A federal district court has granted summary judgment to drugmaker defendants Hoffmann-LaRoche Inc. and Roche Laboratories Inc. in an Accutane failure to warn case. Snyder v. Hoffman-LaRoche, Inc., 2008 WL 4790666 (M.D.Fla., October 30, 2008). Plaintiffs alleged their teenage son was prescribed Accutane in 2000 to treat young Snyder’s severe acne condition. He had three courses of treatment through April, 2003. On February 28, 2005, Snyder committed suicide.

Prior to prescribing Snyder’s first course of Accutane treatment, Dr. Kalb received and reviewed the drug’s 1998 Package Insert, the 1998 Dear Doctor Letter, the 1999 issue of the PDR, the February 25, 1998 FDA Talk Paper, and the Seventh Edition of the Accutane Brochure, all of which discussed the potential suicide risks. Dr. Kalb testified that he discussed the risks and benefits of Accutane with Snyder before prescribing the drug, including specifically the potential risk of depression and suicide. Such discussion was consistent with his regular practice, as was his practice of providing each patient with a copy of the then current Accutane Brochure. Throughout Snyder’s courses of treatment, Dr. Kalb continued to monitor him for symptoms of depression.  According to Dr. Kalb, who would know, no symptoms of depression were reported or observed while Snyder was taking Accutane.

Plaintiff’s Complaint included claims for negligence, strict products liability, breach of implied warranty, and negligent and fraudulent misrepresentation. Each of these claims was predicated upon defendants’ alleged failure to warn that Accutane could cause Snyder to commit suicide. Defendants moved for summary judgment on the issue of the adequacy of the warnings. Snyder resided and was prescribed Accutane in the State of New York. Accordingly, the Court considered whether Defendant’s warnings were adequate under New York law.

Under New York law, a prescription drug manufacturer may avoid liability for injuries that would ordinarily render the manufacturer strictly liable by distributing proper directions and warnings with the drug. To avoid liability, a manufacturer must warn of all potential dangers in its prescription drugs that it knew, or, in the exercise of reasonable care, should have known to exist. New York employs the learned intermediary doctrine, under which physicians act as “informed intermediaries” between manufacturers and patients regarding warnings for prescription drugs. Thus, a manufacturer’s duty to caution against a drug’s side effects is fulfilled by giving adequate warning through the prescribing physician, not directly to the patient.

Because the defendant had issued a warning about this specific risk, plaintiffs were left to try to argue that defendant’s warnings were not direct, unequivocal and sufficiently forceful to convey the risk of suicide. Plaintiff argued defendants’ warnings equivocated in stating that Accutane “may” cause depression and suicidal ideation, that emotional instability “may” bear no relation to therapy, and that the side effect of suicide is “uncommon” and/or “rarely” occurs. Moreover, Plaintiff argued that the defendants’ statement that “no one knows if Accutane caused these suicidal behaviors” further dilutes the warning.

The Court disagreed with plaintiffs. The February 1998 warnings specifically warned that Accutane treatment may cause suicide. MassTortDefense notes that the drug does not always cause suicide, if it ever does (which is unproven), so “may” is perfectly accurate. The statements that Accutane “may” cause suicide, or that such a result “rarely” occurs, do not inappropriately diminish the seriousness of the warning; rather they describe the medical record. The Court properly viewed the extensive warning language as a prescriber would, in full context, not isolating a word or phrase. Taken as a whole, the warnings clearly, accurately, and consistently conveyed to Dr. Kalb that Accutane might cause suicide, with or without prior symptoms of depression. Accordingly, the Court concluded that defendants’ warnings were adequate as a matter of law. Defendants were entitled to summary judgment as to plaintiff’s failure to warn claims.