Source: http://weeksmd.com/2007/12/fda-working-for-you-not/
Timestamp: 2019-04-18 11:22:19+00:00

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Why would Americans trust the FDA to regulate the pharmaceutical industry? Since the Bush administration took office the FDA has become the industry’s partner in crime.
The most notorious protection scheme put in place by the FDA and Big Pharma is the preemption policy that bans private lawsuits against drug companies in state courts once a drug and its label have been approved by the FDA.
On January 18, 2006, the FDA issued new rules for the labeling of prescription drugs, and in the preamble to the rules on page 43, the FDA says, State law actions “threaten FDA’s statutorily prescribed role as the expert Federal agency responsible for evaluating and regulating drugs,” requiring lay persons to second-guess its expert assessments of a drug’s risks and benefits.
So, after all of the concerns raised about the FDA’s failure to protect consumers against dangerous products over the last several year, by top experts from all over the world, the FDA has hereby declared itself the sole authority on decisions regarding prescription drugs, including whether a drug’s label contains adequate descriptions of indications for use, risks and benefits.
The preemption claim reverses a long-standing policy of permitting State actions intended to protect consumers and undermines the States’ ability to protect their citizens, yet State and local entities were given no opportunity to object to it.
Under Executive Order 13132, issued first by President Reagan, and then reissued by President Clinton, the FDA is supposed to consult with State and local authorities about the effects of each regulation it issues that affects the States.
The rule requested comment on products liability issues, but only by asking whether the new “Highlights” section raised liability concerns and, if so, how the FDA might alleviate those concerns without eliminating the Highlights section. This request can hardly be called “notice” of the preemption statement that suddenly appeared in the preamble in 2006.
Legal experts point out that it was never the intent of Congress to preempt private lawsuits in State courts, and that in fact, when Congress was considering the Food, Drug, and Cosmetic Act of 1938, it specifically rejected a proposal to include a private right of action for damages on the ground that such a right already existed under State common law.
Many members of Congress have also weighed in on the issue and reaffirmed that Congress never intended to preempt State claims in a February 23, 2006, letter to Michael Leavitt, Secretary of Health and Human Services, from Representatives Henry Waxman (D-Calif.), John Dingell (D-Mi.), and Sherrod Brown (D-Ohio).
The FDA’s language on page 38 of the preamble that states “whether it be in the old or new format, the Food, Drug and Cosmetic Act preempts conflicting or contrary state law,” appears to imply that the preemption policy is retroactive.
Part of the language also says that lawsuits against doctors are preempted for failure-to-warn patients of risks associated with a drug, apparently even when a drug is prescribed “off-label,” for a use other than those approved by the FDA.
The FDA has never before, in its entire history, claimed that a drug label preempts actions against health care professionals for failure-to-warn patients about risks. In fact, labels carry no information about the risks or benefits of “off-label” uses.
Critics see this language as an attempt to immunize all the doctors who the industry has convinced to over-prescribe drugs to treat conditions or patient populations for which the drugs have never been approved as safe and effective to increase profits.
“Doctors need to be held just as accountable as the drug manufacturers when things go wrong,” attorney Kwok says.
“And with only minimum consumer protection standards set by the FDA, that isn’t very reassuring,” Mr Kwok notes.
distributor from warning health care professionals whenever possibly harmful adverse effects associated with the use of the drug are discovered. The addition to labeling and advertising of additional warnings, as well as contraindications, adverse reactions, and precautions regarding the drug, or the issuance of letters directed to health care professionals (e.g., “Dear Doctor” letters containing such information) is not prohibited by these regulations. 44 Fed. Reg. 37434, 37447 (June 26, 1979).
One of the main authors of the new labeling rules was the FDA’s Chief Counsel at the time, Daniel Troy, who in previous employment fought the FDA in court to allow drug companies to promote drugs to doctors for “off label” use.
Its now obvious when looking back, that Mr. Troy was appointed by the Bush administration to implement tort reform under the guise of preemption, and under the cover of the Office of Chief Counsel at the FDA.
In the midst of the Vioxx and SSRI antidepressant disasters, instead of going after the drug makers for knowingly injuring hundreds of thousands of consumers with dangerous products, Mr. Troy devoted the majority of his time on the clock to filing five amicus briefs on behalf of Big Pharma to be used against the very citizens who were paying his salary.
In his briefs, Mr. Troy focused his main attention on protecting the profits of the makers of SSRIs, drugs second only to Vioxx when it comes to the concealment of studies and information about harm that if revealed, could have prevented tens of thousands of deaths and injuries over the past 20 years.
