MEDICAL DEVICE MANUFACTURERS: A THRIVING INDUSTRY
On June 4th, the Medical Device lobby goes to Capitol Hill asking for continued special treatment given to no other entity in corporate America – immunity from lawsuits when their dangerous or defective products injure or kill patients.
They will tell you that without this immunity, they will not be able to innovate, or that they will be forced to reduce their workforce. What they won’t tell you is that there was no lack of innovation prior to the Riegel decision, and the medical device industry is thriving:
The top 25 medical device manufacturers reported a combined $173.506 billion in revenue in 2007
Revenue for the top 25 medical device manufacturers increased 9.7% between 2006 and 2007
Approximately 40 percent of the top 25 medical device manufacturers are headquartered outside the United States.
They will tell you that the FDA is responsible for the safety of medical devices, and capable of safeguarding the public. What they won’t tell you is that the FDA does not perform ANY testing on medical devices. It relies on the MANUFACTURER to provide data.
They will tell you that The Medical Device Safety Act would create 50 different FDAs, allowing individual juries to undermine FDA approval and authority. What they won’t tell you is that the Medical Device Safety Act does not take away any oversight authority of the FDA. The civil justice system only serves as a deterrent to encourage manufacturers to make their devices safe, and fully disclose all the risks associated with using a device.
They will tell you that this special complete immunity was the intention of Congress when the passed the Medical Device Amendments in 1977. What they won’t tell you is that Senator Kennedy, Chairman Waxman, and Chairman Dingell – all present and involved in the Medical Device Amendments – have stated clearly that this was not the intent of Congress which is why they authored and support HR 1346/S 540, the Medical Device Safety Act.
What else aren’t they telling you?
That also on June 4th, a major medical device manufacturer will file a motion in a Minnesota state court to dismiss hundreds of lawsuits against them for terrible injuries suffered as a result of a faulty sprint fidelis lead in their Implantable Cardiac Defibrillators. Injuries that include multiple and severe unnecessary shocks to their bodies, terrible PTSD, or even death.
That earlier this year, over 1,450 injured heart patients had their cases dismissed under Riegel. During this dismissal, he presiding Judge stated: “Plaintiffs' remedy, therefore, lies with Congress, and not with this Court (or any other court)."
That unless Congress passes the Medical Device Safety Act, this entire industry would have immunity from liability, even when they knowingly sell a dangerous or defective device. Congress must protect consumers from defective medical devices and allow patients to hold wrongdoers accountable in state courts.
It is urgent that Congress act NOW and pass the Medical Device Safety Act
The American Way ... | read more +
The Medical Device Safety Act would address the Supreme Court’s recent decision in Riegel v. Medtronic and restore the rights of injured consumers to hold negligent medical device manufacturers accountable when their products cause injury and death.
The February 2008 decision ignored Congressional intent and disregarded 30 years of experience under the 1976 Medical Device Amendments (MDA), during which FDA regulation and state tort law worked together to protect consumers from dangerous devices. The Riegel decision gives total immunity to device manufacturers who fail to adequately warn consumers about device risks. In Riegel, the device that failed was a Medtronic balloon catheter used in heart surgery. Riegel needed additional surgery but eventually died. Now, thanks to the decision, Riegel’s heirs are left holding the bag for the manufacturer’s negligence.
The MDA authorized FDA requirements for an approved medical device to preempt the numerous state requirements. But the court decision turned the simple preemption provisions of the MDA into a vehicle giving total immunity from any accountability, with no checks and balances. 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 does nothing to help the injured patient, drains public funds, and does not encourage the manufacturer of the faulty device to fix the problem.
The Medical Device Safety Act of 2008 would fix the Supreme Court’s flawed Riegel decision. The bill simply does two things:
- It restores Congressional intent by explicitly stating that actions for damages under state law are preserved.
- It makes the amendment retroactive to the date of enactment of the Medical Devices Amendment of 1976.
The bill doesn’t change the federal preemption of state law; it simply removes the presumption of total immunity and no accountability that the federal courts gave to manufacturers and the FDA decision-makers. The court took the decision-making process out of the hands of Congress and of the court system and put it completely in the hands of FDA bureaucrats. State legislators and attorneys general are joining the cause of rolling back the situation to before the Supreme Court’s decision and restoring the status quo in effect for decades.
An American who cares about states’ rights should be for the act; an American who worries about excessive power in the hands of bureaucrats should be for the act; and an American who worries about judicial usurpation of Congressional intent should be for the act (the drafters of the original act even submitted an amicus curiae brief stating that they never intended for the act to provide immunity). An American who wants federal preemption of state statutory law has nothing to fear, because this act doesn’t dilute that preemption one iota. An American who thinks people should have some access to the courts – any access – should be for the act, because right now, in these situations, there is no access, and that’s not the American way.
