Zantac exec testifies on claims that heat degraded heartburn drug into cancer-causing substance

The plaintiff’s lawyers argue the drug degraded into NDMA when exposed to hot, humid conditions. A Boehringer Ingelheim executive testified refrigeration was never required in any stage of production, transport or sale.

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Close-up of packages of Zantac displayed in a Rite Aid store.

An 89-year-old suburban Chicago woman is suing the drugmakers behind Zantac, a popular heartburn drug she claims caused her colon cancer.

AP file

The attorneys representing a suburban Chicago woman suing the drugmakers behind Zantac continued to make the case Tuesday that the drug degraded into a cancer-causing substance when exposed to high temperatures and humidity.

Mikal Watts, attorney for plaintiff Angela Valadez, on Tuesday questioned Boehringer Ingelheim executive Maureen Oakes over how Zantac was produced and stored — and whether it was refrigerated during the process.

Throughout the trial, Watts has argued that Zantac’s active ingredient, ranitidine, degraded into the cancer-causing substance NDMA when it was exposed to hot and humid conditions.

The lawsuit filed by Valadez, who claims Zantac caused her colon cancer, is the first of thousands of similar suits to make it to a jury trial.

In order to keep the drug safe, it should have been constantly refrigerated, both in storage and in transportation, Watts argued.

Watts’ questioning Tuesday largely focused on how Boehringer Ingelheim managed transportation and storage when it manufactured and sold the over-the-counter version of Zantac, which Valadez took daily for nearly 20 years. The company owned the drug from 2006 to 2017.

He focused on warehouses where the drug was stored in Spain off the Mediterranean Sea, emphasizing the hot and humid conditions of the area.

He asked Oakes — who has worked for the company for nearly 30 years, mostly focused on drug surveillance and regulatory processes — if Boehringer Ingelheim ever required the drug to be refrigerated, including in warehouses where it was stored, the ships and trucks on which it was shipped, and pharmacies where it was sold.

Oakes repeatedly maintained that refrigeration was not necessary to keep the drug safe. The company therefore never required or recommended it to be refrigerated during storage and transportation or when it was sold in pharmacies and kept in customers’ homes.

Watts also asked whether Boehringer Ingelheim ever changed the color of Zantac to mask discoloration. Oakes said the company would have never done that. The attorney asked whether it would be wrong for a major pharmaceutical company to change the color of Zantac to mask discoloration. Oakes did not directly answer the question.

Valadez, an 89-year-old woman from Brookfield, is suing Boehringer Ingelheim as well as the pharmaceutical company GSK.

Defense attorneys for Boehringer Ingelheim and GSK declined to question Oakes.

The plaintiff’s lawyers are nearing the end of their case this week. Defense attorneys representing the two companies will soon present their case to the jury of three men and nine women.

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