FDA runs protection racket for Big Pharma
By Evelyn Pringle
Online Journal Contributing Writer
Jan 11, 2007, 00:43
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.
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.
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.
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.
October 6, 2006, articled titled, "The Doctrine of Preemption," Stan
Kaufman aptly refers to the new policy as the "Doctrine of Preemptive
Crony Capitalism." When announcing this multi-billion dollar immunization
gift to Big Pharma, the FDA told drug makers:
"We think that if your company complies with the
FDA processes, if you bring forward the benefits and risks of your drug, and
let your information be judged through a process with highly trained
scientists, you should not be second-guessed by state courts that don't have
the same scientific knowledge."
statement saying the complete opposite was made in 1996, by the FDA's Chief
Counsel in a speech that 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."[
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.
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
the proposed rule did the FDA provide notice or seek comment on the preemption
provisions added to the preamble. In the only proposed rule known to State and
local officials, the FDA said that the regulation would not preempt State law.
In fact, the language published in the Federal Register on December 22, 2000,
explicitly stated that �this proposed rule does not preempt state law.�
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.
on this false representation, State and local authorities were robbed of any
opportunity to object to the preamble. In a January 2006, letter to Michael
Leavitt, Secretary of Health and Human Services, the National Conference of
State Legislators called the regulation a "thinly veiled attempt on the
part of FDA to confer upon itself authority it does not have by statute."
also stated the failure to allow for an appropriate comment period constitutes
�an abuse of agency process and complete disregard for dual system of
president of the Association of Trial Lawyers of America, was quoted in the
January 19, 2006 Washington Post, as saying, the "fact that the drug
industry can get the FDA to rewrite the rules so that CEOs can escape
accountability for putting dangerous and deadly drugs on the market is the
scariest example yet of how much control these big corporations have over the
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.
to Houston attorney, Robert Kwok, who handles complex pharmaceutical litigation
involving drugs such Fosamax, Norvasc and SSRI antidepressants like Celexa:
"The real losers from this attempted power grab would be the millions of
Americans who depend on safe drugs. Without the protection of state laws Big
Pharma can ride shipshod over Americans who are injured by their unsafe drugs.
That's unacceptable and I'm seeing even conservative judges resist it."
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.) and John Dingell (D-Mi.), and Senator Sherrod Brown (D-Ohio).
Maurice Hinchey (R-NY) and Senator Edward Kennedy (D-MA), have threatened to
fight preemption through legislation if necessary. Rep. Hinchey issued a press
release on January 18, 2006, immediately after the policy was announced,
stating that the "FDA has once again gone to bat for the drug industry by
fully endorsing a policy that shelters pharmaceutical companies from Americans
who want to file lawsuits because a drug has made them or a loved one seriously
ill, or in some cases caused death.�
Hinchey also called it "the latest example of the FDA sticking its nose
where it does not belong and treating the drug companies as clients rather than
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.
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.
would include not only claims against manufacturers," the FDA states,
"but also against health-care practitioners for claims related to
dissemination of risk information to patients beyond what is included in the
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
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.
need to be held just as accountable as the drug manufacturers when things go
wrong," attorney Kwok says.
profession of medicine is in danger of being totally co-oped by the business of
medicine," he warns, "with more and more of the burden is being
placed on the consumer."
with only minimum consumer protection standards set by the FDA, that isn't very
reassuring," Mr Kwok notes.
predict there could be a flood of litigation," he says, "before FDA
policy changes any more."
event, restrictions that the FDA places on drug labeling do not prohibit drug
companies from disseminating warnings about a danger by other means. When it
originally promulgated these regulations, the FDA made clear that:
<>These labeling requirements do not prohibit a
manufacturer, packer, relabeler, or 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.
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.
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.
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.
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.
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.
9, 2006, Mr. Troy published an article in the Legal Times, that said, "I
was also at the FDA while January�s Physician Labeling Rule, which contains a
statement in its preamble about the FDA�s pre-emption authority, was
I now," he states in an obvious ad for new clients, "advise and
represent companies confronting state-law claims that implicate the pre-emptive
effect of FDA requirements."
Times article, Mr. Troy points out the importance of drug companies staying
cozy with the FDA to ensure success in future litigation. "Savvy companies,"
he wrote, "are recognizing that how they interact with the FDA today may
profoundly affect their pre-emption defenses in the future."
are trying to ensure their communications with the agency are as formal as they
can be," he said, "in light of commercial considerations and the need
to stay on the FDA�s good side."
formal communications," he advises, "can help buttress a future case
for why a particular state law claim should be pre-empted."
article, Mr. Troy brags that his filing of FDA briefs on behalf of Big Pharma
"has reduced the negative consequences of the current
once, he at least mentions that it cost the tax
plenty. "FDA involvement in state-law cases is not an ideal solution,"
he writes, "not least because each instance of such involvement involves
the costly investment of substantial agency resources."
