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Product Liability Watch: Lax Standards for Medical Devices
Product liability cases are likely to stem from the latest news out of a Consumer Reports investigation.
The research determined that while tens of millions of Americans have some sort of implantation of a medical device in their bodies, the vast majority of those products have never been vetted for safety.
Our Product Liability Attorneys understand that this research encompasses a host of medical implants, including metal-on-metal hips, Lap-Bands, cardiac devices and surgical mesh. While these are the products highlighted by researchers, the study points to the larger issue of a regulatory system that doesn’t do what it claims: protect consumers.
Consumer Reports goes so far as to call it “broken.” Our product liability attorneys would concur, especially after reading the contents of the report, which indicates that most of the “testing” of these products takes place in the bodies of patients – who mistakenly believe that a surgeon would never push a product on them that could potentially be unsafe.
First, we need to understand that this is not a fringe issue. About one in five adults in America has had some kind of medical device implanted into their bodies for one reason or another. That’s roughly 20 percent, so this is not a minor problem.
While the Institute of Medicine has recommended that the federal Food and Drug Administration completely scrap its current medical product regulatory system and start over, U.S. legislators are instead tossing around a bill that would keep the status quo intact – and in fact, speed up the process of getting these products onto the market.
This legislation has terrifying implications in terms of the health of countless Americans. The reasoning is illustrated in the process that has already been applied to the four most common implantation devices.
The first is surgical mesh, for which there was no prior testing required. Specifically, women were implanted with a transvaginal mesh – which is basically woven fabric used to strengthen tissue – in order to offer bladder support. Although there have been thousands of reports indicating that these mesh products have caused major damage, they are still being hawked as a “moderate risk.” Manufacturers were able to bypass even the minimum testing requirements by exploiting a legal loophole that gave them the ability to grandfather in their product with zero safety testing.
The second major device analyzed was metal hips. In this case, manufacturers missed serious alarms. A subsidiary of Johnson & Johnson was approved to distribute the devices without any medical testing because it was considered a “substantial equivalent” to devices that had already been manufactured. In 2010, five years after hitting the market, nearly 95,000 of these devices were recalled. Metal hips can cause tissue destruction and metal poisoning.
A third device looked at was the Lap-Band. There was minimal testing conducted on these weight-loss devices. That testing included a sample of some 300 people. Of those, more than half reported vomiting, nausea or both. A quarter of those involved had to have the devices removed before the completion of the three-year study because the product was either ineffective or was causing other serious problems.
Finally, the Consumer Report watchdogs looked at cardiac devices – mainly, defibrillators. In the last three years, nearly 30,000 people have died or been hurt as a result of usage of these devices. In most cases, it has to do with the wires that connect to the heart muscle.
The Ferraro Law Firm provides comprehensive legal services, including business litigation on a contingency-fee basis. Offices in Miami, Washington, D.C., and New York City.