A New Jersey court overseeing the centralized litigation regarding the human tissue product AlloDerm has issued a noteworthy ruling in a bellwether case on the duty to warn. See Simineri, et al. v. LifeCell Corp., No. L-5972-11 (Super. Ct. N.J.).

Plaintiffs moved for partial summary judgment on the issue of the learned intermediary doctrine under the New Jersey Products Liability Act. The FDA regulates AlloDerm as a banked human tissue product, not as a drug or medical device, so the motion raised the issue whether the doctrine applied to this type of product. 

Under the Act, N.J.S.A. Sect. 2A:58C-4, an adequate warning must be given to the persons by whom the product is intended to be used, or in the case of prescription drugs and devices, taking into account the characteristics of, and the ordinary knowledge common to, the prescribing physician. Under New Jersey law, a pharmaceutical manufacturer discharges its duty to warn the ultimate user of prescription drugs by supplying physicians with information about the drug’s dangerous propensities. To the extent that the pharmaceutical manufacturer is relived of the duty to warn the ultimate user, the treating physician as the learned intermediary assumes the responsibility to warn the patient of the risks involved in using the prescription product.

The court here noted that the NJ Supreme Court has established several rationales for favoring application of the learned intermediary doctrine, including: 1) the desire to avoid intrusion into the doctor-patient relationship; 2) the superior position of doctors to communicate important information about risks to their patients; 3) the inability of drug makers to communicate effectively and directly with patients; and 4) the nearly impossible task of translating complex medical information and risk factors into terms understandable to the average consumer.

Plaintiffs argued that the LID was inapplicable to AlloDerm because it was not regulated by the FDA as a prescription drug or medical device and that it was supposedly “well-established” that the LID somehow only applies to FDA-approved drugs and devices. Plaintiffs cited a variety of cases, but, said the court, none of the cases relied on actually based their application of the LID on the FDA’s classification of medical products as drugs or devices. Rather, the cases cited by plaintiffs focused on the traditional rationales underpinning the LID: that where the product is available only through the intervention of a licensed physician, any duty to warn is owed to the physician and not the patient. The cases instead stood for the proposition that prescribing physicians act as learned intermediaries between the manufacturer and consumer, and those doctors stand in the best position to evaluate the patient’s needs and assess the risks and benefits of a particular treatment. What was sufficient, and what plaintiffs seemed to ignore, was the fact that AlloDerm is regulated by the FDA. Plaintiffs were unable to explain how the particular FDA classification had any real bearing on the application of the doctrine.

The court next disagreed with plaintiff’s argument that applying the LID to the product would somehow be an expansion of the doctrine. The court believed it was simply considering the well-established rationales underlying the LID and applying them to the product.  It was significant that the product was not marketed or sold directly to patients. It can only be obtained through a licensed healthcare professional. Indeed it must be implanted into the patient by the physician. The patient is necessarily relying upon the doctor’s knowledge, skill, and services, weighing the risks and benefits before the implantation of the product.

Under these circumstances, to require the defendant “to communicate would unnecessarily intrude on the doctor-patient relationship. In a surgical context…the doctor has even more prominent role in evaluating and selecting the most appropriate course of treatment.” The surgeon, rather than the manufacturer, concluded the court, is best positioned to convey the appropriate information to the patient, who was unlikely ever to inspect the product.   A physician choosing to implant this product must consider a number of factors such as the patient’s medical history and co-morbidities, as well as the specific surgical techniques employed. The physician is in the best position with regard to this product to take into account the susceptibilities of the patient, and to give an individualized warning to the ultimate user.

Plaintiff's motion denied.