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PA Courts to Rule on Strict Liability for Medical Devices


The U.S. Court of Appeals for the Third Circuit was recently asked to determine if strict liability should be extended for prescription medical devices in Pennsylvania. Strict liability holds a party legally responsible for the damages or injuries of another party, even in the absence of negligence or intent to harm. Pennsylvania is not the first state to ask its Courts to provide a definitive answer on strict liability, but the decision will make waves through the Commonwealth. It should especially be of interest to those who have been hurt by defective medical devices.

Why the Court Decision Matters

Brought upon by various courts throughout the country, Section 402A of the Restatement of Torts imposes strict liability on anyone who sells a defective product that is unreasonably safe to a consumer. This applies even if the seller exercised the proper level of care. Yet, comment k of the Restatement creates an exception for “unavoidably unsafe” products, which are products that have important benefits, but also pose unavoidable risks to the consumer. Although they are inherently dangerous, the Pennsylvania Superior Court determined that prescription drugs are exempt mainly because they are beneficial to society.

The Court’s decision will have an impact on defective medical device claims. For instance, if someone received a defective medical device, they may decide to sue the manufacturer of the device. If the Court says that medical devices are unavoidably unsafe, the manufacturer may use the exemption in court as leverage.

Are Prescription Drugs and Prescription Medical Devices Alike?

In the recent case of Rosenberg v. C.R. Bard, Inc., a judge relied on the language of comment k to include prescription medical devices merely because the medical device needed to be prescribed by a physician. The Court then found no meaningful distinction between prescription drugs and medical devices. Due to that ruling, the Superior Court expanded comment k to reach implanted medical devices in Creazzo v. Medtronic, Inc.

However, the Pennsylvania Supreme Court determined that strict liability claims are not cognizable in circumstances dealing with prescription drugs. There is still an ongoing debate if medical devices will be included in comment k of the Restatement of Torts. Many people will receive prescription medical devices that do not function as expected. Although a ruling against strict liability will not stop lawsuits against medical device manufacturers, a knowledgeable defective medical device lawyer can help you pursue legal action if you were harmed by a medical device.

Philadelphia Defective Medical Device Lawyers at Brookman, Rosenberg, Brown & Sandler Advocate for Victims Harmed by Medical Devices

Regardless of the decision brought down by the Pennsylvania Courts, the Philadelphia defective medical device lawyers at Brookman, Rosenberg, Brown & Sandler will maintain an aggressive stance on behalf of their clients who have been injured by medical devices. If you think you may have a medical device claim, call us today at 215-569-4000 or contact us online for a free consultation. Located in Philadelphia, we serve clients throughout New Jersey and Pennsylvania, including Delaware County, Chester County, and Philadelphia County.