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OpEdNews Op Eds    H3'ed 7/17/09

Restoring Patient Rights and Promoting Safer Medical Devices

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Avery DeGroh of McHenry, Illinois, was born with a hereditary heart defect that put her at risk for life-threatening arrhythmias. When she was only two years old, her doctor recommended that, as a precaution, she have a defibrillator implanted in her chest. Connecting the defibrillator to Avery's heart was a thin electrical cable called the Sprint Fidelis lead manufactured by Medtronic, Inc.

At three years old, Avery was playing at home when her defibrillator began sending the first of nine powerful electric shocks to her heart. Terrified and unsure of what was happening, Avery began to scream that monsters were attacking her. "It felt like someone was picking me up and dropping me," Avery stated in an interview earlier this year. Her mother could feel the shocks traveling through Avery's body and rushed her to a hospital. A representative from Medtronic was present at the hospital and confirmed that Avery's lead had fractured, causing the defibrillator to malfunction.

Avery's parents decided to have the Medtronic lead replaced with a lead manufactured by St. Jude Medical, Inc., since they were distrustful of Medtronic and wary of another lead fracture. Because they were implanting a St. Jude lead, Medtronic refused to cover the cost of the defective lead replacement.

Avery is one of thousands of people across America who suffered terrifying electrical shocks caused by a faulty Medtronic lead. Some patients were shocked more than 40 times before the defibrillator could be deactivated. Patients experienced great physical pain and suffered deep psychological wounds. In some cases, the experience was so devastating that they are being treated for Post Traumatic Stress Disorder.

In October 2007, Medtronic issued a recall of its Sprint Fidelis lead. Prior to the recall, the device was implanted in approximately 268,000 patients. Medtronic has not disclosed why the Sprint Fidelis leads have repeatedly fractured. It has also downplayed the failure rate. An independent study released in February of this year found that the fracture rate is substantially greater than the rate reported by Medtronic. In March 2009, Medtronic disclosed that at least 13 Sprint Fidelis patients may have died, including four patients whose deaths were related to efforts by doctors to surgically remove the product. Last year, Medtronic generated $10 billion in profits.

Sadly, Avery's nightmare and that of thousands of other patients continue today because they have been deprived of their legal right to hold Medtronic accountable for its negligence. Under a 2008 U.S. Supreme Court decision, Riegel v. Medtronic, Inc., patients injured by faulty medical devices may not be entitled to any compensation for their injuries and losses. The Court held that manufacturers of class III medical devices that have been approved by the Food and Drug Administration may be immune from liability. Medical device manufacturers have argued in subsequent litigation that they owe no duty to compensate injured patients even if their device contained a design or manufacturing defect that they failed to disclose to the FDA.

The checks and balances that the civil justice system creates for manufacturers to produce safe products have been gravely undermined. "Medtronic put profits ahead of patient safety. It was aware the device was failing at abnormally high rates but continued to market the lead as alleged in lawsuits filed against the company," according to Wendy Fleishman, Avery DeGroh's attorney with Lieff Cabraser Heimann & Bernstein, LLP. "Medtronic should not receive the benefit of a judicial doctrine granting the company immunity."

Congress has taken notice of this injustice. The Medical Device Safety Act of 2009 (S. 540/ H.R. 1346), sponsored by Sen. Edward Kennedy (D-MA) and by Rep. Frank Pallone (D-NJ) and House Energy and Commerce Committee Chairman Henry Waxman (D-CA), restores the right of Americans injured by faulty heart defibrillators, artificial valves, prosthetic knees and hips, to seek justice through the civil justice system. The Act overturns the Riegel decision by clearly stating that federal law does not provide immunity to medical device makers who produce defective products.

The Medical Device Safety Act has received the support of scores of consumer, health, women's advocacy, legal and physician groups, including the California Medical Association. The editors of the New England Journal of Medicine also endorsed the bill, noting:

Patients and physicians deserve to be fully informed about the benefits and risks of medical devices, and the companies making the devices should be held accountable if they fail to achieve this standard. We urge Congress to swiftly pass this legislation and to allow lawsuits by injured patients, which have been an important part of the regulatory framework and very effective in keeping medical devices safe, to proceed in the courts.


Despite this support, medical device manufacturers, along with the U.S. Chamber of Commerce, remain vigorously opposed to the bill, and are lobbying hard to defeat its passage.

The collective voice of thousands of patients can overcome this opposition. You can play a critical role in the passage of the Medical Device Safety Act by writing your members of Congress and asking that they support the MDSA. The addresses of Representative and Senators can be found online at www.congressmerge.com or in the white pages of most telephone directories.

Patients harmed by a faulty medical device should not suffer further injury by being deprived of their right to sue the negligent manufacturer. It is vitally important to protect patients from receiving faulty medical devices in the first place and it is equally important to preserve patients' and families' rights to obtain a remedy through exercising their constitutional right to bring a lawsuit against a wrongdoer under our legal system.

 

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Stephen H. Cassidy is an attorney admitted to practice in the State of California. He is a partner at the national plaintiffs' law firm Lieff Cabraser Heimann & Bernstein, LLP. His commentaries should not be considered an invitation to form an (more...)
 
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