Posted On: January 3, 2007 by Ronald V. Miller, Jr.
Paxil and Birth Defects
The FDA last month began advising health care providers and patients about the results of new studies for Paxil (paroxetine) suggesting that the drug increases the risk for birth defects, particularly heart defects, when women take it during the first three months of pregnancy. Paxil is approved for the treatment of depression, anxiety and several other psychiatric disorders. FDA is currently gathering additional data and waiting for the final results of the recent studies in order to better understand the higher risk for birth defects that has been seen with Paxil.
The FDA is advising health care professionals to discuss the potential risk of birth defects with patients taking Paxil who plan to become pregnant or are in their first three months of pregnancy. Health care professionals should consider discontinuing Paxil (and switching to another antidepressant if indicated) for these patients. In some patients, the benefits of continuing Paxil may be greater than the potential risk to the fetus. The FDA is advising health care professionals not to prescribe Paxil to women who are in the first trimester of pregnancy or are planning to become pregnant, unless other treatment options are not appropriate.
The FDA is advising patients, among other things:
(1) Paxil should usually not be taken during pregnancy, but for some women who have already been taking Paxil, the benefits of continuing may be greater than the potential risk to the fetus;
(2) Women taking Paxil who are pregnant or plan to become pregnant should talk to their physicians about the potential risks of taking the drug during pregnancy;
(3) Women taking Paxil should not stop taking it without first talking with their physician.
The FDA reports that early results of two studies showed that women who took Paxil during the first three months of pregnancy were about 1.5 times as likely to have a baby with a heart defect as women who received other antidepressants or women in the general population. Most of the heart defects reported in these studies were atrial and ventricular septal defects (holes in the walls of the chambers of the heart). In general, these types of defects range in severity from those that are minor and may resolve without treatment to those that cause serious symptoms and may need to be repaired surgically.
Evelyn Pringle: Poisoning In the Womb – SSRIs
Monday, 20 February 2006, 10:24 am
Opinion: Evelyn Pringle
Poisoning In the Womb – SSRIs
February 9, 2006. By Evelyn Pringle
New research has linked the use of SSRIs during pregnancy to a complication in newborns of a rare but life-threatening lung problem, according to this month’s New England Journal of Medicine. Infants born to women who took the drugs in the second half of their pregnancy, had 6 times the risk of developing the disorder, the researchers reported.
Only a couple of days ago on February 7, 2006, WebMD reported a new study from Israel, in which about one out of three newborns exposed to antidepressants in the womb showed signs of neonatal drug withdrawal, which included high-pitched crying, tremors, and disturbed sleep.
The Israel study involved 60 newborns whose mothers took SSRIs throughout their pregnancies and reported that 18, or 30%, of the newborns showed signs of drug withdrawal after birth, and in eight cases the symptoms were considered severe.
But then what’s new? A study conducted a year ago at a University in Spain determined that, “drugs known as selective reuptake inhibitors (SSRIs) can cause convulsions, irritability, abnormal crying and tremors.”
For this study, researchers accessed the World Health Organization’s database on adverse reactions and withdrawal symptoms in infants associated with the use of SSRIs from 72 countries, according to the February 15, 2005, Epoch Times
“Risks of neonatal convulsions and neonatal withdrawal syndrome seem to be increased with all SSRIs,” said Professor Emilio Sanz, the leader of the study, of the University of La Laguna in Tenerife.
In February 2004, another study reported that “first-trimester use of SSRIs has been associated with higher rates minor physical anomalies and miscarriages, thus suggesting possible early effects of SSRI exposure on embryonic development,” according to Maternal Selective Serotonin Reuptake Inhibitor, Philip Sanford Zeskind, PhD and Laura E Stephens, Pediatrics Vol 113 No 2 February 2004, pp. 368-375.
Big Pharma Hits On Pregnant Women
If Big Pharma cared one iota about the unborn fetus, at a bare minimum, it would call off its hired-guns traveling around the country peddling SSRI antidepressants to pregnant women by convincing doctors to prescribed the drugs and ignore the studies and FDA warnings that say SSRIs are associated with serious birth defects.
Less than a month ago, on October 16, 2006, the first lawsuit in the nation was filed against GlaxoSmithKline in which an infant charges that his life-threatening lung disorder was caused by exposure to the SSRI Paxil in the womb during his mother’s pregnancy.
Eric Jackson was born in Denver, Colorado on October 28, 2004, with persistent pulmonary hypertension of the newborn (PPHN), a condition in which the infant’s arteries to the lungs remain constricted after birth and limit the amount of blood flow to the lungs and oxygen in the bloodstream.
Immediately after birth Eric had to be placed on a ventilator and eventually had to be placed on an oscillating ventilator for a month.
In his 2 short years on earth, Eric has undergone two cardiac catherizations, and another procedure to combat gastral reflux caused from being on a ventilator for so long. Since birth, he has remained on oxygen and medications to help him breathe and he continues to suffer with eating and digestive problems.
