Latest Drugwonks' Blog
Legal Side Effects
Diana Levine's story is gut-wrenching. It's also the sort of case that makes bad law, which is why Monday's Supreme Court oral argument in Wyeth v. Levine is important for consumers and drug development in America.
A professional guitarist who suffered from migraines, Ms. Levine went into a clinic in April 2000 for an injection of Phenergan, an antinausea drug produced by Wyeth Pharmaceuticals. The clinic administered the drug by what the label described as the "preferred" method -- "deep intramuscular injection." When that didn't help her symptoms, the clinic injected another dose directly into her arm -- a technique known as "IV push." As the label warned, this was dangerous. If Phenergan is accidentally injected into an artery instead of a vein, gangrene can quickly set in and lead to amputation. To avoid this, the drug's label described in detail how to administer an intravenous injection.
Even so, the worst happened. Gangrene set in and Ms. Levine lost her right hand and forearm. She sued the clinic, which settled the case. But then she sued Wyeth in Vermont state court. She argued that Wyeth should have warned health-care providers never to attempt IV-push injection because "other, safer methods" were available. She won, and the Vermont Supreme Court upheld the $6.7 million verdict.
In Wyeth v. Levine, the issue is whether a drug company that had sought and received all the necessary approvals from the Food and Drug Administration, and had labeled that drug in accordance with FDA requirements, can still be held liable under state law. This is not a case about whether a drug company concealed evidence or other misconduct. The FDA-approved label for the drug specifically warned against the risk that became Ms. Levine's reality.
But this case is not just about Ms. Levine. It is about a drug-approval system that balances the risks of treatments against the risk of not being treated at all. And a jury, faced with a single sympathetic plaintiff, is in no position to rule on the correctness of those FDA judgments. The Supreme Court ruled as much in February in Reigel v. Medtronic, a similar case involving medical devices. Justice Antonin Scalia argued for the 7-2 majority in Reigel that a jury "sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court."
Though the tort bar lost that case, Ms. Levine's lawyers are arguing that the relevant federal devices statute explicitly mentions pre-emption, while the drug statute does not. But this is a red herring. As Ms. Levine's lawyer admitted at oral argument, the question in Wyeth is not whether any state-law tort claim was pre-empted by FDA regulation. The question is whether, in a case in which the FDA has made one determination about safety, a state jury should be permitted to come to another. As Justice Scalia put it yesterday, "If you're telling me the FDA acted . . . irresponsibly, then sue the FDA."
Chief Justice John Roberts asked former Solicitor General Seth Waxman, who argued the case for Wyeth, whether this case could be distinguished from Reigel on these grounds. Mr. Waxman's response goes to the heart of this case: "A jury was asked to look at the same information [that the FDA had] and conclude that the precise language that the . . . FDA required Wyeth to use rendered that drug unreasonably unsafe." In other words, the jury is being asked to look at a situation where the worst has happened, and the risks have been realized, and to decide whether the FDA made the right call. This would all but guarantee that the drug companies would be sued whenever a known risk becomes actual in a particular case.
The U.S. drug approval system is imperfect, and the FDA makes mistakes -- most of which involve blocking or slowing drug therapies that could save lives. Congress created that system and asks drug companies to spend some $1 billion per drug and wait years to gain approval. It amounts to double jeopardy to say, even if you do all those things right, and disclose all the known dangers and label the drug as ordered by the FDA, that you can still get sued if something goes wrong because someone else made a mistake.
If a known and disclosed medical risk can still lead to a law suit, drug companies can literally be sued for anything. No doubt there are trial lawyers and Democrats in Congress who would prefer it that way. But if we want state juries second-guessing the FDA at every turn, let's pass a law in broad daylight so everyone knows whom to blame when drug innovation stops cold.
From today’s New York Times:
Justices Weigh Effect of F.D.A. Approval of Drug Labels on Suits in State Courts
By ADAM LIPTAK
The case, Wyeth v. Levine, No. 06-1249, concerns an implied form of the doctrine of pre-emption, which bars state lawsuits from people injured by products that met federal safety standards. The drug law at issue in the case says nothing about pre-emption, and the question before the court was whether the Food and Drug Administration’s approval of drug labels should knock out state lawsuits contending that the labels did not contain adequate warnings.
A broad endorsement of implied pre-emption based on regulators’ actions rather than on statements in laws enacted by Congress could shut down countless injury suits in cases involving not only drugs but also motor vehicles, household products, chemicals and agricultural products.
