The Drug and Device Guys on Prefiling Discovery

We’re not opposed to precomplaint discovery in principle. It exists,for example, in Pennsylvania, which is a fact pleading state. Ifthere’s something specific that’s critical, precomplaint discoveryworks OK. But we’ve also received precomplaint requests that look likesomebody just changed a couple of words in the title and filed theirusual discovery. We consider that abusive.

We’re certainly notgoing to agree to a fishing expedition for unspecified “FDA violations”either before or after a complaint is filed – but if there’s somethingspecific, say an FDA 483 letter, precomplaint discovery to determinewhether the particular drug/device that plaintiff used was within thescope of the FDA’s complaint would be something we’d be open toconsidering (sorry, we can’t be more definitive in a public forum).

Almostall drug product liability cases, and the majority of device cases, arefailure to warn cases. The warning is public information, the allegedrisk is public information, and the injury should be known to theplaintiff. Nothing more is needed to plead plausible facts that wouldsupport a claim under Twombly, and I don’t think you’ll find anyTwombly cases stating otherwise. It’s the multi-defendant and violationclaims that draw these objections. As we said, that’s where we see oldfashioned post-complaint discovery and amendment to complaints asappropriate.