Tagged: Birth Defects

GSK’s Zofran Scandal..


“…..As of May 9, 2017, a total of 366 Zofran birth defect lawsuits have been consolidated in the US District Court of Massachusetts….”

 

 

 

http://zofranlegal.com/gsk-fights-fraud-claims/

GSK Fights To Strike Fraud-Related Zofran Lawsuit Claims

In their Zofran lawsuits, hundreds of families accuse GlaxoSmithKline of guiding a sweeping – and illegal – marketing campaign to convince obstetricians into prescribing the nausea drug as an off-label treatment for morning sickness. The company’s attorneys are now petitioning the US District Court of Massachusetts to have those claims of marketing fraud thrown out.

GSK Moves To Throw Out Zofran Marketing Claims

In some sense, the defense attorneys are simply asking Judge F. Dennis Saylor to follow through on one of his previous decisions. On April 24, 2016, Judge Saylor ruled that plaintiffs’ allegations of an illicit marketing campaign were “too broad” to be heard in court. Now, GlaxoSmithKline is urging the Court to strike those allegations from the record, claims that the company’s lawyers have dubbed “immaterial.” This isn’t an idle request, though.

Capsules In Pill Bottle

After quashing the allegations of fraudulent marketing, Zofran’s manufacturer would like Judge Saylor to limit the scope of discovery, effectively blocking the families from accessing corporate documents on the sales visits that company representatives conducted with individual doctors. Many families have said that GlaxoSmithKline’s sales representatives routinely misrepresented the safety and efficacy of Zofran during their consultations – at the behest of corporate executives. While the company vigorously denies this accusation, it now hopes to block plaintiffs from the very evidence that would either confirm or disconfirm their beliefs.

Fight Continues Over Federal Investigation Communications

This isn’t the only front on which GlaxoSmithKline is fighting plaintiffs’ ability to access potential evidence of wrongdoing. In the late-2000s, the company came under federal investigation. Investigators from the US Department of Justice had been tipped off by a whistleblower lawsuit filed in 2003, which accused GlaxoSmithKline of orchestrating numerous illegal marketing campaigns. As two former high-level corporate employees related, their employer had regularly advertised FDA-approved products for off-label indications, flouting federal law in the process. Zofran had been specifically marketed as a morning sickness treatment, the men said.

The federal government soon took the case on. After years of intense scrutiny, the federal investigation yielded a stunning result. In 2012, GlaxoSmithKline agreed to plead guilty to three criminal charges, the Justice Department reports, notably “two counts of introducing misbranded drugs, Paxil and Wellbutrin, into interstate commerce.” Moreover, the company agreed to pay $2 billion to resolve the government’s civil allegations, including accusations that Zofran had been marketed illegally.

While some details from this investigation have been made public, most of the specifics remain locked in GlaxoSmithKline’s corporate servers. Families are clamoring to obtain these documents, hoping to understand the finer points of the company’s Zofran marketing strategy. In fact, the US District Court of Massachusetts has already ruled that plaintiffs’ have a right to this information, despite GlaxoSmithKline’s arguments to the contrary.

Fraud Dispute Shouldn’t Block Discovery, Magistrate Judge Rules

On April 6, 2017, Magistrate Judge Judith G. Dein denied the corporation’s request for a protective order that would have paused discovery into the documents. GlaxoSmithKline believes that, if the allegations of fraudulent marketing are thrown out, any discovery into the company’s communications with federal investigators should be ruled out as well. After all, and by the company’s own admission, “the DOJ investigation focused on whether the defendant’s sales force had provided false information to physicians.”

Judge Dein, though, felt that the discovery in question could well impinge on allegations beyond those of fraudulent marketing. For example, the families claim that GlaxoSmithKline was “negligent” in warning the medical community of Zofran’s alleged risks. This isn’t a fraud-related allegation, but halting discovery into the company’s communications could have the unintended consequence of preventing plaintiffs’ from gaining evidence to support their negligence-based claims. To avoid that pitfall, Judge Dein felt it was appropriate to compel GlaxoSmithKline to produce documents related to the Justice Department investigation.

The company has yet to produce these documents. Despite Judge Dein’s court order, issued on April 6, 2017, plaintiffs’ attorneys say GlaxoSmithKline is only “constructing new methods of delay and obstruction.” In a new motion to compel the documents filed on May 8, the families have asked the Court to force their opponent into making the information available.

As of May 9, 2017, a total of 366 Zofran birth defect lawsuits have been consolidated in the US District Court of Massachusetts. Judge F. Dennis Saylor has been guiding the litigation through coordinated pre-trial proceedings. Relying on a series of large epidemiological studies, parents from across the country say the potent anti-nausea drug can cause major birth defects, including cleft palate and various forms of congenital heart disease.

 


 

http://www.wbrc.com/story/31258552/zofran-looking-beyond-the-label

Zofran: Looking beyond the label

Thursday, February 18th 2016, 10:37 pm GMTThursday, March 17th 2016, 10:43 pm GMT

L-R: Jon, Nicholas and Clara Rickman. (Source: WBRC video) L-R: Jon, Nicholas and Clara Rickman. (Source: WBRC video)

At only five days old, baby Nicholas underwent his first of three heart surgeries. Source: Jon and Clara Rickman At only five days old, baby Nicholas underwent his first of three heart surgeries. Source: Jon and Clara Rickman

Clara Rickman and her son Nicholas. Source: WBRC video Clara Rickman and her son Nicholas. Source: WBRC video

BIRMINGHAM, AL (WBRC) – Over 200 lawsuits allege that pregnant mothers prescribed Zofran, or a generic equivalent, caused them to have babies born with congenital birth defects.

Jon and Clara Rickman, of the Birmingham area, are plaintiffs in one such lawsuit. They say their baby, Nicholas, was born with congenital heart defects after his mother took the generic form of Zofran, called “ondansetron,” to alleviate her morning sickness during her first trimester.

At only five days old, Nicholas underwent his first of three heart surgeries.

Nicholas’ mother blames herself for taking the drug.

“Every day, you see his scar. And I can’t never fix it and I think it’s my fault,” said Clara.

The Rickmans say if Clara had not taken the generic form of Zofran, Nicholas would not have been born with a heart problem. According to their lawsuit, there is no family history of his conditions and there are no signs of a genetic cause.

The Rickmans are speaking publicly about their lawsuit and Nicholas’ health because they believe they can prevent a similar fate for others.

“I don’t want other mothers to go through what I’ve been through. And I don’t want them to feel guilty for the rest of their life, like I do,” Clara said.

Zofran was FDA-approved in 1991 to prevent post-operative nausea, and to help cancer patients alleviate nausea during chemotherapy treatments. It was not FDA-approved for treatment of morning sickness.

“It’s never been tested in pregnant women for safety and for safety in unborn children,” said the Rickman’s lawyer, Don McKenna, a partner at Hare Wynn in Birmingham.

McKenna says physicians began prescribing Zofran for uses other than what is FDA-approved. This is called an “off-label” prescription, and according to Peter J. Hughes, Pharm. D., such prescriptions are not uncommon.

“The estimates are that as many as one in five prescriptions written and filled in a pharmacy is for an off-label use, so that’s 20 percent,” said Dr. Hughes. 

A professor at Samford University’s McWhorter School of Pharmacy, Dr. Hughes is an expert in drug information and off-label use.

“It’s nothing to lose sleep over, but I do think it’s important for patients to know what they’re taking and why they are taking it,” he said. “The medication in their medicine cabinets may be used for a purpose that’s not associated with original intended use of the drug product.”

Dr. Hughes says patients should initiate a conversation with their doctors about prescriptions. He says patients should ask: Why I am receiving this prescription? Is this an off-label prescription? If so, what is the level of evidence supporting the decision to prescribe it to me?

Clara says she was never advised by her OBGYN that Zofran was not tested on pregnant women. Her lawyer believes that is a problem.

“It’s being continued to be prescribed today off-label because a doctor can prescribe off-label for any use they believe is necessary,” said McKenna. “What we don’t believe they’ve been told by the pharmaceutical company is that this has never been tested for use in pregnant women and safety in their children.”

The Rickmans are suing GlaxoSmithKline, manufacturers of Zofran, alleging that the drug company illegally marketed the drug for use in pregnant mothers and withheld information about the drug’s safety and effectiveness.

McKenna explained it is illegal for a drug company to market an FDA-approved drug for an off-label use.

“You can only market a drug that has been approved for use by the FDA and they never sought approval for use in pregnant women,” he said.

The Department of Justice (DOJ) previously accused GlaxoSmithKline of illegally promoting the off-label use of Zofran for the treatment of morning sickness in pregnant women. The DOJ alleged that GlaxoSmithKline paid kickbacks to doctors to induce them to prescribe Zofran and other drugs. The company settled those claims, without admitting liability, in 2012. 

In a statement, a spokesperson for GlaxoSmithKline said, “There have never been any findings that GSK illegally marketed Zofran at any time. In 2012, GSK agreed to include Zofran in a larger settlement with the government in order to avoid the distraction and expense of litigation.”

GlaxoSmithKline paid over $3 billion for the total settlement, which included criminal and civil charges. It remains a settlement that the DOJ calls the largest combined federal and state health care fraud recovery in a single global resolution in the history of the United States.

Though the FDA does not regulate the off-label use of prescription drugs, it collects data about adverse events associated with use. The FDA has more than 5,000 adverse events involving Zofran reported by a patient, health care provider, or manufacturer. While reporting of adverse events is optional for consumers and healthcare providers, reports are mandatory for drug manufacturers.

More than 400 adverse events from Zofran are reported for “maternal exposure during pregnancy.” More than 300 adverse events are associated with “foetal exposure during pregnancy.” There are 170 adverse events reported for “congenital anomaly.”

These reports were reviewed and considered by the FDA when it issued a public letter in October 2015 about Zofran. The letter responded to a Citizen’s Petition filed with the FDA in January 2013 requesting that the agency reclassify the drug with stronger warnings of potential risks associated with its use by pregnant women.

