Pringle-- FDA Runs Protection Racket For Big Pharma

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FDA Runs Protection Racket For Big Pharma

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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.

 

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. "

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