May 14, 2013

Patient Safety Attorneys Call for FDA Review of “Loophole” That Allowed DePuy Hip Implant Approval

by Levin & Perconti

DePuy hip implants trials and settlement negotiations are underway. Though, the legal ramifications of the defective hip implants will likely continue for a while into the future. That is because there are so many who have been affected, and because some patients may eventually be harmed in the future. The defective metal-on-metal hips designed by DePuy Orthopaedics were only recalled a pair of years ago, and ill-effects sometimes take several years to develop. That means that some patients may seem fine now, but suffer injury as a result of the defect down the road.

The DePuy lawsuits are obviously intended to ensure those harmed receive fair compensation for their losses, including medical bills, lost wages, pain and suffering. In addition, however, many DePuy injury lawyer are also working to ensure that lessons are learned from this situation so that fewer dangerous medical devices make their way into patient bodies in the future. One key aspect of that battle is fixing the current process by which those products are approved by federal regulators and become legal to use.

Altering the FDA Approval Process
Thomas Reuters recently published a story that explores how many attorneys working for plaintiffs are asking the U.S. Food and Drug Administration (FDA) to change the manner by which these products achieve administrative approval. The calls are being made in response to a wide range of metal-on-metal implants which have subsequently been recalled, including DePuy products.

Right now, the current rules allows manufacturers of these products to go through an “alternative” process by which they only need to show certain similarity between the new product and one that was already on the market. This avoids the need to do extra testing, like clinical studies, to ensure that the product is safe and will not cause undue harm to patients.

It looks like that process will change in the future. The FDA announced in January that manufacturers would no longer be able to avoid a more extensive review. This change would apparently apply to both risky products still on the market and any new products that manufacturers may want to introduce down the road. A letter last month from the American Association for Justice, voiced support for a chance in procedure.

Access to Justice Concerns
Yet, in supporting the change in FDA rules, the president of the AAJ noted that it was critical the alteration did not affect the civil justice rights of those harmed by the products. The concern was that manufacturers of these devices might use premarket approval retroactively in an attempt to defeat a personal injury claim that was filed before the change in approval process. Those working on suits for the manufacturers have hinted that they may try to use FDA approval under the new process to beat back injury claims of those hurt by the implants in the past few years. The possibility of this legal tactic working was reinforced by an older U.S. Supreme Court ruling regarding liability following full FDA market approval.

To avoid this, the AAJ is urging the FDA in include language in the final rule to ensure plaintiffs do not have their claims thrown out.

Our DePuy implant lawyers will be following these developments closely, and working to ensure the rights of injured patients and their families are respected every step of the way.


See Other Posts:

FDA Taking Another Look at Safety of Robotic Medical Tools

Significant Compensatory Damages Awarded in First DePuy Hip Implant Trial