A New Jersey appellate panel vacated a $2.1 million verdict in favor of a plaintiff who claimed drug manufacturer Hoffmann-La Roche Inc.’s acne medication Accutane caused her inflammatory bowel disease. While Monday's decision relied on the statute of limitations and the duty-to-warn's learned intermediary doctrine to vacate the Accutane verdict for one plaintiff, it also affirmed jury decisions against two other plaintiffs in the case.
The decision by the New Jersey Superior Court's Appellate Division followed appeals in James Greenblatt v. Hoffmann-La Roche Inc., et al., a 2011 trial involving three California plaintiffs: Gillian Gaghan, Kelley Andrews, and actor James Greenblatt, better known by his stage name James Marshall. The plaintiffs claimed Accutane caused their inflammatory bowel disease, or IBD, and that Roche and its affiliates breached their duty to warn them of the product’s dangers. The case is one of about 8,000 Accutane Mass Tort Litigation suits designated for consolidated case management in New Jersey. After a nearly seven-week trial broadcast by CVN, the Greenblatt jury found against Andrews and Marshall but awarded Gaghan more than $2 million in damages.
Roche’s Duty to Warn Extended Only to Gaghan’s Physician Under the Learned Intermediary Doctrine
Gaghan took Accutane for several months in 1998 and sued Roche in 2004, claiming that the drug caused her IBD. In vacating Gaghan's award, the appellate panel found that her claims were barred by the two-year statute of limitations. The panel noted that Gaghan was diagnosed with IBD two months after she stopped taking Accutane and that she should have known of the potential link between the drug and her IBD.
Relying on California product liability law and the “learned intermediary doctrine,” the panel also found that Roche’s duty to warn extended only to the doctor who prescribed Accutane to Gaghan. The panel then held that Gaghan failed to show that stronger warnings would have caused her doctor to recommend against taking the drug or even led her doctor to discuss the additional warnings with her.
Failure to Establish Proximate Cause Between Andrews’s Injury and the Duty to Warn
However, the panel upheld the jury's verdict against Andrews, including its finding that Roche's warnings, while inadequate, did not cause her IBD. The panel noted that Andrews had suffered emotionally from her severe acne condition. It concluded the jury had sufficient reason to believe Andrews would have taken Accutane regardless of whether her doctor received sufficient warnings from Roche.
Marshall Failed to Establish that Accutane Caused His IBD
Further, the panel upheld the finding that Marshall failed to establish that Accutane was the "substantial" cause of his IBD. The panel noted that Marshall, best known for his role in the 1992 film A Few Good Men, had suffered from ulcerative colitis, a type of IBD, prior to taking Accutane.
Accutane Pulled in 2009 But Generics Continue to Be Sold
Roche began selling Accutane in the early 1980s after securing FDA approval for the drug. Although it stopped producing Accutane in 2009, isotretinoin, the drug’s active ingredient, is still prescribed by dermatologists and sold as a generic acne medicine.
Related Information
Read the appellate panel's decision.