The Iqbal/Twombly Decisions

One of the most frustrating and wasteful legal expenses for a medical device or pharmaceutical manufacturer is the cost of defending against claims where its product is ultimately found not to be involved. This happens where cases are pleaded to include the defendant along with multiple other manufacturers of the same or similar products. Such general pleading tactics in toxic tort cases have become the status quo for many plaintiffs' firms nationwide, where counsel look to “take the easy way out” by simply naming all competing manufacturers of a product rather than doing their investigative homework up front on the issue of product identification. Medical product manufacturers consider this “shotgun” approach to litigation abusive and harassing, and they have long chafed against having to defend against claims that do not involve their products.

Mass Tort Cases

Recently, there has been an uptick in mass tort cases where plaintiffs' counsel, without pleading market-share liability (a theory that is only appropriate in certain, very limited factual circumstances), simply name all industry manufacturers of a device when the patient-plaintiff could only have used a singular medical device from one known or knowable manufacturer. Historically, under these circumstances the named defendant manufacturers will each proceed to retain counsel to answer the complaint; exchange some calls and letters demanding evidence of product ID from the plaintiff; conduct sufficient discovery to properly separate the wheat from the chaff (as far as the defense bar is concerned, an objectionable shifting of the burden of proof); and then, finally, after weeks and perhaps even months of legal maneuvering, ultimately seek dismissal of the action because their product is found not to be the one at issue. This scenario, which is repeated frequently in mass toxic tort cases, is an undeniable waste of our courts' time and resources, and constitutes an unjustified expense for those improperly named defendant-manufacturers.

Plaintiffs have benefited for years from this method of proceeding to court. However, plaintiff attorneys who plan to use these tactics should be aware that the defense bar has a friend in two recent U.S. Supreme Court rulings to attack these types of complaints from the outset.

In May, the Supreme Court, in Ashcroft v. Iqbal, 129 S. Ct. 1937, 1950 (2009), gave defendants a new tool with which to combat generally pleaded complaints against multiple manufacturers. By explaining and extending the reach of Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007), the Iqbal Court heightened the general pleading standard of Federal Rule of Civil Procedure 8 to a level that arguably requires plaintiffs in medical products liability cases to specifically plead the manufacturer and product allegedly involved. Rule 8(a)(2) requires that in order to state a claim for relief, a pleading must contain a “short plain statement of the claim showing that the pleader is entitled to relief.”

Twombly and a Change in Pleading Requirements

Since 1957, federal courts have followed the Conley standard, which interpreted Rule 8 to require plaintiffs only “to give the defendant fair notice of what the claim is and the grounds upon which it rests.” Conley v. Gibson, 355 U.S. 41, 47 (1957).

The 2007 Twombly decision abrogates the minimal Rule 8 pleading standard set forth in Conley. The Twombly court overturned a Court of Appeals' decision and reinstated the ruling dismissing the plaintiffs' complaint, finding that conclusory allegations in support of the elements of a claim were not sufficient to show that the pleader was entitled to relief. Twombly, 550 U.S. at 557. The Court explained:

While a complaint attacked by a 12(b)(6) motion to dismiss does not need detailed factual allegations, a plaintiff's obligation to provide the “grounds” of his “entitlement 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 555 (internal citations omitted).

Twombly, therefore, requires the pleader to make some factual allegations ' at least enough, according to the Court, to “raise a right to relief above the speculative level.” Naked assertions in a complaint of the elements of a claim, stated the Court, “but without further factual enhancement[,] stops short of the line between possibility and plausibility of entitlement to relief.”

Cost saving appears to have been the public-policy driving force behind the Twombly decision. There, the Court alluded to the practical significance of Rule 8, finding that “something beyond the mere possibility of loss causation must be alleged, lest a plaintiff with 'a largely groundless claim' be allowed to 'take up the time of a number of other people.'” Id. at 557-58 (quoting Dura Pharms., Inc. v. Broudo, 544 U.S. 336 (2005)). The Court intends for basic deficiencies in pleading to “be exposed at the point of minimum expenditure of time and money by the parties and the court.” Id. at 558. Ultimately, the Twombly Court reversed the Court of Appeals finding that plaintiffs did not state enough facts to nudge their claims across the line from conceivable to plausible. Id. at 570.

In the immediate aftermath of the landmark Twombly decision, courts were divided as to whether the holding applied to all federal cases or whether it applied only in the context of the antitrust subject matter at issue in Twombly. In 2009, the Court in Iqbal extended Twombly to apply to every application of Rule 8.