Several justices appeared open to the idea that pre-emption could follow from the F.D.A.’s approval of a drug label — but only if drug companies remained subject to lawsuits if they failed to disclose new information about potential risks. There was much discussion of what information should be considered new.
Other justices seemed prepared to allow pre-emption — but only if the drug agency had considered the particular risk before approving the label.
Given the justices’ interest in those refinements, the court seemed unlikely to rule broadly on the larger issues in the case: whether the agency and other federal regulators set minimum safety standards that states are free to augment or whether they make judgments about the optimal balance between risks and benefits that states must follow.
In February, however, an eight-justice majority of the court ruled, in Riegel v. Medtronic, that suits concerning injuries caused by medical devices were pre-empted by a 1976 federal law. But the underlying law in Riegel required pre-emption, in so many words; in the jargon, it involved “express pre-emption.”
The plaintiff in the case argued on Monday, Diana Levine, lost her arm after being injected with a Wyeth drug, Phenergan. The drug is safe, Ms. Levine’s lawyers said, when administered by intramuscular injection or by intravenous drip. But they said that efforts to inject the drug directly into a vein carry enormous risks.
A
Ms. Levine settled with the clinic and sued Wyeth, saying the company should have added a warning telling doctors not to use the risky method.
Seth P. Waxman, a lawyer for Wyeth, said the company had provided “ample, lavish warnings” about the risks involved and left it to medical professionals to make the ultimate judgment about how to administer the drug.
Justices Samuel A. Alito Jr. and Ruth Bader Ginsburg both questioned the cost-benefit calculation that allowed the drug to be administered by IV push.
“On the benefit side of this you don’t have a life-saving drug, you have a drug that relieves nausea,” Justice Alito said. “On the risk side, you have the risk of gangrene.”
Justice Antonin Scalia said that what mattered was not whether the agency’s decision was sound but whether it had addressed the issue at all. “If you’re telling me the F.D.A. acted irresponsibly,” Justice Scalia told Ms. Levine’s lawyer, David C. Frederick, “then sue the F.D.A.”
Chief Justice John G. Roberts Jr. tried to boil down Mr. Frederick’s argument to a simple test. If the F.D.A had considered the risks involved in IV-push administration, Ms. Levine would lose; if the F.D.A. had not considered those risks, Ms. Levine would win.
Mr. Frederick said Ms. Levine would win under that analysis, saying the F.D.A. had never specifically compared the risks of methods of intravenous administration.
Mr. Waxman said he understood that “members of this court are concerned about applying a broad, vague or freewheeling analysis.” But Ms. Levine’s case, he added, is in the “heartland” of implied pre-emption, given that the jury had awarded damages for Wyeth’s failure to alter the very drug label the F.D.A. had approved.
Contribute to CMPI
With your Donation You Will Receive a FREE DrugWonks T-Shirt!
(Please Specify Your Size When Ordering, Men's Size S-XL)
Come Join the Healthcare Fashion Revolution!
Click Here For the Return Policy
Click Here for the Shipping Policy
Click Here for the Privacy and Security Policy
By Mail:
Checks and money orders should be made payable to Center for Medicine in the Public Interest.
Please mail all checks and money orders to:
308 East 38th Street, Suite 201
New York, NY 10016
Get ready Krug. Spring training is nearly over. http://www.nytimes.com/2008/11/03/opinion/03krugman.html?ref=opinion
To view the interview, click here.
And to view Dr. Sarkozy's PowerPoint presentation, click here.
This issue is becoming ever more urgent when you consider today's news from the UK that NICE (the National Institute for health and Clinical Excellence) has extended until January its assessment of four kidney cancer drugs, none of which was deemed cost-effective in a draft appraisal issued in August .
NICE, which "assesses" technology for the national health service in England and Wales, said that bevacizumab (Roche's Avastin), sorafenib (Bayer's Nexavar), sunitinib (Pfizer's Sutent) and temsirolimus (Wyeth's Torisel) did not represent the best use of NHS resources when used to treat advanced and/or metastatic RCC, despite acknowledging their clinical effectiveness in some settings and the narrow choice of other treatment options.
Is this what we want in the US? Because this is what (at least in the current context) "comparative effectiveness" means.
What we need are 21st century assessment tools for a personalized approach to the "4 rights" -- the right medicine in the right dose for the right patient at the right time. In other words, tools for patient-centric rather than cost-based comparative effectiveness.
Consider some of the arguments from the pages of the Journal of Life Sciences.