And even though there has been an infinite number of reports over the past decade regarding an increased risk of suicide with SSRIs, instead of withdrawing the approval of the drugs, requiring more studies, or demanding a warning be added to their label, Mr. Troy did nothing to protect potential SSRI victims as Chief Counsel of the FDA.
In late 2004, Mr. Troy quit the FDA to go back into private practice to once again represent pharmaceutical companies openly against private citizens, only with the added benefit of using the preemption defense he put in place.
It should be noted that two years before Mr. Troy filed his first brief as a kick-off for the preemption policy, the “costly investment of substantial agency resources” went for an FDA brief, in which the FDA acknowledged “the historic primacy of state regulation of matters of health and safety” and the appropriateness of a presumption against preemption where the state-law claims allege defective design, negligent manufacturing, or failure-to-warn in, Buckman v. Plaintiffs’ Legal Committee, 531 US 341 (2001).
Until reading this article, its likely that most people had never realized that Mr. Troy was “forced” to file briefs on behalf of Big Pharma while he worked at the FDA.
In a March 31, 2006 paper, titled, State-Level Protection for Good-Faith Pharmaceutical Manufacturers, Mr. Troy can be found advising State lawmakers to pass shield laws for Big Pharma based on a Michigan model, to “help to reduce the negative consequences of the current pharmaceutical-liability regime,” he says.
Such a statement might be a wee bit credible if it also included a suggestion for the lowering of the multi-million dollar annual salary and benefit packages enjoyed by Big Pharma CEOs or a reduction in the billions of dollars that are spent each year on illegal off-label promotion and marketing schemes.
For all the whining he does about litigation keeping products off the market, Mr. Troy cannot cite a single case in which a failure-to-warn claim interfered with the FDA’s federal regulatory authority or kept a drug off the market. In fact, in a lecture to Big Pharma attorneys in December 2003, on how to use the preemption defense, Mr. Troy told the attorneys that the FDA had “no good evidence” showing product liability concerns “keep good products off the market,” even though he had “combed the literature” to find such evidence.
Mr. Troy filed the FDA’s first brief in support of Big Pharma in September 2002, in the California Zoloft case titled Motus v. Pfizer, after he was contacted by Pfizer attorney, Malcolm Wheeler, in the summer of 2002, requesting that he get the government involved to help Pfizer win the preemption argument.
Despite the fact that Pfizer had paid Mr. Troy’s law firm over $358,000 in the year before he became Chief Counsel, Mr. Troy argued later that he did not become involved in the case until after the 1-year grace period in which employees may not participate in activities involving former clients. From all public accounts, the time period elapsed less then a month before he entered the case.
In the brief, Mr. Troy argued that any warning that suggested a link between Zoloft and suicidality would have been false and misleading, and the FDA would have rejected any effort to add such a warning. However, that argument contradicts 21 CFR § 314.126(b), which requires warnings to be added based on reasonable evidence of an association, even absent proof of a causal relationship. The preemption issue was never decided in Motus because the case was concluded on unrelated grounds.
Legal experts say the preemption defense will not only be used in SSRI-related suicide cases, it will be applied in SSRI cases involving the failure-to-warn about other types of injuries and deaths caused by these drugs as well.
For instance, Big Pharma will no doubt attempt to preempt cases filed on behalf of infants born with birth defects to mothers who unwittingly took the drugs during pregnancy, such as with Lacee Shore, who was prescribed Celexa during her first trimester of pregnancy and as a result, her baby, Gavin Shore, was born with serious heart birth defects and diagnosed with Shone’s Complex, which can lead to the obstruction of blood flowing to the body from the left side of the heart.
Gavin has already gone through several surgeries in attempt to correct the heart defects and will have to undergo more in the future.
The successful use of the preemption argument in a case such as this, where the drug maker, Forest Laboratories, could and should have warned doctors and pregnant women about the possibility of birth defects associated with Celexa, would leave the Shore family strapped with the burden of life-long medical costs related to Gavin’s condition.
Mr. Kwok points to a 1990 study conducted at the University of Michigan that shows the outlook for infants born with heart defects like Gavin is very poor. “One quarter of patients die after their second operation,” he says.
Forest Labs knew about the potential for birth defects caused by Celexa because more than two years before Gavin was born, on June 9, 2004, Web MD reported that the FDA was concerned about reports that SSRIs may cause adverse effects to babies born to mothers taking the drugs late in pregnancy.
According to Web MD, the FDA had been receiving reports for 10 years. In fact, it said that hundreds of reports on adverse effects in babies were received involving all the SSRIs sold in the US, which would include Prozac, Paxil, Luvox, Zoloft, and Celexa.
In July 2004, the FDA finally asked the SSRI makers to change the labels, warning that some infants had developed problems requiring tube feeding, respiratory support, and prolonged hospitalizations.
