Academic journal article Defense Counsel Journal

Liability for Direct-to-Consumer Advertising and Drug Information on the Internet

Academic journal article Defense Counsel Journal

Liability for Direct-to-Consumer Advertising and Drug Information on the Internet

Article excerpt

While the learned intermediary doctrine still lives, drug manufacturers can take some precautionary measures if it is ruled inapplicable

Our medical-legal jurisprudence is based on images of health care that no longer exist. -New Jersey Supreme Court in Perez v. Wyeth Laboratories Inc., 734 A.2d 1245, 1246 (1999).

THE INTERNET and the growing system of managed health care present opportunities and challenges not previously contemplated by the legal community or the judiciary. Manufacturers generally are liable in products liability claims for product defects, including failing to warn consumers of dangers associated with their products. For pharmaceutical drugs, a manufacturer is not liable when it warns physicians regarding the risks inherent in its products. This doctrine, the learned intermediary rule, shields manufacturers from liability to ultimate consumers based on inadequate instructions and warnings accompanying its products.

Created in the 1960s, the learned intermediary rule recognized the importance of the physician in providing patients with warnings associated with prescription drugs and the limited ability of manufacturers to provide warnings directly to consumer-patients. The changing nature of the doctor-patient relationship in an era of managed care and the availability of the Internet as a resource for providing information raises questions regarding the continuing vitality of the learned intermediary rule.

The doctrine, however, has continuing validity despite the changing nature of the provision of health care. There is a general framework for limiting a manufacturer's exposure to liability in the creation and maintenance of Internet web sites. Although it is unclear whether the learned intermediary rule continues to apply to products that manufacturers advertise directly to consumers, manufacturers may take steps to prevent the imposition of liability for failure to warn.

A LOOK AT THE RULE

Although not all states follow the Restatement (Third) of Torts: Products Liability, it provides a general framework for products liability claims regarding pharmaceutical drugs.1 Under Sections 2 and 6(a)-(b) of the Restatement, a manufacturer generally is liable in products liability for (1) manufacturing defects, (2) design defects and (3) failure to warn of dangers associated with its products. According to Comment d to Section 6 of the Third Restatement, allegations of failure to warn of dangers associated with using prescription drugs are one of the primary theories of product liability in this field. The failure to warn theory of liability therefore warrants discussion.

Section 6(b) of the Third Restatement provides that "a prescription drug or medical service is defective if at the time of sale or other distribution of the drug or medical device ... (3) is not reasonably safe due to inadequate instructions or warnings." A manufacturer, however, can assert the learned intermediary rule as an affirmative defense, thereby avoiding the imposition of liability.

The learned intermediary rule limits a prescription drug manufacturer's duty to warn to an obligation to advise the prescribing physician of any potential dangers that may result from using the drug. The Third Restatement's version of the learned intermediary rule, stated in Section 6(d) is:

A prescription drug or medical device is not reasonably safe due to inadequate instructions or warnings if reasonable instructions or warnings regarding foreseeable risks of harm are not provided to:

(1) prescribing and other health-care providers who are in a position to reduce the risks of harm in accordance with the instructions or warnings; or

(2) the patient when the manufacturer knows or has reason to know that healthcare providers will not be in a position to reduce the risks of harm in accordance with the instructions or warnings.

A manufacturer discharges its duty to warn regarding the risks inherent in its pharmaceutical drugs by warning health care providers and physicians regarding those dangers. …

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