With their lawsuit, Eric’s parents hope to recover the medical and other expenses incurred in treating, and attempting to cure Eric’s condition, as well as the related illnesses. Some of the related health problems may not even surface until Eric is a teenager.
A study in the October 3, 2006 Archives of Pediatrics and Adolescent Medicine by Dr Agnes Whitaker, MD, of Columbia University and the New York State Psychiatric Institute, and colleagues, reported that low birth weight infants who require mechanical ventilation, with no obvious disability early on, can have subtle and cognitive deficits discernable at age 16.
The study sample represented a cohort of babies who were born at or admitted to one of three hospitals in New Jersey between September 1, 1984 and June 30, 1987.
The research team said, two factors, male gender and days of ventilation were predictors of motor problems. For each additional week of mechanical ventilation, they said, total and oral motor problem scores were higher by 0.33 and 0.14 points, respectively.
Legal analysts predict that Glaxo will attempt to reach early settlements with the families of infants born with birth defects because the company in no way wants injured toddlers paraded in front of a jury.
Karen Barth Menzies is one of Eric’s attorneys. She is a partner at Baum Hedlund, a national pharmaceutical products liability law firm with offices in Los Angeles, Washington, DC and Philadelphia, where she heads the Pharmaceutical Antidepressant Litigation Department.
Ms Menzies has been waging legal battles against the SSRI makers on behalf of injured consumers for more than a decade and she currently represents many other families in Paxil birth defect cases
Jennifer Liakos is an associate attorney at Baum Hedlund in Los Angeles, and she is also a member of the firm’s Pharmaceutical Antidepressant Litigation Department, handling Paxil birth defect cases. She explains that between 10% to 20% of babies born with PPHN do not survive, even when they receive treatment.
Having been the leader in the Paxil litigation against Glaxo for years now, and through their intensive litigation and discovery, Baum Hedlund has evidence that reveals specifics relating to Paxil and birth defects. Eric’s attorneys do not have to newly learn the inter-workings of Glaxo because they know how the company operates regarding Paxil and how they analyze or fail to analyze data.
According to Ms Menzies, studies have shown that infants who are exposed to selective serotonin reuptake inhibitor antidepressants (SSRIs), after the 20th week of gestation are more likely to develop PPHN than infants who were not exposed to an SSRI during pregnancy.
In addition to Paxil, the other SSRIs sold in the US include Prozac by Eli Lilly; Zoloft, from Pfizer; Celexa and Lexapro, from Forest Laboratories; and Luvox, from Solvay. Wyeth markets Effexor, a serotonin-norepinephrine inhibitor.
Adding to the problem of curtailing the prescribing of SSRIs to pregnant women, is the fact that SSRI makers have doctors prescribing the drugs for many other conditions besides depression, and often for off-label uses, meaning they are not approved by the FDA.
According to Dr Jay Cohen, author of, “Over Dose: The Case Against The Drug Companies,” the “drug companies have marketed SSRI antidepressants vigorously not only to psychiatrists, who are supposed to have some expertise with these drugs, but also to family practitioners, pediatricians, gynecologists, internal medicine specialists, and anyone else who can pen a prescription.”
“But this doesn’t mean,” he says, “that they possess in-depth knowledge of SSRIs or their actions and toxicities.”
A study from the University of Georgia in the June 2006, Journal of Clinical Psychiatry, found that 75% of the people prescribed antidepressants received them for a reason not approved by the FDA.
Little Eric’s lawsuit contends that when allowing Paxil to be prescribed to pregnant women, Glaxo has an ongoing duty of pharmacovigilance. The FDA describes the term pharmacovigilance to mean “all scientific and data gathering activities relating to the detection, assessment, and understanding of adverse events.”
This includes, the agency notes, the use of pharmacoepidemiologic studies and activities “undertaken with the goal of identifying adverse events and understanding, to the extent possible, their nature, frequency, and potential risk factors.”
“During the entire time Paxil has been on the market in the US,” Ms Menzies says, “FDA regulations have required Glaxo to issue stronger warnings whenever there existed reasonable evidence of an association between a serious risk and Paxil.”
“FDA regulations specifically state,” she explains, “that a causal link need not have been proven before a new warning is issued and they explicitly allow Glaxo to issue a new warning without prior FDA approval.”
Ms Menzies reports that research as far back as October 3, 1996 in the New England Journal of Medicine, by Dr Christina Chambers and colleagues, of the Department of Pediatrics, Division of Dysmorphology and Teratology, at the University of California–San Diego, indicated a risk of PPHN in babies born to mothers taking SSRIs.
For this study, the researchers identified 228 pregnant women taking Prozac between 1989 through 1995, and compared the outcomes of their pregnancies with those of 254 women who were not taking Prozac.
The study found that babies exposed to the Prozac, during the third trimester of pregnancy, had significantly higher rates of premature delivery, respiratory difficulties, admissions to special care nurseries, jitteriness, and poor neonatal adaptation including cyanosis on feeding.
