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An important initial ruling was entered by Judge Susan Garsh regarding lawsuits brought On behalf of individuals who have been injured due to the failure of the Charité Artificial Disc, which is manufactured by DePuy Spine, Inc.

The Complaints filed on behalf of the injured Plaintiffs allege that DePuy supplied inaccurate information to the Food and Drug Administration (“FDA”) concerning the performance capabilities of the Charité Disc, and failed to disclose to the FDA critical data concerning failures and complications which arose during clinical studies. The Complaints further allege that the Disc failed to perform in accordance with the express warranties made to physicians, patients and the general public that the Disc would be a safe and effective treatment to replace diseased or damaged intervertebral disc, for individuals suffering from chronic back pain.

DePuy sought the summary dismissal of the Plaintiffs claims under the theory that since the Charité Artificial Disc passed the FDA’s rigorous application process, any claim for injury from the use of such an ‘approved’ medical device is preempted by the FDA’s determination that the product was safe for patient use. Typically, under preemption, the FDA approval of a medical device absolves the manufacturer from any liability for injury caused by the device. As the FDA requires a rigorous testing and application process, in proper cases the preemption doctrine is intended to insulate medical device manufacturers from liability where the device is manufactured and distributed in accordance with the specifications approved by the FDA. Accordingly, DePuy argued that the Plaintiffs’ Complaints should be dismissed regardless of the harm suffered to the Plaintiffs, on the basis that the FDA approved the device after many years of rigorous testing.

On April 9, 2007, Judge Garsh denied DePuy’s Motion for Summary Judgment. In her carefully reasoned decision, Judge Garsh held that the allegations of the Plaintiffs’ Complaints, if proven true, state several causes of action which are not preempted by the FDA’s approval of the Disc. The Plaintiffs’ Complaints contend that DePuy provided the FDA with incomplete and misleading information concerning its clinical trials, and that DePuy made false representations in regard to the performance capabilities of the Disc, Accordingly, Judge Garsh ruled that FDA preemption cannot form a shield to claims whirch are based upon problems with the Disc’s design and performance that DePuy failed to disclose to the FDA during the application process.

In addition, Judge Garsh ruled that DePuy made express representations to doctors, patients and the general public concerning the Disc’s safety and effectiveness, which exceeded the performance capabilities which DePuy presented to the FDA. Noting that preemption immunity cannot extend beyond the performance capabilities that the FDA actually reviewed, Judge Garsh held that DePuy is liable for the promises it made which were never considered or approved by the FDA.

Prior to the Court’s ruling, DePuy had obtained a stay of all discovery. With this ruling in place, the discovery process will begin in earnest, and the Plaintiffs will be able to obtain written documents and to take depositions in pursuit of the resolution of their claims.

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