In the past two years, large multidistrict litigation against pharmaceutical companies and their respective drugs reigns supreme, forming one of the biggest drivers of litigation nationwide.
Law Street Media analyzed litigation involving large pharmaceutical companies in U.S. District Courts from January 1, 2020, to January 15, 2022, finding that the industry, despite being at the center of the fight against COVID-19, has faced relatively little pandemic-related litigation.
Instead, the companies faced cases often set up as multidistrict litigation (MDL), which tend to span years and are often related to drug recalls or failure to warn of pharmaceutical side effects.
Other lawsuits against the industry result from alleged misrepresentations; for example, promoting the drugs outside of the scope of their Food and Drug Administration (FDA) approval. The ongoing opioid crisis has also resulted in litigation; in July 2021, three drug distributors (Cardinal Health, AmerisourceBergen and McKesson) and pharmaceutical company Johnson & Johnson agreed to pay $26 billion to resolve opioid-related lawsuits.
COVID-19 vaccine maker Pfizer was involved in 2,891 federal lawsuits during the last two years, serving as defendant 98% of the time. The vast majority of these lawsuits (2,159) were filed healthcare/pharmaceutical personal injury product liability cases; representing 74% of Pfizer litigation. The related product liability case type makes up 489 cases or 17% of overall litigation and tort product liability comprises 3% of cases; nearly 92% of Pfizer’s cases involve product liability generally.
Some of the product liability litigation are part of a multidistrict case concerning proton-pump inhibitor (PPI) products , which are used to reduce stomach acid; Pfizer’s PPI is Nexium, which helps with heartburn and other issues. The lead case was filed in August 2017, asserting that these medicines caused issues like kidney injuries.
Another large case is an MDL for Zantac (ranitidine) product liability litigation, alleging that Pfizer labeled the heartburn drug Zantac as “safe and effective” despite allegations that it was contaminated with unsafe levels of NDMA, a potential carcinogen. In the few cases where Pfizer serves as plaintiff, the company sued to block Abbreviated New Drug Applications (ANDA), a mechanism by which pharmaceutical companies can make generic versions of pharmaceuticals.
Williams & Connolly represented Pfizer in recent years, but its case load has declined over time. A similar trend also happened with DLA Piper. Other law firms representing Pfizer in both 2020 and 2021 are Morris, Nichols, Arsht & Tunnell; Bradley Arant Boult Cummings; Gibbons; and Fox Smith. Meanwhile, Arnold & Porter; Katz, Teller, Brant & Hild; and Stradley, Ronon, Stevens & Young represented Pfizer in 2020, but not in 2021.
DLA Piper predominantly represented Pfizer in healthcare/pharmaceutical personal injury product liability lawsuits. Additionally, Katz, Teller, Brant & Hild; Arnold & Porter; Williams & Connolly; Bradley Arant Boult Cummings; and Stradley, Ronon, Stevens & Young also represented Pfizer for this type of litigation.
Johnson & Johnson
While known for products like Tylenol and Band-Aids, Johnson & Johnson and its subsidiaries faced more than 43,000 lawsuits over the last two years; it was the defendant 99% of the time. Most of its litigation (23,228 or 87%) occurs in the District of New Jersey as a part of the litigation concerning its talcum powder, one of the biggest lawsuits for 2021.
In both 2020 and 2021, Shook, Hardy & Bacon represented Johnson & Johnson in the greatest number of cases, followed by Faegre Drinker Biddle & Reath. Odom Sparks & Jones; Tucker Ellis; and Thomas Combs & Span both represented Johnson & Johnson in 2020 and 2021 with reduced representation in 2021. Meanwhile, Locke Lord and Skadden, Arps, Slate, Meagher & Flom increased representation from 2020 to 2021 and Butler Snow’s representation stayed the same year-over-year.
AbbVie and Allergan
Pharmaceutical company AbbVie, whose products include Humira, Vraylar and Botox, has been involved in 172 filings during this time period of which it is the defendant in 95% of instances. There were noticeable spikes in litigation in July and November 2020 as well as August 2021. However, in comparison to other pharmaceutical companies, the litigation that AbbVie is involved in has been minimal.