The Citizen’s Petition also wanted OBGYNs to be notified that Zofran may lead to adverse maternal and fetal outcomes.

After reviewing the medical literature studying the off-label use of Zofran, the FDA denied the Citizen’s Petition.

A GSK spokesperson pointed to this FDA letter and said, “They found that the evidence did not support a conclusion that there is an increased risk of adverse fetal outcomes or birth defects from exposure to Zofran during pregnancy.”

Dr. Hughes has also reviewed the FDA letter. He explained that the denial is based on a review of publicly available published medical studies. It did not include a medical study initiated by the FDA.

According to Dr. Hughes, the letter concludes that current available medical literature is inadequate to support a definitive conclusion on whether there is an increased risk of fetal outcomes when pregnant mothers take Zofran.

“The studies that are published cannot support conclusions on whether there is an increased risk,” he said.

The FDA was critical of these studies because, “they were not the highest quality, had low sample sizes, and/or were retrospective studies.”

The FDA letter, itself, recognized, “While a potential association between use during pregnancy and cardiovascular malformation warrants continued vigilance, given the limitations…the study does not support a change in the pregnancy risk category at this time for those products.”

And with regard to its denial of the request to notify physicians about alleged adverse outcomes, the letter stated, :FDA does not believe that such an unusual notification is warranted in this case.”

“Absent a compelling legal or public health concern, FDA generally does not comment on the number or quality of studies regarding the efficacy of a drug product for an unapproved use or provide notification to health care providers regarding its relative efficacy as compared to other drug products for such unapproved use,” the letter stated.

The federal judge presiding over the Zofran litigation, including the Rickmans’ lawsuit, also reviewed the FDA’s response letter. He noted that GSK could be in possession of additional information that the FDA did not consider.

“If – as plaintiffs allege – GSK was in exclusive possession of information not previously submitted to the FDA indicating a need for a new or strengthened warning…that information could not, however, have been submitted by a citizen petition, as no citizen (according to plaintiffs) had access to it,” wrote U.S. District Judge F. Dennis Saylor, IV.

The Rickmans’ lawyer says the next 12 months, or more, will be spent collecting and reviewing internal company documents from GSK about the development, testing, and marketing of Zofran.  It could be three to five years before these cases are ready for a trial.

In the meantime, the Rickmans will raise Nicholas. About one year after his heart surgeries, Clara says baby Nicholas is doing better.

“I want him to know that he’s a really strong baby, that he’s a fighter, and that he should be proud of about it,” said Clara.

“If I could go back,” she said with tears streaming down her face, “I would never take anything, if I knew it would hurt him.”

Copyright 2016 WBRC. All rights reserved.


 

https://www.propublica.org/article/most-drugs-not-tested-pregnant-women-anti-nausea-cure-why-thats-a-problem

Most Drugs Aren’t Tested on Pregnant Women. This Anti-nausea Cure Shows Why That’s a Problem

For years, Zofran was the most popular morning-sickness medication in the U.S. Now it’s being accused of causing birth defects. The larger issue is a drug-safety system that excludes women from clinical trials, potentially putting them and their babies at risk.

Marquita Smiley and her son, Zaidan. (Bob Miller for ProPublica)

This story was co-published with Mother Jones and AL.com.

Marquita Smiley’s first surprise was discovering she was pregnant. Her second was how miserable being pregnant felt. With her older daughter, she had experienced some mild queasiness. This time, the nausea and vomiting were so bad, “I would be calling off work and not wanting to get out of bed.” As a single mom in Birmingham, Alabama, and a social worker who investigated horrific cases of child abuse, she didn’t have that option. Her ob/gyn wrote a prescription for Zofran, generic name ondansetron, which had been developed for cancer patients ravaged by radiation and chemotherapy but had become the preferred treatment for extreme morning sickness. The pills melted in Smiley’s mouth, dissolving the nausea with them. “I felt so much better,” she said. “So we just kept kinda going with it.”

Fifty to 90 percent of women spend some part of their early pregnancies sick to their stomachs, and what begins as simple nausea can become dangerously debilitating. Some expectant women use ondansetron for only a few days; Smiley took it two or three times a week into her second trimester. In her fifth month, an ultrasound showed that the left side of her baby’s heart was critically underdeveloped. Three days after her son, Zaidan, was born in April 2014, cardiologists at the University of Alabama Hospital in Birmingham performed open-heart surgery, but a blood clot caused the baby to have a heart attack and his kidneys began to fail. Somehow Zaidan hung on: At two months, he had a heart transplant; at four months, he went home.

Smiley was torn between feeling extraordinarily lucky — Zaidan was her “miracle baby” — and blaming herself for his suffering. As his first birthday neared, one of her coworkers mentioned she’d seen TV commercials by a law firm claiming that Zofran might cause serious congenital heart problems and other birth defects.

Smiley began doing her own research. She had assumed that medications prescribed in pregnancy are tested and monitored for prenatal use, perhaps even more carefully than other drugs. But ondansetron, for years the most widely used drug to treat the most common complication of pregnancy, was never approved in the U.S. or anywhere for use in pregnancy. The pharmaceutical giant GlaxoSmithKline vigorously denies Zofran causes birth defects, and most research so far seems to support that claim. Smiley acknowledges she can’t be certain what caused Zaidan’s problems. But if she’d known the drug hadn’t been approved for prenatal use, she said one morning in her lawyer’s office, distracting her squirmy toddler with Goldfish crackers, “I would not have placed him at risk.”

A healthy baby is the universal goal of pregnancy, shared by women and doctors, researchers and regulators alike. The nine months from conception to birth are extraordinarily dynamic and complex, and the complications that arise can have lifelong effects. There’s a critical need for knowledge about almost everything, from environmental causes of birth defects to how the mother’s preexisting medical conditions can affect her baby’s well-being.

Yet the same desire to protect the fetus often deters scientists and drug makers from studying the expectant mother. When it comes to drug safety, pregnancy is a largely research-free zone, women’s health experts say. The consequence? Treatment that often is based on informed guesswork rather than solid evidence, in which medications that have never been approved for use during pregnancy, and whose long-term dangers may not be known, become the standard of care. Zofran is a case study in just how problematic this system has become.

Zofran is far from unique — almost every drug prescribed during pregnancy in the U.S. is “off label,” meaning it hasn’t gone through the clinical trials required by the Food and Drug Administration before approving a drug for a specific use in a specific population. Only eight medications are currently approved by the FDA for prenatal use; from 1995 to 2011, the agency OK’d only one pregnancy-related drug. (By contrast, 29 drugs to treat cardiovascular-related conditions have won approval just since 2010.) Pregnant women have become what researchers and ethicists call“therapeutic orphans,” reliant on drugs of uncertain risk, sometimes during the earliest and most vulnerable stages of fetal development.

The problem goes back to efforts to protect women and babies from the kind of severe birth defects and other harm caused by thalidomide and other drugs in the 1960s and ‘70s — and pharmaceutical companies from legal liability for those injuries. Decades later, “pregnant women may be the most underrepresented group in the entire clinical research process,” a 2011 report by the National Institutes of Health’s Office of Research on Women’s Health declared. In a 2013 analysis, 95 percent of industry-sponsored clinical drug trials excluded expectant mothers; a mere 1 percent were designed specifically to study them.

Yet according to the Centers for Disease Control, as many as 9 in 10 expectant mothers use medications — for ailments that occur before they even realize they’re pregnant; for complications such as morning sickness, early labor, or gestational diabetes; for chronic conditions such as epilepsy, high blood pressure, or depression that often become more challenging to manage as the months pass. Hampered by a lack of peer-reviewed evidence and hard data, ob/gyns find themselves in the dark about some basic best practices: How does a drug work in an expectant woman’s body? What’s the right dose to take and the right time to take it? What are the true risks to the fetus (or lack thereof)?“Pregnant women are not like non-pregnant people,” observed Susan Wood, director of the FDA’s Office of Women’s Health from 2000 to 2005 and now an associate professor of health policy at George Washington University. “They have a different fluid volume ratio, a different metabolism … all sorts of [physiological] changes that could affect how well a drug works.”

Fewer than 10 percent of medications have enough information to determine their safety for prenatal use, the CDC notes. Off-label use of a drug during pregnancy thus becomes a kind of unregulated, unmonitored clinical trial. “We learn on the backs of [pregnant] women while pretending we don’t experiment on pregnant women,” said Ruth Faden, director of the Johns Hopkins Berman Institute of Bioethics. “But in fact, we do.” By the time the real risks become apparent, several decades may pass. The watchdog group Public Citizen analyzed how long it can take the FDA to issue a “black box” warning after problems surface with a drug. The average: 27 years after the drug was approved.

In the absence of reliable information, sometimes mothers-to-be and their physicians conclude the risks are too great and stop a medication that’s really needed, triggering an avoidable medical emergency that can do more harm than the drug itself. “If research is important to tell us when medications are unsafe, it is also important to reassure us when drugs are safe,” Faden and a group of women’s health advocates calling themselves the Second Wave Initiative argued in a recent manifesto.

The question of how to improve research on pregnant women has greater urgency as new threats such as the opioid epidemic and the Zika virus have emerged. As policy makers, medical organizations and women’s health experts grapple for a solution, the most intractable problem may be a deep-rooted cultural bias that elevates the fetus above all else. “There’s been a dogma in which pregnant women come last,” Faden said. “Always last.”

Meanwhile, Marquita Smiley and other women are often left with no clear options or answers — and little or no recourse if something goes very wrong. It’s an awful position to be in, Smiley said. “I’m trying to find the words.”


