In October 2007, the FDA announced that medical device maker, Medtronic, would recall four different models of Sprint Fidelis Cardiac Leads, the wires coming out of a heart defibrillator that cause the heart to shock when life-threatening irregular heartbeats are detected.
Doctors were advised to stop implanting them because of a potential for fractures in the electronic leads that caused, in some cases, the defibrillator to deliver unnecessary shocks or not to operate at all.
Some deaths and serious injuries were linked to the Sprint Fidelis leads.
By October 2007, there were an estimated 268,000 Sprint Fidelis leads implanted worldwide.
Medical Device Victims
Avery DeGroh had one implanted as a young child.
At the age of three, Avery was playing in her basement when the implanted defibrillator began shocking her. Her mother ran to pick her up and was also shocked. Avery screamed that monsters were attacking her.
A Medtronic representative at the emergency room confirmed that Avery’s lead had fractured and she had been shocked nine times. Her parents opted to have the Medtronic lead replaced with another brand. Medtronic told them the company would not cover the cost of the defective lead replacement.
Their daughter lived.
Katie Meyer did not. During surgery to have the defective lead from her defibrillator removed, Katie suffered cardiac arrest and brain injury. She spent eight months in the hospital until she died last December, three days short of her 31st birthday. Her family is faced with over a million dollars in unpaid medical bills.
“Hit and Run” Corporate Harm
Individuals hurt by medical devices gathered in Washington Tuesday to talk to members of Congress about corporate harm and accountability.
Everyone there had been harmed by faulty medical devices. Not one of them can file a lawsuit to recover damages and to hold the corporation responsible.
They were brought to Washington by citizen, public interest, and trial lawyer associations to encourage support of the Medical Device Safety Act of 2009 which would reverse the U.S. Supreme Court decision in February 2008, Riegel v. Medtronics, that grants immunity or a shield to corporations against lawsuits because their products have been approved by the federal Food and Drug Administration (FDA).
The Court found in Riegel that claims are barred under a preemption clause included in the Medical Device Amendments of 1976 (MDA).
Ironically, many medical devices, some which do the most harm, were never approved for safety by the federal agency. Instead their manufacturers claimed they were “substantially equivalent” to a device already on the market under an approval process called 510k.
For many devices, the exchange of paperwork is all that is needed to have a device approved for marketing and to avoid the more stringent premarket approval process (PMA).
The film, "Hit and nRun" which can be seen on YouTube, produced by the Alliance for Justice (AFJ), a Washington based consumer group, says holding corporations accountable encourages the safety of products.
“It’s up to Congress to make clear that when big corporations damage your health, they shouldn’t be able to “Hit and Run,” says Alliance for Justice President, Nan Aron.
The AFJ film is being shown around the country and to members of Congress to support passage of the Medical Device Safety Act of 2009. Supporters are asked to sign an online petition.
It is hosted by Diana Levine, the woman who recently reversed the federal preemption of corporate immunity by drugmakers in her action against Wyeth.
The Medical Device Safety Act of 2009
The 2-page House Resolution H.R. 1346, amends Section 521 of the Federal Food, Drug, and Cosmetic Act by adding: “No effect on Liability Under State Law – Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State.”
It was introduced by U.S. Reps. Frank Pallone, Jr. (D-NJ) and Henry A. Waxman (D-CA) the day after the Diana Levine decision before the Court March 4.
The Medical Device Safety Act of 2009 is endorsed by the National Conference of State Legislatures, the New England Journal of Medicine, the American Bar Association, AARP, the Center for Justice & Democracy, Consumer Federation of America, and Consumers Union, among others.
A companion bill has been introduced in the U.S. Senate by Sen. Edward Kennedy (D-MA), where passage is not certain in the face of the budget priorities facing Washington lawmakers.
If approved, the act would apply to any civil action pending or filed on or after the date of enactment of the Act. It would not be retroactive. #