From a post by Alexander on the Drug and Device Law Blog.

Even for a diagnostic device that a patient uses at home, consumer fraud allegations have to be based on the prescribing physician’s knowledge and decision making as long as there is a prescribing physician.  Just as with product liability claims, the plaintiff may be able to make the right allegations up front about the relevant doctor having been misled by a representation or omission, but proving that is much harder than when the plaintiff’s own memory and speculation about taking a different action are the focus of inquiry.  Properly focusing on prescribing physicians also means that class certification, if they ever get that far, should be a pipe dream.

Read the complete post.

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