The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

Lawmakers Catch Glaxo Hiding Paxil Suicide Risks – Again (Part I)

Evelyn Pringle February 12, 2008

GlaxoSmithKline recently received greetings from a Congressional Committee, asking the company to explain the findings in a report unsealed last month in a lawsuit which shows that Glaxo knew as early as 1989 that Paxil increased the risk of suicidal behavior in patients by more than 8-fold compared to patients who received a placebo.

In a February 6, 2008 letter, Senator Charles Grassley (R-Iowa), ranking member of the Senate Finance Committee, is asking Glaxo to explain why the American public was never adequately informed of this risk until May 2006 in a “Dear Healthcare Professional” letter which reported a “higher frequency of suicidal behavior” associated with Paxil as compared to placebo.

The report showing the 8-fold suicide risk, by Harvard instructor and psychiatrist Joseph Glenmullen, was unsealed on January 18, 2008, by a federal judge in a US District Court in Sacramento, California in the Paxil suicide case of O’Neal v SmithKline Beecham d/b/a GlaxoSmithKline, filed by the surviving family members of 13-year-old Benjamin Bratt.

Dr Glenmullen was retained as an expert in the case by the California-based Baum, Hedlund, Aristei & Goldman law firm.

On January 30, 2008, the court dismissed the lawsuit on the basis of the Bush Administration’s new preemption policy, largely unknown to most Americans, which says that once the FDA approves a drug and its label, citizens may not sue a company for failing to warn about a risk not listed on the label, even in cases like this where the plaintiff can prove that the company knew about the risk and intentionally concealed it.

SSRI’s are antidepressants known as selective serotonin reuptake inhibitors and include Paxil, Eli Lilly’s Prozac, Zoloft by Pfizer and Celexa and Lexapro marketed by Forest Labs. Wyeth’s Effexor, Lilly’s Cymbalta and Glaxo’s Wellbutrin are not considered SSRI’s, but they also carry a warning about an increased risk of suicidality in young people.

Two SSRI suicide cases are now awaiting a joint decision from the Third Circuit Court of Appeals for which oral arguments took place in December 2007.

In the case of Colacicco v Apotex, the US District Court for the Eastern District of Pennsylvania was the first to dismiss a failure-to-warn claim based on the new preemption policy, and in McNellis v Pfizer, the US District Court for the District of New Jersey found no preemption.

Also unbeknownst to most Americans, the Bush Administration is instructing judges to dismiss the lawsuits against the SSRI makers in amicus briefs filed by the government’s top attorneys, who also attend hearings when necessary to argue on behalf of the SSRI makers during oral arguments on motions to dismiss.

In fact, in regard to requiring a warning about suicide, during oral arguments in the Third Circuit, Bush Administration attorney Sharon Swingle told the court that the FDA “had again and again and again made an expert determination that the warning was not appropriate.”

She maintained that the claims were preempted because the SSRI makers were not allowed to add warnings to the label under any circumstances without prior approval from the FDA.

At one point, the court asked an attorney for an SSRI maker, “assume for the moment that you had reasonable evidence of an association between your product and a serious hazard or a serious possibility of an enhanced suicide risk.”

Under federal regulations, “what would be your obligation?”

The attorney stated, “our obligation would be to take that information to the FDA, advise the FDA of the information.”

“It then would be the FDA’s determination whether that represented a substantial relationship,” he told the court.

“So if you had evidence internally that there’s an enhanced risk of suicide, you would go to the FDA,” the court said, and asked, “And how long would that take?”

“I do not know the answer to that, your Honor,” the attorney said, and the court asked, “Could it take months?”

“I imagine it would depend on the seriousness –,” the attorney stated.

“But isn’t there a significant possibility that additional people then might have the same consequence that happened here with McNellis, or with Colacicco and McNellis’s father?” the court asked.

The attorney said, “on the basis of the information that was available we would take it per FDA directive to the FDA and they would make the determination whether the label should be changed.”

“Other people could then,” the court continued, “possibly have an enhanced risk of suicide and other people may commit suicide as a result of taking your product?”

“We would be bound by law to comply with the FDA, then to comply with its directives,” the attorney replied.

“Are they requiring that you go through them first rather than act on your own?” the court asked.

“That’s exactly correct, your Honor, because there is the bigger issue of the –” the attorney stated.

However, at the end of the hearing, Pennsylvania attorney Derek Braslow proved beyond any doubt that the claims made by the Bush Administration attorney and the attorneys for the drug makers were blatant lies, when he informed the court that Glaxo had “independently, strengthened their warning in May 2004 to warn about increased suicidality and worsening depression in everyone, not just children.”

“There was specifically in bold letters a new warning with respect to increased suicidality and worsening depression in May 2004,” he stated.

“Glaxo changed the label on their own without FDA approval,” Mr Braslow told the court.

Glaxo did it again in May 2006, he said, when they sent out a “Dear Healthcare Professional” letter and warned about the increased risk of suicidality and suicidal behaviors with Paxil in persons of all ages.

