Washington, DCThe botched safety processes at the FDA have had an extremely negative impact on the nation's public health and tens of thousands of people have died as a result of its negligent handling of the Vioxx debacle alone.
Americans today can no more trust what's in their medicine cabinets than could the pioneers in the 1800s who filled their medicine chests when the snake oil salesmen came to town.
The FDA is now apparently claiming infallibility by telling consumers that if it says a drug is safe and the warnings on a drug's label are sufficient, no consumer can bring a lawsuit against a drug's maker in a state court for injuries caused by a drug, even if it is shown that the drug company actively concealed information about known injuries associated with the drug not only from consumers, but from the FDA as well.
Throughout the FDA's 100 year history, state consumer protection laws have played an important role in protecting Americans from unsafe pharmaceutical products, and consumer protection advocates are rightfully questioning whether the FDA can or will provide the same protection.
Its no secret that the Bush-sanctioned FDA is bent on protecting drug company profits and doesn't care enough about protecting consumers from unsafe drugs. A March 2006 report to Congress issued by the Government Accountability Office, after an investigation of the FDA ability to monitor drug safety, said the FDA's performance was undermined by infighting between drug evaluation administrators whose allegiance is with industry and the Office of Drug Safety.
According to Attorney, Jim Gottstein, who recently scored a major victory in the Alaska Supreme Court protecting patients in state institutions from forced drugging with psychiatric medications, "the fact that current leaders of the FDA have taken the extraordinary step of interjecting the FDA into cases to argue pre-emption, leaves no doubt that it has abdicated its duty to protect the public from unsafe drugs in favor of protecting pharmaceutical profits."
State lawmakers are also crying foul over the FDA's arrogant undermining of state consumer protection laws because under Executive Order 13132, the FDA is required to consult with state authorities about the effects of regulations it issues on states. In the original proposed rule, the FDA specifically said that the regulation would not preempt state laws so state officials had no chance to object to the preemption rule.
According to the National Conference of State Legislatures, the preemption language in the preamble to the Final Rule is a thinly veiled attempt on the part of the FDA to confer upon itself authority it does not have by statute and does not have by way of judicial ruling. The NCSL called the FDA's action an abuse of agency process and a complete disregard for our dual system of government.
According to Baum Hedlund attorney, Karen Barth Menzies, "the FDA's statement is nothing more than the policy position of appointed officials with an agenda unrelated to public safety."
"As such," she says, "it should have zero preemptive effect."
When Congress enacted the Federal Food, Drug, and Cosmetic Act in 1938, it specifically rejected a proposal to include a private right of action for damages caused by products regulated by the FDA, on the grounds that a right of action already existed under state common law.
The new FDA preemption rule provides no exceptions even in cases like Vioxx where the FDA asked the company to change the warning label based on reports of serious adverse effects, and a drug maker like Merck refuses to change the label for more than 18 months while many more patients are killed and injured.
In addition, the FDA contends that the agency's approval of the drug label preempts not only claims related to label warnings but also claims related to false advertising.
Given the on-going heated debate over the FDA's ability to police the pharmaceutical industry as a whole, critics say it is a particularly inappropriate time to eliminate the role that private citizen lawsuits in state courts play.
But then again, what can we expect when the agency's top attorney, Daniel Troy, is recruited directly from Pfizer's stable of lawyers. Troy began the administration's preemption war against Joe Citizen to protect Big Pharma profits as soon as he set up shop at the FDA, by filing amicus briefs on behalf of drug companies, including Pfizer.
Even though Pfizer had been one of his clients and Troy's firm was paid over $350,000 for work he performed in the year before he was appointed chief counsel, Troy agreed to file a brief in support of Pfizer on behalf of the FDA, arguing, unsuccessfully, that state tort claims should be preempted.
He later justified writing the brief by claiming that he did not become involved in the case until after the 1-year period in which government employees may not participate in cases involving former clients. In hindsight, the 1-year grace period reportedly expired less than a month before Troy agreed to go to bat for his former client.
In stark contrast to Troy's pro drug company stance, in a 1996 speech, the Clinton appointed FDA chief counsel, Margaret Jane Porter, said the FDA had a "longstanding presumption against preemption" and that "FDA's view is that FDA product approval and state tort liability usually operate independently, each providing a significant, yet distinct, layer of consumer protection."
