Accutane is a prescription medication used to treat severe cases of acne, a common skin ailment. Hoffmann-La Roche, Inc. (“Roche”) manufactures the medicine in the United States, and it was approved by the United States Food and Drug Administration (FDA) in 1982.
Accutane has long been recognized to cause birth abnormalities when used by pregnant women. Others contend that Accutane is a dangerous medicine that has resulted in depression and suicidal conduct.
Accutane has been connected to several side effects. One such concern, as previously indicated, is the chance of birth abnormalities. Despite a warning label on Accutane, birth abnormalities were caused by the medicine. Some of the risks associated with congenital disabilities include:
Roche has taken precautions to prevent pregnancies while taking Accutane, but women who took the medication nevertheless became pregnant, prompting the FDA to urge Roche to make additional labeling revisions.
Many lawsuits have been brought, alleging that Accutane use caused depression or suicidal behavior in certain patients. Numerous complaints have been filed with the FDA, associating Accutane with depression, suicidal ideation (thoughts of suicide), and suicide attempts. However, there has been no conclusive scientific evidence linking Accutane to depression.
Approximately 8,000 cases against the makers of Accutane were ongoing in courts across the country at one time. Many of these federal lawsuits were consolidated by judges into MDL No. 1626, a federal multidistrict litigation in the Middle District of Florida.
U.S. District Judge James Moody eventually dismissed all federal Accutane lawsuits. He determined that the drug’s warning label was acceptable. The MDL was disbanded in 2015, thus ending federal proceedings against the business.
Following the dissolution of the MDL, most of the remaining Accutane cases were resolved in multicounty litigation in New Jersey under MCL No. 271. Initially, juries ordered Roche to pay millions of dollars to patients, but judges reversed those decisions.
Roche filed an appeal after an appellate court reinstated more than 2,000 cases that had been rejected by a New Jersey MCL judge two years earlier. The state Supreme Court agreed to hear the pharmaceutical company’s challenges.
The New Jersey Supreme Court determined on August 1, 2018, that two plaintiff’s expert witnesses would not be allowed to testify. Due to the experts’ testimony linking the medicine to inflammatory bowel illness and Crohn’s disease, litigating the few remaining Accutane cases became challenging.
The New Jersey Supreme Court dismissed 532 failure-to-warn claims two months later. “As a matter of law,” the justices wrote in their October 2018 ruling, “the warnings supplied physicians with appropriate information to warn their patients of the dangers of IBD.”
While some of those who filed claims against Roche blamed Accutane for psychosis, despair, and suicide, most claimed the medicine caused inflammatory bowel disease (IBD). IBD is a gastrointestinal disorder characterized by chronic inflammation. IBD often appears as either ulcerative colitis or Crohn’s disease. IBD is a chronic illness.
Accutane complaints claimed the medicine is “defective” and “hazardous to human health, unfit and unsuitable for commercial marketing and sale.”
Plaintiffs claimed the drug “lacked sufficient warnings as to the dangers linked with its usage,” accusing Roche of knowing about the link between gastrointestinal issues and the acne medication:
“There has been speculation since 1984 that Accutane may be associated with several forms of inflammatory bowel disease, including Crohn’s disease.”No such correlation has been discovered despite research – at least not with significant reliability.”
Concerns were expressed regarding these issues before the FDA authorized Accutane in 1982. Despite this, plaintiffs claim that Roche did not include any warnings concerning the risk of IBD.
On the other hand, the manufacturer said there is no convincing data linking the medicine to IBD or Crohn’s disease. Roche insisted that they had provided patients with adequate information about potential negative effects.
The American Medical Association also backed the manufacturer’s fight against “abusive litigation against physicians.”
Before the justices overturned their findings, juries had ordered Roche to pay the plaintiffs more than $53 million.
In 2007, Andrew McCarrell obtained the first big Accutane verdict. After claiming that the medicine caused him to acquire IBD, jurors awarded him $2.7 million. According to McCarrell’s claim, physicians had to remove his colon and rectum, and he still suffers from incontinence.
Roche filed an appeal, and the judges ordered a fresh trial. In 2010, the jury awarded McCarrell $25 million after the second trial. However, the verdict was overturned once more in 2017.
Julia Bishop filed a case against Roche in 2002. Just weeks after the 9/11 attacks, her 15-year-old son, Charles Bishop, crashed a Cessna into the 28th floor of the Bank of America
Building in Tampa, Florida. Bishop said Accutane was to blame for her son’s suicide. According to The Tampa Tribune, she requested $70 million from Roche. Bishop dropped her claim five years later. Her counsel stated that she was emotionally and physically unable to continue owing to the drugmaker’s insults.
Carla Gray of Ada, Oklahoma, went to trial in 2002 for her Accutane depression case. She requested $3 million in damages because the medicine firm neglected to warn about depression. A jury rejected her claim.
Kathleen Rossitto and Riley Wilkinson were successful in their claims in June 2012. According to Rossitto and Wilkinson, Accutane led them to develop inflammatory bowel illness. Roche was ordered by a New Jersey court to pay $18 million in compensatory damages.
Each of the women was to earn $9 million. Roche filed an appeal. The appellate court approved the manufacturer’s appeal. It concluded that the trial court judge “seriously erred” in allowing certain revelations in court while banning others. FiercePharma covered this decision in 2016.
Accutane was first released in 1982 and has become the gold standard for treating severe inflammatory acne. Because of the speed with which results can be noticed, it has become the most preferred treatment option.
Given the hazards, however, a medicine other than Accutane would have been a preferable choice for many individuals.
There are Accutane alternatives that are successful in treating severe inflammatory acne. Benzoyl peroxide, antibiotics, and hormone therapy are among them. They are not as rapidly acting as Accutane but do not carry the same life-altering hazards.
Medical research has shown the link between Accutane medication and the development of serious adverse effects. These have caused Roche Pharmaceuticals, the company that manufactures Accutane, to initiate an Accutane withdrawal/recall.
Thousands of lawsuits have been brought and are now being resolved because Accutane use causes significant medical issues that impair a person’s quality of life.
Suicide risk, seizures, bone degeneration, heart attacks, and strokes are among the medical issues. Most of these lawsuits address significant side effects, such as Crohn’s disease and Ulcerative Colitis, which affect the digestive tract.
It can be difficult to get damages for Accutane-related injuries. An expert class action lawyer can assist you in completing the necessary papers and filing a lawsuit on your behalf.
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