Medicare could be stuck paying more than $1 billion for monitoring and replacement of faulty pacemakers, according to a statistical analysis commissioned by a group of plaintiffs lawyers. The report says the cost to taxpayers results from the Supreme Court’s 2008 ruling in Reigel v. Medtronic, which greatly limited the legal exposure of manufacturers when FDA-approved medical devices were later found to be defective. The expense could fall on the Medicare program if manufacturers are sheltered from lawsuits, the study says.
Costs were calculated for monitoring and replacing Medtronic’s Sprint Fidelis leads, which connect the pacemaker to the heart. The leads were recalled in 2007 because they were prone to fracture and send off false shocks. The report said the cost of the Sprint Fidelis lead defect to Medicare “is an example of the cost of this liability … for a single defective medical device.” It noted that many other devices have been put on the market and later found to be defective.
Medtronic spokesman Christopher Garland called the findings “questionable, at best,” noting that it was funded by lawyers suing the company over the Sprint Fidelis leads. In an e-mail to FairWarning, he said the analysis contained ”serious flaws,” including reliance on ”unverified selected facts” from newspaper articles.
Last Monday, the 8th Circuit Court of Appeals began hearing oral arguments in an appeal of dismissal of federal cases against Medtronic for the faulty leads.
A bill in Congress, the Medical Device Safety Act, would expand liability for manufacturers of faulty medical devices. The bill is supported by the leading trial lawyers group, the American Association for Justice.
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It is sad that those of us with Sprint Fidelis leads in Medtronic pacemakers should be left in the cold with no way to sue the company that supplied faulty leads!
The cost to Medicare? Ok, so it will be a huge amount of dollars that Medicare can’t really spare. But what of the cost to us, the patients??? Death?? Injury??? All of which we or our family have no recourse because of the way the law reads.
I say that the government must NOT disallow lawsuits against the company for what they put on the market as safe, which are proving to be faulty and dangerous. They should not be let off the hook. Someone must step in for us and act as our liaison so we can have a way to file suit and win against Medtronic for using the defective leads!
I have one of those leads, and I don’t rest well knowing it could fracture and cause complications, including death.
Thanks for nothing to the FDC in allowing these leads to be considered “held harmless” for damages and death to the recipients.