Wash. Cnty. Health Care Auth., Inc. v. Baxter Int'l Inc.
Wash. Cnty. Health Care Auth., Inc. v. Baxter Int'l Inc.
Opinion of the Court
John J. Tharp, Jr., United States District Judge *827Salt water composes almost three-fourths of the planet, so some may be surprised to learn that the United States has a salt water shortage, of sorts. Specifically, for the last several years, the US has lacked sufficient quantities of intravenous saline solution, a medical product used to treat dehydration that consists of sodium chloride (or, as it is commonly known, salt) dissolved in water. The plaintiffs in this antitrust suit allege that the shortage was no accident; they assert that it was artificially manufactured by intravenous saline solution suppliers in an effort to increase prices. The complaint posits that the defendants, the two largest producers of intravenous saline products, violated Section 1 of the Sherman Act by colluding to increase prices by initiating a series of bogus voluntary recalls that depleted the saline inventories of health care facilities throughout the nation, precipitating a health care crisis. Defendants assert that this theory is implausible and move to dismiss the complaint. This Court agrees and grants the defendants' motions without prejudice.
BACKGROUND
With over one billion units used in the United States each year, intravenous saline solution ("IV saline") is among the most ubiquitous and essential products in emergency medicine. Consolidated Amended Complaint ("CAC"), ECF No. 35 at ¶¶ 4, 106. Consisting of various concentrations (0.9% being the most prevalent) of sodium chloride dissolved in water, IV saline is used to prevent and treat dehydration and to dilute other intravenous medications. Id. ¶¶ 39-40. Hospitals, predictably, are the largest purchasers of IV saline. Defendants Baxter and Hospira are the biggest sellers, each with about 45% market share. Id. ¶ 43. One other seller, B. Braun Medical Inc., has the remaining 10%. Id. ¶ 96. In part because there are so few sellers, the Department of Justice and the Federal Trade Commission classify the IV saline market as highly concentrated. Id. ¶ 98.
*828The IV saline market also has high barriers to entry, as a new manufacturer would have to build or develop manufacturing plants that meet strict FDA requirements. Id. ¶ 100. An FDA economist estimated that it would take three to five years and hundreds of millions of dollars to open a new IV saline plant. Id. Moreover, because Baxter and Hospira are vertically integrated with respect to the production of IV saline (i.e. , they acquired companies providing goods and performing services in the IV saline supply chain), it would be onerous for a competitor to gain the economies of scale necessary to compete. Id. ¶ 101.
In November 2013, Baxter informed customers that there was an IV saline shortage, purportedly resulting from a harsher than expected flu season. Id. ¶ 44. No previous major flu outbreak, however, had resulted in an IV saline shortage, including the 2009-2010 swine flu outbreak that hospitalized 274,000 people in the United States in addition to those hospitalized for the common flu. Id. ¶¶ 126-128. Two months after Baxter's letter, the Food and Drug Administration publicly acknowledged the shortage and gave new approval for certain foreign plants-including one owned by Baxter-to ship IV saline to the United States. Id. ¶ 46. The new imports, however, were unable to eliminate the shortage. Id. ¶ 47. Health care facilities, including those operated by the Veterans Health Administration, subsequently implemented policies designed to conserve IV saline supplies. Id. ¶ 50-51. This included use of oral hydration whenever possible and flushing central venous access devices less frequently. Id. ¶ 50. There is, however, no true substitute for IV saline, and the FDA has indicated that the IV saline shortage "poses a serious threat to patients." Id. ¶¶ 49, 107-108.
Concurrent with the shortage, Baxter and Hospira issued a number of voluntary recalls of IV saline, which are summarized in the following table:
No. of Bags: No. of Bags: Recall Date Baxter Hospira Reason for Recall 05/21/13 845,520 Leakage 06/06/13 676,872 Leakage 10/14/14 16,500,000 Punctures 12/08/14 542,080 ParticulateMatter 12/22/14 30,840 Leakage 03/18/15 597,498 Missing closures/Leakage 04/07/15 128,050 Leakage 07/02/15 314,600 Leakage 07/17/15 322,720 ParticulateMatter Total Recalls 2,307,818 17,650,362 19,958,180 Percentage 11.56% 88.44%
The summary reflects that in May and *829June 2013, Baxter and Hospira both recalled hundreds of thousands of IV saline bags, citing a potential for leakage. Id. ¶ 61. Neither company, however, followed up with any recall of IV saline solution for more than 16 months. Then, in October 2014, Hospira recalled 16.5 million IV saline bags due to the potential for punctures; Baxter, however, did not announce another recall until December, when it recalled half a million bags because particulate matter had been discovered floating inside a sealed bag of saline solution. Later that month, Hospira issued a small recall of about 31,000 bags due to leakage. Id. And finally, within three weeks of each other in both the spring and summer of 2015, Baxter and Hospira again issued voluntary recalls, due to leaks and the presence of particulate matter (specifically, Baxter recalled two lots of saline bags after a customer reported a free-floating insect in one of the bags).