Not so long ago, doctors viewed nausea and vomiting of pregnancy (the medical term for morning sickness, abbreviated as NVP) as largely a psychological problem, at its worst a sign that a woman was so unhappy being pregnant she literally wanted to throw up her fetus. Now, the key culprit is believed to be the hormone human chorionic gonadotropin, which is produced in the placenta and surges through a woman’s body as the embryo begins its rapid growth. Studies suggest that some nausea is actually a healthy sign, with mothers who suffer from it less likely to miscarry or go into premature labor. But up to 2 percent of pregnant women develop hyperemesis gravidarum (HG), nausea and vomiting so serious it can require hospitalization — Charlotte Bronte is believed to have died from it. As with so much else about pregnancy, the long-term effects of hyperemesis are mostly unknown: “Because they see HG as a maternal disorder that lasts three months, they don’t fund the research for it,” said Kimber MacGibbon, founder of the HER Foundation, a patient advocacy group.

Three decades before Zofran arrived on the scene, thalidomide seemed like an answer. The German drug was marketed as a sedative and sleeping pill. But it also eased nausea and was believed to pose no dangers to human fetuses — until women began giving birth to babies with severely deformed limbs. After thalidomide was banned in the early 1960s, doctors and women relied on a drug called Bendectin that had received FDA approval in the 1950s specifically for morning sickness and had a long track record for safety; still, lawsuits eventually blamed it for fetal harm, ranging from skeletal malformations to blood disorders and cancer. The claims proved to be unfounded, but in 1983, the litigation-weary manufacturer voluntarily yanked it from the market. For the next 30 years, there was no FDA-approved treatment for NVP.

Other reproductive-health scandals erupted over the cancer-causing synthetic estrogen DES, which was prescribed to prevent miscarriages, and the potentially deadly Dalkon Shield intrauterine device, used to prevent pregnancy. In their aftermath, the ethical and scientific pendulum swung in the direction of extreme caution.

Pharmaceutical companies and regulators concluded that the best way to avoid injuring women and their offspring — and the resulting crush of lawsuits — was to stop doing research on all women. “The fear of bad outcomes in pregnancy led to this sort of general exclusion,” said Wood, the former FDA official. In 1977, the FDA issued formal guidelines stating that women of “childbearing potential” — i.e., anyone who had not gone through menopause or been surgically sterilized — could only be included in late-stage clinical trials, after the safety and effectiveness of a drug had already been established (a rule widely interpreted as “never”).

Thanks in large part to the furious lobbying of feminists and anti-AIDS activists, the FDA finally reversed its stance against most women in research in 1993. But pregnancy remained a conundrum. The influential Institute of Medicine argued in a report co-edited by Faden, that “If a drug is going to be used in pregnant women, then the availability of safety and effectiveness information” is critical, including “adequate information about the risks and benefits.” Moreover, pregnant women should be “treated as competent adults capable of making their own decisions.”

Over the next two decades, the FDA encouraged the pharmaceutical industry in numerous ways. It ran a series of meetings and drafted a “guidance” on how to ethically determine the biochemical and physiological effects of drugs on the pregnant body. It spent years revising labeling rules on drug safety during pregnancy (the final version was issued in 2014) and pressed companies to establish pregnancy registries to simplify tracking adverse outcomes in drugs.

Yet, widespread aversion to prenatal research persisted. The National Institutes of Health continued to categorize pregnant women as “vulnerable,” with a “questionable” capacity to give informed consent — in the same category as kids, prisoners, and the mentally disabled. Conducting research on mothers-to-be was complicated and costly, and women themselves were often hesitant to sign on. “We honestly haven’t really addressed the issue of actively trying to recruit pregnant women into clinical trials,” a research expert for the drug industry said in a recent interview, speaking on the condition of anonymity. A 52-page document by the Pharmaceutical Research and Manufacturers of America, outlining principles for conducting clinical trials and revised in 2015, doesn’t contain a single reference to pregnancy.

Physicians responded by doing what they have always done: They prescribed drugs to pregnant patients “off label,” and shared the benefits and potential risks in medical journals and at conferences. The scientific establishment and the FDA consider this part of the basic practice of medicine, beyond the scope of regulators. The result was something of a vicious cycle, Faden said. “If your product eventually will be used in this population anyway, off label, what’s your incentive for testing the drug in pregnant women before it’s approved?”

Zofran’s introduction in 1991 occurred in the midst of this research vacuum. The drug worked by blocking the action of the chemical serotonin in the brain’s so-called vomiting center. It had been extensively tested on cancer and surgical patients, and on pregnant rats and rabbits. These studies showed “no evidence of impaired fertility or harm to the fetus,” the FDA-approved package insert said. But because animal studies are imperfect predictors of human toxicity and there were “no adequate and well-controlled studies in pregnant women,” the drug “should be used during pregnancy only if clearly needed,” the label added.

Plenty of ob/gyns believed it was needed — desperately. The journal Lancet soon published letters from doctors in Greece and Britain who had used Zofran on patients with severe hyperemesis. Physicians in Hong Kong described a patient so weak that she had considered having an abortion — until the drug turned her pregnancy around. The HER Foundation’s MacGibbon had HG with both her kids, and the drug was such a salvation that she and her husband joked about naming their daughter “Zofrana.” As a registered nurse, she understood the off-label dilemma, “but I knew that if I didn’t [take it], literally, I would just sit there and puke until I couldn’t breath.”

By the time Marquita Smiley was pregnant with Zaidan in 2013, Zofran/ondansetron was available in both liquid and pill form and as a generic from 30 or so manufacturers. The online price for 30 pills had plummeted from nearly $800 to $26. Last year, more than 21 million prescriptions were filled in the U.S. for all uses of the drug, according to an analysis by IMS Health — 10 times as many as in 2006. Doctors were no longer reserving the drug for only the most difficult cases, said Smiley’s lawyer, Don McKenna of the Birmingham law firm Hare Wynn. “It got to the point where if anyone complained of an upset stomach, they would get a prescription.”


Although doctors may decide to prescribe a medication for unapproved uses, it’s illegal for drug companies to encourage them to do it. In 2012, the U.S. Justice Department announced that GlaxoSmithKline had crossed the line.

The allegations originated with ex-Glaxo marketing execs turned whistleblowers. The DOJ accused the company of engaging in all kinds of banned behavior to drive up sales — plying doctors with Caribbean vacations and hunting trips, misreporting clinical trial findings to a medical journal, withholding safety data from the FDA. The most serious, criminal charges covered the antidepressants Paxil and Wellbutrin and the diabetes drug Avandia. But in a civil settlement, DOJ said Glaxo had also spread “unsubstantiated and/or false representations” about Zofran’s use for morning sickness and “paid illegal remuneration” to doctors to promote and prescribe the drug, in violation of federal anti-kickback laws. Glaxo didn’t admit any wrongdoing where Zofran was concerned, but it pleaded guilty to fraud in connection with other drugs and paid a $3 billion fine, the largest ever levied against a drug maker. (Read ProPublica’s reporting about another drug in the civil case, the asthma medication Advair, here.)

The DOJ case hit the news at a delicate moment. For years, reports in medical journals raised few concerns about the Zofran’s use in pregnancy, but they were small and frequently observational — hardly the scientific gold standard. By 2012, however, large-enough numbers of pregnant mothers had used the drug to conduct more meaningful analyses. Researchers associated with the National Birth Defects Prevention Study found an increased risk of cleft palate in infants whose mothers had used ondansetron (a separate, unpublished analysis detected a “modest increased risk” of the type of heart problem suffered by Marquita Smiley’s son). Next came studies based on medical registries in Denmark and Sweden that tracked every pregnancy in those countries going back to the 1990s. One found no difference in birth defects between the Zofran-exposed and unexposed babies; another found an elevated risk — up to twice as high — of hole-in-the-heart defects.

Among scientists, the inconsistent studies triggered calls for more research but no major alarms. Birth defects afflict 3 percent of babies, and heart defects are the most common among them. If ondansetron does harm the fetus, “It absolutely can’t be anything huge or we would have already seen it,” said Christina Chambers, a professor at the University of California, San Diego School of Medicine who is a leading expert on environmental exposures and pregnancy.

Plaintiffs lawyers, though, thought they saw plenty of red flags. Over the next couple of years, they hired their own experts and began digging through everything from adverse-event reports filed with the FDA (more than 450 involving prenatal exposures), to the LinkedIn profiles of Zofran sales people, to obscure Japanese medical journals in which scientists working for Glaxo had published animal studies in the early 1990s.

By this spring, parents had filed more than 200 lawsuits, alleging that Zofran caused heart defects, cleft palates, and kidney problems in babies exposed to the drug in utero; in a few instances, the babies died. Lawyers contended there might be many more cases but for recent U.S. Supreme Court rulings that make it almost impossible for consumers in all but a few states to sue for injuries if the medication at issue was a generic version of a brand-name pill, as ondansetron is for Zofran. One state whose courts did allow such lawsuits was Alabama — until legislators there rewrote the law in 2015. Marquita Smiley, who took generic ondansetron, filed her lawsuit last fall, just before the courtroom doors slammed shut.

In a written statement, Glaxo said the allegations linking Zofran to birth defects are “entirely unfounded,” and pointed to the FDA’s rejection last fall of a citizen’s petition that had sought stronger pregnancy warnings on the label. The company said doctors have a right to “assess the health care needs of their patients and apply their own knowledge, training, and experience in deciding whether the therapeutic benefits of a medicine outweigh the potential risks in each patient.”

But plaintiffs’ lawyers argue that drug makers have a heightened responsibility to assure that medications likely to be used in pregnancy are safe — especially if they are used to treat a condition as common as morning sickness, and if they are marketed off-label.

“When you throw a stone in the water, you have to expect there will be ripples,” said Tobias Millrood, a Philadelphia lawyer who is one of the lead counsels. “It’s really quite that simple.”


