Biologic Investigation Attorney
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 contact 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.
An Experienced and Determined Advocate
W. Craft Hughes is an accomplished personal injury lawyer with a record of success in cases involving Zimmer Durom hip replacements, DePuy ASR hip recall and other defective products. He understands the medical and legal issues that these cases present and will aggressively pursue compensation for you. If you have a defective ReGen Menaflex knee implant, you deserve compensation for corrective surgery, loss of income and pain and suffering.
Hughes Ellzey, LLP will seek maximum compensation for you
Important - if you are scheduled to have surgery to replace your knee implant, ask your surgeon to save the product and give it to you. It will serve as important evidence in your case.
Protect Your Rights - Contact Attorney W. Craft Hughes
For a free consultation with Hughes Ellzey, LLP, call 1-888-350-3931 or send us an e-mail. Located in Houston, we serve clients throughout Texas and across the nation.
ReGen Biologics Knee Device Faces FDA Review Of Earlier Approval
ReGen Biologics is about to face an FDA review of the agency's decision last December to approve the Menaflex knee-surgery device, the agency told Congress. Several scientists and managers at the FDA objected to its approval of the device, and congressional committees weighed in on the matter, prompting the FDA review. ReGen's device is intended for patients with severely torn tissue in their knee joint. The FDA was accused of excluding FDA experts who were concerned about the device and ReGen's role in the FDA's review process. ReGen contends the FDA was correct in the first place and said its device was safe and effective. However, there is a possibility the FDA may issue a ReGen Menaflex knee implant recall.
UPDATE: FDA: ReGen Knee Device OK Should Be Re-Evaluated
(Updates with additional information from FDA report and comment from deputy FDA director.)
By Alicia Mundy and Jared A. Favole
Of DOW JONES NEWSWIRES
WASHINGTON -(Dow Jones 09/24/2009)- The U.S. Food and Drug Administration said Thursday it still has "troubling" questions about the approval of ReGen Biologics Inc.'s (RGBO) knee-device and wants the approval completely re-evaluated.
In a report, the FDA said a review of the decision to approve ReGen's Menaflex knee device shows there isn't enough evidence to dispel questions about outside influence to approve the product. The device was approved in December 2008 despite reviews from a handful of FDA scientists showing the product shouldn't have been.
Joshua Sharfstein, the deputy director of the FDA, said in a conference call that the report shows there were "definite threats" to the integrity of the FDA's medical device review process.
The FDA report says over the device's 17-year approval history "multiple departures from processes, procedures, and practices occurred" and key important FDA reviewers failed to document the reasons for their decisions.
"This failure constitutes a clear deviation from the principles of integrity used in this review and undermines the ability of the agency to counter the suggestion that lobbying on behalf of ReGen affected the decision," the FDA report says.
The FDA director who granted approval for the device, Daniel Schultz, has since left the agency.
The FDA's report could have far-reaching effects for ReGen and the medical device industry, as the FDA announced Wednesday that it is reviewing its rapid- approval process for medical devices. Regen's device went through the FDA's rapid-approval process.
The FDA's clearance of the knee device has been under investigation by the agency since April, following reports in The Wall Street Journal that a top official at the agency had personally approved it under pressure from the company and members of Congress and over the objections of FDA scientists.
The approval was granted by then-FDA device division director Schultz, via the 510-K rapid approval process.
A half-dozen senior scientists at the FDA had reviewed the device, intended for meniscus surgery, over the three previous years and had all recommended against its approval because of concerns over safety and a lack of detailed testing data on its effectiveness. The company has said that the device is safe and that its effectiveness was proved in a study that was published in 2008. ReGen executives weren't immediately available for comment.
Sen. Chuck Grassley, R-Iowa, welcomed the FDA report; the Finance Committee on which he is ranking member has been investigating the knee device in part because of his ongoing concerns that too many medical devices were being approved over FDA science and medical officer objections.
"The report issued today is more good news about the FDA," Grassley said in a statement. "The agency failed to follow procedures, excluded the review team from speaking before an advisory panel, and was too quick to accommodate demands made by the device manufacturer."
ReGen Biologics Inc.'s Menaflex Device Said To Be "unsafe" - FDA Approves For Sale
September 25, 2009
In a front-page story, the New York Times (9/25, A1, Harris, Halbfinger) reports that the FDA released a report Thursday that said "four New Jersey congressmen and its own former commissioner unduly influenced the process that led to its decision last year to approve a patch for injured knees." FDA reviewers had determined that ReGen Biologics Inc.'s Menaflex device was "unsafe" because it "often failed, forcing patients to get another operation." Still, in response to "'extreme,' 'unusual' and persistent pressure," agency managers "approved the device for sale," the report indicated.
Joshua Sharfstein, the agency's principal deputy commissioner, said the report "shows there were 'definite threats' to the integrity of the FDA's medical-device review process," and as a result, the agency is now "reconsidering its decision on" the device, the Wall Street Journal (9/25, A4, Mundy, Favole) reports. But, he added that "the report isn't a reason for patients...to panic." Sharfstein also said "the ReGen issue was one reason that the agency has begun a complete review of the 510(k) program," the "fast-track process...under which Menaflex was approved."
"The report offered several recommendations to insulate FDA staff from outside pressures, all of which," Sharfstein said "will be adopted," according to the Washington Post (9/25, Layton). Among issues flagged by the report were "problems in the way the FDA regulates the $200 billion-a-year medical-devices market."
In fact, the report said that "after the FDA twice rejected the company's request for fast-track approval, ReGen enlisted the support of New Jersey lawmakers, who called then-FDA Commissioner Andrew von Eschenbach on the company's behalf," the AP (9/25, Perrone) reports. Eschenbach then "became involved in the case and pressed reviewers to issue a decision quickly," Bloomberg News (9/25, Larkin) reports.
Protect Your Rights - Contact Attorney W. Craft Hughes
For a free consultation with Hughes Ellzey, LLP, call 1-888-350-3931 or send us an e-mail. Located in Houston, we serve clients throughout Texas and across the nation.
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