Can I sue if metformin gave me cancer?

by Jeffrey Nadrich Managing Partner, Nadrich & Cohen, LLP

Yes, you can file a personal injury lawsuit if you took metformin and were subsequently diagnosed with cancer.

An announcement came out of Singapore’s Health Sciences Authority in December 2019, saying the statutory board discovered levels of the probable carcinogen N-nitrosodimethylamine (NDMA) in three drugs containing metformin which were over the internationally accepted amount of NDMA.

Testing laboratory Valisure responded to this announcement by testing 38 metformin batches for contamination with NDMA. The lab discovered that 16 of the 38 batches contained an amount of NDMA which was over the 96 nanogram daily acceptable intake limit. Many of the batches contained over 10 times the limit. Valisure then sent the FDA a citizen petition, urging them to recall the contaminated metformin.

Metformin lawsuit allegations

Metformin manufacturers are already facing numerous lawsuits over the NDMA contamination.

Product liability lawsuits typically involve one or more of the following three allegations:

• Failure to warn: this is when a company knew or should have known that use of their product was risky, yet failed to warn consumers about this risk.

• Design defect: this is when a product is dangerous by design.

• Manufacturing defect: this is when a product’s design is safe but problems during the manufacturing process make the product unsafe.

One lawsuit that metformin manufacturers are currently facing accuses the manufacturers of failure to warn. The lawsuit states that defendants were duty bound to disclose to consumers that “they were in fact manufacturing, distributing, and selling harmful metformin unfit

for human consumption,” yet “defendants failed to discharge their duty to disclose these materials facts.”

“In so failing to disclose these material facts to Plaintiff and the Class and Subclass, Defendants intended to hide from Plaintiff and the Class and Subclass that they were purchasing and consuming metformin with harmful defects that was unfit for human use, and thus acted with scienter and/or an intent to defraud,” the lawsuit continues.

The lawsuit notes that metformin manufacturers were aware their products may have been contaminated with NDMA since at least December 2019, when the announcement from Singapore’s Health Sciences Authority was released. “Since at least December

2019, Defendants have been aware that NDMA was detected in metformin-containing

medications in other nations.”

The first metformin recall occurred on May 27, 2020, so metformin manufacturers continued to sell metformin for over five months after the December 2019 announcement before a recall ever occurred. The labels for the drugs containing metformin never warned of the NDMA contamination risk during that time period.

The lawsuit also alleges that “metformin contains dangerously high levels of

NDMA that would not be present if the medication were properly manufactured.” This is a manufacturing defect claim.

The lawsuit notes that Valisure noted that “the presence of NDMA in metformin products may be primarily due to contamination during manufacturing as opposed to a fundamental instability of the drug molecule.”

Metformin recalls

Five drug manufacturers have recalled medications containing metformin so far. They are:

• Apotex Corp voluntarily recalled their 500mg Metformin Hydrochloride Extended-Release Tablets on May 27.

• Amneal Pharmaceuticals LLC voluntarily recalled all lots of their 500mg and 750mg Metformin Hydrochloride Extended Release Tablets on May 29.

• Marksans Pharma Limited voluntarily recalled their 500mg Metformin Hydrochloride Extended-Release Tablets on June 2.

• Teva Pharmaceuticals USA voluntarily recalled 14 lots of their 500mg and 750mg Metformin Hydrochloride Extended-Release Tablets on June 2.

• Lupin Pharmaceuticals, Inc. voluntarily recalled one lot of their 500mg Metformin Hydrochloride Extended-Release Tablets on June 11.

NDMA and cancer

The United States Environmental Protection Agency considers NDMA to be a probable carcinogen. It has been known that NDMA might cause cancer since at least 1979, when a news article stated that “NDMA has caused cancer in nearly every laboratory animal tested so far.” Data has shown that NDMA can cause cancer in a wide variety of animals, including frogs, newts, fish, ducks, mastomys, guinea-pigs, rabbits, Syrian gold, European and Chinese hamsters, rats and mice. NDMA used to be used to make rocket fuel, but this practice has stopped because of NDMA contamination in the areas surrounding rocket fuel manufacturing sites. NDMA’s only use today is intentionally giving laboratory animals cancer so scientists can study the cancer. The World Health Organization has said there is “conclusive evidence that NDMA is a potent carcinogen” and there is “clear evidence of carcinogenicity.”

About the author

Jeffrey Nadrich is the managing partner of Nadrich & Cohen, LLP, a California personal injury law firm with offices in Los Angeles, San Francisco, Fresno, Modesto, Tracy and Palm Desert. The law firm has recovered over $350,000,000 on behalf of clients since its founding in 1990 and its lawyers possess over 70 years of combined legal experience. For more information on metformin lawsuits, visit https://www.personalinjurylawcal.com/california-metformin-lawsuits/