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).
Legal Times, Mr. Troy goes on to explain that the new labeling rule is intended
to limit the direct involvement of the FDA in lawsuits. "The preamble to
that rule," he says, "makes an official statement of FDA�s views on
preemption easily available to courts hearing state-law tort cases."
courts give appropriate deference to this statement of FDA�s considered
judgment," he notes, "FDA will not be forced to file briefs in
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
so doing," he states, "they would help to encourage the development
of new drugs, preserve the availability of existing drugs, reduce upward
pressure on drug prices, and assure rational prescribing."
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.
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
to help resolve this nagging little problem, Mr. Troy told the defense
attorneys to pay for research to find some evidence to back this claim even if
it was weak, stating: "you guys really shoot yourself in the foot by not
funding research to this effect. . . . I'll even take anecdotal evidence and
stories if you have them."
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.
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.
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
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.
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
already gone through several surgeries in attempt to correct the heart defects
and will have to undergo more in the future.
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.
to attorney Kwok, who is handling the Shore case, the birth defect situation is
even more devastating than with patients harmed by Vioxx because the Celexa
victims are so young. "Their whole lives," he says, "if they
survive, will be under the threat of illness and additional surgery, with a
very poor prognosis.�
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.
second operations are very often necessary," he explains, "because of
the complexity of the heart problem."
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.
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,
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.
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
show that women are prescribed SSRIs twice as often as men and yet the drug
makers have made no effort to evaluate the use of these drugs with pregnant
women. And as a result, Mr. Kwok says, "new moms are finding out too late
that the Celexa they took was putting their unborn baby in grave danger.�
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.
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.
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.
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.
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.
also noted that the FDA �failed . . . to allow the states an opportunity to
participate in the proceedings prior to a preemption decision,� and dismissed
the FDA�s brief stating that it �will not treat amicus briefs as the force of
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).
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
on his own initiative, invited the FDA to file a brief. The current Chief
Counsel, Sheldon Bradshaw, went to bat for the drug makers and filed a brief at
record speed within 20 days, urging the court to dismiss the lawsuit on the
basis of preemption, stating that in October 2003, when Paxil was prescribed to
the suicide victim, "there was no reasonable evidence available at the
time of an association between adult use of the drug and suicide."
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.
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.
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.
plaintiff argued that the preamble which was promulgated in 2006 could not be
retroactively applied to the October 2003, death of his wife. However, the
Court said that preemption could be applied retroactively because the preamble
simply clarified the FDA�s �longstanding views on preemption,� and
characterized the preamble as an �interpretive rule,� rendering retroactivity
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.
is pending on the Colacicco decision, and the case has drawn amicus support
from a dozen scientists and doctors who contend that preemption "would
threaten the public health and eliminate an important counterpart to the public
health objectives of the FDA."
national non-profit consumer advocacy organization, Public Citizen, the Trial
Lawyers for Public Justice, a national public interest law firm, and the
Association of Trial Lawyers of America, an international coalition of
attorneys, law professors, paralegals, and law students, have together filed an
amicus brief supporting Mr Colacicco, stating:
"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.
"Furthermore, because FDA lacks authority to
subpoena documents from the companies it regulates, products liability lawsuits
help to uncover information that can lead to safer products."
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.
brief also notes that the FDA�s preemption statement lacks the �consistency�
needed to warrant any degree of deference because prior to 2002, the FDA�s
consistent view was that State common law was not preempted by federal drug
regulation. "For example," the brief wrote, "in both 1979 and
1998, in preambles accompanying various drug regulations, FDA stated that state
tort law did not interfere with federal regulation."
when addressing pharmacists� provision of written patient information for
�Medication Guides,� when issuing the final rule, the FDA rejected calls for
the agency to express an intent to preempt State regulation of labeling requirements
"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.
to the amicus brief, "The authority to regulate drug labeling may carry
with it the authority to address state drug labeling regulations, but it does
not carry with it authority to determine the preemptive effect of federal
regulation on state common-law compensation systems."
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.
group states that the preamble is not part of the regulation, will not appear
in the Code of Federal Regulations, and does not have the force of law.
"In fact," the brief notes citing FDA regulations, "a
longstanding FDA regulation provides that a statement in a regulatory preamble
constitutes only an �advisory opinion.�
recognizes that an advisory opinion may be used to �illustrate acceptable . . .
procedures or standard, but not as a legal requirement,� the brief
made no effort to legislate on the topic of drug-related damages
remedies," the brief concludes, "Congress can hardly be said to have
authorized FDA to supersede the damages remedies traditionally provided by the
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.