During oral arguments in the O’Neal case on January 21, 2008, Glaxo’s preemption argument was presented by King & Spalding attorney Mark Brown, who just happens to be a former Associate Chief Counsel for the FDA from the first Bush Administration.

The family intends to ask the court to reconsider the ruling in the O’Neal case, according to a statement by Baum Hedlund.

In his report, Dr Glenmullen sums up the inadequacy of the system, including the FDA, that allowed Glaxo to keep this vital information hidden from prescribing doctors and patients for nearly 2 decades and states, in part:

“One of the most sobering aspects of the story of Paxil-induced suicidality is that GlaxoSmithKline was not forthcoming with its data demonstrating the risk and regulatory agencies like the FDA did not take the initiative to get to the bottom of and expose the true risk.”

“Rather, the impetus came from attorneys and medical experts surprised by what they found in GlaxoSmithKline’s confidential documents, which only came to light through litigation.”

“The GlaxoSmithKline documents that have so-far made it into the public record have in turn been critical to educating patients, the public, and the media about the true risk. The media – particularly the BBC in England – played a crucial role in turning the tide in the history of Paxil-induced suicidality.”

According to Dr Glenmullen, “it was the diligent efforts of plaintiff’s attorneys that forced GlaxoSmithKline to divulge the inaccurate counting method to the FDA.”

Another leading expert on pharmacology, Dr Peter Breggin, warns that an 8-fold increased risk of suicidality in controlled clinical trials could mean 80-fold in actual practice. “We can’t determine exactly how much greater the risk will be in clinical practice but it will be astronomically greater,” he advises.

In actual practice, he explains, many patients are already suicidal when they start taking the drug, increasingly the likelihood that the drug can push them over the edge.

Despite the warnings to watch patients closely, Dr Breggin says, busy doctors do not monitor patients properly. He explains that they are almost never evaluated for suicidality and are often given multiple drugs at the same time, by doctors who know little about their adverse effects on the mind.

Glaxo is facing lawsuits from surviving family members of Paxil suicide victims all over the country and is attempting to use preemption to avoid public trials for good reason. The first case to go before a jury in Wyoming in 2001, involved a man who shot his wife, daughter and infant granddaughter before shooting himself after being on Paxil for just a matter of days.

The trial resulted in a verdict against Glaxo for $6.4 million after the jury weighed the expert testimony of famed pharmacologist Dr David Healy, who presented a summary of Glaxo’s hidden suicide data on Paxil, against the testimony of the industry-funded SSRI defender Dr John Mann, whose name appears on many of the studies issued over the years, some as late as 2007, that steadfastly proclaim that SSRI’s are not linked to suicide and should be prescribed to children.

In addition to Dr Healy’s revelations about hidden data showing that Glaxo was aware of the increased risk, Dr Mann’s credibility was likely weighed against the fact that he had received over $30 million in research funding from drug companies between the early 1990’s and the trial in 2001, which was brought out during his testimony by Houston attorney Andy Vickery.

Mr Vickery also established that, roughly 10 years and $30 million earlier, Dr Mann had published a paper stating that SSRI’s could increase suicidality in a small subset of patients.

In his report, Dr Glenmullen states that, since Glaxo had the original data in 1989 that showed a greater than eightfold increased risk, it should have warned doctors and patients about the risk “a decade-and-a-half ago when Paxil was first approved by the FDA.”

The report includes portions of an April 29, 1991 report, written by Glaxo psychiatrist Dr Geoffrey Dunbar, sent to the FDA in response to a specific request for information on suicidality in which Glaxo openly lies in stating: “analyses of our prospective, clinical trials for depression show that patients who were randomized to Paxil therapy were at no greater risk for suicidal ideation or behavior than were patients randomized to placebo or other active control therapies.”

Dr Glenmullen notes the importance of the date that this false data was submitted because the FDA had scheduled a hearing with a nine-member advisory panel for September 20, 1991, to discuss concerns raised a year earlier about the possibility of Prozac making patients suicidal. Paxil was not approved for use in the US until December 2002.

In his report, Dr Glenmullen points out that 5 of the 9 members on the advisory panel had conflicts of interest with drug makers and that 2 psychiatrists, Dr David Dunner of the University of Washington in Seattle and Dr Stuart Montgomery from England, had done research on Prozac for Eli Lilly, and later played crucial roles in Glaxo’s publishing of what he calls “bad” suicide numbers in the Paxil story.

Dr Glenmullen’s report includes portions of a September 19, 1991, memo distributed to over 20 senior staff the day before the hearing with a “Statement to be used to respond to inquiries re Paxil/Suicide,” which claims explicitly that during GlaxoSmithKline’s studies: “the incidence of suicide was lower among patients receiving Paxil than among those receiving placebo.”

This was the statement the company ordered employees to make, even though 5 patients on Paxil committed suicide while no patients in the placebo group did. In addition, Dr Glenmullen points out that, up to 1989, seriously suicidal patients were excluded from Glaxo’s studies, and therefore “anyone who became seriously suicidal during the studies only became so after being given Paxil or a placebo.”