There have also been studies specific to the use of Paxil during pregnancy that have shown respiratory problems in exposed infants upon delivery. For instance, in 2003, researchers at the Motherisk Program at the University of Toronto, reported that exposure to Paxil in late pregnancy was associated with a significantly higher rate of neonatal complications among 55 exposed newborns, when compared to infants exposed to Paxil in early pregnancy or to newborns with no exposure, and respiratory distress was the most commonly reported adverse reaction.
In June 2004, the journal, Prescrire International, reported that newborns exposed to SSRIs toward the end of pregnancy had breathing and suction problems and showed signs of agitation, and altered muscle tone. The study estimated that 20% to 30% of infants were effected and warned that doctors should be aware of the risks when considering treatment during pregnancy with Paxil, Celexa, Prozac, Zoloft, and Lexapro.
The following month, on July 9, 2004, WebMd reported that over the past decade the FDA had received “hundreds” of reports of adverse effects with infants born to mothers taking SSRIs.
That same month, the FDA changed the labeling for all SSRIs, warning that upon delivery, some infants exposed to SSRIs required respiratory support, tube feeding and prolonged hospitalizations.
In May 2005, a University of Pittsburgh study in the Journal of American Medical Association, combined the previous research and found that women who took SSRIs late in pregnancy had a three times higher risk of giving birth to infants suffering from serious respiratory problems, jitteriness, and irritability in the first couple of weeks after birth.
The drugs involved in this study also included the serotonin norepinephrine reuptake inhibitor Effexor. The researchers estimated that in any given year in the US, at least 80,000 pregnant women are prescribed the drugs. According to psychiatrist, Dr Eydie Moses-Kolko, the lead author of the study, serious respiratory problems develop in about one out of 100 infants born to these women.
As a follow-up to her findings of breathing problems in the previous Prozac study in 1996, Dr Chambers, now an assistant professor of pediatrics at the University of California, San Diego, and colleagues, performed a case control study of women on SSRIs who gave birth between 1998 and 2003, to determine whether PPHN was associated with exposure to SSRIs in late pregnancy.
The results of the study published in the February 9, 2006, New England Journal of Medicine, reported that mothers who took SSRIs in the second half of their pregnancies were 6 times more likely to give birth to babies with PPHN.
The study found 14 infants with PPHN in the group who had been exposed to an SSRI, compared to 6 infants with the disorder in the group who were not exposed to the drugs.
The FDA found the study so alarming that it prompted the agency to hold a press conference. “This appears to be a very well-conducted study and we find the results to be very concerning,” said Dr Sandra Kweder, deputy director of the office of new drugs at the FDA.
She also told reporters that women of reproductive age are the “biggest users of antidepressant drugs.”
Instead of immediately taking action to warn doctors and consumers of this development, the pharmaceutical industry went into all-out damage control to protect SSRI profits by encouraging pregnant women to keep taking SSRIs.
A corresponding study in the February 2006, Journal of the American Medical Association, warned that pregnant women who stopped taking the drugs could greatly increase their risk of a relapse of depression. The authors of the study predicted that their findings would prompt some women to stay on SSRIs throughout pregnancy.
The JAMA study got much more media attention than Dr Chambers, and included headlines warning about the dangers of relapse in pregnant women going off SSRIs. Many local television news broadcasts even ran an unedited video provided by JAMA, featuring a study author and one of his patients.
However, 5 months later, on July 11, 2006, the Wall Street Journal published an expose on the researchers involved in the study who were encouraging pregnant women to keep taking SSRIs. “But the study,” it reported, “and resulting television and newspaper reports of the research failed to note that most of the 13 authors are paid as consultants or lecturers by the makers of antidepressants.”
Most of the authors, the WSJ noted, were leading psychiatrists at Massachusetts General Hospital, the University of California Los Angeles, and Emory University
The lead researcher, Dr Lee Cohen, a professor at Harvard Medical School, it reported, “is a longtime consultant to three antidepressant makers, a paid speaker for seven of them and has his research work funded by four drug makers.”
Among the most significant of the missing financial disclosures, the Journal said, were those of study author, Lori Altshuler, director of the Mood Disorders Research Program at UCLA, who was a speaker or consultant for at least 5 antidepressant makers.
Vivien Burt and Victoria Hendrick were also authors who did not report financial relationships with SSRI makers, and Dr Viguera, another author, did not disclose her paid speaking relationship with Glaxo.
All total, the Journal said, “the authors failed to disclose more than 60 different financial relationships with drug companies.”
“The work of these academic researchers,” the article wrote, “highlights the role of “opinion” or “thought” leaders coveted by drug companies because of their ability to influence not only the practice of doctors, but popular opinion as well.”
In the case of SSRI use by pregnant women, the WJS said, the industry-paid opinion leaders have become dominant authorities in the field and stated:
“They help establish clinical guidelines, sit on editorial boards of medical journals, advise government agencies evaluating antidepressants and teach courses on the subject to other doctors. In some cases, the financial ties between industry and these leading researchers are not disclosed.”