(Bob Miller for ProPublica)

Under Alabama law, a woman who uses illicit drugs while pregnant can be arrested, prosecuted and stripped of her parental rights — even if she was just using marijuana to treat her morning sickness. Smiley’s agency, the state Department of Human Resources, is the one often called upon to investigate allegations that pregnant women and new mothers have chemically endangered their babies. Smiley doesn’t handle those kinds of cases, but she knows irony when she sees it: A woman could face 10 years in prison for endangering her unborn child with drugs, while a huge corporation could put children at risk with a drug that’s never been approved for use in pregnancy.“It’s crazy,” she said.

Take a Valium, Lose Your Kid, Go to Jail

In Alabama, anti-drug fervor and abortion politics have turned a meth-lab law into the country’s harshest weapon against pregnant women. Read the story.

In her lawyers’ office one late winter morning, Zaidan was sweet-tempered and surprisingly sturdy, exploring the unfamiliar environment with sippy cup in hand. But his skin was blotchy and his hair had been falling out. The transplant drugs have wreaked havoc on his immune system, and he spent most of March in the hospital with breathing and other problems. As much as Smiley worries about his physical health, she’s just as concerned about his cognitive and emotional development. “He had a lot of loss of oxygen to his brain early on,” she said. She has to protect him from infections, which means keeping him way from a lot of people, “and I know that’s bad because he needs social skills.” Thanks to her job, she knows where to get help: “The social worker in me had him sign up for early intervention….I’m on the receiving end of the services now.”

With so much to worry about, she hasn’t been paying much attention to the lawsuit. Glaxo lost a bid earlier this year to have the cases dismissed, and now the litigation is in its discovery phase: “GSK has to put all its cards on the table and say … ‘This is everything we knew,’” attorney Don McKenna said. The latest research has not gone in the plaintiffs’ favor: A new study looking at birth outcomes in more than 1,000 women who took Zofran or ondansetron for hyperemesis suggested that HG itself, and not the drug, might be to blame for birth defects.

Back in Washington, D.C., there has been quiet movement on the larger issue of research and pregnancy. Bipartisan bills introduced this spring in the Senate and the House of Representatives would establish a task force on research specific to pregnant women and (in the case of the House legislation) require annual updates from the FDA. The FDA is scheduled to issue its own draft guidance entitled “Pregnant Women in Clinical Trials — Scientific and Ethical Considerations” later in the year.

The agency also has approved a new drug for morning sickness called Diclegis — basically, the long-abandoned Bendectin under a new name. Last year the American College of Obstetricians and Gynecologists revised its practice bulletin, urging doctors to prescribe Diclegis as the first line of defense against NVP and ondansetron only after weighing the benefits against the risks. But Diclegis is less powerful, more costly, and Smiley and her lawyers believe women are still being given ondansetron out of habit.

Recently, she saw an old friend at church who happened to be pregnant. “She said, ‘I’m having these really bad spells with nausea. It’s hard for me to get out of bed. It’s hard for me to go to work.’”

Smiley told her friend about Zaidan and everything her family had been through. “I was like, ‘Hey, whatever you do, I don’t know if there’s any truth to this, but please find something else to take.’”

“Please don’t forget about me”: Antidepressants and birth defects “I was absolutely distraught”


Good coverage on this site of SSRI -Paxil/Seroxat (antidepressant) induced birth defects scandal.

This is the third of a three part series from the Canada Free Press.

See the website (here) for more..


Part III: “Please don’t forget about me”: Antidepressants and birth defects

“I was absolutely distraught”


Lyam David-Kilker was born on 24 October 2005, the second son of Michelle David and Miles Kilker of Bensalem, Pennsylvania. At birth he seemed like a normal, happy, healthy infant, but all that soon changed. His breathing was labored, and he became lethargic and lost his appetite. His parents took him to the doctors, who delivered devastating news. Lyam was born with multiple cardiac defects: a hole in his atrial septum, a hole in his ventricular septum, along with transposition of the great arteries—the same condition which afflicted Christiane and Amery’s son Daniel. Lyam required two open-heart surgeries and spent the first six months of his life in the hospital.

Shortly before conceiving, Michelle David had been prescribed Paxil for mild anxiety and occasional panic attacks, and she continued to take the drug throughout her pregnancy. After Miles Kilker heard a commercial message on television for the law firm linking Paxil to congenital heart defects, Michelle called the number and was referred to Sean Tracey, a personal injury lawyer from Houston.

Part I: “Please don’t forget about me”: Antidepressants and birth defects
Part II: A gigantic uncontrolled experiment
Part III: I was Absolutely Distraught

During the trial, the plaintiff’s lawyers cited a couple of 2001 emails to GlaxoSmithKline from a woman (not Michelle David) who had taken Paxil while pregnant. The woman’s name was redacted from all court documents. The first email from her, dated 31 May, read:

“My name is [redacted]. I was diagnosed with panic disorder about four-and-a-half years ago. Since that time I’ve been taking Paxil, which is truly a miracle drug. I’ve been panic-free with this drug and have been able to go on with a normal life.

“I was married in October of 2000.My husband and I found out we were pregnant at Christmas time. I was so excited. I love children. The only problem is that I carried the baby to six months gestation and then had to have a termination.

“The doctors diagnosed my son with Truncus arteriosis. They said he would not lead a normal childhood and would most likely not make it through the open heart surgery that he would need as soon as he was delivered (if he was able to make it to that time). To say the least, I was absolutely distraught with this news.I thought this was something that I did, was because I stayed on the Paxil for selfish reasons.

“I wanted to know if you could direct me to any information you might have of any woman that has taken Paxil and still had healthy babies. My husband and I are ready to try again to get pregnant in the next month or two. I am so nervous. I don’t want to stop taking my miracle pill. But, then again, if there is a chance that this might hurt or affect the baby I want to know upfront. And I will somehow stop taking it for the time being.

 

“Please contact me as soon as possible. I love everything this drug has done for me. I am so thankful that your company had this available for me.I just want to continue to have a normal life and have the child that I always wanted. Please contact me as soon as possible.

“Please don’t forget about me,Thank you.”

GSK responded:

“Thank you for your inquiry. We are attaching a copy of our current product information for Paxil. Please review the section on use during pregnancy. Further questions about your treatment should be directed to the physician, pharmacist or healthcare provider who has the most complete information about your medical condition. Because patient care is individualized, we encourage patients to direct questions about their medical condition and treatment to their physician. We believe that because your physician knows your medical history, he or she is best suited to answer your questions.

“Our drug information department is available to answer any questions your physician or pharmacist may have about our products. Your healthcare professional can call our drug information department at 1-888…”.

Continued below…



Congenital malformations associated with this drug

At that time, the prescribing information for Paxil made no mention of the number of reports of congenital malformations associated with this drug, and it was company policy not to tell doctors, patients, or pharmacists, either.

On 1 June, the mystery woman wrote again:

“This response is in regards to an e-mail that I had sent you previously. I was asking to see if you have any or are in the process of any clinical trials for women who are currently on Paxil and pregnant. I wanted to find out information to see how many women were on Paxil during pregnancy and if they were able to successfully have healthy babies.

“I am in no way insinuating your product did this to my child. I love the product, and I don’t think I could have gotten through my panic attacks without the wonderful help of this miracle drug. I just want to start to try and get pregnant again soon. I do not want to put my unborn child through anything that would hurt him/her.

“Please, if you do not have this information, where is this information held? Does anyone do studies like this?Please, any information you may give me would be great.Thanks again for your help.”

GSK responded to the mystery woman’s query by certified mail, asking her to sign a form authorizing the release of her medical records to GSK. The letter never reached her—it was returned as “undeliverable” by the US Postal Service. GSK apparently made no further efforts to communicate with her, although they did send a Medwatch report to the FDA, stating that “mother’s concurrent medications and medical conditions were not specified.” An internal GSK document, dated 13 June 2001, stated the link between Paxil and the cardiac defects suffered by the mystery woman’s unborn fetus was “almost certain.”

 

Continued below…



Lawyers for GSK argued that somebody must have checked the “almost certain” box by mistake. The jury didn’t buy it, and on 29 October 2009 awarded $2.5 million to Lyam Kilker.

Lyam survived, but hardly unscathed. For the rest of his life he will suffer from high blood pressure and diminished energy, and he will need repeat surgeries to replace the grafts covering the holes in his heart.

On 2 July 2012, the United States Department of Justice announced that GlaxoSmithKline had agreed to pay $3 billion to settle claims of illegal marketing of its products, including Paxil—the largest such payout in history. The same day the settlement was announced, the value of GSK shares rose 1.3%.

David Healy is a Professor of Psychiatry at Bangor University and the author of Pharmageddon, and he also testified as an exert witness at the Kilker trial. In a telephone interview he blasted SmithKline Beecham for not following up on early indications that paroxetine could cause birth defects. “They didn’t do what they ought to have done, do the kind of studies that they ought to have done.” He likened their attitude to that of tobacco company executives confronted with evidence of the harm their product could cause: “Let’s not look too closely at this.”

The mystery woman was later identified as Joanne Thomas, and she subsequently filed a wrongful death suit against GSK. On 27 November 2013, the Common Pleas Court of Philadelphia ruled against her on the grounds that the developing fetus (whom she called Ryan) had not reached the age of viability when the pregnancy was terminated. The certificate of fetal death listed Ryan’s gestational age as 21 ¬Ω weeks, whereas 3 days before the pregnancy was terminated, a cardiologist estimated Ryan’s age at 22 weeks. According to Pennsylvania law, a fetus is not considered “viable” until the age of 23 weeks.

Next: Part 4: “Patient safety is our highest concern”


Patrick D Hahn — Bio and Archives |Patrick D Hahn is an Affiliate Professor of Biology at Loyola University Maryland and a free-lance writer. His writing has also appeared in Biology-Online, Loyola Magazine,Popular Archaeology, Natural News,Canada Free Press, and the Baltimore Sun.

Glaxo Looks To Bar FDA, Plea Evidence From Paxil Trial


Interesting article on the Paxil (seroxat) birth defect trials that GSK is trying to quash at the moment, particularly these parts-

“…The drugmaker also railed against evidence that lab notebooks from 1979 animal studies were destroyed in 1993, saying the claim “grossly distorts the regulatory practices in place at the time” and is “a manufactured controversy” likely to make jurors assume malfeasance….”