Subsidiary Allergan, which it bought in May 2020 for $63 billion, is facing MDL litigation over its recalled BIOCELL breast implants after new FDA information revealed the “uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL),” a form of non-Hodgkin’s lymphoma. In June 2020, the FDA required Allergan to recall BIOCELL breast implants. The spike of litigation in July 2020 is likely a result of the timing of this FDA announcement, however, filings in the MDL are ongoing.
AbbVie and Allergan were sued in December 2020 for antitrust violations by CVS and Rite Aid. The lawsuit claims that defendants AbbVie and Allergan “delayed market entry of generic versions of the drug Bystolic, a beta blocker used to treat high blood pressure.” There were similar lawsuits filed in July and November 2020. In August 2021, litigation included prescription opioid-related filings and BIOCELL breast implant – related filings.
Squire Patton Boggs as well as Reed Smith and Butler Snow have represented AbbVie in both 2020 and 2021. White & Case represented AbbVie the most in 2020, but did not represent the pharmaceutical company in 2021. Finnegan, Henderson, Farabow, Garrett & Dunner as well as Ulmer & Berne and Latham & Watkins represented the company in 2021, after not doing so the year prior.
AbbVie’s subsidiary Allergan is the defendant in 99% of its litigation, consisting of 1,495 filings over the past two years. Similarly, Allergan had a large increase in litigation in July 2020 relating to the BIOCELL breast implant recall, but it also included prescription opioid – related filings.
Various Merck entities faced more than 1,000 lawsuits, specifically, Merck & Co. Inc. doing business as Merck, Sharp & Dohme was involved in 1,904 lawsuits.
The majority of these lawsuits were filed in the Eastern District of Pennsylvania. The top case types are healthcare/pharmaceutical personal injury product liability with almost 900 cases. Merck’s litigation peaked in March 2020, driven by the ongoing multidistrict case about the Zostavax shingles vaccine. Merck was also sued for proton-pump inhibitor product liability.
Merck is primarily represented by Venable for both 2020 and 2021, but also by McCarter & English; Williams & Connolly; Jones Day; and Morgan, Lewis & Bockius. Meanwhile, Gibbons, Ice Miller and Gibley & McWilliams only represented in 2020 and Hughes Hubbard & Reed as well as Ashby & Geddes only represented in 2021. Law firms representing multiple Merck entities include: Venable; McCarter & English; Morgan, Lewis & Bockius; and Hughes Hubbard & Reed.
Pharmaceutical company Eli Lilly is known for drugs like Trulicity, Humalog and Prozac. Over the past two years, it has been involved in 66 lawsuits, drastically less than some of the other analyzed pharmaceutical companies. The top three courts for its litigation are the Northern District of California, the Southern District of Indiana and the Eastern District of New York. Most of its cases were healthcare/pharmaceutical personal injury product liability, but also civil rights – jobs, product liability, statutory and patent case types, among others.
Eli Lilly is primarily the defendant in its litigation. Lawsuits peaked in September 2021. It was sued over DES, a synthetic estrogen used in the mid 1900s, which is now thought to be a potential carcinogen; plaintiffs often sued for being exposed to it in utero. The company sued the Department of Health and Human Services and the Health Resources Administration claiming that the government overstepped its authority to rule over drug prices, in relation to a program expanding affordable prescription medicine. Additionally, Eli Lilly has been sued for employment discrimination and patent-related filings.
Eli Lilly has a variety of firms representing the company in 2020 and 2021. Specifically, Covington & Burling represented Eli Lilly in both years, although its representation decreased in 2021, contrarily, Kirkland & Ellis also represented in both years, but its representation in 2021 increased from 2020. Meanwhile, Faegre Drinker Biddle & Reath; Troutman Pepper Hamilton Sanders; Nelson Mullins Riley & Scarborough; and Barnes & Thornburg also represented the company in both years. However, Reed Smith only represented Eli Lilly in 2020 and Ford & Harrison as well as Bryan Cave Leighton Paisner only represented the pharmaceutical company in 2021.
Many big pharma companies have faced sprawling MDL cases concerning product liability, leading to big numbers when it comes to litigation volume. MDLs drove large spikes in new case filings from month to month, for these companies, while other spikes were driven by unrelated issues like opioids or a new FDA recall.
The complex nature of the industry and the disputes core to litigation means that the lawsuits can last for years, well beyond the issuance of an initial FDA or self-initiated recall. These long litigation timelines can drive business for the law firms that handle the complex legal work, but the same trends raise the stakes for the pharmaceutical clients that produce the treatments in question.