Staying Ahead in Life Sciences: 2023 in Review and 2024 Trends – Part 3

As part of the life science community, Berkley Life Sciences (BLS) stays current on litigation trends and regulatory developments that affect the industry. BLS presents these updates in an annual webinar with Kim Schmid, Executive Managing Partner at Bowman & Brooke.

BLS is offering a series of three articles highlighting information from the webinar, such as a review of pertinent litigation and mass tort trends, new case law developments, regulatory updates, and what to watch for in 2024.

The final article of this three-part series will focus on recalls, regulatory updates, and what to watch for in 2024.

Medical Device Recalls

Class 1 medical device recalls soared in 2023 to 499, in stark contrast to both 2021, when there were just 169 Class 1 recalls, and to 2022, when that number dropped even lower to 149. The total number of medical device recalls for 2023, regardless of class, was 2602, which is 756 more than in 2022. (data source FDA Compliance Dashboards)

Some examples of Class 1 recalls in 2023 are:

• the Smiths Medical recall of nearly 20 million drug delivery devices following two deaths;
• the GE HealthCare recall of body scanners based on the risk of trapping and crushing; and
• the Datascope recall of 2000 heart balloon pumps due to the potential for unexpected pump shut down.

Drug Recalls

Unlike Class I medical device recalls, Class 1 drug recalls have steadily dropped from a record high of 570 in 2019 to just 53 in 2023. Overall, the total for all drug recall classifications has also declined since 2019 to 1,138 in 2023.

Some of the more significant Class 1 recalls include:

• Hospira’s sodium bicarbonate injection recall due to the presence of glass particulates; and
• Cipla’s albuterol recall for failing to deliver the recommended dose.

Nearly all Class 3 recalls involved specific lots with labeling errors or contamination of non-sterile products.

Regulatory Updates

Device Innovation

Device innovation was highlighted in the Center for Devices and Radiological Health (CDRH) Annual Report in January 2022. A total of 167 submissions were designated as Breakthrough Devices (up from 135 in 2022); 29 Breakthrough Devices received market authorization, 124 novel devices received authorization, and 15 STeP (Safer Technologies Program) requests were granted.

Between January 2023 and July 2023, the FDA authorized 108 artificial Intelligence or machine learning-enabled (AI/ML) medical devices. GE HealthCare and Siemens Healthineers led the list with the most cleared AI/ML devices between August 2022 and July 2023, with radiology devices accounting for the majority of the new AI/ML devices.

It is worth noting that despite rising interest in language models like ChatGPT, none of the cleared devices used generative AI.

Clinical Trials: Final Guidance

On August 15, 2023, the FDA issued a new guidance document on informed consent (the “Final Guidance”). The Final Guidance finalizes the 2014 “Informed Consent Information Sheet” and supersedes FDA’s guidance from 1998. Topics covered included:

• Streamlining of the IRB Review of Informed Consent Forms;
• What New Information Needs to be Communicated to Subjects;
• Conflicts of Interest – Clinical Investigations;
• Informed Consent Form Templates;
• Disclosure of Presence of Sponsor Personnel; and
• Circumstances for Enrollment in Multiple Investigations.

What to Watch in 2024

By the Numbers

Overall, life science product liability cases pending as of 2024 decreased by thirty percent. As of January 1, 2024, pending life sciences product liability cases filed in federal court — both MDL-associated and not—numbered 194,723. New Jersey had the most MDL filings (71,893), and of the 1878 federal non-MDL life sciences product liability cases, New Jersey also had the most filings with 577. These numbers were provided by Bowman & Brooke based on legal analytics from Lex Machina. As discussed above, despite the lower numbers, case law and regulatory change have continued to impact the life science industry.

Looking ahead to 2024 and beyond, the landscape of product liability law remains dynamic and ever-evolving. Each year brings forth myriad legal challenges shaping the standards and responsibilities of manufacturers, distributors, and sellers alike. In 2024, several significant product liability cases are poised to capture the attention of the industry’s legal experts, professionals, patients, and consumers. These cases highlight the complexities of product liability law and serve as pivotal moments that may define rights and protections afforded to both manufacturers of life science products and individuals alleging harm. Decisions in these cases can potentially influence legal precedent, industry practices, and consumer safety standards for years. As we anticipate the unfolding of these legal battles, it is essential to examine the key issues at stake, the parties involved, the products, and the potential implications for the industry and the public.

AI Learning in Brain Stimulation Devices

Deep brain stimulation, or DBS, uses a surgically implantable medical device that selectively electrically stimulates the brain to treat certain types of neurological movement disorders such as Parkinson’s disease. This technological evolution expands clinical diagnosis and treatment, including neuroimaging of the disease state. It is also being studied to treat mental health conditions such as depression and obsessive-compulsive disorders.

This year, the FDA’s Center for Devices and Radiological Health (CDRH) will publish Final Guidance on market submissions for AI/Machine Learning-enabled devices.

Influencer Marketing: Legal Risks

Increasingly, consumer protection lawsuits are targeting brands and influencers. The FDA has posted a social media policy on its website. Due to the popularity of this type of promotion, more litigation is expected in this arena.

PFAS Litigation - an increasingly complex issue for life science companies

These chemicals have been dubbed forever chemicals and are omnipresent. They are found in numerous products, including personal care products and packaging. Contamination is alleged to occur through the consumption of food, water, and skin absorption. Potential litigation targets include manufacturers using PFAS in products or packaging, manufacturers of cleaning products and personal care products, manufacturers of cleaning products and personal care products, importers, and transporters of products containing PFAS.

In 2023, 3M reached a $12.5 billion settlement related to drinking water allegedly contaminated by PFAS in 3M firefighting foam. This settlement followed a $1.1 billion settlement reached by DuPont, Chemours, and Corteva in a South Carolina MDL involving water companies across the country. Legal pundits predict that PFAS may follow a path similar to the ongoing asbestos litigation. In April 2024, The Environmental Protection Agency (EPA) made headlines by adding two PFAS chemicals, perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), to its list of hazardous substances. It also issued the first-ever national standard for municipal drinking water systems to protect water supplies from PFAS chemicals. With settlement numbers and federal actions like these, the plaintiff’s bar is expected to start targeting the life sciences industry in pursuing PFAS claims.

Conclusion

The year 2023 was replete with litigation battles that have the potential to influence the life science industry in significant ways. High-profile decisions, such as the “failure to innovate” ruling in Gilead, could establish precedents that will resonate for years. The new FRE 702 and other legal and regulatory developments could significantly impact how cases are tried and decided.

Life science companies will need to remain vigilant in assessing the impact of court precedent, product recalls, and regulatory changes on their ability to develop new, innovative, lifesaving, and life-enhancing products.

Click here for the webinar, “Stay Ahead in Life Sciences: 2023 in Review and 2024 Trends.

Authored by Cindy Khin, Berkley Life Sciences, Life Sciences Casualty Resolution Director