A new bill to restore liability claims against device manufacturers

Posted on: March 24, 2009  |   Author: Julia
Filed Under: Drug & Device   |   1 Comment

Last week, in Wyeth v. Levine the Supreme Court ruled that drug manufacturers will no longer be immune to lawsuits in state courts. The day after the Court came out with this ruling, the Democratic party reintroduced a bill that would allow similar lawsuits against companies that manufacture medical devices.  The bill to restore liability claims against device makers in co-sponsored by Rep. Henry Waxman, and enjoys wide range support from consumer interest groups.

http://www.kansascity.com/438/story/1069235.html

Wyeth v. Levine: changing the face of state tort litigation

Posted on: March 24, 2009  |   Author: Julia
Filed Under: Drug & Device   |   Leave a Comment

Last week, in Wyeth v. Levine, the Supreme Court held that the FDA approval of a drug does not protect drug manufacturers from lawsuits in state courts. This ruling is leading drug industry analysts to speculate that the $6.7 million jury award against Wyeth will cause drug manufacturers to scrutinize safety issues of the experimental drugs in development, as well as existing products, and going as far as pulling some medicines off the market. An attorney representing Wyeth, Bert Rein, stated that the manufacturer believed that it could not change the FDA-approved warning in the package insert, which disclosed the risk of gangrene if a drug injection accidentally hit an artery, but left it up to the doctor to determine whether the patient should be administered the medication through an intravenous drip or shot in a muscle. Further, Mr. Rein asserted that the Court’s decision will have a practical impact on the way doctors decide whether to use the most effective or least risky method of administering the drug. While Mr. Rein believes that the ruling will cause physicians to exercise greater caution in administering intravenous medications, the ruling itself might place a greater burden on drug manufacturers to improve existing drugs in order to avoid law suits. Although Wyeth has suggested to the Court that FDA should bear “primary responsibility” for drug labeling, the Court stated that “through many amendments to the FDCA and to FDA regulations, it has remained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times. It is charged both with crafting an adequate label and with ensuring that its warnings remain adequate as long as the drug is on the market.”

The practical effect of the litigation against drug companies and the status of federal pre-emption remain to be seen. Although the Court’s decision in Wyeth allows consumers to bring lawsuits against drug makers in state courts, Mr. Rein asserts that the ruling does not eliminate federal pre-emption defense. The Court stated that “absent clear evidence that the FDA would not have approved a change to Phenergan’s label we will not conclude that it was impossible for Wyeth to comply with both federal and state requirements.” Here, the ruling suggests that a plaintiff will be able to overcome the federal pre-emption defense if he can demonstrate that FDA would have approved a change to drug label warnings. However, the Court also notes that it does not consider a pre-emptive effect of a specific agency regulation bearing the force of law, finding that “it is not impossible for Wyeth to comply with its state and federal law obligations and that Levine’s common-law claims do not stand as an obstacle to the accomplishment of Congress’ purposes in the FDCA.”

Religious freedom or child abuse?

Posted on: March 24, 2009  |   Author: Kelly
Filed Under: Bioethics, Liability & Litigation, Other   |   2 Comments

Parents of an 11 year-old girl were each charged with reckless endangerment for choosing to treat her with prayer and not medicine. After other relatives pleaded with authorities to intervene, their daughter was pronounced dead on arrival from diabetic ketoacidosis, resulting from untreated and undiagnosed juvenile diabetes.  This latest in a decades-old string of cases regarding the withholding of medical treatment based on religious grounds is likely to set a precedent in a still-developing area of law.

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