Zofran Birth Defect Lawsuits Allege Babies Exposed To Zofran Suffer Cleft Lip, Cleft Palate, Heart Murmur, And Other Congenital Birth Defects.
U.S. District Judge Dennis Saylor denied GlaxoSmithKline’s motion to dismiss more than 200 federal Zofran birth defect lawsuits pending in the U.S. District Court, District of Massachusetts. The pharmaceutical giant is defending itself against Zofran complaints that allege the anti-nausea medication causes birth defects that include cleft lip, cleft palate, heart murmur, atrial septal defect, musculoskeletal defects and other abnormalities.
In an order issued on January 22, Judge Saylor, who is managing the Zofran litigation, said it was too premature to make a decision on GlaxoSmithKline’s request because discovery had not yet started in the litigation. The pharmaceutical company argued that the Zofran lawsuits contained state law claims alleging the company failed to warn patients and their physicians about the birth defects risks associated with the drug. The company contended in its motion that the state failure-to-warn claims were pre-empted by federal “clear-evidence” law. According to GlaxoSmithKline, under that measure, the company had “clear evidence” that the U.S. Food and Drug Administration (FDA) would not have approved the changes that plaintiffs asked the company to make to Zofran’s warning label. (In Re Zofran Products Liability Litigation – MDL 2657)
“We are pleased with Judge Saylor’s decision to allow the pretrial proceedings for the Zofran ltigation to move forward,” says Wright & Schulte LLC, which is offering free Zofran lawsuit evaluations to families whose children suffered side effects of Zofran and other harmful drugs. To speak to one of the firm’s Zofran Side-Effects Attorneys, contact the firm today by calling 1-800-399-0795 or visit www.yourlegalhelp.
Zofran (ondansetron) is approved by the FDA to treat nausea and vomiting associated with chemotherapy, radiation, and surgery. GlaxoSmithKline, however, has promoted the drug for use by pregnant women to treat morning sickness, which includes nausea and vomiting. Zofran complaints contend the anit-nausea medication is not safe for expectant mothers to use, particularly during the first trimester of pregnancy. The Zofran lawsuits cite a study published in the Reproductive Toxicology journal in December 2014, indicating that babies exposed to Zofran are born with congenital defects. The study examined data from the Swedish Medical Birth Register and the Swedish Register of Prescribed Drugs to identify 1,349 infants whose mothers took Zofran in early pregnancy from 1998 to 2012. The study found a 62 percent increased risk in cardiovascular defects, most notably a cardiac septum defect.
[ncbi.nlm.nih.gov/pubmed/25450422, Reproductive Toxicology, December 2014]
The Zofran complaints maintain that Zofran was not approved by the FDA to treat morning sickness in pregnant women who often experience nausea and vomiting. The Zofran birth defects lawsuits point to the U.S. Department of Justice (DOJ) citing GlaxoSmithKline for illegally promoting Zofran to treat morning sickness in pregnant women when the FDA only approved the drug to treat post-operative nausea. GlaxoSmithKline agreed to pay $3 billion to resolve civil claims and criminal charges of improperly marketing Zofran and its other drugs and paying kickbacks to health care professionals as an incentive to promote and prescribe Zofran and its other drugs.
[justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report, U.S. Department of Justice, July 2, 2012]
The Zofran birth defects complaints accuse GlaxoSmithKine of knowing since 1992 that Zofran presented “unreasonable risk of harm” to developing fetuses because Zofran passes through the human placenta. The Zofran lawsuits also claim animal studies conducted by the company link Zofran use to congenital heart defects. The complaints further allege GlaxoSmithkline promoted Zofran without conducting “a single clinical trial” in pregnant women. (In Re Zofran Products Liability Litigation – MDL 2657)
About Wright & Schulte LLC: Wright & Schulte LLC, an experienced personal injury firm, is dedicated to the belief that America’s legal system should work for the people. Every day, the attorneys of Wright & Schulte LLC stand up for the rights of people who have been injured or wronged and fight tirelessly to ensure that even the world’s most powerful corporations take responsibility for their actions. If you’re looking for a law firm that will guarantee the aggressive and personal representation you deserve, please do not hesitate to contact Wright & Schulte LLC today. Free Zofran lawsuit case evaluations are available through yourlegalhelp.com or by calling 1-800-399-0795.
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