Ashcroft v. Iqbal and Medical Products Cases

Iqbal advances the Twombly decision in two important ways: 1) by clarifying the Court's intention that the Twombly pleading standard apply to all federal civil actions; and 2) by setting forth a two-part framework for use in the determination of whether a pleading states a claim. These changes in the way the law is applied have had two effects on medical device litigation.

First, Iqbal makes very clear that the heightened Twombly pleading standard constitutes the pleading standard for “all civil actions.” Much to the benefit of medical device and drug manufacturers, all cases governed by the Federal Rules of Civil Procedure now fall within the broad reach of Iqbal and Twombly. In practice, this may result in yet another factor medical device manufacturers may consider when determining whether to remove select state cases to federal court ' the benefit of leveraging cost savings available via an Iqbal/Twombly motion to dismiss.

Second, the Court in Iqbal set up a road map to aid courts in determining when a litigant has sufficiently stated a claim under the new, heightened standard. The first step in the analysis is to identify any conclusory pleadings. Pleadings that are factually or legally conclusory are not entitled to a presumption of truth and must be supported by well-pleaded factual allegations. “Threadbare recitals of the elements of a claim, supported by mere conclusory statements, do not suffice.” Id. at 1949 (citing Twombly, 550 U.S. at 555). The second step in the analysis, where a pleading does contain well-pleaded factual allegations, is to “assume their veracity and determine whether they plausibly give rise to an entitlement to relief.” Id. at 1950. The Iqbal Court said, “A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Id. at 1949. The Court went on to state that the standard for plausibility “is not akin to a 'probability requirement,' but it asks for more than a sheer possibility that a defendant has acted unlawfully.” Id. (citing Twombly, 550 U.S. at 556.)

Applying this test to the facts in Iqbal, the Court determined that the plaintiff had not “nudged his claims of invidious discrimination across the line from conceivable to plausible.” Id. at 1950'51. The Court found that the formulaic recitation of the elements of a constitutional discrimination claim did not trigger an assumption of truth. For instance, the Court determined that the following statements, as pleaded by the plaintiff, were conclusory: “Ashcroft was the 'principal architect'” and “petitioners knew of, condoned, and willfully and maliciously agreed to subject [him] to harsh conditions ' solely on account of [his] religion, race, and/or national origin.” Id. Therefore, the Court concluded, the Iqbal plaintiff did not meet his burden on several elements, and his claims were properly dismissed.

Recent Defense Successes Applying Iqbal/Twombly

Medical device and pharmaceutical defendants have only begun to reap the benefits of the new Iqbal/Twombly pleading standard. Indeed, since the Supreme Court decided Twombly in 2007 and Iqbal in May 2009, several federal district courts have already granted manufacturers' motions to dismiss. This trend is likely to continue in favor of similarly situated defendants.

For instance in Wolicki-Gables v. Arrow Int'l, Inc., Not Reported in F.Supp.2d, 2008 WL 2773721 (M.D. Fla. June 17, 2008), the plaintiff did not specifically identify the “implantable drug delivery system” it alleged caused plaintiff's injury. As to negligence, defendants argued that the existence of a duty was not sufficiently pleaded where there was no factual basis that identified a relationship between the defendants and the product. The Wolicki-Gables plaintiff conceded the point and asserted that it had documents that would allow it to identify the product. In light of this, the court dismissed the plaintiff's claims, granting leave to amend to specifically identify the medical device in question. The court came to the same result with regard to the plaintiff's strict liability claim, finding that “the occurrence of symptoms without more [factual allegations], does not plausibly suggest a defect.”

Similarly, in Sherman v. Stryker Corp., Not Reported in F.Supp.2d, 2009 WL 2241664 (C.D. Cal. Mar. 30, 2009), a pain pump case in which the plaintiff alleged that she developed glenohumeral chondrolysis, the court dismissed all claims against AstraZeneca, Hospira, and Abbott Laboratories because the plaintiff did not allege the names and types of medications administered. The court found that the plaintiff merely generally alleged that she received doses of “anesthetics,” “anesthetic drugs,” and “pain relief drugs,” so it dismissed the claims against AstraZeneca, Hospira, and Abbott with prejudice, holding that plaintiff had not alleged enough facts to show causation or liability. In fact, at most, the plaintiff alleged that the defendants where a handful of the many manufacturers that made medications that could have been administered to plaintiff. The court also dismissed the plaintiff's claims against pump manufacturer Stryker and allowed the plaintiff 20 days to re-plead claims against that defendant.

