The House and Senate have proposed legislation to make it easier for injured
patients to sue medical device manufacturers. If passed, the Medical Device
Safety Act of 2009 would overturn the Supreme Court’s 2008 ruling in
Riegel v. Medtronic.

That case held that a medical device manufacturer usually cannot be sued
by injured patients if the Food and Drug Administration approved the device
for marketing through its premarket approval (PMA) process, said consumer
advocacy organization Public Citizen. The FDA’s website states that
PMA is “the most stringent” marketing application. The
Riegel ruling essentially protected makers of defective devices from
product liability lawsuits.

Or so they thought until musician Diana Levine filed a defective drug injury
lawsuit that forced legislators to rethink preemption.

Levine, a musician, went to the emergency room for a migraine. There, she
was injected with Wyeth drug Phenergan to alleviate nausea. According to the
Wall Street Journal, the physician assistant who administered the drug missed Levine’s
vein, and she developed gangrene and had to have part of her arm
amputated.

“The problem wasn’t with the drug itself, but with the way
it was administered,” wrote Jacob Goldstein. “Levine argues
the label, which did warn about the risks of inadvertent intra-arterial
injection, should also have clearly warned against IV push.”

Per Cornell University Law School, “Wyeth … argued that federal
law preempted Levine’s state law claims, as state law directly conflicted
with the requirements of the Federal Food, Drug and Cosmetic Act.”

Levine was awarded $6.7 million in damages.

Only time will tell whether the Medical Device Safety Act of 2009 will
pass, but one thing is certain: Given the number of defective medical
devices making the news,
something needs to change.