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Heparin: The Payoffs and the Pitfalls of Manufacturing Drugs in China

The Boston Globe published an article on Friday about the concerns surrounding the manufacture of drugs and medical devices in China. Looking at the Baxter Heparin cases and seeking input from the perspective of a plaintiff’s lawyer, the Globe called me for an interview. This is an excerpt from the article:

“But there are also risks, as evidenced by the heparin incident, that could damage a company’s reputation and lead to expensive litigation. Ronald V. Miller, Jr., a Baltimore lawyer who is considering filing a lawsuit on behalf of patients injured by heparin, said it is easier to win damages against a company that sells defective products made in China instead of the United States.”

“Reasonable people understand that there is some level of concern about Chinese manufacturing,” said Miller, a partner in the law firm Miller & Zois, LLC. “Indeed,” he said, “jurors might conclude that companies make products in China to cut costs at the expense of safety.”

I think this is true. In fact, I think it would be difficult to argue with that statement. But that does not mean that any manufacturing defect case against a Chinese-made drug is a slam dunk by any stretch. But if you will manufacture a drug or medical product, particularly a life-saving drug like Baxter’s heparin, in China or anywhere outside of the United States, you are distancing yourself from the product. This is okay, as long as you take the proper precautions. Here’s a quick checklist companies might want to consider:

•Has the FDA inspected the manufacturing site? (heparin: no)

•Has the foreign version of the FDA inspected the manufacturing site? (heparin: no)

•Is there any ultimate means to verify the product is safe after that stage through the manufacturing process? (heparin: no)

•Is the product one where, if there is a mistake in the manufacturing process, it is likely to have serious or fatal repercussions? (heparin: no)

Obviously, for Baxter with Heparin, it failed every element of this list and, as a result, its Heparin product’s reputation was transformed from lifesaving to fatal for many consumers.

Concerns about the loss of jobs at home notwithstanding, drug companies may serve their customers well by manufacturing their products abroad to cut costs because they pass along, in whole or part, these savings to their customers. But if that is the plan, they have to realize that the further they slip away from the nuts and bolts of the manufacturing process the more they need to make sure there are adequate safeguards in place to keep the product safe.

  • 2020 update: valsartan reminds me of the heparin litigation
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