Zofran Fraud Claims Can Proceed against GSK

Plaintiff attorney Tobias L. Millrood of Pogust Braslow & Millrood LLC.
Plaintiff attorney Tobias L. Millrood of Pogust Braslow & Millrood LLC.

US District Judge F. Dennis Saylor IV shot down a defense motion and allowed fraud claims filed by 365 plaintiffs to proceed, charging that manufacturer GlaxoSmithKline (GSK) marketed Zofran to pregnant women, knowing it would cause birth defects.

The judge is overseeing litigation in  In Re: Zofran (Ondansetron) Products Liability Litigation, MDL No. 2657 in the District of Massachusetts.

“[b]ecause plaintiffs adequately pleaded the content, time, and place of the allegedly false representations made in Zofran’s product labeling, the fraud-based claims premised on that misrepresentation satisfy the requirements of Rule 9(b),” the judge said. “Whether those representations were actually false is, of course, a question for another day.”

See Zofran Memorandum And Order On Defendant’s Motion To Dismiss Fraud-based Claims

There are three categories of alleged misrepresentations in this case.

  • The first category consists of statements allegedly made by GSK in its advertising, marketing, and promotional materials—in other words, statements made generally to the marketplace.
  • The second category consists of specific statements made by GSK representatives to prescribing physicians, including statements made by sales representatives to physicians, or specific written materials provided to individual physicians.
  • The third category consists of statements made in Zofran’s product labeling.

Serotonin receptor antagonist

The allegations are in either the master complaints or the individual short-form complaints. The plaintiffs are represented by Tobias L. Millrood of Pogust Braslow & Millrood LLC, Kimberly D. Barone Baden of Motley Rice LLC, M. Elizabeth Graham of Grant & Eisenhofer PA, and Robert K. Jenner of Janet Jenner & Suggs LLC and and Kimberly Dougherty of Andrus Wagstaff.

Zofran is an anti-emetic referred to as selective serotonin 5-HT3 receptor antagonists. Serotonin signaling in the body triggers nausea and vomiting. The active ingredient in Zofran, ondansetron, is believed to alleviate symptoms of nausea and vomiting by inhibiting the body’s serotonin signaling.

Serotonin signaling regulates developmental processes that are critical to normal embryonic development. Inhibiting serotonin signaling during embryonic development can therefore increase the risk of birth defects.   According to the complaint, pre-clinical studies conducted by or on behalf of GSK in the 1980s revealed that Zofran ingested by mammals—in particular, rats and rabbits—during pregnancy crosses the placental barrier, exposing the fetus to the drug. The complaint alleges that subsequent scientific research has confirmed that Zofran also crosses the placental barrier during human pregnancies.

According to the complaint, animal studies conducted by or on behalf of GSK in the 1980s in Japan revealed clinical signs of toxicity, intrauterine fetal deaths, stillbirths, congenital heart defects, craniofacial defects, impairment of ossification (incomplete bone growth), and other malformations in fetuses exposed to Zofran during gestation. The complaint also alleges that from 1992 to the present, GSK has received reports—either directly or through studies published in medical literature—of birth defects in children exposed to Zofran or ondansetron during pregnancy.

GSK marketing scheme

Around 1997, GSK launched a marketing scheme to promote Zofran to obstetrics and gynecology healthcare practitioners and consumers as a safe and effective treatment for pregnancy-related nausea and vomiting.

According to the complaint, “[a]s a result of GSK’s fraudulent marketing campaign,” by 2002 Zofran had become the most frequently prescribed drug for treating pregnancy-related nausea and vomiting in the United States.

Since 1993, the prescribing information for Zofran has included the following statement about its use during pregnancy:

Pregnancy: Teratogenic Effects: Pregnancy Category B. Reproduction studies have been performed in pregnant rats and rabbits at I.V. doses of up to 4 mg/kg per day and have revealed no evidence of impaired fertility or harm to the fetus due to ondansetron. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

The complaint alleges that “[t]his statement is false and misleading because animal studies conducted by or on behalf of GSK outside of the United States have in fact revealed evidence of teratogenic effects due to ondansetron.”  It further alleges that the statement is false and misleading “because [d]efendants failed to conduct post-market studies that were properly designed to identify Zofran’s true teratogenic risk.”

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Court Sets Discovery Timetable in Zofran Products Liability Litigation

zofranUS District Judge F. Dennis Saylor organized discovery into five phases on Nov. 10  In Re: Zofran (Ondansetron) Products Liability Litigation, MDL No. 2657 in the District of Massachusetts.

About 300 lawsuits have been filed against GlaxoSmithKline LLC, based in Wilmington, DE, since the MDL was formed by the Judicial Panel on Multidistrict Litigation on Oct. 13, 2015.

Phase 1 — Product identification fact sheets, plaintiff fact sheets and defendant fact sheets must be released as required by MDL orders 10, 11 and 12 dated May 26, 2016.

Phase 2 — Electronically stored information relating to whether Zofran causes birth defects and injuries alleged, and all potential preemption issues must be released. Phase 2 is likely to require expert and fact discovery.

Phase 3 — Beginning immediately, this phase will cover general causation issues and whether any FDA approval or other action preempts any of theplaintiff’s claims.

Phase 4 — To star on Feb. 1, 2017 will consist of discovery concerning individual causation, product identification or damages.

Phase 5 — Beginning at a date to be determined, this phase will covery any remaining potentialy relevant issues.

