Accutane

Accutane was manufactured by Hoffmann-LaRoche Inc. of Nutley, New Jersey and was originally developed as a chemotherapy drug for certain types of cancer. However, those involved in the development of the drug discovered that Accutane was also effective in the treatment of severe cystic acne.  Subsequently, in 1982, the FDA approved Accutane for this particular use in the United States.  The manufacturer marketed the drug so aggressively that it was prescribed even for common acne and it quickly became a leading form of acne treatment. Approximately 13 million people have ingested Accutane since it was approved.  The medication was one of Roche’s top selling drugs before the patent expired in 2002 and generic versions became available.  After years of scrutiny and eventual litigation for its serious side effects, Roche pulled Accutane from the market in June of 2009.   A Roche press release indicated the decision to withdraw Accutane from the U.S. market was made for economic reasons rather than safety reasons. The manufacturer cited the growing competition from generics and the high cost of product liability lawsuits.  To date, the generic equivalent of Accutane, isotretinoin, is still available by prescription in the U.S.

Long History of Accutane Controversy

Since its approval in 1982, Accutane has been linked to severe and even life-threatening side effects.  In the late 1980s, widespread reports of severe fetal abnormalities and miscarriages began to surface among pregnant women who had taken Accutane.  In 1988, the national consumer advocacy group Public Citizen petitioned the FDA for a ban on the drug due to concern about birth defects and other medical problems being reported. The FDA did not grant the petition or pull Accutane from the market.  Over the next two decades, Accutane was associated with a number of other serious adverse events including serious depression, suicidal ideations (with hundreds of suicides being reported to the FDA), kidney and liver problems, cardiovascular and musculoskeletal problems.  More recent studies indicate that Accutane may trigger the development of inflammatory bowel disease (IBD), including Crohn’s Disease and ulcerative colitis.

In 2004, a senior safety officer at the FDA referred to Accutane as "a 20-year regulatory failure" during a U.S. House subcommittee hearing.  The FDA finally launched the iPledge registry program in 2006. The program requires all Accutane patients sign a document informing them of the drug’s risks.  The iPledge system was a mandatory registry for doctors who prescribe Accutane, pharmacists who dispense the drug and patients who take it.  The iPledge program also contained a special requirement that women of childbearing age must use birth control pills while taking Accutane and undergo a mandatory pre-requisite pregnancy test as well as regular pregnancy tests before getting a new prescription filled, with the results of the pregnancy tests being entered into the iPledge database.

Accutane Lawsuits

Over the last few years, Roche has lost several trials and juries have ordered the company to pay more than $56 million in damages due to the inadequate warnings regarding the risks associated with the use of Accutane.  A brief synopsis of some of the trials is contained below:

• February of 2010 – Roche was ordered to pay $25.16 million in the re-trial of a case involving a 38 year-old Alabama man who developed inflammatory bowel disease and underwent five surgeries, including one to remove his colon.  Previously, in May of 2007, a jury awarded him $2.62 million but that verdict was overturned.
• November of 2008 – a New Jersey court ruled that Roche must pay $12.9 million in compensatory damages to three individuals who developed inflammatory bowel disease.
• April of 2008 – a New Jersey jury ordered Roche to pay $10.5 million to a Utah woman who developed ulcerative colitis.  However, this verdict was reversed on appeal in August of 2010.
• October of 2007 – a Florida jury awarded $7 million in damages to a 31 year-old male Accutane user who developed Crohn’s disease and later had his colon removed.
• May of 2007 – a Jury ordered Roche to pay $2.62 million to an Accutane patient who needed surgery to have his colon and most of his rectum removed and had to wear a colostomy bag for years after taking the medication for only four months.

Injured by Accutane?

Accutane has been the subject of controversy for years.  If you or a loved one took Accutane and have developed inflammatory bowel disease, Crohn’s Disease, or ulcerative colitis, please contact the law firm of Alley, Clark & Greiwe for important information regarding your legal rights.