Medical Device Safety Act of 2008

James Sabatini — Sun, 29 Jun 2008 13:45:02 GMT

U.S. Reps. Frank Pallone, Jr. (D-NJ), Chairman of the House Energy and Commerce Subcommittee on Health, and Henry A. Waxman (D-CA), Chairman of the House Oversight and Government Reform Committee, recently introduced legislation in the House that will reverse a U.S. Supreme Court decision earlier this year involving medical devices

In February, the U.S. Supreme Court immunized medical device companies from state lawsuits brought by patients who are injured by certain medical devices. In Riegel v. Medtronic, Inc. the Court found that the product liability claims are barred by a preemption clause included in the Medical Device Amendments of 1976 (MDA). This decision was wrong. It ignored both congressional intent and 30 years of experience in which FDA regulation and tort liability played complementary roles in protecting consumers from device risks.

The Medical Device Safety Act of 2008 protects patients from dangerous and defective devices by correcting the Court’s flawed interpretation of the MDA. The legislation explicitly clarifies that state product liability lawsuits are preserved. People should contact thier elected Congressmen and Senator to voice support of this legislation to ensure that injured people have a right to compensation for injuries caused by dangerous and defective medical devices.

Originally posted at InjuryBoard by James Sabatini

Insulin Pumps for Teens Have Been Linked to Injuries and Deaths

Jenny Albano — Thu, 08 May 2008 02:59:55 GMT

A federal review from the FDA found that insulin pumps used by teenagers with Type 1 diabetes can be dangerous and have been linked to injuries and deaths.

Researchers from the FDA did not advise against teens using the devices, but said that parents should watch their children's use of the pumps while safety concerns are addressed.

The federal review of use by young people over a decade found 13 deaths and more than 1,500 injuries connected with the pumps. At times, the devices malfunctioned, but other times, teens were careless or took risks, the study authors wrote. Some teens didn't know how to use the pumps correctly, dropped them or didn't take good care of them. There were two possible suicide attempts by teens who gave themselves too much insulin, according to the analysis.

These pumps are popular because they allow teens to give themselves insulin discreetly in public and up to 100,000 teens may be using them. The pumps are used for Type 1 diabetes, which is also called juvenile diabetes.

The FDA study, which appears in the May issue of the Journal Pediatrics, reports injuries and deaths related to the pumps from 1996-2005. The report analyzed reports from patients 12 to 21 years old.

While some teenagers want to switch from insulin injections to pump therapy to gain more flexibility in their lives, doctors said device problems such as a blocked tube can lead quickly to dangerous episodes of high blood sugar.

Many doctors screen teens before prescribing a pump and some refuse refuse pumps to immature young patients. Teenagers need to be able to monitor their glucose or else the pump can increase the risk of getting sick more quickly compared to injections.

Originally posted at InjuryBoard by Jenny Albano

Connecticut Personal Injury Blog - Medical Devices & Implants

Medical Device Safety Act of 2008

Insulin Pumps for Teens Have Been Linked to Injuries and Deaths