Blog Topic
Defective Products
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Study Highlights the Importance of Consumers Right to Bring Suit Against Big Pharma
Posted by: Emily C. Wecht
March 28, 2008
A study published in the New England Journal of Medicine on Thursday, March 27, 2008 shows that drugs approved by the FDA under tight deadlines are more likely to harm consumers.
The Associated Press reports: "Approval deadlines were first imposed on FDA by a 1992 law that allowed drug makers to pay millions of dollars in fees directly to the cash-strapped agency so it could hire more reviewers and clear a backlog of pending drug applications. In return, FDA had to make a decision - either approve or reject - on 90 percent of all drug candidates within 12 months of their application, or lose money. The deadline was 6 months for drugs so novel or potentially lifesaving to be classified high-priority. Congress tightened the deadline for most drugs to 10 months in 1997."
The FDA has approved a host of infamous drugs at or near the approval deadlines, including: Vioxx, Bextra, Rezulin, and Baycol. All were withdraw from the market because they were unsafe only after they harmed hundreds of consumers.
The study's findings highlight the importance of a consumer's right to bring suit against pharmaceutical companies that produce dangerous drugs - regardless of whether the FDA has approved the drugs.
For many years, we have fought hard to preserve that right. As Spencer Pahlke reported yesterday, that right is now under attack. The U.S. Supreme Court should consider the realities that this study exposes when deciding Wyeth v. Levine: a federal agency under enormous political and economic pressure cannot unfailingly protect the public. The public must retain the right to pursue justice through the courts.
Think these drugs are dangerous now?...just wait
Posted by: Spencer Pahlke
March 27, 2008
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."
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