff’s punitive damages claim because (1) the plaintiff’s personal interest in punitive damages was not adequately represented by the AG because the prior action did not seek damages for personal injuries, but sought damages for the Commonwealth’s increased medical expenditures; and (2) the two causes of action were distinguishable because the “wrong” that the plaintiff sought to remedy was the loss sustained due to her husband’s death, while the “wrong” the Attorney General sought to remedy was the Commonwealth’s increased medical expenditures.

Nemirovsky v. Daikin North Am., LLC, et al.
177 N.E.3d 901 (Dec. 16, 2021)

Significant Holding: The component parts doctrine applies to non-defective components even if they cannot function separate and apart from the integrated product or were produced specifically for use in the integrated product. 

The consumer of an HVAC system sued various defendants, including the distributor of evaporator coils used to replace leaking coils in the system. After the jury found the coil distributor liable for breach of implied warranty and other claims, it filed a motion for judgment notwithstanding the verdict, contending that the component parts doctrine precluded liability. Under this doctrine, the manufacturer of a non-defective component placed in an integrated product generally is not liable for damage caused by a defect in the integrated product. The trial court denied the defendant’s motion, holding that (1) the doctrine only applies to “stand-alone components,” i.e., components that function separate and apart from the system in which they are integrated; and (2) the coils here were not stand-alone, because the manufacturer produced and distributed them specifically for use in the subject HVAC system.

On appeal, the SJC reversed, accepting the Restatement (Third) of Torts, §5, analysis that the doctrine also applies to specialized components that have no functional capabilities unless integrated into other products. Unless the coils themselves were found to be defective, the component parts doctrine applied, and liability should not flow to the coil distributor for harm caused by the defective HVAC system. The SJC also clarified that this doctrine applies to both tort and warranty claims, as it arises in the context of product liability which involves the intersection of both legal schemes.

4. SUPERIOR COURT

Noorchasm et al. v. Muto et al.
1584-CV-03245 2021 WL 3612425 (Suffolk Cnty. Sup. Ct. July 8, 2021)

Significant Holding: Under some factual circumstances, a medical device manufacturer’s duty to warn a learned intermediary runs not only to the treating surgeon, but also to the purchasing hospital.

This claim stems from the use of a power morcellator which led to the dissemination of cancerous tissue within a patient’s body and caused her death. The plaintiffs brought a negligent failure to warn claim, among others. The manufacturer defendant moved for summary judgment on multiple grounds, arguing in part that because the surgeon did not read the instruction manual, any harm could not have been caused by a deficiency in the product warnings. The manufacturer relied on the learned intermediary doctrine to support its argument that the treating surgeon has superior knowledge of her patient’s medical history, and the manufacturer need only warn the surgeon who in turn owes a duty to advise her patient of the risks associated with the use of the product.

The plaintiffs responded that when a surgeon relies on her hospital to apprise her of the relevant risks, a manufacturer’s duty to warn runs not only to the treating surgeon, but also the purchasing hospital. Here, evidence existed that the hospital’s unit chief received notifications about product safety, forwarded them to physicians in his department, and would have shared allegedly missing information with his department surgeons and required them to comply with it. Under these factual circumstances, the court held that the learned intermediary doctrine does not require that a manufacturer defendant’s duty runs only to the surgeon using the product, and therefore denied summary judgment.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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