FDA
Runs Protection Racket
For Big Pharma
By Evelyn Pringle
11 January, 2007
Countercurrents.org
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.
In an 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."
A 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."[
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.
Nowhere in 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.”
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.
By relying 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."
The NCSL also stated the
failure to allow for an appropriate comment period constitutes “an
abuse of agency process and complete disregard for dual system of government.”
Ken Suggs, 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
political process.”
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.
According 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."
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).
Rep. 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.”
Rep. 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 regulated
entities.”
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.
"Pre-emption 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 labeling."
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.
"The 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."
"And with only minimum
consumer protection standards set by the FDA, that isn't very reassuring,"
Mr Kwok notes.
"I predict there could
be a flood of litigation," he says, "before FDA policy changes
any more."
In any 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, re-labeler, 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.
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.
On October 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 written."
"And 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."
In the 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."
"They 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."
"More formal communications,"
he advises, "can help buttress a future case for why a particular
state law claim should be pre-empted."
In the article, Mr. Troy
brags that his filing of FDA briefs on behalf of Big Pharma "has
reduced the negative consequences of the current pharmaceutical-liability
regime."
But for once, he at least
mentions that it cost the tax payers 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."
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).
In the 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."
"If courts give appropriate
deference to this statement of FDA’s considered judgment,"
he notes, "FDA will not be forced to file briefs in individual
cases."
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.
"In 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."
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.
Apparently 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."
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.
According 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.”
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.
"The second operations
are very often necessary," he explains, "because of the complexity
of the heart problem."
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.
Studies 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.”
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.
The court 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 law.”
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 judge 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."
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 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 concerns “irrelevant.”
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.
An appeal 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."
The 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."
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.
The amicus 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."
In 1998, 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 stating:
"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.
According 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."
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 amicus 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.”
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.
"Having 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
states."
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.
"The 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."
"What the preamble is
saying," Judge Higbee noted, "is the FDA should be the final
word."
She refused to dismiss the
claims based on the preamble she said, because it "has nothing
to do with science." In conclusion, she told Merck defense attorneys:
"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."
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.
Saying the 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.”
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.
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 appeal
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.
In her 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 failure-to-warn
statutes."
Ms. 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 tort laws."
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.
Elidel belongs to a class
of drugs known as calcineurin inhibitors, so called because they
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.
In their 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."
"The 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."
It also 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."
In denying 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 analysis."
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.
In 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."
"But where an interpretation
has changed frequently in significant respects," it wrote, "the
persuasive force of the argument diminishes."
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.
The court 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."
In its 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."
In 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."
"Until it does so, however,"
the court said, "in the absence of a specific FDA safety determination,
such suits can go forward."
[email protected]
(Evelyn Pringle is a columnist
for OpEd News and an investigative journalist focused on exposing corruption
in government and corporate America)
(This article is written
as part of a series on pharmaceutical litigation and is sponsored by
Robert Kwok & Associated, LLP)
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