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Documents Show FDA Repeatedly Overruled Scientists’ Rejections in Menaflex Knee Device Approval

Political lobbying may have trumped FDA scientists’ opinions during the approval process for the medical device Menaflex, the Wall Street Journal reported March 6. According to the newspaper, internal documents and emails show that FDA scientists twice rejected an application for controversial “fast-track” approval by Menaflex maker ReGenBiologics Inc. before the agency later approved the device. Agency emails show that officials later removed language from a draft letter because it documented special treatment for ReGen.
Menaflex is an implant used to treat tears to the meniscus, the most commonly injured part of the knee. Millions of people undergo surgery to correct a torn meniscus every year, and some need to repeat the surgery later. This device is unique, according to Dr. Jay Mabrey, an orthopedic surgeon who chaired the FDA advisory committee that considered Menaflex. For that reason, Mabrey told the Wall Street Journal, he believes it should not have been fast-tracked. Mabrey said he now suspects that the FDA packed the committee with friendly members to secure approval for Menaflex.
The ordinary approval process was not working out well for Menaflex. According to the article, ReGen started a clinical trial required under the conventional approval process, only to be rebuked by the FDA for recordkeeping violations and a conflict of interests on its independent oversight panel. ReGen then applies fast-track approval process — which doesn’t require a clinical trial — even though devices must be substantially similar to an approved device to qualify. After the FDA rejected its request twice, ReGen enlisted lobbying help from elected officials and sent letters pressuring the FDA to remove officials who had rejected their requests before. The agency did what ReGen asked, even after FDA scientists disputed ReGen’s favorable analysis of the results in its clinical trial.
The agency is already under fire for its handling of medical device approvals. An anonymous group of FDA staffers wrote to the Obama transition team in January calling for the removal of top medical device officials, saying the process was “corrupted and distorted by current FDA managers.” Also in January, the watchdog General Accountability Office said the FDA was too quick to allow fast-track approval. If all of these allegations are true, they point to severe corruption of the regulatory process — and the science behind that regulation. And that would put patients who use and trust Menaflex in potential danger from an untested, unproven device.
As a defective medical device lawyer practicing in Missouri and around the nation, I have seen multiple cases of medical devices with serious flaws that cause real harm to patients. If improper pressure from ReGen contributes to another, victims could have a strong case against the company for knowingly bypassing safety regulations and selling an untested, unproven product. In a dangerous medical device claim, patients can win back all of the costs related to the injury, plus compensation for physical pain, emotional suffering and any permanent disability. Carey, Danis & Lowe handles these claims throughout the United States for a variety of unsafe medical devices, along with defective prescription drugs.
If you or someone you love has been hurt by Menaflex or any other flawed medical device and you’d like to learn more about your legal options, please contact the Lowe Law Firm online or call us at 1-877-678-3400.