Most recently, in Dittman v. DJO LLC, Slip Copy, 2009 WL 3246128 (D. Colo. Oct. 5, 2009) ' another pain pump case in which the plaintiff alleged that she developed chondrolysis ' the court dismissed all claims against AstraZeneca and Abbott Laboratories where the plaintiff again failed to allege the names and types of medications allegedly administered through the pain pump. The court determined that the plaintiff, in not naming a specific product and in failing to allege that the defendants' products were actually used, had not sufficiently alleged that the products could have caused his injury. The court went on to find that:

• This deficiency is fatal to the claim. Plaintiff has no facts, only speculation, on which to base his claim that defendants' products caused or contributed to his injury. This mere possibility, i.e., that the medicine used could have been made by these defendants, rather than by any number of other manufacturers of anesthesia drugs, is not adequate to state a claim under the prevailing standards as set forth by Twombly and Iqbal. Id.
• The court dismissed the plaintiff's claims against these defendants without express leave to re-plead.

Application of the Iqbal/Twombly Standard to Future Pleadings

An Iqbal/Twombly motion will not be appropriate in every case, but where applicable, it is likely to be deftly used as a sword by the defendants to stop a pleading practice that has plagued their legal departments in the past. The key to a medical product manufacturer's winning the dismissal of form complaints that allege liability against multiple defendants under the Iqbal/Twombly standard will be in their leaning heavily on the plaintiff's conclusory, formulaic statements and the lack of product identification.

Form complaints that are used serially in mass toxic tort matters and transferred from counsel to counsel are general by nature, so that they can be adapted to each case in any jurisdiction. In most instances, such complaints only very generally outline the elements of some or all of the causes of action alleged. Pleadings of this type were sufficient under the old Conley pleading standard, and plaintiffs mistakenly continue to fall into this trap, especially in the context of mass tort litigation. However, under Iqbal/Twombly, a formulaic and conclusory recitation of the elements of negligence, strict liability, or breach of warranty claims, as commonly seen in medical products litigation, is insufficient to state a claim for relief. Plaintiff attorneys should now take note of the possibility that courts will look for something more than the elements of a claim, and if the plaintiff does not allege any well-pleaded facts in support, such a claim is susceptible to a 12(b)(6) attack.

Of course, there is no guarantee that all Iqbal/Twombly 12(b)(6) motions will prove effective for medical product manufacturers, because of the recent and still evolving nature of this area of the law. Each judge will decide on a case-by-case basis whether a complaint states enough factual material to be “plausible.” And it may be rare that a judge will dismiss a complaint with prejudice. Defendants, however, can consider dismissal of complaints with leave to amend and plead more specific facts a victory. Re-pleading will shift costs currently expended by defendants back onto plaintiffs, and force plaintiffs to conduct the necessary investigation, pre-suit, regarding product identification. Defendants in inadequately pleaded cases may now be able to extricate themselves instantly from cases in which their product is not at issue, without the costs associated with discovery. Granted, such a motion will still constitute a cost to manufacturers, but in cases where plaintiff does not plead product identification and refuses informal requests for product identification, a Rule 12(b)(6) motion will be much more cost effective than engaging in the often long and winding road of serving written discovery to obtain product ID documents. As a practical matter, co-defendants may even split the costs of an Iqbal/Twombly motion, reducing defense costs even further.

Where plaintiffs allege that every manufacturer in the industry made the one device used by plaintiff, the case is perfectly suited to bring a Rule 12(b)(6) motion to dismiss for failure to state a claim. The availability of the new Iqbal/Twombly motion practice strategy should alert plaintiffs' counsel who have become comfortable with filing dozens, if not hundreds, of “shotgun” complaints, to think twice before sticking to the status quo.

Kim M. Schmid is a partner of the national litigation firm, Bowman and Brooke LLP, where she focuses her practice defending companies in drug and medical device litigation in courts across the country. In addition to her defense litigation practice, she advises her clients on FDA regulatory compliance and reporting requirements. She is located at the firm's Minneapolis, MN, office and may be reached at [email protected]. William N.G. Barron IV is an associate at the firm and concentrates his practice on defending medical device and pharmaceutical manufacturers in cases across the country. He is also located at the firm's Minneapolis office and may be reached at will.barron@bowman andbrooke.com.

