Zantac Lawsuit

Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Wednesday, July 12, 2006

Lawsuits - Only Weapon Available Against Giant Big Pharma Pushers

Over the past several years, new studies have shown the new generation of psychiatric drugs to be not only extremely dangerous but also ineffective, and the majority of these medications in fact now carry black box warnings about a number of life-threatening side effects associated with their use. The drugs include selective serotonin reuptake inhibitors antidepressants (SSRIs), like Paxil, Prozac, Zoloft, and Effexor, and the atypical antipsychotics, that include Zyprexa, Risperdal, Geodon, Seroquel, Clozaril, and Abilify.

Hidden studies dating back to before many of the drugs were even FDA approved have also surfaced, many as a result of litigation, that demonstrate that Big Pharma knew all about the problems with the drugs, but concealed the adverse event reports, and only allowed the findings from positive clinical trials to become public. GlaxoSmithKline has now lost several lawsuits because it knowingly concealed years of negative information about the serious adverse reactions to Paxil.

In one lawsuit it was shown that GSK deliberately misled both physicians and patients to believe that Paxil was not addictive and had no withdrawal reactions with a question and answer pamphlet distributed to doctors' offices to be disseminated to patients, in which GSK asks the question: "Is Paxil addictive?"And, in response, the pamphlet states: "Paxil has been studied both in short-and-long-term use and is not associated with dependence or addiction."

By the time the lawsuit was filed on August 21, 2001, the plaintiffs' attorneys had been individually contacted by approximately 500 Paxil withdrawal victims. As a result of GSK's fraudulent marketing of Paxil as non-addictive, the Las Angeles based Baum Hedlund law firm won a major settlement in this class action filed on behalf of patients who got hooked on the drug, and in many instances, found they were unable to stop taking it.

The documents that surfaced during litigation showed that since before Paxil was approved, GSK had known about the withdrawal affects from it own clinical trials and from many others conducted by prominent scientists, in addition to receiving thousands of complaints by individuals who used Paxil. According to the lawsuit's complaint, "GSK's motive of deliberately failing to advise physicians and the public of the adverse effects that can lead to withdrawal problems (and that it knew a percentage of users of the drug inevitably would experience) was for financial gain and its fear that, if properly labeled the drug,

Paxil would lose its share of the SSRI market."The complaint alleges that GSK over-promoted Paxil in order to increase sales at the expense of revealing the truth about the addictive and dependency nature of Paxil and fraudulently conveyed to all health care providers in the US that Paxil's side effects were only "mild," when in fact GSK knew the drug's withdrawal effects were severe. It also claims that GSK fraudulently conveyed to health care providers in the US that a British study involving 13,741 patients found that all SSRI's exhibited a similar rate of withdrawal reactions, when in fact GSK knew that the study found Paxil to have the highest rate of withdrawal reactions of any SSRIs.

Over the last several years, evidence has surfaced that also proves that GSK concealed negative information and studies that demonstrated that Paxil drastically increases the risk of suicide and self-harm, especially with children.

A report by psychiatrist, Dr Peter Breggin, a court certified expert and author of numerous books on psychiatric drugs, written years earlier when he served as an expert witness in a Paxil lawsuit, reveals how GSK not only concealed negative studies, but also manipulated data about Paxil-induced suicidality so that actual suicide attempts in clinical trials were underreported, while attempts by subjects taking a placebo were inflated.

The report also notes how GSK hid the events related to akathisia (agitation with hyperactivity) and stimulation, which Dr Breggin says, are known risk factors for suicidality and violence.

Excerpts from the report were recently published by Dr Breggin, in the Spring 2006 issue of Ethical Human Psychology and Psychiatry, Vol 8.His original report was attached to a July 21, 2001, affidavit submitted in the California case of Lacuzong v GSK, filed by the widow of a man who drowned the couple's 2 children, before drowning himself in a bathtub, after taking Paxil for only three days.After the Lacuzong case was resolved, at GSK's insistence, the report was sealed under a protective order.

