Drug Distributors and Medical Device Makers Increasingly Targeted in Lawsuits

The number of product liability lawsuits continues to rise, with pharmaceutical and medical device manufacturers among the targets of many of these filings. According to a Lex Machina® report on federal product liability litigation trends, pharmaceutical and medical device manufacturers faced 2,011 filings in 2019, down slightly from 2018 but far above the average since 2010 and greater than the number of lawsuits in the aircraft, vehicles and asbestos categories.

Given the concentration of pharma and medical device litigation, let’s take a look at ongoing issues and cases in four key categories.

Opioid Litigation

As widespread opioid addiction became a public health emergency, about 3,000 municipalities, counties, states and American Indian tribes sued pharmaceutical manufacturers, distributors and pharmacies.

A bellwether trial is scheduled for October 2020 in federal court in West Virginia, and another in November in Northern Ohio—part of national multidistrict opioid litigation against drug distributors McKesson, Cardinal and AmerisourceBergen. The governments of Huntington and Cabell County, West Virginia, claim that drug distributors McKesson Corp., AmerisourceBergen Drug Corp. and Cardinal Health Inc. helped fuel the opioid crisis through distribution practices that allowed diversion and suspect orders.

One case so far has gone to trial, resulting in a $465 million decision in Oklahoma against manufacturer Johnson & Johnson, significantly less than the requested $17 billion. Facing lawsuits from thousands of hospitals, cities, counties, states and other plaintiffs seeking to hold companies accountable for an epidemic of addiction to prescription narcotics, OxyContin maker Purdue Pharma filed for bankruptcy protection in 2019, seeking to implement a multibillion-dollar settlement plan.

Other cases have settled for smaller amounts, and settlement talks are underway in a number of cases, but most cases have yet to be resolved.

Zantac

The Food and Drug Administration requested drug manufacturers to remove Zantac and generic versions of the widely prescribed heartburn drug from the U.S. market in April due to concerns that they contained nitrosodimethylamine, a suspected carcinogen. In a multidistrict lawsuit in the Southern District of Florida, Sanofi, Pfizer Inc., Boehringer Ingelheim Pharmaceuticals Inc. and GlaxoSmithKline LLC, as well as manufacturers of the generic version of the drug, retailers, distributors and active pharmaceutical ingredient makers, face claims of false advertising, failure to warn, and other claims related to NDMA.

Pelvic Mesh

Transvaginal/pelvic mesh litigation is one of the largest mass torts in U.S. history. At one time, the pelvic mesh multidistrict litigation centralized in 2012 in Charleston, West Virginia, had more than 107,000 cases against seven manufacturers, including Boston Scientific, American Medical Systems and Johnson & Johnson’s Ethicon subsidiary. It ended up being the second-largest MDL behind asbestos and has yielded nearly $8 billion to date in settlements and verdicts.

The MDL involving women claiming that they suffered serious injury from surgical mesh used to treat pelvic organ prolapse and urinary incontinence has closed to new cases, but plaintiffs continue to file lawsuits related to the medical devices in the states where they reside or where the manufacturers are based. The FDA ordered manufacturers to withdraw these products from the U.S. market in April 2019.

3M Combat Arms Earplugs

In an MDL, more than 140,000 military members allege in the Northern District of Florida that 3M’s Combat Arms military earplugs were defectively designed and manufactured, causing damage to the inner ear and causing wearers to develop tinnitus and suffer permanent hearing loss. In 2018, 3M had agreed to pay $9.1 million to settle a whistleblower False Claims Act suit accusing it of selling the defective earplugs to the military, knowing that they were too short to be properly inserted into users’ ears. The company didn’t admit liability.

These lawsuits and an increasing number of other cases involving drugs and medical devices highlight potentially serious injuries that users can suffer and the legal exposure that medical companies, pharmaceutical makers and distributors, and other manufacturers face when plaintiffs raise defective product claims in litigation.