When simply filing amicus briefs did not work because no judge accepted the FDA's at best feeble and at worst ridiculous arguments, in January 2006, the FDA added the preamble to the new drug labeling rules stating that the Food, Drug and Cosmetic Act "pre-empts conflicting or contrary state law."
Judges are having mixed reactions to the FDA's preemption position. In a stinging rebuke, New Jersey judge, Carol Higbee, during a June 6, 2006 hearing involving Vioxx lawsuits, called the Final Rule's preamble "a political statement by the FDA."
As for the claim that state lawsuits should be preempted, she said, "It is contrary to the U.S. Supreme Court's decisions. It is contrary to all the law on preemption."
"In addition to being contrary to the law of the land," she stated, "it is also contrary to the Constitution of the United States."
She ended her comments by telling Merck's Vioxx attorneys, "And I am not going to allow you to use it."
On June 2, 2006, the Associated Press reported that a federal judge had refused to dismiss a lawsuit filed against Pfizer and Wyeth, on behalf of the parents of an 11-year-old boy who committed suicide after taking the antidepressants Zoloft and Effexor.
The judge rejected the preemption argument stating: "Federal labeling laws are minimum standards; they do not necessarily shield manufacturers from state law liability."
"Defendant's pre-emption argument ultimately fails because Congress has not expressed a specific intent to pre-empt state consumer-protection laws in the area of prescription-drug labeling," the court said.
"In the absence of Congress's express statement," the judge stated, "defendant must overcome the presumption against implying congressional pre-emptive intent. It has not done so."
In what can only be viewed as a rare ruling, In Bextra and Celebrex, on August 16, 2006, the US District Court for the Northern District of California dismissed the state law failure-to-warn claims saying they conflict with the FDA's determination of the proper warning and pose an obstacle to the full accomplishment of the objectives of the Food, Drug and Cosmetic Act.
The court attempted to justify the FDA's "180-degree reversal of its prior position" on preemption, by noting that an agency's view may change over time and especially with a change in administration.
But in New Jersey on September 29, 2006, a federal district court in McNellis v Pfizer Inc, refused to allow the preemption defense and based on the fact that the text of FDA regulations had remained unchanged for years, ruled that the regulations did not conflict with New Jersey's failure-to-warn laws.
The court also said that FDA regulations allow increased warnings when new risks emerge and that the Food, Drug and Cosmetic Act does not contain a preemption clause.
Following the McNellis decision, on October 16, 2006, a federal court in Pennsylvania refused to grant the drug maker's preemption motion in Perry v Novartis Pharma Corp, noting concerns about the effectiveness of the FDA's monitoring of recently approved drugs, making the availability of state tort suits an "important backstop to the federal regulatory scheme."
On October 5, 2006, the 2nd Circuit Court of Appeals was also critical of the FDA's preemptive reach stating, "[W]hatever deference would be owed to an agency's view ... an agency cannot supply, on Congress's behalf, the clear legislative statement of intent required to overcome the presumption against preemption," in Desiano v Warner-Lambert et al.
Three weeks later, on October 28, 2006, the Associated Press reported another state court victory against preemption in a case where Wyeth was ordered to pay nearly $6.8 million to a Vermont women after the Vermont Supreme Court upheld a lower court's ruling.
The court's decision said federal labeling requirements "create a floor, not a ceiling" for state regulation, noting that the FDA regulations allow drug companies to go beyond required warnings.
"When further warnings become necessary, the manufacturer is at least partially responsible for taking additional action, and if it fails to do so, it cannot rely on the FDA's continued approval of its labels as a shield against state tort liability," the court wrote.
Peter Lurie, deputy director of the health research group at Public Citizen, told the Associated Press that the case appeared to mark a push-back against efforts by the industry, the administration and the FDA to preempt state regulation of prescription drugs.
"If you have a wide enough berth that you can strengthen the label," he said, "you can't use the FDA-approved label as an automatic protection against lawsuits."
Since May 2006, all eyes in the legal field have been on the appeal in the case of Colacicco v Apotex, Inc, - F Supp 2d -, 2006 WL 1443357 (ED Pa), in the 3rd Circuit Court of Appeals, where the lower court ruled against a man whose wife committed suicide after taking Paxil.
