May 29, 2009
The Drug and Device Guys on Prefiling Discovery
Here's what they write, with a link too...
We're certainly not going to agree to a fishing expedition for unspecified "FDA violations" either before or after a complaint is filed - but if there's something specific, say an FDA 483 letter, precomplaint discovery to determine whether the particular drug/device that plaintiff used was within the scope of the FDA's complaint would be something we'd be open to considering (sorry, we can't be more definitive in a public forum).
Almost all drug product liability cases, and the majority of device cases, are failure to warn cases. The warning is public information, the alleged risk is public information, and the injury should be known to the plaintiff. Nothing more is needed to plead plausible facts that would support a claim under Twombly, and I don't think you'll find any Twombly cases stating otherwise. It's the multi-defendant and violation claims that draw these objections. As we said, that's where we see old fashioned post-complaint discovery and amendment to complaints as appropriate.
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