Your company has just been served with a new products liability complaint. Although the complaint includes all the proper legal jargon, you are left to wonder: What legal theory is plaintiff pursuing here; how exactly was plaintiff injured; and what is plaintiff claiming is defective about the product? Fortunately, after the United States Supreme Court decision in Bell Atlantic Corporation v. Twombly, you should no longer have to engage in the expensive and time-consuming discovery process just to get answers to these questions. As explained below, the decision in Twombly places a new arrow in the company’s quiver to force a plaintiff to either clearly articulate his claim or risk dismissal of the action.

Pleading Requirements Prior to Twombly: “No Set of Facts”

In the days of common law and code pleading, plaintiffs were required to plead a set of ultimate facts in order to maintain a cause of action. In 1938, the Federal Rules of Civil Procedure were introduced and notice pleading became the norm. Initially, defendants experienced some success in defeating factually vague complaints via Rule 12(b)(6) motions to dismiss for failure to state a claim. Then in 1957, the United States Supreme Court handed down its decision in Conley v. Gibson and held that “a complaint should not be dismissed for failure to state a claim unless it appears beyond doubt that the plaintiff can prove no set of facts in support of his claim which would entitle him to relief.”¹ This “no set of facts” standard allowed a complaint to survive a motion to dismiss even if the claims asserted were conclusory.

Since Conley, complaints have, for the most part, degenerated into a rote recitation of a cause of action’s element — a mere shadow of even the most basic form of notice pleading. Defendants, weary of being told that this type of pleading was sufficient, all but stopped filing motions to dismiss and opted to respond, as best they could, to the factually insufficient complaint and proceed with discovery.

Twombly: From Conceivable to Plausible

Mercifully, before we reached the point where a pleading alleging simply “I’m hurt, you did it, pay me” was deemed sufficient to state a claim for relief, the United States Supreme Court issued its decision in Twombly. Twombly redefined the standard for initial pleadings and breathed new life into Rule 12(b)(6) motions to dismiss.²

In Twombly, the plaintiffs filed suit in federal court alleging that the defendants conspired to restrain trade in violation of Section 1 of the Sherman Act by inflating the cost of local telephone and internet service and by refraining from competing with each other. The complaint alleged that the defendants had engaged in “parallel conduct” but failed to set forth any other facts that would support illegal agreements to restrain trade. In response to the complaint, the defendants filed a Rule 12(b)(6) motion to dismiss for failure to state a claim and asserted that the simple allegation of parallel conduct did not state sufficient grounds to entitle plaintiffs to relief.

The United States District Court for the Southern District of New York dismissed the action because the complaint’s allegations of parallel conduct did not rise to the level of conspiracy as required by the Sherman Act.³ The Second Circuit, applying Conley’s “no set of facts” standard, reversed and held that for dismissal “a court would have to conclude that there is no set of facts that would permit a plaintiff to demonstrate that the particular parallelism asserted was the product of collusion rather than coincidence.”⁴ The Supreme Court reversed the Second Circuit and dismissed the complaint on the grounds that the complaint failed to allege sufficient facts to move the plaintiffs’ claims from conceivable to plausible.⁵

The Court rejected Conley’s “no set of facts standard” as dicta and suggested that it was “best forgotten as an incomplete, negative gloss on an accepted pleading standard; once a claim has been stated adequately, it may be supported by showing any set of facts consistent with the allegations in the complaint.”⁶ In further explanation of the proper pleading standard, the Court noted that while Rule 8(a)(2) “requires only a ‘short and plain statement of the claim showing that the pleader is entitled to relief,’ in order to ‘give the defendant fair notice of what the […] claim is and the grounds upon which it rests […] a 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.”⁷ Thus, to maintain a cause of action, some factual allegations must accompany the elements of the claim. Although the factual allegations do not have to be detailed, they “must be enough to raise a right to relief above the speculative level” and cross the “threshold of plausibility.”⁸

Application Beyond Twombly

Twombly marks the end of notice pleading and the dawn of plausibility pleading. As awareness of Twombly has grown, an increasing number of defendants have tested its holding in areas outside antitrust and have found success. For example, district courts have applied Twombly in cases of civil rights violations and breach of contract.⁹ Additionally, because many states have adopted rules of civil procedure modeled after the federal rules, state court defendants have successfully used Twombly persuasively to obtain dismissals. ¹⁰

Most importantly for the healthcare industry, courts have applied Twombly’s elevated pleading requirements in medical device product liability cases to dismiss claims of negligence, strict liability, and breach of express warranty.

In Heck v. American Medical Systems, a medical product liability action, the court granted American Medical System’s motion to dismiss because it found that the 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).”¹¹ Specifically, the court found the complaint lacking because it:¹²

• “state[d] legally operative terms in a conclusory fashion”;
• “fail[ed] to articulate the theory being pursued, the elements of that theory, and the facts that establish those elements”;
• “baldy conclude[d]” that the defendant was negligent; that “the device was ‘warranted as good and in a functional condition;’” and that the “defendant was liable for the defective device that was ‘used without any warning or knowledge’” by the implanting surgeon;
• “[i]ncluded language that could sound in tort, contract, or product liability law” but failed to offer more than “unsubstantiated labels and conclusions”;
• failed to identify how the product was defective;
• included information that tended to negate defectiveness at the time of sale;
• failed to set forth facts to suggest that the product was unreasonably dangerous;
• failed to set forth facts to support allegation of defect, resorting instead to unsubstantiated legal conclusions.

