Roche Ordered to Pay $25 Million to Accutane User

The following article was written by By David Voreacos and John Martin

Feb. 16 (Bloomberg) — Roche Holding AG, the Swiss drugmaker, must pay $25.16 million in damages to a former user of its Accutane drug who blamed the acne medicine for his inflammatory bowel disease, a New Jersey jury ruled.

Andrew McCarrell, 38, won the verdict today at a retrial in Atlantic City, New Jersey. An appeals court ordered the new trial after overturning a $2.62 million award he won in May 2007. McCarrell, a computer technician from Birmingham, Alabama, testified he got sick after taking the drug for acne in 1995. He needed five surgeries, including one to remove his colon.

“I never thought it would be like this,” McCarrell said after the verdict in state Superior Court. “Never in my wildest dreams.”

The verdict today was the largest of six for Accutane users who won awards totaling $56 million. Roche lost every case, although a Florida appeals court overturned one of those judgments for $7.2 million. In each case, plaintiffs claimed Roche failed to warn adequately of the risks.

Roche stopped selling the drug in June 2009, citing generic competition and the high cost of defending personal injury lawsuits. Roche faces almost 1,000 other lawsuits over Accutane.

Birth Defects

More than 13 million people took Accutane after it was introduced in 1982. The drug also has been associated with birth defects and depression. Accutane was made by Roche unit Hoffmann-LaRoche Inc. of Nutley, New Jersey.

In a statement, the company said it would appeal, as it has in all the other cases.

“Our sympathies remain with Andrew McCarrell over his disease,” Roche said in a statement. “Both the finding and the amount of damages were unsupported by the evidence. Roche acted appropriately in providing information about Accutane, including a direct warning about inflammatory bowel disease, to the medical, scientific and regulatory communities.”

The nine jurors deliberated for 3.5 hours today before ruling unanimously that McCarrell deserves $25 million in compensatory damages and $159,000 for past medical expenses. McCarrell claimed Roche violated New Jersey’s consumer fraud law.

‘Fair Amount’

Seven of the nine jurors agreed that Roche failed to provide an adequate warning, and that the company’s failure was a “proximate cause” of his inflammatory bowel disease.

“I think it’s a fair amount, I really do, considering all he’s been through these 15 years,” said juror Dorrine Simms.

Juror Vince Packer said, “It was all about the wording on the label. It didn’t give a clear-cut explanation as to what you can get by taking this drug. That’s my issue — was it properly labeled?”

McCarrell attorney Michael Hook represents plaintiffs in hundreds of other Accutane cases. McCarrell gasped and hugged Hook after the jury foreman announced the award.

“Every single one of these cases could be like this,” Hook said outside the courtroom.

READ MORE

Acne is a painful enough problem for any young individual to deal with.But now there is evidence that antibiotics frequently prescribed by doctors for helping manage serious acne problems might, in a really small quantity of patients, result in inflammatory bowel disease.

Bowel disorders connected to acne treatment are “a rare outcome,” cautioned Dr. David Margolis, a dermatologist and lead author of a study in the American Journal of Gastroenterology.

Nevertheless, prior studies have indicated that the acne drug isotretinoin, identified generally by the brand name Accutane, may be the reason for inflammatory bowel disease in a small number of patients being treated for severe acne problems.

Noting that most people given isotretinoin have already been taking antibiotics for months, if not years, Margolis and colleagues at the University of Pennsylvania wanted to know if antibiotics might play a role in triggering the bowel condition.

As much as 90 percent of teenagers and young adults battle acne problems at some point.Drugs from the tetracycline family are the most commonly prescribed antibiotics for the treatment of severe acne.

“They limit scarring and the outbreak of pimples. They’re exceedingly effective and have been used for years,” Margolis said.

The researchers looked at the medical records of more than 94,000 British teenagers and young adults diagnosed with acne between 1998 and 2006.

They found that long-term use of antibiotics appeared to double the risk of developing inflammatory bowel disease in these subjects.Of the 207 cases of inflammatory bowel disease diagnosed among the 94,487 patients in the study, 152 (.26 percent of all subjects) were taking one of three commonly prescribed tetracycline-based antibiotics and 55 (.14 percent) were not.

Patients taking one of the three drugs, doxycycline, appeared to be at a slightly higher risk (.21 percent) of developing an inflammatory bowel disease compared to patients taking minocycline (.17 percent risk) or tetracycline (.20 percent risk).

You can read the entire article at www.worldbreakingnews.com

Accutane comes under the prescription forms and under the following names: Amnesteem, Claravis, Decutan, Istane, Sotret, Ratane, Raccutane, and the generic Isotretinoin. The original use for Accutane was to treat severe acne, but it has bean proven that dermatologists have prescribed the drug for mild cases of acne that should have never been prescribed because of the risks behind taking the drug.

Some of the leading side effects of those who have  taken the prescription drug Accutane are:

• Crohn’s Disease
• Inflammatory Bowel Disease
• Ulcerative Colitis

These are some of the most harmful side effects, however; there are many other severe side effects patients have suffered.

