The first lawsuit in response to the ongoing and massive DePuy ASR debacle is being heard this week. Opening statements reveal some rather distressing issues about how DePuy Orthopaedics and it parent company, Johnson & Johnson, appeared to have prioritized financial concerns over patient care. Some 10,000 hip implant lawsuits have been filed against DePuy over its all-metal ASR hip devices.
Attorneys for the plaintiff in this case, Loren Kransky, are looking to show jurors how DePuy long knew its device suffered from a serious design defect that was kept from surgeons, noted Bloomberg.com. Kransky’s attorneys allege that the ASR led to hip instability. Constructed with metal cups, the device components were unable to create an “ingrowth” with the bone, an issue blamed on the ASR’s shallow design. Also, the chromium and cobalt construction and that the components rub against one another in normal wear and tear, have allegedly caused toxic metal ions to seep into the bloodstream, leading to dangerous adverse effects.
The ASR’s flaws led to its 2010 recall, according to Magnus Flett, a DePuy project manager, called as the first witness this week, said Bloomberg.com. Flett led a design team and was also responsible for a group that conducted a “failure mode and effect” (FMEA) review of a device cup designed to be shallower than traditional cups.
Kransky’s case alleges failure to warn, defective design, and negligent recall. DePuy denies these allegations and accuses Kransky’s attorney of weaving “snippets of e-mails, smidgens of depositions and sound bites of memos” to falsely present the device maker, said Bloomberg.com.
A May 2, 2008 email was introduced in which DePuy’s head of U.S. marketing, Paul Berman, wrote that, “We will ultimately need a cup redesign but the short-term action is manage perceptions.” Bloomberg.com also wrote that, on July 2, 2008, one of Berman’s emails concerning sales representatives stated that, “telling surgeons DePuy is making an emergency change to the ASR cup. We must keep the ASR 2 project under total wrap, particularly in the U.S. where we will not make the change immediately. As expected, the competition will use this information against us.”
In yet another damaging email, Berman wrote that, “Lastly, I propose any future reference to ASR 2 is Project Alpha. Please be cognizant about who you discuss this project with, particularly outside the company,” according to Bloomberg.com. Flett said DePuy abandoned ASR redesign efforts over financial and business concerns, adding that DePuy never advised surgeons about ASR failure rates and the need for revision surgeries were occurring at a rate eight times greater than that of DePuy’s Pinnacle device saying. “I don’t believe that was clinically relevant,” according to Bloomberg.com.
Concerning a proposed study comparing two metal-on-metal devices—the ASR and the Pinnacle—Flett, in an email presented in the case, said, “This study seems like suicide to me. Under testimony, he said that he felt the study would be suicide because “it will prove that one is better than the other and they are both our products and that means one will be worse.” DePuy ceased selling the device in late 2009, said Bloomberg.com. “We didn’t see the sales of the product continuing the way we wanted, so we took it off the market,” Flett said.
When data from Britain revealed a more-than 12 percent failure rate in the devices after five years—a significantly high failure rate—Johnson & Johnson recalled the devices. Meanwhile, according to Kransky’s attorney, internal company documents revealed that 38 percent of the hips failed in 4.6 years; an Australian joint registry revealed a 44 percent failure rate in seven years, said Bloomberg.com. In fact, according to a DePuy document dated September 27, 2007, “massively increased wear” can take place when the device’s cup is “oriented at a steep angle.” The document pointed out that DePuy could “significantly redesign” the device to remove a design groove, or ridge. This design change was never made.