When Paxil is taken during pregnancy, autism and birth defects can result. This led to a number of lawsuits. Drugwatch can help you understand your legal options.
Since being approved by the U.S. Food and Drug Administration (FDA) in 1992, the antidepressant prescription drug Paxil was linked to serious and severe side effects. Some of its side effects are life-threatening, but the drug is also linked to life-altering side effects.
In 2004, the FDA found an increased risk of suicide among children and adolescents taking Paxil. The same year, the New York Attorney General accused drug manufacturer GlaxoSmithKline of hiding information about suicide risks associated with the antidepressant drug Paxil.
In 2005, the FDA issued another advisory about increased health risks related to women taking Paxil during pregnancy. The risks, according to the FDA, were a litany of life-changing and debilitating birth defects.
In addition to birth defects, a 2015 study also linked Paxil and other selective serotonin reuptake inhibitors (SSRIs) to an increased risk of autism in babies born to women who take the drug while pregnant. The study, published in JAMA Pediatrics by Anick Bérard and colleagues, revealed women who take antidepressants in the second and third trimester have double the chance of having a child diagnosed with autism by age 7.
Paxil use can lead to autism, someone's death or a malformation of a newborn, prompting families affected by the drug's side effects staked legal claims against Paxil and drug manufacturer GlaxoSmithKline.
Why Do People Sue for Paxil Injuries?
Like other antidepressant drugs Prozac and Zoloft, Paxil is considered a selective serotonin reuptake inhibitor – SSRI for short. Doctors prescribe Paxil to balance chemicals in the brain to treat conditions that include depression, obsessive-compulsive disorder, post-traumatic stress disorder and pre-menstrual dysphoric disorder.
If they had been properly warned about the risks to their babies, many women may not have been prescribed or taken the drug. When drug companies fail to properly test their drugs and warn about the risks, they may be held financially liable for the resulting injuries.
Developmental disorders like autism cannot be cured and cause hardship to children and families for the rest of their lives. Children with autism need special care, therapy and education. The average lifetime cost for an individual with autism without intellectual disability is $1.4 million and $2.4 million when intellectual disability is involved, according to Autism Speaks.
In addition, dealing with autism causes stress on the health, social and financial well-being of families and those coping with the disorder.
Infants born to Paxil patients may also suffer serious congenital heart defects.
|Potentially fatal injuries to newborns include:|
|Atrial septal defects (ASD)|
|Persistent pulmonary hypertension of the newborn (PPHN)|
|Omphalocele (abdominal defects)|
|Ventricular septal defects (VSD)|
These conditions are potentially life-threatening. Families of children who suffer these injuries must cope with related medical costs, ongoing care, lost wages and considerable pain and suffering. However, financial compensation may be available to them because the drug manufacturer failed to warn about the dangers.
In addition to seeking needed financial assistance, families also want to hold GlaxoSmithKline accountable. There has been evidence that, as early as the 1980s, GlaxoSmithKline was aware of research linking Paxil to potential birth defects. They are outraged the company apparently disregarded the dangers and pushed the product to market without proper warnings in 1992.
The move reportedly generated $11.7 billion in U.S. sales for GlaxoSmithKline in just nine years beginning in 1997. But it also generated a trail of injuries. In 2009 alone, Paxil accounted for almost two percent, or $793 million, of GlaxoSmithKline’s total revenue.
The same year, a Philadelphia jury awarded $2.5 million to three-year-old Lyam Kilker and his family for birth defects caused by Paxil.
Legal Claims for Paxil Injuries
Drug makers have a duty to test their products for health risks and to warn the public if a drug carries an elevated risk or a high number of risks. They are mandated by federal law to disclose risks and side effects of their drugs and products.
The U.S. Food and Drug Administration (FDA) is supposed to regulate how well drug manufacturers investigate and disclose results from medical studies related to the drug or device. Drug makers sometimes fail in those duties and face legal liability for causing serious injuries to innocent victims like the Kilkers.
$2.5 Million Paxil Verdict
A few weeks after he was born, Lyam's parents notice that his appetite and energy had decreased and that he was having trouble breathing. They took him back to the hospital where they received troubling news. There were two holes in his heart and his aorta was undeveloped, keeping blood from circulating properly through his body. He would need open-heart surgery to survive.
Before her pregnancy, Lyam’s mom Michelle saw her doctor about mild anxiety and occasional panic attacks. Her doctor prescribed Paxil before and throughout her pregnancy. Like many pregnant women and their doctors, they were unaware that Paxil carried an elevated risk of birth defects. That is because GlaxoSmithKline did not warn about the dangers.
During the trial, the Kilkers' attorneys introduced a 1997 internal GlaxoSmithKline memo stating that it would "bury" negative results if forced to perform animal studies on Paxil. As early as 1980, scientific studies done on rats linked the drug to birth defects.
The company knew about the studies, but did not warn doctors and expectant mothers about the risks when Paxil hit the market. It continued to do nothing to warn the public when a 1998 internal review noted "an alarmingly high number" of birth defect reports or when it received a letter in 2001 from a pregnant Paxil user whose fetus showed signs of birth defects.
The jury found that GlaxoSmithKline "negligently failed to warn" Michelle's doctor about the risks of birth defects and that the drug caused Lyam’s injuries. The jurors awarded the Kilker family damages, including past and future medical costs.
They were so persuaded by evidence that GlaxoSmithKline failed to reveal scientific evidence of birth defect risks, they awarded the Kilker’s $2.5 million – twice the amount sought by the family.
Although many Paxil birth defect cases have since gone to trial with various results, the Kilker’s victory helped encourage GlaxoSmithKline to settle several claims. By 2010, GlaxoSmithKline had paid over $1 billion to settle more than 800 claims.
Average Lawsuit Recovery: $1.25 Million
At the time, a University of Richmond Law School professor explained that the severity of the injuries to children led to an average recovery of $1.25 million. In November 2011, GlaxoSmithKline paid over $3 million to settle Department of Justice investigations of the marketing of Paxil and other drugs.
Find a Prescription Drug Attorney
It's important to remember that all cases are different. The chances of obtaining an award and the amount of compensation will vary from case to case. But if your family has suffered because of Paxil injuries, help may be available. A prescription drug attorney can explain your rights and help you file a potential claim.
Speak with a qualified prescription drug attorney as soon as possible, because time is important in cases like these. The law limits the amount of time available to file a claim.