Yet the actual numbers show that there were 40 suicide attempts in the clinical trials by patients taking Paxil compared to 1 suicide attempt in the placebo groups.

Despite the poor quality of the data available to the advisory committee, and despite the many conflicts of interest of its members, one third of the members still voted for a warning in 1991, Dr Glenmullen points out.

Three months later, in December 1991, Dr Dunner, together with Glaxo psychiatrist Dr Dunbar, presented Glaxo’s Paxil data with the “bad” numbers at a meeting of the American College of Neuropsychopharmacology (ACNP) in Puerto Rico.

During the presentation, the doctors told the ACNP: “Suicide and suicide attempts occurred less frequently with Paxil than with either placebo or active control,” according to the Glenmullen report.

The ACNP’s members are considered prominent academic psychiatrists who specialize in pharmacology, and the group has issued a number of position papers over the years which consistently denied a link between SSRI’s and suicidality.

Dr Mann led an ACNP task force which included Dr Fred Goodwin, Dr Charles O’Brien and Dr Robinson, which supposedly reviewed all the clinical trial data on SSRI’s and issued a consensus statement with the position that SSRI’s did not increase the risk of suicidal behavior, which was published in the journal Neuropsychopharmacology in 1993.

In March 1995, Dr Dunner, Dr Montgomery and Dr Dunbar published the paper, “Reduction of suicidal thoughts with paroxetine in comparison with reference antidepressants and placebo,” in the European journal Neuropsychopharmacology. This paper included a table with the “bad” numbers and claimed that other antidepressants were more likely to increase the risk of suicide than Paxil.

The paper specifically states: “Consistent reduction in suicides, attempted suicides, and suicidal thoughts, and protection against emergent suicidal thoughts suggest that Paxil has advantages in treating the potentially suicidal patients.”

On July 5, 1995, Glaxo’s marketing department issued a memo urging its sales force to use the Dunner-Dunbar paper to reassure doctors who were concerned over Paxil-related suicide that there was no need for concern.

The fact is, documents obtained in litigation prove that the FDA has known about the suicide risks of SSRI’s for roughly 23 years. Two years before Prozac was approved, in May 1985, the FDA’s chief investigator, Dr Richard Kapit, wrote: “Unlike traditional tricyclic antidepressants Fluoxetine’s profile of adverse side effects more closely resembles that of a stimulant drug than one that causes sedation.”

“It is Fluoxetine’s particular profile of adverse side-effects which may perhaps, in the future give rise to the greatest clinical liabilities in the use of this medication to treat depression,” he noted.

Dr Kapit’s review described data from 46 clinical trials with a total of 1,427 patients and under the section, “Catastrophic and Serious Events,” he listed 52 cases of “egregiously abnormal laboratory reports which were the reason for early termination,” and “additional adverse event reports not reported by the company were revealed on microfiche.”

“In most cases,” he wrote, “these adverse events involved the onset of an unreported psychotic episode.”

There were ten reports of psychotic episodes including 2 reports of completed suicides, 13 attempted suicides, 4 seizures, and 4 reports of movement disorders. In 1985, Dr Kapit recommended “labeling warning the physician that such signs and symptoms of depression may be exacerbated by this drug”.

When Prozac was approved, no such warning was issued.

Two weeks after the FDA advisory panel met in February 2004 to review the data on SSRI’s to determine whether they were linked to suicide, Dr Healy sent a report to Peter Pitts, Associate Commissioner for External Relations, at the FDA, in response to an invitation by Dr Robert Temple for a submission of the details of studies referred to in the course of a presentation at the meeting.

“A great number of the patient testimonies in the course of the Feb 2nd hearing were from individuals who became suicidal on an SSRI when their underlying disorder was Lyme Disease, migraine or a condition such as social phobia,” Dr Healy pointed out.

He also noted that this had been the case in the 1991 hearings, when it was framed by FDA’s Dr Temple as follows:

“The discussion we heard earlier showed that people who commit suicide are highly likely to have a diagnosis of depression, which means that somebody identified them as in a high-risk category. But there were still a significant number of people who committed suicide without having that sort of diagnosis and I guess I would like some advice or discussion on who those people were.”

“The anecdotes that one hears that are most evocative to me anyway are not the ones where people who have a 20-year history of suicidal ideation and then finally do it – that is not too surprising – it is where they assert that there has never been anything in their minds like that before and yet now they have suddenly become excessively concerned with suicide and may even do it.”

Dr Healy’s analysis submitted to the FDA included the data from the pediatric trials on suicidality and hostility, including some that were concealed for years. To distinguish the difference between suicide caused by SSRI’s verses suicide caused by the underlying depression, he separated the data on children who were treated for depression and children who were treated for obsessive compulsive disorder or social phobia.

The analysis found that SSRI’s can cause some children who are not depressed to become suicidal when taking the drugs for other conditions. From a pool of 931 depressed patients taking SSRI’s versus 811 depressed patients taking placebo, Dr Healy determined that there were 52 suicidal acts by patients on SSRI’s versus 18 in the placebo group.

