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MO Archives - Carey Danis & Lowe

Attorney Jeff Lowe Speaks about Paxil Birth Defects

By | Paxil, Pharmaceutical litigation, Uncategorized

Posted April 27, 2010 

St. Louis, MO: Women who took Paxil during the first trimester of pregnancy and whose children were born with birth defects should consider speaking with an attorney about their options. Jeff Lowe, a partner at Carey Danis & Lowe, says serious birth defects have been linked to the use of Paxil during pregnancy.

Attorney Jeff Lowe Speaks about Paxil Birth Defects “The cases that we’re handling are birth defects that occurred primarily for woman who took Paxil during the first trimester,” Lowe says. “The primary birth defects are Persistent Pulmonary Hypertension of the Newborn (PPHN) and cardiac defects. Those cardiac defects are mainly atrial or septal defects—holes in the heart.”

That does not mean that babies born with other birth defects are excluded from a potential lawsuit. Pregnant women who took any antidepressants from a class of drugs known as selective serotonin reuptake inhibitors (SSRIs, a class that includes Paxil) or serotonin-norepinephrine reuptake inhibitors (SNRIs, a class that includes Effexor) and whose babies were born with birth defects may want to consider speaking to an attorney about their options.

So far the medical literature has made the strongest link between use of certain antidepressants during the first trimester and an increased risk of PPHN or cardiac defects.

“There were studies looking at SSRIs and the early literature didn’t see a connection [between SSRIs and birth defects],” Lowe says. “Then some studies began finding a connection between Paxil and birth defects such as PPHN and cardiac defects. GlaxoSmithKline [Paxil’s manufacturer] had a database they were keeping that was based on their own studies. In 2006, they published their online database, which demonstrated a higher risk in major malformations for infants exposed to Paxil in the first trimester. Additional independent peer reviewed studies confirmed the link.

“Paxil’s warning was changed in 2005 [to include the risk of birth defects]. There was an FDA warning letter issued on December 8, 2005 and a Dear Doctor letter issued in September 2005.”

The good news for potential plaintiffs is that the statute of limitations is not as much of an issue in Paxil birth defect cases as in other situations, because the person most affected by the Paxil is the child. In all states, according to Lowe, “the statute of limitations doesn’t begin to run for a minor until the minor is either 18 to 21 years old, depending on state law, so there isn’t a statute of limitations issue for most children born with birth defects as a result of their mothers taking Paxil.”

Zoloft Lawsuit Underscores Parents’ Heartbreak

By | Pharmaceutical litigation, Uncategorized, Zoloft

Posted March 18, 2012 on LawsuitInformation.org

St. Louis, MO: The recent filing of a Zoloft birth defects lawsuit underscores the pain, heartbreak and frustration evident in the plaintiffs—parents of innocent children who came into the world saddled with life-altering defects allegedly at the behest of the SSRI antidepressant, Zoloft.

It is no secret that antidepressants have been a success for pharmaceutical companies. They also represent important options in the tool belts and treating protocols of psychiatrists and medical doctors, for the treatment of depression.

However, the link between Selective Serotonin Reuptake Inhibitors and birth defects, such as Zoloft cleft palate, have driven the parents of 18 children suffering from Zoloft defects to the courts.

Reuters reports that the lawsuit filed by plaintiff Shainyah Lancaster et al last month in St. Louis, accuses Zoloft manufacturer Pfizer of suppressing information to the medical community and the public at large as to the risks associated with Zoloft when used by women of childbearing age. The lawsuit further alleges that Pfizer knew or should have known of the existence of SSRI studies, which suggested a greater risk of congenital birth defects in concert with a Zoloft pregnancy.

The Zoloft birth defects lawsuit further alleges that Pfizer was aware that Zoloft was being prescribed to pregnant women by their doctors, but that Pfizer failed to warn the medical community about the risks.

Zoloft has been the center of controversy for some time. Dr. Sidney Wolfe, of the consumer advocacy group Public Citizen, took Pfizer to task for promoting Zoloft for unapproved uses. In a statement released in October 1996, Wolfe referenced a communiqué directed to Pfizer from the US Food and Drug Administration (FDA) in August of that year, chastising Pfizer for promoting Zoloft for use in cardiac patients with depression, amongst other unapproved uses.

More recently, Peter Breggin MD, blogging in the Huffington Post on June 28, 2007, noted the spin that often accompanies the release of data. He noted that headlines and media reports surrounding the release of data from a 2007 study seemed to downplay the risks associated with SSRI drugs—Zoloft among them—even though, according to Breggin, “several severe birth defects were doubled or nearly tripled in frequency when SSRIs were taken in the first trimester. This combined with the other known toxic effects of SSRIs, including brain damage and dysfunction, make these drugs contraindicated in pregnancy.”

One of those defects—Zoloft craniosynostosis—was described in Dr. Breggin’s blog post as “the premature closing of one or more sutures or fibrous joints knitting the bones of the infant’s skull.” He noted that craniosynostosis occurs in about four per 10,000 births according to the National Institutes of Health. “A 2.8 times greater occurrence of this condition will cause 2,305 more US babies to be born each year with this birth defect as a result of their mothers taking SSRIs in the first trimester of pregnancy.”

The particular afflictions of the 18 children who allegedly suffer from Zoloft birth defects were not identified in the news reports. However, regardless of the defect suffered by the Zoloft child—Zoloft PPHN, cleft palate or Zoloft heart defects—it is assumed that their parents are facing a lifetime of stormy seas as the result of having a Zoloft newborn. As Zoloft parents face reality, they equally expect Pfizer to face the music.