However, in the more recent case against the company, Moffett v Glaxo SmithKline, in Mississippi the protective order was lifted and the report was entered in the public record. Dr Breggin has also made it available on his web site at"The publication of a previously sealed report is rare," he says, "the first in my experience."

According to Dr Breggin, drug companies settle almost all lawsuits out of court in order to seal incriminating scientific data. "This deprives the FDA, medical profession and public of critical information on drug safety and efficacy," he says. He wants the laws changed so that they require drug makers to publish all of the safety and efficacy information they generate regarding their products. In March, 2006, Baum Hedlund's leading SSRI attorney, Karen Barth Menzies, filed another class action lawsuit against GSK, in federal court in the company's hometown of Philadelphia, this time on behalf of patients under the age of 18, who attempted suicide while on Paxil, and on behalf of the family members of children who committed suicide while taking the drug. Its important to note that Paxil has never been approved by the FDA for any use with children, and so therefore, every prescription written for the children involved in this lawsuit was for off-label use.

One suicide in the case involves 11-year-old Trevor Blain who was prescribed Paxil for "separation anxiety disorder" by his pediatrician in October 2000, and immediately began having trouble sleeping and exhibited angry outbursts. His family knew nothing about the connection between Paxil and these adverse events and so Trevor continued to take the drug. In early November 2000, Trevor hanged himself with his dog's leash in the family laundry room and although he initially survived the suicide attempt, he remained in a coma for several weeks before he died on December 7, 2000.

Another plaintiff in the case, is 17-year-old Tonya Brooks whose family doctor diagnosed her with "social anxiety disorder" and prescribed Paxil in 2004. While taking the drug, Tonya became agitated, aggressive and had difficulty sleeping. She first attempted suicide by taking an overdose of Paxil and sleeping pills. After surviving the first attempt, 2 days later Tonya gouged a hole in her leg with a pair of scissors and was hospitalized for several days. Recounting the horror when she found her daughter sprawled on the bathroom floor after her second suicide attempt, with blood everywhere, Tonya's mother, Cheryl Brooks, says, "no parent should have to go through what we did."

According to Attorney Menzies, this is another case where GSK concealed information to protect profits. "Through our Paxil litigation," Ms Menzies states, "we've obtained documents that show a seriously troubling mentality of profit over safety and a callous disregard for the welfare of children.""That's about as reprehensible as you can get," she adds. "Governmental regulators around the world have now analyzed the actual data from the clinical trials, not GSK's version of it," she notes, "and have found an increased risk of suicidality.""We wanted to make sure the rights of all of these kids," she says, "are protected by filing this lawsuit."

Pfizer's SSRI, Zoloft is no better than Paxil. There were also clear indications of probable suicidality risk in clinical trials on this drug long before it was approved. For instance, in a "healthy volunteer" Zoloft study conducted by Ian Hindmarch in 1983 in which 12 volunteers were randomized to either a placebo or Zoloft, every volunteer but one, who took Zoloft dropped out within days, due to severe agitation, after making comments such as "I was running like a machine inside" and "I have never felt as bad as this in my life"

In 2003, the Journal of the American Medical Association published the results of 2 trials on children treated with Lustral (Zoloft) in which 17 children who were given the drug were pulled out of the trial because of side effects, compared with five children who received a placebo, and only 10% more children improved on Zoloft than on a placebo. And yet the authors of the study wrote: "the results of this pooled analysis demonstrate that sertraline (Lustral) is an effective and well-tolerated short-term treatment for children and adolescents with major depressive disorder."

