in Newswire Published on September 17, 2019

Sanofi, Boehringer Ingelheim Hit with Class Action Over Allegedly Unsafe Levels of Probable Carcinogen NDMA in Zantac

Garza et al. v. Sanofi-Aventis U.S. LLC et al.

Filed: September 13, 2019 ◆§ 5:19-cv-05772

Zantac makers Sanofi-Aventis U.S. and Boehringer Ingelheim face a class action over the allegedly high NDMA content in the over-the-counter heartburn and indigestion drug.

Defendant(s)

Sanofi-Aventis U.S. LLC Boehringer Ingelheim Pharmaceuticals, Inc. Sanofi US Services, Inc. Chattem, Inc.

Law(s)

State(s)

California

Over-the-counter drug Zantac is at the center of a proposed class action lawsuit wherein four California consumers allege the indigestion, heartburn and acid reflux treatment contains high quantities of the probable carcinogen N-Nitrosodimethylamine—NDMA.

The 31-page complaint out of California’s Northern District alleges that Zantac (ranitidine) has become one of the most widely used and highest-selling drugs in the United States due in part to defendants Sanofi-Aventis U.S. and Boehringer Ingelheim Pharmaceuticals’ “deception” in failing to disclose to consumers the product’s NDMA content. According to the lawsuit, Sanofi and Boehringer “knew or had reason to know” that consumers who took Zantac were exposed to “unsafe levels” of NDMA yet failed to disclose the risk on the drug’s labels or by any other means.

“Had Defendants disclosed that Zantac results in unsafe levels of NDMA in the human body, no person, let alone a reasonable person, would have purchased and consumed Zantac,” the lawsuit states.

According to suit, NDMA belongs to a family of chemicals, N-nitrosamines, recognized by the U.S. Environmental Protection Agency (EPA) and World Health Organization (WHO) as carcinogenic. The dangers of NDMA, which the case notes is no longer produced or used commercially in the U.S., have been known since at least the early 1980s, and in 2018 several recalls were issued for drugs with NDMA levels found to fall short of FDA safety standards. As the lawsuit tells it, however, Zantac stands apart from its now-recalled counterparts given the levels of NDMA detected in the product. From the complaint:

“Zantac poses a greater safety risk than any of the recently recalled valsartan tablets. Applying the FDA-recommended GC/MS protocols for detecting NDMA—the same protocols used by the FDA to detect NDMA in valsartan45—the level of NDMA in Zantac is 2,511,469 ng per Zantac tablet—124 times more than the highest amount detected in the recalled valsartan.

Moreover, the high levels of NDMA produced by Zantac are not caused by a manufacturing defect but rather are inherent to the molecular structure of ranitidine, the active ingredient in Zantac: ‘The ranitidine molecule contains both a nitrite and a dimethylamine (‘DMA’) group which are well known to combine to form NDMA.’ Thus, ranitidine produces NDMA by ‘react[ing] with itself,’ which means that every dosage and form of ranitidine, including Zantac, exposes users to NDMA.”

Cited in the lawsuit is testing conducted by Valisure, an ISO 17025 accredited online pharmacy and analytical lab, that found “extremely high levels of NDMA in all lots

of [Zantac] tested across multiple manufacturers of ranitidine products.” Valisure’s testing, the results of which the case states were shared with the FDA on September 13, 2019, showed that ranitidine can react with itself in standard analysis conditions “at high efficiency to produce NDMA at dangerous levels well in excess of” the permissible and relatively low daily intake limit of 96 ng. Valisure’s testing, the suit continues, found excessively high levels of NDMA per 150 mg Zantac tablet. From the case:

“Valisure’s testing—which employs the FDA’s own gas chromatography/mass spectrometry (‘GC/MS’) protocol—detects 2,511,469 ng of NDMA per 150 mg tablet of Zantac. In other words, the FDA-recommended protocol detects a quantity of NDMA in each Zantac tablet that is more than 26,000 times greater than the amount that can be safely ingested daily.”

A typical consumer who takes Zantac over the course of eight weeks to treat peptic ulcer disease “is exposed to more than 280,000,000 ng (or .028 grams)” of NDMA, the lawsuit says. According to the case, an individual who takes a 150 mg maintenance dose of Zantac once daily is exposed to 0.889 grams of NDMA over the course of a year.

The lawsuit asks the court to certify a proposed class of consumers who bought the over-the-counter version of Zantac in California at any time between January 1, 2010, and the present.

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