Accutane expert Dr. David Sachar has published over 220 articles on inflammatory bowel disease (IBD), ulcerative colitis, and Crohn’s disease.  A Professor of Medicine at Mount Sinai School of Medicine and former chairman of the FDA advisory committee on gastroenterology, he is board-certified in internal medicine and has specialized in IBD, Crohn’s disease, and ulcerative colitis for thirty years.

In McCarrell v. Hoffman-La Roche, Inc., a case involving Accutane ulcerative colitis, Dr. Sachar testified that, to a degree of medical probability and certainty, the prescription drug Accutane was responsible for the plaintiff’s Crohn’s disease, originally diagnosed as Accutane ulcerative colitis.  After unsuccessfully attempting to bar Dr. Sachar’s testimony, the manufacturers of Accutane appealed to the New Jersey Superior Court.

Dr. Sachar’s Findings Regarding Accutane Ulcerative Colitis and IBD

Accutane is designed to clear up serious acne by targeting epithelial cells and inhibiting their growth.  Unfortunately, Accutane is toxic to more than the cells that cause acne.  Dr. Sachar suggests that Accutane also disrupts the mucous lining of the intestines.  The intestines become inflamed as a result, and some individuals develop either Accutane ulcerative colitis or Crohn’s disease.

Accutane ulcerative colitis and Crohn’s disease are both manifestations of inflammatory bowel disease.   The difference between Accutane ulcerative colitis and Crohn’s disease is that while Crone’s disease affects the entire digestive tract, the effects of Accutane ulcerative colitis are limited to the colon.

Expert’s Conclusion On Accutane Ulcertaive Colitis Drawn from Varied Sources

Although he consulted medical journals, individual accounts, and the plaintiff’s own medical history, much of Dr. Sachar’s opinion comes from the studies that Roche, the manufacturer of Accutane, performed itself. As required by the FDA, Roche performed trials on animals before putting Accutane on the market.  In one study, the dogs that Roche dosed with Accutane suffered gastrointestinal bleeding.  Accutane’s manufacturer failed to follow up on evidence that the drug may cause Accutane ulcerative colitis and Crohn’s disease, it’s though their own researchers issued internal memoranda recommending more study on the matter. 

In a human trial conducted by the manufacturers of Accutane, 21.6% of the patients reported gastrointestinal side effects, primarily because of an adverse impact on mucous membranes, which could cause Accutane ulcerative colitis.  The makers of Accutane also failed to act when subsequent reports by Accutane users suggested that the drug caused their Crohn’s disease and ulcerative colitis.

Dr. Sachar also considered “challenge/dechallenge/rechallenge”? events recorded by MedWatch.  A “challenge”? occurs when a patient shows symptoms of a possible side effect while taking a drug.  If the symptoms disappear when the patient is taken off the medication, that is a “dechallenge.”?  Finally, if the symptoms return when the drug is introduced, it is a “challenge/dechallenge/rechallenge”? event, and very strong evidence that the medication is the cause of the illness.  This event occurred several times with sufferers of Accutane ulcerative colitis and Crohn’s disease.

Superior Court Agrees that Doctor’s Opinion Regarding Accutane Ulcerative Colitis is Well Founded

Dr. Sachar concluded that Accutane’s manufacturer “as a matter of policy, chose to minimize and downplay this risk and, as a matter of policy, deliberately inhibited the dissemination of this concern to the profession and the public.” Although it ordered a new trial for an unrelated evidentiary reason, the New Jersey Superior Court upheld the trial court’s ruling that Dr. Sachar is “one of the premier experts in the field of IDB,” that he used data generally followed by experts in the field, and that his opinions were based on proper scientific methodology. Thus, Dr. Sachar’s conclusion that the drug causes ulcerative colitis has merit.

Accutane Ulcerative Colitis and Crohn’s Disease Lawsuits

Hundreds of Accutane users diagnosed with Accutane ulcerative colitis or Crohn’s disease have filed lawsuits against Accutane’s manufacturer.  The plaintiffs suffering from Accutane ulcerative colitis allege that Accutane caused their illnesses.

If you or a loved one has used Accutane and developed Accutane ulcerative colitis or Crohn’s disease, please contact us today.  You may be entitled to compensation.

Published November 17, 2011 by