On September 1, 2005, the BBC reported that Danish and U.S. scientists found that cardiac birth defects appeared to be 60% more likely in newborns when women used SSRIs.
A successful preemption ruling would go a long way as far as protecting profits against damage awards based birth defects, because pregnant women represent a major share of the market. According to a May 2005, study in the Journal of American Medical Association, 80,000 pregnant women are prescribed SSRIs in any given year in the U.S., which means there are bound to be many cases where babies were born with birth defects.
The majority of courts that have addressed the preemption argument have ruled against it. One of the first federal courts to specifically rule against the FDA’s preamble position was a Nebraska District Court on May 31, 2006, in Jackson v. Pfizer, where the plaintiffs’ son took both Zoloft and Effexor and then committed suicide.
The parents alleged that the drugs caused their son to commit suicide and Nebraska law required additional warnings about the suicide risk. The drug maker defendants moved for summary judgment claiming that the State law claims were preempted by the FDA.
The court said that the claims were not preempted because the federal regulations did not conflict with State law and specifically held that there was no Congressional directive that the field was preempted.
The court stated the FDA preamble was not persuasive and pointed out that the Eighth Circuit had adopted the proposition that the FDA prescribes only minimum standards and the Fourth Circuit had declared that complying with federal regulations does not release a manufacturer from liability.
On May 25, 2006, a federal court in Pennsylvania was the first to grant the FDA’s preemption rule full deference in a wrongful death and survival action, with failure-to-warn claims against Paxil maker GlaxoSmithKline, and generic Paxil maker Apotex, in Colacicco v. Apotex, Inc, Civ No 05-cv-5500, 2006 WL 1443357 (E.D. Pa. May 26, 2006).
In this case, the plaintiff alleged that his wife’s suicide resulted from the drug makers’ failure-to-warn of the increased risk of suicide linked to Paxil and its generic equivalent.
The FDA argued that any such warning regarding an association between Paxil and suicide would have been false or misleading, and thus would have constituted misbranding under the FDCA.
The plaintiff responded by arguing that the court should not afford deference to the brief because 21 C.F.R. § 314.70, does permit manufacturers to strengthen labels without FDA approval and the FDA has no authority to simply declare that a drug is misbranded.
The court disagreed and determined that it was to give significant deference to the amicus brief based on the U.S. Supreme Court’s decisions in Chevron, Medtronic, and Geier which state that an amicus brief is an appropriate form to express preemptive intent and held that the principles of deference do not permit a court to question the FDA’s interpretation of its own regulations.
The Court went on to say that even if the preamble did not apply retroactively, it would have found preemption anyway based on the views previously expressed in amicus briefs by the FDA.
“Products liability lawsuits help to protect patients from drugs with undisclosed risks because the potential for being held liable for harm caused by their products provides a powerful incentive for drug companies to make their products as safe and effective as possible and to revise labels as soon as new risks become apparent.
In fact, the group points out, since at least several months before the victim’s suicide, the FDA had been reviewing data about a possible link between SSRIs and suicidality, and the agency issued a Public Health Advisory on the topic in October 2003, the same month that Mrs. Colacicco died.
“FDA regulations establish minimal standards necessary, but were not intended to preclude states from imposing additional labeling requirements. States may authorize additional labeling but they cannot reduce, alter, or eliminate FDA-required labeling.” 63 Fed. Reg. at 66384.
It appears that the FDA’s own regulations acknowledge that preambles are not statements of law and that they should not be presented as such in legal proceedings.
The FDA recognizes that an advisory opinion may be used to “illustrate acceptable . . . procedures or standard, but not as a legal requirement,” the brief points out.
There was an extremely important preemption ruling handed down on June 9, 2006, in the Vioxx case of Doherty v. Merck prior to the beginning of the actual jury trial. Merck moved to dismiss the failure-to-warn claim arguing that the preamble barred claims with respect to FDA approved drugs.
The June 9, ruling from the bench, drew massive attention to the case when New Jersey Superior Court Judge, Carol Higbee, refused to exclude the claims.
“The preamble, as I see it, is a political statement by the FDA,” she said.
“It has nothing to do with what happened back in 2000, 2001, 2002, when these issues were being debated. It is contrary to the U.S. Supreme Court’s decisions. It is contrary to all the law on preemption.
Merck later enjoyed a victory at trial when a jury decided that Vioxx was not the main cause of Elaine Doherty’s heart attack, but a favorable ruling on the preemption issue prior to trial could have potentially saved the company billions of dollars. According to the company’s SEC filings, as of October 9, 2006, Merck is a named defendant in about 13,850 Vioxx cases in the New Jersey State court coordinated litigation.