The complaint alleges that these recalls substantially reduced the supply of IV saline solution and resulted in a dramatic increase in IV saline prices. The complaint includes no allegations about the defendants' production levels during this time period, but alleges that in the fourth quarter of 2014 Baxter and Hospira's collective recalls removed approximately 28.5% of IV saline bags from the U.S. market. Id. ¶ 62.
During this period, Hospira and Baxter submitted information to the FDA's publicly accessible drug shortage database. Id. ¶ 66. The database includes information from manufacturers on the availability of certain drugs, including the estimated duration of an expected shortage and the reason for the shortage. Id. ¶ 67. Baxter used the database in December 2013 to indicate that it was suspending the manufacturing of 150 mL IV saline bags to meet higher demand for 250 mL IV saline bags. Id. ¶ 69. On the same day, January 17, 2014, Hospira and Baxter both submitted shortage letters to the FDA indicating that IV saline customers would be put on allocation. Id. ¶ 70.
Hospira and Baxter used the IV saline shortage to bolster other areas of their businesses. Hospira and Baxter informed some purchasers that they would not be able to purchase IV saline at any price unless they also purchased other Baxter or Hospira products, and imposed greater price increases on other customers who declined to purchase non-saline products. Id. ¶ 77. Baxter and Hospira also used the IV saline shortage to lock their customers into long term contracts. Id. Baxter's CEO, Robert L. Parkinson, Jr., indicated that he thought the IV saline shortage "sensitized a lot of people to the value of *830these products." Id. ¶ 86. Baxter subsequently saw an 8% increase in its "Fluid Systems" franchise (a business unit which includes IV saline), driven in part by "pricing for IV solutions." Id. ¶ 88. Hospira similarly indicated that it saw an "uptick in IV solutions prices," which drove a 19% increase in net sales in the division that included IV saline. Id. ¶ 89. Hospira's CEO noted that the increase in sales was "primarily driven by the strong performance from our solutions products, which benefitted from the continued strong demand from protracted market shortages." Id. The price of IV saline rose even though the price of plastic-the primary raw material in IV saline bags-remained stable or fell. Id. ¶¶ 122-125.
Plaintiffs, purchasers of IV saline, filed suit against Baxter and Hospira on behalf of themselves and others similarly situated, alleging that Baxter and Hospira violated the Sherman Act,
Baxter and Hospira now move to dismiss the complaint, asserting that it does not plausibly allege that they colluded to restrict the output and increase the price of IV saline solution. Because the facts to which the plaintiffs point do not plausibly support the existence of "a preceding agreement" distinguishable from "mere[ ] parallel conduct that could just as well be independent action," Bell Atlantic Corp. v. Twombly ,
DISCUSSION
I. Existence of an Agreement
Section 1 of the Sherman Act,
The focus in this case is on the first element of a Section 1 claim. Defendants *831maintain that that the complaint does not adequately allege the existence of agreement to restrain the supply and increase the price of IV saline. The Supreme Court set forth the framework for evaluating the adequacy of a complaint alleging unlawful collusion in Twombly . As the Supreme Court there explained, a § 1 claim "requires a complaint with enough factual matter (taken as true) to suggest that an agreement was made."
To see this, it will be helpful to consider along the way what a complaint that adequately alleges an agreement would look like. In Twombly , the Supreme Court endorsed the views of commentators who suggested that agreements to restrain trade can be differentiated from mere parallel conduct by considering whether the behavior at issue "would probably not result from chance, coincidence, independent responses to common stimuli, or mere interdependence unaided by an advance understanding among the parties," and whether the conduct at issue is suggestive of "the sort of restricted freedom of action and sense of obligation that one generally associates with agreement."
A. Parallel Conduct
Plaintiffs' theory is that Baxter and Hospira used the FDA shortage reporting mechanism to signal forthcoming output restrictions to each other, and that they subsequently initiated product recalls under false pretenses, all in an effort to increase the price of IV saline. While the parties spill much ink debating the finer points of the relevant FDA regulations (which the Court will address in turn), a sound analysis of the complaint must begin with Twombly -specifically, Twombly 's admonition that "lawful parallel conduct fails to bespeak unlawful agreement.... [A]n allegation of parallel conduct and a bare assertion of conspiracy will not suffice."