In a pool of 638 patients taking SSRI’s for other disorders versus 562 patients taking a placebo, there were 10 suicidal acts in the SSRI group versus 1 in the placebo group.

When these data sets were combined, there were 62 episodes of suicidality in the 1,569 patients on SSRI’s versus only 19 episodes in the 1,373 patients on a placebo.

In his submission to the FDA, Dr Healy also explained that he had conducted his own trial on Zoloft in 2000 with 20 “healthy volunteers,” meaning they had no mental disorder when entering the trial, and two of the Zoloft patients became suicidal. This type of study provides the strongest evidence of drug-induced suicidality because it’s impossible for drug companies to claim that a patient became suicidal as a result of the underlying depression.

Seven years ago, during the Wyoming jury trial involving the tragic Paxil-induced murder-suicide, the man’s physician testified that he may not have prescribed Paxil if a warning regarding homicide and suicide had been added to the drug’s label.

In his report released last month, Dr Glenmullen offers the following heart-wrenching conclusion to the court: “It is my opinion to a reasonable degree of medical probability that if GlaxoSmithKline had provided a warning all these years, Benjamin Bratt would still be alive today.”

On April 24, 2004, the Lancet medical journal published an editorial entitled, “Depressing Research,” with the following comments that surely ring doubly true today for the Bratt family, as well as all the other families whose children committed suicide while on SSRI’s:

“It is hard to imagine the anguish experienced by the parents, relatives, and friends of a child who has taken his or her own life. That such an event could be precipitated by a supposedly beneficial drug is a catastrophe. The idea of that drug’s use being based on the selective reporting of favourable research should be unimaginable.”

Filed under: 2008, Baum, Braslow, Breggin, Colacicco, FDA, FDA hearing, Fraud, ghostwritten, Glaxo, KOL, Mann, Paxil, Preemption, SSRIs, Study 329, suicide, Vickery

FDA and Big Pharma Gang Up On Joe Citizen

Evelyn Pringle November 6, 2006

The botched safety processes at the FDA have had an extremely negative impact on the nation’s public health and tens of thousands of people have died as a result of its negligent handling of the Vioxx debacle alone.

Americans today can no more trust what’s in their medicine cabinets than could the pioneers in the 1800s who filled their medicine chests when the snake oil salesmen came to town.

The FDA is now apparently claiming infallibility by telling consumers that if it says a drug is safe and the warnings on a drug’s label are sufficient, no consumer can bring a lawsuit against a drug’s maker in a state court for injuries caused by a drug, even if it is shown that the drug company actively concealed information about known injuries associated with the drug not only from consumers, but from the FDA as well.

Throughout the FDA’s 100 year history, state consumer protection laws have played an important role in protecting Americans from unsafe pharmaceutical products, and consumer protection advocates are rightfully questioning whether the FDA can or will provide the same protection.

Its no secret that the Bush-sanctioned FDA is bent on protecting drug company profits and doesn’t care enough about protecting consumers from unsafe drugs. A March 2006 report to Congress issued by the Government Accountability Office, after an investigation of the FDA ability to monitor drug safety, said the FDA’s performance was undermined by infighting between drug evaluation administrators whose allegiance is with industry and the Office of Drug Safety.

According to Attorney, Jim Gottstein, who recently scored a major victory in the Alaska Supreme Court protecting patients in state institutions from forced drugging with psychiatric medications, “the fact that current leaders of the FDA have taken the extraordinary step of interjecting the FDA into cases to argue pre-emption, leaves no doubt that it has abdicated its duty to protect the public from unsafe drugs in favor of protecting pharmaceutical profits.”

State lawmakers are also crying foul over the FDA’s arrogant undermining of state consumer protection laws because under Executive Order 13132, the FDA is required to consult with state authorities about the effects of regulations it issues on states. In the original proposed rule, the FDA specifically said that the regulation would not preempt state laws so state officials had no chance to object to the preemption rule.

According to the National Conference of State Legislatures, the preemption language in the preamble to the Final Rule is a thinly veiled attempt on the part of the FDA to confer upon itself authority it does not have by statute and does not have by way of judicial ruling. The NCSL called the FDA’s action an abuse of agency process and a complete disregard for our dual system of government.

According to Baum Hedlund attorney, Karen Barth Menzies, “the FDA’s statement is nothing more than the policy position of appointed officials with an agenda unrelated to public safety.”

“As such,” she says, “it should have zero preemptive effect.”

When Congress enacted the Federal Food, Drug, and Cosmetic Act in 1938, it specifically rejected a proposal to include a private right of action for damages caused by products regulated by the FDA, on the grounds that a right of action already existed under state common law.

The new FDA preemption rule provides no exceptions even in cases like Vioxx where the FDA asked the company to change the warning label based on reports of serious adverse effects, and a drug maker like Merck refuses to change the label for more than 18 months while many more patients are killed and injured.

