A couple in Louisiana has filed a Reglan birth defect lawsuit, claiming that the anti-nausea drug prescribed to the mother during pregnancy led to their child suffering severe and permanent physical disabilities.
The lawsuit was originally filed by Joshua and Lindsey Whitener in Louisiana state court in February, but was transferred to federal court late last month at the request of Pliva Pharmaceuticals, one of the defendants. Other defendants in the lawsuit include other generic Reglan manufacturers, including Barr Laboratories, Teva Pharmaceuticals, and Watson Pharmaceuticals. The Rue De Sante Women’s Center and John McCrossen are also named as defendants in the lawsuit.
According to the complaint, Lindsey Whitener was prescribed Reglan during pregnancy to combat morning sickness in her seventh week of pregnancy. She gave birth to her son, Lucas, prematurely after only 36 weeks of gestation, and he was hospitalized for the first six months of his life due to health problems. Lucas suffers permanent disabilities and complications from Reglan side effects, the lawsuit claims.
Reglan (metoclopramide) is approved in the United States by the FDA for the short-term treatment of gastrointestinal disorders like diabetic gastroparesis, gastroesphageal flux (GERD) and delayed gastric emptying. While it is commonly used to treat even mild cases of pregnancy nausea in Europe and other foreign countries, doctors in the United States tend to prescribe the drug off-label only in cases of extreme morning sickness.
In February 2009, the FDA required the manufacturers of all metoclopramide drugs to add a “black box” warning to all generic Reglan products about potential risk of tardive dyskinesia from Reglan, which can cause repetitive and involuntary muscle movements. However, that risk is primarily associated with long-term use of more than 12 weeks, and use to treat morning sickness typically only involves short-term use.
Prior studies have suggested that Reglan is safe for short-term use against nausea during pregnancy, and a study published last year in the New England Journal of Medicine found that there was no statistically significant increase in birth defects, malformations or low birth weight in infants born from women who took Reglan for nausea during pregnancy.
The Whiteners allege that a number of physicians who reviewed the case could not rule out Reglan as a cause or possible contributing factor to Lucas’s birth defects, according to a report in the Louisiana Record. The Whiteners have requested that a panel of experts be convened by the Louisiana Commissioner of Administration to review the safety of Reglan use during pregnancy.
The manufacturers of name brand Reglan, as well as generic metoclopramide manufacturers, currently face a number of Reglan lawsuits pending throughout the United States, most involving claims for tardive dyskinesia following long-term use. Those complaints involve allegations that the drug makers failed to adequately research the side effects of the medication or warn about the risk of tardive dyskinesia associated with long term use.
In June 2009, the U.S. Judicial Panel on Multidistrict Litigation denied a request to consolidate the federal Reglan litigation. Therefore, all federal cases are proceeding in individual courts across the country.