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Popular heart drugs that can cause cancer face slew of US lawsuits

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Teva Pharmaceutical Industries is one of the companies named in over 50 lawsuits, including at least 27 patients.

Washington, DC

DOZENS of lawsuits have been filed against drugmakers and sellers over widely prescribed generic heart medications tainted with potential carcinogens, the first claims in what some lawyers expect to be a wave of litigation.

Millions of Americans have taken the drugs, which are at the centre of a widening recall being overseen by the US Food and Drug Administration (FDA), and have been for decades used to treat high blood pressure, heart failure and other common conditions.

A lawyer involved in an effort to combine about 50 lawsuits, including at least 27 by patients who say they contracted cancer by using the recalled medicine, told a US federal court he expects a surge of legal action.  "My best estimate sitting here today is I expect that we will have approximately 2,000 personal-injury cases on file in the next two years," Daniel Nigh, who has filed 12 such lawsuits so far, told judges at a conference in the US District Court in New Jersey last month, according to a transcript.

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The FDA has been coordinating a recall of adulterated heart medications since last July, when the carcinogen NDMA was discovered in valsartan manufactured by Zhejiang Huahai Pharmaceutical Co. The contaminated valsartan was sold to a number of major drugmakers and used as an ingredient in other popular cardiovascular therapies.

Zhejiang Huahai and its affiliates are the primary targets of the lawsuits. Other companies named in the complaints include generic-drug giants Teva Pharmaceutical Industries Ltd and Mylan NV, as well as CVS Health Corp, which operates large pharmacy and drug-benefit management businesses. Almost 40 defendants have been sued so far.

The FDA has said that the pills may have been contaminated with NDMA for as long as four years before the problem was found. The number of patients, if any, who developed cancer as a result of taking valsartan is unknown.

Earlier this year, Bloomberg News reported wide-ranging problems with testing data used to assure drugs' safety and effectiveness. Bloomberg found that FDA inspectors who'd expressed concerns about data integrity at some manufacturing facilities were at times overruled by senior officials at the agency. At a Zhejiang Huahai plant in Linhai that's at the centre of the recall, an FDA inspector determined that some of the drugs produced there were substandard-14 months before the agency took steps to facilitate the removal of valsartan and its combinations from the US market.

A spokeswoman for Zhejiang Huahai declined to comment. Representatives for Teva, Mylan and CVS didn't immediately respond to requests for comment.  The FDA said last month it plans to revamp rules governing how medicines are manufactured to ensure the safety of the nation's drug supply, in response to what former Commissioner Scott Gottlieb said were inadequate quality controls that have led to "a lot of instances" of contaminated products.

"I expect that we will have approximately 2,000 personal-injury cases on file in the next two years." Andres Rivero, an attorney for MSP Recovery, a Florida-based claims recovery service, told judges at the New Jersey hearing last month that his client represents insurers covering 73,311 people who took valsartan and that their claims were worth more than US$91 million. In 2018, 1.5 million people in the US took contaminated valsartan, said Mr Nigh.

Other drugs that are similar to valsartan-losartan and irbesartan have also been recalled. It's unclear if those drugs will be included in the combined litigation, plaintiffs' lawyers told the court, because not as much is known about the degree of contamination of those pills. Other carcinogens, NDEA and NMBA, have been found in the drugs as well.

Zhejiang Huahai didn't make all of the valsartan found to be tainted, though carcinogen levels were highest in its drugs, according to the FDA. The US agency has said it's looking into how the chemicals could have been created during the manufacturing process.

Proving the link between exposure to the contaminated medication and the plaintiffs' cancers may be difficult, Senior US District Judge Robert Kluger told the lawyers at the March 27 hearing.

"There's a number of people who claim, I understand, that they've contracted cancer from taking this drug," Mr Kluger said. "It's probably going to be a heavy lift to prove that, but you know, we'll see what happens."

Plaintiffs' lawyers said in the complaints that the amount contained in valsartan was far above accepted levels. Shortly after the recalls started in July, the FDA said that it's reasonably safe to consume up to 0.096 micrograms of NDMA a day. FDA test results released on Oct 5 found NDMA levels in recalled valsartan ranging from 0.3 micrograms to 17 micrograms. BLOOMBERG