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From Health Law Daily, December 7, 2015

Defectiveness claims hold (unlike the bone cement in question)

By Kayla R. Bryant, J.D.

A products liability case filed by a patient who suffered injuries allegedly related to bone cement manufactured by DePuy Orthopaedics, Inc. (DePuy) was largely dismantled by an Ohio district court, although the claims for defective manufacturing and design were permitted to proceed. The court dismissed the claims of defective design based on one component of the cement, inadequate warning, nonconformance with representations, misrepresentations, claims based on federal requirement violations, and the request for punitive damages (Thompson v. DePuy Orthopaedics, Inc., December 4, 2015, Barrett, M.).

Procedure. The patient underwent a partial knee replacement surgery in January 2009 in which the doctor used the CMW 1 Gentamicin Bone Cement, manufactured by DePuy. About two years later, the patient suffered from pain and swelling. After a bone scan revealed that a component had loosened due to a failure of the bone cement, the patient underwent a revision surgery in which another company’s bone cement was used.

Bone cement. The bone cement’s two components, liquid and powder, are packaged separately and mixed at the time of the surgery. DePuy’s original cement was a Class III device, requiring premarket approval (PMA) from the FDA. The FDA eventually reclassified polymer poly (methyl methacrylate) (PMMA) bone cement into Class II, which requires special controls combined with general controls of Class I to ensure the safety and effectiveness of the product.

According to the doctor who performed the both the initial and revision surgery, the Gentamicin bone cement failed at both the bone and implant interfaces. He also stated that after an initial period of success when he started using the bone cement in 2004, he started seeing failures in 2009. He reported the failures to DePuy, who sent representatives to talk to the doctor and review his staff’s cement preparation procedures. They could not identify any issues in his techniques, facilities, or staff actions, and the doctor decided to stop using the DePuy cement.

Preemption. DePuy argued that because the medical device amendments to the Food, Drug, and Cosmetic Act (FDC Act) (21 U.S.C. §360k(a)) expressly preempts some state causes of action regarding medical devices, and all of these claims can be traced back to the original PMA approval, the patient’s claims were preempted. The court disagreed, finding that the bone cement was approved through a different process when it was reclassified as a Class II device, and that DePuy cannot “piggyback” on the prior approval after the medical device underwent some changes and the 510(k) approval process.

Defective claims. The patient brought a defective manufacturing claim, which DePuy argued was based on testimony from an expert who admitted he did not have enough information about the company’s process to rule that a manufacturing defect occurred. However, the court noted that circumstantial evidence supporting a manufacturing defect precludes summary judgment. The doctors offering expert testimony stated that the implant is expected to last ten to twenty years, and that failure within three years is not typical. A defective design claim was brought as well, on the basis that the foreseeable risks of the product exceeded the benefits of the design based on expert opinion. The court agreed with DePuy that there was no evidence showing a defect related to the liquid component of the bone cement, but that there was a plausible argument that the changes made to the particles in the powder formulation resulted in a defective design.

The case is No. 1:13-CV-00602.

Attorneys: Melanie Sue Bailey (Burg Simpson Eldredge Hersh & Jardine, PC) for Myrtle Thompson. Jeffrey M. Whitesell (Tucker Ellis & West LLP) for Depuy Orthopaedics, Inc. and Johnson & Johnson.

Companies: Depuy Orthopaedics, Inc.; Johnson & Johnson

MainStory: TopStory CaseDecisions FDCActNews MDeviceNews PLDeviceNews PreemptionNews SafetyNews OhioNews

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