For several reasons, the probative force of plaintiffs' allegations of parallel conduct is particularly weak. Chief among them is that the IV saline market is an oligopoly in which "conscious parallelism"-"a common reaction of firms in a concentrated market that recognize their shared economic interests and their interdependence with respect to price and output decisions"-is to be expected. Twombly ,
The complaint also has problems that arise not from market structure, but from its allegations describing how the purported output restriction conspiracy occurred. These problems-which affect both the alleged instrument of output restriction (voluntary recalls) and the alleged signaling mechanism (shortage letters sent to the FDA)-also undermine the plausibility of the plaintiffs' theory.
1. Voluntary Recalls
Plaintiffs' theory that Baxter and Hospira used voluntary recalls to manufacture a shortage is quite implausible in light of the gaping factual deficiencies in the complaint, affirmative allegations that undermine the purported scheme, and the regulatory landscape in which IV saline producers operate. As an initial matter, the complaint contains no allegations suggesting that the reasons Baxter and Hospira provided for the recalls were false. Further, the complaint demonstrates that Hospira recalled about eight times as many units as Baxter, incurring substantially greater costs despite roughly equal market share. And even were it plausible to believe that one schemer would agree to absorb wildly disproportionate costs for no additional benefit, the odds that it would agree to this scheme are minute, as voluntary recalls impose high upfront costs and invite FDA scrutiny of the very instrument of the unlawful agreement.
a. No Allegations That the Recalls Were Bogus
To begin, it must be recognized that the plaintiffs' theory about how the defendants colluded to increase the price of IV saline solution rests on the premise that the product recalls the defendants made were bogus. Plaintiffs charge the defendants with "creating a public health crisis that denied medical providers and others the IV Saline Solution necessary to treat ...
*833the hospitalized and those needing emergency medical attention." Resp. at 1, ECF No. 83. The defendants did this, the plaintiffs allege, "by restraining supply and fixing the price of IV Saline Solution."
The necessary implication of these allegations is that the product recalls announced by the defendants were phony-that is, unnecessary because the products were not defective. If the recalls were legitimate-i.e. , if the products were, in fact, defective-then the resulting shortages they caused could not have been the product of collusion (i.e. , agreement). There is certainly no plausible basis to conclude that the defendants colluded to create actual defects in their products so that they could then coordinate recalls of those products. The recalls could only have operated as an unlawful collusive "output restriction" device, then, if the defects were fictitious; recalls are required when defects may compromise the safety of the product. See
Yet, as Hospira observes (Mem. at 2, 9, ECF No. 58), the complaint contains not a single allegation of fact to support an inference that the recalls were shams-no allegations that the bags were not prone to leakage and puncture, as reported; no assertions that the reports of missing closures were feigned; no claim that particulates were not found in the bags recalled on that basis.
In attempting to respond to this argument, the plaintiffs try to have it both ways, contesting the claim that they have not alleged that the recalls were phony while also acknowledging, both implicitly and expressly, that they were not. As to the former, the plaintiffs point to no allegations of fact that, if true, would support a plausible inference that the recalls were shams. Instead, they actually assert, in complete disregard of Twombly 's teaching that conclusory labels do not fact allegations make, that they have adequately pleaded the false nature of the recalls because the complaint "uses the words 'purported' or 'purportedly' in referencing the alleged reasons for every one of the recalls."
*834Resp. at 37. There could not be a more textbook illustration of the sort of inadequate reliance on "mere conclusory statements" that Twombly disparaged. The plaintiffs then implicitly concede their failure to plead any facts to support an inference that the recalls were shams in acknowledging that they are "unable to prove either that Defendants' recalls were unnecessary or what they cost Defendants." Resp. at 38 n.23. The plaintiffs, of course, point out that they are not required to prove that the recalls were unwarranted.
The plaintiffs also argue, in grudging but inconsistent acknowledgment that the defects that prompted the recalls were genuine, that the defects were nevertheless "inconsequential" or "technical" and thus permitted the defendants to engage in the recalls "without significant business or reputational risks." Resp. 5, 35-36. But this contention is belied by the FDA's findings when it evaluated Baxter and Hospira's recalls. Each of Baxter and Hospira's recalls were classified as either Class I or Class II recalls by the FDA.
