Accutane Recall Due To Safety Issues Or Declining Sales Or Lawsuit Losses Or Some Combination Of These Factors?
(Posted by Tom Lamb at DrugInjuryWatch.com)_____________________________________________________________________
Update: Accutane Retrial Verdict: Roche Ordered to Pay $25 Million to Accutane User
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....
On June 26, 2009 we learned from a Blooomberg news report, "Roche Pulls Accutane Off Market After Jury Verdicts", that Accutane will no longer be available to American patients:
Roche Holding AG, the world’s biggest maker of cancer drugs, is pulling its Accutane acne medicine from the U.S. market after juries awarded at least $33 million in damages to users who blamed the drug for bowel disease.
Roche notified the U.S. Food and Drug Administration today that it was withdrawing Accutane after a “reevaluation” of its product lines showed it faced serious challenges from generic competitors, company officials said in a statement.
“In addition, Roche has been faced with high costs from personal-injury lawsuits that the company continues to defend vigorously,” according to the statement.
About 13 million people have taken Accutane since it went on the market in 1982. The medication was Roche’s second-biggest selling drug before the patent expired in 2002 and rivals started selling generic versions. Roche’s prescription market share of the drug is now below 5 percent, the company said.
From the above information, the apparent reasons for this June 2009 Accutane recall are loss of market share and mounting personal injury lawsuits.
This brought to mind the Tequin recall by Bristol-Myers Squibb (BMS) in April 2006.
Here is an article from September 2009 regarding what the FDA had to say about how and (really) why BMS decided to remove its unsafe antibiotic Tequin from the U.S. market -- "FDA: Tequin Was Withdrawn From U.S. Market "For Reasons Of Safety Or Effectiveness" -- Recall That Bristol-Myers Had Said Decline In Sales Was Reason For Its Decision To Stop Selling Tequin" (emphasis added):
On September 2, 2008 the FDA issued a Notice entitled "Determination That TEQUIN (Gatifloxacin) Was Withdrawn From Sale for Reasons of Safety or Effectiveness" which provides (and confirms) the real reason that Bristol-Myers Squibb Co. (BMY) decided to pull Tequin from the U.S. market in the spring of 2006:
SUMMARY: The Food and Drug Administration (FDA) has determined that TEQUIN (gatifloxacin) Tablets, Injection, and Oral Suspension, were withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not accept or approve abbreviated new drug applications (ANDAs) for gatifloxacin oral tablets, injection, or oral suspension that refer to any previously approved dosage forms and strengths of TEQUIN (gatifloxacin).
As you may recall, in April 2006 when the news first broke that Bristol-Myers had decided to stop selling Tequin -- an antibiotic which was increasingly associated with potentially fatal blood-sugar problems -- the drug company said a continuing decline in Tequin sales was its reason for deciding to stop selling Tequin.
Returning to the June 26 Bloomberg article and its headline which implicates the Accutane lawsuit losses as being the primary reason for Roche deciding to pull Accutane, there have been some recent developments in the Accutane litigation.
In mid-June a New Jersey Superior Court judge ruled that Roche could not name new experts in the retrial of Andrew McCarrell v. Hoffman-La Roche Inc., et al.(No. ATL-L-1951-03-MT, N.J. Super., Atlantic Co.), a personal injury case where the plaintiff had alleged Accutane caused his inflammatory bowel disease (IBD). I defer to a March 13, 2009 post on the Drug and Device Law blog, "Accutane: McCarrell Remanded For New Trial", concerning the appeal of this Accutane jury verdict for the plaintiff.
A better result in June 2009 for Roche came from the federal court system's 11th Circuit Court of Appeals, which upheld a summary judgment in favor of the drug company in a case where it was alleged that Accutane caused the son of U.S. Rep. Bart Stupak, D-Mich., to commit suicide. The essential ruling reportedly there was that the plaintiff failed to produce evidence that Hoffman-La Roche Inc. knew or should have known that Accutane could cause suicide without premonitory symptoms (Laurie A. Stupak v. Hoffman-La Roche Inc., et al., No. 07-15980, 11th Cir.; 2009 U.S. App. LEXIS 12482).
We will watch to see if more information comes out in the future which will explain why Roche decided to remove Accutane from the market in June 2009.