The North Carolina Medical Society is siding with consumers in a U.S. Supreme Court case, which will be heard Nov. 3, that allows patients to sue drug companies and medical device makers based on state laws that are more restrictive than FDA guidelines.
The case, Wyeth v. Levine, stems from an incident in 2000 when a professional guitarist in Vermont named Diane Levine got a shot of migraine headache medicine and ended up having her arm amputated after the onset of gangrene.
A Vermont jury awarded Levine $6.8 million because it determined that Wyeth's faulty labeling did not sufficiently warn doctors about the possible dangers of incorrectly injecting the drug Phenergan. Wyeth says if the label is good enough for the FDA it should be good enough for Vermont.
You can read this Wall Street Journal article about how both sides of the issue are all atwitter.
The Texas Medical Association and the North Carolina Medical Society have filed a brief in support of Levine, which you can read here .
The two groups argue that if drug and device makers are exempt from lawsuits then patients will start suing doctors. But they also note that vesting sole regulatory authority in the FDA is bad for everyone because the government agency does not have enough staff to keep up with all of the changes in the health care industry. Pre-empting state laws is also an unwarranted expansion of federal authority, according to the brief.
This is an enormously important case for consumers and has implications for a wide variety of cases, including, according to the WSJ article, three suits against GlaxoSmithKline related to its antidepressant drug Paxil.
It is good to see the North Carolina Medical Society taking the side of consumers over industry. The organization has an obligation to protect the interests of doctors, but it's nice when those interests align with the good of patients.