Roche sold Accutane for 27 years knowing it caused colitis — 7,000 lawsuits, then it quit

Accutane (isotretinoin) was Roche's blockbuster treatment for severe cystic acne, approved by the FDA in 1982. It was phenomenally effective — the only drug that could clear the most disfiguring cases of acne. But it came with devastating side effects. In pregnant women, it caused severe birth defects in 20–35% of exposed fetuses. And in a significant number of patients, it triggered inflammatory bowel disease — ulcerative colitis that required colectomy surgery and lifelong ostomy bags. Roche knew about these risks from early clinical trials but continued marketing the drug aggressively.

By the mid-2000s, Roche faced a tidal wave of litigation. Over 7,000 patients sued, alleging Roche had known about Accutane's IBD risks and failed to warn them. Jury verdicts came in against Roche — $2.6 million in 2007, $10.5 million in 2008, $25.16 million in 2010, $18 million in 2012. Most were later overturned or reduced on appeal, but the flood of cases never stopped. The litigation costs mounted, even as Accutane's market share fell to generics after its 2002 patent expiry.

In June 2009, Roche announced it was discontinuing Accutane, citing 'falling market share and rising costs from personal injury lawsuits.' The drug remained available as generic isotretinoin. Roche had sold Accutane for 27 years, generating billions in revenue while knowing it could cause lifelong intestinal damage. The lawsuits cost Roche tens of millions in verdicts and far more in defense costs, and the reputational damage was lasting. The case stands as a textbook example of a drug company prioritizing profit over patient safety until litigation made continued sales untenable.