Blog Post
Think these drugs are dangerous now?...just wait
Posted by: Spencer Pahlke
March 27, 2008
Topic: Defective Products
This post would fit equally well in our threats to plaintiff's rights section because it goes along with Riegel v. Medtronic case that Mike Kelly discussed a few days ago.
The New York Times reports that a major defective drug case has settled in Alaska. The case, between the citizens of Alaska and Eli Lilly, the manufacturer of Zyprexa, had reached its 3rd week of trial when the Alaska Attorney General decided to settle the case for pennies on the dollar. The reason?--fear that the Supreme Court would extend blanket protection (called preemption) to drugs like Zyprexa in October when it hears a case entitled Wyeth v. Levine.
The Alaska Attorney General's fear--that the suit would be thrown out after the Supreme Court's decision--is sadly appropriate. As Mike explained, in Riegel v. Medtronic, the Supreme Court decided that because the FDA had approved the medical device that hurt Mr. Riegel, no plaintiff should be allowed to sue when that device later proves to be defective. What's the impact here?--if the FDA approves a device, no one can sue when that device later injures them. Sound scary?
The Alaska Attorney General feared the same outcome with drugs approved by the FDA: if the Supreme Court decides in Wyeth v. Levine that the FDA's approval "preempts" all state-court lawsuits, then people injured by FDA approved products have no legal recourse. None.
And, consider these additional problems. First, during the Alaska trial, documents had proven that Eli Lilly "encouraged its use for off-label conditions." That means that the drug was used for purposes that the FDA did not test for--imagine not being able to sue after being instructed to take the drug for an off-label purpose. Second, as the Times reported, "federal prosecutors in Pennsylvania are investigating Lilly's marketing of Zyprexa and whether the company hid Zyprexa's dangers from doctors and the Food and Drug Administration." So here's the rub: even though Eli Lilly--and other drug manufacturers--may be hiding dangers from the FDA, it may still get protection from all lawsuits for those very drugs.
The result, as explained by an attorney in the case: "without the threat of lawsuits in state courts, drug makers would be even more aggressive about hiding risks and promoting drugs for unapproved uses." So, "If you think these guys speed now, wait and see what happens when they get pre-emption."
