When things go wrong in the operating room, it can sometimes be difficult to discern who the real perpetrator is. In the case of thousands of hip implants designed and sold by Johnson & Johnson, the issue is with the company producing and selling the implants, not the hospital or the doctor. Andrew Ekdahl, appointed in 2011 to head the company’s troubled DePuy Orthopaedics division after the flawed implant had been recalled, tried at first to say that it was not the design that was flawed. Rather, he argued that the surgeons were not implanting them correctly.
However, there is much evidence which allegedly points to the contrary. Before it was sold in the U.S., the device (the Articular Surface Replacement, or A.S.R.) was used in other countries for an alternative hip replacement procedure called resurfacing. It was not used in the United States because the Food and Drug Administration would not pass it due to concerns about “high concentration of metal ions” found in the blood of patients who had received the device.
Mr. Ekdahl, head of the marketing team in charge of the device at the time, failed to disclose this information when marketing the device outside of the United States. When a news article appeared last year about the FDA’s ruling, Mr. Ekdahl issued a statement that any implication that the FDA had determined there were safety issues with the A.S.R. was “simply untrue”. In 2009, the FDA was still asking the company for more safety information regarding the hip implant version which was being used in the United States.
Since the A.S.R.’s introduction to the U.S. in 2005, more than 10,000 lawsuits have been filed against DePuy regarding the device. The first of these cases to go to trial is currently being fought in court in Los Angeles. Recently, portions of Mr. Ekdahl’s videotaped testimony was shown for the jury. In the video, when pressed as to whether DePuy decided to recall the A.S.R. due to safety issues, Ekdahl insisted that the company did it “because it did not meet the clinical standards we wanted in the marketplace.”
Despite that assertion, Mr. Ekdahl and other DePuy marketing executives all allegedly publicly stated at the time that the device was performing extremely well. Internal documents on the other hand, conflict with those statements. The documents have recently been made available to the public as a result of the litigation.
Included in these documents is a statement made in 2008 by Dr. William Griffin, a surgeon who served as one of DePuy’s top consultants. He allegedly told Mr. Ekdahl and two other DePuy marketing officials that he had concerns regarding the cup component of the A.S.R. and that he believed it should be “redesigned”.
Before the device was recalled in 2010, DePuy was aggressively promoting it in the U.S. as a breakthrough device and implanting it into thousands of patients. Yet internal DePuy projections estimated that it would allegedly fail in 40% of patients within five years, a rate eight times higher than normal.
According to Mr. Ekdahl’s testimony, he did participate in a meeting that resulted in a proposal to redesign the A.S.R.’s cup, but the plan was dropped. The reasoning used was that sales of the device did not justify the expense.
At DiTommaso Lubin, with offices located in Oak Brook and Chicago, our business litigation attorneys represent business owners and professionals in this and other business disputes and claims throughout the Chicagoland area including Cook, DuPage, Lake, Kane, McHenry and Will Counties and in the Mid-West region including Indiana, Wisconsin and Iowa including in Naperville and Aurora.