At least three other medical device manufacturers have used the new requirements imposed by Twombly to dismiss factually inadequate claims. In each of the three cases, the motion to dismiss for failure to state a claim was brought in conjunction with defendants’ motion to dismiss based on express federal preemption under the 1976 Medical Device Amendments to the Food Drug and Cosmetic Act. In Heisner ex rel. Heisner v. Genzyme Corporation, the court dismissed plaintiff’s “parallel” state law claim — a claim that a manufacturer failed to adhere to the specifications imposed by the FDA through a Premarket Approval. Based on the Twombly standard, the court held the complaint’s “vague suggestion” that the defendant violated reporting requirements failed to put the defendant on notice as to the substance of the claim.¹³ The court also dismissed plaintiff’s claims for breach of express warranty because he did not specify “any particular affirmation, promise, description, or sample that formed part of the basis of his bargain” or otherwise allege any facts to suggest that an express warranty existed.¹⁴

Similarly, in Parker v. Stryker, the court granted the defendant’s motion to dismiss and held that to properly allege parallel claims post-Twombly, a plaintiff must do more than simply allege that a defendant violated FDA regulations.¹⁵ To avoid dismissal, the complaint must allege some facts to back up its claims.¹⁶ Finally, the court, in In re Medtronic, Inc., Sprint Fidelis Leads Products Liability Litigation, also dismissed plaintiffs’ allegedly parallel claims noting that pursuant to Twombly, “[p]laintiffs cannot simply incant the magic words ‘Medtronic violated FDA regulations’ in order to avoid preemption.”¹⁷ Rather, the court held that plaintiffs were required to provide “some factual detail about why that [manufacturing technique] violates federal standards.”¹⁸

What to Look for in Your Complaint

There is little doubt that Twombly will prove to be a useful tool for defendants. The next time a complaint lands on your desk, do not just resign yourself to filing an answer and proceeding down the long and costly road of discovery. Instead, you should carefully scrutinize the plaintiff’s allegations. Examples of what to look for include, but are not limited to, situations in which the plaintiff:

• alleges FDA violations but fails to set forth the regulation at issue and how the defendant violated it;
• alleges a defective product but does not state how the product fails to meet specifications or is otherwise defective;
• alleges misrepresentation but does not plead the circumstances surrounding the misrepresentation;
• alleges inadequate warnings but does not state how a different warning would have changed the physician’s decision to prescribe or plaintiff’s decision to use the product;
• alleges breach of express warranty but does not specify any particular affirmation, promise, description, or sample that formed part of the basis of the bargain or otherwise allege any facts to suggest that an express warranty existed; or
• alleges some facts, but the facts alleged are consistent with both liability and with innocent alternative explanations.

In essence, if the plaintiff has failed to support allegations with facts, you should consider filing a Rule 12(b)(6) motion to dismiss. Whether the motion leads to a dismissal of the action or to an amended pleading supported by proper factual allegations enabling your company to better assess exposure, your company will benefit.

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[1] Conley v. Gibson, 355 U.S. 41 (1957).

[2] Bell Atlantic Corp. v. Twombly, 127 S. Ct. 1955 (2007).

[3] Twombly v. Bell Atlantic Corp., 313 F. Supp. 2d 174, 188 (S.D.N.Y. 2003), vacated, 425 F.3d 99 (2d Cir. 2005), rev’ d 127 S. Ct. 1955 (2007).

[4] Twombly v. Bell Atlantic Corp., 425 F.3d 99, 114 (2d Cir. 2005), rev’ d 127 S. Ct. 1955 (2007).

[5] Bell Atlantic Corp. v. Twombly, 127 S. Ct. 1955 (2007).

[6] Id. at 1969.

[7] Id. at 1965.

[8] Id.

[9] See e.g. Thomas v. Rhode Island, 542 F.3d 944 (1st Cir. 2008); Umland v. PLANCO, 542 F.3d 59 (3d Cir. 2008); Iqbal v. Hasty, 490 F.3d 143 (2d Cir. 2007); Alvarado v. KOB-TV, LLC., 493 F.3d 1210 (10th Cir. 2007).

[10] See e.g. Western Innovations, Inc. v. Sonitrol, Corp., 187 P.3d 1155 (Colo. Ct. App. 2008); American Fed. of Teachers, AFL-CIO v. Federacion De Maestros De Puerto Rico, 2008 WL 2078964 (D.C. May 26, 2008); In re Seneca Investments, LLC, 2008 WL 4329230 (Del. Sept. 23, 2008); Iannacchino v. Ford Motor Co., 888 N.E.2d 879 (Mass. 2008); Bean v. Cummings, 939 A.2d 676 (Me. 2008); Hebert v. City of Fifty Lakes, 744 N.W.2d 226 (Minn. 2008); Sisney v. Best, Inc., 754 N.W.2d 804 (S.D. 2008); Robles v. Hovensa, LLC, 2008 WL 2439881 (V.I. June 12, 2008); Charles H. Wesley Edu. Found., Inc., v. State Election Board., 654 S.E.2d 127 (Ga. 2007).

[11] Heck v. American Medical Systems, Inc., 2008 WL 1990710 (D. Md. April 30, 2008).

[12] Id. at *2-*3.

[13] 2008 WL 2940811 *5-6 (N.D. Ill. July 25, 2008) (citations omitted).

[14] Id. at *9.

[15] 2008 WL 4716879 *2 (D. Colo. October 22, 2008).

[16] Id.

[17] In re Medtronic, Inc., Sprint Fidelis Leads Products Liability Litigation, Multidistrict Litigation No. 08-1905, United States District Court, District of Minnesota, Memorandum Opinion and Order, slip op. at 21, January 5, 2009.

[18] Id.

Finis