In addition, the FDA contends that the agency’s approval of the drug label preempts not only claims related to label warnings but also claims related to false advertising.

Given the on-going heated debate over the FDA’s ability to police the pharmaceutical industry as a whole, critics say it is a particularly inappropriate time to eliminate the role that private citizen lawsuits in state courts play.

But then again, what can we expect when the agency’s top attorney, Daniel Troy, is recruited directly from Pfizer’s stable of lawyers. Troy began the administration’s preemption war against Joe Citizen to protect Big Pharma profits as soon as he set up shop at the FDA, by filing amicus briefs on behalf of drug companies, including Pfizer.

Even though Pfizer had been one of his clients and Troy’s firm was paid over $350,000 for work he performed in the year before he was appointed chief counsel, Troy agreed to file a brief in support of Pfizer on behalf of the FDA, arguing, unsuccessfully, that state tort claims should be preempted.

He later justified writing the brief by claiming that he did not become involved in the case until after the 1-year period in which government employees may not participate in cases involving former clients. In hindsight, the 1-year grace period reportedly expired less than a month before Troy agreed to go to bat for his former client.

In stark contrast to Troy’s pro drug company stance, in a 1996 speech, the Clinton appointed FDA chief counsel, Margaret Jane Porter, said the FDA had a “longstanding presumption against preemption” and that “FDA’s view is that FDA product approval and state tort liability usually operate independently, each providing a significant, yet distinct, layer of consumer protection.”

When simply filing amicus briefs did not work because no judge accepted the FDA’s at best feeble and at worst ridiculous arguments, in January 2006, the FDA added the preamble to the new drug labeling rules stating that the Food, Drug and Cosmetic Act “pre-empts conflicting or contrary state law.”

Judges are having mixed reactions to the FDA’s preemption position. In a stinging rebuke, New Jersey judge, Carol Higbee, during a June 6, 2006 hearing involving Vioxx lawsuits, called the Final Rule’s preamble “a political statement by the FDA.”

As for the claim that state lawsuits should be preempted, she said, “It is contrary to the U.S. Supreme Court’s decisions. It is contrary to all the law on preemption.”

“In addition to being contrary to the law of the land,” she stated, “it is also contrary to the Constitution of the United States.”

She ended her comments by telling Merck’s Vioxx attorneys, “And I am not going to allow you to use it.”

On June 2, 2006, the Associated Press reported that a federal judge had refused to dismiss a lawsuit filed against Pfizer and Wyeth, on behalf of the parents of an 11-year-old boy who committed suicide after taking the antidepressants Zoloft and Effexor.

The judge rejected the preemption argument stating: “Federal labeling laws are minimum standards; they do not necessarily shield manufacturers from state law liability.”

“Defendant’s pre-emption argument ultimately fails because Congress has not expressed a specific intent to pre-empt state consumer-protection laws in the area of prescription-drug labeling,” the court said.

“In the absence of Congress’s express statement,” the judge stated, “defendant must overcome the presumption against implying congressional pre-emptive intent. It has not done so.”

In what can only be viewed as a rare ruling, In Bextra and Celebrex, on August 16, 2006, the US District Court for the Northern District of California dismissed the state law failure-to-warn claims saying they conflict with the FDA’s determination of the proper warning and pose an obstacle to the full accomplishment of the objectives of the Food, Drug and Cosmetic Act.

The court attempted to justify the FDA’s “180-degree reversal of its prior position” on preemption, by noting that an agency’s view may change over time and especially with a change in administration.

But in New Jersey on September 29, 2006, a federal district court in McNellis v Pfizer Inc, refused to allow the preemption defense and based on the fact that the text of FDA regulations had remained unchanged for years, ruled that the regulations did not conflict with New Jersey’s failure-to-warn laws.

The court also said that FDA regulations allow increased warnings when new risks emerge and that the Food, Drug and Cosmetic Act does not contain a preemption clause.

Following the McNellis decision, on October 16, 2006, a federal court in Pennsylvania refused to grant the drug maker’s preemption motion in Perry v Novartis Pharma Corp, noting concerns about the effectiveness of the FDA’s monitoring of recently approved drugs, making the availability of state tort suits an “important backstop to the federal regulatory scheme.”

On October 5, 2006, the 2nd Circuit Court of Appeals was also critical of the FDA’s preemptive reach stating, “[W]hatever deference would be owed to an agency’s view … an agency cannot supply, on Congress’s behalf, the clear legislative statement of intent required to overcome the presumption against preemption,” in Desiano v Warner-Lambert et al.

Three weeks later, on October 28, 2006, the Associated Press reported another state court victory against preemption in a case where Wyeth was ordered to pay nearly $6.8 million to a Vermont women after the Vermont Supreme Court upheld a lower court’s ruling.

The court’s decision said federal labeling requirements “create a floor, not a ceiling” for state regulation, noting that the FDA regulations allow drug companies to go beyond required warnings.

“When further warnings become necessary, the manufacturer is at least partially responsible for taking additional action, and if it fails to do so, it cannot rely on the FDA’s continued approval of its labels as a shield against state tort liability,” the court wrote.

