A major player in China's drug industry is set to face a US jury next month in New Jersey.
At issue is when the drugmaker, Zhejiang Huahai Pharmaceutical, knew pharmaceutical ingredients it was selling for the US market six years ago were contaminated with a chemical that likely causes cancer. Emails that may be able to help answer that question disappeared. And China's Communist Party wouldn't let Huahai's chief executive leave the country to answer lawyers' questions in a deposition. In response to a plaintiffs' request, Huahai's counsel provided certification in October 2022 that the company didn't have any more documents, according to the company's objections to the judge's ruling. Lawyers for Huahai also said the emails do not exist because a key hard drive had been damaged.
Yet while the courtroom drama has played out, Huahai has been approved to make more drugs for American patients. The US Food and Drug Administration has cleared Prinston Pharmaceuticals, one of Huahai's subsidiaries, to sell generic copies of the ADHD drug Vyvanse and the erectile dysfunction drug Cialis as well as an antibiotic and another ADHD drug, among others.
When another pharmaceutical company discovered a carcinogen in a blood pressure drug Huahai made in 2018, it set off a cascade of recalls. (You can read more about that here.) The FDA sent inspectors to the plant in China and found conditions poor enough to ban the factory from sending products to the US. The FDA reversed the ban in 2021 after it said Huahai had cleaned up its act.
Still, it can be difficult to keep an eye on pharmaceutical companies in China. US inspectors haven't been back to Huahai for a full accounting since 2021, according to an FDA website. Back in the US, the retired judge helping oversee preliminary hearings, Thomas Vanaskie, wrote in July that the missing evidence and elusive CEO support that Huahai "likely knew of the contamination before its ultimate disclosure in 2018," according to his 22-page ruling.
The ruling lays out how a jury will hear about these omissions and be told they can decide whether Huahai was involved in a cover-up. Huahai and Prinston didn't respond to a request for comment.
Even though the FDA allowed the company to make more drugs for the US market, I'm not sure I'd want to take them given, what the court has revealed. But since Huahai makes key drug ingredients and sells them to companies besides Prinston, we don't always get to know whether Huahai is in our medicine cabinets or not. — Anna Edney |
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