According to the WSJ, as soon as their study was published, Dr Cohen and some the other authors went out on the lecture circuit, telling doctors about their findings and pointing out flaws in the studies that found an increased risks of birth defects with infants exposed to SSRIs.
For instance, the panel of experts who criticized the Chambers study during the May 17, 2006, continuing medical education lecture, “Psychotropic Drug Use During Pregnancy,” sponsored by the Massachusetts General Hospital Psychiatry Academy, was comprised entirely of psychiatrists with financial ties to drug companies.
During the lecture, the panelists were also critical of the FDA for adding new warnings about birth defects to Paxil’s label. On December 8, 2005, the FDA issued a Public Health Advisory after US and Swedish studies showing that exposure to Paxil in the first trimester of pregnancy to be associated with an increased risk of heart birth defects.
With the warning, the agency for the first time placed an SSRI in the D category, its second highest for the risk of birth defects. Category D means that either controlled or observational studies of pregnant women “have demonstrated a risk to the fetus.”
The agency did not ban Paxil from use with by pregnant women, but it did go so far as to say, “FDA is advising patients that this drug should usually not be taken during pregnancy.”
At the May 17 conference, panelist, Zachary Stowe, from the women’s mental health center at Emory University, described the FDA’s decision to change the label as “driven by a single set of data that is unpublished, non-peer reviewed, and somehow this trumps the very nicely done prospective investigations that have really failed to find this risk.”
However, here once again, according to the WSJ, Dr Stowe has served as an paid adviser and speaker for several SSRI makers.
In July 2006, corresponding with the WSJ’s expose about the undisclosed financial relationships of the Cohen study authors with SSRI makers, JAMA published a correction to announce that 7 of the authors of the February 2006, study had failed to reveal their financial ties with drug companies.
Critics of Big Pharma‘s influence over studies published in medical journals were quick to respond to the disclosure. On July 11, 2006, Merrill Goozner, director of the Center for Science in the Public Interest, issued a statement saying: “It’s clear that the Journal of the American Medical Association does not evaluate conflict of interest disclosures when articles are submitted.”
“As a result,” Mr Goozner said, “some authors with blatant conflicts of interest apparently feel they can ignore the journal’s policy with impunity.”
“The only solution,” he added, “is for journals to adopt strong penalties for authors who fail to disclose – a three-year ban from publishing in the pages in the journal.”
A month later in August 2006, another study in the Archives of General Psychiatry, by Canadian researchers at the University of British Columbia, found babies born to women who took SSRIs during pregnancy to be at an increased risk of having respiratory distress and low birth weight.
Lead investigator, Dr Tim Oberlander, told Reuters Health on August 25, 2006, that “our study was undertaken to distinguish the effects of maternal mental illness — pregnancy-related depression — from its treatment — SSRIs — on neonatal outcomes.”
The researcher reviewed health records for almost 120,000 live births between 1998 and 2001 and determined that 14% of the mothers were diagnosed with depression. They then compared the outcomes of infants born to women treated with SSRIs to those born to depressed women who were not treated with SSRIs and found a significantly higher incidence of respiratory distress in infants exposed to SSRIs by a ratio of 13.9% to 7.8%.
The study reported longer hospitalizations for infants born to mothers on SSRIs, and found birth weight and gestational age were also significantly less in SSRI exposed infants.
“These findings are contrary to an expectation that treating depressed mothers with SSRIs during pregnancy would be associated with lessening of the adverse neonatal consequences associated with maternal depression,” Dr Oberlander told Reuters.
In October, 2006, the journal, Pediatrics, reported that CDC researchers cited preterm birth as the leading cause of infant mortality in the US, accounting for at least one-third of all infant deaths in 2002.
The contribution of prematurity to infant mortality may be twice as high as originally estimated, reported Dr William Callaghan, MD, MPH, and colleagues.
The research team looked at the top 20 causes of infant deaths in 2002, and found that 34% occurred in preterm infants, 95% of whom were born before 32 weeks gestational age of 32 weeks and weighed less than 3.3 pounds.
“The extreme prematurity of most of the infants and their short survival indicate that reducing infant mortality rates requires a comprehensive agenda to identify, to test, and to implement effective strategies for the prevention of preterm birth,” the authors wrote in Pediatrics.
There are also studies showing infants born with symptoms of neurological damage associated with SSRI exposure in the womb. In February 2004 a study in the American Journal of Pediatrics reported abnormal sleeping patterns, heart rhythms and levels of alertness linked to SSRIs.
Dr Philip Zeskind, a developmental psychologist and research professor at the University of North Carolina, Chapel Hill, led the investigation and on February 22, 2006, told the Sunday Telegraph, “What we’ve found is that SSRIs disrupt the neurological systems of children, and that this is more than just a possibility, and we’re talking about hundreds of thousands of babies being exposed to these drugs during pregnancy.”