9, ruling from the bench, drew massive attention to the case when New Jersey
Superior Court Judge, Carol Higbee, refused to exclude the claims.
preamble, as I see it, is a political statement by the FDA," she said.
primary purpose of it," she stated, "is to criticize state courts and
to set forth the FDA's position, not to criticize state courts so much as to
set forth the FDA's position that they believe there should be federal
preemption of all tort actions."
the preamble is saying," Judge Higbee noted, "is the FDA should be
the final word."
refused to dismiss the claims based on the preamble she said, because it
"has nothing to do with science." In conclusion, she told Merck
"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.
"And I am not going to allow you to use it."
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.
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).
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
FDA specifically considered the safety risks about Celebrex alleged in the
lawsuit and determined the risks should not be included on the label, the court
said the failure-to-warn claims �conflict with the FDA�s determination of the
proper warning and pose an obstacle to the full accomplishment of the
objectives of the FDCA.�
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.
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.
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.
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
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.
After the FDA published the new rule and preamble with the preemptive language
in January 2006, Pfizer filed another motion asking the court to vacate the
order denying summary judgment, or to certify the question for interlocutory
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.
brief filed on March 2, 2006, Ms. McNellis argued that the FDA had also
exceeded its authority, stating:
"In this instance, an executive agency, the FDA,
has expressed an opinion that Congress has never agreed to. Without notice or
comment, the FDA found it within its jurisdiction to go against the wishes of
Congress as well as the wishes of those states which have product liability
McNellis also pointed out that the last six courts to decide the issue
"have found, consistent with this Court's finding, that the FDA
regulations establish minimum requirements such that they do not preempt state
noted that the preamble was not in effect at the time that her father committed
suicide as a result of taking Zoloft.
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
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.
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
belongs to a class of drugs known as calcineurin inhibitors, so called because
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
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.
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.
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.
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.
brief in opposition to the preemption motion to dismiss, the plaintiffs said
that the FDA�s broad claim of preemption is not entitled to deference,
"whether it is expressed in the January 2006 Preamble to the Final
Rule," or "in amicus curiae briefs filed by the agency in
support of drug manufacturers."
FDA�s claims," the brief wrote, "which are tantamount to an advisory
opinion, lack the force of law and contradict the FDA�s governing statute, its
regulations, and its regulatory purpose."
noted that the FDA�s current opinion directly opposes the FDA�s longstanding
views on preemption. "For these reasons," the brief pointed out,
"a majority of courts that have considered this issue, both before and
after the FDA issued the Preamble, have held that FDA approval of labeling does
not preempt state failure-to-warn claims."
Novartis' preemption motion, U.S. District Court Judge, Stewart Dalzell, of the
Eastern District of Pennsylvania, wrote in the decision that the FDA's new
"Preamble is not entitled to any special consideration in our
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.
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.
discussing the FDA's assertions in its amicus brief, the court stated, "To
be sure, because of its expertise in the area, the FDA's construction of its
own regulations is likely to carry great weight."
where an interpretation has changed frequently in significant respects,"
it wrote, "the persuasive force of the argument diminishes."
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.
also noted that the FDCA provides no remedy for an injured consumer and said,
"a finding of preemption here will foreclose a remedy that was
traditionally available and for which federal law provides no substitute."
decision, the court made an interesting observation about the viability of the
preemption defense on failure-to-warn claims based on other available methods
of warning the public about the dangers of a drug, stating:
"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.
"If, for example, a plaintiff claimed that a
manufacturer was negligent in not sending a letter to prescribing physicians or
other health care professionals, that might present a different case, even if
modification of the approved labeling were prohibited."
conclusion, citing a September 23, 2006, New York Times report by Gardiner
Harris, the court said, "given the recent concerns about the effectiveness
of the FDA's safety monitoring of recently approved drugs, . . . the
availability of state law tort suits provides an important backstop to the
federal regulatory scheme," and further stated:
"If, at some future date, Congress determines
that FDA monitoring is sufficiently effective on its own to warrant the
elimination of state law incentives for manufacturers to provide adequate
warnings, it also has the authority to declare that failure-to-warn suits, like
the Perrys' action, are preempted."
it does so, however," the court said, "in the absence of a specific
FDA safety determination, such suits can go forward."
seeking legal advice for infants born with birth defects to mothers who were
prescribed Celexa during pregnancy can contact Robert Kwok & Associates, LLP
at (713) 773-3380.
Evelyn Pringle is a
columnist for OpEd News and an investigative journalist focused on exposing corruption in government and
This article is written as part of a series on
pharmaceutical litigation and is sponsored by Robert
Kwok & Associated, LLP.
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