Medical Device Safety Act would restore needed safeguards and allow victims to be compensated

When 2 ½ year old Avery DeGroh’s defibrillator shocked her nine times because of a broken lead, her mother “grabbed her to hug her, and…could feel all the electricity jolting back and forth, cycling through her body.” (Details here.) The defibrillator lead was soon recalled by manufacturer Medtronic, but the DeGroh family was still stuck with $30,000 in medical bills for the cost of replacing the device, not to mention the trauma of Avery’s experience. DeGroh’s mother explains that “as the law stands, we don’t have any way to seek compensation for what Avery has gone through…we were just asking for her hospital bills [to be paid].”

The DeGroh family and others testified before the Senate’s Committee on Health, Education, Labor, and Pensions on August 4 in support of the Medical Device Safety Act (MDSA), which will restore an injured patient’s right to sue manufacturers.

Without a change in the law, medical device manufacturers will continue to enjoy complete immunity from liability under the Supreme Court’s 2008 Reigel v Medtronic decision. This is true even if a defectively designed or manufactured medical device injures or even kills patients.

The MDSA, 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), would restore the right to seek justice in state courts for patients who are injured by faulty medical devices. MDSA (designated H.R. 1346 in the House and S. 540 in the Senate) would simply overturn the 2008 Supreme Court decision which found that a 1976 federal statute allowing FDA to regulate and approve the marketing and sale of medical devices also broadly preempts state authority, including those state laws that allow injured consumer to sue a manufacturer.

At the hearing, Dr. William Maisel, Director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center, testified that while “we are fortunate to have the preeminent medical regulatory system in the world,” the FDA must regulate “more than 100,000 different medical devices manufactured by more than 15,000 companies.” After approval, the FDA must rely on manufacturers to report problems because they simply do not have the resources to adequately monitor all of the devices on the market.

Before Riegel, lawsuits were the main incentive for device companies to report problems. But in light of the Riegel decision, manufacturers have little, if any incentive to report problems, because to do so might decrease sales. In short, now that consumers cannot sue, there is very little incentive for manufacturers to act responsibly and inform FDA as soon as they have evidence of public health risks associated with their devices.

Bill cosponsor Senator Harkin described the ability to sue manufacturers as an important “safety net” that is complementary to FDA regulation. “In our system of justice, access to the court system is critical in exposing dangers and bringing about remedies.” (Watch the hearing here.) Another victim of Medtronic’s defective defibrillator lead, Nick Evola, was shocked 43 times. According to his lawyer Wendy Fleishman, “Medtronic put profits ahead of patient safety. They were aware the device was failing at abnormally high rates but continued to market it as alleged in lawsuits filed against the company.” (See article here.)

The profits on medical devices are significant. In 2008, Medtronic’s revenue topped $13 billion, with $10 billion in profits, according to the American Association for Justice, an advocacy group supporting the MDSA.

In support of the bill, Dr. Maisel cautioned that “the Riegel decision eliminates an important consumer safeguard – the threat of manufacturer liability – and will lead to less safe medical devices and an increased number of patient injuries.”

Senator Harkin explained at the hearing that “this bill is really about real people, who have been…let down, sometimes catastrophically. Right now they have no access to justice and no ability to hold those that cause them harm accountable.”

Janice Baird, another supporter of the bill whose son died due to a defective pacemaker, explained that the law is needed because manufacturers “have to be responsible, and [because the law] will also, in my heart, give me some peace to know that Robert’s death was not in vain.” (See article here.)

More information can be found in our Fact Sheet on the MDSA, or at the website stopcorporateimmunity.org.

Help reverse the medical device “tort reform” by the Supreme Court that has left thousands of injured patients without the right to sue, and puts many more patients at risk! 

The following announcement and open letter to Congress was organized by the Campaign to Stop Corporate Immunity, a coalition of consumer and advocacy organizations (including PAL, Community Catalyst, AARP, Consumers Union, and many others) working to restore patient’s rights to sue manufacturers when they are harmed by dangerous or defective medical devices.

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Medical Device Patient Lobby Day

On March 31st, Medical Device Patients from around the country will travel to Washington, DC and ask Congress to pass the Medical Device Safety Act.  Please click here to learn more about the Faces of Preemption.  Following is the Patients’ Letter to Congress:

Dear Members of Congress,

Because we have had a defective medical device implanted in our bodies, we are here today asking Congress to support HR 1346/S 540, the Medical Device Safety Act.

In February of 2008, the Supreme Court decided that medical device manufacturers cannot be held accountable for producing dangerous and defective products. They felt that FDA’s approval of a medical device warranted this immunity. It should not. 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.