When The FDA Failed ... | read more +When FDA Failed… Civil Justice System Prevailed
Civil Justice System Forced Removal of FDA Approved Tampons Linked TSS
International Playtex, Inc. voluntarily removed from the market tampons linked to toxic shock syndrome (TSS) after a federal court jury awarded compensatory damages to the family of Betty O'Gilvie in 1985. O’Gilvie died from TSS after using Playtex super-absorbent tampons. While Playtex had complied with FDA regulations concerning the product's warning labels, the jury found FDA requirements only set minimum standards and mere compliance with those standards here had been inadequate under the circumstances.[1]
Civil Justice System Proved That Defibrillator Manufacturer Knew Of Danger 6 Months before Taking Action
A state court proceeding forced Guidant Corporation to release internal documents indicating that company executives knew of potentially deadly problems with their defibrillators six months before sharing those concerns with the public. The documents included a slide-presentation dated October 20, 2004 which warned that up to 55 Guidant defibrillators could short circuit by November, 2005. Despite the internal warnings Guidant did not notify the public and recall devices until June 17, 2005. The New York Times estimates that more than seven people have died because of faulty Guidant defibrillators.[2]
Civil Justice System Helped Get Dangerous Breast Implants Off the Market
In a 2005 article published in the University of Texas Law Review, Edward T. Schroeder wrote that, “the breast implant lawsuits demonstrate how litigation can stimulate regulation.” Schroeder noted that while federal law gave the FDA authority to regulate silicone implants since 1976, the agency did not require safety studies by manufacturers of implants until 1992. Internal documents from silicone implant maker Dow Corning revealed that the company had known about health risks associated with their products for years, yet went ahead and developed “a new, less sturdy implant because it was concerned about losing market share.” In 1994, scientific research, which was “prompted by the litigation,” inspired an FDA ban on silicone breast implants.[3]
Civil Justice System Pushed FDA to Mandate Labels Warning Mixture of Tylenol And Alcohol
On October 22, 1994 a jury in Fairfax County, VA awarded $8.8 million to a 39 year-old man who suffered liver failure after combining Tylenol (acetaminophen) with alcohol. That same day, the FDA announced that it would mandate warning labels detailing the adverse effects that could result from the mixture of the drug with alcohol. While the risk of mixing acetaminophen with alcohol was apparent as far back as the late 1970’s, the FDA neglected to act until the verdict was returned.[4]
Civil Justice System Forced Withdrawal of Dangerous FDA Approved Contraceptive Device
The Dalkon Shield was an implanted contraceptive device with a flawed design that caused bacteria to become trapped in the patient’s uterus. Complications arising from Dalkon Shield use included pelvic infections, infertility and, 20 recorded deaths. Internal documents, made public during pre-trial discovery hearings, suggested that A.H. Robins Inc. manufactured and marketed the Dalkon Shield despite evidence that their product was unsafe. Lawsuits pushed A.H. Robins to urge doctors to remove the device and compensate injured women. The FDA removed the Dalkon Shield form the market in 1974.[5]
[1] O'Gilvie v. International Playtex, Inc., 609 F. Supp. 817 (D. Kan. 1985), rev'd, 821 F.2d 1438 (10th Cir. 1987)
[2] New York Times, 1/20/05; New York Times, 6/18/05
[3] University of Texas Law Review, 2/1/05; Newsday, 2/11/92
[4] Washington Post, 10/23/1993
[5] Tetuan v. A.H. Robins Co., 738 P.2d 1210 (Kan. 1987); Health Facts, 5/1996
The Evolution of the Supreme Court’s Decision in Riegel v. Medtronic
The Supreme Court’s decision in Riegel v. Medtronic gives medical device manufacturers total immunity for their defective devices. This decision was based on the use of the word “requirements” in the Medical Device Amendments of 1976 (MDA). The Supreme Court traditionally has declined to afford total immunity to members of any industry in the absence of a clear congressional intent. In the early 1990s, however, the Court began to depart from its traditional approach. The addition of new Supreme Court Justices facilitated this movement towards strict constructionism (i.e., literal interpretation of the text of a statute) and away from the analysis of laws in the context of legislative history and social policy. The Court’s decision in Riegel is the result of a gradual change in approach culminating in a much broader interpretation of “requirements” than was ever intended by Congress.