This drug has also been linked to severe violent behavior in children. On January 26, 2006, a psychologist on Court TV announced that 14-year-old, Cody Posey, was on Zoloft when he killed his parents and sister. He started taking the drug on April 20, 2004, and committed the murders on July 5, 2004. Cody's father was the range manager for well-known TV reporter Sam Donaldson. As for the granddaddy of SSRIs, Eli Lilly's Prozac, the first to be approved back in 1987, within one decade of the drug's arrival on the market, there were 39,000 adverse event reports submitted to the FDA's Medwatch, according to award-winning investigative reporter, Robert Whitaker. And that number is said to represent only about 1% of the actual number of adverse events, he reminds people. "So, if we get 39,000 adverse event reports about Prozac,"

Mr Whitaker said in an interview for Street Spirit in August 2005, "the number of people who have actually suffered such problems is estimated to be 100 times as many, or roughly four million people.""There were more adverse event reports received about Prozac in its first two years on the market," he told Street Spirit, "than had been reported on the leading tricyclic antidepressant in 20 years.""This makes Prozac the most complained about drug in America, by far," he said.

Linda Hurcombe, an American citizen who resides in the UK, lost her 19-year-old daughter, Caitlin, to suicide as a result of Prozac. She describes how 8 years ago, her "undepressed daughter saw an ad for antidepressants on television while visiting the US.""Caitlin decided she wanted this pill," Ms Hurcombe explains, "because she was nervous about final exams and had heard at the university too that Prozac made you lose weight and feel great."Caitlin got a prescription from the doctor, she said, with no problem."After 63 days on this medication," Ms Hurcombe says, "during which time her behavior descended into chaos, Caitlin hanged herself from a beam in the guest bedroom of our home."

Ms Hurcombe has written a book titled, "Losing a Child," and says, most shockingly, during the research for the book, "I have found that Caitlin was just one of thousands whose lives have been snuffed out in a similar manner."

On February 2, 2004, investigative reporter, Kelly O'Meara, wrote an article that reported on the first clinical trial of its kind, by Dr David Healy, director of the North Wales Department of Psychological Medicine at the University of Wales, in which Prozac was given to a volunteer group of mentally healthy adults.The study determined, apparently just as in the case of Ms Hurcombe's "undepressed" daughter, that even mentally healthy adults were adversely affected by the drug.

According to Ms O'Meara, between one in 20, and one in 10, people in the study on Prozac experienced akathisia, "whereby they become mentally restless or manic and lose all inhibitions about their actions.""People don't care about the consequences as you'd normally expect," Dr Healy explains, "they're not bothered about contemplating something they would usually be scared of."He said the study showed that: "We can make healthy volunteers belligerent, fearful, suicidal, and even pose a risk to others."

Kelly O'Meara's coverage of the adverse effects of psychiatric drugs is virtually unmatched by any other journalist in the US. During her 6-year stint with the Washington Times' Insight magazine, she wrote more than two dozen investigative articles about the link between SSRIs and the bizarre, violent acts committed by patients taking the drugs, which include the majority of children involved in school shootings in the US. Her new book, "Psyched Out: How Psychiatry Sells Mental Illness and Pushes Pills That Kill," is about informed consent. "The people need and deserve the whole truth about their psychiatric diagnosis," Ms O'Meara advises, "and the mind-altering drugs that are prescribed as treatment." Experts say the book is a must read for patients considering whether to take psychiatric drugs. The "chemical imbalance in the brain" theory that drug maker's tell patients they have when marketing the drugs, is debunked in the book by some of the nation's leading experts, and according to Ms O'Meara, the drug companies themselves have been forced to admit that they do not understand how the drugs work in the human brain during the treatment of an alleged mental illness. "In fact," she says, "a test that measures a person's brain chemicals does not exist.""Never in the history of the world has science discovered what the correct brain chemical levels are for any living person," Ms O'Meara explains, "making it impossible to know if these naturally occurring chemicals are out of balance.""If confirmable proof of a chemical imbalance were required prior to filling a prescription for any antidepressants," she says, "not a single prescription would be written because to date the only known method of determining chemical levels in the brain is during autopsy."

Over the last decade the drug companies have conned doctors into writing millions of prescriptions to children for these SSRIs, under the guise of protecting them from suicide, and yet the suicide rates for kids during this time period have remained statistically unchanged, with boys varying by at most one suicide up or down, and the rate for girls not moving an inch, according to a review of statistics put out by the Department of Health and Human Services.

