Since the onset of the COVID-19 pandemic, the Food and Drug Administration (“FDA”) has received more attention than perhaps ever before. While Americans anxiously awaited for approval of a COVID-19 vaccine, the FDA and its regulatory scheme were ever-present topics on the news and in social media. The American population’s newfound familiarity with the FDA is especially pertinent in a medical device litigation context. As litigators well know, jurors already enter a courtroom with preconceived notions of medical device companies, the FDA and the relationship between the two. So how will this newfound knowledge of the FDA influence juror opinions? Put another way, what would happen if a jury participating in a medical device trial failed to hear any reference to the FDA at all? Potentially, the results would be catastrophic to device manufacturers.
On March 2, 2021, a New Jersey appellate court overturned two pelvic mesh jury verdicts totaling over $83 million dollars, holding that the trial courts committed reversible error by excluding all evidence related to the FDA clearance process. This decision represents a substantial victory for medical device manufacturers, particularly in light of the staggering jury verdicts that have been handed down over the past few years.
This ruling represents two separate cases that were consolidated for purposes of appeal. See Hrymoc et al., v. Ethicon Inc. et al., Docket No. A-005151-17, and McGinnis et al. v. C.R. Bard Inc. et al., Docket No. A-001038-18. In both cases, the respective juries found the medical device defendants liable for design and failure-to-warn defects that caused injuries to plaintiffs. In Hrymoc, the jury awarded the plaintiff and her husband $5 million in compensatory damages, and $10 million in punitive damages. Conversely, in McGinnis, the jury awarded the plaintiff and her husband $33 million in compensatory damages, and $35 million in punitive damages. Continue reading “510(k) Clearance Evidence Gains New Life After $83 Million Verdicts Overturned”
The Massachusetts Supreme Judicial Court recently addressed the question of what pleading standard is required in Massachusetts to allege parallel state law claims involving medical devices to avoid preemption under the federal law regulating medical devices. The Court’s decision sheds light on the lack of consensus among state and federal courts on this issue, which may impact the time and resources that litigants and the courts expend on claims that may later prove to be meritless.
As background, the Food and Drug Administration (“FDA”) must approve or clear medical devices before they can be marketed or sold to the public. The approval process employed depends upon the category of the medical device. Under the Medical Device Amendments of 1976 (the “MDA”) to the Federal Food, Drug, and Cosmetic Act (the “FDCA”), devices are separated into three categories depending on the potential risks they present: Class I, Class II, and Class III. Class I devices “are those that present no unreasonable risk of illness or injury and therefore require only general manufacturing controls; Class II devices are those possessing a greater potential dangerousness and thus warranting more stringent controls; Class III devices ‘presen[t] a potential unreasonable risk of illness or injury’ and therefore incur the FDA’s strictest regulation.” Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 343-44 (2001) (citation omitted); see also 21 U.S.C. § 360c. Class III devices include replacement heart valves, implanted cerebella stimulators, and pacemaker pulse generators, among other devices. Riegel v. Medronic, 552 U.S. 312, 316 (2008). Continue reading “Parallel or Preempted? The Massachusetts Supreme Judicial Court Highlights the Inconsistency Among Courts Regarding Pleading Standards for Parallel Claims Involving Medical Devices”
With each passing year, the long-predicted aspirational advantages of 3D printing in the life sciences industry become a reality. Forecasts of large scale printing operations at or near major hospitals are fulfilled. Visions of bioprinted organs have become a reality. 3D printing is reaching the lofty potential projected by the life sciences industry years ago. However, the topic of litigation risks with 3D printing in the life science industry is often overlooked. […]
Yet, the widespread use of additive manufacturing by companies and individuals outside of the life sciences industry also underscores the potential litigation risks with 3D printing.
With the Senate set to return from recess on Monday, liability protections related to the COVID-19 pandemic are anticipated to be a hot button issue. While state and local governments are seeking financial aid from the federal government to assist in their battle against the COVID-19 pandemic, relief packages may also include protection from future legal actions against businesses.
