FDA Advisors Failed to Disclose Financial Gains from Medical Device Manufacturers

Stryker Hip; Zimmer Knee; Da Vinci Robot; the power morcellator – these are all products that consumers trusted because they were approved by the U.S. Food and Drug Administration (FDA), but that are now the targets of defective medical device lawsuits.

In each case, the product has left patients more injured than the original condition to be treated. But it turns out that the FDA approval process may not be as neutral as most people expect.

FDA advisers receive cash from device makers

According to a recent Wall Street Journal report, the FDA continuously fails to disclose financial gains that advisory committee members receive from manufacturers of the devices under their review for approval. The FDA states that its advisory committees “play an essential role in FDA’s activities to protect and promote public health through regulation of human and animal drugs, biological products, medical devices, and foods. FDA’s advisory committees provide independent expert advice to the agency on scientific, technical, and policy matters related to the development and evaluation of FDA-regulated products.” It goes on to explain that the FDA screens all potential advisory committee members for a financial conflict of interest and may grant a waiver in situations such as where the potential member’s expertise outweighs the potential for conflict of interest.

The FDA’s waiver guidelines allow for a waiver where the expert’s conflicting financial interest is $50,000 or less and his or her expertise is considered essential. However, according to the Wall Street Journal, nearly 10% of the FDA’s advisors have received research or consulting fees from the companies that manufacture the products they evaluate. Physicians on advisory committees received payments ranging from $500 to over $100,000, but the FDA reports only about 1% of the corporate ties.

Ongoing defective medical device lawsuits

Unlike many personal injuries, defective medical devices often harm scores of individuals in a similar way. To handle hundreds or thousands of product liability lawsuits related to a single device, the federal courts tend to create a multidistrict litigation (MDL) to streamline the claims. The MDL has the benefit of preventing duplicative pretrial discovery and contradictory rulings from different jurisdictions. It also encourages wide-spread settlement negotiations – for example, in the recent past, a multidistrict litigation led to a $1.43 billion settlement between Stryker Corporation and plaintiffs who received Rejuvenate and ABG II metal hip implants.

MDL proceedings are also beneficial for plaintiffs in that each party retains its own claim, unlike a class action lawsuit where a class representative stands in place of all of the other similarly-situated plaintiffs. Even though there are MDLs underway against many defective device manufacturers, other victims can still file lawsuits and be added to the proceedings.

New Jersey product liability lawyers on your side

If you have been injured by a defective medical device, you may be entitled to compensation for your medical expenses for revision procedures, lost wages, and for non-economic losses such as pain and suffering and loss of companionship.

Eisbrouch Marsh is committed to helping New Jersey and New York area residents recover compensation as a way to keep others safe from faulty medical devices. We offer a free legal consultation to review your situation and determine your best course of action. Of course, you do not pay us unless we win compensation on your behalf.

Call 201-342-5545 to discuss your options with our leading team of New Jersey product liability lawyers.

Resources

1. Medscape, FDA Often Fails to Disclose Advisers’ Corporate Ties: WSJ, http://www.medscape.com/viewarticle/836327
2. FDA.gov, Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees, http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/LawsRegulationsGuidance/default.htm