” GSK asked the judge to bar evidence about a 2012 plea agreement and three civil settlements; it pled guilty to one misdemeanor count of drug misbranding. This guilty plea carried no implication of fraud with it, the company said. And the misbranding had to do with Paxil’s use for patients under 18.”..


GSK’s attorneys are lower than gutter slime..

An Amoeba would have more depth of character …

https://www.law360.com/trials/articles/884297/glaxo-looks-to-bar-fda-claims-guilty-plea-from-paxil-trial

Glaxo Looks To Bar FDA, Plea Evidence From Paxil Trial

Law360, New York (January 24, 2017, 4:49 PM EST) — Jurors in an upcoming trial over birth defects allegedly caused by the antidepressant Paxil must not be told about drugmaker GlaxoSmithKline‘s alleged campaign to defraud the FDA, about destruction of study data or about its 2012 guilty plea on misbranding charges, the company insisted Tuesday.

The company filed a slew of motions seeking to box out evidence it said is irrelevant to mother Kathryn Kiker’s claims that taking the drug while pregnant caused her child’s ventricular septal defect, a serious heart problem. The trial is set for Feb. 21 in the Columbus, Ohio, courtroom of U.S. District Judge Edmund Sargus.

“GSK anticipates that plaintiffs will argue at trial that GSK committed ‘fraud on the FDA’ by not cooperating fully with, and by withholding information from, the FDA regarding adverse events, animal studies and/or clinical trials  … so that the FDA did not undertake regulatory action with regard to Paxil,” the company said. But the claims “are incorrect, irrelevant and inadmissible,” it said. “Furthermore, the U.S. Supreme Court has held that FDA — not a private plaintiff — has exclusive authority to police disclosures made to [the] FDA.”

The drugmaker also railed against evidence that lab notebooks from 1979 animal studies were destroyed in 1993, saying the claim “grossly distorts the regulatory practices in place at the time” and is “a manufactured controversy” likely to make jurors assume malfeasance.

And in another motion, GSK asked the judge to bar evidence about a 2012 plea agreement and three civil settlements; it pled guilty to one misdemeanor count of drug misbranding. This guilty plea carried no implication of fraud with it, the company said. And the misbranding had to do with Paxil’s use for patients under 18.

Even as information about character, the plea deal is not usable, the company said.

“Evidence regarding felonies and any crime whose elements require proof of a dishonest act or false statement may be admissible for impeachment. GSK’s plea to no-intent, strict-liability misdemeanors under the FDCA is inadmissible for impeachment purposes because it does not fall within either category,” it said.

And it requested oral argument on another motion seeking to bar evidence about other lawsuits, investigations or media reports.

In October 2015, an Ohio federal judge ruled that GSK must face the suit because the mother successfully pled fraud.

U.S. District Judge Edmund Sargus denied GlaxoSmithKline LLC’s motion for judgment on the pleadings, rejecting its argument that Kiker’s claims accrued in September 2005, when the company told the medical community about Paxil’s links to birth defects, and are thus abrogated by the Ohio Product Liability Act, which was amended in 2005 and curtailed common-law liability claims in the state.

But the judge sided with Kiker’s argument that her claims accrued when her child, referred to as C.S., was born in 2001.

The judge said that a provision in the 2005 Tort Reform Act includes a discovery rule so that a bodily injury claim may be extended to a date when it was reasonable for the injured party to have discovered her injury was related to a product. The judge also found that the fraud allegations in Kiker’s proposed amended complaint were sufficiently particular, and granted her leave to file the amended complaint.

“At the time Paxil was prescribed to Ms. Kiker, GSK knew … that Paxil was associated with a significant increased risk of cardiac birth defects in babies,” Kiker said. “Other studies showed that increased levels of serotonin, the primary human substance affected by Paxil, had profound effects on the prenatal cardiac development of study animals.”

Despite knowing these risks, she said, GSK suggested Paxil was safer than other available selective serotonin reuptake inhibitors, or SSRIs, and misled the medical community as to its safety. Kiker said GSK did not begin to inform doctors of the risks until September 2005, when third-party research showing the association was released.

The entire time the drug has been on the U.S. market, federal regulations have required stronger warnings in the presence of evidence of a birth-defect link, Kiker said. These FDA regulations specifically state that the link need not be proven and that the company can issue the warning without agency approval.

Kiker is represented by Benjamin Anderson of Anderson Law Offices LLC and Bryan Aylstock, James Barger, Bobby Bradford, Roger Cameron and R. Jason Richards of Aylstock Witkin Kreis & Overholtz.

GSK is represented by Andrew Bayman, Halli Cohn and Meredith Redwine of King & Spalding LLP and William Darrell Kloss Jr., Adam Rusnak and Jessica Goldman of Vorys Sater Seymour & Pease LLP.

The case is Kiker v. Smithkline Beecham Corp., case number 2:14-cv-02164, in the U.S. District Court for the Southern District of Ohio.

–Additional reporting by Emily Field. Editing by Philip Shea.

GSK Can’t Ax Out-Of-Staters From Ill. Paxil (Seroxat) Suit, Court Says


GSK Can’t Ax Out-Of-Staters From Ill. Paxil Suit, Court Says

http://www.law360.com/articles/833842/gsk-can-t-ax-out-of-staters-from-ill-paxil-suit-court-says

Law360, Boston (August 29, 2016, 5:06 PM EDT) — GlaxoSmithKline LLC had enough purposeful contacts with Illinois during clinical trials for the antidepressant Paxil for it to face claims from out-of-state residents that the company failed to warn that the drug could cause serious birth defects, a state appeals court ruled Friday.

The First District Appellate Court of Illinois, Fifth Division, ruled that the standard for a showing that a defendant’s conduct was “arising from” its contacts with the state was “lenient and flexible,” giving the state courts jurisdiction over the pharmaceutical giant. The decision in an interlocutory appeal upholds the trial court’s denial of GSK’s dismissal bid.

“In light of the lenient and flexible ‘arising from’ and ‘related to’ standard, plaintiffs meet the low threshold of a prima facie showing that their claims arose from defendant GSK’s Paxil trials in Illinois,” the appeals court said.

In the suit, eight minors from six states — Illinois, Florida, Colorado, Virginia, Michigan and Wisconsin — said that they suffered catastrophic birth defects because their mothers were taking GSK’s Paxil. The label failed to warn them of serious birth defects that the drug could cause, the plaintiffs said, and that was the result of inadequate clinical trials, 18 to 21 of which occurred in Illinois via 17 Illinois doctors. That meant that the claims arose directly out of or were related to GSK’s purposeful contacts with Illinois, the plaintiffs argued.

GSK argued that Illinois did not have jurisdiction over the out-of-state plaintiffs.

“GSK is disappointed by the court’s decision and is considering its options,” the company said in an emailed statement Tuesday.

Tor Hoerman, whose firm represented the plaintiffs, said in an emailed statement: “This decision is entirely in line with existing precedent of the Illinois Supreme Court and Appellate Court. … Drug makers who conduct inadequate or manipulated clinical trials in Illinois should not be surprised that they can be sued in Illinois for that conduct.”

In trying to have the suit dismissed as to the out-of-state plaintiffs, GSK said that its clinical trials occurred in 44 states and foreign countries, too attenuated for personal jurisdiction in one state where it’s not headquartered. Its alleged acts or omissions in Illinois were not the “but for” cause — in other words, GSK said, the plaintiffs couldn’t show that the harm would not have occurred but for what GSK did in Illinois.

In addition, GSK argued, the plaintiffs weren’t study subjects there, and the out-of-state plaintiffs didn’t take Paxil or suffer injuries in Illinois.

The children and their mothers argued that GSK had meaningful contacts with Illinois through its clinical trials of Paxil, during which they said it failed to track 18 pregnancies, one of which resulted in a heart defect. According to Friday’s decision, GSK employs 16,323 people in the U.S., including 217 who reside in Illinois, and from 2000 to 2006, GSK had between 79 and 121 employees marketing Paxil in Illinois.

They did not have to prove that any act was committed in Illinois, but just make a prima facie showing, the defendants said.

In a ruling Friday, the appeals court sided with the plaintiffs.

“The quality of defendant GSK’s relationship with Illinois can hardly be characterized as random, attenuated or the like; the contacts with Illinois, over the course of two decades, were purposeful and directed,” the appeals court ruled.

The plaintiffs, and the judges, used some of GSK’s own statements to show that the case could continue. In a declaration, GSK said that the principal Paxil investigators had “little or no input into or control over the study design protocol or analysis of the aggregate data collected from all study sites.”

“As plaintiffs argue, the word ‘little’ invites the inference that the physicians had some degree of input into, and control over, the clinical trials, or else the word would have been omitted,” the appeals court said. Absent further guidance in the record, we ‘resolve in favor of the plaintiff any conflicts in the pleadings and affidavits.’”

Judges Robert E. Gordon, Bertina E. Lampkin and Eileen O’Neill Burke sat on the panel for the First District.

GlaxoSmithKline is represented by Dentons.

The plaintiffs are represented by Ken Brennan of TorHoerman Law LLC.

The case is M.M., a minor, et al. v. GlaxoSmithKline LLC et al., case number 1-15-1909, in the Appellate Court of Illinois, First District, Fifth Division.

–Editing by Mark Lebetkin.

Update: This story has been updated to include a comment from GSK.

