This is not the first time GlaxoSmithKline has found themselves in hot water with the Department of Justice – Office of Public Affairs over violating federal laws when it comes to manufacturing pharmaceuticals. In 2012, the Department of Justice – Office of Public Affairs issued a press release announcing that GlaxoSmithKline (GSK) agreed to plead guilty to a three-counts of criminal information, including two counts of introducing misbranded drugs, Paxil and Wellbutrin, into interstate commerce and one count of failing to report safety data about the drug Avandia to the Food and Drug Administration (FDA). This was the largest health care fraud settlement in U.S. history and the largest payment ever by a drug company.
Under the terms of the plea agreement, GSK paid out a total of $1 billion, including a criminal fine of $956,814,400 and forfeiture in the amount of $43,185,600. GSK also was required to pay $2 billion to resolve civil liabilities with the federal and state governments under the False Claims Act.
In the press release, it also said that “GSK promoted its asthma drug, Advair, for first-line therapy for mild asthma patients even though it was not approved or medically appropriate under these circumstances. GSK also promoted Advair for chronic obstructive pulmonary disease with misleading claims as to the relevant treatment guidelines. The civil settlement also resolves allegations that GSK promoted Lamictal, an anti-epileptic medication, for off-label, non-covered psychiatric uses, neuropathic pain and pain management. It further resolves allegations that GSK promoted certain forms of Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women. It also includes allegations that GSK paid kickbacks to health care professionals to induce them to promote and prescribe these drugs as well as the drugs Imitrex, Lotronex, Flovent and Valtrex. The United States alleges that this conduct caused false claims to be submitted to federal health care programs.”
James M. Cole, Deputy Attorney General (at the time of the press release), said, “At every level, we are determined to stop practices that jeopardize patients’ health, harm taxpayers, and violate the public trust – and this historic action is a clear warning to any company that chooses to break the law.” But has the warning made a difference? It appears not since GSK is in the news again for a similar offense.
In the Digital Journal, it was reported that seven families have now brought legal claims against GSK, in an ongoing litigation surrounding anti-nausea drug Zofran and its link to increased risks of birth defects. In the more recent lawsuits, plaintiffs say that GSK knew about Zofran’s potential to cause fetal harm for over two decades. Rather than warn the public, parents allege that GlaxoSmithKline concealed safety information from the FDA and medical community. In fact, they say that GlaxoSmithKline has violated federal law, claiming that the company has been promoting Zofran as an “off label” morning sickness treatment.
Some of the most common types of birth defects associated with Zofran use during pregnancy include:
- Musculoskeletal anomalies – Deformed skull; Limb defects
- Mouth deformities – Cleft lip; Cleft palate
- Kidney malformation or missing kidney
- Heart defects – Atrial Septal Defect (ASD)- hole in the heart; Ventricular Septal Defect (VSD)- hole between two lower chambers of the heart; and Heart Murmur
- Fetal growth restriction
- Fetal death
If your child has suffered from a birth defect due to taking Zofran during your pregnancy contact the Law Offices of Wolf & Pravato to schedule a free, confidential consultation.