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

The good folks over at Alliance for Justice are premiering a new 22-minute documentary about Diana Levine, the Vermont musician who lost her forearm to gangrene caused by a prescription drug made by Wyeth, and whose suit against Wyeth has gone all the way to the Supreme Court.

Here’s the description:

When Diana Levine went to the hospital in April 2000 seeking relief for a severe migraine headache, the professional musician and children’s record producer never imagined that faulty drug labeling would result in the amputation of her arm. Today she is at the center of a closely-watched Supreme Court case and a national debate about the federal courts and corporate accountability.

Produced in conjunction with 12-time Emmy award-winning producers/directors Jon Alpert and Matt O’Neill, Alliance for Justice’s documentary Access Denied?: The Fight for Corporate Accountability tells Ms. Levine’s powerful story and exposes the slow but steady transformation of our federal courts into institutions that favor corporate interests over everyday Americans. Through an examination of Diana Levine’s case against Wyeth Pharmaceuticals – and the experiences of others like her – Access Denied? takes the legal issue of preemption out of the courtroom and into the real world, where millions of Americans find themselves unable to access the courts and hold corporations accountable for their misconduct.

And here’s the trailer:

Bradley Whitford, of West Wing fame and other films & TV shows, is promoting the film. (If I may digress for a moment: Your humble blogger once was a humble stage crew intern at an off-off-Broadway theater in Hell’s Kitchen in New York in 1987. A then-completely-unknown Bradley Whitford was in a one-act play in said theater. So was Marisa Tomei, who at the time was NOT unknown, because she was in the Cosby Show spinoff series “A Different World.” One exciting night saw Lisa Bonet and then-hubby Lenny Kravitz come to see the show.)

And speaking of celebtrity actors, one can’t help but wonder: Who would play Rep. Henry Waxman in the feature film?

There are plenty of good candidates in the roster of bald actors, such as:

Sir Ben Kingsley:

Or perhaps Alan Arkin:

Or Robert Duvall:

We could do this all day! Your other Waxman portrayal suggestions welcome in the comments.

The Center for Progressive Reform < (CPR)issued this week a report called "Protecting Public Health and the Environment by the Stroke of a Presidential Pen: Seven Executive Orders for the President’s First 100 Days,”

As CPR’s Blog describes,

Through Executive Orders, a President exercises his broad authority over the executive branch; and in so doing can have a profound influence on how the federal government responds to important policy issues. By directing federal agencies to focus on particular priorities, and by reshaping the internal processes by which agencies do their business, President Obama can impose new policies, while at the same time sending a clear message to Americans and the world that change is under way.

Readers of this blog know that we frequently write about FDA preemption of consumer lawsuits against drug companies. The Supreme Court just heard on November 3 arguments in Wyeth v. Levine, a case that could very well shut the Courthouse doors across the U.S. to consumers who’ve been injured by unsafe drugs. Wyeth, the drug company defendant in the case, argued that the lawsuit against it for failing to warn musician Diana Levine and the medical staff that cared for her that a particular method of administering the anti-nausea drug Phenergan could cause gangrene should be preempted by the FDA’s authority to approve prescription drug labels. Most observers expect the Supreme Court to decide in Wyeth’s favor, and to say that consumers cannot file lawsuits alleging drug company “failures to warn.”

But the push for preemption in the past several years has not just been in the Courts. The FDA too has been aggressively arguing for preemption for the past 8 years. The FDA actively intervened in numerous lawsuits on unsafe drugs and medical devices to argue for preemption. In 2006, the FDA included a lengthy “preamble” in its revised rules on drug labelling requirements that argued that such lawsuits are/should be preempted. And the FDA’s new “Changes Being Effected” regulations, enacted in late August, (about when drugmakers can change the label of their drugs to include new information on risks) seems designed to preempt such suits as well.

This 8-year push for preemption is in stark contrast to the FDA’s previous approach to the subject for many years, which was to treat such suits as complementary to the FDA’s regulation of drugs and not antagonistic.

CPR proposes that the Obama administration adopt an Executive Order on preemption, or, specifically an order that would amend the existing Executive Order on Federalism. The main feature of their proposed Order would be to restore the traditional “presumption against preemption” (i.e. in order to preserve the powers that States are granted under the constitution — see, e.g. the Tenth Amendment– it should be presumed that state laws do NOT conflict with federal law unless shown otherwise.) They also propose a number of specific procedures that federal agencies like the FDA would need to follow to get White House approval before they take an action or position in favor of preemption.

Such an Executive Order would be a step in the right direction, at least in terms of halting the FDA’s (and other federal agencies) eight-year battle to limit the rights of states to protect public health and safety. But such an Order would not do anything to reverse a finding in favor of the pharmaceutical industry in Wyeth v. Levine (a decision is not expected from the Supreme Court until sometime in the first half of 2009).

To do that, Congress would have to step in and pass a law essentially reversing a Supreme Court decision in favor of preemption. Earlier this year, in Riegel v. Medtronic, the Supreme Court held that patient claims about unsafe medical devices are preempted, and more than 80 members of Congress and Senators are trying to restore patients’ rights to sue device companies in such cases with the Medical Device Safety Act. (H.R.6381 and S.3398). It is virtually certain that a similar bill will be filed if and when the Supreme Court decides in Wyeth’s favor.

An Executive Order also arguably wouldn’t do anything to affect the preemptive effect of the FDA’s Changes Being Effected regulations, which have already been promulgated and which stand as the “law of the land” for now. To undo the preemptive effect of those rules would most likely require that the FDA amend those regulations. Whether the new administration at the FDA will seek to tackle that remains to be seen — given the scandals that have rocked the FDA over the past few years, there may be bigger fish to fry (food safety, inspections of foreign drug manufacturing plants, etc.)

But an Executive Order would be important – not just to ensure that the Executive branch thinks long and hard before it tramples on the traditional powers of the States to protect public health and safety, but to change the tone and tenor of federal agencies’ approach to the issue. A restoration of the “presumption of preemption” in the FDA (and other federal agencies) would naturally affect what new regulations are promulgated, what old regulations are amended or scrapped, whether the FDA chooses to intervene in private lawsuits and what position it takes when it does so, what the FDA’s overall priorities are, and even what laws and regulations States pass – right now, the fear of preemption has a chilling effect on what measures States and state agencies will put into place to protect the public from unsafe drugs, food, and medical devices.