Los Angeles Parents File Suit to Hold GlaxoSmithKline Accountable for the Death of Their Daughter and Warn Pregnant Mothers of the Link Between Zofran and Birth Defects


http://www.businesswire.com/news/home/20151113005936/en/Los-Angeles-Parents-File-Suit-Hold-GlaxoSmithKline

Los Angeles Parents File Suit to Hold GlaxoSmithKline Accountable for the Death of Their Daughter and Warn Pregnant Mothers of the Link Between Zofran and Birth Defects

November 13, 2015 07:40 PM Eastern Standard Time

SAN FRANCISCO–(BUSINESS WIRE)–Sarah R. London and Paulina do Amaral of the national plaintiffs’ law firm Lieff Cabraser Heimann & Bernstein, LLP, announce that Paul Ramirez and Dulce A. Morga, residents of Los Angeles County, California, have filed a personal injury lawsuit against pharmaceutical giant GlaxoSmithKline LLC (“GSK”) for injuries leading to the death of their infant daughter, Baby Sarah Ramirez Morga, allegedly as a result of Ms. Morga being prescribed GSK’s drug ondansetron (brand name Zofran) while pregnant.

“But the loss of Sarah will be a pain we carry with us for the rest of our days. We hope our lawsuit helps to alert other women to the issues with this drug.”

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“We are deeply grateful for the excellent medical care our daughter received,” stated Dulce Morga. “But the loss of Sarah will be a pain we carry with us for the rest of our days. We hope our lawsuit helps to alert other women to the issues with this drug.”

Zofran is a potent drug developed by GSK that was approved by the U.S. Food and Drug Administration to treat only patients afflicted with the most severe nausea imaginable – nausea suffered as a result of chemotherapy or radiation treatment. GSK nevertheless marketed Zofran “off-label” as a safe and effective treatment for the very common side effect of a normal pregnancy – pregnancy-related nausea and vomiting – otherwise known as “morning sickness.”

In 2012, GSK pled guilty to criminal charges filed by the U.S. Department of Justice for its off-label promotion of certain prescription drugs, including Zofran, for uses never approved by the FDA. Zofran, however, continues to be widely prescribed to pregnant women across America to treat morning sickness even though it was never approved for this use.

Ms. Morga and Mr. Ramirez’ daughter was born in late 2014 with congenital heart defects, including severe Epstein’s anomaly of the tricuspid valve. Per her doctor’s notes, she was born with an enormous heart with a very large atrialized right ventricle that was not functioning. She underwent open heart surgery when she was just five days old, and did not survive the trauma and passed away in her mother’s arms five days later.

“Despite having received hundreds of reports of birth defects associated with Zofran and continuing strong sales to pregnant women, GSK has not performed any clinical studies on the safety or efficacy of Zofran for treating morning sickness,” stated London, counsel for Mr. Ramirez and Ms. Morga. “Moreover, GSK has not updated Zofran’s labeling to warn mothers and physicians that epidemiology studies report an increased risk of birth defects in infants exposed to Zofran during pregnancy. Recent studies report that a mother exposed to Zofran had greater than doubled risk of having a baby with a heart defect as compared to a mother who did not ingest Zofran during pregnancy.”

The lawsuit was filed November 13, 2015 in federal court in the Central District of California. The lawsuit alleges claims of negligence, strict products liability, intentional misrepresentation, concealment, negligent misrepresentation, breach warranty, and violations of California law. Mr. Ramirez and Ms. Morga seek compensatory and punitive damages from GSK.

July 2015: Prozac and Rival Seroxat Can Increase Chance Of Some Birth Defects By Up To Three And A Half Times


http://www.dailymail.co.uk/health/article-3154229/Risk-baby-anti-depressants-mums-Prozac-rival-Seroxat-increase-change-birth-defects-three-half-times.html

Risk to baby from anti-depressants for mums-to-be: Prozac and rival Seroxat can increase chance of some birth defects by up to three and a half times

  • Problems include heart defects, brain problems and irregular skull shape 
  • Findings highlight concerns over increasing use of antidepressants 
  • Paroxetine and fluoxetine account for 8million UK prescriptions in 2014
  • But experts have stressed the risk to the unborn baby is still small  

Two of the most-commonly prescribed antidepressants increased the risk of some birth defects by up to three and a half times

Two of the most-commonly prescribed antidepressants increased the risk of some birth defects by up to three and a half times

Women who take certain antidepressants during pregnancy are more likely to have a baby with a birth defect, research suggests.

Two of the most-commonly prescribed antidepressants – fluoxetine, sold under the brand name Prozac, and paroxetine, sold as Paxil or Seroxat – increased the risk of some birth defects by up to three and a half times.

Problems include heart defects, brain problems and irregular skull shape.

Experts stressed that the absolute risk is still small – heart defects among babies whose mothers took paroxetine, for example, increased from just 10 per 10,000 births to 24 per 10,000.

But the findings highlight concerns that the increasing use of antidepressant drugs could be having a detrimental effect on patients and their children.

The findings, published last night in the British Medical Journal, come after NHS figures released this week revealed that the use of antidepressants has nearly doubled in the last decade, from 29million prescriptions in 2004 to 57million last year.

Paroxetine and fluoxetine are among the most commonly prescribed, between them accounting for 8million prescriptions in 2014.

British experts last night insisted that antidepressants remain important – and that harm is far more likely to befall a baby if a depressed or anxious mother stops taking their medication.

Researchers in the US focused on selective serotonin reuptake inhibitor (SSRI) antidepressants, which they said are increasingly being used by women during pregnancy.

The team said that while they found reassuring evidence for some types of SSRI drugs, others significantly increased the chance of a baby being born with a defect.

The research, led by the National Centre on Birth Defects and Developmental Disabilities in Atlanta, Georgia, looked at the health records of 28,000 pregnancies between 1997 and 2009.

They recorded use of the SSRI drugs citalopram (Celexa or Cipramil), escitalopram (Lexapro), fluoxetine (Prozac), paroxetine (Seroxat or Paxil), and sertraline (Zoloft) at least once in the period from one month before conception through to the third month of pregnancy.

The two most commonly used SSRI drugs in England – citalopram and sertraline which together account for 22million prescriptions – were not associated with any increase in birth defects.

But fluoxetine and paroxetine – the third and fourth most widely used SSRIs – were linked to a significant increase in problems.

Fluoxetine was linked with heart wall defects and irregular skull shape.

But experts have tressed that the absolute risk is still small - heart defects among babies whose mothers took paroxetine, for example, increased from just 10 per 10,000 births to 24 per 10,000

But experts have tressed that the absolute risk is still small – heart defects among babies whose mothers took paroxetine, for example, increased from just 10 per 10,000 births to 24 per 10,000

Mothers who took paroxetine were more likely to have babies with brain and skull formation problems and abdominal wall defects.

The chance of brain and skull problems associated with paroxetine increased from two per 10,000 to seven per 10,000, and for heart defects from 10 per 10,000 to 24 per 10,000.

The authors wrote: ‘Although our analysis strongly supports the validity of the associations that were observed, the increase in the absolute risks, if the associations are causal, is small.

‘Continued scrutiny of the association between SSRIs and birth defects is warranted, and additional studies of specific SSRI treatments during pregnancy and birth defects are needed to enable women and their healthcare providers to make more informed decisions about treatment.’

But Dr Michael Bloomfield, a clinical lecturer in psychiatry at University College London, said that doctors in the UK generally prescribe lower doses of psychiatric medicines to patients than in the US and warned that no one should stop taking treatment without talking to their doctor first.

However the findings highlight fears the increasing use of antidepressants could be having a detrimental effect

However the findings highlight fears the increasing use of antidepressants could be having a detrimental effect

He added: ‘Whilst common, depression can be a potentially life-threatening illness. Any decision around treatment in pregnancy needs to weigh up the potential small risks of birth defects against the benefits of treatments including helping a mother get better from depression.

‘In addition, there is evidence to suggest that a baby whose mother had depression during pregnancy may be more likely to have mental illnesses themselves during later life.’

Dr Patrick O’Brien, spokesman for the Royal College of Obstetricians and Gynaecologists, added: ‘Our advice for pregnant women suffering with depression would be that generally the benefits outweigh the risks, however, all pros and cons should be discussed and weighed up by a woman, together with her obstetrician.’

Parents Sue GlaxoSmithKline for Daughter’s Zofran Death


June 28, 2015, 08:00:00AM. By
Deertrail, CO: Amanda recently filed a product liability complaint against GlaxoSmithKline (GSK), the maker of Zofran, claiming the drug she used during pregnancy caused her son to be born with a birth defect.

Zofran Linked to Hypospadias Birth Defect, Mother Furious“My son was born with hypospadias, where the urethra forms abnormally and is not at the top of his penis,” says Amanda. “The urologist told me that it is a birth defect.” The urethra forms during weeks 8-14 of pregnancy: Amanda took Zofran to help treat morning sickness during her second trimester, which is from week 13 to the end of week 26.

The abnormal opening can form anywhere from just below the end of the penis to the scrotum, and there are different degrees of hypospadias; some can be minor and some more severe, according to the Centers for Disease Control and Prevention. Amanda’s son required surgery when he was two months old to correct the problem but he still suffers from the birth defect.

“I don’t know if I can put my son through another surgery,” says Amanda. “I first noticed that his penis wasn’t normal after his circumcision – he wasn’t urinating properly. Now he is three years old and still having problems: he says it hurts. I’m scared about putting him through another surgery in case it doesn’t get corrected again. But I am getting a second opinion.”

When Amanda discovered last year that there was a link to Zofran and hypospadias, she was furious. “I cried so much, and the guilt is overwhelming. I am constantly dealing with this issue. You think that taking a drug is safe, especially for something ‘simple’ like morning sickness. Finding out the danger of this drug really is devastating, and very scary. And to top it off, I heard that the Zofran manufacturer was aware of Zofran birth defects yet didn’t recall it.”

In 2004, the medical journal An International Journal of Obstetrics and Gynaecology indicated a “possible” link between Zofran (ondansetron)] and hypospadias. The study noted that more studies are required and suggested that GSK lacked safety research on its drug. As well, the researchers said that “Despite the fact that it is not indicated, women are being prescribed this drug for the treatment of nausea and vomiting of pregnancy (NVP).”

