More testimony is being heard in the second of nearly 11,000 lawsuits brought over the now-recalled DePuy Orthopaedics’ ASR metal-on-metal hip device implant. DePuy Orthopaedics is a unit of Johnson & Johnson.
Testimony was heard from an orthopedic surgeon who assisted DePuy in its development of the ASR. Thomas P. Schmalzried testified that, while he believed the design process was thorough, he would not implant the device today, wrote Law360. Schmalzried also testified that he served on the design teams for the ASR and DePuy’s Pinnacle cup system, another hip replacement device, and was paid some $20 million over the past 13 years.
The money was received, for the most part, through royalty payments related to the intellectual property he contributed to DePuy’s Pinnacle and the ASR. Schmalzried also testified that DePuy collaborated with surgeons from around the world in the development of the ASR; the design process continued for a number of years before the ASR was released, according to Law360.
The surgeon also testified that he believed DePuy had acted responsibly on the ASR design process; however, on cross-examination, he confirmed that for every ASR implanted, he received a royalty payment. This included ASRs implanted across the globe and did not include implant surgeries he conducted or that were conducted at the hospital where he worked, said Law360. In fact, said Schmalzried, he received ASR royalties even after he stopped using them in 2009. Schmalzried also received Pinnacle cup royalties, which have been used in revision surgeries for some patients who had the ASR removed and replaced with a different device, said Law360.
When asked if could be paid an ASR royalty and then paid a Pinnacle royalty on a patient whose ASR was replaced with a Pinnacle, Schmalzried said that he could, noted Law360. Schmalzried confirmed that of the 66 ASR XLs he implanted, 15 required revision; he also acknowledged that this represented an unacceptable revision rate, stating “I would not implant the ASR XL today,” adding that he has not used any device in the metal-on-metal category in some time. He also testified that he agreed that the benefits of the ASR XL do not outweigh its risks, said Law360.
We’ve long written that the relationships and finances exchanged between industry and researchers points to a bias in which patients are often not the prime concern. When industry pays physicians, treatment options are potentially influenced and doctors often opt for more expensive drugs and devices, which in turn, tends to drive costs. A prior The New York Times review revealed that about 25 percent of all physicians accept cash from drug and device makers and about 2/3rds accept meals in exchange for advice and speaking engagements. The Times also revealed that physicians receiving money from drug makers tend to practice medicine in different ways than physicians who do not accept industry gifts, and that doctors working with industry also tend to prescribe medications in riskier and unapproved ways.
Johnson & Johnson continues to deny that the ASR was defectively designed. Meanwhile, the defendant in the first case, which was heard in Los Angeles, was recently awarded $8.3 million in compensatory damages over the DePuy ASR. That jury found that the ASR was defectively designed, said Bloomberg News. This second case, brought by Carol Strum, 54, includes allegations that the DePuy ASR failed three years after implantation. This caused Strum to undergo revision surgery, a painful and costly process that involves removing and replacing the ASR. DePuy ASR’s faulty design caused its failure and the need for additional surgery and also caused her to develop high metal concentrations in her blood, Strum alleged.
The DePuy ASR was recalled globally in August 2010 after Johnson & Johnson stated that the device was associated with a 12 percent failure rate in five years in the United Kingdom. Since, Australian joint registry data has revealed a more than 40 percent failure rate there. Johnson & Johnson said the recall was implemented over the device’s high failure rate, not a product defect, Bloomberg News noted.