It’s true: regulation is often not good for business. The American food industry no doubt took a hit when the government decided to test products for poisons before they hit grocery stores. But we accept those regulations because we know it’s best for public safety. Last week, the New York Times name-checked DePuy Orthopedics and its faulty hip implants in a report on medical device companies that are increasingly critical of government regulation of their products. These companies say US regulation will cause the industry to lag behind nations with more relaxed laws, with little mention of the dangerous side effects associated with lesser regulation.
Some companies, like Biosensors International, have already started to send their business abroad, citing the easier regulation climate. “We decided, let’s spend our money in China, Brazil, India, Europe,” said Jeffery Jump, the chief of Biosensors in Switzerland. Among other drawbacks, the medical supplies companies claim that the cost of increased regulation prevents consumers from having access to the newest technology and medical devices. That seems to suggest that the public should make the impossible choice between having access to safe products or the newest innovations.
To improve this problem, the FDA has proposed an “innovation pathway” for the most groundbreaking devices. “A consistent and predictable review process will stimulate investment here at home and keep jobs from going overseas,” said Dr. Jeffery Shuren of the agency’s medical device division, which would be responsible for hip implants like DePuy’s. But this “pathway” is just the type of shortcut that led to DePuy’s line of dangerous hip implants. DePuy never had to test the hip implants or seek FDA approval because they were similar to the Ultima model, which the FDA approved years before.
Although intensive regulation has some economic downsides, it is important to ensure medical safety. And as DePuy lawsuits pile up, it appears that the regulation could have saved Johnson & Johnson a bundle, as well.
Andy Gillin received his Bachelor’s Degree from the University of California at Berkeley and his law degree from the University of Chicago. He is the managing partner of GJEL Accident Attorneys and has written and lectured in the field of plaintiffs’ personal injury law for numerous organizations. Andy is a highly recognized wrongful death lawyer in California.