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Liability Claim for a Defective Spinal Implant Denied
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Synthes USA

Summary: The argument that prescription drugs are the same as prescription medical devices was at the heart of a strict liabilities case over a defective spinal implant rod.

A U.S. District Judge decided that the exclusion from liability claims that applies to prescription drugs applies to prescription medical devices as well. While the judge rejected the plaintiff’s liability claim, he has allowed the plaintiff’s manufacturing defect, failure-to-warn, negligent design, and negligence per se claims to progress against the manufacturer of the spinal implant, Synthes USA Products.


The District Judge took the ruling from a July 2014 as an example to go off of. The Pennsylvania Supreme Court has not fully addressed if the exemption for “unavoidably unsafe” products covers prescription medical devices but the judge sees no reason that the rationale doesn’t apply in this case. Another case from 1996, Hahn v Richter, found that plaintiffs cannot use strict liability claims on the manufacturers of medical devices.

The plaintiff, James P. Wilson had two N-Hance spinal fixation rods placed in his spine to repair a back injury. The rods were manufactured by Synthes USA. Two years after the procedure, the rods failed and his back was broken.

A properly designed and manufactured spinal rod will not bend, break, or fracture. Wilson alleges that the implant is designed badly and manufactured incorrectly, causing it to break. Pennsylvania does not recognize strict liability claims against manufacturers, allowing Synthes to file a motion to dismiss. The case would have to be filed as a theory of negligence against the medical device company.

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The plaintiff argued that prescription devices are different than prescription drugs but the judge disagreed with his reasoning. Wilson’s claims lacked sufficient reasoning and clearly defined arguments that would have allowed the case to move forward.

Wilson is represented by Maxwell S. Kennerly of the Beasley Firm.

Synthes USA is represented by Terry Henry of Blank Rome.




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