Peter Lurie, deputy director of the health research group at Public Citizen, told the Associated Press that the case appeared to mark a push-back against efforts by the industry, the administration and the FDA to preempt state regulation of prescription drugs.

“If you have a wide enough berth that you can strengthen the label,” he said, “you can’t use the FDA-approved label as an automatic protection against lawsuits.”

Since May 2006, all eyes in the legal field have been on the appeal in the case of Colacicco v Apotex, Inc, – F Supp 2d -, 2006 WL 1443357 (ED Pa), in the 3rd Circuit Court of Appeals, where the lower court ruled against a man whose wife committed suicide after taking Paxil.

Joseph Colacicco filed a lawsuit against both drug makers alleging that his wife committed suicide in October 2003, just 21 days after she began taking Paxil for mild depression with claims of wrongful death, negligence and a failure to warn her doctor of a link between Paxil and an increased risk of suicide.

In moving for dismissal, Paxil maker, GlaxoSmithKline, and Paxil generic maker, Apotex, relied on the FDA’s position that state failure-to-warn claims are preempted.

The judge ruled that the defendants were entitled to a dismissal of all claims because the FDA controls the content of warnings and requires generic drug makers to use the same labeling as approved for the drug’s original maker.

In this case, the judge on his own initiative, asked the FDA to submit an amicus brief. And in response, on the tax payer’s dime, the FDA wrote a brief asking the court to rule against the American citizen and dismiss the lawsuit against the drug companies.

In fact the FDA was the strongest supporter of preemption in this case because according to the attorneys handling the case, Glaxo itself barely addressed the preemption issue during oral arguments on the motion.

In a decision that experts predict may end up before the US Supreme Court, the judge ended up dismissing the claims without ever considering whether the FDA regulations pose a conflict to the plaintiff’s state tort claims.

Attorneys Derek Braslow, Harris Pogust and Matthew Leckman from the Conshohocken, Pennsylvania firm of Pogust & Braslow are representing the plaintiff in the case.

Attorney, Harris Pogust, says the judge’s ruling “could potentially do away with all failure-to-warn pharmaceutical cases”

The FDA action he notes, “does not seem to be a public health concern as much as a political concern.”

According to Mr Braslow, “the Judge readily admits that he did not analyze whether there is or was a conflict between state law and federal law and surmises that he probably would not find a conflict if he actually did the analysis.”

“But, the Judge explained,” he said, “that it doesn’t matter – if the FDA says there is preemption, then there must be preemption. Far be it for a Judge to interpret the law.”

“The Bush-era FDA,” Mr Braslow notes, “in a complete reversal of the position it took in its 2000 rule proposal, has now officially cemented its role as a pawn for the pharmaceutical industry.”

“It was not that long ago,” Mr Braslow points out, “that the FDA came forward with amicus briefs on behalf of the consumer in prescription drug litigation.”

“Now,” Mr Braslow says, “an argument first put forward in a couple Zoloft suicide cases, has become the primary argument in every prescription drug case, and could,” he warns, “potentially, mean the end for anyone seeking recourse from injuries resulting from prescription drugs, no matter how fraudulent the drug company’s conduct.”

“Make no mistake,” he states, “the position taken by the Bush-era FDA is an attempt by the current administration to achieve tort reform for the benefit of big pharma and at the expense of the injured consumer, without the consent of Congress.”

“The Bush-era FDA takes this position,” he warns, “unconcerned by the reality that preemption would allow drug companies to peddle their drugs with impunity and avoid being justifiably called into court for deceiving the public about the safety and effectiveness of those drugs.”

“Notwithstanding the FDA’s position on preemption,” Mr Braslow says, “courts examining this issue, if they take any time to actually look at the FDA regulations in question, would realize that there is no conflict between federal drug regulations and state tort claims.”

“Federal drug regulations specifically mandate drug companies to strengthen their drug’s label,” he explains, “as soon as there is reasonable evidence of an association of a serious hazard with their drug.”

“A state tort claim,” Mr Braslow points out, “does not force a drug company to take any action that is not already permitted by federal regulations.”

“Because federal regulations for prescription drugs are minimum standards,” he notes, “federal regulations can never conflict with a state common law claim.”

“The District Court erred,” he states, “in abdicating to FDA legal opinion, as opposed to interpreting the law.”

“What the Colacicco court did,” he says, “was improperly abdicate to the FDA’s legal opinion.”

Critics say it’s time for the FDA to get back to protecting consumers from dangerous products, rather than protecting the profits of the pharmaceutical industry.

According to career scientist, Dr David Graham, in a 2005 interview with Jeanne Lenzer in the journal Public Library of Science, “The pharma-FDA complex has to be dismantled and the American people have to insist on that, otherwise we’re going to have disasters like Vioxx that happen in the future.”

