CHICAGO, April 22, 2015 /PRNewswire/ -- A Chicago law firm said today it is considering filing the first nationwide class action lawsuit against GlaxoSmithKline (GSK), the makers of Zofran, a powerful anti-nausea drug alleged to increase the risk of birth defects when used by pregnant women, particularly during the first trimester.
Moll Law Group (www.molllawgroup.com) reports that, based on a federal investigation, the U.S. Department of Justice (DOJ) announced that GSK agreed to plead guilty and pay $3 billion to resolve its criminal and civil liability arising from the company's unlawful promotion of certain prescription drugs, including Zofran. The law firm notes, however, that this ruling does not specifically address the severe fetal defects that Zofran allegedly may cause.
"As early as 1992, GSK began receiving more than 200 reports of birth defects associated with the use of Zofran by pregnant women, conditions ranging from congenital heart, orofacial and septal defects to kidney malformation and even stillbirths," said attorney Ken Moll of Moll Law Group, which concentrates in product liability and protecting the rights of consumers. "We believe the number of events reported to GSK is only a small fraction of the actual incidents. However, in all that time, GSK failed to warn and never updated Zofran's labeling to disclose that the drug can cause fetal harm when administered to a pregnant woman.
"Despite evidence showing the unreasonable risk of harm to babies exposed to Zofran prenatally, GSK continued to promote to obstetrics and gynecology healthcare practitioners, among others, that Zofran is a safe treatment alternative for morning sickness in pregnant women," Moll said. "In addition, back in 1999, the U.S. Food & Drug Administration (FDA) directed GSK to immediately cease distribution of its promotional materials about the drug, a mandate we believe was disregarded.
"The lawsuit we are considering would focus on such acts and how GSK failed to protect newborns from serious and life-threatening medical conditions," Moll added. Moll said his firm has initiated discussions with women whose babies were possibly affected through use of Zofran during pregnancy and is available to talk to others (Moll can be contacted at 312-462-1700).
According to Moll, GSK developed Zofran to treat cancer patients afflicted with severe cases of nausea that resulted from chemotherapy or radiation treatments. The FDA approved Zofran for such use in 1991.
"However, due to the many cases of pregnancy-related nausea, and the absence then of a prescription medication approved by the FDA for such a condition, GSK recognized an opportunity to significantly expand sales of Zofran and proceeded to promote its off-label use to pregnant women," said Moll.
A new FDA rule that takes effect this June will help expand the availability of information about drugs such as Zofran, Moll said. The rule will require manufacturers to summarize the risks of using a drug during pregnancy, offer data to support that summary, and provide healthcare providers key information to help them counsel pregnant women about the use of drugs.
"But GSK should be taking measures immediately to comply with this vital FDA stipulation to prevent further harm and injuries to newborns," said Moll.
About Moll Law Group
Chicago-based Moll Law Group represents people around the nation who were severely injured, and families who have lost a loved one, due to defective products, dangerous prescription drugs, faulty medical devices or unsafe vehicles. The firm works with leading product safety professionals, medical experts and attorneys to assist in both the representation of clients in personal injury and wrongful death litigation and in development of injury prevention information for all consumers, which includes its Legal News Network (LNN) website (www.legalnewsnetwork.com) that offers fact-filled videos in a mini-documentary style to foster awareness of dangerous products and communicate product safety tips.
SOURCE Moll Law Group