"There are tens of thousands of individual claims, and potentially millions of class action claims, currently pending in the lower federal and state courts, in which plaintiffs contend that a manufacturer's use of FDA-approved labeling for its prescription drug is inadequate to satisfy state-law duties to warn."
A win against Ms Levine could potentially wipe out a majority of those lawsuits and save the industry billions upon billions of dollars. Wyeth would save the nearly $6.8 million owed to Ms Levine after the Vermont Supreme Court upheld a lower court's jury verdict."To find preemption in this context would eliminate all compensation for often devastating injuries – lost wages, medical costs, and other traditional forms of damages – without providing any federal remedy as a substitute."
According to an amicus brief filed in support of Ms Levine by eighteen members of Congress including Senators Patrick Leahy, Ted Kennedy, Sheldon Whitehouse, Tom Harkin, Dianne Feinstein, Richard Durbin, Bernard Sanders, Russ Feingold, and Representatives Henry Waxman, John Conyers, John Dingell, Frank Pallone, Bart Stupak, Zoe Lofgren, Linda Sánchez, Debbie Wasserman Schultz, Maxine Waters, and Peter Welch. In arguing against the FDA's unauthorized preemption policy, the lawmakers' brief state that:
"For more than 70 years, Congress has operated against the background understanding that FDA approval of a drug label does not bar state-law failure-to-warn claims. If that rule of law is to be altered, it should be changed directly by Congress.
"This Court should not nullify more than 70 years of practice under the FDCA by bestowing an immunity that Congress has thus far declined to grant, nor should it permit the FDA to accomplish such a result indirectly through an unauthorized expansion of its regulatory power."
"Whatever the FDA's view of its labeling regulation," they write, "Congress never intended to allow the FDA to adopt regulations that would preempt failure-to-warn lawsuits under state law."
They maintain that state tort cases provide an invaluable source of data for regulators. "Time and time again, problems with long-term use of drugs were identified first in failure-to-warn litigation, involving such drugs as Vioxx, Bextra, Celebrex, Avandia, Rezulin, Baycol, Halcion, and Zomax," they point out.
"The voluntary physician reporting system on which FDA relies for collecting real-time information on drug side effects identifies fewer than 1% of serious side effects," they report.
FDA oversees the safety of 12,000 drugs made by 5,000 manufacturers around the world, according to the brief. "Given the agency's limited resources and information, it is utterly unrealistic to expect that the FDA alone – with no assistance from state tort suits – can protect patients from the post-market risks of even a fraction of these products," the lawmakers told the court.
Texas attorneys, Earl (Lanny) Vickery and Mark Lanier, have filed an amicus brief in support of Ms Levine on behalf of Kim Witczak, Sara Bostock, and Healthy Skepticism.
Kim Witczak lost her husband, Tim "Woody" Witczak, to a Zoloft induced suicide in 2003. Sara Bostock and her husband Peter lost their 25-year-old daughter, Cecily, to suicide 26 days after she began taking Paxil. Healthy Skepticism is an international non profit organization for health professionals and others with an interest in improving overall health.
Mr Vickery's firm won a $6 million plus verdict in the only Paxil-suicide case against GlaxoSmithKline ever to make it to a jury. Mark Lanier beat Merck in several Vioxx trials prior to the company's agreement to pay close to $5 billion to settle the remaining cases.
In their brief, the attorneys address the claims made by the FDA and Wyeth, that a drug company may not add a warning without prior FDA approval, pointing out that their actual practice contradicts their litigation position in stating:
"Wyeth added a warning of the increased risk of suicidality with respect to its antidepressant Effexor, without prior FDA approval, in August 2003. Three years later, GlaxoSmithKline ("GSK") added its own warning with respect to its antidepressant Paxil without prior FDA approval."
"Although the added warnings were not based on "newly discovered evidence," but on a reevaluation of long-existing data," they write, "FDA did not pursue misbranding actions."
