- Uptick in Pharmaceutical, Medical Device and Healthcare Litigation Activity as COVID-19 Pandemic Wanes – Between delayed treatments and post-peak COVID-19 pandemic, expect to see an uptick in healthcare and related litigation as a result of resumption in mass tort activity, particularly with the return of trials post peak COVID-19. Such activity is likely to be complicated by tolling provisions in emergency orders, which, because of the ever-evolving and unprecedented nature of the pandemic, were not clearly defined and have not had occasion for interpretation by pertinent appellate courts.
- Heightened Food & Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) Public Awareness – The COVID-19 pandemic has highlighted the FDA and CDC and their roles within the public consciousness, which will likely result in increased importance of strategic usage of regulatory approvals for pharmaceutical products and medical devices. Public perception of FDA/CDC roles—which is constantly evolving and has been polarized due to the politicization of the COVID-19 pandemic and the government’s response—can at any moment reframe the reputation of drug and device companies and the work they have done to protect, treat, and heal patients during the pandemic. This impact is already apparent with juries. Expect to see more changes along these lines over time as additional information becomes available to the public on vaccines and other pandemic-related treatments come out regarding their effectiveness.
- Digital Health Will Continue to be Developing Frontier – As artificial intelligence and machine learning become more ubiquitous in everyday life, expect plaintiffs to treat this proliferation as springboards for litigation with novel theories. Similarly, increased deployment of digital health technologies, including wearable devices, personal device applications, precision health software, telehealth, and connected medical devices, each result in unique theories of liability given the environments in which the technologies operate.
- Continued Copycat Litigation Against Classes of Products – Plaintiff lawyers continue to aggressively file mass tort and class actions across numerous product classes that attempt to leverage lawsuits already filed by using factual and expert evidence previously obtained in prior litigation in new cases. Recent examples include the ever-expanding nitrosamines litigation, as well as testing by plaintiff-affiliated labs of other products for potentially harmful chemicals (e.g., benzene in sunscreen and deodorant, etc.). Others include Plaintiff lawyers following the successful formulas of prior mass torts like the Roundup cases for new ones like Paraquat, or asserting new types of risks for products that have long been in litigation, like new allegations of laminal duct obstruction against Taxotere, which was already subject to a large MDL formed in 2016 on allegations of persistent or permanent alopecia.
- Amendments to Rule 702 Impacting General Causation Issues – Proposed amendments to Federal Rule of Evidence 702 were published on August 6, 2021 and are open for public comment through February 16, 2022, after which they will likely go into effect. The proposed amendments are purportedly intended to clarify the court’s gate-keeping function and correct erroneous findings that an expert’s deficiencies as to basis or methodology are questions of weight and not admissibility. Where so many mass torts are now won or lost on general causation, particularly in cases alleging a product caused cancer, the impact of these changes will be significant.
About the Authors
Greenberg Traurig’s Pharmaceutical, Medical Device & Health Care Litigation Practice includes more than 100 trial attorneys representing clients in complex litigation in courts across the country. The team regularly serves as national, regional, special trial, or science counsel – in both mass torts and individual cases – to leading global companies that produce innovative, life-saving products.
Irvin Hernandez is an Atlanta based associate who defends high-profile product liability, pharmaceutical, and medical device cases throughout the country in state and federal courts. Irvin also helps advise companies on regulatory, compliance, and risk management strategies as well as compliance matters governed by the FDA and other federal and state regulatory bodies.
Miami associate, Akiesha Gilcrist Sainvil, focuses her practice on defending medical device, pharmaceutical, and consumer products manufacturers in high-stakes complex products liability and mass torts litigation. Akiesha brings a broad range of industry experience to her practice, having also defended major retailers, automotive and transportation companies, financial and health care institutions, and insurance providers in complex commercial litigation matters throughout the country in federal and state courts (including appellate courts) and in arbitration.