One of the most frustrating and wasteful legal expenses for a medical device or pharmaceutical manufacturer is the cost of defending against claims where its product is ultimately found not to be involved. This happens where cases are pleaded to include the defendant along with multiple other manufacturers of the same or similar products. Such general pleading tactics in toxic tort cases have become the status quo for many plaintiffs' firms nationwide, where counsel look to “take the easy way out” by simply naming all competing manufacturers of a product rather than doing their investigative homework up front on the issue of product identification. Medical product manufacturers consider this “shotgun” approach to litigation abusive and harassing, and they have long chafed against having to defend against claims that do not involve their products.

Mass Tort Cases

Recently, there has been an uptick in mass tort cases where plaintiffs' counsel, without pleading market-share liability (a theory that is only appropriate in certain, very limited factual circumstances), simply name all industry manufacturers of a device when the patient-plaintiff could only have used a singular medical device from one known or knowable manufacturer. Historically, under these circumstances the named defendant manufacturers will each proceed to retain counsel to answer the complaint; exchange some calls and letters demanding evidence of product ID from the plaintiff; conduct sufficient discovery to properly separate the wheat from the chaff (as far as the defense bar is concerned, an objectionable shifting of the burden of proof); and then, finally, after weeks and perhaps even months of legal maneuvering, ultimately seek dismissal of the action because their product is found not to be the one at issue. This scenario, which is repeated frequently in mass toxic tort cases, is an undeniable waste of our courts' time and resources, and constitutes an unjustified expense for those improperly named defendant-manufacturers.

Plaintiffs have benefited for years from this method of proceeding to court. However, plaintiff attorneys who plan to use these tactics should be aware that the defense bar has a friend in two recent U.S. Supreme Court rulings to attack these types of complaints from the outset.

In May, the Supreme Court, in Ashcroft v. Iqbal , 129 S. Ct. 1937, 1950 (2009), gave defendants a new tool with which to combat generally pleaded complaints against multiple manufacturers. By explaining and extending the reach of Bell Atl. Corp. v. Twombly , 550 U.S. 544 (2007), the Iqbal Court heightened the general pleading standard of Federal Rule of Civil Procedure 8 to a level that arguably requires plaintiffs in medical products liability cases to specifically plead the manufacturer and product allegedly involved. Rule 8(a)(2) requires that in order to state a claim for relief, a pleading must contain a “short plain statement of the claim showing that the pleader is entitled to relief.”

Twombly and a Change in Pleading Requirements

Since 1957, federal courts have followed the Conley standard, which interpreted Rule 8 to require plaintiffs only “to give the defendant fair notice of what the claim is and the grounds upon which it rests.” Conley v. Gibson , 355 U.S. 41, 47 (1957).

The 2007 Twombly decision abrogates the minimal Rule 8 pleading standard set forth in Conley. The Twombly court overturned a Court of Appeals' decision and reinstated the ruling dismissing the plaintiffs' complaint, finding that conclusory allegations in support of the elements of a claim were not sufficient to show that the pleader was entitled to relief. Twombly, 550 U.S. at 557. The Court explained:

While a complaint attacked by a 12(b)(6) motion to dismiss does not need detailed factual allegations, a plaintiff's obligation to provide the “grounds” of his “entitlement 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 555 (internal citations omitted).

Twombly, therefore, requires the pleader to make some factual allegations ' at least enough, according to the Court, to “raise a right to relief above the speculative level.” Naked assertions in a complaint of the elements of a claim, stated the Court, “but without further factual enhancement[,] stops short of the line between possibility and plausibility of entitlement to relief.”

Cost saving appears to have been the public-policy driving force behind the Twombly decision. There, the Court alluded to the practical significance of Rule 8, finding that “something beyond the mere possibility of loss causation must be alleged, lest a plaintiff with 'a largely groundless claim' be allowed to 'take up the time of a number of other people.'” Id . at 557-58 (quoting Dura Pharms., Inc. v. Broudo , 544 U.S. 336 (2005)). The Court intends for basic deficiencies in pleading to “be exposed at the point of minimum expenditure of time and money by the parties and the court.” Id. at 558. Ultimately, the Twombly Court reversed the Court of Appeals finding that plaintiffs did not state enough facts to nudge their claims across the line from conceivable to plausible. Id. at 570.

In the immediate aftermath of the landmark Twombly decision, courts were divided as to whether the holding applied to all federal cases or whether it applied only in the context of the antitrust subject matter at issue in Twombly. In 2009, the Court in Iqbal extended Twombly to apply to every application of Rule 8.

