Roche has been on a legal roller coaster with its acne drug Accutane. Facing thousands of claims that the drug triggers inflammatory bowel disease, the Swiss drugmaker is now enjoying a high point, as an appeals court reversed a $25 million verdict against the company.

In a lawsuit over a patient who developed Crohn’s disease while taking the drug, a New Jersey appeals court ruled that the plaintiff, Andrew McCarrell, did not file his suit in time and that a lower court mistakenly applied New Jersey state law, rather than the law in McCarrell’s home state of Alabama, the New Jersey Law Journal reports. The court used a precedent laid out in a 2012 Supreme Court ruling in favor of Johnson & Johnson, which dismissed a suit over a faulty stent after finding that lower courts applied the wrong state law.

This is not the first time the court has overturned a verdict over McCarrell’s Accutane claims. In 2007, a court awarded McCarrell $2.7 million, but the drugmaker ultimately got the verdict reversed, based on an issue with evidence. McCarrell won the $25 million verdict after a 2010 retrial.The appeals court decision is “very disappointing,” David Buchanan, McCarrell’s lawyer, told the NJLJ. McCarrell has fought Roche for 12 years over “permanent and devastating injuries” he got from using Accutane,

Sep 19 2011

Judge Upholds $25M Award in Accutane Bowel Disease Lawsuit

Accutane

New Jersey judge has rejected Roche’s request for a new trial or reduction of a jury’s award of more than $25 million in damages for a man who developed severe inflammatory bowel disease from Accutane.

In an order issued last week, Judge Carol Higbee denied Roche’s request for a new trial or remittitur in a case brought by Andrew McCarrell, which was one of the first Accutane lawsuits in the United States to reach a jury.

McCarrell’s Accutane bowel disease suit was originally filed in 2003 and first went to trial in April 2007, resulting in a jury award of $2,619,000. However, following an appeal the verdict was overturned and the case was remanded for a new trial so that Roche would be permitted to introduce evidence on the total number of Accutane uses.

Following a second trial in January 2010, another New Jersey state court jury awarded McCarrell $159,540.19 to cover his medical bills and another $25 million in compensation for pain and suffering damages caused by Accutane.

Apr 8 2011

Hagens Berman Applauds $2 Million Verdict in Accutane Lawsuit

Accutane

Hagens Berman LLP, a nationally recognized law firm today praised a jury’s verdict that ordered pharmaceutical company Roche to pay $2 million to a woman who suffered serious gastrointestinal damage caused by the drug Accutane, while denying similar claims of actor James Marshall and another plaintiff.

Accutane, along with its active ingredient, isotretinoin, was approved by the Food and Drug Administration in 1982 to treat severe acne and became one of the biggest selling drugs for Roche with more than 16 million users. However, the drug’s success has also been tainted by a history of more than 20 product-labeling modifications, FDA warning letters and litigation.

The woman, Gillian Gaghan, took the drug and developed serious complications, including ulcerative colitis and lupus-like symptoms, and has lost nighttime bowel control, court records show.

The seven-person jury concluded that the Swiss drug giant did not warn Gaghan of the risks associated with taking the drug, which led to her developing the ulcerative colitis.

May 11 2010

Settlement of Accutane Lawsuit Reached Prior to Trial

Accutane

A man who claimed that he developed severe bowel problems from Accutane, an acne medication, has reached a pre-trial settlement with Roche Laboratories, the drug’s manufacturer.

Roche has asked Madison County Circuit Judge David Hylla to approve the Accutane settlement, according to a report in The Madison Record. The case, which was brought by plaintiff Jason Peipert, also involves a medical malpractice claim against an Illinois doctor, who may also be in settlement talks with the plaintiff.

Peipert alleges that Dr. Daniel Goran prescribed him Accutane to treat his acne, and that the drug caused him to develop the debilitating condition, inflammatory bowel disease (IBD). The case was set to go to trial on April 19, but start of the trial was delayed due the potential settlement with Accutane manufacturers.

Roche faces nearly 1,000 Accutane lawsuits, which involve allegations that the drug maker failed to adequately warn users about potential side effects of Accutane. The company has lost all six Accutane bowel disease trials that have reached a jury so far, with verdicts totalling $56 million.

The largest judgment so far was awarded to Andrew McCarrell, of Alambama, who received $25.16 million in compensation by a New Jersey jury in an Accutane trial earlier this year.

Jul 8 2009

Acne Drug Accutane No Longer Sold

Accutane

Accutane won’t be sold any more, drug giant Hoffmann-La Roche Inc. has announced.

Generic versions of the acne drug, called isotretinoin, are still available from several manufacturers. But Roche, which has sold the drug to 13 million patients since 1982, will not be one of them.

The decision was made for “business reasons,” Roche announced in a news release. Those reasons include declining sales: Accutane sales now make up less than 5% of the isotretinoin market.

Another big reason: Accutane personal injury lawsuits, which Roche is aggressively defending.

Accutane and other isotretinoin products are effective treatments for serious acne. But the drug can have extremely serious side effects: mental health problems — including depression, psychosis, and suicide — and, when taken by pregnant women, miscarriage or birth defects.

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