“When my son pees, his penis points down at an angle. He has two holes, and urinates from one of them. He is a healthy boy except for this,” Amanda adds. “I didn’t take Zofran with my second child and he is fine. Thank god I didn’t have NVP with him, or maybe I was just able to handle the nausea better.

“I can’t believe there is a drug on the market that can harm innocent babies. I’d like to see that come off the shelf. I hope this message serves as a warning to pregnant women who are considering taking Zofran.” Add to Amanda’s warning, doctors who prescribe it.

The US Department of Justice in 2012 reached a $3 billion settlement with GSK after the government alleged the company promoted the off-label uses of several drugs, including Zofran.

GSK’s Zofran Drug And Birth Defects..


http://www.lawyersandsettlements.com/articles/zofran-birth-defects/zofran-glaxosmithkline-llc-gsk-us-20540.html#.VRduKEbIto5

Is Zofran Manufacturer GSK Talking from Both Sides of Its Mouth?

March 27, 2015, 08:00:00AM. By

Pittsburgh, PA: Twenty-three years is a long time. And yet, that’s the timespan a Zofran lawsuit alleges that Zofran manufacturer GlaxoSmithKline (GSK) has been in possession of evidence suggesting a risk of birth defects associated with the use of Zofran in pregnancy.

Is Zofran Manufacturer GSK Talking from Both Sides of Its Mouth?Various studies have offered conflicting views on Zofran, and other generic versions of ondansetron (Zofran). And there is little doubt about ondansetron’s capacity for curbing nausea – an often debilitating byproduct of pregnancy. For some women, morning sickness can be so extreme that only medication can prevent the sometimes constant vomiting, dehydration and weight loss that severe morning sickness can foster.

And yet, ondansetron was never approved by the US Food and Drug Administration (FDA) for use as a treatment for morning sickness. Zofran manufacturer GSK makes that very point, noting in a Canadian media report last June that “the safety of ondansetron for use in human pregnancy has not been established…[GSK] monitors and reports all adverse event reports…” (The Toronto Star, 6/25/14).

But is GSK talking from both sides of its mouth? That’s the way it appears, as GSK was previously accused of promoting Zofran off-label for morning sickness, or so it is alleged. The US Department of Justice asserted that GSK had not only promoted Zofran and other drugs off-label, but that the company provided kickbacks to doctors in exchange for prescribing Zofran for morning sickness. Court documents, according to The Toronto Star, alleged that GSK disseminated false and misleading information about the safety and effectiveness of Zofran.

In 2012, GSK settled with the US Department of Justice for $3 billion. As part of the settlement, GSK was not required to admit to any wrongdoing. That latter bit is a frequent feature of government settlements: the ability to escape a finding of wrongdoing in exchange for a massive payment.

One of the more recent Zofran lawsuits, filed by plaintiff Cheri Flynn in Pennsylvania, mirrors allegations contained in the US Department of Justice lawsuit: that GSK knowingly marketed Zofran to pregnant women without sharing information about the potential for Zofran birth defects – information the lawsuit alleges GSK has had in its possession since 1992, if not before.

“GSK not only concealed this knowledge from healthcare providers and consumers in the United States, and failed to warn of the risk of birth defects,” the Flynn lawsuit states, “but GSK also illegally and fraudulently promoted Zofran to physicians and patients specifically for the treatment of morning sickness in [pregnant] women.”

Drug manufacturers do not have the legal, ethical or medical authority to market a drug off-label. Ondansetron was originally approved by the FDA for treatment of nausea in cancer patients following chemotherapy. It was never indicated for pregnant women, although doctors have always had the authority to prescribe off-label should they feel it would benefit the patient. And yet, The Toronto Star last June suggested that doctors in Canada are prescribing ondansetron off-label without having all the facts.

One wonders if the same thing is happening in the US.

“Women ingested the drug because they innocently believed that Zofran was an appropriate drug for use in their circumstance,” the Flynn lawsuit contends. “When they ingested the drug, these pregnant women had no way of knowing that Zofran had never been studied in pregnant women, much less shown to be a safe and effective treatment for pregnancy-related nausea.”

The Zofran lawsuit is Cheri Flynn v. GlaxoSmithKline LLC, Case No. 2:15-cv-00709-PD, United States District Court of the Eastern District of Pennsylvania. The lawsuit alleges that Flynn’s two children suffered congenital heart defects and other birth defects following fetal exposure to Zofran.

http://www.wkrg.com/story/28277705/zofran-lawsuit-alleges-gsk-failed-to-disclose-zofran-dangers

Zofran Lawsuit Alleges GSK Failed to Disclose Zofran Dangers

Posted: Mar 06, 2015 8:06 AM GMT

This article was originally distributed via PRWeb. PRWeb, WorldNow and this Site make no warranties or representations in connection therewith.

Zofran lawyers at the Onder Law Firm have expanded their website to provide information about the allegations made in a new Zofran lawsuit filed in Pennsylvania.

St. Louis, MO (PRWEB) March 06, 2015

A new Zofran lawsuit has been filed in U.S. District Court in Pennsylvania, according to attorneys handling Zofran lawsuit claims alleging birth defects.* The lawsuit alleges that the plaintiffs two children suffered congenital heart defects and other birth defects after fetal exposure to Zofran, according to court documents.

This Zofran lawsuit alleges that the defendant, pharmaceutical company GlaxoSmithKline (GSK) was aware of evidence supporting a link between Zofran use during pregnancy and the increased incidence of congenital heart defects and other birth defects, according to court documents:

Since at least 1992, GSK has had mounting evidence showing that Zofran presents an unreasonable risk of harm to babies who are exposed to the drug during pregnancy.* According to court documents, the lawsuit cites numerous pieces of evidence in support of this statement, saying GSK was aware of the following:

  • Zofran readily crosses human placental barriers during pregnancy.*
  • Animal studies conducted on Zofran indicate that Zofran cannot be used safely or effectively in pregnant women.*
  • Since 1992, GSK has received hundreds of reports of major birth defects associated with prenatal Zofran exposure.*

According to court documents, the plaintiff alleges that GSK knowingly marketed Zofran to pregnant women, without issuing a birth defects warning, despite evidence suggesting this was not a safe application of the drug: GSK not only concealed this knowledge from healthcare providers and consumers in the United States, and failed to warn of the risk of birth defects, but GSK also illegally and fraudulently promoted Zofran to physicians and patients specifically for the treatment of morning sickness in pregnancy women.*

The FDA has never approved Zofran as safe for pregnant women, yet women are still being prescribed Zofran during pregnancy, believing the drug is safe, according to court documents: “Women ingested the drug because they innocently believed that Zofran was an appropriate drug for use in their circumstance. When they ingested the drug, these pregnant women had no way of knowing that Zofran had never been studied in pregnant women, much less shown to be a safe and effective treatment for pregnancy-related nausea.”*

A few women have now stepped forward to file Zofran lawsuits. As more families learn about the allegations of birth defects from Zofran, we anticipate hearing from others interested in filing Zofran lawsuits, said Jim Onder of the Onder Law Firm.

The Onder Law Firm, nationally-renowned as a leading family safety and consumer liability law firm, provides legal representation for families seeking to file Zofran lawsuits for allegations of birth defects. Zofran attorneys representing clients nationwide offer Zofran lawsuit news and updates at their website. The firm provides no-cost, no-obligation case evaluation for mothers and families whose babies wer born with a birth defect following prenatal exposure to Zofran. Individuals who fit this description may contact a lawyer to discuss whether they have grounds for a Zofran lawsuit. The firms Zofran lawyers believe persons who meet this description may be entitled to real compensation. For more information, visit the Zofran lawsuit website.

The Onder Law Firm welcomes Zofran case inquiries from law firms in regards to handling them or working as co-counsel.

About The Onder Law Firm
Onder, Shelton, OLeary & Peterson, LLC is a St. Louis based personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. The pharmaceutical and medical device litigators at The Onder Law Firm have represented thousands of Americans in lawsuits against multinational conglomerates from products liability for manufacture of defective or dangerous products to deceptive advertising practices. Other firms throughout the nation often seek its experience and expertise on complex litigation. It is also a recognized leader in products liability cases such as window blind cord strangulation. The Onder Law Firm offers information on Zofran lawsuits at http://www.247LawsuitNews.com.

*Cheri Flynn vs. GlaxoSmithKline LLC, Case 2:15-cv-00709-PD, United States District Court of the Eastern District of Pennsylvania

For the original version on PRWeb visit: http://www.prweb.com/releases/zofran-birth-defects/zofran-lawsuit/prweb12564236.htm

Information contained on this page is provided by an independent third-party content provider. WorldNow and this Station make no warranties or representations in connection therewith. If you have any questions or comments about this page please contact pressreleases@worldnow.com.

Bob Fiddaman Draws Attention To Paxil (Seroxat) Birth Defect Litigation…


Great post from Seroxat Sufferers Blog..

Tuesday, April 08, 2014

http://fiddaman.blogspot.ie/2014/04/ryan-glaxos-non-viable-fetus-part-i.html

Ryan, Glaxo’s Non-Viable Fetus – Part I

Joanne Thomas, disputes Glaxo’s claim that her fetus was “non-viable”
Disputes the Statute of Limitations Defence used by Glaxo’s attorneys.





Intro:

The following is probably one of the most complex posts I have ever written. It’s been months in the making, it’s been chopped, changed, edited, re-edited and even circulated among attorneys before finally making publication here today.

I’ve tried to simplify things as much of what is contained has to do with points of law, to be more specific, Pennsylvania law.

It’s fair to say that corresponding and speaking with Joanne Thomas has been eye-opening, to say the least.

The law is the law and cases like this expose its ludicrousness.

This is the story of Joanne Thomas and her unborn child, Ryan. It’s part I of II and is leading up to some pretty startling revelations regarding GlaxoSmithKline and their lawyers, King & Spalding.

