Thousands of failures later, feds to finally regulate hip replacements


The environmental issues that I most typically blog about here are really part of a larger problem in our society. It’s something we see time and time again — government failing to protect the little guy, and instead kowtowing to powerful and wealthy interests. Certainly you see that in a matter like the BP oil spill, where the government was too lax in regulating off-shore drilling before the Deepwater Horizon catastrophe, and then compounded its errors after the explosion, allowing the firm to spray its toxic dispersant Corexit with little oversight. Only now, two years later, is the government pushing for billions in penalties from BP — after the Gulf and its marine life have been devastated.

It’s a similar story with another issue that I’ve been following, involving federal regulation of medical devices. In recent years, doctors began using all-metal hip replacements on patients, with little or no testing on what side effects might arise from their use. The results — serious complications, even death — have been sadly predictable. Only now is Washington moving in with a solution that should have been obvious in the first place:

After an estimated 500,000 patients in the United States have received a type of artificial hip that is failing early in many cases, the Food and Drug Administration is proposing rules that could stop manufacturers from selling such implants.

Under the proposal, which the agency is expected to announce on Thursday, makers of artificial hips with all-metal components would have to prove the devices were safe and effective before they could continue selling existing ones or obtain approval for new all-metal designs. Currently, companies have to show only that their devices resemble ones already on the market, and they are not required to conduct clinical studies before selling them.

The F.D.A. action is intended to close a loophole in the 1976 federal law under which medical devices were first regulated. It is the agency’s first use of powers that Congress granted to it last year to deal with medical devices, like all-metal hips, that have been in regulatory limbo for decades.

The move comes amid one of the biggest device-related failures in decades. Just a few years ago, all-metal hips — implants in which the ball and cup component is made from a metallic alloy — were used in one of every three joint replacement procedures performed annually in the United States.

As the article notes, major companies such as Johnson & Johnson and Zimmer Holdings were permitted by the FDA to begin implanting some all-metel hip replacements without any clinical trials whatsoever. That’s appalling. When many of these replacements began to fail, comtamination from the metal components has caused serious illness. It make take a generation for lawyers such as myself to obtain justice for the injured patients and their families.

These lawsuits against the manufacturers and their shoddy medical devices are a necessary response now — but it didn’t have to be this way. If the FDA had enforced the rules that it’s proposing now over the last 10-15 years, thousands of people with hip replacements would still be in good health. How many times does Washington have to close the barn door after all the horses have escaped — and stampeded — before the public officials trusted with our health and safety get it right on the first try?

To read the New York Times articles on the FDA’s new proposed rules for clinical trials on hip replacements, check out:

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Stuart H. Smith is an attorney based in New Orleans fighting major oil companies and other polluters.
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