The next victory using the preemption argument was a major win in August, 2006, when a California court dismissed the Celebrex failure-to-warn claims against Pfizer, In re Bextra and Celebrex Marketing Sales Practices and Product Liability Litigation, No M: 05-1699 CRB, 2006 WL 2374742 (N.D. CA, August 16, 2006).
In opposing the motion, the plaintiffs argued that because the FDCA does not provide a monetary remedy, Congress must not have intended the FDA to have authority over damage claims and that the FDA’s position on preemption was not entitled to deference because it was clearly erroneous and inconsistent with the regulations.
But the judge refused to dismiss the false advertising claims. The plaintiffs argued that the Celebrex ads were false and misleading because they exceeded the labeled and approved gastrointestinal benefits and also minimized the established risks of the drug.
Pfizer claimed that because it submitted the ads for FDA approval, and the FDA did not object, the FDA had determined that the ads were accurate and struck a fair balance of the risks and the benefits of Celebrex.
However, the court refused to preempt the claims without a record showing that the FDA had reviewed each ad and approved it. The court also pointed out the FDA’s silence about whether its regulations preempt false advertising claims, in contrast to its stated position on failure-to-warn claims.
A little over a month later, on September 29, 2006, across the country in New Jersey, the court in McNellis v. Pfizer, refused to allow the preemption defense based in part on the fact that the text of FDA regulations had remained unchanged for years, and the regulations did not conflict with New Jersey’s failure-to-warn laws.
The McNellis Zoloft-suicide case comes with a history. On December 29, 2005, the U.S. District Court for the District of New Jersey had also denied Pfizer’s original motion for summary judgment. The court reasoned that the FDA’s approval of a label creates only a minimum standard and that the drug maker may strengthen the warnings as long as the new warning is not false or misleading.
In opposing the motion, Ms. McNellis said that the preamble amounted to nothing more than the FDA’s opinion on preemption; the same opinion expressed previously by the FDA in amicus briefs, and the same opinion already rejected by the court. It is irrelevant that this opinion now comes in the form of a preamble to a regulation rather than an amicus brief, she said.
She also noted that the preamble was not in effect at the time that her father committed suicide as a result of taking Zoloft.
The court held that regulations allow a drug company to increase warnings when new risks emerge, that the Food, Drug and Cosmetic Act does not contain a preemption clause, and that Congress gave no implicit empowerment to the FDA to preempt State law.
Following the McNellis decision, on October 16, 2006, a federal court in Pennsylvania refused to grant the drug maker’s preemption motion on the failure-to-warn claims in Perry v. Novartis Pharma Corp, — F Supp 2d —-, 2006 WL 2979388.
This case involved Elidel, a drug used to treat eczema, prescribed to Andreas Perry when he was 2-years-old. Six months after he began using the cream, in October, 2003, Andreas was diagnosed with a form of cancer known as lymphoblastic lymphoma.
reduce immune activity by inhibiting the activity of the enzyme calcineurin. Prior to the approval of Elidel for treating skin conditions in children over 2 years of age, calcineurin inhibitors were used as systemic immunosuppressants in organ transplant patients.
Systemic use of the drugs has long been known to increase the risk of cancer and the labels on the drugs prescribed to organ transplant patients say so. But because Elidel is applied topically for eczema, it was not known at the time of approval in December 2001, whether long-term use posed a risk of cancer.
This case illustrates why drug companies must be made to alert the public of known dangers as soon as they are known. On February 15, 2005, an FDA advisory committee met to discuss calcineurin inhibitors. In particular, reports of “off label” use of the drugs in children under two caused concern for some members of the committee.
At the meeting, the committee voted to add a “Black Box” warning about the possible increased risk of cancer associated with the topical use of Elidel, and the lack of long-term safety data on the use of the drug.
On March 10, 2005, the FDA told the drug maker to add a “Black Box” warning and issued a public health advisory about the possible cancer risk. However, it was nearly a year later when Novartis finally got around to adding a “Black Box” warning to Elidel’s label on January 19, 2006.
Where the agency attempts to “supply, on Congress’s behalf, the clear legislative statement of intent required to overcome the presumption against preemption,” no deference is warranted, he noted.
In reaching its decision, the court said preemption would only apply if a specific warning about Elidel and pediatric cancer had been considered by the FDA and found to be unnecessary and that had not happened in this case.
The court also said that even if the Preamble represents a change of policy with the force of law, it would not apply to this case. “The FDA cannot retroactively absolve Novartis of a duty it may have owed the Perrys in 2003,” it wrote.
“It is worth noting that, even where FDA regulations or other federal law prevent a manufacturer from modifying the approved labeling, a modification of the label is not the only form that a warning could take.
Poisoning our food – with the approval of… your elected representatives.

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