In reaching their results, the team of researchers compared 17 babies born to mothers who took the Prozac, Paxil, Zoloft or Celexa throughout their pregnancy, with 17 babies born to mothers who had never taken SSRIs.
According to Dr Zeskind, “These babies are bathed in serotonin during a key period of their development and we really don’t know what it’s doing to them or what the long-term effects might be.”
“It could be that they go `cold turkey’ when they are born,” he explained in the Telegraph, “or the serotonin could be having an effect on their brains, or it could be a bit of both.”
“We’re not saying that pregnant women should not take the drugs, because depression is itself a big problem,” he said. “But these drugs are being given away like smarties, and this is a big problem,” Dr Zeskind warned.
Legal analysts predict that this first PPHN lawsuit is just the tip of the proverbial iceberg because there are tens of thousands of infants exposed to SSRIs in the womb each year.
After the results of her study were made public, Dr. Chambers says she heard from women all across the country who took SSRIs during pregnancy and had babies born with PPHN.
The fact that Glaxo has not ordered its hired-guns to stop promoting the sale of Paxil to pregnant women, proves that the company plans to go on sacrificing the lives of babies in the name of profits and that should be a fairly easy point to get across to a jury.
Families seeking justice for infants born with Paxil related birth defects can contact the Baum Hedlund Law Firm at: (800) 827-0087; http://www.baumhedlundlaw.com/
By Evelyn Pringle
(Written as part of the Paxil Litigation Monthly Round-Up series, Sponsored by Baum Hedlund’s Pharmaceutical Antidepressant Litigation Department)
Paxil Birth Defect Litigation – Battle of the Decade
A year ago, the FDA reclassified Paxil from a Category C drug to a Category D for pregnant women. Category C is for drugs that have been shown to harm the fetus in animals. Category D means a drug has been found to harm the human fetus.
In a December 1, 2006, news release, the American College of Obstetricians and Gynecologists’ Committee on Obstetric Practice, advised that Paxil should be avoided “by pregnant women or women planning to become pregnant due to the potential risk of fetal heart defects, newborn persistent pulmonary hypertension, and other negative effects.”
An interesting comment in the announcement states: “Unpublished data regarding the use of Paxil® during the first trimester of pregnancy have raised concerns about an increased risk of congenital heart malformations.”
This discussion begs the question of exactly how much more “unpublished data” is out there about the dangers of Paxil that the public will hear about later, rather than sooner.
On December 8, 2005, the FDA issued a public advisory to report that a Swedish study showed women who received Paxil in early pregnancy had an approximately 2-fold increased risk of having an infant born with a cardiac defect compared to the general population.
The agency also reported that another study, of a US insurance claims database, found that infants born to women who received Paxil in the first trimester of pregnancy were at a 1.5-fold increased risk for cardiac malformations compared to women who received other antidepressants or women in the general population.
Medical experts say Paxil exposure is especially harmful in the first trimester because fetal heart development occurs early in pregnancy. According to Dr Lara Jana, MD, FAAP, in Early Fetal Heart Development: 0-9 Weeks, published on the Dr Spock Web site, the most critical period in development is between three and seven weeks after fertilization, when a heart tube assumes the shape of a 4-chambered heart.
It is always important to point out that because GlaxoSmithKline (GSK) promotes Paxil to treat a wide variety of “disorders,” many pregnant women may be taking the drug, who are totally unaware of the risks because they have never been diagnosed with depression.
According to GSK, Paxil is indicated for the treatment of obsessive-compulsive disorder, major depressive disorder (MDD), panic disorder, social anxiety disorder, generalized anxiety disorder, and posttraumatic stress disorder; and Paxil CR is indicated for the treatment of panic disorder, social anxiety disorder, and premenstrual dysphoric disorder. Doctors are also too eager to prescribe Paxil off-label for everything from migraines to nail biting.
An important point to consider when weighing the risks and benefits of prescribing Paxil to pregnant women, is that most experts who have evaluated the study data on SSRIs, say the drugs do not work.
One of latest reviews in the July 2005, British Medical Journal, by Moncrieff & Kirsch, states in part: (1) Recent meta-analyses show [SSRIs] have no clinically meaningful advantage over placebo; (2) Methodological artefacts may account for the small degree of superiority over placebo; and (3) Given doubt about their benefits and concern about their risks, current recommendations for prescribing antidepressants should be reconsidered.
Infant SSRI Withdrawal Syndrome
The fact that SSRIs can be extremely difficult to quit due to debilitating withdrawal reactions also adds to the dilemma that women face if they become pregnant. “A lot of these medicines are associated with withdrawal syndromes, which can be very problematic for many patients, so stopping is something that needs to be monitored carefully by your doctor,” Sandra Kweder, MD, deputy director of the FDA’s Office of New Drugs, states in a March/April 2006 update about the risks of Paxil use by pregnant women on the FDA’s Web site.
