Given the recent problems of hip and knee replacement devices, the FDA approval process for implanted high-risk or Class II products like Stryker Rejuvenate and ABG II should be called into question
West Palm Beach, Florida (PRWEB) May 08, 2014
The United States Judicial Panel on Multidistrict Litigation (JPML) statistics show sharp increases in pending cases against Stryker Rejuvenate and ABG II hip implants in only a few months. In February 2014, there were 576 pending cases. That number jumped to 699 in April 2014. These increases can be attributed to more patients coming forward to seek legal advice because they are experiencing the effects of these hip implants and want to find out what their options are. (MDL Case No. 2441, Stryker Rejuvenate and ABG II Hip Implant Products Liability Litigation Donovan W Frank (U.S. District Judge))
As a member of the Plaintiff’s Steering Committee for the multi-district litigation case against Stryker Rejuvenate and ABG II devices, Joseph A. Osborne of Babbitt Johnson Osborne & Le Clainche has been following the complexities of the Stryker case closely.
Experienced in handling large medical device cases such as this one, Osborne believes the case increase is due to the fact that firms like Babbitt, Johnson, Osborne and Le Clainche have encouraged people injured as a result of hip replacement surgery, to speak to knowledgeable Stryker Rejuvenate and ABG II Lawyers about their rights and what they can do to put their life back together.
Osborne also takes the long view of this medical device case, and suggests that the FDA approval process bears some responsibility for the product reaching the market. “Given the recent problems of hip and knee replacement devices, the FDA approval process for implanted high-risk or Class II products like Stryker Rejuvenate and ABG II should be called into question,” said Osborne.
The Stryker Corporation is one of the world’s largest medical device companies. In 2010, it released its Rejuvenate and ABG II devices; a modular hip system of femoral bodies and necks. Heavily promoted to surgeons, the product was touted for its enhanced stability, proven modularity, and inoperative flexibility. Yet the Stryker Rejuvenate and ABG II hip implants were not obligated to undergo more rigorous and stringent clinical trials as other high-risk or Class II medical devices would. Instead, this product obtained FDA approval through the less stringent 510(k) process that allows a medical device manufacturer to obtain FDA approval without clinical trials as long as the product is “substantially equivalent” to a product already on the market. (MDL Case No. 2441, Stryker Rejuvenate and ABG II Hip Implant Products Liability Litigation Donovan W Frank (U.S. District Judge))
Osborne believes that high-risk, Class II medical device manufacturers, like Stryker should be required to conduct more testing and complete the clinical trials before submitting their application for FDA approval so that these high-risk products will be much safer for patients in the future.
“Sadly, if a high-risk medical device is found to be defective, the FDA only learns of the harm after it has already been used by the public,” states Osborne. “In those cases, the FDA may issue a warning or a ‘recall’ to prevent further harm, and to stop the product from being used but by then it’s too late for those already injured. There is no recourse after the fact.”
If you have been injured from a Stryker hip implant device, contact our Stryker Rejuvenate and ABG II attorneys for a free confidential consultation and case evaluation at http://www.babbitt-johnson.com or 561-684-2500.
About Babbitt, Johnson, Osborne and Le Clainche
Since 1965, Babbitt, Johnson, Osborne and Le Clainche, P.A. in West Palm Beach, Florida has been seeking justice for its clients in personal injury cases against people and businesses whose negligent behavior has caused serious injury. To find out more about how Babbitt, Johnson, Osborne and Le Clainche can help, visit babbitt-johnson.com or call (888) 666-0523.