Archive for the ‘Preemption’ Category

Semper Fidelis – Was Medtronic Committed to Patient Safety when they continued to sell now recalled defective Defibrillator lead wires

Wednesday, March 5th, 2008

In today’s New England Journal of Medicine, Dr. William H. Maisel, M.D., M.P.H. , the director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center in Boston, Massachusetts, published an editorial, entitled Semper Fidelis — Consumer Protection for Patients with Implanted Medical Devices examining whether consumers can ever recieve adequate protection for faulty medical devices. Dr. Maisel focused his artcle on the recent debacle over defective Medtronic lead wires for their pacemaker/defibrillator models, otherwised known as Implantable Cardio-Defibrillators, or ICDs. Medtronic, at the behest of the FDA, recalled Medtronic Sprint Fidelis lead wires in October, 2007. But according to the article, Medtronic had alerted some doctors via a cryptic letter in March of 2007 that they were detecting a greater number of reports of lead failure, or lead fracture than expected. And by May, 2007, Medtronic had applied for a manufacturing change for the lead wires to correct the manufacturing defects which were causing the lead wire fractures. But for nearly 6 months, Medtronic sold defective defibrillator lead wires, Sprint Fidelis Lead wires, to unsuspecting patients. As reported in the article, the defective lead wires could contribute to significant medical propblems for these patients, including: a failure to pace, a failure to defibrillate, unnecessary shocks, and death.

According to Maisel’s article,

“by October 2007, Medtronic had confirmed the occurrence of 665 fractures in returned leads, five patient deaths to which a Fidelis lead fracture may have contributed, and a 2.3% fracture rate within 30 months of implantation (according to an analysis of the remote-monitoring data)”

For More information about the Maisel artcile in the NEJM, please visit www.nejm.org, or for more information about the litigation regarding these recalled Medtronic lead wires, please visit our website at www.awkolaw.com or www.awkolaw.com/medical_medtronicnews.html

Drug Company Immunity- Preemption

Monday, March 3rd, 2008

In a 4-4 vote, the United States Supreme Court today affirmed the 2nd Circuit opinion in Kent v. Warner Lambert, a Rezulin case filed in Michingan. The 2nd Circuit Court of Appeals had reversed the trial courts dimissal of the case. Under Michigan law, a pharmaceutical manufacturer was immune from liability if a drug was approved by the FDA, unless the injured party could bring a claim which would be supported by proof of “fraud on the FDA.” The Kent trial court dismissed the claim, finding that this one available method of proving your claim, required the Plaintiff to bring a “Fraud on the FDA” claim, which the United States Court had held was completely preempted in the Buchman decision. The 2nd Circuit reversed, holding that the Michigan law did not go that far, as such would result in complete preemption of the claims, which was obviously contrary to the Michigan statutes’ plain language. Chief Justice Roberts recused himself from the deliberations, leaving an 8 member court, which split evenly 4-4, in a surprise ruling. Most on the pharmaceutical side believed this Court would reverse the 2nd Circuit, and place another peg on the board for their push to completely immunize pharamceutical companies from liability. The fight is hardly over, as the Supreme Court will be hearing in the fall term another drug case known as Levine v. Wyeth. That case does not involve an FDA approval immunity statute like Kent, but instead focuses on the FDA’a approval of the drug, and the labeling infomation. The justice attorneys of Aylstock, Witkin, Kreis & Overholtz will be fighing hard to preserve our client’s rights to seek redress from pharmaceuttical companies who have sold defective drugs, with defective warnings, and have misled the FDA, patients, and doctors along the way.