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Zofran Multidistrict Litigation

Lawsuits filed against GlaxoSmithKline alleging that Zofran caused birth defects have been consolidated into a multidistrict litigation in the District of Massachusetts.

Lawsuits filed against GlaxoSmithKline (GSK) alleging that the anti-nausea medication Zofran caused birth defects have been consolidated into a multidistrict litigation (MDL) in the District of Massachusetts before Judge Dennis F. Saylor, IV.

Free Confidential Case Evaluation: If your child was born with a heart defects, cleft lip/cleft palate, or other birth defect after the mother took Zofran during pregnancy, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.

Update: GSK Seeks ‘Unilateral’ Right to Redact Documents in Zofran MDL

March 21, 2016 – GlaxoSmithKline is requesting the liberty to redact what it considers “highly confidential” information from the documents produced for plaintiffs to inspect in the Zofran multidistrict litigation currently underway in Boston. Plaintiffs countered the request in a memorandum (PDF) filed earlier this month,
stating that “information GSK believes is a trade secret or otherwise highly confidential or irrelevant should be produced in unredacted form and designated as Confidential Information in accordance with the proposed Protective Order, which expressly allows such qualifying material to be designated confidential.”

What’s the problem?

October 13, 2015 – MDLs are designed to speed up the litigation process by consolidating all federal cases citing similar allegations before a single judge. This eliminates duplicative discovery and conflicting pretrial rulings from different judges that could slow the litigation down.

Consolidation may also encourage large-scale settlements after initial bellwether trials, should jurors find GSK liable and render large verdicts. However, each case will be decided on an individual basis, and in the event that a large-scale settlement is not reached, will be returned to the court where they were originally filed.

Zofran was developed by GlaxoSmithKline (GSK) and approved by the U.S. Food & Drug Administration (FDA) in 1991 for use in cancer patients undergoing radiation or chemotherapy. However, not long after Zofran hit the market, GSK began marketing the drug “off label” for the treatment of morning sickness without conducting a single study regarding its use in this capacity.

In 2012, GSK pled guilty to criminal charges filed by the U.S. Justice Department over the company’s illegal promotion of Zofran and other medications. Around the same time, GSK also entered civil settlements with the U.S. government that included over $1 billion in payments for its illegal marketing of numerous drugs, including Zofran.

Lawsuit Allegations

The complaints surrounding Zofran have been consolidated because they all have nearly identical allegations:

  • GSK fraudulently misrepresented Zofran to doctors about the safety of Zofran for use during pregnancy.
  • GSK knew and concealed the drug’s alleged link with severe congenital birth defects, and failed to provide the public and medical communities with information about this risk.
  • GSK marketed the drug to pregnant women “off-label” for uses not approved by the U.S. Food & Drug Administration (FDA).

The litigation is: In Re: Zofran (Ondansetron) Products Liability Litigation – MDL 2657.

Are Lawsuits Still Possible After MDL Consolidation?

It is still early in the litigation process, and there is time for additional Zofran birth defect lawsuits to be filed and consolidated in the MDL, should they qualify under the statute of limitations. Our lawyers are working to help ensure that any women who took Zofran while pregnant and had a child with a birth defect are able to explore their legal options.

New Cases Added to Zofran Litigation

February 12, 2016 – At least 9 new lawsuits have been added to the Zofran MDL already this month. Of the 9 cases, only one was transferred from another jurisdiction. The other 8 were filed directly into the litigation last week. The MDL now includes at least 224 lawsuits, according to the court docket.

MDL Plaintiffs Discover Canadian Zofran Labels Warn of Birth Defect Risk

February 10, 2016 – It has come to the attention of plaintiffs in MDL 2657 that labels of Zofran in Canada warn against use during pregnancy, unlike the labeling in America. Canadian labels read “the safety of ondansetron for use in human pregnancy has not been established,” and “use in pregnancy is not recommended.” Plaintiffs in the MDL are wondering why the same warnings were not provided to U.S. customers.

Lawsuits Can Now Be Filed Directly into MDL

December 30, 2015 – In a move that will streamline the process of filing Zofran birth defect lawsuits, Judge Saylor has allowed new plaintiffs to enter claims directly into the multidistrict litigation currently underway in Boston. The order (PDF), Saylor’s 6th to help streamline the MDL, will significantly cut red tape, saving time and resources for all parties involved in the litigation. Click here to learn more.

Birth Defect Lawsuits Piling up as MDL Set to Begin

December 28, 2015 – At least 296 Zofran lawsuits have been consolidated into the multidistrict litigation set to get underway in Boston. The complaints accuse GSK of hiding evidence that Zofran causes birth defects in babies exposed to the drug in the womb. Defects most commonly alleged are cleft lip / cleft palate, heart defects including atrial septal defect (ASD), ventricular septal defect (VSD) and transposition of the greater vessels, as well as kidney defects and clubfoot.

Co-Lead Counsel Appointed for Zofran MDL

December 19, 2015 – Three attorneys have been appointed by Judge Saylor as co-lead counsel of the Zofran birth defect multidistrict litigation, according to CBS News. These individuals will be responsible for ensuring that all parts of the litigation process are completed correctly, and will function as spokespersons for each plaintiff at pretrial hearings, as well as help to coordinate pretrial proceedings and discovery throughout the process.

Do I have a Zofran Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Zofran lawsuits. We are handling individual litigation nationwide and currently investigating potential settlements in all 50 states.

Free Confidential Case Evaluation: Again, if your child one was injured by Zofran side effects, you should contact our law firm immediately. You may be entitled to a settlement by filing a class action suit and we can help.

Free Confidential Case Evaluation

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