Even though the atypical antipsychotics are not FDA approved for any use with children, and their package inserts specifically state that their safety and effectiveness with children have not been established, Big Pharma has doctors prescribing them off-label to children of all ages for a long list of so-called mental disorders.

According to a study in the March-April 2006, Ambulatory Pediatrics journal, between 1995 and 2002, the rate of children receiving antipsychotics increased five-fold, to an estimated 2.5 million, or an increase from 8.6 prescriptions for every 1,000 children in the mid-1990s, to nearly 40 in every 1,000 in 2002.

A recent review by USA Today of the FDA's adverse reporting system from 2000 to 2004, found at least 45 deaths in children under 18 listing atypicals as the "primary suspect."

There were also an additional 1,328 reports of other side effects, including many that were life-threatening. Other life-long physical adverse effects of these drugs are beginning to emerge in children.

The Children's Hospital of Philadelphia recently found that 19% of newly diagnosed Type 2 diabetic children were being treated with atypical drugs, according to Robert F Kennedy Jr vs the Medical Elite, by Mark Sircus Ac, OMD, on June 22, 2005. "The most studied adverse effect of the newer generation of antipsychotics," he notes, "is their association with hyperglycemia, in some cases leading to ketoacidosis, coma, or death.""Many of these drugs carry black box warning to alert MD's about the dangers of diabetes," according to Mr Sircus. Psychiatrist, Dr Stefan Kruszewski, also says the atypicals substantially increase the risk of other serious physical illnesses such as heart attack, hypertension, and stroke.

For the past 30 years, Dr Breggin, has served as a medical expert in lawsuits involving psychiatric drugs and has testified in cases involving tardive dyskinesia. All antipsychotics also now carry a warning about the extremely serious condition of tardive dyskinesia. According to Dr Breggin, the condition is a drug-induced movement disorder that is usually irreversible and there are no adequate treatments for the disorder."Tardive dyskinesia often looks so "strange" or "bizarre," Dr Breggin says, "that it is mistaken for a mental illness rather than a neurological disorder." The abnormal movements, he says, can afflict any muscle group of the body and can impair the ability to walk, speak, breathe and swallow."It is highly variable in expression and severity," according to Dr Breggin. One variety involves painful spasms of muscles, he says, that can literally torture the victim, and another involves an agonizing inner agitation that drives people to move their arms or legs, or to pace. "Some cases," he advises, "are painful, disfiguring, exhausting and ultimately disabling."

Dr Breggin has served as an expert in a half dozen tardive dyskinesia cases that resulted in verdicts for the plaintiffs including several cases in which Risperdal caused tardive dyskinesia in children, where the drug was prescribed to control behaviors that were in fact, he says, caused by stimulant ADHD drugs that the child was already taking. According to Dr Breggin, tardive dyskinesia occurs at a cumulative rate of 4-7% per year in otherwise healthy patients treated with antipsychotics and after only a few years, 20% or more of patients will be afflicted. In older patients, he says, the rate is even higher.

Overall, according to estimates by a 20-year career FDA scientist and researcher, Dr David Graham, the use of atypicals antipsychotics increases the annual death rate in the US by more than 12,000 people a year.They are approved for a very limited number of psychiatric disorders but once again, drug makers have found way to get doctors to prescribe them off-label for a multitude of unapproved illnesses for age groups that they were never intended.

The off-label prescribing of these drugs is so out of control that according to a July 7, 2006 report by Decision Resources, Inc, a leading research and advisory firm on pharmaceutical and healthcare issues, antipsychotics represented the fourth-highest-ranking class of drugs in worldwide sales in 2005, and two of the top ten drugs in sales are atypicals.

But the icing on the cake as to the absurdity of their widespread use, come from a government study published in the September 22, 2005, New England Journal of Medicine, that determined that the new atypicals are only barely more effective than no drugs at all.

