Are medical device makers now relieved of liability?
The Supreme Court gave Medtronic, and by extension many other medical-product makers, a very nice gift on February 20. In an 8-1 decision it ruled that the Medical Device Amendments of 1976 overrides most state-law claims seeking damages for injuries caused by medical devices approved by FDA under the PMA process. I suspect you've heard about this, since the business press has been all over it. The best coverage I've seen so far is by Canon's MX magazine. My first reaction: Great news for medtech manufacturers (drastically reduced liability insurance premiums); very bad news for injured patients (forget about suing said manufacturers). My second reaction: Not so fast!
There's no question that, at least for now, FDA will shoulder more of the burden and manufacturers of PMA-track products less. But I would advise against reducing your QA budget, firing your legal staff and discharging your litigation advisors just yet. Curb your giddiness. Here's why:
- The great majority of medical devices are 510(k)-track products, so most medical products are not affected by this decision. And, by the way, those products -- or the clinicians using them -- cause most of the injuries.
- Do you really believe that today's FDA can handle the entire liability burden created by this court decision? And, if the agency is reconfigured to do so and takes this responsibility seriously, will another PMA-track device ever be approved? I think fear of litigation is a better motivator than over-regulation and its attendant higher costs.
- It's my understanding that the U.S. Congress can turn this decision on its head with some new, clarifying legislation. Do you think that might happen? Who will be in control of Congress in 2009?
- Along the same lines, do you think that trial lawyers exert some influence in the Congress?
- As the MX article nicely points out, you can still be successfully sued for failing to meet FDA's specifications and labeling rules or for delivering any product with manufacturing defects. You will definitely not be off the hook.
Finally, if you're thinking of jumping on the PMA track just to gain some liability protections, you're nuts! The added regulatory costs and extended time-to-market are certainly not worth it.