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.

———————————————————————————
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 

———————————————————————————

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.

PAL’s most important lawsuit and settlement to date wins final approval!

Yesterday, the Massachusetts federal District Court approved class action settlements with publishers First Databank and MediSpan that will require the roll back the illegally inflated prices of over 400 drugs!

PAL coalition members AFSCME District Council 37 Health and Security Plan in New York, and New England Carpenters Health Benefit Fund here in Boston brought the lawsuit against these two publishers, and the pharmaceutical wholesaler McKesson, for their role in unilaterally raising the prices of over 400 drugs through their alleged manipulation of the published “average wholesale price” or AWP. Though the system of pharmaceutical pricing and reimbursement is complex, the AWP is a benchmark that is used by insurers and government programs to reimburse pharmacies. It also effects the cost to cash-paying customers. It is alleged that defendants First Databank, Medispan, and McKesson raised the AWP, while keeping the actual cost (called a ‘wholesale acquisition cost’) the same. This done to give  the large chain and other pharmacies, many of which are McKesson’s customers, an increased return on each of these drugs.

It has been estimated that this 5% increase in the cost of hundreds of drugs by the defendants may have cost consumers, insurers, and government programs over $2 billion in additional drug expenses.

It is estimated that the “rollback” of the price of these 400 drugs could yield between $1.5 Billion or more in future savings on drug costs. Perhaps of even greater importance, this lawsuit, along with other litigation (AWP, Remicade, Lupron) by PAL members, has exposed the weaknesses of the pharmaceutical pricing system that have allowed drug makers and wholesalers to manipulate or “game” the benchmark prices that government programs and insurers use for reimbursement.

The Judge in the case did allow a six month delay before the rollback of the drug prices, ” to alleviate the impact on independent and rural pharmacies.” This addressed the concern raised that small ‘mom and pop’ pharmacies may be forced to bear the full cost of the price rollback if they were unable to renegotiate their supply contracts for drugs with manufacturers and wholesalers.

The settlement also provides $2.7 million to be distributed along with the $350 Million in the preliminary McKesson settlement.

Thanks to PAL members New England Carpenters Health Benefit Fund, and AFSCME District Council 37 Health and Security Plan in New York for their work in bringing this important lawsuit.

Follow these links to see a copy of the Judge’s decision, the First Databank settlement, the Medispan settlement, or the pending McKesson settlement.

 Today, the Supreme Court rejected arguments by the prescription drug industry that having their labels approved by the Food and Drug Administration should be a shield from state law tort liability.  In a rousing victory for consumers of prescription drugs, the Supreme Court rendered a decision preserving consumer rights to access the courts when injured physically or financially by prescription drugs. 

In the case Wyeth v. Levine, the Court ruled 6 to 3 that the FDA’s approval of a drug label does not preempt consumer’s rights to sue the manufacturer for their failure to warn of knows risks associated with the drug. 

The lawsuit was brought by Diane Levine, a musician from Vermont who while suffering from a migraine was given the anti-nausea drug Phenergan. Her physician’s assistant did so in a manner that caused the drug to contact her arteries, which caused gangrene and resulted in the loss of her arm. Ms. Levine sued and settled with her doctor. She also sued the drug’s Manufacturer, Wyeth. In its defense, Wyeth argued that the FDA’s approval of the label under federal law preempted Ms. Levine’s rights under state law, but lost. After a 5-day trial, a Vermont jury concluded that the drug maker did not adequately warn of the known risks of gangrene associated with the use of the drug, and awarded Ms. Levine $7.4 million.

After losing in appeals all the way up to Vermont’s Supreme Court, Phenergran’s manufacturer, Wyeth appealed to the U.S. Supreme Court. The Court accepted the case, and addressed the issue 

whether federal law preempts Levine’s claim that Phenergan’s label did not contain an adequate warning about using the IV-push method of administration. 

In today’s decision, the Court decided that there was no preemption, and found in favor of Ms. Levine.

The Court first noted that it was not impossible for the drug maker to comply with both state law and federal requirements in preparing the drug’s label.  The court concluded that the drug maker could have added warnings to the label at any time to reflect the risks of gangrene that had occurred to over twenty people since the labeling was approved by FDA. Wyeth had incorrectly argued that the federal regulations prohibited their changes to the label, because they must have been based on “newly acquired information….”  The Court countered that Wyeth was incorrect, and that they could have added warnings to reflect the 19 amputations that had arisen from Phenergan’s use before Ms. Levine’s case.

The Court also concluded that Wyeth suffered from a “more fundamental misunderstanding” about the duty to warn consumers of the risks of prescription drugs.  The Court noted that

Wyeth suggests that the FDA, rather than the manufacturer, bears primary responsibility for drug labeling. Yet through many amendments to the FDCA and to FDA regulations, it has remained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times. It is charged both with crafting an adequate label and with ensuring that its warnings remain adequate as long as the drug is on the market.

 

Wyth also argued that the Ms. Levine’s lawsuit should be preempted because it interferes with “Congress’s purpose to entrust an expert agency to make drug labeling decisions that strike a balance between competing objectives.” The Court rejected this argument as being both out of line with the intent of Congress, and as based on “an overbroad view of agency’s power to pre-empt state law.”

On the first point, the Court notes that “[i]f Congress thought state-law suits posed an obstacle to its objectives, it surely would have enacted an express preemption provision at some point during the FDCA’s 70-year history” like it did with a 1976 amendment allowing “express pre-emption … for medical devices….”

The Court also spoke to the FDA’s role in the preemption debate, especially it’s position in favor preemption announced in the preamble to the 2006 regulations that redesigned the format and content requirements for prescription drugs.  The Court also assessed how much weight to give an agency position that “state law is an obstacle to achieving its statutory objectives….” The Court found that in cases lacking express authority by Congress, the deference given to an agency “depends on its thoroughness, consistency, and persuasiveness.”  Based on this, the Court decided that FDA’s position “does not merit deference.”   

First, the Court pointed out a glaring procedural lapse by FDA in adopting the position that their regulations and approval of drug label preempts state law.   In proposing the draft rule in 2000, the FDA had stated that the rule would “not contain policies that have federalism implications or that preempt State law.”

Despite this, FDA adopted a position in favor of preemption upon publishing the final rule in 2006. FDA did so “without offering States or other interested parties notice or opportunity for comment….” As a consequence, the Supreme concluded that “[t]he agency’s views on state law are inherently suspect in light of this procedural failure.”

The Court also noted that the FDA position on preemption “is at odds with … Congress’s purposes, and it reverses the FDA’s own longstanding position….” The Court summarized the history of FDA’s relationship to state law, noting that

the FDA traditionally regarded state law as a complementary form of drug regulation. The FDA has limited resources to monitor the 11,000 drugs on the market,and manufacturers have superior access to information about their drugs, especially in the postmarketing phase as new risks emerge.

The Court also stated 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.12 The agency’s 2006 preamble represents a dramatic change in position.

We recognize this decision as an important victory for consumers, and we applaud the Court for this decision.

We hope to post more details on this decision, and its potential impact on our other lawsuits, soon.

You can read the full decision at

http://www.supremecourtus.gov/opinions/08pdf/06-1249.pdf