Predictive Legal Memo
MEMORANDUM TO: Partner FROM: Associate DATE: November 25, 2002 RE: Alma Mahler – Learned Intermediary Doctrine and Aggressive Marketing ISSUE Whether a federal court applying New York law will allow Dulcamara Pharmaceuticals, Inc. (“Dulcamara”) to avail itself of the shield provided by the learned intermediary doctrine (“LID”), when Dulcamara used aggressive direct-to-consumer (“DTC”) advertising to market its prescription drug Passaclear, and Alma Mahler (“Mahler”) suffered severe liver damage after requesting a prescription from her physician and taking Passaclear to treat her asthma. BRIEF ANSWER Dulcamara will probably be able to avail itself of the LID, since New York is unlikely to adopt a DTC advertising exception. Only one state has recognized DTC advertising by drug manufacturers as an exception to the general defense provided by the LID. Further, New York has historically been reluctant to recognize exceptions to the LID. FACTS Our client, Mahler, is a 45-year old woman that suffers from chronic asthma. Dulcamara is a pharmaceutical company that manufactures the drug Passaclear for the treatment of asthma. Mahler filed suit against Dulcamara in a New York federal court for, among other things, failure to warn, after developing liver problems from taking Passaclear. Dulcamara has moved for summary judgment on all counts. This memorandum only addresses the failure to warn claim. Beginning in 1999, Dulcamara ran a six-month marketing campaign for Passaclear that used television advertisements on all major networks. Dulcamara advertised Passaclear as a “breakthrough drug” in the treatment of asthma that provided a “significant advance” in chronic asthma symptoms. The commercial said, “It you suffer from chronic asthma, and must use an inhaler at least three times a week, you owe it to yourself to ask your doctor about Passaclear.” Mahler learned about Passaclear from Dulcamara’s television advertisements. Having used her inhaler at least three times a week for the past eight years, and often more than once a day, Mahler sought relief from her symptoms. Mahler spoke with her doctor about the drug the week after seeing the commercial, and her doctor wrote her a prescription that same day, based on his belief that she was a likely candidate for Passaclear therapy. Six months after Mahler began taking Passaclear, she developed severe liver problems. Eventually she required a liver transplant. The firm has consulted several experts that believe that Passaclear was responsible for Mahler’s liver problems. After Mahler stopped taking the drug, Dulcamara reported to the FDA that 35 cases of liver damage had been reported as related to Passaclear. Based on this, Dulcamara voluntarily removed Passaclear from the market. Duclamara’s television advertisements made general mention of potential side effects, but there was no specific warning about liver damage. The complete text of the warning from the advertisement viewed by Mahler was as follows: Passaclear is as safe as we can make it. Nonetheless, serious side effects can result from your taking Passaclear. In order to determine if you are suffering any of these side effects, your doctor might order tests for you. You should speak with your doctor to discuss this testing, and the potential side effects you might suffer if Passaclear is prescribed for you. The product labeling and information sheet given to doctors noted the risk of liver damage posed by Passaclear, and that patients should have their liver enzymes checked monthly. DISCUSSION To succeed in her claim for failure to warn, Mahler must show that Dulcamara breach its duty to warn her of Passaclear’s adverse side effects, and that this breach caused her severe liver damage. To establish that a duty exists, Mahler must show that under New York law Dulcamara cannot avail itself of the defense provided by the LID given its DTC advertising of Passaclear. I. Learned Intermediary Doctrine An “overwhelming majority of jurisdictions” accept the LID as a defense to the “general rule imposing a duty on manufacturers to warn consumers about the risks of their products.” In re Norplant Contraceptives Prods. Liab. Litig., 215 F. Supp. 2d 795, 803, 806 (E.D. Tex. 2002). The LID excuses drug manufacturers from warning patients directly when adequate warnings are given to the prescribing physician. Id. at 803. The August 14, 2002 opinion issued by the United States District Court in Texas represents a multidistrict application of the LID, which identifies the four “theoretical justifications” commonly given to support the doctrine. Id. at 815. A. General Theories of the Leaned Intermediary Doctrine The first theory is based on an effort to “preserve the doctor-patient relationship, which could be undermined if patients received warnings directly from drug manufacturers that differed from their doctor’s warnings.” Id. The second theory is that “physicians are in a better position to convey information to patients than manufacturers.” Id. Third, “manufacturers lack an efficient means to communicate warnings to individual consumers.” Id. Finally, there is concern that “patients cannot comprehend complex medical information.” Id. II. New York Courts New York courts view prescription drugs as inherently unsafe products, which usually would result in strict liability against the manufacturer. Martin v. Hacker, 83 N.Y.2d 1, 8 (1993). However, a defense is available to drug manufacturers under the LID when the drug is “properly prepared, and accompanied by proper directions and warning.” Id. A. Leaned Intermediary Doctrine As a manufacturer of prescription drugs, Dulcamara will likely fall within the general confines of the LID.