Evelyn Pringle May 13, 2009
On May 12, 2009, the House Energy and Commerce Subcommittee on Health held a hearing on the Medical Device Safety Act of 2009. HR 1346 would overturn the February 2008 Supreme Court decision that, for the first time, denied patients the right to sue device makers for compensation when injured by certain medical devices.
In the case of Riegel v Medtronic, the court ruled that a device maker cannot be sued under state law by patients alleging injury from a device that received marketing approval from the FDA.
"The Court's decision has left consumers without any ability to seek compensation for their injuries, medical expenses and lost wages resulting from injuries caused by defective premarket approval (PMA) devices or inadequate safety warnings," according to a March 5, 2009 press release by Representatives Frank Pallone, Jr (D-NJ), Chairman of the Energy and Commerce Subcommittee on Health, and Henry Waxman (D-CA), Chairman of the Energy and Commerce Committee, issued when introducing the Medical Device Safety Act of 2009.
"It also removed one of the industry's most important incentives to maintain product safety after approval and disclose newly-discovered risks to patients and physicians," the release noted.
A companion bill has been introduced in the Senate by Senators Edward Kennedy (D-MA) and Patrick Leahy (D-VT).
Dr Gregory Curfman, executive editor of the New England Journal of Medicine, testified at the hearing from prepared remarks and urged Congress "to swiftly pass" the legislation and stated in part:
"This bill would nullify the Court's ruling in Riegel by adding language to the Medical Device Amendments to make explicit that the law does not preempt suits against device companies and thereby to place medical devices and drugs on a level playing field with respect to patient lawsuits."
"The critical issue of preemption, which directly affects the disclosure of risks and thus the safety of the nation's supply of medical devices and drugs, should properly be decided by officials elected by the people, with whom the responsibility for the health of the public rightfully resides."
On March 31, 2009, a group of medical device patients from around the country traveled to Washington to ask Congress to pass the Device Safety Act, as part of the "Campaign to Stop Corporate Immunity," a coalition of consumer, health, and trade associations fighting to restore the rights of patients injured by faulty devices.
In a March 31, 2009 letter to Congress, the patient group explained in part: "The Medical Device Safety Act will return our rights that have been taken away by fixing this problem and putting the law back the way it was just over a year ago."
"Most of us here today have received a Medtronic Implanted Cardiac Defibrillator (ICD) that had a defective Sprint Fidelis lead attaching it to our hearts. This lead has malfunctioned causing patients like us to suffer unnecessary shocks that can only be compared to getting kicked in the chest by a horse. While these are meant to be life saving devices, some of us are here representing loved ones who lost their lives as a direct result of their defects."
"Medtronic knew this lead was faulty and failed to report problems to the FDA. As a result, hundreds of the defective leads were implanted in heart patients across the country. This was all before they had immunity from lawsuits! Imagine how reckless they will be with out the checks and balances of our civil justice system."
"If we cannot hold medical device manufacturers accountable for their actions, we cannot pay for our medical care, a cost that will fall to taxpayers. Why should Americans have to finance the medical device industry?"
"Please, consider us when it comes time to vote on the Medical Device Safety Act, and vote YES for patient safety."
A day earlier on March 30, 2009, the Center for Justice & Democracy released a study titled, "HEART SICK Hazardous Heart Devices and the Importance of Litigation," and pointed out that while "saving many lives, heart implants are also among the most dangerous and recalled medical implants ever made."
"This study tells a devastating tale of greed, cover-ups and reckless behavior by some companies that manufacturer heart devices, such as pacemakers, defibrillators, heart valves and stents," said Joanne Doroshow, Executive Director of the Center, in a press release.
"Some of these devices were placed on the market without adequate testing," she continued. "This has been with the acquiescence of the Food and Drug Administration, which has repeatedly been unable to properly oversee this hazardous industry."
"Heart devices have saved millions of lives, but hundreds of thousands have malfunctioned due to design and manufacturing defects that should have kept these devices off the market," said report author Amanda Melpolder in the press release.