But on the other hand, staying on the SSRI places infants at risk. A February 2006, study in the Archives of Pediatrics & Adolescent Medicine reported that nearly one-third of babies born to mothers taking SSRIs showed severe symptoms of withdrawal, including high-pitched crying, tremors, gastrointestinal problems and disturbed sleep patterns.
Other Birth Defects
Over the past several years, in addition to heart defects, a variety of birth defects have been found to be associated with Paxil and the other SSRIs. A 2005 study in Teratology Society Abstracts, found that women who took Paxil were more likely to have an infant with omphalocele, a malformation where the abdominal contents protrude into the base of the umbilical cord, and craniosynostosis, an early closing of one or more of the sutures of an infant’s head, causing a malformation of the skull.
A February 2004, study in the Pediatrics journal, linked abnormal heart rhythms, sleeping patterns, and levels of alertness to exposure to SSRIs in the womb. Dr Philip Zeskind, a professor of pediatrics at the University of North Carolina-Chapel Hill, and lead author, said the results were alarming.
According to the study, infants exposed to SSRIs tended to be locked in one “sleep state,” and showed “fewer of the smooth and predictable changes in heart rate that normally occur in newborn infants.”
Earlier this year, on April 7, 2006, the BBC reported that a Canadian study from the University of Ottawa, of almost 5,000 mothers found that SSRI use during pregnancy doubled the risk of delivering a stillborn baby and that women who took the drugs were also more likely to have a premature or low birth weight baby.
In the US, preterm birth is reportedly the leading cause of infant mortality, accounting for at least a third of all infant deaths in 2002. The contribution of prematurity to infant mortality may be twice as high as originally estimated, reported William M. Callaghan, MD, MPH., and colleagues, in the October 2006 issue of Pediatrics.
Five More Birth Defect Lawsuits
Earlier this month, five more lawsuits were filed on behalf of families of infants born with birth defects to mothers who were prescribed Paxil during pregnancy. Of the five cases, two are personal injury lawsuits and three are wrongful death cases. The lawsuits allege that GSK failed to warn doctors and consumers about the risk of birth defects and Paxil.
In the case of one West Virginia family, twin daughters were both born with heart defects. One daughter survived but the other died when she was 20-months-old. The parents have two older children who were born without birth defects. Their mother had not taken Paxil during pregnancy.
Another Paxil exposed infant with heart defects was born to an Omaha, Nebraska couple and lived only 24 days even after he underwent four surgeries in an attempt to save his life. There are three other normal children in this family, all born during times when their mother was not on Paxil.
A Toledo, Ohio, infant lived only 17 days after she was born with heart defects and underwent several surgeries in attempts to save her life. There is one older child in this family born without birth defects when the mother was not taking Paxil.
In Westerville, Ohio, another infant was born with heart defects to a mother who was prescribed Paxil during pregnancy and required two life-threatening surgeries during the first nine months after birth. The child is scheduled for an additional surgical procedure next year.
Less than five months ago, on July 28, 2006, a Texas couple filed suit against GSK. The lawsuit alleges that after the mother’s use of Paxil caused their infant to be born with heart defects requiring multiple open-heart surgeries and the implantation of a pacemaker.
Baum Hedlund, a Los Angeles-based law firm that specializes in pharmaceutical product liability claims is handling these lawsuits, and has the longest track record of SSRI litigation in the country, representing over 3,000 antidepressant plaintiffs over the past 16 years. The firm currently represents families in dozens of birth defect cases and has five attorneys assigned specifically to SSRI litigation.
Karen Barth Menzies is a partner at Baum Hedlund and heads the Antidepressant Litigation Department. For more than a decade, she has been handling SSRI-induced suicide/violence litigation involving Prozac, Paxil and Zoloft and now also represents families in antidepressant birth defect cases.
Jennifer Liakos and Robert Brava-Partain are associate attorneys at the firm and members of the pharmaceutical products liability department handling all of the firm’s antidepressant birth defect cases and suicide and/or suicide attempt cases involving Paxil.
The firm is also being retained in birth defect cases for antidepressants other than Paxil.
Infant Lung Disorders
In July 2006, the FDA issued a Public Health Advisory on the latest type of birth defect believed to be associated with SSRIs, based on a study in the February 2006, New England Journal of Medicine. The study found an increased risk of a live-threatening lung disorder in infants exposed to SSRIs during pregnancy, stating:
“A recently published case-control study has shown that infants born to mothers who took selective serotonin reuptake inhibitors (SSRIs) after the 20th week of pregnancy were 6 times more likely to have persistent pulmonary hypertension (PPHN) than infants born to mothers who did not take antidepressants during pregnancy.”
Infants with PPHN have difficulty making the transition from breathing inside the womb to normal breathing upon delivery causing respiratory failure that often requires mechanical ventilation. Even with treatment, between 10% to 20% of PPHN babies do not survive.
