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 
[email protected]

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SOURCE Wisner Baum