DePuy Knee Recall
Medical Device Giants DePuy and Johnson & Johnson in the news again
DePuy Orthopaedics, a Johnson & Johnson subsidiary, has recalled another orthopedic product. This time it is a DePuy knee recall - defective knee replacements, specifically the LPS Diaphyseal Sleeve. According to DePuy, the LPS Diaphyseal Sleeve was intended for "use in primary and revision knee joint replacement in the treatment of patients presenting bone loss and deformity associated with bone tumors resection, trauma, infection, and difficult revision arthroplasty." Johnson & Johnson is currently involved in more than 10,000 lawsuits over its recalled ASR hips and nearly as many lawsuits over its recalled transvaginal mesh. While Johnson & Johnson has a reputation of denying claims and fighting to its last breath against defective products claims, it is fighting a losing battle on (now) three different fronts by tens of thousands of injured patients. And in at least two of those lawsuits, Johnson & Johnson has admitted that its products were defective and/or dangerous.
DePuy LPS Diaphyseal Sleeve Recall - DePuy Knee Recall
According to the FDA, the LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients. This may result in fracture of the sleeve at the taper joint which may also lead to loss of function or loss of limb, infection, compromised soft tissue, or death.
On Jan. 4, 2013, DePuy issued an Urgent Medical Device Recall informing hospitals and surgeons of the problem and to immediately stop distributing or using the recalled lots.
DePuy Knee Lawsuit - Defective Hips all over again?
Mr. Merman is currently involved in the DePuy hip litigation in Ohio. As he stated in his original complaint against DePuy and Johnson & Johnson in the Southern District of Texas, "The ASR devices were not subject to the rigorous premarket approval (PMA) testing and approval pursuant to 21 U.S.C. § 360(e). Instead, DePuy Orthopaedics, Inc. and/or Johnson & Johnson, Inc. obtained approval from the FDA to market the ASR XL Acetabulum System in the United States through the 510(k) premarket notification process pursuant to 21 U.S.C. § 360(k) asserting that it was substantially equivalent to other hip replacement systems already available on the market."
The DePuy knee recall and DePuy knee lawsuit involve a lot of similar issues. With its DePuy LPS Diaphyseal Sleeve, DePuy claimed that the device was "substantially similar" to several products previously approved by the FDA, at least one of which was intended for use in hips. But DePuy claimed they were so similar that they did not need to go through full and rigorous premarket approval.
Mr. Merman was quoted on PRWeb discussing the recent DePuy knee recall and discussing the imminent litigation. Mr. Merman (of the Merman Law Firm) explained that the DePuy LPS Diaphyseal Sleeve was not subjected to the rigorous full premarket approval that new products are required to achieve.
DePuy Knee Lawsuit - The Merman Law Firm
Mr. Merman was quoted as saying "DePuy, as it did with the defective ASR hips, circumvented full FDA premarket approval by claiming its DePuy LPS Diaphyseal Sleeve (DePuy knee replacement) was substantially similar to products made decades earlier. This is the same strategy it used to receive approval to market its defective hips that resulted in more than 10,000 lawsuits." See the full article at http://www.prweb.com/releases/2013/2/prweb9423116.htm