Filed under: 2006, Baum, Braslow, Colacicco, FDA, Preemption, Supreme Court, Troy

Big Pharma Braces For Democrat Hurricane

Evelyn Pringle November 2006

The morning after the mid-term elections, shares of drug company stock fell as Americans handed control of Congress back to the Democrats. Shares of Eli Lilly were down 1% in early trading, shares of Pfizer as much as 3%, and Schering-Plough dropped 3.7%.

Over all, since the election, major drug stocks have dropped more than 5%, according to Forbes.com on November 16, 2006. In fact, knowledge of the sure to come pressure from a Democratic Congress, caused stocks to fall across the board not only for drug companies, but for health insurers and pharmacy benefit managers as well.

Health insurers were hit the hardest. For instance, with Humana Inc, shares dropped nearly 6%, and shares of UnitedHealth Group were down 3.2%. Democrats say these firms have reaped great profits from the new Medicare prescription drug program that should have been passed on to seniors in the form of cheaper drug prices.

But the pharmaceutical industry itself remains at the top of the Democratic hit list. Democrats are pushing for stricter safety regulations at the FDA and plan to investigate drug pricing, direct-to-consumer advertising, and the marketing of drugs for off-label uses not approved by the FDA.

Democrats now have the power to hold hearings on the profits that drug makers, health insurers and pharmacy benefit managers have made since the prescription drug bill went into effect earlier this year.

And last but not least, Democrats reportedly will work to eliminate some of the liability protections the Republicans granted vaccine makers.

First up on the agenda is the promise to pass legislation to allow consumers to import cheaper drugs from Canada and have the government to negotiate for lower prices with drug companies on behalf of Medicare beneficiaries.

According to the November 24, 2006 New York Times, Big Pharma executives have been busy planning their battle strategy. “It’s all hands on deck,” Ken Johnson, a senior vice president at Pharmaceutical Research and Manufacturers of America, the industry’s trade group, told the Times.

“It’s like a hurricane warning flag,” he told the Times. “You don’t know where it will hit. You don’t know who will be affected. But everybody has to be prepared,” he said.

However, skeptics who question the ability of Democrats to make radical changes are quick to point out that Bush will still have the authority to veto any new legislation and his political appointees who run the FDA and Centers for Medicare & Medicaid, can drag their heels when it comes time to implementing provisions that will have a negative effect Big Pharma.

Moreover, as long as the Bush administration is in power, the FDA will no doubt continue to be the industry’s strongest ally and there remains that nagging little matter involving the FDA’s recently enacted “preemption rule” that seeks to ban private citizen lawsuits against drug makers in state courts once a drug and its label have been approved by the FDA.

The FDA apparently elected itself to be the sole authority for decisions regarding scientific and public health issues related to prescription drugs, including whether a drug’s label contains an adequate description of indications, risks and benefits. In presenting this multi-billion dollar prize 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.”

The statement was made by FDA deputy commissioner, Scott Gottlieb, who recently managed a coup of his own by successfully gaining FDA approval to bring silicone gel breast implants back on the market, much to the joy of one of his former employers. Presumably, women who are injured by the implants will be barred from suing Mr Gottlieb’s former employer as well in state courts.

Legal experts say the preemption rule was used to bring tort reform through the back door of the White House when the administration could not get it through the front. According to attorney, Ted Parr, of the Washington law firm of Ury & Moskow, “The FDA’s position was a direct result of this administration’s tort reform effort – after the administration failed to obtain tort reform in Congress, they decided to seek reform through administrative fiat.”

Why would the administration engage in such a blatantly unlawful power grab? According to FDA career scientist, Dr David Grahma, “Because Big Pharma co-conspirators have realized that lawsuits threaten to bankrupt the drug companies.”

“The products of these companies,” he said during a June 29, 2006 interview for News Target, “are so universally harmful, and their ability to hide this truth is slipping away so rapidly, that the financial burden of settling lawsuits (or defending them in court) threatens to crush the entire pharmaceutical empire.”

Dr Graham says the arrogance and greed in the industry will ultimately be its downfall. “They have pushed too hard, too far,” he states, “and they have landed themselves in a realm of such obvious scientific fraud and criminal negligence that the backlash is inevitable.”

The preemption claim comes at a time when experts are saying today’s FDA is both unwilling and incapable of protecting consumers against Big Pharma. And the strongest criticism comes from within. On October 9, 2006, Dr Curt Furberg, of Wake Forest University Baptist Medical Center, was one of five current and former members of the FDA’s Drug Safety and Risk Management Advisory Committer, who called for Congress to change how the FDA polices Big Pharma in the Archives of Internal Medicine journal.

Because of the FDA’s poor performance in regulating the industry, Dr Furberg said, “new drugs are introduced on the market with inadequate safety documentation.”

“Serious adverse drug reactions are later reported from the marketplace, and a large number of patients are unnecessarily injured before the drugs are withdrawn or better managed,” he said.

The FDA’s new preemption position breaks a long-standing presumption by the agency against preempting state tort claims and critics say the guy most deserving of the credit for the fiasco, is the FDA’s former Chief Counsel, Daniel Troy, appointed to his position at the FDA straight from Pfizer’s greenest pasture.

