Plaintiffs claim DePuy, J&J circumvented FDA premarket approval

NEW ORLEANS- A Jefferson Parish husband and wife are suing an orthopedics company and the manufacturer of a knee implant which the plaintiffs claim was defective.

Kim Green and James Cenance filed suit against Depuy Orthopaedics Inc. and Johnson & Johnson Services Inc. in the Orleans Parish Civil District Court on Aug. 6.

The couple claims that Green's right knee was implanted with the Depuy PFC Knee System on Sept. 23, 2010. On Dec. 18, 2013, Green states that she underwent a risky revision surgery after experiencing progressively worsening pain. PFC stands for "Press-Fit-Condylar" and the system depends on the patient's bone growing around the prosthetic, rather than using a surgical cement. The suit states that Green's prosthetic was easily removed during surgery, as no bone had been attached to the device.

The plaintiffs claim that the design of the PFC Knee Prosthesis was never approved by the FDA as safe or effective. Allegedly defined as a Class III medical device, it should have undergone pre-market approval by the FDA as directed under the 1976 Medical Device Amendments to the Food, Drug and Cosmetics Act of 1938, the suit says.

According to the petition, medical devices that were on the market prior to the 1976 amendments are not subject to the FDA's rigorous pre-market approval standards, which require clinical trials. The suit claims that if a new medical device is "substantially equivalent" to a pre-amendment device, then it can also bypass the pre-market approval process by notifying the FDA under section 510(k) of the 1976 Medical Device Amendments and explaining the device's substantial equivalence to a pre-amendment device. Then the FDA can approve the device, the petition claims.

Green and Cenance assert that DePuy obtained FDA approval for the PFC Knee System under section 501(k) in 2006, telling the FDA that the system was "substantially equivalent" to other knee system products on the market. The plaintiffs say that the 510(k) notification process does not call for scrutiny or clinical testing of a device's safety and effectiveness.

Green and Cenance claim that in order to market the PFC Knee Prosthesis for surgical use, the FDA would have required DePuy to undergo the normal premarket approval process, thereby proving that the knee system was safe, effective, and could provide long-term safety and performance once placed on the market.

Particularly, the plaintiffs allege that Depuy failed to warn them that the PFC Knee System's limitations, in that a prosthesis that relies solely on bone growth around the implant could fail depending on the health or bone structure of the patient. Green and Cenance assert that when the device failed to adhere in Green's case, it became loose, causing intense pain and allowing for infection.

The defendants are accused of negligence, including strict products liability for the knee system's defective design, for failing to warn the plaintiffs of the knee system's risks, for defective manufacturing, for failure to adequately test the knee system and for breach of Louisiana's products liability act.

The plaintiffs are seeking a trial by jury, as well as an unknown amount in damages for medical expenses, disfigurement, pain and suffering, mental anguish, emotional distress, lost wages, lost earning capacity, attorney's fees and costs. The plaintiffs are also praying for restitution and disgorgement of all revenue that defendants have obtained through the manufacture, marketing, sale, and administration of the PFC knee system, and punitive and exemplary damages as may be found appropriate.

Kim Green and James Cenance are represented by Charles M. Thomas of Huber, Slack, Thomas & Marcelle LLP.

The case has been assigned to District A Judge Tiffany G. Chase.

Case no. 2014-07733.