Another increasingly popular class of dangerous drugs being over-prescribed to children of all ages are the ADHD medications, commonly known as "speed" to addicts.

Information released by the FDA in February 2006, showed that between 1999 and 2003, seventy-eight million prescriptions were written for ADHD drugs for children ranging in age from one to 18.

On March 14, 2006, the FDA posted a review on its web site of reported adverse events between January 2000, and June 30, 2005, that found nearly 1,000 reports of psychosis or mania possibly linked to ADHD drugs. Psychosis is defined as a mental disorder characterized by the inability to distinguish real and imaginary events. "The most important finding of this review is that signs of psychosis or mania, particularly hallucinations, can occur in patients with no identifiable risk factors, at usual doses of any of the drugs used to treat ADHD," according to a March 3, 2006, memo from 2 members of the agency's ADHD psychiatric review team.

The FDA also disclosed reports of 25 deaths in children and adults between 1999 and 2003, and 54 cases of serious cardiovascular problems, including heart attack, stroke, hypertension, palpitations and arrhythmia.

Yet experts say that the FDA is stalling at best, and refusing at worst, to add appropriate warnings to the labels of ADHD drugs to alert all the parents of the ever growing number of children being placed on these drugs, about their numerous life-threatening adverse effects, that experts predict, would no doubt result in a decrease in use.

Psychiatrist, Dr Grace Jackson, author of, "Rethinking Psychiatric Drugs: A Guide for Informed Consent," says that "whether by ignorance or design, the regulators remain oblivious to the evidence-based limitations of the prescription pad: at least 40% of all children fail to tolerate or respond to stimulant therapy; about twice as many respond at least as well to non-pharmacological interventions.""The long term outcomes for medicated children," she notes, "demonstrate diminishing returns over time, persistent suppression of growth (about 1 cm per year), and artificial behavioral improvements which dissipate when treatment is withdrawn.""The connection between stimulants, cardiovascular disability, and death," Dr Jackson says, "has long been documented in the medical literature, but physicians and government regulators have refused to acknowledge the hazards associated with prescriptions."

Dr Breggin, warns that all stimulant drugs can cause "a continuum of stimulation, including agitation and irritability, anger, hostility, disinhibition, hypomania and mania."The stimulant or activation syndrome, he advises, was observed decades ago with stimulant drugs such as amphetamines, Adderall, and Dexedrine, and methylphenidates such as Ritalin and Concerta.

In addition, Dr Breggin brings up an all too common situation with children who are recruited by the mental health industry. "As the child's emotional control breaks down due to medication effects, mood stabilizers may be added," he explains. "Eventually, these children end up on four or five psychiatric drugs at once and a diagnosis of bipolar disorder by the age of eight or ten," he warns. According to pediatric neurologist, Dr Fred Baughman, another well-known expert and author of the new book, "ADHD Fraud, How Psychiatry Makes Patients Out of Normal Children," in addition to the deaths listed by the FDA between 1999-2003, in persons using ADHD drugs, the MedWatch database also contains 186 more deaths between 1990 and 2000.

According to Dr Baughman, drugging kids has become rampant. "Its happening all across country," he says, "not by thousands but tens of thousands, picking most on the disenfranchized, powerless." "These children become for-profit receptacles for psychiatric drugs," he warns, "which will undoubtedly alter their bodies and brains." Dr Baughman's alarming prediction is apparently becoming a reality.

According to a study by Medco Health Solutions, a managed-care firm, there was an 85% increase in the use of sleeping pills among children between 2002 and 2004 and about 15% of the children who took sleeping pills were also taking ADHD drugs. Since stimulant drugs cause insomnia, experts say, the sleeping pills are obviously being used to counteract their side effects. Due to the fact that only between 1% and 10% of all adverse drug reactions are ever reported to the FDA, experts point out that the actual combined number of deaths and serious injuries associated with psychiatric drugs each year is much, much higher than FDA statistics indicate.

