Republicans often bemoan what they view as the heavy burden of government regulation. But the absence of such regulation, combined with the prevalence of industry-bought loopholes, adversely affects Americans every single day.
A case in point: I recently read an alarming story by Will Bunch of the Philadelphia Daily News about how thousands of patients received faulty hip replacements from DePuy Orthopaedics, a subsidiary of Johnson & Johnson. They were infected, Bunch wrote, “with toxins like chromium, the same cancer-causing substance at the heart of the movie ‘Erin Brockovich’… DePuy has already recalled 93,000 of the devices and the president of the subsidiary has resigned.”
The FDA, as Bunch notes, should’ve caught this problem before it escalated. Reported the New York Times last year:
Until late summer, officials at the Johnson & Johnson unit, DePuy Orthopaedics, the largest maker of replacement hips worldwide, maintained that the A.S.R. [Articular Surface Replacement] was performing on a par with competing devices. But interviews with doctors indicate that DePuy received repeated warnings that the implant was failing and that surgeons were abandoning it.
The brief and troubled life of DePuy’s A.S.R. hip points to a medical implant system that is piecemeal and broken on many fronts, critics say. Unlike new drugs, many of which go through a series of clinical trials before receiving approval from the Food and Drug Administration, critical implants can be sold without such testing if a device, like an artificial hip, resembles an implant already approved and used on patients….
As patients began complaining, doctors and regulators here remained largely unaware that the problem was widespread because no independent monitoring system exists in this country that tracks implant failures. Such a database, used in other countries, might have clued in American orthopedists to the problem. In addition, doctors who tried to sound an alert said they had been rebuffed by DePuy.
Houston-based attorney Ed Blizzard is now representing at least a dozen of several hundred patients who suffered from defective hip implants and are suing DePuy for damages. “The company knew the risk and failed to warn physicians and patients about the risk,” said Blizzard. In 2007, Blizzard won a $4.85 billion settlement from Merck on behalf of 27,000 patients who suffered complications, including cardiac arrest, after taking its drug, Vioxx, for arthritis pain.