Biopharma company GSK reached settlement agreements with 10 law firms representing multiple plaintiffs in cases related to the company allegedly selling carcinogenic drugs.
The plaintiff companies that are part of the proposed agreement are “unanimously recommending” to their clients that they accept the terms, the company said.
Once approved by all sides, the agreements are expected to be implemented by the end of the first half of next year. Details of the settlement were not revealed.
The withdrawal request was issued after an agency investigation found the medications to be contaminated with a chemical, NDMA, that can be carcinogenic to human beings. This triggered a rush of lawsuits against the drug manufacturers in federal and state courts.
GSK has not admitted any liability in the agreements.
“Scientific consensus remains that there is no consistent or reliable evidence that ranitidine increases the risk of any cancer,” it stated.
However, GSK said it “strongly believes that these settlements are in the best long-term interests of the company and its shareholders as they remove significant financial uncertainty, risk, and distraction associated with protracted litigation.”
The company also announced it would pay $70 million to settle another complaint filed by health care-quality assurance company Valisure.
GSK expects a $2.3 billion charge in its third-quarter results from these settlements. Shares of the company rose after the announcement of the agreements.
NDMA Cases, Drug Risk
In addition to GSK, cases were also filed against other ranitidine manufacturers: Pfizer, Sanofi, and Boehringer Ingelheim.Pfizer has agreed to settle most of the Zantac cases against it in state court, according to its most recent financial statement, and Sanofi in April announced that it was settling about 4,000 cases.
Boehringer Ingelheim has not announced any major settlements but is currently facing a state court trial over the drug in Oakland, California. The company has denied any wrongdoing.
“We continue to pursue claims against Boehringer Ingelheim for its wrongdoing for exposing millions of people to a known carcinogen for over a decade,” Moore and Wisner said.
The FDA first became aware of NDMA contamination in ranitidine drugs in the summer of 2019 from an independent laboratory testing, according to an April 2020 statement.
While low levels of NDMA are ingested through regular diet without much harm, “sustained higher levels of exposure may increase the risk of cancer in humans,” the agency noted.
An initial test done by the FDA only found NDMA at low levels in ranitidine drugs. However, later testing and evaluation found that NDMA levels increased even when the medications were in normal storage conditions.
“NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers,” the FDA stated.
“The testing also showed that the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater the level of NDMA. These conditions may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit.”
The agency then sent letters to ranitidine manufacturers, asking them to withdraw the drugs from the market. Customers who bought the drugs were recommended to stop taking them, dispose of the medication, and never buy them again.
