Two people whose physicians prescribed them the drug Reglan for different indications are suing the manufacturers of the generic versions (metoclopramide) they both took. Both plaintiffs were on the drug for extended periods and subsequently developed tardive dyskinesia.
One (Gladys Mensing) originally sued both Wyeth (the manufacturer of the trade-name drug) as well as the generics manufacturers in state court on the grounds that they (the manufacturers) did not adequately warn of the risks of long-term usage of the drugs.
The district court dismissed her suit against the brand-name manufacturer (Wyeth), since the plaintiffs had not used their product. It also dismissed her case against the generic manufacturers on the basis of federal preemption. She then appealed to the Eight Circuit Court of Appeals, which reversed the judgment that had been made in favor of the generic manufacturers. These then appealed to the Supreme Court.
The Supreme Court accepted review of Mensing's case, and merged it with two others, agreeing to "... clarify the legal duty of makers of generic medicines to change their labels to warn consumers of a new threat of harmful side effects, and to decide whether state court lawsuits may be filed for failure to do so. .." (see here). Note: the Acting Solicitor General had recommended that the Court deny certiorari in these cases, but was ignored.
In March 2009, in Wyeth v. Levine, the Supreme Court had already ruled (6-3) that the FDCA did not preempt state failure-to-warn laws against brand-name drug manufacturers. This case will now clarify this same issue with regards to generic drug manufacturers.
One (Gladys Mensing) originally sued both Wyeth (the manufacturer of the trade-name drug) as well as the generics manufacturers in state court on the grounds that they (the manufacturers) did not adequately warn of the risks of long-term usage of the drugs.
The district court dismissed her suit against the brand-name manufacturer (Wyeth), since the plaintiffs had not used their product. It also dismissed her case against the generic manufacturers on the basis of federal preemption. She then appealed to the Eight Circuit Court of Appeals, which reversed the judgment that had been made in favor of the generic manufacturers. These then appealed to the Supreme Court.
The Supreme Court accepted review of Mensing's case, and merged it with two others, agreeing to "... clarify the legal duty of makers of generic medicines to change their labels to warn consumers of a new threat of harmful side effects, and to decide whether state court lawsuits may be filed for failure to do so. .." (see here). Note: the Acting Solicitor General had recommended that the Court deny certiorari in these cases, but was ignored.
In March 2009, in Wyeth v. Levine, the Supreme Court had already ruled (6-3) that the FDCA did not preempt state failure-to-warn laws against brand-name drug manufacturers. This case will now clarify this same issue with regards to generic drug manufacturers.
Argument preview: FDA drug labeling requirements and failure-to-warn claims
PLIVA, Inc v. Mensing
Some previous blog entries related to pharma suits:
Misc update III - Feb 13th, 2011
Say what? - Aug 25th, 2010
Wyeth v. Levine - Mar 22nd, 2009
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