As stay-at-home restrictions are beginning to be lifted, and businesses are starting to reopen, there are concerns that employees and customers will file suit against businesses, claiming that they were infected with COVID-19 as a result of the businesses’ failure to take appropriate measures to protect them once reopening occurs. This fear is likely in response to lawsuits that have already arisen against businesses related to COVID-19. For instance, earlier this month, a Celebrity Cruises crewmember, who contracted COVID-19 while working on a Celebrity ship, filed a proposed class action alleging that the cruise company failed to take adequate measures to protect the employees on its ships. The crewmember filed the proposed class action in a Florida federal court, claiming that the cruise company failed to follow safety precautions after receiving notice that COVID-19 was or was likely present on the ships, such as permitting crewmembers to continue to eat in a buffet setting, and mandating crewmembers’ participation in shipboard drills. Continue reading “Liability Protections Under Consideration for Businesses Set to Reopen During the COVID-19 Pandemic”
On April 3, 2020, the United States District Court for the Southern District of Florida issued an order in the pending Zantac multidistrict litigation (”MDL”) requiring disclosure of funding arrangements and funding documentation between plaintiffs’ counsel and third-party litigation financiers. This order represents some increased traction in favor of arguments seeking to require disclosure of third-party funding arrangements in MDLs.
The Zantac MDL, In re Zantac (Ranitidine) Prods. Liab. Litig., MDL No. 2924, was originally formed by the Judicial Panel for Multidistrict Litigation on February 6, 2020. The plaintiffs sued various defendants, including manufacturer Sanofi and its distributors, alleging that the active ingredient in the heartburn medication Zantac breaks down to form a carcinogen that caused personal injuries. Included in the MDL are also six putative classes of consumers who sought refunds and economic damages based on their purchase of Zantac. Due to a number of actions already pending in the Southern District of Florida, the Panel transferred the remaining actions to that court to be assigned to the Honorable Robin L. Rosenberg.
In recent months, reports of asbestos-contaminated cosmetics have illustrated the enduring challenges of manufacturing and marketing cosmetics as safe for consumers, particularly teens, children and expectant mothers. This is especially true where still-developing science, emotion and rapidly disseminated information (and misinformation) all play critical roles in shaping public perception, even influencing jury outcomes.
This article explores the potential legal challenges for supply chain participants arising from contaminated cosmetics, as well as significant proposals to change the way the U.S. Food and Drug Administration regulates cosmetic safety.
On May 20, 2019, the Supreme Court of the United States issued a rare unanimous decision in Merck Sharp & Dohme Corp. v. Albrecht, et al., holding that judges, not juries, must decide whether state law failure-to-warn claims against brand-name drug manufacturers are preempted by the FDA’s labeling regulations. In so holding, the Court further clarified the preemption standard set forth in an earlier decision, Wyeth v. Levine, concluding that such claims are preempted where a drug manufacturer can show “that it fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve changing the drug’s label to include that warning.”
Additive manufacturing, commonly known as 3-dimensional (3D) printing, has been billed as the new industrial revolution. It is a lofty prediction; but we are seeing this prognostication materialize. Everyday consumer products ranging from children’s toys to running shoes are being 3D printed, sometimes right in consumer stores or at home. More and more manufacturers have begun or are exploring additive manufacturing options for their products. 3D-printed products even won an Oscar, when Ruth Carter won Best Costume Design for her work in the movie Black Panther, where portions of Carter’s costumes were 3D printed. From everyday consumer products, to its appearance on the red carpet, 3D printing has arrived.
Recognizing the potential advantages, endless possibilities, and unique manufacturing capabilities offered by 3D printing, more and more medical device manufacturers are entering this new field of technology. However, industry standards and regulations lag behind the pace of innovation. The unique aspects and potential availability of additive manufacturing raise novel products liability issues that may impact traditional product liability litigation doctrines. This article examines the current status of additive manufacturing as well as potential issues and uncertainties it raises for the future of product-liability litigation.
The most recent talc verdicts have demonstrated some traction in defeating claims based on certain go-to defense strategies, including personal jurisdiction dismissals, the use of expert testimony and Daubert motions discrediting scientific causation, and even requests to jurors to use their “common sense” in evaluating scientific evidence. However, there is another tool that defense attorneys should consider in talc cases: federal preemption.
Part of the mass appeal of talc cases lies in the prevalence of talc-based products in the marketplace, due to the numerous uses for talc in a variety of consumer products across cosmetics, over-the-counter (OTC) drugs, and even foods. As talc litigation expands into products that may be regulated as OTC drugs, defense counsel should consider the options that they might have in invoking federal preemption as a defense strategy. While the defense remains untested, there is a sound basis for its application. This article will discuss the federal U.S. Food and Drug Administration (FDA) regulatory scheme that is applicable to talc-based products and when federal preemption may support an argument for defeating conflicting state law claims against talc-containing OTC drugs.