As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702 updates that took place this year, which will carry over into 2023?), but provides a brief recap and assessment of five of the most interesting and consequential developments affecting drug and device law in 2022.
On April 14, 2022, the Environmental Protection Agency (EPA) released draft conclusions in a report updating its analysis regarding formaldehyde exposure, suggesting that long-term exposures to small amounts of formaldehyde in the environment can increase the risk of rare head and neck tumors, leukemia, and other threats to health. The conclusions are not final agency action. Still, manufacturers should be aware of the potential for EPA’s analysis to influence both regulation and litigation at both the state and federal levels.
For over a decade, there has been much debate and study on the long-term effects of exposure to formaldehyde. The EPA’s new analysis is an update of a 2010 draft EPA report that was heavily panned by scientists, legislators, and chemical manufacturers and that drove the EPA back to the drawing board. For example, the National Academies of Sciences, Engineering, and Medicine criticized the 2010 draft EPA report for failing to describe the rationale behind its methodology and failing to sufficiently support its conclusions.
A new study regarding phthalates has garnered media attention this month, but readers should recognize the study’s limitations. Some media coverage of this study blurs the important distinction between “association” and “causation.”
What Are Phthalates?
Phthalates, sometimes called plasticizers, are a group of chemicals generally used to make plastics more durable, or to dissolve other materials. Phthalates may be found in products such as vinyl flooring, food wraps, intravenous tubing, lubricating oils, and some personal care products such as shampoos, soaps, and hairsprays.
Jury selection in California is undergoing significant change. In August 2020, the California legislature passed AB 3070, which was signed by Governor Gavin Newsome on September 30. Beginning in 2022, objections to peremptory challenges in criminal cases will have more teeth, including a list of presumptively invalid reasons for striking a prospective juror and a new standard of review for appellate review of a trial court’s decision. While AB 3070 does not apply officially to civil jury trials until 2026, the significant overhaul in procedure effectuated by this new law is likely to influence a court’s analysis of the civil jury selection process before that time. The new law’s aim is noble: to bring an end to discrimination in jury selection. However, critics, including many within the California judiciary, say the new procedure is “unworkable.”
The Maryland Court of Appeals has retired the inflexible Frye-Reed standard and adopted the framework of Daubert for evaluating the admissibility of expert testimony. In Rochkind v. Stevenson (August 28, 2020), Maryland officially joined the supermajority of states that have considered the issue and now follow Daubert.