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.
But as I pointed out last year, all of this new FDA money was for clinical trials and other pre-market efforts. They made no investment in post-market surveillance once consumers used the product. While the FDA still looked at drugs and medical devices after market introduction, this wing of the FDA became the odd man out regarding funding, which means it lost the best people and resources.
The Prescription Drug User Fee Act in 1992 had good intentions. But we need to focus more energies and money on trying to find new funding and give more attention to these products after they are on the market. As the Times article points out, many believe that a starting point is a national database — used by such countries as Australia, Britain, Norway, and Sweden—to register these problems and require the companies to explain the reports.
For a real-life example, Zimmer still sells in the United States a knee implant, known as the Unispacer, even though Australian doctors stopped using it three years ago after registry data showed it had quickly failed in more than half the 40 patients who received it there.
While a national registry and more accountability would not be a panacea, it would be a great starting place. We have 1 million hip replacements in this country each year. From an economic standpoint alone – for those of you who are not moved by human suffering – wouldn’t it make sense if we monitor how well the replacements are working?
We are investigating the Zimmer Durom Cup recall claims. Call 800-553-8082 or click here for a free Zimmer free consultation.