News tagged with 'Preemption'

Actor Dennis Quaid and his wife have filed his second lawsuit against Baxter Healthcare over the near-death experience of their twins over a drug mix-up at a Los Angeles hospital. The labels of the two drugs were never changed even though the drug maker knew they had caused prescription errors that led to the death of three infants, the complaint says.

Actor Dennis Quaid has brought his family's hospital error tragedy to the public forefront by promoting patient safety and eliminating medical errors, which kill at least 100,000 Americans every year.

Medtronic, with a history of defective heart products, has had a catheter-placed heart valve approved by the FDA on humanitarian grounds because it will be used by fewer than 4,000 patients annually.

The FDA issues a recall notice for the ev3 catheter, but the company says it has collected all defective medical devices. Meanwhile, consumers injured or their survivors still cannot pursue litigation under the existing U.S. Supreme Court Riegel decision.

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.