Maryland Injury Law Center
A New York Times article yesterday on the Zimmer Durom Cup’s problems underscores the post-market surveillance problem with drugs and medical devices, pointing to the Zimmer Durom Cup problems that have led to Zimmer recalling their hip replacement component. This is a Zimmer fault; they should have a system of tracking and honestly responding to reports of problems with their hip replacement components. But we cannot expect drug and medical device companies to police themselves. Here, the Zimmer Durom Cup recall was precipitated by Larry Dorr, an orthopedic surgeon who is the medical director of the Dorr Institute for Arthritis Research and Education in California, who outed Zimmer, who previously paid him as a consultant, by speaking up in public about the problems and Zimmer’s blind eye to them.
Safety and speed are the yin and yang of regulating drugs and medical devices. Americans want both; we want safe and well-tested medical devices, but we also want instant access to breakthrough products. But not we should not treat all new drugs and devices equally. We needed to rush new AIDS drugs onto the market with little testing 10 years ago because the risk-benefit analysis demanded it. But some of this other stuff? Sure, the marketing department of the drug and device companies would prefer it that way, but is that the best thing for the consumer or even the pharmaceutical company in the long run?
Adding to the problem is the Prescription Drug User Fee Act in 1992, which was a deal between the FDA and the drug industry. Drug and medical device companies agreed to pay millions of dollars in fees, and the FDA promised that they would complete drug and medical device reviews within a year for those products on the fast track.