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$25M Failure to Warn Verdict; Accutane Manufacturer, Distributor


A 24-year-old man was prescribed Accutane (isotretinoin), a prescription medication for the treatment of severe cases of acne. The warning label for Accutane included the risk of adverse side effects including potential gastrointestinal disorders. The man took daily doses of the medicine for four months.

 

Ten months after the man stopped taking Accutane, the man began experiencing intense stomach pain and diarrhea. Over the next several months, the man’s condition worsened. The man’s primary care physician referred him to a gastroenterologist. The man was diagnosed with a virulent form of inflammatory bowel disease (IBD).

 

Fourteen months after the man stopped taking Accutane, the man became anemic as a result of constant bleeding from the rectum. The man’s weight dropped from 162 pounds before taking Accutane to just 114 pounds. The man underwent multiple surgeries. The man’s colon and rectum were removed and another reservoir was created for bowel contents to exit the man’s body by surgically creating a J-shaped reservoir called a J-pouch. The J-pouch became inflamed, causing the man to suffer persistent and severe gastrointestinal pain and flu-like symptoms. To permit the J-pouch to heal, a colostomy bag was attached to the man’s small intestine through a surgical procedure. The man subsisted with the colostomy bag for four and a half years until another surgery reconnected the J-pouch to the man’s small intestine. The man continued to suffer from severe abdominal cramping, multiple bowel movements every day, and episodes of incontinence.

 

The man filed a product liability action against the manufacturer and distributor. The complaint alleged that the man developed IBD as a result of taking Accutane. The complaint also claimed that had Accutane’s warning labels adequately informed the man of the risks and dangers associated with Accutane, he would not have taken the medication. Specifically, the complaint claimed that the Accutane label and other warnings conveyed the impression that the listed adverse reactions would arise while the man was taking the medication and that discontinuing its use would resolve such problems. The complaint also contended that the warning did not suggest that the man could develop an irreversible case of IBD after completion of the Accutane regimen. The complaint asserted that, during the period the man took Accutane, the manufacturer and distributor knew or should have known that Accutane could not only trigger IBD after its use, but also cause irreversible damage to the man’s  organs, and that the manufacturer and distributor failed to provide adequate warnings to the man and his physician about those risks.

 

The manufacturer and distributor filed a motion to dismiss on the grounds that the man’s home jurisdiction’s statute of limitations had expired by the time of the filing. The man argued that the statute of limitations of the state where the manufacturer and distributor were located, New Jersey, applied. New Jersey’s statute of limitations had not expired at the time the man filed the complaint.

 

The Superior Court of New Jersey for Atlantic County, Law Division, concluded that New Jersey’s statute of limitations applied. Specifically, the trial court determined that the man did not become aware that his use of Accutane could have caused his IBD until a particular date. Because the man filed his complaint within six weeks of that discovery, the trial court concluded that, under New Jersey’s equitable tolling statute, the complaint was timely filed.

 

After a trial, the jury found the manufacturer and distributor liable on the man’s failure to warn claim and awarded damages in the amount of $25,159,530. The jury rejected the man’s consumer-fraud claim.

 

The Appellate Division of the New Jersey Superior Court reversed and dismissed the action. The appellate court found that the man’s home jurisdiction’s statute of limitations applied.

 

The Supreme Court of New Jersey reversed and reinstated the jury’s verdict and award. The court held that New Jersey’s statute of limitations applied.

 

New Jersey’s statute of limitations applied. The court adopted section 142 of the Restatement (Second) of Conflicts of Law (1971) (Am. Law Inst., amended 1988) as the choice-of-law framework for determining whether the forum state’s or another state’s statute of limitations would apply. The court reasoned that New Jersey had a substantial interest in deterring its manufacturers from placing dangerous products in the stream of commerce. Inadequate warning labels could render prescription medications dangerous. Therefore, New Jersey had a substantial interest in deterring its manufacturers from placing prescription medications with inadequate warning labels into the stream of commerce. The court found no exceptional circumstances were present that would render the application of New Jersey’s statute of limitations unreasonable.

 

The Supreme Court of New Jersey reversed the appellate court’s dismissal of the man’s failure to warn claim against the prescription drug manufacturer and distributor and reinstated the jury’s verdict and award of $25,159,530.

 

See: McCarrell v. Hoffmann–La Roche, Inc., 2017 WL 344449 (N.J., January 24, 2017) (not designated for publication).

 

See also Medical Law Perspectives, December 2016 Report: Gut-Wrenching Pain: Liability Risks Related to Gastrointestinal Disorders

 

See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication

 

See also Medical Law Perspectives, September 2012 Report: Cosmetic Surgery Gone Wrong: High Hopes Meet Unexpected Results

 

See also Medical Law Perspectives, March 2012 Report: Off-Label Use of Prescriptions: When is this Medical Malpractice? Is the Pharmaceutical Company Liable for Overpromotion? 

 

 

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