In their brief, the lawmakers also note that, "the FDA's current regulations appropriately require manufacturers to warn of risks as early as possible – regardless of whether the risk is "newly discovered" or not."
They further state that "even if prior FDA approval for labeling changes to enhance safety were required, such a requirement could not possibly shield a manufacturer from liability (if it could have any preemptive effect at all) when the drug maker had never even requested the approval."
Manufacturers may also provide risk information by other means such as "Dear Health Care Professionals' letters," they note. "A manufacturer's failure to use such non-label measures may serve as a basis for imposing state-law failure-to-warn liability," they point out.
An amicus brief in support of Ms Levine was also filed on behalf of ten current and former editors and contributing authors of the New England Journal of Medicine including Doctors Jeffrey Drazen, Gregory Curfman, Stephen Morrissey, Marcia Angell, Jerome Kassirer, Arnold Relman, Paul Stolley, Harlan Krumholz, Stuart Rich and Eric Topol. In their brief, the doctors inform the court that:
"Pharmaceutical companies at times learn about dangers caused by their drugs long before the FDA does, but have failed to disclose this information to the FDA. Thus, as exemplified by the cases of Pondimin/Redux, Vioxx, and Trasylol, the drug companies have withheld key information from the FDA and ardently negotiated against stricter label warnings – all the while continuing to market their unsafe drugs to an unsuspecting public."
"In the case of these three drugs alone," they state, "literally tens of thousands of American lives have been lost or ruined long after the manufacturers realized that the drugs were not safe."
"In light of this sad reality," the brief notes, "Petitioner's/Amici's argument that failure-to-warn suits actually pose a danger to public health is nothing short of specious."
It has been estimated, they report, "that between 88,000 and 139,000 Americans suffered Vioxx induced cardiovascular events, of whom 30-40 percent (24,000-55,600) died."
Their brief points out that once approved, "Vioxx quickly became one of the most successful drugs in pharmaceutical history, averaging over two billion dollars in sales per year, with total sales from 1999 through 2004 exceeding ten billion dollars."
"During the five years Vioxx was on the market, over 100 million prescriptions were written for an estimated 20 million patients," the doctors advise.
They say the "argument that tort suits have led Americans to underutilize prescription drugs or companies to limit product development is baseless," and make the following points:
"The prescription drug industry earns global revenues of more than $700 billion per year, an increase of $178 billion over the last five years.
"As of 2004, Americans were responsible for $248 billion in pharmaceutical sales, accounting for nearly 45 percent of all revenue worldwide.
"Despite representations of a so-called explosion of stifling litigation, the pharmaceutical market has grown, not shrunk. ... In 2007 alone, there were approximately 445 million more prescriptions written than in 2003."
Due to lack of media attention, most Americans know little or nothing about the Levine case or preemption. "In fact most people believe that preemption has something to do with the war in Iraq and our preemptive strikes," says Bijan Esfandiari, lead motions attorney at Baum, Hedlund, Aristei & Goldman in Los Angeles and a member of the firm's pharmaceutical products liability litigation team.
"It is for that reason that when I talk to others about this issue I do not use the term preemption but rather refer to it as 'immunity,'" he says, "since after all, a finding of preemption results in immunity for the pharmaceutical manufacturers."
"When you ask most people if they think that drug manufacturers should be immune from compensating victims who are injured by their drugs," he reports, "the majority of the people usually respond with a resounding 'NO.'"
"The problem is that people don't usually focus on such things until they become the victims of a pharmaceutical company's negligence," he advises, "and they shockingly find out that they may have no judicial recourse."
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Ms Levine sought treatment for a migraine headache and left the hospital with injuries that led to the amputation of her arm after Wyeth's drug Phenergan was administered by IV to alleviate the nausea associated with migraines and the drug reached her arteries. Ms Levine alleges that Wyeth was aware of the risk and failed to warn against using this method to administer Phenergan.
"In the event that Wyeth wins and the Supreme Court issues a broad opinion," Mr Esfandiari explains, "such a ruling could have an effect on all pending failure-to-warn lawsuits."