Attention must be paid.
http://www.cnn.com/2008/HEALTH/10/30/ep.doctors.prescribe.placebos/
Next, rather than paying doctors for keeping people healthy or simply being there, health plans are -- even as legislative and ideological forces seek to eliminate the role of drug, biotech and device companies in discussing products with physicians -- filling the void with dollars and demands to swtich patients or start them on generic drugs. Nothing wrong with generic drugs, they are saving Medicare billions, but ultimately we want to get to point where prescribing is based on value, not just cost. But getting information about that will require close and open communication between everyone.
http://ap.google.com/article/ALeqM5hsuaRf6mJu1lKskznFkkD9tHg6MAD944C4HG0
So you see, both power and knowledge abhor a vaccuum. And it will be filled by those pushing a financial and political agenda, such as trial attorneys and the consumer groups that benefits from their largesse, medical quacks and shakedown artists (like Steve Nissen).
How does this pentultimate preemption affect patients?
The most recent study from my former perch at the Center for Medical Progress at the Manhattan Institute (home to many solid Yankee fans!) tells the tale. The analysis, conducted by Columbia University Frank Lichtenberg is entitled:
Alive and Working: How Access to New Drugs has Slowed the Growth in America’s Disability Rates
It concludes that "access to pharmaceutical innovations has been responsible for keeping large numbers of U.S. residents off disability rolls who otherwise would have joined them."
The study shows that if " the average vintage of drugs prescribed since 1995 and paid for by Medicaid had not become more recent, the rate of increase at which working-age people were classified as disabled would have been 30 percent higher than it actually was, resulting in 418,000 additional people receiving disability payments in 2004. Social Security benefits paid to this population would have been an additional $4.5 billion."
Are generics really the best value for Americans? For millions of us, of course they are. But to say it's better to prescribe generics in all cases is to suggest that the only valuable thing doctors do is not to prescribe new drugs...
Better drugs (the right drug for the right person!), more time with doctors. That's a much better bang for the buck than what the social engineers and health policy elite have in mind.
http://www.manhattan-institute.org/html/mpr_07.htm
(I represented the "pro"/public health side of the argument. The "anti"/tort lawyer argument was proferred by Brian Wolfman of Public Citizen.)
Here's a link to the segment.
Have a look and judge for yourself.
Janet Woodcock, MD, Director, CDER, FDA
“Safety means doing the right things for patients.”And you would have missed this penultimate statement from the flurry of memos (I read them all)
"I agree with the idea that we should preempt state requirements for labeling of drugs. It makes no sense for us not to have a federal system for labeling approved drugs that is based on a careful scientific review of the available data and a consistent application of labeling policies across products. I see this as a legitimate FDA area of involvement given our statutory authority over the drug approval process."
That was John Jenkins. And not one of the memos take issue with the position that FDA should preempt state requirements, especially those dredged up from tort proceedings.
The issue was and is about whether the FDA had enough control over labeling and safety monitoring in a coordinated fashion to produce the appropriate balance between risk and benefit, patient rights and company behavior. The goal is to encourage companies to do more to make sure labeling reflects the most up to date science and is communicated clearly and quickly to patients and everyone else to improve the use of the product and public health. The idea that FDA officials and their words are being twisted to promote a trial attorney agenda is disgusting beyond imagination...
Jenkins seeks a compromise which is now part of the fabric of the Critical Path and FDA authority under FDAAA:
"If we are going to go this route to protect sponsors, the appropriate balance in the favor of public health may be to give FDA more authority over labeling."
Which is exactly what has happened since 2003 when the memos were written. Where oh where have the self-serving solons at JAMA and NEJM been the past five years. They keep flogging VIoxx as an example of why tort lawyers should have control over labeoling. But within the FDA Vioxx was and is regarded as a safe drug under certain conditions that no longer apply since the drug was withdrawn:
Jenkins again:
"Had Merck not decided to voluntarily withdraw the product it would have been necessary for them to make labeling changes to add warnings about ,the new findings. We probably would not have issued an approval letter on the labeling changes since we would not have had access to the full study report for review so we could evaluate the actual data that would be added to the labeling. So, we probably would have agreed to interim labeling and asked Merck to submit it as a CBE and we would have made more official determinations later after we reviewed the full study report. "
It was the withdrawal of Vioxx and the failure to work with the FDA to make labeling changes that triggered the "Vioxx scandal" and the ensuing mess. Waxman wants us to believe FDA officials want more of the same instead of a science-based approach to label changes.. The Waxman report is all about manipulating the truth and is an example of how "facts" are treated in the courts that he and others would want to determine what is said about medicine and how it's practiced.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