*835For other reasons, too, the rigorous regulatory framework in which Baxter and Hospira operate undermines the plausibility of the plaintiffs' theory. The FDA only considers a removal of a product from the market to be a voluntary recall if it "regards the product as involving a violation that is subject to legal action, e.g., seizure."
A complaint premised on a theory that the defendants intentionally manufactured a public health crisis by orchestrating bogus product recalls that would, despite the public health crisis and rigorous regulatory oversight of product recalls, escape the FDA's attention, lacks facial plausibility. To survive a motion to dismiss, it requires (among other things) some factual allegations which, taken as true, suggest that the output restricting recalls were, in fact, a sham. But the complaint in this case includes no such allegations and, for that reason alone, the complaint is implausible and must be dismissed.
b. The Recalls Were Not Parallel
In view of the complaint's implicit concession that the recalls were not bogus, it is not surprising to see that, in fact, the recalls were not really "parallel," as the plaintiffs allege. Nor is the defendants' alleged conduct consistent with the plaintiffs' theory that product recalls were used to create shortages.
For starters, the initial recalls alleged in the complaint did not create any shortage. There are no allegations of shortages existing until the 2013-14 flu season, see CAC ¶ 10, and the defendants in May/June 2013 collectively recalled only about 1.5 million bags. Indeed, plaintiffs effectively acknowledge that 2013-14 flu season was, in fact, unexpectedly harsh and that shortages reported in November 2013 could be explained by that fact.
To be sure, one could argue that certain aspects of the defendants' recalls and shortage notices were parallel: the notices, and subsequently the recalls, were relatively close in time to one another, and comparable recalls were unprecedented in the IV saline industry.
Nor does the timing of the recalls support a plausible inference of collusion. Although the first recalls by each defendant occurred within a few weeks of each other, and were of comparable size, thereafter the recalls do not occur in a predictable pattern or scale, much less move in lockstep. After the 16-month delay noted previously, Hospira then made its recall of 16.5 million bags, but that recall was not, as one might expect were there a collusive scheme, followed by a series of Baxter recalls closing the gap; rather, Baxter followed two months later with a recall that was a third smaller than its first recall and which was necessitated by an entirely different problem. Oddly-if the recalls were phony-Hospira then followed up its *837massive October 2014 recall with a miniscule recall of 30,000 bags that could have contributed nothing to an allegedly collusive scheme. Just as odd is the fact that in April and July of 2015, Hospira conducted back-to-back recalls, without an intervening recall by Baxter-despite the fact that those recalls widened the gap between the number of recalls conducted by Hospira and Baxter by another 400,000 bags. This chronology is difficult to reconcile with the plaintiffs' collusion theory; if anything, it tends to undermine, rather than support, the notion that the defendants engaged in parallel conduct.
Even if the disparities in the magnitude and timing of the defendants' recalls does not, in and of itself, render plaintiffs' complaint implausible (see Kleen Prods., LLC v. Packaging Corp. of Am. ,
c. Voluntary Recalls Are an Implausible Means of Restricting Output
If plaintiffs' theory is accurate, then Baxter and Hospira took a remarkably circuitous and pricy route to hiking IV saline prices.
Beyond that, the notion that the recalls themselves had a material effect on the price of IV saline solution over the multi-year life of the alleged conspiracy is fanciful. As noted, Hospira's October 2014 was the single largest recall conducted and accounted for 82% of the total product recalled. The complaint credibly alleges that a recall of that size affected availability during the fourth quarter of 2014, but that's as far as it goes. During the rest of the period from May 2013 to July 2015, only 3.4 million bags were recalled. The complaint affords no basis to support the inference that a shortage of 3.4 million bags-which, even using plaintiffs' low-end volume estimate, consists of only 17% of one month's supply of IV saline solution-would cause a significant rise in prices over the course of more than two years. The complaint alleges no facts concerning the defendants' total production or capacity; no facts addressing the number of bags that were ordered from the defendants; and no facts detailing how many bags were ordered that the defendants were unable to supply. And although the complaint acknowledges that in response to the saline solution shortage, the FDA permitted saline to be imported from foreign manufacturers-another fact that illustrates the implausibility of the plaintiffs' theory that the defendants colluded in a manner that convinced their regulator to allow imports from foreign competitors-it provides no allegations about the number of units supplied by such foreign competitors. Plaintiffs'
*839theory, then, rests almost entirely on a single act-Hospira's October 2014 recall-taken by only one member of the alleged conspiracy, and begs the question: if the defendants adopted a scheme to create shortages by recalls, why was there only one recall, involving only one party, that was reasonably capable of materially raising IV saline solution prices? Neither the complaint nor the plaintiffs' briefs provides a discernable answer.
