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When the Supreme Court decided Bell Atlantic Corp. v. Twombly, 127 S. Ct. 1955 (U.S. 2007), we thought right away that there wasn’t any good argument to limit the Court’s toughened pleading standard to some discrete subset of cases, such as antitrust. We said:

As product liability practitioners, we’re drawn to the Court’s broader ruling that pleadings must actually plead the facts that justify the requested relief – which is something not limited by the legal theory before the Court. The federal rules are the federal rules. There’s not one set of rules for antitrust and another for what we do.

It took a bit of time, but it looks like we were right. Twombly has now come to prescription medical product product liability litigation.

The harbinger is Heck v. American Medical Systems, Inc., 2008 WL 1990710 (D. Md. April 30, 2008), a case that, if it weren’t for Twombly, we wouldn’t have spared a second glance. Heck is basically your garden variety poorly-pleaded product liability case – something we’ve encountered more times than we care to think about. Before Twombly, unless there were extenuating circumstances (that is, if we thought there was some benefit to making opposing counsel do some work that exceeded the cost of preparing a motion) we probably wouldn’t have even bothered filing the motion.

That’s because 99 out of 100 federal courts would have said, “that’s enough, you can find out what they’re really upset about in discovery.” After all, as has been repeated ad nauseum, the federal rules require notice, not fact, pleading.

But in Heck the same sorts of inadequacies, after Twombly, produced an outright dismissal. The case involved the alleged malfunction of a medical device – an implanted “artificial sphincter” – due to an allegedly “defective valve.” 2008 WL 1990710, at *1.

We know what you’re thinking, so stop it. No jokes, please, after all, life can be heck sometimes.

In fact, however, the complaint was a heck of a mess. Specifically, under Twombly, the “complaint failed to put the defendant on notice of the claim(s) [plaintiff] sought to bring … and the reasons he may be entitled to relief.” Id.

What exactly did the plaintiff do (or not do) that ran afoul of Twombly?

Let us count the ways.

In general, the dismissed complaint “failed to articulate in a clear fashion the theories [plaintiff] is asserting and the underlying facts necessary to satisfy the elements of his cause of action(s).” 2008 WL 1990710, at *1. Twombly, however, no longer lets plaintiffs get away with this sort of thing:

Following the Supreme Court’s ruling in Twombly, 127 S.Ct. at 1965, “[f]actual allegations must be enough to raise a right to relief above the speculative level, on the assumption that all the allegations in the complaint are true (even if doubtful in fact).” “Once a claim has been stated adequately, it may be supported by showing any set of facts consistent with the allegations in the complaint.” Id. at 1969. Moreover, the “plaintiff’s obligation to provide the ‘grounds’ of his ‘entitle[ment] to relief’ requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do.” Id. at 1964-65.

2008 WL 1990710, at *2 (non-Twombly citations omitted).

Twombly was violated because the complaint:

  • “state[d] legally operative terms in a conclusory fashion.” Id.
  • “Fail[ed] to articulate the theory being pursued, the elements of that theory, and the facts that establish those elements.” Id.
  • “baldly conclude[d]” that the device was “defective.” Id.
  • “baldly conclude[d]” that “the defendant was “negligent” in the manufacture of the device. Id.
  • “baldly conclude[d]” that “the device was ‘warranted as good and in functional condition.’” Id.
  • “baldly conclude[d]” that “the defendant is liable for the defective device that was ‘used without any warning or knowledge’” by the implanting surgeon. Id.
  • merged together “language that could sound in tort, contract, or product liability law.” Id.

These are all no-nos after Twombly (we would have wished they were anyway), because “a viable complaint must offer more than these unsubstantiated ‘labels and conclusions.’” 2008 WL 1990710, at *2 (again quoting Twombly).

The plaintiff didn’t do himself any favors in his response to the motion to dismiss either. Despite all the mixed up language in the complaint, he argued that the suit was for “strict liability only.” Id. But the complaint didn’t contain facts that would support the elements of strict liability cause of action under the relevant state’s (Maryland) law. The complaint “failed to articulate a clear strict liability theory” because:

  • It did “not identify how [the device] was defective.” Id. at *3. All the complaint included was “vague language” that did not specify whether there was a warning, design, or manufacturing defect. Id.
  • The complaint contained language that tended to defeat the strict liability element of defect at sale. Id. (stating, instead, that “the product was activated several times by the surgeon, after it was implanted, ‘with resulting proper action’”).
  • There were no facts “suggest[ing] that [the product] was unreasonably dangerous.” Id.
  • The complaint ignored the strict liability element that the product reached plaintiff “without substantial change in its condition.” Id.
  • The plaintiff did not allege enough facts – only an “unsubstantiated legal conclusion” – to support the allegation of defect. Id. (plaintiff’s “only evidence” was an affidavit from his physician,” but the affidavit “simply concludes that the valve in the device was ‘defective’”).

The Heck court goes on to discuss, “for the sake of completeness” similar deficiencies in the plaintiff’s pleading of both negligence and warranty causes of action. Id. We won’t bore you with those because the deficiencies are more of the same – either not pleading elements or doing so in conclusory, unsupported fashion.

Heck is the first prescription drug or medical device product liability case that we’ve seen applying Twombly to allegations of the usual theories we see in that kind of litigation (let alone less common theories). What we take away from is that Twombly can have some real teeth. It requires (at least according to Heck): (1) both the type of defect (warning, design, manufacturing) and the specific nature of the defect must be alleged in a strict liability complaint; (2) all essential elements of a cause of action must be pleaded; (3) all the essential elements must be supported by enough facts to “suggest” a plausible case; (4) pleading facts that tend to defeat an essential element is fatal; and (5) a conclusory supporting affidavit is no better than a conclusory allegation in the complaint itself.

We don’t think it should be all that hard for a plaintiff with a real claim to satisfy these rather basic pleading requirements, but they may require at least some movement away from cookie-cutter, word processor complaints that don’t tell the other side anything substantive about the claim other than the type of product that’s involved.

We also note the suggestion in Heck, 2008 WL 1990710, at *3, that the plaintiff may have lost the device in question. That may well have contributed to the result – at least the court seemed to think so.

It remains to be seen how Twombly will affect more sophisticated mass litigation that includes that same sort of conspiracy and similar allegations that were actually before the Supreme Court, but at least we’ve had a demonstration of how tougher pleading requirements can be useful in eliminating one-off cases like Heck, especially when ambiguous pleadings are being employed to try to keep a deficient claim afloat for what looks like its nuisance value.

It’s a start. We hope it’s not a finish.