Recalls and Financial Conflicts of Interest

Written by: Barbara Postol

Johnson & Johnson recently recalled a hip implant due to the potential risks it posed for patients. The bad news is that over 90,000 patients have this device already implanted and it is expected that the device will fail in 40 percent of the patients in the next five years. The New York Times quotes a compliance officer for DePuy Orthopedics, division of Johnson & Johnson, who stated that in regard to appropriate engineering controls to foresee any problems with the device, “They did their job, but they could have done it better.”

Meeting the standard may be all right when we are buying a new pair of shoes or a new refrigerator, but a hip implant? I would hope that any device being surgically implanted into my body would exceed any standard. Unfortunately these occurrences are not uncommon with medical devices.

There are often recalls after the fact. We as patients may ask ourselves how this can happen. We feel safe that medical devices we need are safe and effective. How are they on the market if they are not?  What should we know? A big question I always ask myself is what role profit may play. Financial conflicts of interest are very real…and very dangerous in medicine. Sometimes devices go to market that appear safe and effective only to discover “something” was  not right… but it is when patients are harmed that action is taken.

A good first step is being an aware patient. When the renowned Cleveland Clinic was under fire for having financial associations with industry and not having these relationships disclosed to patients, the medical center changed policy. All conflicts of interest were submitted for approval and beginning in 2008 are disclosed on their website. More institutions are moving toward online disclosure models. The method at Cleveland Clinic is a good example. All industry ties are disclosed; these include royalty payment, stock, inventor, consulting, and any officer or director duties. Additionally, many physicians must disclose to their patients their ties with industry. For example, surgeons who are going to do a knee replacement surgery and may have any tie with the medical device manufacturer should let patients know of this association.

While disclosure is not the ultimate solution, it is a start. What other information should be disclosed to patients?