Although all the latest research clearly shows that the benefits of SSRI use by pregnant women could never outweigh the risks, the July 2006, FDA advisory titled “Treatment Challenges of Depression in Pregnancy,” almost appears to be encouraging women to keep taking SSRIs, citing a study that warns that pregnant women who stop taking the drugs might relapse into depression.
Are Drug Manufacturers Selling Sickness?
In the research paper cited, the authors predicted that their findings would prompt some women to stay on antidepressants throughout pregnancy. However, the study ended up making frontpage news on July 11, 2006, after an investigation by the Wall Street Journal discovered that 9 of the 13 authors had undisclosed financial ties to the SSRI makers.
Which raises the question of whether SSRI makers are “selling sickness,” using these so-called “experts” to convince doctors to keep prescribing drugs that are known to harm the fetus to increase profits.
By now, the industry’s habit of planting bogus studies in medical journals and the media to promote drugs has become widely recognized. In the paper, “Selling sickness: the pharmaceutical industry and disease mongering,” published in 2002, in the British Medical Journal, the authors describe how alliances of drug companies, doctors, and patient advocacy groups, use the media to portray conditions as being severe and widespread.
The paper notes that “in many cases the formula is the same: groups and/or campaigns are orchestrated, funded, and facilitated by corporate interests, often via their public relations and marketing infrastructure.”
The authors could be discussing the study cited in the FDA advisory when they say: “A key strategy of the alliances is to target the news media with stories designed to create fears about the condition or disease and draw attention to the latest treatment.”
The paper goes on to list the different components of this marketing technique. “Company sponsored advisory boards supply the “independent experts” for these stories, consumer groups provide the “victims,” and public relations companies provide media outlets with the positive spin about the latest “breakthrough” medications.
Members of the medical profession are critical of medical journals that publish these “studies” and help make a mockery of “evidence-based medicine” with false claims about the safety and value of drugs whose lethal side effects are concealed from readers–i.e., physicians, health care policy officials, the judiciary, and the public at large, in “Research and Clinical Practice Guidelines: Can We Trust the Evidence in Evidence-Based Medicine?”, by Dr. John Abramson, of Harvard, and Dr. Barbara Starfeld, a professor at Johns Hopkins, in the October 2005, Journal of the American Board of Family Practice.
According to Dr Abramson and Dr Starfeld: “Although one can make a case that the purpose of an industry is to make a profit and not necessarily to serve the public good, it is difficult to accept this as a justification for the behavior of medical scientists and regulatory agencies.”
15-Year History of SSRI Litigation
Unbeknownst to most people, hundreds of SSRI suicide lawsuits have been ongoing behind the scenes for more than 15 years and Baum Hedlund has been involved from the start. The drug makers have done everything in their power to keep these cases from going to trial.
In one of the only three cases to ever go to trial, Eli Lilly was caught corrupting the judicial process by making a deal with the plaintiff’s attorney to throw the case, in part by not disclosing damaging evidence to the jury.
The case involved a Kentucky man on Prozac, who went to his workplace and opened fire with an assault rifle killing 8 people, and injuring 12 others before turning the gun on himself. The jury returned a 9-to-3 verdict in favor of Lilly.
In the media, Lilly touted the verdict as a vindication for Prozac, but the judge in the case figured out what had happened and was outraged that a secret settlement occurred behind his back. He complained to a reporter from the British Broadcasting Company, stating:
“After the verdict came in, Eli Lilly gave it a great deal of publicity and various people went on television and on the radio and in newspapers proclaiming that this was a vindication of Prozac.
“I think the public has a right to expect that a trial is a bona fide contest and not some sort of show that one side puts on with the consent of the other to influence public opinion. Because it was done to discourage other plaintiffs and to help settle the pending lawsuits for less money than they might have been settled otherwise.”
The judge, in the end, took the matter to the Kentucky Supreme Court, which found that “there was a serious lack of candor with the trial court and there may have been deception, bad faith conduct, abuse of judicial process and, perhaps even fraud.”
The judge later revoked the verdict and instead, recorded the case as settled. The value of the secret settlement deal has been reported to be over $20 million.
Will Birth Defect Cases Follow Suit?
The few cases that have made it to a jury illustrate why the drug makers work so hard to get these cases dismissed or settled before trial. For instance, in a Paxil case in Wyoming in 2001, a jury awarded a surviving family member over $6 million after it determined that Paxil had caused a man to kill his wife, daughter and granddaughter before killing himself.
In addition, drug companies should be concerned over trial publicity because medical experts estimate that there are hundreds, if not thousands, of infants who were born with SSRI-related birth defects to mothers who do not know that the drugs could be to blame. After the PPHN study was published, the lead author, pediatric researcher, Dr Christina Chambers, told the Wall Street Journal that she heard from women all across the US who used SSRIs and gave birth to babies with PPHN.
In avoiding publicity, companies must consider that nagging little matter of profits. According to the Wall Street Journal, “Whether or not pregnant women continue or stop the use of antidepressants has big ramifications for makers of those drugs.”
