An executive at Johnson & Johnson allegedly has admitted in an e-mail that the U.S. Food and Drug Administration (“FDA”) rejected approval on a DePuy Hip Replacement after reviewing studies conducted by the company. It is alleged, that the studies established that considerable numbers of the product failed too soon, thus creating the need for patients to undergo repeat surgeries.
According to news reports, the alleged statements that the executive made in the e-mail are in direct contrast with statements made by the company concerning the ASR hip replacement. The e-mail was reportedly written in August of 2009 by a DePuy Orthopedics vice president a few days after the FDA privately informed the manufacturer that one version of the hip replacement device did not gain approval.
Before the products recall, Johnson & Johnson was stubbornly maintaining that it was safe and insisted that company studies countered complaints made by surgeons and regulators overseas that the hip replacement apparatus was faulty. The New York Times reports that the mechanism that the FDA disapproved was only sold abroad, but a similar version was allegedly used in hundreds of Atlanta patients that was also recalled.
Several news sources have said that the executive allegedly told three other top ranking executives the reason given by the FDA. She allegedly told them that the apparatus did not meet FDA standards and that the FDA was troubled with the low rate of success seen in clinical trials. She also allegedly advised them not to send the FDA more information because it would not help to gain the products approval.
Australian regulators were advising DePuy to discontinue the product at about the same the e-mail was sent out. Shortly thereafter, Johnson & Johnson removed the hip replacement apparatus from the market claiming that poor sales and a softening market was to blame.
On Friday, February 20, 2015, Johnson & Johnson agreed to pay approximately $420 million more to resolve approximately 1400 additional DePuy ASR lawsuits. The order came from the Court extending the settlement offer to Plaintiffs who had revision surgery after August 31, 2013 up through January 31, 2015. Johnson & Johnson is offering the proposed settlement to citizens and residents of the United State who: 1) had an ASR hip implanted in the U.S.: and 2) whose ASR hip was revised between August 31, 2013 and January 31, 2015. DePuy is only making the settlement proposal to patients who received an ASR hip. The proposal does not cover any other hip implant device manufactured by DePuy.
The settlement proposal lists a number of factors which will determine the value of a settlement offer, such as whether you suffered a loss of income, whether you required another surgery after the revision of the ASR hip, your age, smoking history, and/or obesity.
Attorney Robert J. Fleming has been handling wrongful death cases, automobile accident cases, personal injury cases, dental malpractice and medical malpractice lawsuits for individuals and families who have been harmed, injured or died as a result of the carelessness or negligence of another for more than 20 years in and around Atlanta, Georgia and its surrounding areas, including Alpharetta, Austell, Avondale Estates, Chamblee, College Park, Conyers, Duluth, Decatur, Doraville, Hapeville, Johns Creek, Jonesboro, Lawrenceville, Norcross, Peachtree City, Riverdale, Roswell, Sandy Springs, Stone Mountain, and Smyrna. If you have been seriously injured and would like quality legal representation, contact Robert J. Fleming directly on (404) 525-5150 or contact us online.