According to Zofran complaints filed:

GSK knew about birth defects

Defendant GlaxoSmithKline LLC d/b/a GlaxoSmithKline GSK knew as early as 1992 that Zofran passed through the placenta and into a developing fetus and presented “unreasonable risk of harm” to developing babies.

GSK marketed Zofran “off-label” for treatment of nausea and vomiting associated with pregnancy. The company represented that Zofran was a safe and effective treatment for the nausea and vomiting associated with pregnancy. However, the drug had not been studied for its adverse affects upon pregnant mothers, or the possible teratogenic effects upon their fetuses at any time between 1991 and 2011.

Between April 2009 and December 2013, GSK reported that it made paid doctors and healthcare institutions more than $437.9 million dollars in the United States for speaking fees, consulting fees, research, travel fees and meals.

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Paxil Judge Won’t Lift Litigation Stay for GSK in Birth Defect Litigation

Tetralogy of fallot, which is a combination of several congenital heart defects.
Tetralogy of fallot is a combination of several congenital heart defects.

Philadelphia County Court of Common Pleas Judge Arnold New denied GlaxoSmithKline‘s motions on July 12 to lift a stay on litigation over birth defects allegedly caused by the antidepressant Paxil, according to Law360.

The court entered the stay on April 21 over the mass tort litigation until an appeal is decided in the initial case, Rader et al. v. SmithKlineBeecham Corp. et al.

Braden Rader was born with tetralogy of fallot, a combination of several congenital heart defects, allegedly caused by his mother’s use of Paxil during her 2003 pregnancy.

GSK argued unsuccessfully that the stay should be lifted because the other Paxil cases (see below) have dispositive issues that are unconnected to the Rader decision, according to Law360. It also argued that the stay does not advance a timely resolution of the litigation.

Case Status Court Term & No. Case Name
Active Case 0702-03220 In Re: Paxil Pregnancy Cases
Stayed By Order Of Court 1008-01144 Moore, Deceased Etal Vs Smithkline Beecham Corpor
Stayed By Order Of Court 1106-00402 Nieman Etal Vs Smithkline Beecham Corporation
Stayed By Order Of Court 1106-00489 Powell Etal Vs Smithkline Beecham Corporation Etal
Stayed By Order Of Court 1109-03678 Kenney Etal Vs Smithkline Beecham Corporation
Stayed By Order Of Court 1109-03686 Staley Etal Vs Smithkline Beecham Corporation
Stayed By Order Of Court 1109-03694 Cammarota Etal Vs Smithkline Beecham Corporation
Stayed By Order Of Court 1109-03727 Guddeck Etal Vs Smithkline Beecham Corporation
Stayed By Order Of Court 1109-03758 Cintao Etal Vs Smithkline Beecham Corporation

$3 billion in criminal fines over Paxil

In 2012 GSK pleaded guilty and agreed to to pay $3 billion in fines for introducing misbranded drugs, Paxil and Wellbutrin, into interstate commerce and failing to report safety data about the drug Avandia to the Food and Drug Administration (FDA). Under the terms of the plea agreement with the Department of Justice, GSK must pay

  • A total of $1 billion, including a criminal fine of $956,814,400 and forfeiture in the amount of $43,185,600.
  • The criminal plea agreement also includes certain non-monetary compliance commitments and certifications by GSK’s U.S. president and board of directors. GSK’s guilty plea and sentence is not final until accepted by the U.S. District Court.
  • 2 billion to resolve its civil liabilities with the federal government under the False Claims Act. The civil settlement resolves claims relating to Paxil, Wellbutrin and Avandia, as well as additional drugs, and also resolves pricing fraud allegations.

For further reading, check out Top 5 Mass Tort Cases for Plaintiff Lawyers Right Now

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Judge Approves Short-Form Complaint in Zofran Products Liability Litigation

Zofran cleft palate birth defect
Zofran cleft palate birth defect

US District Judge F. Dennis Saylor IV on July 8, 2016 approved the new Short-Form Complaint and Jury Demand submitted by the parties in Zofran (Ondansetron) Products Liability Litigation.

Specifically the court approved:

  1. Master Short-Form Complaint and Jury Demand—Brand Zofran Use, Docket No. 274, Exhibit A, filed June 20, 2016
  2. Master Short-Form Complaint and Jury Demand—Generic Ondansetron Use, Docket No. 274, Exhibit B, filed June 20, 2016.

This Order will trigger certain requirements under MDL Order No. 14, including the requirement that each current plaintiff file a Short-Form Complaint within 30 days of this Order.

The Zofran litigation is consolidated in MDL No. 2657 in US District Court in Boston, Massachusetts. According to Zofran complaints filed:

GSK knew about birth defects

Defendant GlaxoSmithKline LLC d/b/a GlaxoSmithKline GSK knew as early as 1992 that Zofran passed through the placenta and into a developing fetus and presented “unreasonable risk of harm” to developing babies.

GSK marketed Zofran “off-label” for treatment of nausea and vomiting associated with pregnancy. The company represented that Zofran was a safe and effective treatment for the nausea and vomiting associated with pregnancy. However, the drug had not been studied for its adverse affects upon pregnant mothers, or the possible teratogenic effects upon their fetuses at any time between 1991 and 2011.

Between April 2009 and December 2013, GSK reported that it made paid doctors and healthcare institutions more than $437.9 million dollars in the United States for speaking fees, consulting fees, research, travel fees and meals.

In 2013, GSK made $12.8 billion in sales in the United States, making it the fifth most lucrative pharmaceutical company doing business in the United States according to IMS Health.

For more, read our article 260 Zofran Cases Filed Against GlaxoSmithKline

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