September 30, 2016

Learned Intermediary Doctrine Remains Jersey Strong

A recent decision out of Atlantic County, New Jersey, continues to bode well for the application of the learned intermediary doctrine.  The learned intermediary doctrine is a defense rule that states a manufacturer of a product has fulfilled his duty of care when he provides all of the necessary information to a "learned intermediary" who interacts with the consumer of a product.  The "learned intermediary" is usually the treating physician.  This rule helps defendants defeat causation in a strict liability, failure-to-warn case.  In a majority of U.S. states, the courts have accepted this doctrine as a liability shield for pharmaceutical and medical device companies.

In the case of Goodson v. C.R. Bard, Inc., the plaintiff was prescribed and implanted with a synthetic mesh for hernia repair.  As is common, the surgeon knew about the involved risks and did not read the manufacturer's warnings.  The surgeon, by his own testimony, was aware of the risks and benefits of using synthetic mesh for hernia repair, including the risk of chronic debilitating pain, infertility, and the possibility of nerve ingrowth.  The surgeon discussed the risks of numbness and chronic debilitating pain with the plaintiff.  The surgeon testified that he did not read the manufacturer's warnings that accompanied the product.

In the decision of Goodson, the court granted summary judgment for all claims against the manufacturer.  Regarding the failure-to-warn claims, the court noted that the surgeon was aware of the risks of numbness, tingling, and pain associated with the use of mesh for inguinal hernia mesh repair for the patient and also that the surgeon knew such symptoms could persist on an on-going basis.  Most importantly, the surgeon testified that he did not review the warnings accompanying the product and would have prescribed the same course of action even if he had read the warning information.

What It Means to You

The decision of Goodson reaffirms the application of the generally used learned intermediary doctrine.  By providing adequate warnings to a prescribing physician, who in turn provides appropriate patient-specific warnings, the manufacturer discharges its warning responsibilities and should likely avoid liability when sued in a strict liability, failure-to-warn context.