Prominent doctors argue that lawsuits protect the public
It isn't often that you see a headline where doctors are arguing to protect patient's right to sue; that makes the brief recently filed by the editors of the New England Journal of Medicine, the country's most-respected medical Journal, even more remarkable. In the case of Wyeth v. Levine, the highly respected doctors joined 47 state Attorneys General and two former FDA commissioners in urging the U.S. Supreme Court to reject Wyeth's appellate claims.
Ms. Levine was a Vermont guitarist who lost her right arm below the elbow after an injection of Phenergan. She argued that the labeling on the drug was inadequate (since it did not identify this known risk) and she obtained a substantial verdict. Wyeth then sought to overturn the verdict, arguing that Ms. Levine's claim was "pre-empted" by the FDA's decision to approve the drug. The pre-emption doctrine precludes other actions when the Federal government has attempted to "cover the field" with a regulatory scheme.
Earlier this year, the Supreme Court ruled, in a partisan decision, that FDA approval of medical devices pre-empts individual patient lawsuits. Wyeth is hoping that the Court will treat prescription drugs similarly, even though the pertinent federal legislation pertaining to drugs contains different language and does not even suggest that Congress sought to pre-empt claims.
The Doctors who edit the New England Journal of Medicine argued to the Court that it should not recognize pre-emption of patient claims. They noted that the FDA is not equipped to serve as the sole guarantor of patient health, and that patient lawsuits are "a vital deterrent" to pharmaceutical abuses. They also pointed out that much of the information gleaned about patient safety and pharmaceutical abuses actually originates from private lawsuit discovery. The Bush Administration has also filed a brief---supporting Wyeth's pre-emption claims.