"When they fail, the results for patients can be catastrophic," she advised. "Only through litigation have patients and their families been compensated, and in many cases, lawsuits have been the only way information has come to light about some of the most dangerous heart devices.”
"Because of medical risks, heart implants are not always removable even if the device fails or is later recalled," the summary on the study points out. "Sometimes devices are recalled long after manufactures were aware of problems and tens of thousands of devices are implanted in patients, forcing them to live with ticking time bombs in their chests."
"Time and again, medical device companies have shirked their responsibilities to ensure the safety of heart devices," the summary notes.
At the subcommittee hearing, Professor of Law at Georgetown University Center, David Vladeck, testified from prepared comments and point out that:
"Riegel has already been invoked to dismiss claims involving defective defibrillators, defibrillator cables, hip replacements (even though the model was recalled), knee replacements, heart valves (also subject to recall), silicon breast implants, and “adhesion barriers” used in surgery."
"All of these case would have been viable prior to Riegel," he said.
"Because of the structural limitations in the preapproval process," Professor Vladeck advised, "FDA’s track record demonstrates the agency’s inability to single-handedly protect the American people against defective and dangerous medical devices.
Just in the past few years, he said, we have seen massive recalls of defibrillators, pacemakers, heart valves, heart pumps, and prostheses — "which have exacted a terrible toll on the patients who have had them implanted in their bodies, and who often face the daunting prospect of explantation and replacement surgery."
"Post-Riegel, these patients will now be left with no remedy at all: no compensation for the pain and suffering they endure, no reimbursement for the expenses of surgery, no reimbursement for lost wages, and no recompense to their loved ones should they die as a result of a defective device," he pointed out.
On its website, the Stop Corporate Immunity group explains that: "When patients with devastating injuries are unable to hold the negligent manufacturer accountable, the patient and the taxpayers are left footing the bill."
"For a patient with private health insurance, the health insurance would most likely cover the additional surgery. However, this raises the cost of insurance, and still leaves the patient with no compensation for the physical limitations caused by the device’s failure."
"For Medicare or Medicaid-covered patients, the costs of the additional medical care are passed to the taxpayers. And for patients who can no longer work, they may need additional taxpayer supported programs, such as Social Security disability."
"All this cost shifting," the group says, "does nothing to help the injured patient, drains public funds, and does not encourage the manufacturer of the faulty device to fix the problem."
"A quarter of a million people received the Sprint Fidelis cable in the three years from its introduction in 2004 until Medtronic “recalled” the product in 2007 because of its high failure rate," Professor Vladeck told the committee.
"Although Medtronic has admitted that the Sprint Fidelis cable has a dangerously high fracture rate," he said, "it has offered patients no financial assistance at all other than the cost of the replacement cables."
"Patients alone must bear the full costs of the surgery — which can run as high as $15,000 — the recovery, the lost time from work, and the pain and suffering they endure," he explained.
Four patients have already died during extractions, and at least nine others have died as a result of the device’s defect. "The FDA has received 2,200 reports of serous injuries associated with the cable’s failure," the Professor reported.
"The most patients can hope for is that some of their medical costs will be offset by private insurance or by Medicare," he said.
"Medtronic has offered nothing more to patients and post-Riegel patients stuck with a Sprint Fidelis cable cannot compel Medtronic to do more," he added.
"Consumers, like the thousands of patients struggling to decide whether to undergo risky extraction surgery with the Sprint Fidelis cable, are left with the worst of both worlds," he advised, "an FDA premarket approval system that cannot possibly guarantee the safety of devices and no recourse if their devices fail."
In June 2009, Professor Vladeck will take a leave of absence from the Georgetown Center to join the Federal Trade Commission as Director of the Bureau of Consumer Protection.
The Medical Device Safety Act 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, Consumers Union, Homeowners Against Deficient Dwellings, National Association of Consumer Advocates, National Consumers League. OWL - The Voice of Midlife and Older Women, Progressive States Network, Public Citizen, and the National Research Center for Women & Families