News Archives
House Bill Presented to Ban Tainted Drywall
A House companion Bill to the Drywall Safety Act of 2009 (recently introduced by U.S. Senators Bill Nelson and Mary Landrieu on March 30th), was filed in Congress today by Representative Robert Wexler (D-Fla.) that calls for an immediate study by the Consumer Product Safety Commission to determine whether new safety standards are necessary to...
The U.S. Consumer Product Safety Commission (CPSC), in cooperation with Yamaha Motor Corporation, U.S.A. is announcing a free repair program to address safety issues with all Rhino 450, 660, and 700 model off-highway recreational vehicles. Yamaha has also agreed to voluntarily suspend sale of these models immediately until repaired. Consumers...
The potential scope of the problem involving Chinese-made drywall is huge, with an estimated 60,000-100,000 homes nationwide affected. U.S. Senators Bill Nelson (D-Fl.) and Mary Landrieu (D-La.) filed legislation today in hopes of initiating a recall on tainted drywall from China. The goal of the legislation is to press the Consumer Product Safety...
About 150,000 people in the United States have been implanted with the Medtronic Sprint Fidelis leads. A previously undisclosed FDA report provided to New York Times Reporter Barry Meier indicates that soon after the Medtronic Sprint Fidelis lead was approved in late 2004, Medtronic received multiple reports that the device was fracturing.Within a...
Data released from Medtronic to doctors on March 13, 2009, in the form of a “Dear Doctor” letter indicates that at least 13 people may have died from a defective heart defibrillator cable that connects the device to a patient’s heart. Reports indicate that lead wire fractures may cause a defibrillator to fail to deliver a lifesaving shock...
U.S. Supreme Court Ruling Supports Drug Lawsuits
We have been anxiously waiting many months for an important ruling by the United States Supreme Court in the case of Wyeth v. Levine regarding federal preemption. On March 4, 2009, the Supreme Court rendered its decision and ruled that FDA approval of a drug product does not preempt state tort law claims with regard to the safety of an approved...
Public Health Advisory Issued on Psoriasis Drug Raptiva
On February 19, 2009, the FDA issued a public health advisory for patients using the psoriasis drug Raptiva concerning three confirmed and one possible report of a rare but extremely serious brain infection called progressive multifocal leukoencephalopathy (PML) that has been linked to long-term use of the drug. Raptiva was approved by the FDA...
Federal probe begins over imported drywall from China during 2004-2006
A new report in The Wall Street Journal indicates the U.S. Consumer Product Safety Commission (CPSC) has launched an investigation into imported Chinese drywall at the request of Florida Senator Bill Nelson amidst reports that the sulfur-based gases emitted from the drywall are corroding household wiring and posing potential safety hazards to...
Proposed budge increase of $335 Million over last year to FDA
House lawmakers unveiled an omnibus appropriations bill on Monday, February 23, 2009 called The Food Safety and Tracking Improvement Act that would bring the FDA’s total budget to $2 Billion for the current fiscal year ending on September 30, 2009 and is intended to help the FDA improve the safety of domestic and imported food and medical...
Lawmakers plan to reintroduce legislation to reverse Supreme Court decision on medical device liability
In the near future, democratic lawmakers Henry Waxman (D-California) and Frank Pallone (D-New Jersey) plan to reintroduce legislation that would overturn a decision in 2008 by the Supreme Court in the Riegel v. Medtronic case where it was ruled that FDA approval of certain medical devices protects manufacturers from product liability lawsuits filed...
