Thousands of people who suffered severe side effects of Accutane have filed lawsuits against Hoffman-LaRoche. They claimed the drugmaker did not warn them about the dangers of the medication, which include depression, suicide, ulcerative colitis and Crohn’s Disease.
The bulk of litigation against Hoffman-LaRoche dealt with Crohn’s disease and ulcerative colitis. Historically, Accutane litigation has favored the manufacturer. Judges dismissed the majority of lawsuits and overturned jury verdicts that had awarded millions of dollars to plaintiffs.
While an appellate court reinstated lawsuits filed in state court in New Jersey in 2017, the state’s high court dismissed more than 500 suits on Oct. 3, 2018.
There have been no known class actions or large-scale settlements for patients injured by the acne medication.
History of Accutane Litigation
At one time, close to 8,000 lawsuits against the makers of Accutane were pending in courts across the country. Judges consolidated many of these into federal cases into a federal multidistrict litigation in the Middle District of Florida under MDL No. 1626.
U.S. District Judge James Moody ultimately dismissed all the federal Accutane cases. He ruled that the warning label on the drug was adequate. The MDL dissolved in 2015, and this effectively put an end to federal lawsuits against the manufacturer.
After the MDL dissolved, most of the remaining Accutane cases continued in multicounty litigation in New Jersey in MCL No. 271. At first, juries ordered Hoffman-LaRoche to pay millions to patients, but judges overturned those verdicts.
After an appellate court in 2017 reinstated more than 2,000 cases that had been dismissed by the New Jersey MCL judge two years earlier, Hoffman-LaRoche appealed the reinstatements. The state Supreme Court agreed to consider the drug company’s appeals.
On Aug. 1, 2018, the New Jersey Supreme Court ruled that two plaintiff’s expert witnesses would not be allowed to testify. This made litigating the few remaining Accutane cases difficult since the experts’ testimony connected the drug to inflammatory bowel disease and Crohn’s.
Two months later, the New Jersey Supreme Court dismissed 532 failure-to-warn cases.
“As a matter of law, the warnings provided physicians with adequate information to warn their patients of the risks of IBD,” the judges said in their October 2018 decision.
Suicide, IBD and Other Injuries Related to Accutane
While some people who sued Hoffman-LaRoche blamed Accutane for psychosis, depression and suicide, the majority of lawsuits claimed the drug caused inflammatory bowel disease (IBD). IBD is a condition that involves chronic inflammation of the gastrointestinal tract. IBD usually manifests in one of two diseases: ulcerative colitis or Crohn’s disease. IBD is a permanent condition.
Accutane lawsuits said the drug is “defective” and “dangerous to human health, unfit and unsuitable to be marketed and sold in commerce.”
Accusing Hoffmann-LaRoche of having knowledge of the link between gastrointestinal symptoms and the acne medication, plaintiffs claimed the drug “lacked proper warnings as to the dangers associated with its use.”
“Since 1984, there have been suggestions that Accutane might be linked to various forms of inflammatory bowel disease, including Crohn’s disease. Despite numerous studies on the subject, no such linkage has been found — at least not with substantial reliability.”
Before the FDA approved Accutane in 1982, it raised concerns about these issues. Despite this, Hoffmann-LaRoche did not include any warnings about the risk of IBD, lawsuits claim.
But the manufacturer argued that there is no reliable evidence linking the drug to IBD or Crohn’s disease. Hoffman-LaRoche maintained they had given ample warning to patients about potential side effects.
The American Medical Association also supported the manufacturer against what it called “abusive litigation against physicians.”
Judges Overturn Verdicts Awarding $53 Million
Before judges overturned their verdicts, juries had ordered Hoffmann-LaRoche to pay more than $53 million to plaintiffs.
Andrew McCarrell won the first major Accutane verdict in 2007. Juries awarded him $2.7 million after he claimed the drug led him to develop IBD. McCarrell’s lawsuit said doctors had to remove his colon and rectum and he continues to suffer from incontinence.
Hoffman-LaRoche appealed that verdict, and judges ordered a new trial. After the second trial, the jury awarded McCarrell $25 million in 2010. But in 2017, the verdict was overturned yet again.
In 2002, Julia Bishop filed a lawsuit against Hoffmann-LaRoche. Her 15-year-old son, Charles Bishop, had crashed a Cessna into the 28th floor of the Bank of America Building in Tampa, Florida, just weeks after the 9/11 attacks. Bishop claimed Accutane caused her son to commit suicide. She demanded $70 million from Hoffmann-LaRoche, The Tampa Tribune reported. Five years later, Bishop withdrew her lawsuit. Her attorneys said she was emotionally and physically unable to continue due to personal attacks by the drugmaker.
Carla Gray of Ada, Oklahoma, took her Accutane depression case to trial in 2002. She asked for $3 million because the drug company failed to warn about depression. A jury denied her claim.
Kathleen Rossitto and Riley Wilkinson
Kathleen Rossitto and Riley Wilkinson won their lawsuits in June 2012. Rossitto and Wilkinson claimed Accutane caused them to develop inflammatory bowel disease. A New Jersey court ordered Hoffmann-LaRoche to pay $18 million in compensatory damages. The women were to receive $9 million each. Hoffmann-LaRoche appealed. The appellate court granted the manufacturer's appeal. It found that the trial court judge “seriously erred" when it allowed some revelations in court while restricting others. FiercePharma reported on this ruling in 2016.
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