Just when you think that the inexorable march of progress will make us safer, you learn that medical device manufacturers have recalled almost twice as many defective products than they did ten years ago. According to The Wall Street Journal the total number of recalls jumped from 604 in 2003 to 1,190 in 2012. The vast majority of these recalls were considered “Class II” recalls, which are serious concerns. The FDA defines a Class II recall as a “situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
On the one hand, the increase of recalls may suggest that the FDA and the industry are now quicker to recall a product. On the other hand, the medical device industry is expected to reach $434.4 billion by 2017. They make money when they sell their products. The increase in recalls may suggest an additional push to get products on the market—and into human guinea pigs—before adequate testing, with the notion that they can simply recall the product later if it proves unsafe. If that is the case, then the needs of the public will be best served with a robust combination of FDA oversight and a strong civil justice system to ensure that the manufactures who break the safety rules are held accountable, and victims of defective products are fairly and fully compensated.