Valisure, Represented by Wisner
Baum, alleges in qui tam suit that
GlaxoSmithKline (GSK) lied to the FDA and Federal Government about
the ability of its "blockbuster" drug to expose consumers to a
potent human carcinogen, resulting in billions of dollars in false
claims to government healthcare programs.
PHILADELPHIA, May 20, 2024
/PRNewswire/ -- Valisure LLC, a technology company that conducts
independent chemical analysis of pharmaceuticals, filed an amended
complaint in a recently unsealed whistleblower suit originally
filed in 2019 against GlaxoSmithKline alleging the pharma company
defrauded the federal government about how that Ranitidine, sold
under the brand name Zantac, was unstable and degraded into a
potent human carcinogen.
GSK's documented fraud on the FDA and Federal
Government started in the early 1980s, years before Zantac was ever
approved. That fraud allowed GSK to market and sell
Zantac for decades causing thousands of false claims—worth billions
of dollars—to be paid with taxpayer money by the federal and state
governments, the complaint alleges.
According to the lawsuit, GSK concealed the link between
Ranitidine and the potent carcinogen N-Nitrosodimethylamine (NDMA)
for nearly four decades. Only after Valisure published its testing
data on Ranitidine in September 2019
(after first disclosing this information to the U.S. government)
did the FDA grant Valisure's citizen petition and request and pull
the popular antacid from the market in 2020, citing the fact that
ranitidine degrades into NDMA.
The suit alleges that GSK buried NDMA data and
lied to the FDA "through a campaign of deception" since the early
1980s. The complaint further alleges GSK's efforts to
ensure medical researchers would not discover the problem by
advocating fraudulent NDMA testing protocols and publishing
fraudulent studies in scientific and medical journals.
Investigations have found NDMA in nearly every Zantac (generic:
ranitidine) pill tested. Prompted by third-party laboratory testing
and citing risks of consumer exposure to NDMA and "sustained higher
levels of exposure" increasing "the risk of cancer in
humans," the FDA issued a market withdrawal for all ranitidine
products from the market in 2020. Testing by regulators, ranitidine
manufacturers, and independent laboratories show that one
ranitidine 300 mg tablet can contain tens of thousands of nanograms
(ng) of NDMA, greatly exceeding the FDA's daily acceptable intake
limit of 96 ng.
"Zantac is a unique situation for Valisure," said David Light, Co-Founder and President of
Valisure. "We not only had concern over the results of the
scientific testing we conducted, but also had concern over the
potential false claims implications of the historical testing
conducted by GSK. This case vividly highlights the critical
need for independent checks and balances in the pharmaceutical
industry."
The suit seeks damages for violations of the Federal False
Claims Act and for states' counterpart false claims statutes.
Plaintiffs seek to recover treble damages, civil penalties, and
other recoveries provided for under the FCA and the State False
Claims Acts. Wisner
Baum attorney R. Brent
Wisner and Jennifer A.
Moore of Moore Law Group PLLC are co-lead counsel
representing the relator, Valisure.
"The FDA pulled Zantac off the market after finding this potent
carcinogen at extreme levels in GSK's product, something GSK knew
since the early 1980s prior to the drug's approval," Moore said.
"This type of corporate greed and malfeasance should never be
tolerated and the American taxpayer should rightfully recover for
having to spend billions of dollars on a drug that GSK fraudulently
obtained approval to sell in the United
States and lied about its safety to the American
public."
"Valisure conducted the same tests that GSK did in the
1980s. The difference—instead of lying to the FDA and burying
the results, Valisure turned everything over to the FDA." Wisner
said. "GSK has a criminal history of defrauding the federal
government—having been fined over $3
billion by the Department of Justice in 2012. This is worse.
For forty years, GSK knowingly exposed millions of Americans
to a carcinogen without their consent, and bilked taxpayers along
the way."
"Our growing customer base in the pharmaceutical and healthcare
industry reflects our commitment to ethical business practices,"
said Chip Phillips, Chief Executive
Officer of Valisure. "Pursuing this case demonstrates our
dedication to challenging industry norms and ensuring the highest
standards of quality and safety."
The case is captioned United States
of America et al., ex rel Valisure LLC v. GlaxoSmithKline
PLC, Case No. 2:19-cv-04239-JP, U.S. District Court for the
Eastern District of Pennsylvania.
The award-winning law firm of Wisner Baum has
successfully litigated cases against many of the largest
pharmaceutical companies in the world. Since 1985, the firm has
earned a reputation for breaking new legal ground, holding
corporations accountable, influencing public policy, and raising
public awareness on important safety issues. Using its longstanding
tradition of success in the courtroom, the firm always strives to
shine a spotlight on unsafe products or harmful practices to
protect consumers from dangerous products. Across all areas of
practice, the firm has won more than $4
billion in settlements and verdicts.
Media Contact:
Robin McCall
Director of Public Relations Wisner Baum
RMcCall@WisnerBaum.com
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SOURCE Wisner Baum