Pa. SC affirms ruling in favor of medical device maker

By Jessica M. Karmasek | Mar 29, 2012


HARRISBURG, Pa. (Legal Newsline) - The Pennsylvania Supreme Court ruled last week that trial courts are not restricted to considering a single use of a multi-use product in design defect, threshold, risk-utility balancing.

The Court, in its March 22 opinion, affirmed the ruling of a superior court in a lawsuit over a medical device's use.

The device at issue is a linear cutting and stapling instrument. It is used in place of traditional scalpel and suture techniques in various surgical applications.

The decedent in the case, Sandra Selepec, underwent gastric bypass surgery in August 2002.

As part of the procedure, her stomach was transected to create a smaller pouch.

The surgeon used a product manufactured by Ethicon Endo-Surgery Inc., known as an ETS-Flex45 Articulating Endoscopic Linear Cutter or "endocutter."

The instrument was designed to be used in endoscopic surgery, or those less invasive procedures in which small incisions are made and a camera or light source is inserted.

However, it also was marketed to be used in more traditional surgery, as in Selepec's case.

During recovery, Selepec experienced complications, and surgeons reentered her abdomen.

They discovered that staples were absent in two small line segments, consistent with mechanical staple failure.

Doctors tried to repair the area, but leaked stomach contents fostered sepsis, a severe illness in which the bloodstream is overwhelmed by bacteria.

Selepec died.

Jeffrey K. Beard, as estate administrator for Selepec, sued Johnson and Johnson Inc. and Ethicon, which is a subsidiary of Johnson and Johnson, for product liability, including an asserted defective design of the endocutter.

A jury returned a verdict in favor of Beard, awarding Selepec's estate $5 million.

On appeal, a divided superior court panel vacated the award in a memorandum opinion and directed the trial court to enter judgment notwithstanding the verdict in Johnson and Johnson's favor.

The state's high court was asked, on appeal, to determine whether the superior court's threshold risk-utility analysis should be limited to the particular application alleged to have caused the plaintiff harm.

The Court also was asked to consider the degree to which an appellate court is bound by such weight and credibility determinations, as may be made by a trial court in a risk-utility assessment.

The Court, in its 28-page opinion, declined to "disturb" the superior court's legal determination as to the appropriate risk-utility "calculus."

"In terms of the appropriate focus of design defect risk-utility analysis, for many of the reasons identified by Appellee (Johnson and Johnson), we decline to limit it to a particular intended use," Justice Thomas Saylor wrote for the Court.

"For better or worse, this Court's decisions have relegated our trial courts in the unenviable position of 'social philosopher' and 'risk-utility economic analyst.' This having been done -- and as the present case does not provide an appropriate opportunity for reconsideration of such assignment -- we decline to require the trial courts to put on blinders.

"It should be enough to say that a product's utility obviously may be enhanced by multi-functionality, so that it would be imprudent to deny trial courts the ability to assign some weight to this factor in assessing product design."

Saylor added, "Moreover, Appellant (Beard) simply does not address why the other theories which may be available to a plaintiff, such as failure to warn, do not provide sufficient protection against deficient marketing and instruction practices."

From Legal Newsline: Reach Jessica Karmasek by email at jessica@legalnewsline.com.

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