Biologic FDA Investigation
The Associated Press (3/19, Perrone) reported that ReGen Biologics, the medical device maker "at the center of a highly controversial Food and Drug Administration approval, is pushing back against the agency's plan to reevaluate" its Menaflex knee repair implant. The company's "implant spent more than three contentious years under review at the FDA before gaining approval in 2008." But "when newly appointed Obama administration officials re-examined the approval last year, they concluded that FDA's decision was influenced by intense lobbying by lawmakers from Regen's home state of New Jersey."
However, the Wall Street Journal (3/22, Mundy) notes that the move to reevaluate the device is raising concerns over whether the FDA has the authority to reevaluate the previously-approved device. Regarding an advisory panel's reevaluation of the device this week, FDA Deputy Commissioner Joshua Sharfstein said, "The FDA is committed to a fair and thorough decision-making process on this device, including obtaining key scientific input from the expert panel this week." He added that the panel "will explain the scientific and legal basis of its decision."
In an earlier article, the Wall Street Journal (3/20, Mundy, Favole) reported that the agency stated, "Overall, the FDA believes that [ReGen] did not provide adequate pre-clinical mechanical testing data to clearly demonstrate safety against mechanical failure."
New Jersey's Star Leger (3/20, Todd) called the FDA's move "unprecedented," while ReGen CEO Gerald Bisbee "described the company as a scapegoat." Bisbee said, "We don't feel this is fair. ... We don't know why we have to do this. It does seem like double-jeopardy."
Help for Knee Replacement Patients
Hundreds of people who received a ReGen Menaflex knee implant now face a painful reality - the products in their bodies may be defective and need to be replaced. If you have a ReGen Menaflex knee implant in your body, you should speak with your doctor. Symptoms of defective implants include pain and reduced mobility.
Then call Hughes Ellzey, LLP, at 1-888-350-3931.
You should also complete the ReGen Menaflex Knee Implant Client Questionnaire and return it to our office as soon as possible. The ReGen Menaflex law firm of Hughes Ellzey, LLP is seeks to obtain compensation for individuals who received the ReGen Menaflex defective knee implant. ReGen knee implant lawyer W. Craft Hughes will work to help you obtain the compensation you deserve. This compensation can include money for replacement surgery, related medical bills, physical therapy, lost of income and pain and suffering.
The content on www.crafthugheslaw.com should NOT be taken as a substitute for advice by a competent attorney or medical professional. The site is sponsored by attorney W. Craft Hughes and the law firm of Hughes Ellzey, LLP, located at 2700 Post Oak Blvd., Suite 1120 Galleria Tower I Houston, TX 77056; Phone 1-888-350-3931. The law firm is licensed to practice in Texas but not elsewhere. On certain mass tort claims, cases may be filed in a state and/or transferred for multi-district litigation to a state other than the client's primary residence. Use of this website or submission of an online form does NOT constitute the forming of an attorney-client relationship. Accordingly, no attorney-client relationship is formed until (1) you are contacted by an attorney from Hughes Ellzey, LLP and (2) you sign a written client agreement. Information contained on www.crafthugheslaw.com, including but not limited to written text, images, informational articles, on-site links and off-site links, has not been prepared, endorsed or reviewed by any form of licensed medical professional, including but not limited to physicians, doctors, medical experts and so on. Nothing on this website should be taken as medical advice, but instead should act as a useful resource in providing general information that may be useful to members of the general public. All visitors are encouraged to consult with a physician or other licensed medical professional for any form of medical advice.