2. Shortage Notices
The signaling mechanism alleged in the complaint is also suspect. Plaintiffs posit that the defendants sent letters to the FDA to inform customers of upcoming IV saline shortages. The complaint suggests that the defendants came to an accord wherein each would further restrict output-via voluntary recalls-when the other indicated to the FDA that a shortage was imminent. There are two principal problems with this theory. First, shortage letters are not necessarily made public and the decision to publish them rests with the FDA, not with the company submitting them. The regulation addressing publication of shortage notices indicates that the "FDA may choose not to make information collected [concerning shortages] available on the drug shortages list ... if FDA determines that disclosure of such information would adversely affect the public health (such as by increasing the possibility of hoarding or other disruption of the availability of the drug to patients."
In addition, the timing of the shortage notices calls plaintiffs' signaling theory into doubt. The complaint notes that Baxter sent the "first relevant" shortage letter to the FDA on December 16, 2013. CAC ¶ 69. But the complaint also alleges that Baxter and Hospira's conspiratorial recalls began in May 2013, seven months before the first shortage letter.
*840In short, the "parallel" conduct alleged by the complaint is not parallel and does not support an inference of unlawful agreement. The facts affirmatively pled in the complaint establish that the recalls were overwhelmingly one-sided, subject to federal scrutiny, and timed in a way that would render agreement unlikely. The complaint's silence speaks volumes as well. The failure to plead any facts suggesting that the recalls were bogus, failure to grapple with the complex regulatory framework in which defendants operate, and failure to allege facts indicating that all but one of the recalls could have meaningfully affected the marketplace reinforce the inadequacy of the theory set forth in the complaint. On these pleadings, the inference that the parties colluded together to raise IV saline solution prices by coordinating product recalls is quite implausible.
B. Plus Factors
Plaintiffs also identify "plus factors" that, they say, push their claim into the realm of plausibility. Defendants counter that plausible allegations of parallel conduct are required to state a Section 1 claim in the absence of direct evidence. In defendants' view, because the complaint does not plausibly allege parallel conduct, the Court need not even consider the additional factors the plaintiffs argue render their theory plausible. In that, the defendants are mistaken. The plaintiffs' only burden at the pleadings stage is to "allege facts from which the Court can plausibly infer that the defendants had a conscious commitment to a common scheme designed to achieve an unlawful objective." In re Broiler Chicken Antitrust Litig. ,
Ultimately, however, whether plaintiffs are required to plead plausible parallel conduct does not matter: Even if the plaintiffs' allegations sufficed to establish a strong inference of parallel conduct (and, as discussed above, it does not), the complaint would still fall short because the "plus factors" the plaintiffs identify do not make the inference of an express agreement between Baxter and Hospira any more plausible. The "plus factors" the plaintiffs identify-industry structure, trade association membership, and Baxter's settlement of an unrelated price-fixing law suit-are no more probative of an express agreement between the defendants than are the plaintiffs' allegations of parallel conduct. While consistent with the *841possibility of collusion, they do not provide factual support that makes a finding of collusion plausible rather than merely possible.
The plaintiffs' arguments about "plus factors" rely heavily on the Seventh Circuit's application of Twombly in Text Messaging I , where the court addressed the adequacy of price-fixing allegations that included "a mixture of parallel behaviors, details of industry structure, and industry practices[ ] that facilitate collusion." Id. at 627. Like the IV saline industry, the text messaging industry was highly concentrated, with the four defendants to the suit providing 90% of all U.S. text messaging services. Id. at 628. The text messaging service providers attended trade meetings where they directly exchanged price information and participated in an organization whose "stated mission was to urge its members to substitute 'co-opetition' for competition." Id. Each of the service providers simultaneously shifted their heterogeneous and complex price structures to a uniform price structure featuring a one third increase in prices. Id. The price increases coincided with steadily falling costs. Id. The court concluded that, taken together, these facts constituted "parallel plus" allegations sufficient to survive a motion to dismiss. Id.
