DePuy ASR, An Example of What Happens When Doctors Don’t Come Forward

when-doctors-dont-come-fowardThe first of some 10,000 lawsuits over the DePuy ASR is being heard and is revealing a troubling trend seen in the physicians who were paid consultants to the device maker, DePuy Orthopaedics. DePuy is a unit of health care giant, Johnson & Johnson.

In one case, noted The New York Times, a doctor sent a note to a number of Johnson & Johnson executives stating that one of the firm’s artificial hips was so badly designed, its marketing should have been cut so that the firm could review why the device was injuring patients. The physician consultant wrote the note nearly two years before 93,000 of the DePuy Articular Surface Replacement (ASR) devices were globally recalled in 2010.

This was not the only “early waning” the device makers’ executives received from its paid consultants, noted The Times. Yet, despite numerous warnings DePuy Orthopaedics continued to tout the now-recalled device that is at the center of thousands of lawsuits and patient claims of serious injury. As bad, pointed out The Times, are the physician consultants who never went public with what they learned about the ASR to other surgeons and who kept implanting the faulty device. The startling memos have surfaced as part of the first trial brought against Johnson & Johnson over the ASR.

Metal-on-metal hip implant devices were created for greater durability and longevity and with the intention that the seemingly stronger components would be far superior over their more traditional counterparts that are constructed with plastic or ceramic components. In recent years, the metal devices have come under fire for failing at unexpectedly high rates and leaving patients with significant and, often, life long injuries. Some experts say that European and American regulators worked to ensure patients were unaware of the devices’ risks and many have criticized device makers for placing profits before patient safety.

As we’ve long been writing, research has linked the controversial metal-on-metal hip devices to adverse events that include tissue necrosis, implant site pain that can spread to the groin and back, inflammation, swelling, metal poisoning, high failure rates, osteolysis (bone loss), and fluid collection/solid mass development around the hip joint.

The Times points out that the case has brought into focus a significant medical issue concerning physicians’ ethical duty to warn colleagues about defective drugs and medical devices. “Questioning the status quo in medicine is not easy,” Dr. Harlan Krumholz, a professor at Yale School of Medicine, told The Times. Krumholz and other experts say doctors may remain quiet for any number of reasons, including fear of lawsuits, that a noted problem is anomalous, or that the problem has to do with an error they made, said The Times.

In some cases, it’s a matter of not wanting to handle the paperwork; in others, the issue may have to do with the doctor’s financial ties to the device or drug maker; in others, one doctor may fear the repercussions of coming forward when others do not, The Times pointed out.  “The standard in the medical community is not to report,” said Dr. Robert Hauser, a cardiologist who, with a colleague, warned other doctors in 2005 about a defective heart implant, said The Times.

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.

George Loewenstein, a professor at Carnegie Mellon University who has studied medical conflict-of-interest policies told The Times that money can shift a physician’s sense of loyalty. “If someone has been paying you or employing you, it is very difficult to blow the whistle,” said Professor Loewenstein, who teaches economics and psychology. “It offends our sense of loyalty,” he added. Dr. Krumholz pointed out that these so-called loyalties were between the physician and a firm’s executive, not with the company or its brand, wrote The Times. A doctor may actually see his relationships with these officials as friendships, while companies view these physicians as assets who help create these products and increase sales.

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