E-Alert Case Updates

Another Learned Intermediary Dismissal

King v. Pfizer Pharmaceutical Co.
(D. Md. July 22, 2011) July 2011
by Kevin M. Cox, Associate
Semmes, Bowen & Semmes (www.semmes.com)

In 2007, Plaintiff Patricia King (“Ms. King”) was prescribed Lipitor by her primary physician and immediately began taking the recommended dosage. She began to experience pain and numbness in her legs and weakness in her arms and legs in December 2009. Ms. King believed that Lipitor was causing her pain, and immediately stopped taking the medication. Thereafter, her pain gradually lessened, but was not entirely eliminated.

Ms. King filed a complaint in the Circuit Court for Prince George’s County, Maryland on December 7, 2010, against Pfizer. She sought damages from Pfizer claiming that Pfizer was liable to her because the company placed drugs into the market place knowing that they could cause serious harm if taken as prescribed. On January 14, 2011, Pfizer removed the action to Federal court, and on January 21, 2011, moved to dismiss the complaint for failure to state a claim upon which relief could be granted, which Ms. King opposed. Pfizer argued that Ms. King could not recover under any products liability cause of action under Maryland law, and that its warning labels were adequate as matter of law.

Initially, the court noted that design defect claims are generally incompatible with actions concerning prescription medications because these medications are thought to be “unavoidably unsafe.” Ms. King did not, however, designate a specific theory of recovery for her products liability action in her complaint. She did, however, clarify in her opposition that she was asserting a failure to warn claim. In support of her claim, she argued that Pfizer was liable to her because she did not have access to information concerning the side effects she later experienced at the time she began taking the medication. Specifically, she asserted that Pfizer’s past improper sales, marketing, and advertising practices undermined the role of the “learned intermediary,” and Pfizer’s reliance on its warning labels, for protection, as a matter of law.

The “learned intermediary” doctrine provides that manufacturers need only warn the prescribing physician, and not the patient directly. A doctor acts as a “learned intermediary” between the manufacturer and the consumer because he is in the best position to understand the patients’ needs and assess the risks and benefits of a particular course of treatment. Thus, the doctrine protects a manufacturer from liability provided that the doctor has been sufficiently warned.

Ms. King’s first argument in support of her failure to warn claim was that she had not been provided access to information at a time when its importance could be evaluated. Yet, under the “learned intermediary” doctrine, if the prescribing physician had received adequate notice of possible complications, the manufacturer had no duty to warn the consumer. Ms. King had conversations with her treating physician about the possible side effects of Lipitor, one of those being leg pain. Thus, she failed to state a cognizable failure to warn claim because: (1) there is no legal duty for a manufacturer of a prescription drug to directly inform the consumer of possible side effects, and (2) her physician was clearly informed of the risk and side effects of taking Lipitor.

Ms. King’s second argument was that certain alleged past violations of FDA guidelines undercut the ability of Pfizer to communicate warnings adequately to physicians and thus undermined the role of the “learned intermediary.” This argument appeared to be Plaintiff’s attempt to present an over promotion claim, which the court quickly dismissed because Pfizer’s alleged illegal promotion had “no discernable relevance to her individual claim.” Therefore, the court’s rationale appeared to be an endorsement of the proposition that alleged improper promotion must have affected the plaintiff's own prescriber in order to be relevant. Specifically, the court held that Ms. King did “not even attempt to show how [defendant’s] past improper practices affected her own physician’s ability to understand the risks and side effects associated with [the drug], nor does it appear that she reasonably could have. . . . Accordingly, [Ms. King’s] apparent attempt to sidestep the ‘learned intermediary’ doctrine must fail.”

Thus, this case is just one more linchpin that defense lawyers can use to extricate their drug manufacturing clients from frivolous off label/over promotion claims, and constitutes a “win” under for the learned intermediary defense under such fact patterns.