SUPPORT HR 1346/S 540, THE MEDICAL DEVICE SAFETY ACT 

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Additional information:

This legislation is needed not only to restore the rights of current patients who have been harmed, but also to safeguard for the safety of future patients who use any prescription medical device. The right to sue manufacturers of faulty or dangerous medical devices helps ensure that manufacturers develop and produce safer devices. For instance, earlier this month, in the case Wyeth v Levine (related to the safety of prescription drugs) the Supreme Court noted that:

State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly. They also serve a distinct compensatory function that may motivate injured persons to come forward with information. Failure-to-warn actions, in particular, lend force to the FDCA’s premise that manufacturers, not the FDA, bear primary responsibility for their drug labeling at all times. Thus, the FDA long maintained that state law offers an additional, and important, layer of consumer protection that complements FDA regulation.

Unfortunately the regulation of medical devices by FDA involves some slightly different federal statutes than those related to prescription drugs. Back in the late 70′s, consumers were being harmed by newly available medical devices, and the states had started to regulate.  In this context, Congress enacted the Medical Device Amendments of 1976 in order to create a unified national system of device labeling under federal law. They did so by expressly preempting, or nullifying labeling requirements imposed under state law.

Gradually over the next twenty years, corporations starting broadly asserting federal regulatory law to get immunity from state law consumer protection and product liability statutes. Corporations exploited many such federal laws as a back-door method to achieve a judicial form of “tort reform” which Congress had long denied them.

You may wonder how federal labeling requirements could affect state laws related to product safety? The ‘reasoning’ goes like this. To win a lawsuit, oftentimes a consumer must prove to a jury that the manufacturer of a product failed to provide adequate warnings that would allow the product to be used safely. A jury verdict is a decision, as a matter of law, that a warning was not adequate. Nearly all warnings are contained in the labeling of the product’s packaging. So a jury decision on the adequacy of a warning is regulation of product labeling under state law. Therefore, such jury verdicts concerning medical devices must be preempted by the superior federal laws enacted in 1976.

So, despite a rather clear intent by Congress to preempt state regulation of what a medical device label must disclose, federal court judges started to buy these ‘preemption’ arguments over twenty years later. Then, in February of 2008, the Supreme Court agreed with this reasoning in the case Riegel v. Medtronic (see our blog here). The Court ruled that consumer claims addressing the adequacy of medical device labeling were preempted.

The current Medical Device Safety Act (HR 1346 in the House, S 540 in the Senate) would simply reverse the decision in Riegel v. Medtronic, and narrow, or limit the preemption under federal law to just the regulation of device labeling, and to restore the rights of patients to sue a device manufacturer when they are harmed.  

To help, follow the link below, and urge your Congressperson and both your U.S. Senators to vote for the Medical Device Safety Act, and reverse the tort reform decided by the Supreme Court in Riegel v Medtronic.

Contact your Congressperson here: https://writerep.house.gov/writerep/welcome.shtml

Contact your Senators here: http://www.senate.gov/general/contact_information/senators_cfm.cfm

To help your organization sign on in support of this legislation, please contact PAL at PAL@communitycatalyst.org.

For more information, go to the Campaign to Stop Corporate Immunity website.

This past Wednesday, the Prescription Project, a sister project to PAL at our parent organization, Community Catalyst, filed four petitions with the FDA raising concerns about online advertising of medical devices and drugs on YouTube.com. The petitions cited ads posted on YouTube by Abbott Laboratories (NYSE: ABT), Medtronic (NYSE: MDT) and Stryker (NYSE: SYK).

Within hours, the two videos about Medtronic and Stryker’s devices cited by the Prescription Project were removed, and the remaining videos about an Abbott Laboratoriess device were labeled with safety information, and removed from public access the next day.

The Prescription Project’s petitions have gotten widespread media attention, including articles in the Wall Street Journal, Associated Press, Crain’s Chicago Business, Chicago Tribune, Minneapolis Star Tribune, and Pioneer Press.

The Prescription Project’s press release on the petition is here.

Here is the entry from PostScript, the Prescription Project’s blog, about the request for FDA action:

Devicemakers’ bypass marketing rules on YouTube
December 3rd, 2008

Today the Prescription Project filed a series of citizen petitions with the FDA asking that six YouTube videos be removed immediately from the self-broadcast internet supersite because they appear to have been posted by medical device manufacturers, but do not contain the federally-mandated warnings or provisions required of medical device advertisements.

The videos include four posted by Abbott Laboratories about its XIENCE-V drug eluting stent, one for Medtronic’s Prestige® Cervical Disc, and one for Stryker’s Cormet™ Hip Resurfacing Technology. Here they are.

The Prescription Project is petitioning the FDA, which is charged with regulating the marketing of approved medical devices as well as prescription drugs, to require the makers to remove the ads from YouTube immediately and to post “curative” ads that contain the proper risk information. In addition, the Project calls on the FDA to:

• Advise all major prescription drug manufacturers and medical device manufacturers that online/Internet drug and device advertisements and promotions are subject to the same requirements as drug and device promotions in other media, and recommend that they review their online advertisements for compliance.

• Issue a Guidance on Consumer-Directed Broadcast Advertising of Prescription Drugs and Restricted Devices on the Internet to clarify how federal law and FDA regulations apply to online drug and device promotions.