Everyone is entitled to a good defence team, even GlaxoSmithKline has that right. If I was to ever step into law I’d rather work for a prosecution team, you know, go after the bad guys and not defend them when I know they have done wrong.

I’d love to be able to bring back people from the dead too, children and adults, you know those ones who had their lives cut short through no fault of their own, those who were not forewarned that their actions could, ultimately, lead to their premature deaths.

Wouldn’t it be great if we, after death, did meet up with those that had passed before us. Whether we actually do or not is just a belief, one of hope.

This post is about those who didn’t have a chance to walk the earth, who, through no fault of their own, were introduced to medicine before they were born. This post is also about GlaxoSmithKline and their highly paid defence lawyers and just how far they go to keep their name and products intact. It’s about how they hold on to their coffers because to simply compensate a mother who aborts a fetus that was malformed due to Paxil  (Known as Seroxat in Europe and Aropax in Australia and NZ) ingestion is not a road that Glaxo or their attorneys wish to go down. They use every trick [lawfully] in the book, blame everyone and everything. They operate within a law that gives them the upper hand, that, I believe, allows them to twist a knife in the gut of a mother who has already lost something so precious, the life of a child.

Their abject denial at something so abhorrent as a life dying before it has had a chance at living sickens me. Their defence of Paxil [paroxetine] causing birth defects or forcing the arm of a pregnant mother to abort sickens me too.

Here’s an insight into how GlaxoSmithKline and it’s lawyers operate. I am posting this because not many people truly understand what we are dealing with here. It’s a post that has taken a number of months to piece together, it’s a post that highlights the tenacity of a mother driven to seek justice on her own because the law has failed her. I’d like to thank Joanne Thomas for her patience and all those who worked behind the scenes and who offered advice and support to Joanne during this difficult time.

Ryan, Glaxo’s non-viable fetus

Joanne Thomas fell pregnant in 2000, during the course of which Joanne was taking 40mg of Paxil. Back in 2000 Paxil was classed as a Category C drug (Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. Or No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.), in other words Paxil, according to the FDA, may or may not cause birth defects, there was no definitive answer. In order to classify the risk to the fetus, the Food and Drug Administration (FDA) established five categories to indicate the potential of a drug which crosses the placenta to cause birth defects.

The timeline is important in this particular birth defect case as we shall see.

Joanne was sent to have an echo cardiogram by her obstetrician after a routine ultrasound.

The ultrasound had found that Ryan, Joanne’s chosen name for her unborn child, had echogenic bowels and one kidney. They were unable to verify if there were issues with his heart as they could not get a good visual. An appointment was then made for Joanne to see her pediatric cardiologist.

During the echocardiogram performed on April 23, 2001, the pediatric cardiologist estimated fetal gestational age to be 22½ weeks, and notified Joanne that her baby had severe congenital heart defects. It was unknown, at the time, what caused the fetal abnormalities and Joanne was referred for another appointment some 5 to 6 weeks later.

3 days later, however, Joanne decided to abort. The fetal death certificate estimated gestational age to be 21½ weeks, which was one week different to the pediatric cardiologist’s estimation.

In one of many conversations with Joanne, she told me, “What scared me was when the cardiologist drew what a normal heart looks like and another drawing of Ryan’s. That is when I was told he most likely would not be able to take his first breath. He would be intubated [placement of a flexible plastic tube into the trachea] immediately, and flown to a specialty hospital for heart surgery…if he survived.”

Joanne saved the drawing that her cardiologist drew and has kindly passed it on to me.

Sketch of Ryan’s heart defects drawn by Joanne’s Pediatric Cardiologist

Joanne put this behind her as much as she could, she never, during the following years, made any connection to heart defects and Paxil. Why would she? At the time there was no warning.

In 2006 whilst studying her nursing boards she ran across items that suggested that Paxil had now been re-categorized by the FDA. They had moved it from a ‘C’ to a ‘D’ (Studies, adequate well-controlled or observational, in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk.)

Shocked, Joanne decided to ring the GSK Consumer hotline. According to court documents she asked a GSK representative manning the line if Paxil was a Cat C or D drug, she was incorrectly told that Paxil was a “Category C” drug.

Further investigation by Joanne confirmed that Paxil had indeed been moved from a Category C to D drug.

It was at this point that Joanne filed her Short Form Complaint [September 2007], alleging her Paxil ingestion during pregnancy caused her son, Ryan Swindle’s wrongful death. It was to be part of a class action lawsuit against GSK.

GSK, via their highly paid law firm, King & Spalding, moved for summary judgment. They argued that Joanne’s claims should be dismissed for two fundamental reasons. First, Joanne could not bring a wrongful death or survival action because her fetus was non viable at her therapeutic abortion. (Non viable means not capable of living, growing, or developing and functioning successfully. It is antithesis of viable, which is defined as having attained such form and development of organs as to be normally capable of living outside the uterus. (1))

This is where GSK’s law team really earned their corn. This from one of the court documents:

GSK argues as a matter of law there must be either [1] a child born alive; or [2] a viable fetus, capable of an independent existence at death. (2)  Under Pennsylvania law, viability occurs no earlier than 23 weeks gestational age. (3) Relying on Plaintiff’s fetal death certificate, GSK argued she cannot sustain a wrongful death or survival action because she [was] at 21½ weeks, before viability occurred.

Next, GSK argued even if the fetus was viable when aborted, any claim would be barred under Pennsylvania’s two year statute of limitations because Plaintiff filed her action November 27, 2007, more than 6 years [after] its death. GSK contends the two-year period commenced on the day Ryan Swindle died, regardless of when survivors knew, or should have known, cause of death. 

Let’s tackle GSK’s first argument.

Firstly, there was two estimations on the age of the fetus.

  • Joanne’s pediatric cardiologist estimated fetal gestational age to be 22½ weeks.
  • The fetal death certificate estimated gestational age to be 21½ weeks

Why were Glaxo allowed to pick the one age that best suited their argument?

Let’s say, for argument sake, that GSK were wrong and the actual age was what the pediatric cardiologist estimated (22½ weeks). According to Pennsylvania law the fetus still wasn’t viable. Remember these are just estimations, they are not, and never have been, set in stone yet Glaxo used this to their advantage.

Secondly, they argue “even if the fetus was viable when aborted, any claim would be barred under Pennsylvania’s two year statute of limitations because Plaintiff filed her action November 27, 2007, more than 6 years [after] its death.”
 

So, isn’t this like saying we committed a murder but you didn’t know it was us during your first two years of mourning. The fact you found out it was us (some years later) holds no water because the two year statute of limitations covers our ass?

I guess all those investigating the 1888 murders of Jack the Ripper should give up. It’s a pointless, dare I say it, futile exercise, according to the Glaxo mantra that is. Let’s abolish all the cold case files whilst we’re at it.

At a fetal age of 20 weeks here’s what was probably going on inside Joanne Thomas. I just want Glaxo’s lawyers to be aware of this.
  • Ryan would have reacted to loud sounds.
  • Ryan would have started having a regular sleeping and waking rhythm.
  • Joanne’s movements could have woke Ryan.
  • Taste buds were forming on Ryan’s tongue.
  • Ryan was around 28cm long (crown to heel) and probably weighed around 450 grams.
Non viable huh?

Furthermore, if GSK argued that Joanne’s fetus was non viable what does this say about the following claim taken from the fetal development website baby2see.com.

You are 20 weeks pregnant. (fetal age 18 weeks)

Your baby now weighs about 11 ounces and at roughly 7 inches long they are filling up more and more of the womb. Though still small and fragile, the baby is growing rapidly and could possibly survive if born at this stage.


Glaxo claimed the fetus was 21½ weeks, let’s say they were correct. They argued that 21½ weeks meant that the fetus was non-viable. Let’s see what the fetal development website baby2see.com have to say about a fetus at 21 weeks.

You are 23 weeks pregnant. (fetal age 21 weeks)

If born now, your baby would have a 20% chance of survival, the odds going up with each passing day. By this week, your baby weighs a little over 1 pound (500g). Its crown to heel length is 11 inches (28cm).

20% chance of survival, yet Glaxo dismissed this. Joanne fetus had a 20% chance of survival ergo she terminated when Ryan had a 20% chance of life. These odds were drastically reduced because Ryan had developed  a rare congenital heart disease that was caused by the Paxil she was taking.

The court disagreed and sided with GSK’s argument in July 2012. Joanne’s case was lost on the grounds of the non-viability issue and the statute of limitations issue. Glaxo also successfully argued that the child either must be born alive or it must be a viable fetus, capable of an independent existence at death. Joanne appealed the decision but in Nov 2013 a three-judge Superior Court panel agreed that a Philadelphia Common Pleas Court judge was correct in July 2012 to issue summary judgment to GlaxoSmithKline.

Grounds for a second appeal seemed futile until Joanne wrote me and we spoke for many hours discussing her case. It appeared that Joanne, without actually knowing it, was someone who many lawyers and advocates had been trying to hunt down for years.

In cases like Joanne’s the plaintiff bears the burden of proof and must demonstrate fraudulent concealment by clear, precise, and convincing evidence.

In Part two I shall, on behalf of Joanne, try to present that evidence.

GSK’s company tagline is “We are a leading healthcare company that helps people to do more, feel better and live longer”



Coming up in Part II

  • How Glaxo knew about the possible birth defect risk many years ago but failed to act.
  • I unearth new evidence that shows, I believe, how Glaxo’s statute of limitation defence holds no water.
  • The link between Joanne’s birth defect case and the Kilker v GlaxoSmithKline birth defect case.
  • Did Glaxo and/or their attorneys, King & Spalding, hold back items of discovery from Joanne’s law team and the presiding Judge?
  • I contact Joanne’s law team with new evidence, they submit an appeal to the Supreme Court.
  • Glaxo U-Turn – An offer is made to Joanne Thomas after an appeal is submitted to the Supreme Court, an offer which, after much consideration, Joanne rejected.
 
 
Bob Fiddaman

 

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