Our system of checks and balances requires Congress to consider the real world impact of its laws, as it is the body that is answerable to the will of the people. Congress also has the duty to overturn decisions that do not adhere to its legislative intent, as it did with 124 Supreme Court decisions between 1967 and 1990[1]. Given that the Court used a literal interpretation of the MDA and a fractured Supreme Court opinion to render its decision, it is up to the Congress to overturn Riegel and restore proper checks and balances. Here’s the history:
Prior to 1992 – The Supreme Court recognized the distinction between state tort law and state statutes/ regulations.
- The Court consistently recognized state tort law serves a different and complementary function to state statutes and regulations. See United Construction Workers v. Laburnum Construction Corp., 347 U.S. 656 (1954); Int’l Union v. Russell, 356 U.S. 634 (1958); Silkwood v. Kerr-McGee Corp., 464 U.S. 238 (1984); English v. General Electric Co., 496 U.S. 72 (1990).
- The Court would not afford total immunity to defendants absent clear and manifest evidence that Congress intended to do so. Silkwood v. Kerr-McGee Corp., 464 U.S. 238 (1984).
1992 – The Supreme Court ignored the distinction between state tort law and state statutes/regulations. Cipillone v. Liggett Group, Inc., 505 U.S. 504 (1992).
- The Court granted immunity to the Liggett Group under the Public Health Cigarette Smoking Act of 1969, relying on the word “requirements” to find that the statute included common law and, therefore, afforded immunity to cigarette companies from certain tort claims. The fractured Court issued concurring opinions, resulting in a plurality, not a majority decision.
1992-2005 – The Supreme Court wavered between Silkwood and Cipillone approaches.
- The Court did not grant immunity to Medtronic for claims based on one of its defective pacemakers, which the FDA had approved based on its 510(k) process (i.e., approval was based on the fact that the pacemaker was “substantially equivalent” to another device that had received FDA approval). Medtronic v. Lohr, 518 U.S. 470 (1996).
- In a case based on decidedly unique circumstances, the Court affords total immunity to a defendant automobile company. Geier v. Honda Motor Co., 529 U.S. 861 (2000).
- The Court does not afford immunity to Dow but does again determine that the word “requirements” in the applicable statute includes common law and that Congress intended for pesticide companies to have immunity from certain tort claims relating to labeling of risks. Bates v. Dow Agrosciences, 544 U.S. 431 (2005).
2008 – In Riegel, strict constructionist justices led the Court back to Cipillone, finding that the word “requirements” in the MDA should be interpreted to afford complete immunity to medical device manufacturers. The Riegel decision gives great weight to the Cipillone analysis of “requirements,” which applied to a limited statute and was not adopted by a majority of the Court. The Justices in Riegel failed to properly consider Congressional intent or the historical context when the MDA was enacted in 1976. It is now Congress’ duty to respond.
[1]W. Eskridge, Overriding Supreme Court Statutory Interpretation Decisions, 101 Yale L. J. 331 (1991).
Protect Injured Veterans from Dangerous Medical Devices
In a February 2008 report entitled “Prosthetics in the VA: Past, Present, and Future,” the U.S. Naval Institute stated that the seven year war on terror has resulted in 737 soldiers losing limbs, 116 suffering spinal cord injuries, 53 instances of total blindness, and 3,145 traumatic brain injuries. All of these veterans will require the use of medical devices in order to assist them with daily activities and provide them with the quality of life they deserve. The Supreme Court’s ruling in Riegel v. Medtronic puts these soldiers at further risk by taking away their right to hold medical device manufacturers accountable for faulty products.
Without a legislative solution, any costs attendant to defective devices, including rehab and perhaps long-term care, will have to be paid by the VA without reimbursement through the tort system. Our veterans who served nobly in Iraq and Afghanistan, as well as our Vietnam War, Korean War, and World War II veterans, deserve better than to have their families and the taxpayers stuck with the tab for the carelessness of device makers.
Medical device manufacturers receive complete immunity under the Riegel decision for devices commonly used to treat service men and women.
- Prosthesis (artificial limbs)
- Pacemakers
- Implantable Cardioverter Defibrillators
- Orthopedic hips and knees
- Ocular Implants
- Cochlear Implants
- Interactive Wound and Burn Dressings
- Spinal Cord Stimulator (Implanted)
- Stair Climbing Wheelchair
The Medical Device Safety Act will correct the Riegel decision by taking away immunity for the manufacturers of faulty products. This will give the manufacturers incentive to provide safe medical devices to our veterans, preventing painful and costly additional surgeries, or even death. This is the least we can do to protect those who lost so much protecting us.
