Consumer Reports Takes On DePuy Hip Replacement

Washington, DCOne has to wonder if we might be better off if the Consumers Union regulated the country's medical device industry, rather than the US Food and Drug Administration (FDA). Consumers Union publishes the venerable Consumer Reports magazine, a bastion of independent thought and testing upon which consumers have come to rely for unbiased ratings of products. But DePuy Hip replacement?

From appliances to cars, Consumer Reports is famous for fairness and neutrality. The publication has a reputation for "telling it like it is." And now, a new investigation by Consumer Reports decries the fact that too many implants and medical devices have not been properly tested and are failing early. DePuy hip is part of that list.

The Buffalo News, in its "MoneySmart" section published May 7, summarized an investigation by Consumer Reports—an entity which has been in existence for virtually as long as the FDA itself—that focused on four problematic areas inherent with the implant and medical devices industry. DePuy hip implant, together with all of its cousins in the metal-on-metal product line—made the list.

In fact, according to the Buffalo News, DePuy hip implant was singled out by the investigation as having been introduced in 2005 by the orthopedic division of pharmaceutical giant Johnson & Johnson based on an FDA policy that allows for the fast-tracking of medical devices to market based on their "substantial equivalence" to earlier devices.

The report noted that DePuy had distributed 93,000 of the problematic hips worldwide before triggering a Hip Replacement Recall in 2010 due to high failure rates. Prosthetic hips historically are expected to last, on average, about 15 years. The DePuy ASR, however, was failing in many patients within a few years, and in some cases, within 18 months.

Many patients have filed a DePuy lawsuit after their implant failed early and caused other health issues. The Consumer Reports investigation noted that the largely untested metal-on-metal hips could cause metal poisoning and the breakdown of tissue, amongst other health problems.

Current FDA policy states that so long as a medical device is substantially equivalent to one already on the market, the manufacturer can be spared the more rigorous testing necessary for a new device. The result is a fast track to market for a medical device or implant that requires little more than paperwork and a user fee to facilitate, according to the report.

The Buffalo News report noted that Congress is considering legislation that would not only preserve the current system, but also rather ratify an agreement between the FDA and the medical devices industry to facilitate an even earlier introduction to market of "grandfathered" devices such as DePuy Hip Replacement.

In contrast, Consumers Union and Consumer Reports is founded on the premise that there is no relationship between the publication and manufacturers. The organization does not rely on supplied products for testing, but rather purchases them from retail much in the same way as the average consumer. Ratings, as a result, are unbiased. The magazine recently pulled its recommendation for a popular motor vehicle because, in its view, the on-board dashboard and accessory interface on a newer model was too complex, and could cause the driver to remove his or her attention from the road.

In its report, Consumers Union supports the recommendation of the prestigious Institute of Medicine, issued last year, that the FDA overhaul its regulatory system for medical devices such as DePuy hip implant. To that end, the people who publish Consumer Reports call on the FDA to require that implants and other "life-sustaining" devices be tested at least as rigorously as drugs, and that the practice of grandfathering new devices and implants against existing devices be terminated.

The Hip Replacement Recall involving DePuy hip has seen countless patients have to go through revision surgery just a few years and sometimes months after their first surgery. The experience has led many DePuy patients to seek the services of a DePuy hip lawyer to pursue compensation.