For a couple years, Mr Troy served as Big Pharma’s right-hand man until he quit the FDA in the fall of 2004, to return to the much more lucrative field of working directly for drug companies, but not before he stirred up plenty of grief for private citizens.

In the midst of the Vioxx and SSRI disasters, instead of prosecuting the drug makers for knowingly injuring consumers with dangerous product, Mr Troy devoted the majority of his time on the clock to filing 5 briefs on behalf of drug companies and against the private citizens who were paying his salary.

He even went so far as to give lectures on preemption during which he would invite Big Pharma attorneys involved in litigation against private citizens to submit their cases for his consideration and approval for future filing of amicus briefs by the FDA.

On March 1, 2004, an attorney in a case against Pfizer by the name of Jessica Rae Dart, filed an affidavit in support of a motion to describe a lecture given by Mr Troy in New York City that she attended. Ms Dart explained in great detail how he offered the FDA’s services to attorneys who were representing the giant drug companies.

On December 15, 2003, Ms Dart said in the affidavit, Daniel Troy headed a discussion for pharmaceutical firms and defense attorneys titled, “The Case for Preemption,” at the 8th Annual Conference for the In House Counsel and Trial Attorneys, Drug and Medical Device Litigation.

During Mr Troy’s portion of, “The Case for Preemption” discussion, she said, he stated that he was the initiator behind all the FDA Amicus Briefs and/or Statement of Interest filed on behalf of manufacturers “since the new administration” took over.

More specifically, he told the group, “I am not the only one who decides,” but “I am the initial proposer.”

Mr Troy made it clear, Ms Dart noted in the affidavit, that he wanted to file more briefs on behalf of Big Pharma and told attorneys in the audience how to submit successful requests for briefs, stating “we can’t afford to get involved in every case,” we have to “pick our shots,” so “make it sound like a Hollywood pitch.”

In 2004, Congressman, Maurice Hinchey (D-NY), sharply criticized the Bush administration for “seeking to protect drug companies instead of the public,” and persuaded Congress to eliminate $500,000 from the budget of the Chief Counsel’s office as a penalty for the FDA’s aggressive opposition to lawsuits filed by private citizens.

In his amicus briefs, Mr Troy focused his main attention on protecting the profits of the makers of SSRIs starting off with Pfizer. These drugs are second only to Vioxx when it comes to a drug company’s concealment of studies and information that if revealed, could have prevented tens of thousands of deaths and injuries over the years.

Although there have not been many successes when drug makers try to convince a court to dismiss a lawsuit based on the preemption rule, In re Bextra and Celebrex Marketing Sales Practices and Product Liability Litigation, No M: 05-1699 CRB, 2006 WL 2374742 (ND CA, August 16, 2006), another case against Pfizer, the court threw out the state failure-to-warn claims, saying the FDA specifically considered the safety risks 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.”

However, the court did not preempt the false advertising claims. The plaintiffs argued that Celebrex ads were false and misleading because they exceeded the labeled and approved gastrointestinal benefits and minimized the established risks.

Pfizer argued that because it submitted its ads for FDA approval, and the FDA did not object to them, the FDA had determined that the ads were both accurate and struck a fair balance between the risks and the benefits of the drug.

The court refused to preempt the false advertising claims without a record showing that the FDA had reviewed each ad and approved it. The court also noted the FDA’s silence about whether its regulations preempt false advertising claims, in contrast to its stated position on failure-to-warn claims.

However, according to Attorney Parr, state court judges overseeing other Bextra and Celebrex cases are likely to reach conclusions regarding preemption that are inconsistent, both with the federal court and with each other to some extent. “We really do not know yet how extensive the preemption problem will be nationwide,” he says.

In May 2006, a federal court in Pennsylvania also applied the FDA’s preemption rule to the 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 (ED Pa May 26, 2006).

In this case, the FDA went to bat for the drug makers and filed a brief with the court stating in part, 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.”

On the other hand, the plaintiff has now drawn amicus support from a dozen scientists and doctors who evaluate pharmaceutical products and contend that preemption “would threaten the public health and eliminate an important counterpart to the public health objectives of the FDA.”

The cases are currently making their way through the appellate process and experts predict that applications for review will proceed all the way up the US Supreme Court.

However, while the appeals process drags on for years, legal analysts say to look for more lawsuits with claims of consumer fraud, false advertising, and injuries from defective products which are not specifically implicated by the new preemption rule.

Filed under: 2006, Colacicco, FDA, Gottlieb, Graham, Preemption, Troy

FDA Runs Protection Racket For Big Pharma

January 7, 2007 Evelyn Pringle

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.”

(This article is written as part of a series on pharmaceutical litigation and is sponsored by Robert Kwok & Associated, LLP)

Filed under: 2007, Bextra, Birth Defects, Bush, Celexa, Colacicco, Elidel, FDA, Glaxo, Kwok, McNellis, Novartis, Paxil, Perry, Preemption, SSRIs, Troy, Vioxx

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