As 2013 came to a close, the Pennsylvania Supreme Court set the landscape for product liability litigation for years to come.

 

In Tincher v. Omegaflex (No. 17 MAP 2013), the Pennsylvania Supreme Court was asked to decide whether Section 402A of the Restatement (Second) of Torts or the distinct analysis set forth in the Restatement (Third) of Torts should be utilized in products liability cases filed in the Pennsylvania.

 

Approximately 35 years ago, in the landmark decision of Azzarello v. Black Brothers Co., Inc., the Pennsylvania Supreme Court established the arguably murky and sometimes confusing standard courts and juries were to follow in product liability cases: 480 Pa. 547 (1978).

 

In Azzarello, the court held that, before a product liability case based on an alleged defective design or warning can be submitted to a jury, the trial judge was to perform a “risk-utility” balancing test for the allegedly defective product at issue. This “risk-utility” test included certain factors to be applied by the trial judge which included, but were not limited to, the usefulness and desirability of the product, the safety aspects of the product, the availability of a substitute product, and the user’s awareness of the dangers inherent in the product itself. If the trial judge determined the product at issue failed this “risk-utility” test, only at this point could the case be submitted to a jury.

 

Prior to jury deliberations, the jury was then instructed that it may “find a defect where the product left the supplier’s control lacking any element necessary to make it safe for its intended use or possessing any feature that renders it unsafe for the intended use.” Importantly, the jury was not asked to consider the conduct of the manufacturer and whether, at the time the product left the hands of the manufacturer, if there existed reasonable alternative designs or reasonable alternative warnings or instructions for the product itself.

 

In the years following the decision, it became apparent the Azzarello framework was unworkable. Specifically, various federal court decisions in Pennsylvania noted that, in order to properly determine whether a product was truly defective based on its design or warning, there must ultimately be a consideration of the specific conduct of the defendant and whether reasonable alternative designs and warnings could have be used. Covell v. Bell Sports, Inc., 651 F.3d 357 (3d Cir. 2011).

 

The Restatement (Third) attempted to address this shortfall. As for design defect claims, the Restatement (Third) states a product is defective in design when the foreseeable risks of harm could have been reduced or avoided by the adoption of a reasonable alternative design by the seller. As to manufacturing defect claims, the Restatement (Third) states a product is defective in its warning when the foreseeable risks of harm could have been reduced or avoided by the provision of reasonable warning by the seller.

What It Means to You

The ultimate outcome of the Tincher decision is an important one. As seen above, the analysis used by the Restatement (Second) and Restatement (Third) have significant textual and practical differences for legal practitioners, manufacturers, and insurers of medical devices distributed and sold in Pennsylvania. The Restatement (Third) would appear to shift the balance in favor of manufacturers of medical devices as the jury is asked to not solely ask itself the vague and potentially confusing question whether the product “lacked any element necessary to make it safe,” but whether reasonable alternative designs or warnings existed at the time the product was sold to the public.