Friday, May 29, 2009
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.
Thursday, May 28, 2009
The AP story is here. The American Constitution Society reports the following on the case:
A lot of people have been writing about the new pleading standards lately. One very intriguing observation was offered by Prof. Edward Brunet (Lewis & Clark Law School). Brunet is the author of a treatise on summary judgment and links summary judgment and the new pleadings standards. The concept of "plausibility," he writes, is imported from substantive law of antitrust, now morphed into pleadings doctrine. His full analysis is below.
I think the origin of a plausible assessment of the
nonmovant's case was based in substantive antitrust law. In Matsushita(1986 trilogy) the p
word is used 10 times. However, the
context of usage of the word is substantive antitrust law and not Rule 12(remember
this was a summary judgment case). What
Matsushita meant is that antitrust is hostile to predation cases, particularly
those in which the plaintiff cannot demonstrate
recoupment of the defendant's costs expended in phase one of
a predation case ( the price cutting phase).
The plaintiffs' case was implausible because it was incredible that a monopolist
would lose money on its U.S. sales for a lengthy 25 year phase one.
The Matsushita majority also made a substantive point when asserting that "antitrust law limits the range of permissible inferences from ambiguous evidence in a section one case.” In other words, the term plausible was not intended to be a procedural yardstick in all cases but, instead, had a substantive antitrust meaning. This reading was bolstered by Matsushita's citation and quotation from Monsanto (1984) (another antitrust case and one not involving pleading) requiring the antitrust plaintiff who seeks to avoid summary judgment to have proof that "tends to exclude the possibility" of independent conduct.
As early as 1969 in the Cities Service case, the Supreme Court used the p word (plausible) when describing a plaintiff's antitrust theory and its ability to overcome a Rule 56 motion. So, up to the plate goes Justice Souter who reinterprets "plausible" in a procedural way in Twombly. And Justice Kennedy ignores the substantive antitrust meaning of "plausible" in Iqbal. My theory is based upon a willingness to have cause of action specific norms and flies in the face of a purely trans-substantive set of motion rules.
Tuesday, May 26, 2009
The United States isn't the only country experiencing civil reforms (i.e., Iqbal and Twombly). England and Wales are reevaluating their rules of civil procedure and the debate over class actions or "collective redress" has been brewing for some time. On May 8, 2009, Lord Justice Jackson released his preliminary report, which reviews civil litigation costs. The report follows two reports issued by the Civil Justice Council that recommended adopting an opt-out system of collective redress, introducing American style contingency fees, and doing away with the loser-pays English system. Lord Justice Jackson's preliminary report similarly suggests that abolishing the cost-shifting loser-pays system "merits serious consideration." Moreover, he raises the idea of one-way cost shifting to collective actions where claimants would be awarded their costs upon winning, but wouldn't bear the risk of taking on the defendant's attorneys' fees and costs if they lost.
As for collective redress, Jackson broaches the subject but ultimately refrains from recommending either the current opt-in procedure or a more encompassing opt-out procedure. He does, however, note that the current opt-in model discourages these type of enforcement actions. He invites written comments on the report and requests that they be sent by July 31. The submission information can be found here. Lovells LLP has written a brief and helpful overview of the report, which is available here.