Ashcroft v. Iqbal and Medical Products Cases

Iqbal advances the Twombly decision in two important ways: 1) by clarifying the Court's intention that the Twombly pleading standard apply to all federal civil actions; and 2) by setting forth a two-part framework for use in the determination of whether a pleading states a claim. These changes in the way the law is applied have had two effects on medical device litigation.

First, Iqbal makes very clear that the heightened Twombly pleading standard constitutes the pleading standard for “all civil actions.” Much to the benefit of medical device and drug manufacturers, all cases governed by the Federal Rules of Civil Procedure now fall within the broad reach of Iqbal and Twombly. In practice, this may result in yet another factor medical device manufacturers may consider when determining whether to remove select state cases to federal court ' the benefit of leveraging cost savings available via an Iqbal/Twombly motion to dismiss.

Second, the Court in Iqbal set up a road map to aid courts in determining when a litigant has sufficiently stated a claim under the new, heightened standard. The first step in the analysis is to identify any conclusory pleadings. Pleadings that are factually or legally conclusory are not entitled to a presumption of truth and must be supported by well-pleaded factual allegations. “Threadbare recitals of the elements of a claim, supported by mere conclusory statements, do not suffice.” Id. at 1949 (citing Twombly, 550 U.S. at 555). The second step in the analysis, where a pleading does contain well-pleaded factual allegations, is to “assume their veracity and determine whether they plausibly give rise to an entitlement to relief.” Id. at 1950. The Iqbal Court said, “A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Id. at 1949. The Court went on to state that the standard for plausibility “is not akin to a 'probability requirement,' but it asks for more than a sheer possibility that a defendant has acted unlawfully.” Id. (citing Twombly, 550 U.S. at 556.)

Applying this test to the facts in Iqbal, the Court determined that the plaintiff had not “nudged his claims of invidious discrimination across the line from conceivable to plausible.” Id. at 1950'51. The Court found that the formulaic recitation of the elements of a constitutional discrimination claim did not trigger an assumption of truth. For instance, the Court determined that the following statements, as pleaded by the plaintiff, were conclusory: “Ashcroft was the 'principal architect'” and “petitioners knew of, condoned, and willfully and maliciously agreed to subject [him] to harsh conditions ' solely on account of [his] religion, race, and/or national origin.” Id. Therefore, the Court concluded, the Iqbal plaintiff did not meet his burden on several elements, and his claims were properly dismissed.

Recent Defense Successes Applying Iqbal/Twombly

Medical device and pharmaceutical defendants have only begun to reap the benefits of the new Iqbal/Twombly pleading standard. Indeed, since the Supreme Court decided Twombly in 2007 and Iqbal in May 2009, several federal district courts have already granted manufacturers' motions to dismiss. This trend is likely to continue in favor of similarly situated defendants.

For instance in Wolicki-Gables v. Arrow Int'l, Inc., Not Reported in F.Supp.2d, 2008 WL 2773721 (M.D. Fla. June 17, 2008), the plaintiff did not specifically identify the “implantable drug delivery system” it alleged caused plaintiff's injury. As to negligence, defendants argued that the existence of a duty was not sufficiently pleaded where there was no factual basis that identified a relationship between the defendants and the product. The Wolicki-Gables plaintiff conceded the point and asserted that it had documents that would allow it to identify the product. In light of this, the court dismissed the plaintiff's claims, granting leave to amend to specifically identify the medical device in question. The court came to the same result with regard to the plaintiff's strict liability claim, finding that “the occurrence of symptoms without more [factual allegations], does not plausibly suggest a defect.”

Similarly, in Sherman v. Stryker Corp., Not Reported in F.Supp.2d, 2009 WL 2241664 (C.D. Cal. Mar. 30, 2009), a pain pump case in which the plaintiff alleged that she developed glenohumeral chondrolysis, the court dismissed all claims against AstraZeneca, Hospira, and Abbott Laboratories because the plaintiff did not allege the names and types of medications administered. The court found that the plaintiff merely generally alleged that she received doses of “anesthetics,” “anesthetic drugs,” and “pain relief drugs,” so it dismissed the claims against AstraZeneca, Hospira, and Abbott with prejudice, holding that plaintiff had not alleged enough facts to show causation or liability. In fact, at most, the plaintiff alleged that the defendants where a handful of the many manufacturers that made medications that could have been administered to plaintiff. The court also dismissed the plaintiff's claims against pump manufacturer Stryker and allowed the plaintiff 20 days to re-plead claims against that defendant.

