Federal Judge Dismisses All Medtronic Sprint Fidelis Defibrillator Lead Cases

United States District Judge Richard H. Kyle has dismissed all lawsuits against Medtronic for faulty design or manufacture of its Sprint Fidelis cardiac defibrillator leads. Citing the Supreme Court’s ruling in Riegel v. Medtronic, Inc., Judge Kyle opined that the consumers have no legal basis for pursuing consumer justice lawsuits against large medical device manufacturers for FDA approved Class III devices, even if the medical device causes significant injury. The reason given is the same one proffered in the Riegel decision-if the FDA gave the device pre-market approval the device is immune from lawsuits and consumers have no recourse.
This decision, which is actually broader and more sweeping than the Riegel verdict, is wrong on many levels. 1) it is a clear case of federal encroachment on states’ rights. 2) it slams the door of consumer justice on those wrongfully injured by faulty medical devices, 3) it protects the large and financially well-heeled medical device corporations from any responsibility to the consumer. Given the FDA’s recent history of inadequacy and the frequent reports of the federal agency being unduly influenced by the pharmaceutical and medical device industries, this reliance on the FDA for consumer safety isn’t warranted. Consumer justice lawsuits are an integral component of protecting the public health.
Consumer justice lawyers all around the country, including me, will vigorously appeal this ruling. As part of the party platform, the Republican Party has a particular disdain for consumer justice and lawyers who fight for the ordinary citizens. Just look at the party platform,
“America’s litigation system is broken. Junk and frivolous lawsuits are driving up the cost of doing business in America by forcing companies to pay excessive legal expenses to fight off or settle often baseless lawsuits….And the bulk of jury awards to plaintiffs don’t even go to the people who deserve it…. Trial lawyers get rich from the misfortune of others. They cost hundreds of thousands of good jobs, drive honest employers out of business, deprive women of critical medical care – then skip out with fat wallets and nary a thought for the economic havoc and human misery they leave in their wake.”
A bill has already been introduced into Congress which we blogged about yesterday. The bill, if passed and signed into law by President Obama, would nullify this decision. Change has come to the White House and I hope with this change a new dawn of corporate accountability and responsiblity is on the horizon.