St. Cloud Personal Injury Lawyer - Medical Devices & Implants

Congress Has A Chance To Protect Consumers Who Use Medical Products

Mike Bryant — Fri, 28 Aug 2009 09:23:00 GMT

For some time now, members of the Injuryboard have been writing about the major impediment on medical device cases. They have been thrown out of court, because of federal preemption. There are tragic stories of people who are injured by these products who simply have no recourse. It's one of the hardest things to do, when someone calls with a letter that says the product that they have in them is faulty, and they have to be told, sorry you have no protection, despite what the Constitution says about your civil rights.

The question is if Congress should reverse the 2008 US Supreme Court decision of Riegel v. Medtronic, Inc? That ruling granted immunity to medical devices that gain approval from the Food and Drug Administration under the Medical Devices Amendment of 1976. In affect silencing individual state's consumer protections.

Last week, the U S Senate took testimony on the Medical Device Liability Bill:

Two Minnesota families testified concerning their children who died due to problems with Medtronic pacemakers and Medtronic implantable cardiac defibrillators.

Another Medtronic defibrillator user from Iowa testified that he received 22 electric shocks within a span of 53 minutes from a faulty implant . He said, “My hope is that no one else ever has to go through the pain and agony that I experienced with the fractured lead, and that Medtronic is held responsible for the injuries it has caused other patients like me.” He was asked to testify by Senator Tom Harkin (D-IA).

Also testifying were a Texas man who was shocked six times by a faulty pacemaker and a six year-old Illinois girl, who was also shocked by a faulty defibrillator.

William Maisel, MD, director of the Medical Device Safety Institute and a cardiologist who chairs an FDA advisory committee, testified that "the FDA does an 'exceptional job' of monitoring the safety of medical devices." But, he added, "the postmarketing data is an issue." Dr. Maisel "said it is 'simply impossible' for the FDA to continue to monitor the safety of every medical device it has approved."

Hopefully, the senate will listen. The question isn't what these people should get. It is simply that they should have the right to make the claim. Let the system work with each case standing on it's merits.

Originally posted at InjuryBoard by Mike Bryant

Medtronic Recalls Quick-set Infusion Set

Mike Bryant — Wed, 22 Jul 2009 09:31:00 GMT

The first week of July, Medtronic, Inc. (NYSE:MDT) recalled specific lots of Quick-set® infusion sets that are used with MiniMed Paradigm insulin pumps. An infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a diabetes patient, and is typically replaced by the patient every three days. Medtronic recently discovered that approximately two percent of "Lot 8" Quick-set infusion sets (which represents approximately 60,000 infusion sets out of an estimated 3 million infusion sets currently with customers) may not work.

This recall involves Affected infusion sets are reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with the number "8." The lot number (for example 8XXXXXX) is clearly marked on both the product box label, and on each individual infusion set package. Visit the Medtronic Diabetes website at www.medtronicdiabetes.com/lot8 to view the labels of "Lot 8" Quick-set infusion sets.

Product problems should be reported to the Diabetes business at Medtronic by calling
800-345-8139 at any time. Adverse reactions or quality problems may also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

If you or a family member is injured by a product, you need to get immediate medical care. If there is a significant affect or injury, you should contact an attorney concerning the problem. Early investigation can include the collection of product, checking recall alerts, and the proper notifying of those who caused the problem.

Originally posted at InjuryBoard by Mike Bryant

U S Supreme Court Ruling On Drug Preemption Reminds Us That Medical Devices Should Follow Suit

Mike Bryant — Thu, 19 Mar 2009 09:46:00 GMT

This past week, saw a victory for consumers with the U S Supreme Court's decision in Wyeth v. Levine. Basically, the decision allowed state law to stand in cases against drug manufactures. It's time the court also looks at the use of preemption to protect those injured by medical devices.

The issues is one of preemption. A topic that members here at the Injuryboard have spent a lot of time on. Do federal laws and regulations preempt state laws? It's a question of state's rights and if individual states can set the laws to protect their own citizens. It's also a question of who's making the laws. Presently, big business is being protected by eight years of pointed regulations that were meant to shield them from liability.

The argument they make is that without the certainty of one national law, they won't make the devices. That they need to rely upon the FDA to grant approval or the system won't work. Taking part in a cost-benefit analysis that includes that though the patients "injured by medical devices make for great news stories...patients who don't get the devices that never made it to the market because of the risk of litigation won't get the same attention" and "will just die."

Recently, a local federal court threw out the cases of thousands of patients with heart-defibrillator wires that have been shown to fracture and dispatch potentially lethal shocks. The court reasoned that despite the injuries, preemption was the law of the land. Hopefully, this new ruling will be extended to recognize that there are individual states that make up that land.

Originally posted at InjuryBoard by Mike Bryant

University of Minnesota Medical School Considering A Ban On Gifts

Mike Bryant — Sat, 01 Nov 2008 09:07:00 GMT

Following a recent series of articles in both the Minneapolis Tribune and the Wall Street Journal, the University is looking at banning all gifts to the doctors from outside groups. Looking at the issue both from the value and the quality of what may be received, the board looking at the issue seems to be coming to a conclusion that a complete ban is the safest way to protect the institution's integrity.

The policy would be so strict that it would prohibit the receipt of Post-it notes. While some are concerned that limits on free drug samples and loss of support for doctors' continuing medical education might have some negative impacts, the concerns about what is expected in return out weigh the losses.

Doctors' consulting relationships will be disclosed to patients and all financial ties will be closely monitored. As was pointed out by the prior articles, this could have a significant impact on a number of the doctors. It is expected that there will be a settled rule by the end of the semester.

Originally posted at InjuryBoard by Mike Bryant