BOSTON, Oct. 13, 2015 – Families across the country have filed 112 product liability lawsuits against GlaxoSmithKline (GSK) related to the pharmaceutical company’s blockbuster anti-nausea drug Zofran and congenital birth defects alleged to have been caused by their fraudulent misrepresentations to prescribing physicians about the safety profile of this drug for pregnant women.
Due to the large number of Zofran birth defects lawsuits against GSK, The United States Judicial Panel on Multidistrict Litigation (JPML) has ordered that all pending and future lawsuits be centralized in the District of Massachusetts before US District Court Judge Dennis F. Saylor, IV. The lawsuits were consolidated into MDL No. 2657 on October 13, 2015.
An MDL is a special federal legal procedure that speeds up the process of handling complex cases, such as complex product liability lawsuits, by consolidating all of the cases before a single Judge to reduce the likelihood of duplicative discovery and conflicting pretrial rulings from different judges that could serve to slow a litigation down. According to Walter Kelley, Managing Attorney of Kelley Bernheim Dolinsky’s Massachusetts office, “As a local law firm with one of the very first filed cases against GSK before Judge Saylor, we strongly advocated for Massachusetts to be the home court of this litigation. We look forward to moving these cases forward on behalf of the families who have entrusted us with protecting their rights and holding this company accountable.”
Zofran is a powerful drug developed by GSK and approved by the FDA in 1991 for use in cancer patients who required chemotherapy or radiation therapy. Even though the only FDA approval for this drug was only for seriously ill patients, GSK began marketing Zofran “off label” as an established safe and effective treatment for “morning sickness” without undertaking a single study establishing that this powerful drug was safe or effective for pregnant mothers and their growing children.
This lawsuit is not the first time GSK has been scrutinized in Court over Zofran. In 2012, GSK pled guilty to criminal charges lodged by the United States Department of Justice, for its “off-label” promotion of its drugs for uses never approved by the FDA. Around this same time, GSK also entered civil settlements with the United States that included more than $1 billion in payments to the federal government for its illegal marketing of various drugs, including Zofran specifically. The civil settlement agreement reports GSK’s settlement of claims that GSK:
(a) “promoted the sale and use of Zofran for a variety of conditions other than those for which its use was approved as safe and effective by the FDA (including hyperemesis and pregnancy-related nausea)”
(b) “made and/or disseminated unsubstantiated and false representations about the safety and efficacy of Zofran concerning the uses described in subsection (a) [hyperemesis and pregnancy-related nausea]”
(c) “offered and paid illegal remuneration to health care professionals to induce them to promote and prescribe Zofran”
In one of the original Zofran Massachusetts lawsuits, Attorney Kelley alleges that as direct a result of GSK’s nationwide fraudulent marketing scheme, Plaintiff, a Massachusetts resident, gave birth in 20008 to a child who was born with congenital heart defects requiring immediate corrective surgery. “Had Beth and her prescribing physicians known the truth about Zofran’s unreasonable risk of harm, long concealed by GSK, she would never have taken this drug, and her child would never have been injured,” said Kelley, who went on to say, “Sadly, it is too late to prevent this tragedy. Our only recourse now is to hold GlaxoSmithKline fully accountable to this family for their actions; and we will work tirelessly to ensure they are financially able to provide the very best medical care available and help alleviate the lifelong burden that has needlessly been placed on their child.”