• Severe depression
• Suicidal thoughts
• Birth Defects
• Allergic Reaction Resulting in Liver Disease
• Liver Damage

Other side eddects of Accutane inclue:

• Loss of Hair
• Skin Dryness, Lips, Eyes, Nose
• Acne Breakouts
• Thinning of the skin tissue
• Headache
• Eczema
• Fatigue
• Muscle Pain
• Stomach Cramps

The prescription drug Accutane created by the drug company Roche had been known to cause a variety of dangerous side effects and has been recalled by the FDA.

These diseases can be very harmful and inconvenient for those individuals suffering.

A pre-trial settlement with Roche Laboratories, the drug manufacturer of the prescription drug Accutane, was reached with a man who claimed that he developed severe bowel problems after using the drug Accutane to treat acne.

The drug 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.

The drug manufacturer Roche has nearly 1,000 Accutane lawsuits ahead of them, which involve allegations that the drug maker failed to adequately warn users about the potential side effects of Accutane. Currently the company has lost all six Accutane bowel disease trials that have reached a jury thus far, with verdict totaling $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.

Details of this particular Accutane lawsuit settlement with Peipert have not been disclosed. However, it should go without saying that the terms of the agreement do not include an admission of guilt from the pharmaceutical giant Roche, and Peipert has reportedly agreed not to bring another case against Roche in the future.

Lawyers and Settlements

Study Links Acne to Suicidal Thoughts, an Accutane Side Effect
Lawyers and Settlements
Accutane side effects, such as depression, may make the problem worse. The study, which was funded by the Norwegian Institute of Public Health and published …
Acne impact more than skin deepNorthShoreOfLongIsland.com

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]]> http://www.sideeffectsofaccutane.net/side-effects/study-links-acne-to-suicidal-thoughts-an-accutane-side-effect-lawyers-and-settlements/feed/ 0 http://www.sideeffectsofaccutane.net/accutane-legal/new-study-may-deal-final-blow-to-acne-drug-accutane/ http://www.sideeffectsofaccutane.net/accutane-legal/new-study-may-deal-final-blow-to-acne-drug-accutane/#comments Sat, 07 Nov 2009 07:00:00 +0000 Los Angeles Times - Science http://2969611 According to the Los Angeles Times. The study bolstered evidence of a link between the drug, pulled from the market in June, and inflammatory bowel disease. No medication is as effective in treating severe cases of acne.

Teenagers and young adults suffering from severe, scarring acne may ultimately lose the most effective treatment for the condition.

According to the article:

FOR THE RECORD:
Accutane’s side effects: An article in Saturday’s Section A about the possibility of the acne drug isotretinoin, best known by the brand name Accutane, being taken off the market because of side effects misstated the results of a study that compared people with inflammatory bowel disease to people without the disease. The article said the study showed 1.2% of people diagnosed with inflammatory bowel disease had used isotretinoin before diagnosis, compared with 1.1% who had not used isotretinoin. Instead, the study showed that 1.2% of people with inflammatory bowel disease had used isotretinoin before diagnosis, compared with 1.1% of people in the healthy group who had used the drug and not developed the disease. —

(Source: Los Angeles Times – Science)

They go on to say that patients who used the medication were 1.68 times more likely to develop the disease, according to Seth Crockett, MD, of the University of North Carolina Chapel Hill, and colleagues who presented the findings at a poster session at the American College of Gatroenterology meeting there.

To read the article in its entirety go to medpagetoday.com

(Source: MedPage Today Gastroenterology)

Objective: To investigate the putative association between isotretinoin treatment and depressive symptoms or suicidal ideation among Finnish male military conscripts. Methods Consecutive acne patients were enrolled into an uncontrolled, prospective 12-week follow-up study conducted at the Central Military Hospital, Helsinki, Finland. Of the 135 patients prescribed isotretinoin, 126 (93.3%) completed the follow-up. Depression and suicidal ideation were investigated with the Beck Depression Inventory (BDI) at baseline, weeks 4-6, and weeks 10-12. Results BDI mean score was low at baseline and declined further significantly (p < 0.001) during the follow-up from 3.0 (SD 3.948) to 1.8 (SD 3.783) among patients on isotretinoin. Moreover, the proportion of patients with clinically significant depressive symptoms (BDI >/= 10) declined non-significantly from 7.1 % to 3.2 %. Suicidal ideation was reported by 17 (13.5 %) patients at baseline and 9 (7.1%) patients at the end of the follow-up (NS). During the follow-up, one non-depressed patient attempted suicide while intoxicated by alcohol. Conclusion On group level, isotretinoin seems not to be typically associated with treatment-emergent depression or suicidal ideation among young men. However, the possibility that individual patients may be susceptible for mood effects of isotretinoin as a rare idiosyncratic reaction can not be excluded. Conflicts of interest None declared.

(Source: SafetyLit: All (Unduplicated))