Although this case bears some resemblance to Text Messaging I (the IV saline industry is also highly concentrated, the product at issue is homogenous, and demand is inelastic), we know from Twombly and its progeny that industry structure alone cannot get the complaint across the finish line. If the complaint's allegations must render it more than merely possible that the defendants entered into an illegal agreement, it cannot be the case that allegations that a market is oligopolistic and a product is homogeneous are sufficient to survive a motion to dismiss. If that were so, an antitrust complaint targeting any industry with those features would survive a motion to dismiss regardless of whether there were any additional facts suggesting an agreement. Hence, while market structure can provide some evidence of an unlawful agreement, it (even combined with parallel conduct) cannot sustain plaintiffs' complaint all on its own. See High Fructose Corn Syrup ,
The second purported "plus factor" that plaintiffs identify is Baxter's alleged history of anticompetitive conduct. The complaint alleges that Baxter previously settled antitrust claims against it for price fixing in the blood plasma derivatives market. CAC ¶ 131. The plaintiffs in the previous case alleged that Baxter signaled output restrictions at meetings called by the FDA. Id. at ¶ 132. Although this information is of questionable admissibility, see High Fructose Corn Syrup ,
Text Messaging and this case also feature another "plus factor," namely, seemingly anomalous price increases; in both cases, prices rose amid stagnant or falling costs. This behavior reasonably arouses suspicions, as "falling costs increase a seller's profit margin at the existing price, motivating him, in the absence of agreement, to reduce his price slightly in order to take business from his competitors, and certainly not to increase his price." Text Messaging I ,
The absence of a structural shift is significant because anomalous price hikes in highly concentrated industries are often the result of typical, non-conspiratorial market behavior. "Oligopolies pose a special problem under § 1 because rational, independent actions taken by oligopolists can be nearly indistinguishable from horizontal price fixing." Valspar Corp. v. E.I. Du Pont De Nemours and Co. ,
"[O]ligopolistic rationality" can cause supracompetitive prices because it discourages price reductions while encouraging price increases. A firm is unlikely to lower its price in an effort to win market share because its competitors will quickly learn of that reduction and match it, causing the first mover's profits to decline and a subsequent decline in the overall profits of the industry. Similarly, if a firm announces a price increase, other market participants will know that if they do not increase their prices to the first-mover's level, the first-mover may be forced to reduce its price to their level. Because each of the other firms know this, each will consider whether it is better off when all are charging the old price or the new one. They will obviously choose the new price when they believe that it will maximize industry profits.
Unsurprisingly, then, Text Messaging I 's most compelling allegations supporting the existence of an agreement had little to do with industry structure, and everything to do with specific suspicious communications among the defendants: the defendants had attended industry conferences during which they exchanged price information and sought to substitute "co-opetition" for competition.
The "plus factors" the plaintiffs identify here are, therefore, substantially weaker than those present in Text Messaging I . And the alleged collusive scheme at issue in Text Messaging I was garden variety price-fixing; here, by contrast, the complaint alleges an implausibly complex and outlandish scheme to restrict output. This poses a problem for the plaintiffs, as the more complex the allegations, the more facts are required under Federal Rule of Civil Procedure 8 to "show how, in the plaintiff's mind at least, the dots should be connected." Swanson v. Citibank, N.A. ,
II. Noerr-Pennington Doctrine
Although the Court dismisses the plaintiffs' complaint for failure to state a claim, for the benefit of the parties, it will address the alternative grounds for dismissal posed by defendants. Baxter argues that the Noerr-Pennington doctrine alternatively bars plaintiffs' claim. The Noerr-Pennington doctrine "extends absolute immunity under the antitrust laws to businesses and other associations when they join together to petition legislative bodies, administrative agencies, or courts for action that may have anticompetitive effects." Mercatus Group, LLC v. Lake Forest Hosp. ,
The Court finds that this issue is ill-suited for resolution on a motion to dismiss. While Baxter posits in its briefing that its recalls and shortage notices were undertaken for the purpose of petitioning the government-and not merely to fulfill a legal responsibility-the complaint, not surprisingly, contains no facts suggesting that was the case. It is possible that some, or even most, voluntary recalls and shortage notices are undertaken to petition the FDA to take a certain course of action. But nothing in the complaint indicates that the specific recalls and shortage notices at issue in this case were issued with that purpose in mind. Immunity is an affirmative defense, and at the motion to dismiss stage, "dismissal is appropriate only when the factual allegations in the complaint unambiguously establish all the elements of the defense." Hyson USA, Inc. v. Hyson 2U, Ltd. ,
III. Antitrust Injury
Baxter also argue that the complaint should be dismissed because it fails to allege an antitrust injury. An antitrust plaintiff must allege "that her claimed injuries are of the type the antitrust laws were intended to prevent and reflect the anticompetitive effect of either the violation of or anticompetitive acts made possible by the violation." Kochert v. Greater Lafayette Health Servs., Inc. ,
* * *
For the foregoing reasons, the consolidated amended complaint is dismissed without prejudice. Although there is reason to doubt that plaintiffs will be able to successfully replead in light of the affirmative allegations made in the CAC, which provide ample basis to infer that the defendants' recalls were not the product of an unlawful agreement, the plaintiffs should not be foreclosed from attempting to address the issues identified in this opinion in a second amended complaint. Their first amendment was predicated not on remedying issues raised in a motion to dismiss or by the Court, but on the need to consolidate claims of multiple plaintiffs. If the plaintiffs wish to stand on the adequacy of the CAC, however, they should so advise the Court and judgment will be entered in accordance with this ruling, thereby permitting the plaintiffs to appeal if they wish to do so.
