Opinion ID: 1189000
Heading Depth: 1
Heading Rank: 7

Heading: learned intermediary defense

Text: An additional reason why the district court did not err in granting summary judgment to Merck may be found in the learned intermediary defense. This defense is one that this court has never addressed. A learned intermediary was defined in Reyes as a medical expert, such as a prescribing physician, whose task is to weigh the benefits of any medication against possible dangers and to make an individualized medical judgment bottomed on a knowledge of both patient and palliative. Reyes, 498 F.2d at 1276. The pharmaceutical company's duty, in selling prescription drugs, is to warn only the prescribing physician, who acts as a `learned intermediary' between manufacturer and consumer. Id. One exception to this doctrine is what is referred to as the mass immunization exception. This exception applies when a vaccine is administered at clinics without a physician. In such cases, it is the duty of the manufacturer to warn the consumer. Reyes, 498 F.2d at 1276; see also Davis, 399 F.2d at 131. In Stanback v. Parke, Davis and Co., 657 F.2d 642 (4th Cir.1981), the recipient of an influenza vaccine contracted Guillain-Barre Syndrome as a result of the vaccine. The physician had not received the manufacturer's package insert with the vaccine, nor did the package insert warn of the risk of Guillain-Barre Syndrome associated with the vaccine. However, the physician testified that he was aware of the risk, but that it was not his practice to warn patients of the risks associated with the influenza vaccine. Consequently, the patient received no warnings prior to receiving the vaccine. The court concluded that even if the manufacturer had sufficiently warned the physician, the patient would not have received the warning. Id. at 645. The court held that the physician's decisions and actionsmade in full knowledge of the information which an adequate warning would have containedtherefore insulate Parke, Davis from any liability resulting from its failure to warn. Id. In the instant case, Dr. Potter advised Mrs. Allison that her son needed to be vaccinated against measles, mumps and rubella. He then prescribed the MMR II vaccine. He was in possession of the package insert provided by Merck containing information regarding adverse reactions. Yet, Dr. Potter failed to provide Mrs. Allison with any information or warnings regarding the possibility of side effects such as encephalitis. Had Mrs. Allison chosen not to go to CCHD for the vaccination, Dr. Potter, in all probability, would have administered the MMR II vaccine. Therefore, I must conclude that Dr. Potter, as the prescribing physician, was a learned intermediary in this case, one to whom Merck had a duty to warn of possible adverse reactions of the MMR II vaccine. Merck fulfilled this duty by providing prescribing physicians with the package insert containing all relevant information regarding adverse reactions. While Thomas received the vaccination at CCHD, it was Dr. Potter who, without warning Mrs. Allison, prescribed the vaccination based upon his medical knowledge. Merck should not be held liable simply because the learned intermediary failed to perform his duty to warn his patient. Stanback, 657 F.2d at 645.