Wednesday, November 5, 2008
Article on Reuters -- U.S. court reinstates Bhopal water pollution case, by Martha Graybow. Here's an excerpt:
A lawsuit contending that thousands of people in India were exposed to polluted drinking water after the 1984 Union Carbide toxic-gas disaster in Bhopal was reinstated on Monday by a U.S. appeals court, which said a lower court improperly threw out the case.
The U.S. Court of Appeals for the Second Circuit in New York sent the lawsuit back to a Manhattan federal court judge for further proceedings.
A three-judge panel of the appeals court found that the lower court had erred by granting the defendants' request for summary judgment in the case before giving the plaintiffs the opportunity to gain access to certain pretrial documents and other information they had sought.
The lawsuit was brought on behalf of people who lived or worked near the Bhopal plant who say they suffered ailments including cancer and neurological damage caused by contaminated groundwater. The legal claims were first brought in 1999 after a study by environmental group Greenpeace found widespread water contamination in the area, said Richard Lewis, one of the lawyers for the plaintiffs.
Tuesday, November 4, 2008
Legal commentators have already begun speculating about the upcoming Supreme Court decision in Wyeth v. Levine. After yesterday's oral argument, Tony Mauro of the Legal Times reports that "the case could be decided narrowly, giving little guidance about a broader pre-emption issues beyond the area of drug labeling." Here's an excerpt:
Appearing for Wyeth, former Solicitor General Seth Waxman told the justices that the FDA took into account the possibility of gangrene as a result of that kind of injection, but balanced it with the benefits of the drug. That produced a sharp response from Justice Samuel Alito Jr., who asked, "How could the FDA conclude that IV-push was safe and effective" when the benefit was relief of nausea while the risk was gangrene?
Justice Ruth Bader Ginsburg also asked incredulously, "No matter what benefit there was, how could the benefit outweigh that substantial risk?"
Waxman, a partner at Wilmer Cutler Pickering Hale and Dorr, answered that the label provided "ample, lavish warning" about the IV method, but the FDA determined that the method could be medically warranted in some circumstances -- the kind of considered judgment that a jury, looking at a single case, would not make. Justice David Souter also took Wyeth to task for not, on its own, going back to the FDA to urge changes in the label to prohibit IV-push administration: "Wyeth could have done that at any time, and it simply didn't do it."
Waxman pointed out that Wyeth in fact did ask for stronger language, but the FDA rejected it.
David Frederick of Kellogg, Huber, Hansen, Todd, Evans & Figel, representing Levine, picked up on Souter's point and said the law would have allowed Wyeth to make a unilateral change in its label. The FDA, he said, never weighed the comparative risks of different types of IV administration of Phenergan.
"The idea that a label is set in stone for all time misunderstands the way the process works," argued Frederick. "No reasonable person could have made this balance."
"If you're telling me the FDA acted irresponsibly, then sue the FDA," said Justice Antonin Scalia. Scalia and several other justices seemed to have been persuaded that Wyeth had acted responsibly in informing the FDA about the risks and should not be punished for doing what the agency ordered it to do.
"You're saying FDA approval doesn't give you any protection at all?" asked Scalia. Frederick responded that it gives a company "a basis for marketing" a product but does not end the company's duty to reveal problems that arise with that product.
Here's a link to the Wall Street Journal Law Blog on Wyeth.
Sunday, November 2, 2008
Oral argument in the big preemption case of the Supreme Court Term, Wyeth v. Levine (06-1249) is scheduled for Monday, Nov. 3, 2008. The case concerns whether federal law preempts state torts claims imposing liability on drug labeling that the FDA had previously approved.
Edited to add: the transcript is available on the Supreme Court website here.
Documents related to the case are available on Scotusblog. The Scotusblog coverage is very good. Readers might also be interested in the anti preemption point of view, which can be found (among other places) in the linked ACS publication by Law Professor David Vladeck. The pro-preemption point of view can be found at Drug and Device Law blog and the links therein.