Most recently, in Dittman v. DJO LLC, Slip Copy, 2009 WL 3246128 (D. Colo. Oct. 5, 2009) ' another pain pump case in which the plaintiff alleged that she developed chondrolysis ' the court dismissed all claims against AstraZeneca and Abbott Laboratories where the plaintiff again failed to allege the names and types of medications allegedly administered through the pain pump. The court determined that the plaintiff, in not naming a specific product and in failing to allege that the defendants' products were actually used, had not sufficiently alleged that the products could have caused his injury. The court went on to find that:

• This deficiency is fatal to the claim. Plaintiff has no facts, only speculation, on which to base his claim that defendants' products caused or contributed to his injury. This mere possibility, i.e., that the medicine used could have been made by these defendants, rather than by any number of other manufacturers of anesthesia drugs, is not adequate to state a claim under the prevailing standards as set forth by Twombly and Iqbal. Id.
• The court dismissed the plaintiff's claims against these defendants without express leave to re-plead.

Application of the Iqbal/Twombly Standard to Future Pleadings

An Iqbal/Twombly motion will not be appropriate in every case, but where applicable, it is likely to be deftly used as a sword by the defendants to stop a pleading practice that has plagued their legal departments in the past. The key to a medical product manufacturer's winning the dismissal of form complaints that allege liability against multiple defendants under the Iqbal/Twombly standard will be in their leaning heavily on the plaintiff's conclusory, formulaic statements and the lack of product identification.

Form complaints that are used serially in mass toxic tort matters and transferred from counsel to counsel are general by nature, so that they can be adapted to each case in any jurisdiction. In most instances, such complaints only very generally outline the elements of some or all of the causes of action alleged. Pleadings of this type were sufficient under the old Conley pleading standard, and plaintiffs mistakenly continue to fall into this trap, especially in the context of mass tort litigation. However, under Iqbal/Twombly, a formulaic and conclusory recitation of the elements of negligence, strict liability, or breach of warranty claims, as commonly seen in medical products litigation, is insufficient to state a claim for relief. Plaintiff attorneys should now take note of the possibility that courts will look for something more than the elements of a claim, and if the plaintiff does not allege any well-pleaded facts in support, such a claim is susceptible to a 12(b)(6) attack.

Of course, there is no guarantee that all Iqbal/Twombly 12(b)(6) motions will prove effective for medical product manufacturers, because of the recent and still evolving nature of this area of the law. Each judge will decide on a case-by-case basis whether a complaint states enough factual material to be “plausible.” And it may be rare that a judge will dismiss a complaint with prejudice. Defendants, however, can consider dismissal of complaints with leave to amend and plead more specific facts a victory. Re-pleading will shift costs currently expended by defendants back onto plaintiffs, and force plaintiffs to conduct the necessary investigation, pre-suit, regarding product identification. Defendants in inadequately pleaded cases may now be able to extricate themselves instantly from cases in which their product is not at issue, without the costs associated with discovery. Granted, such a motion will still constitute a cost to manufacturers, but in cases where plaintiff does not plead product identification and refuses informal requests for product identification, a Rule 12(b)(6) motion will be much more cost effective than engaging in the often long and winding road of serving written discovery to obtain product ID documents. As a practical matter, co-defendants may even split the costs of an Iqbal/Twombly motion, reducing defense costs even further.

Where plaintiffs allege that every manufacturer in the industry made the one device used by plaintiff, the case is perfectly suited to bring a Rule 12(b)(6) motion to dismiss for failure to state a claim. The availability of the new Iqbal/Twombly motion practice strategy should alert plaintiffs' counsel who have become comfortable with filing dozens, if not hundreds, of “shotgun” complaints, to think twice before sticking to the status quo.

Kim M. Schmid is a partner of the national litigation firm, Bowman and Brooke LLP, where she focuses her practice defending companies in drug and medical device litigation in courts across the country. In addition to her defense litigation practice, she advises her clients on FDA regulatory compliance and reporting requirements. She is located at the firm's Minneapolis, MN, office and may be reached at [email protected]. William N.G. Barron IV is an associate at the firm and concentrates his practice on defending medical device and pharmaceutical manufacturers in cases across the country. He is also located at the firm's Minneapolis office and may be reached at will.barron@bowman andbrooke.com.