Articles Posted in Products Liability

The New England Journal of Medicine is hardly a tool of the plaintiffs’ bar. So when the Journal criticizes the lack of complete disclosures in reports concerning clinical trials people should stand up and take notice.

The editor of the Journal says that some companies “are meeting the letter but not the spirit of the law.” Read the study of the compliance rate of drug manufacturers with the federal law that governs clinical trials here.

Here is an editorial written by the Journal staff on the subject. An excerpt: “In our opinion, it is unacceptable for a trial sponsor not to register its trial in a complete, meaningful, and timely fashion. We call for all clinical investigators and patients to participate only in fully registered trials.”

The President will sign a budget bill containing a provision for immunity for manufacturers of certain vaccines. I cannot track down the legislation itself but here is an ATLA summary of it:

“The liability provisions allow the Secretary of HHS to declare that a drug, device, or vaccine is a covered countermeasure for a pandemic, epidemic, or potential public health emergency. Once a product is covered, the manufacturer is provided immunity for even reckless misconduct. The bill does not even provide a compensation fund for injured patients. Instead it established a compensation process, but appropriates no funding to provide compensation for those who are injured.”

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