News tagged with 'Federal Preemption'

A review of the process that fast-tracks medical devices into the marketplace without a safety review will be undertaken by the Institute of Medicine. The review will take two years, long overdue say patients hurt by devices that have been fast-tracked.

Diana Levine is in the news again. The woman whose case against Wyeth delivered the death knell to federal preemption in drug product liability cases, today got part of her wish. The drug that took her right arm will now carry a more explicit warning against administering it via IV push.

Lana Keeton's near death experience with synthetic surgical mesh has transformed her into a powerful online patient advocate.  With a chorus of others, Truth in Medicine is working to urge Congress to remove the medical device from the market. Already the group has generated an FDA notice warning of 1,000 adverse events and 10 deaths due to mesh.

President Obama will have an opportunity to shape future decisions from the highest court in the land.  Supreme Court Justice David Souter is retiring in June. Souter is one of the more liberal leaning justices and sided with the majority in the case of Diana Levine v. Wyeth and with the majority in the case of Riegel v. Medtronic, both tests of federal preemption.

The state appeals court in Houston has ruled Wyeth must face a personal injury lawsuit filed by a woman who claims Prempro, a hormone-replacement drug, caused her breast cancer.

If you assumed that a medical device that's implanted to help hold up internal organs passed some safety review by the FDA, you'd be wrong.  Synthetic surgical mesh was approved for marketing only. Some in the medical profession suspect there's a problem - some women and men know there is.  

National Voices  - For years, Texas District Judge Michael Schattman sat on the bench in Fort Worth listening to product liability and personal injury cases.  Now he is a medical device injury victim who feels the Riegel decision prevents Americans from exercising an American right. 

Medtronic Sprint Fidelis Defibrillator Lead is implicated in more deaths than previously reported, admits the company.  That updated count was released after a federal judge dismissed about 700 cases against Medtronic citing the Riegel decision affirming federal preemption and a shield for device makers.

Lawmakers heard from those injured by medical devices in Washington, as a film and rally was held in support of the Medical Device Safety Act, currently before Congress. It would lift the shield devicemakers currently have from lawsuits. 

Michiganders gathered in Lansing today to have their say about a proposed repeal of the state drugmaker immunity law, the only one in the country. This year they want it overturned and the Republican majority in the house to stop stonewalling, especially in light of a recent Supreme Court decision that negated the federal preemption argument.

Opposing forces, from citizens injured by drugs or their survivors, to lobbyists from the largest drug companies are expected in Lansing, Michigan Wednesday, as the state considers repealing its drugmaker immunity law - the only one in the nation put in place by former Gov. John Engler. 

Some Michiganders say they feel left out since the Diana Levine decision by the Supreme Court threw out the federal preemption argument of drug companies. Michigan law does not permit remedies in court from dangerous drugs, but a hearing this week could begin to change that. 

Michiganders did not rejoice over the Diana Levine decision by the U.S. Supreme Court last week. The court rejected the federal preemption argument of drugmaker, Wyeth and returned to citizens the right to sue in state court.  That is, unless you live in Michigan, which offers drugmakers immunity from lawsuits. 

The Medical Device Safety Act introduced into Congress, would allow consumers to hold manufacturers of defective medical devices accountable, even if the device has been approved by the FDA. 

One day after the Supreme Court decision, the cameras have left and Diana Levine realizes that even with a decision in her favor and a $6.7 million award for damages, she's still missing most of her right arm.