As this is a motion to dismiss, the Court accepts all well-pleaded facts as true and construes all inferences in favor of the plaintiff. Zemeckis v. Global Credit & Collection Corp. ,
The complaint (¶ 61) identifies the number of bags recalled for only four of the nine recalls. Nevertheless, the Court takes judicial notice of the number of units recalled during each recall, as such information is publicly available on the FDA's recall database. See Food and Drug Administration , FDA Recall Information Search , https://www.accessdata.fda.gov/scripts/ires/index.cfm.
See Food and Drug Administration , FDA Recall Information Search , Recall Nos. D-1335-2015 and D-1336-2015, https://www.accessdata.fda.gov/scripts/ires/index.cfm.
The complaint does not identify a source for this statistic, but it can be derived using the Q4 2014 recall numbers on the summary chart and the estimate of monthly IV saline use in the United States that the plaintiffs cite in paragraph 62 of the complaint: 20 million bags/month x 3 months = 60 million bags x 28.5% = 17.1 million bags, the amount recalled in Q4 2014. Elsewhere in the complaint, however, the plaintiffs allege that "[o]ver a billion units of IV Saline Solution are used in the United States every year." AC ¶ 4. Using that estimate, the Q4 2014 recalls would amount to only 6.8% of the IV saline solution used in the United States over that period: 1 billion/year = 250 million/quarter; 17.1 million/250 million = 6.8%). The plaintiffs offer no explanation for why they use a higher estimate of saline use when describing the IV saline shortage as a public health crisis and a lower estimate when calculating the impact of the defendants' recalls.
To the contrary, to the extent that the complaint alleges facts relevant to the legitimacy of the recalls, those facts support the validity of the recalls. The complaint acknowledges that recalls are necessary if sterility is compromised by punctures or the solution contains particulates, both reasons that the defendants provided for their recalls. CAC ¶ 41. And in discussing the defendants' "purported justifications for the IV Saline Solution shortage," the complaint omits any reference to the recalls whatsoever; what it describes as the defendants' pretextual justifications for the saline shortages are the claim that shortfalls today cannot be explained by a harsh 2013-14 flu season and that saline price increases are anomalous in light of declining prices for plastic, a principal component of the product. See CAC ¶¶ 18-19.
Nor is this an impossible requirement; the plaintiffs acknowledge, for instance, that there is public information that would bear on the question (and which they intend to pursue). What they don't explain is why they didn't do so before alleging that the defendants' manufactured a public health crisis by means of sham recalls.
Baxter's recalls related to particulate matter in IV saline bags-including one initiated after a customer reported a free floating insect inside an IV saline bag-were designated as Class I. Baxter and Hospira's recalls related to punctures and leakage were designated as Class II. See Food and Drug Administration , FDA Recall Information Search , https://www.accessdata.fda.gov/scripts/ires/index.cfm.
It does not matter that the plaintiffs have not asserted a claim of fraud; "the dictates of Rule 9(b) apply to allegations of fraud, not claims of fraud." Pirelli Armstrong Tire Corp. Retiree Medical Benefits Trust v. Walgreen Co. ,
Plaintiffs cite In re Plasma-Derivative Protein Therapies Antitrust Litigation ,
Baxter contends that the IV saline solution shortage was caused not by recalls but by "a perfect storm" of events that adversely affected production. Baxter Mot. to Dismiss 2-3, 7, ECF No. 60. Its assertion relies on information outside the limited record the Court may consider, however-specifically sources on which the plaintiffs rely for some of the allegations in the complaint. The plaintiffs' limited citation to news articles addressing the saline shortage, however, permits the Court to consider other material in the same sources as is necessary to place the statements cited by the plaintiffs in context; it does not authorize the wholesale consideration of all information set forth in those sources as established fact. The cause of the IV saline shortage is, undoubtedly, a fact-intensive question that cannot be appropriately answered in the context of evaluating a motion to dismiss, but it is not necessary to answer that question in the context of the defendants' motions. While they fall short of definitively establishing the cause of the shortage, the defendants succeed in demonstrating that the plaintiffs have not plausibly alleged that the shortfall was the product of a collusive output restriction scheme.
