› $150,000,000 verdict in personal injury case
Medical device maker Medtronic sent a letter to doctors worldwide earlier this month warning that nearly 37,000 of its Sigma and Kappa pacemakers, most manufactured between November 2000 and November 2002, could have faulty wiring that can cause the pacemakers to work improperly or not at all. This defect can be deadly for the estimated 1.7 million people who have pacemakers implanted in their chests.
President Barack Obama’s top pick for Food and Drug Administration (FDA) commissioner, Bioterrorsim expert and former New York City health commissioner Dr. Margaret Hamburg, says if confirmed she would “create a culture (at the agency) that would enable all voices to be heard,” according to Thompson, a human resources Web site. The comment was made during a question-and-answer exchange with Sen. Barbara Mikulski (D-Md) during the 1 ½-hour confirmation hearing.
Ron Albrecht lives in fear – fear that one day he will learn that the defibrillator implanted in his chest is defective and will cause him excruciating pain when it fails, like his previous one did two years ago. That device turned out to be among the defective heart defibrillators that were recalled by the device’s manufacturer, Medtronic. Albrecht’s device had to be replaced, and while his new one appears to be operating fine, he still worries.
People with Medtronic cardiac defibrillators implanted in their chests converged on Washington, D.C., this week to lobby for the passage of the Medical Device Safety Act. The act will allow consumers who have been hurt by defective medical devices to sue the device’s maker even if the devices have been approved by the Food and Drug Administration (FDA).
Medtronic Inc. has issued a letter to doctors stating that a defective lead wire in its popular heart defibrillator, which was recalled in October 2007, may have contributed to the deaths of 13 individuals in which the heart devices were implanted, according to the Star Tribune. That death toll is up from the medical device company’s original estimate two years ago of five deaths.
Congressional dems seek reversal of Supreme Court DecisionA new study published Monday in the Heart Rhythm medical journal suggests that the more than 200,000 recipients of Medtronic heart defibrillator leads may be at a greater risk than previously thought.
The 2007 Medtronic Sprint Fidelis Defibrillator Lead Recall could just be the tip of the iceberg when it comes to defective implantable medical devices. That’s because the number of medical devices meant to be implanted in patients’ bodies is rapidly rising. Unfortunately, despite their rising numbers, as the case of the Sprint Fidelis Lead recall illustrates, the Food & Drug Administration (FDA) is doing a poor job of regulating implantable devices, and often ignores reports of device failures until someone dies.
Medtronic Inc., the maker of the defective Sprint Fidelis Defibrillator Lead, announced last week that it had reached a settlement agreement regarding another of its faulty medical devices. The company has agreed to pay out $114 million to settle product liability lawsuits filed as the result of injuries cased by its malfunctioning Marquis line of implanted cardiac defibrillators. Despite the huge settlement agreement, Medtronic said it does not admit liability in the litigation.
Many patients implanted with defective Medtronic Sprint Fidelis Defibrillator Leads have found themselves in a medical limbo. If they are fortunate enough not to have already experienced a lead fracture, they must decide between two difficult choices, leave the Sprint Fidelis lead alone and hope it won’t fracture; or undergo a difficult and dangerous surgery to have the faulty lead replaced. Both options are bad ones, a fact that has left many Sprint Fidelis Lead patients anxious and confused.
Medtronic Inc., the maker of the faulty Sprint Fidelis Defibrillator Lead Wire, is now facing a lawsuit filed by a group of Canadians who claim the company failed to warn consumers of a defect in the batteries installed in its defibrillators. Last week, Ontario Superior Court Judge Alexandra Hoy certified the class-action lawsuit in a ruling released Dec. 6 in Toronto, allowing the plaintiffs to seek a portion of Medtronic profits for damages.