Joseph Colacicco filed a lawsuit against both drug makers alleging that his wife committed suicide in October 2003, just 21 days after she began taking Paxil for mild depression with claims of wrongful death, negligence and a failure to warn her doctor of a link between Paxil and an increased risk of suicide.
In moving for dismissal, Paxil maker, GlaxoSmithKline, and Paxil generic maker, Apotex, relied on the FDA's position that state failure-to-warn claims are preempted.
The judge ruled that the defendants were entitled to a dismissal of all claims because the FDA controls the content of warnings and requires generic drug makers to use the same labeling as approved for the drug's original maker.
In this case, the judge on his own initiative, asked the FDA to submit an amicus brief. And in response, on the tax payer's dime, the FDA wrote a brief asking the court to rule against the American citizen and dismiss the lawsuit against the drug companies.
In fact the FDA was the strongest supporter of preemption in this case because according to the attorneys handling the case, Glaxo itself barely addressed the preemption issue during oral arguments on the motion.
In a decision that experts predict may end up before the US Supreme Court, the judge ended up dismissing the claims without ever considering whether the FDA regulations pose a conflict to the plaintiff's state tort claims.
Attorneys Derek Braslow, Harris Pogust and Matthew Leckman from the Conshohocken, Pennsylvania firm of Pogust & Braslow are representing the plaintiff in the case.
Attorney, Harris Pogust, says the judge's ruling "could potentially do away with all failure-to-warn pharmaceutical cases"
The FDA action he notes, "does not seem to be a public health concern as much as a political concern."
According to Mr Braslow, "the Judge readily admits that he did not analyze whether there is or was a conflict between state law and federal law and surmises that he probably would not find a conflict if he actually did the analysis."
"But, the Judge explained," he said, "that it doesn't matter - if the FDA says there is preemption, then there must be preemption. Far be it for a Judge to interpret the law."
"The Bush-era FDA," Mr Braslow notes, "in a complete reversal of the position it took in its 2000 rule proposal, has now officially cemented its role as a pawn for the pharmaceutical industry."
"It was not that long ago," Mr Braslow points out, "that the FDA came forward with amicus briefs on behalf of the consumer in prescription drug litigation."
"Now," Mr Braslow says, "an argument first put forward in a couple Zoloft suicide cases, has become the primary argument in every prescription drug case, and could," he warns, "potentially, mean the end for anyone seeking recourse from injuries resulting from prescription drugs, no matter how fraudulent the drug company's conduct."
"Make no mistake," he states, "the position taken by the Bush-era FDA is an attempt by the current administration to achieve tort reform for the benefit of big pharma and at the expense of the injured consumer, without the consent of Congress."
"The Bush-era FDA takes this position," he warns, "unconcerned by the reality that preemption would allow drug companies to peddle their drugs with impunity and avoid being justifiably called into court for deceiving the public about the safety and effectiveness of those drugs."
"Notwithstanding the FDA's position on preemption," Mr Braslow says, "courts examining this issue, if they take any time to actually look at the FDA regulations in question, would realize that there is no conflict between federal drug regulations and state tort claims."
"Federal drug regulations specifically mandate drug companies to strengthen their drug's label," he explains, "as soon as there is reasonable evidence of an association of a serious hazard with their drug."
"A state tort claim," Mr Braslow points out, "does not force a drug company to take any action that is not already permitted by federal regulations."
"Because federal regulations for prescription drugs are minimum standards," he notes, "federal regulations can never conflict with a state common law claim."
"The District Court erred," he states, "in abdicating to FDA legal opinion, as opposed to interpreting the law."
"What the Colacicco court did," he says, "was improperly abdicate to the FDA's legal opinion."
Critics say it's time for the FDA to get back to protecting consumers from dangerous products, rather than protecting the profits of the pharmaceutical industry. According to career scientist, Dr David Graham, in a 2005 interview with Jeanne Lenzer in the journal Public Library of Science, "The pharma-FDA complex has to be dismantled and the American people have to insist on that, otherwise we're going to have disasters like Vioxx that happen in the future."