But who watches YouTube for info about health, anyway? Well, it seems that number is growing rapidly. According to a 2007 survey conducted by the Pew Internet and American Life Project, somewhere between 75% and 80% of internet users have looked online for health information. And a Manhattan Research poll about physician online habits released just last month found that 83% of physicians watch video clips online, as compared with 34% of all US adults.

So statistically, these ads are being seen by both patients and doctors. And without the proper risk information that’s required in other broadcast drug device advertising, that’s a problem.
In fact, we think it’s an even bigger problem because consumers injured by medical devices can no longer sue device manufacturers for failing to warn them about known but undisclosed risks, a result of the February 2008 Supreme Court decision in Riegel v. Medtronic. And consumers injured by prescription drugs may well lose that same right if the Supreme Court issues a similar ruling in Wyeth v. Levine, a case argued before the Court last month.

To read the petitions and view the videos, go here.

Readers of this blog know that we here often get our knickers in a twist over federal preemption arguments by pharmaceutical defendants seeking to avoid liability in lawsuits. Prescription drug and medical device companies have been arguing with increasing frequency in recent years that lawsuits against them brought under state law are “preempted” by the FDA’s authority under federal law. (Remember that 8th Grade U.S. Civics course? Under the Constitution’s “Supremacy Clause,” federal law trumps state law when the two conflict).

Unfortunately, the FDA has been aiding and abetting them by intervening in products liability lawsuits and by adding a preamble to a Guidance on Drug Labellng, making the same arguments. Given the FDA’s abdication of its responsibility to aggressively enforce drug and device safety, this amounts to “We won’t enforce it, and we won’t let anyone else either.”

There’s a pendulum effect to corporations’ approach to federalism, and we’re at one apex of its swing. When the federal government is aggressive with regulation and enforcement, business is all about “states’ rights.” When the federal government moves away from enforcement and regulation, states step in to fill the void. Suddenly, the federal government is paramount to business, and those pesky states are “interfering” in the unique and exclusive prerogatives of federal agencies. We’ve witnessed the recent odd spectacle of various industries pushing for federal regulation, as ably documented in this recent New York Times article: “In Turnaround, Industries Seek U.S. Regulations” (Sept. 15, 2007). The shifting allegiance of course reeks of what it is – opportunism.

But the Constitution remains, and its delicate balance of federal and state powers. (Digression into the 10th Amendment omitted for your comfort). The Supreme Court has agreed to hear two cases concerning whether federal law preempts the rights of consumers to bring lawsuits under state law against drug and device manufacturers. The first, Riegel v. Medtronic, is summarized below, by Public Citizen Litigation Group, which represents the Riegels:

After suffering serious injury when a balloon catheter burst while he was undergoing an angioplasty procedure, Charles Riegel and his wife sued the catheter’s manufacturer, Medtronic, Inc (NYSE:MDT). Medtronic moved to dismiss the lawsuit, arguing that the Food, Drug, and Cosmetic Act expressly preempts state-law damages actions brought by patients who have been injured by medical devices that received premarket approval from the Food and Drug Administration. The court agreed and dismissed the case.

Public Citizen represented the Riegels on appeal and represents them now before the U.S. Supreme Court. The Supreme Court granted cert. on June 25, 2007, and will hear the case next Fall. The question before the Court is whether the express preemption provision of the Medical Device Amendments to the Food, Drug, and Cosmetic Act preempts state-law claims seeking damages for injuries caused by medical devices that received premarket approval from the FDA.

[PAL joined an amicus curiae ("friend of the Court") brief submitted by Community Rights Counsel to the Supreme Court. That brief can be found here.]

The second was covered in an AP Story earlier this week (“Court Takes Drug Liability Case“):

The case involves a product liability lawsuit against Pfizer’s (NYSE:PFE) Warner-Lambert unit. A group of Michigan plaintiffs led by Kimberly Kent in April 2000 sued Warner-Lambert Co. over alleged injuries caused by its Rezulin diabetes drug. Rezulin was ordered off the market in March 2000 by the Food and Drug Administration after it was linked to nearly 400 deaths and hundreds of cases of liver failure.

The District Court dismissed the case, arguing that a Michigan state law that prohibits virtually all lawsuits against drug companies applied, and then also ruling that a narrow exception in that law — that suits are allowed when the drug company misled the FDA to get the drug approved — was preempted. Talk about damned if you do, damned if you don’t! The Court basically ruled that state law applied, except when it might benefit the injured consumers, in which case federal law applied and preempted the exception written into state law. The 2nd Circuit Court of Appeals disagreed, reinstating the suit, and of course Warner Lambert appealed to the Supreme Court, which agreed to hear the case.

Hopefully the Supreme Court will rein in the running joke that federal preemption has become, acknowledge that state law litigation does not interfere with the FDA’s regulation of drugs (a position the FDA itself took for years, and only changed under the current administration) and restore the balance set out in the Constitution that protects the states’ historic “police powers” to protect the health and safety of their citizens.