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.

FDANews Drug Daily Bulletin reported today:

The House Subcommittee on Health passed legislation renewing the Prescription Drug User Fee Act (PDUFA) and other provisions with few amendments after staff meetings resolved concerns including language eliminating the FDA’s preemption authority. The bill now goes to the House Committee on Energy and Commerce for a markup June 21.

That language would have said:

“Nothing in this act or the amendments made by this act may be construed as having any legal effect on any cause of action for damages under the law of any state (including statutes, regulations, and common law.”

It would have clarified that the FDA’s approval of a drug does not preempt a lawsuit brought under state law alleging that a drug company injured a patient who took a drug, or failed to warn them about risks of the drug. This would reverse the FDA’s attempt to establish that its authority preempts such claims, which we addressed earlier this week in this blog (“‘The Hill’ gets it (partially) wrong on FDA & Preemption”). Henry Greenspan addressed this further in an excellent post over at TortDeform.com (“Preempting Preemption: Will Congress have the will to state its will?”)

The FDA and industry had taken great pains to characterize this provision as a change in the law, rather than what it was, a restatement and reestablishment of long-standing practice regarding the FDA and preemption: that state law claims are NOT preempted by the FDA’s approval of a drug (except in Michigan, which has the most draconian law in the country on this subject, denying even the most grievously injured patients the right to sue drug makers).

With the House version of the bill going before the full Energy and Commerce Committee now mirroring the Senate bill in saying nothing on this, the issue seems to be a dead letter.

I predict that before the ink is dry on this bill we will see drug companies arguing in such lawsuits that the Subcommittee’s removal of this language somehow demonstrates Congress’s intent to have the FDA preempt all state law claims on personal injury and failure to warn. Legislative intent, like beauty, is so often in the eye of the beholder. Can we say that a Subcommittee’s removal of a proposed particular clarifying provision means that the entire Congress intended that its passage of a bill express the exact OPPOSITE? (I.e. “since the bill didn’t say that the FDA doesn’t have preemptive authority, then the FDA does have such authority”) That seems like one heck of a stretch, but stay tuned — it will soon be appearing in a Motion to Dismiss near you.

“The Hill” today ran an article on June 15, titled “Trial lawyers’ win on suit provision threatens FDA bill.” The article discusses a provision added to several discussion drafts of an unidentified FDA bill (presumably Prescription Drug User Fee Act [PDUFA] reauthorization) before the House Energy & Commerce Committee. The provision would state:

“Nothing in this act or the amendments made by this act may be construed as having any legal effect on any cause of action for damages under the law of any state (including statutes, regulations, and common law)”

The overall thrust of the Hill article is that this is a change in the law and in current practice. In fact, whether state court lawsuits alleging that prescription drugs or medical devices are dangerous and defective are preempted by the Food Drug and Cosmetics Act (FDCA) is an issue on which courts are currently very divided. The pendulum has swung a bit towards preemption in the wake of the FDA’s issuing a preamble to its new rule on drug labelling in 2006. (see page 38 for the Preamble).

In a nutshell, the FDA declared its opinion that such state court lawsuits are preempted. The FDA has been making such arguments for several years, more or less since the Bush administration took office, mostly by intervening and filing briefs in individual state court lawsuits. This marked a change in FDA policy, and was apparently initiated by former FDA general counsel Daniel Troy, now a partner at Sidley Austin, a law firm that represents drug and device companies.

Public Citizen release an excellent analysis of why the FDA’s Preamble is wrong, both as a matter of law and as a matter of policy.

The Hill’s article momentarily appears to admit that this is not a change in the law, but a clarification:

“Democrats are not trying to roll back federal preemption, the committee spokeswoman said. “We are not attempting to change the status quo on preemption,” she said. Instead, the Democrats want to forestall the expansion of federal preemption into new areas of drug and device law.

But by attributing this to Democrats only, the article refuses to analyze whether in fact federal preemption is a recent change in how courts address these cases, or whether it is the norm which “the Democrats” and “trial lawyers” are now trying to change. It is true that there has been a greater trend towards courts finding preemption — but there has also been a countertrend of courts refusing to find such cases preempted. (e.g. Kelly v. Wyeth, and Perry v. Novartis)

And then the article goes on to say:

“The pharmaceutical and device makers contend that the change in the law could grant state courts the authority to override FDA decisions about the safety and efficacy of their products or about warnings on the products’ labels.” [emphasis added]

By characterizing this as a “change in the law,” rather than saying, for example “pharmaceutical and device makers contend that this is a change in the law,” the article seems to accept the premise that it is in fact a change in the law.

But, the semantics of the article aside, the ‘trend’ towards federal preemption comes amidst justifiable skepticism about whether the FDA is adequately protecting unsafe drugs. This concern has been renewed in recent weeks as the heart attack risks of the diabetes drug Avandia have come to light.

Some of the worst risks and dangers of prescription drugs only come to light years after the drug has been approved. The FDA has shown itself unwilling to do enough to take dangerous drugs off the market. Recall that Vioxx was withdrawn voluntarily by Merck, not because of any FDA order. With the FDA proving itself unwilling to even force drug companies to complete the post-approval studies that they often promise to do, can we rely on the FDA to police drugs once they are on the market?

It is this very question that has led to the numerous bills in Congress to strengthen the FDA’s ongoing oversight of drugs, such as by separating the functions and divisions within FDA that approve new drugs and that police drugs already on the market. But in the absence of adequate ongoing oversight by the FDA, lawsuits play a vital role — in bringing the dangerousness of drugs to light, in forcing manufacturers to revise the labelling of their drugs or even take them off the market, and in compensating people who’ve been injured by dangerous drugs. The FDA’s and the pharmaceutical industry’s arguments that the FDA preempts these cases amounts to a “do-nothing” system — the FDA won’t do anything, and the Courts can’t do anything.

A recent article in the Journal of the American Medical Association addressed the role that litigation plays in highlighting safety issues: “The Role of Litigation in Defining Drug Risks, Aaron S. Kesselheim, MD, JD; Jerry Avorn, MD, JAMA. 2007;297:308-311.”

Whenever the climate in Congress and the Administration shifts towards a refusal to regulate corporate behavior, states begin to step in to fill the gap and protect public health and safety. Preemption is being pushed by big business and its allies in Congress and the Administration to undermine these efforts, not just in prescription drugs and medical devices, but in food safety, banking and financial services, privacy and countless other arenas.