Did you know this version of Internet Explorer is out of date?

To get the latest experience from our website, please upgrade your browser.

Have a drug or medical device concern?

call 888-646-1884

Accutane Lawsuit

The acne medication Accutane (isotretinoin) has a troubled history. It has been heavily regulated since its introduction in 1982 due to its strong causal relationship with birth defects, and has recently faced a spate of lawsuits related to other side effects.

Jump To Topic

In 2009, Roche ceased selling Accutane due to flagging sales, increased competition from generics, and the cost of fighting litigation.

Accutane Lawsuits and Compensation

In addition to birth defects, Accutane has a range of serious side effects including depression, inflammatory bowel disease (IBD), muscle pain, hearing impairment, and decreased night vision. The vast majority of Accutane lawsuits have been brought by users who experienced IBD (including Crohn’s disease and ulcerative colitis), alleging that the company failed to properly warn physicians and patients of side effects.

A small minority of lawsuits are related to Accutane’s possible connection with depression and suicidal thoughts and behavior.

Plaintiffs in Accutane lawsuits may be eligible for compensation for medical expenses, lost earnings (past and future), pain and suffering, loss of consortium (loss or degradation of family relationships, e.g. spousal relationships), and emotional distress, as well as punitive damages.

James Marshall and Colon Lawsuit

Actor James Marshall, best known for his roles as James Hurley in the cult TV series Twin Peaks and Private Louden Downey in A Few Good Men, suffered from Crohn’s disease and ultimately had his colon removed as a consequence.

Marshall sued Roche, alleging that use of Accutane caused the medical problems that derailed a once-promising acting career. Actors Martin Sheen and Brian Dennehy as well as director Rob Reiner testified on Marshall’s behalf. A jury, however, ruled against Marshall in 2011 due to a preexisting bowel condition.

At the end of 2012, Roche was fighting approximately 7,800 legal actions. Most lawsuits have been consolidated into multidistrict litigation in state court in New Jersey and federal court in Florida.

Other Accutane Rulings and Ongoing Lawsuits

Juries in New Jersey Superior Court have ruled in favor of the plaintiffs in nine out of thirteen cases that have reached a decision, awarding nearly $70 million, including $9 million each to Kathleen Rossitto and Riley Wilkinson in 2012. Roche has vigorously appealed rulings against it, and three decisions have been reversed or thrown out.

A New Jersey court awarded 38-year-old Accutane user Andrew McCarrell $25.16 million after he developed IBD and had his colon removed. That ruling came after a $2.6 million judgment in McCarrell’s favor was overturned on appeal.

At the end of 2012, Roche was fighting approximately 7,800 legal actions. Most lawsuits have been consolidated into multidistrict litigation in state court in New Jersey and federal court in Florida.

Acne Drug Labeling Changes and FDA Updates

Accutane has gone through a multitude of labeling changes due to the problems patients taking the drug have faced. In a December 11, 2002 statement, it was noted that it was evident from its approval in 1982 that a risk management program would be needed regarding the use of Accutane. 1 Initially, due to the drugs’ harmful effects in pregnancy, an Accutane Prevention of Pregnancy Program was put into action in 1989.

As things progressed, the need to educate patients became more important and in June of 1999, Congress made a ruling to include Medication Guides with certain prescriptions that are used to inform patients when a product poses any serious risks and significant public health concerns.

S.M.A.R.T. and iPledge Programs

In January of 2001, the Accutane medication guide was approved. Around the same time, patients and prescribers were being informed of possible adverse psychiatric events. Later that year, the S.M.A.R.T. (System to Manage Accutane Related Teratogenicity) program was set in place to replace the previous program. S.M.A.R.T included a number of practical tools to help patients, prescribers, and pharmacists manage the risk of birth defects.1

The FDA strengthened the risk management plan once again and approved the iPLEDGE program FDA for Accutane and generic isotretinoin on August 12, 2005. 2 That same year, the FDA alerted the public that it continued to assess the risks of suicidal thoughts and actions while taking Accutane. 3

On March 28, 2007, the FDA began to address the issues of buying certain medications online. Due to the risks involved with taking the drug without proper supervision, a website was launched warning people against buying Accutane and any generic versions online. 4

June 29, 2009, 5 a press release is issued by Roche noting that it will discontinue Accutane and delist Accutane in the U.S.
6
7
8
9
10
11
12
13
14
15

  1. U.S. Food and Drug Administration. Concerns Regarding Accutane (isotretinoin) [Internet] Revised July 24,2009 available at: http://www.fda.gov/NewsEvents/Testimony/ucm115126.htm, accessed: August 21,2013 

  2. U.S. Food and Drug Administration. iPLEDGE Information Revised October 22, 2010, available at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094307.htm, accessed August 21, 2013 

  3. U.S. Food and Drug Administration, Revised October 22, 2010, available at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094305.htm, accessed: August 21, 2013 

  4. U.S. Food and Drug Administration, FDA Launches Web Page Warning Against Buying Accutane And Its Generic Versions Online, Revised April 10, 2013, available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108876.htm, accessed on August 21, 2013 

  5. Roche Pharmaceuticals, Inc. ROCHE DISCONTINUES AND PLANS TO DELIST ACCUTANE IN THE U.S. revised June 29, 2009, available at http://www.rocheusa.com/portal/synergy/static/file/synergy/alfproxy/download/1414-cd2ddc12b4d211deadd62f6357bc6b3c/ accessed: August 20, 2013 

  6. Feeley, J. (2012, June 29). Roche ordered to pay $18 million to former Accutane users. Bloomberg News. Retrieved December 9, 2013 

  7. Edney, A. (2013, October 10). FDA examines advertising of acne, ADHD drugs to teenagers. Bloomberg News. Retrieved December 9, 2013 

  8. Amon, E. (2011, February 24). Kissel, Assange, Credit Suisse, Goldman, J&J in court news. Bloomberg News. Retrieved December 9, 2013 

  9. Feeley, J. (2010, August 5). Roche wins reversal of $10.5 million Accutane verdict in New Jersey case. Bloomberg News. Retrieved December 9, 2013 

  10. Voreacos, D. and Krueger, M. (2007, October 11). Roche must pay Accutane user $7 million for illness (Update2). Bloomberg News. Retrieved December 9, 2013 

  11. Voreacos, D. (2007, May 30). Roche found liable in first of 400 suits over Accutane. The Washington Post. Bloomberg News. Retrieved November 26, 2013 

  12. Hubbard, R. (2010, February 17). Birmingham-area man wins verdict against drugmaker over Accutane. Business News. Retrieved August 3, 2016 

  13. Feeley, J. (2011, March 11). Roche drug trial witness Dennehy says actor’s loss a ‘tragedy’. Bloomberg News. Retrieved August 3, 2016 

  14. Supreme Court of New Jersey. (2012, February 27). Kendall versus Hoffman La Roche Inc. 

  15. Roche Group. (2012, December 31). Roche Finance Report 2012.