More information for injured parties can be found at Lawyers and

Evelyn Pringle

Sunday, July 09, 2006

Litigation Inoculation

Litigation Inoculation
By Thomas Ginsberg
Inquirer Staff Writer

Joseph Colacicco's wife, Lois, slashed herself to death with razor blades in 2003 while taking the antidepressant Paxil, painting her final thoughts in blood in their bathroom: "Thanks."
"She felt it was over, finally," Colacicco said of his wife's mental torment. "She had no inkling it was because of Paxil. The pharmaceutical companies fooled the public, fooled me, fooled my wife."

Colacicco's accusation stands out not just because it is tragic. His lawsuit has become a front-line case in the Bush administration's efforts to rein in claims against pharmaceutical companies, with tens of millions of dollars at stake on both sides.

Colacicco's claim that GlaxoSmithKline P.L.C. and Apotex Inc., maker of generic Paxil, failed to warn patients in 2003 about Paxil's suicide risks was dismissed last month in U.S. District Court in Philadelphia, where GlaxoSmithKline has a U.S. headquarters.

The dismissal was based partly on the newly articulated argument that the U.S. Food and Drug Administration alone is accountable for what is, and is not, written on prescription-drug warning labels, preempting any judge or jury. Under that principle, an FDA-approved warning label is the last word on safety, and courts shouldn't second-guess it.

Lawyers on both sides say such FDA preemption on prescription-drug warnings, if upheld, could block many "failure to warn" claims against drug companies. Such claims constitute many, although not all, of the infractions alleged in tens of thousands of pharmaceutical liability lawsuits each year.

Since 2000, the FDA had asserted the principle only in legal briefs in isolated lawsuits, not as an agency policy.

Now the principle is codified in the preamble of the FDA's new drug-labeling code, which was published in January and took effect June 30. Brandishing the preamble in recent months, drug companies have papered courtrooms nationwide with motions to dismiss failure-to-warn claims.
Most of the motions have failed. On June 6, New Jersey Superior Court Judge Carol E. Higbee denied Merck & Co. Inc.'s motion seeking dismissal of a Vioxx case, calling the FDA preamble "a political statement." On May 31, U.S. District Judge Joseph Bataillon, in Nebraska, rejected Pfizer Inc.'s motion in a case involving its antidepressant Zoloft, saying that the FDA had contradicted its own past positions and that Congress had never given the agency preemption power over courts in prescription-drug cases.

But on May 25 in Philadelphia, U.S. District Judge Michael M. Baylson threw out Colacicco's claim. In a broad ruling, Baylson said courts should defer to the agency's scientific expertise and regulatory authority. It is this deference that other judges have rejected.

"It is not the function of this court, or for a jury empaneled to decide this case, to substitute its judgment for the FDA's about medical issues," Baylson wrote.

He added: "Ultimately, this court believes it is far more desirable that the important issues presented by this case, indeed tragic in its facts, are better addressed by elected officials, legislative and executive, than by appointed judges."

Colacicco, of Long Beach, N.Y., appealed to the U.S. Court of Appeals for the Third Circuit in Philadelphia, taking the lead in a jurisdictional dispute that attorneys predict will not end until it hits the U.S. Supreme Court.

GlaxoSmithKline, which denies that Paxil led Lois Colacicco to kill herself, "believes the agency is in the best position to know what should or should not be in a label," said Andrew Bayman, a GlaxoSmithKline defense attorney from the Atlanta firm King & Spalding.

But Colacicco's attorneys, Derek Braslow and Harris Pogust of Conshohocken, said the FDA lacked the resources, punitive powers, and political support to protect every patient or prosecute drug companies that obscured data. Pogust noted that the FDA changed the label last year and ordered suicide warnings on Paxil, Zoloft and similar antidepressants.
"We really don't blame the FDA" for safety problems, Pogust said. "But what they're doing now with preemption is outrageous. They have no business in civil litigation."