The complaint acknowledges that Hospira, in particular, conducted voluntary recalls of IV saline solution between 2010 and 2012, before the alleged conspiracy began. CAC ¶ 60.
Both Baxter and Hospira argue at length that they would risk severe business consequences as a result of recalls, i.e. , customers would purchase IV saline elsewhere. The complaint, however, contains factual allegations suggesting that customers may not necessarily have other options: Baxter and Hospira account for 90% of the IV saline market, there is only one other manufacturer, the cost of entry into the IV saline market are astronomically high, and Baxter and Hospira both lock customers into long term contracts. The problem posed by the complaint is not that customers would stray from Baxter and Hospira collectively; it's that Hospira risks losing customers to Baxter by recalling eight times as much product. It is implausible that Hospira would agree to suffer substantial reputational harm and allow Baxter to escape comparatively unscathed.
The defendants point out as well that the complaint's allegations about price increases are not robust. The Court does not agree, however, that the absence of specific allegations regarding the prices the plaintiffs themselves paid for IV saline solution renders the complaint implausible given the statements by executives of the defendants, quoted in the complaint, acknowledging that IV saline solution prices did rise during at least some portion of the relevant period, even if the complaint's allegations do not allege the magnitude of the increase. See CAC ¶¶ 85-90.
Defendants also argue that because the shortage letters were legally required, they could not have been used to signal output restrictions. But there is no reason that is the case; Baxter and Hospira could easily have agreed to pursue output restrictions upon receipt of a legally required notice. The problem with the complaint is not that legally-required public notices are inherently implausible signaling mechanisms, it's that the complaint contains paltry factual support for-and indeed undermines-the proposition that the shortage letters at issue in this case actually functioned as a signaling mechanism.
Plaintiffs, in asserting that the defendants unlawfully colluded, also point to the ways in which Baxter and Hospira used the saline shortage. Specifically, plaintiffs maintain that Baxter and Hospira both pressured customers to purchase other products in conjunction with their IV saline purchases in exchange for discounts on saline. Although tying arrangements often run afoul of the antitrust laws, plaintiffs concede that they are not pursuing standalone tying claims against either defendant. Resp. at 24. The plaintiffs instead posit that the defendants' conduct is merely another factor that points toward coordination. But there is no basis to draw that inference. At best, plaintiffs' allegations bespeak efforts by the defendants to use the shortage to bolster other areas of their business. The complaint contains no facts suggesting that these efforts were the product of an agreement, and not the result of independent strategies designed to expand defendants' business relationships.
After briefing was completed, the plaintiffs asked the Court to take judicial notice of public records reporting the issuance of a grand jury subpoena by the Antitrust Division of the Department of Justice to an unnamed employee of Baxter seeking documents and testimony relating to the manufacture, sale, pricing, and shortages of intravenous solutions and containers, and to a request for similar information from the New York Attorney General's office. While the Court takes judicial notice of this information, it does not-contrary to the plaintiffs' assertion-enhance the plausibility of the plaintiffs' claim. The records in question do nothing more than report the existence of investigations; they include no information or findings concerning conduct by the defendants. The mere fact that an investigation is being conducted says nothing about whether unlawful conduct has occurred. Investigations require no minimum predication or threshold of evidence to begin; indeed, the purpose of an investigation is to determine whether there is evidence of unlawful conduct; its existence does not therefore signal that there must be such conduct. The Court therefore accords no weight to the information that is the subject of the plaintiffs' request for judicial notice.
Hospira argues that plastic and resin costs are not the only drivers of the cost of an IV saline bag; specifically, Hospira asserts that the manufacturing and compliance costs required to meet strict FDA requirements also drive cost. But Hospira does not suggest that these costs increased in a way that would offset declines in the price of raw materials or would otherwise explain increases in the price of IV saline. This argument therefore merits little weight.
Reference
- Full Case Name
- WASHINGTON COUNTY HEALTH CARE AUTHORITY, INC., Cesar Castillo, Inc., Warren General Hospital, and Erie County Medical Center Corporation v. BAXTER INTERNATIONAL INC., Baxter Healthcare Corporation, Hospira, Inc., and Hospira Worldwide, Inc.
- Cited By
- 5 cases
- Status
- Published