Citing US government estimates, the Journal reports that women are at a 25% risk for developing depression, with the highest risk period being in childbearing years.
As for industry influence on regulatory agencies, legal experts predict that GSK will file motions in an attempt to dismiss the birth defect cases using the FDA’s new preemption policy announced in January 2006, which basically says that state failure-to-warn claims are barred against drug companies if a drug and its label were approved by the FDA.
“In essence,” Ms. Menzies says, “the government’s position is that unless and until the FDA takes action regarding a safety risk associated with an approved drug, nobody else can — not a drug company, not another state, and not a plaintiff in a lawsuit.”
Before the Bush Administration took control of the FDA, the agency’s consistent position was that the drug’s label did not preempt state laws except in rare circumstances, precisely because the label would not reflect advances in knowledge about drugs once they were on the market. Critics point to the preemption policy as evidence of the administration’s commitment to protect the profits of its largest political contributors.
It should be noted that, prior to his appointment as Chief Counsel at the FDA, Daniel Troy was a partner at Washington’s Wiley Rein & Fielding, where he filed lawsuits against FDA regulations in support of the pharmaceutical industry. He left the FDA in late 2004, and is now back representing drug companies and applying the preemption policy that he put in place.
Up until now, most preemption cases have involved failure-to-warn claims about the association between suicide and SSRIs.
But the stakes are higher with birth defect cases and a massive filing of preemption motions is expected, aimed at keeping these families, considered to be extremely sympathetic plaintiffs, out of the sight of a jury.
However, when it comes to preemption motions, GSK could not be up against more formidable opponents than the attorneys at Baum Hedlund. Ms. Menzies and her Baum Hedlund associate, Robert Brava-Partain, have already soundly defeated preemption arguments by SSRI makers and the FDA in numerous cases, including Witczak v Pfizer, Cartwright v Pfizer, and Zikis v Pfizer.
According to Ms. Menzies, the use of the FDA to shield the industry from liability actually began in 2002, when Mr Troy began submitting briefs in private lawsuits on behalf of drug companies arguing that state tort failure-to-warn claims should be preempted because the FDA had the final word when it came to drug labeling.
In the first brief in Motus v Pfizer, Mr. Troy argued that even though Pfizer had never asked to strengthen Zoloft’s label, any warning would have been false and misleading. “Had Pfizer given a warning as to a causal relation between Zoloft and suicide, the FDA would have disapproved the warning,” Mr. Troy wrote in the brief. The court never decided the preemption issue in Motus, because the case was concluded on other grounds.
In September 2002, Mr. Troy filed a brief with the same argument in another lawsuit that alleged that GSK failed to adequately warn about the withdrawal effects of Paxil. Ms. Menzies won that round when the judge held that the preemption argument “contravenes common sense” and “vitiates, rather than advances, the purpose of protecting the public.”
Pfizer also tried to use Mr. Troy’s brief from the Motus case, in support of a preemption motion in the Minnesota case of Witczak v Pfizer. The judge rejected it, stating:
“State consumer-protection law compliments, rather than frustrates, the FDA’s protective regime. This is especially apparent when one considers that prescription drugs were once marketed primarily to trained health care providers — sophisticated and discerning intermediaries.
“Today, on the other hand, pill-rolling apothecaries and the mortar and pestle have disappeared. They have been replaced by drug manufacturers who urge the use of their drugs in mass-market print and television advertisements targeted directly at the public. Defendant, for example, advertises the drug involved in this case by personifying it as a happy, bouncing-oval cartoon character.”
Mr. Brava-Partain, who argued for Mrs. Witczak, praised the ruling. “The Court correctly recognized that drug manufacturers, like Pfizer,” he stated, “cannot hide behind the rules and regulations of the FDA when they engage in conduct that harms the public.”
The fact is, FDA regulations require drug makers to add a new safety warning whenever there is “reasonable evidence” of an association between a particular hazard and the drug, and that a “causal relationship need not have been proved.”
“With respect to the SSRIs,” Ms. Menzies states, “drug companies have utterly failed to add warnings to the labels despite far more than reasonable evidence of an association of a serious hazard.”
The claim that only the FDA can decide whether there is reasonable evidence to change the label is contradicted by its own inaction when it allowed Wyeth to strengthen the label with a warning about suicide and Effexor in August 2003, without prior approval.
According to Ms. Menzies, immunizing the pharmaceutical industry under the misplaced belief that the FDA is infallible is a threat to public health. “Recent regulatory failures,” she states, “demonstrate that the agency is neither infallible nor does it have the capability of policing drug makers’ negligent misconduct.”
Families seeking justice for infants born with Paxil and other antidepressant related birth defects can contact the Baum Hedlund Law Firm at: (800) 827-0087; http://www.baumhedlundlaw.com/
By Evelyn Pringle
(Written as part of the Paxil Litigation Monthly Round-Up, Sponsored by Baum Hedlund’s Pharmaceutical Antidepressant Litigation Department)