If Colacicco's case doesn't get to the Supreme Court, others are right behind, lawyers noted. Pfizer has filed preemption motions in at least a dozen pending cases involving Zoloft, it said.
In one federal case in Philadelphia, a North Wales couple, Tom and Kathy Woodward, say their 17-year-old daughter, Julie, hanged herself in the family's garage after seven days on Zoloft.

The Woodwards have accused Pfizer of suppressing suicide-risk information, and Tom Woodward scoffed at the idea that the FDA alone could protect the public, offering his own insights as a former marketing-promotions consultant for drug companies.

"I would hear them talk about doctors in a very negative way, about the FDA in a very negative light," said Woodward, owner of a small consulting firm, the Pathway Group. "The FDA is always going to be one, two, three steps behind the drug companies."

Pfizer rejected the claim that Zoloft caused Julie Woodward to take her life in 2003. It insisted the elevated risk of suicide among some patients had not been proved until later, when the FDA responded by changing the label.

"If Pfizer had included a warning of any such association at that time, the Zoloft label would have been false and misleading under federal law," said Malcolm E. Wheeler, Pfizer's Zoloft defense lawyer from the Denver firm Wheeler Trigg Kennedy L.L.P.

Wheeler and Bayman said the FDA preamble was significant because, for the first time, it comprehensively spelled out the FDA position on litigation over drug labels, including excessive warnings.

"Patients may be discouraged from using important, potentially lifesaving treatments if the lawsuit-generated warnings are more severe than the neutral medical and scientific experts at FDA consider warranted," Wheeler said.

Critics scoff at the drug companies' suggestion that, if not for the FDA, they voluntarily would put extra warnings on their products.

"It's a naked power grab for the industry, and I think the courts are seeing through it," said Leslie Brueckner, staff attorney at Trial Lawyers for Public Justice, a Washington-based group that helps plaintiffs suing drug companies.

The sides are divided on the potential impact of preemption, a policy initiated by former FDA chief counsel Daniel Troy, who stepped down in 2004 and returned to corporate defense work.
"This will end failure-to-warn claims," said Pogust, who represents Colacicco and the Woodwards.

One member of Congress, Rep. Maurice Hinchey (D., N.Y.), has introduced legislation to limit the FDA's ability to preempt state consumer-protection laws.

But Wheeler called the fears "a Chicken Little argument." He said preemption would be "helpful" but not significant in reducing lawsuits because it would not affect fraud, faulty-design or negligence claims.

Eric G. Lasker, a pharmaceutical defense lawyer at Spriggs & Hollingsworth in Washington, said preemption would "not do away" with litigation but might provide some relief.

"Prescription-drug litigation now is a huge financial issue, and it's driving a lot of what drug companies have to do," Lasker said.

Colacicco himself said he agreed there were too many "frivolous lawsuits." But the pro-Bush registered Republican and entrepreneur said preemption might go too far.

"I do believe we have to support our pharmaceutical companies. But they have to be true to us, as well," Colacicco said.

Legal Basis for Drug Firms' Motions

Pharmaceutical companies cite the Food and Drug Administration's statement on preemption in its new labeling rules as a basis for dismissing lawsuits that assert the firms failed to warn patients about drug risks.

Excerpts from FDA statement

"FDA believes that State laws conflict with and stand as an obstacle to achievement of the full objectives and purposes of Federal law when they purport to compel a firm to include in labeling or advertising a statement that FDA has considered and found scientifically unsubstantiated."
Court rulings "can erode and disrupt the careful and truthful representation of benefits and risks that prescribers need to make appropriate judgments about drug use."

Example of preemption

The FDA offers six examples of lawsuit claims that it says its rules should preempt. Here is one:
"Claims that a drug sponsor breached an obligation to warn by failing to include in labeling or in advertising a statement, the substance of which FDA has prohibited in labeling or advertising."

Other claims are allowed

"The Supreme Court has held that certain state law requirements that parallel FDA requirements may not be preempted."

SOURCE: U.S. Food and Drug Administration

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