Bayer HealthCare LLC v. Aeropres Corporation

CourtDistrict Court, N.D. Illinois
DecidedMarch 28, 2024
Docket1:23-cv-04391
StatusUnknown

This text of Bayer HealthCare LLC v. Aeropres Corporation (Bayer HealthCare LLC v. Aeropres Corporation) is published on Counsel Stack Legal Research, covering District Court, N.D. Illinois primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Bayer HealthCare LLC v. Aeropres Corporation, (N.D. Ill. 2024).

Opinion

UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF ILLINOIS EASTERN DIVISION Bayer HealthCare LLC,

Plaintiff, No. 23 CV 4391 v. Judge Lindsay C. Jenkins Aeropres Corporation,

Defendant.

MEMORANDUM OPINION AND ORDER Plaintiff Bayer HealthCare LLC (“Bayer”) filed this action against Defendant Aeropres Corporation (“Aeropres”), seeking damages for breach of contract, breach of express and implied warranties, negligence, and strict liability arising from benzene contamination of a component used in Bayer’s antifungal spray products. [Dkt. 1.] Before the Court is Aeropres’s motion to dismiss for lack of subject-matter jurisdiction under Federal Rule of Civil Procedure 12(b)(1), or alternatively, for failure to state a claim under Federal Rule of Civil Procedure 12(b)(6). [Dkt. 13.] For the reasons stated below, the motion is granted in part and denied in part. I. Legal Standard A motion to dismiss pursuant to Rule 12(b)(1) challenges the Court’s subject- matter jurisdiction, while a motion to dismiss under Rule 12(b)(6) tests the legal sufficiency of the plaintiff’s claims. In both cases, the Court takes well-pleaded factual allegations as true and draws reasonable inferences in favor of the plaintiff. Choice v. Kohn L. Firm, S.C., 77 F.4th 636, 638 (7th Cir. 2023); Reardon v. Danley, 74 F.4th 825, 826−27 (7th Cir. 2023). “To survive a motion to dismiss under Rule 12(b)(6), plaintiff’s complaint must allege facts which, when taken as true, plausibly suggest that the plaintiff has a right to relief, raising that possibility above a speculative level.” Cochran v. Ill. State Toll Highway Auth., 828 F.3d 597, 599 (7th Cir. 2016)

(cleaned up). II. Background1 Bayer, a Delaware limited liability company,2 is a pharmaceutical company that develops, manufactures, and sells antifungal spray products Lotrimin and Tinactin. [See Dkt. 1, ¶¶1−2, 25−26, 31, 34, 40−41.] Aeropres is a corporation incorporated in and with its principal place of business in Louisiana; it manufactured and supplied Bayer with Propellant A-31, an isobutane product used in Lotrimin and

Tinactin. [Id., ¶¶1−2, 21, 26.] In July 2017, Bayer and Aeropres entered into a Quality Assurance Agreement (“QAA”), outlining Aeropres’s responsibilities regarding the quality assurance and regulatory aspects of manufacturing and supplying Propellant A-31 for Bayer’s Lotrimin and Tinactin products. [See id., ¶¶25−30.] As alleged in the Complaint, the QAA calls for Aeropres to: manufacture, process, package, test and distribute

products “on its own responsibility, in accordance with agreed chemical formulae, manufacturing processes, instructions, applicable law, and Good Manufacturing

1 The following factual allegations are taken from Bayer’s Complaint and are accepted as true for the purposes of the motion. Smith v. First Hosp. Lab’ys, Inc., 77 F.4th 603, 607 (7th Cir. 2023). In setting forth the facts at the pleading stage, the Court does not vouch for their accuracy. See Goldberg v. United States, 881 F.3d 529, 531 (7th Cir. 2018).

2 For federal jurisdiction, Bayer has nine members and is a citizen of Delaware, New Jersey, Pennsylvania, and the Netherlands. [Dkt. 1, ¶¶11−20.] Practice (‘GMP’)”; ensure that the components of Propellant A-31 were on the “Generally Recognized as Safe List”; and “conduct manufacturing and quality control operations of [Propellant A-31] according to formulas, instructions and valid

manufacturing procedure set up by [Aeropres] and approved by [Bayer], as well as applicable United States Food and Drug Administration (‘FDA’) requirements and GMP.” [Id., ¶¶27−29; Dkt. 15-1 at 1−2.]3 The QAA also specified that in case of a product recall, Aeropres would bear the costs of product technical and quality complaints, recalls, and replacement of affected Propellant A-31, provided the cause of the complaint or recall occurred within Aeropres’s scope of responsibility, with

these costs charged to Aeropres by Bayer. [Dkts. 1, ¶30; 15-1 at 4.] Approximately two years after the QAA was executed in May 2019, Bayer’s parent company assigned Bayer’s rights under the QAA to Beiersdorf AG (“Beiersdorf”). [Dkt. 1, ¶¶31−32, 34.] After receiving the Notice of Assignment, Aeropres consented to assignment of the QAA to Beiersdorf in August 2019, and shortly thereafter, the transaction between Bayer and Beiersdorf was finalized. [Id., ¶¶32−34; see Dkt. 15-2.] From that point forward, Aeropres supplied Propellant A-31

directly to Beiersdorf, which in turn manufactured, packaged, and supplied finished Lotrimin and Tinactin products to Bayer. [Dkt. 1, ¶¶34, 63.]

3 Although Bayer did not attach the QAA, the Notice of Assignment of the QAA, or Aeropres’s benzene contamination letter to the Complaint, [see Dkt. 1], Aeropres attached these documents to its motion to dismiss. [Dkts. 15-1; 15-2; 15-5.] A court may consider a document “referred to in the complaint provided it was a concededly authentic document central to the plaintiff’s claim (the usual example is a contract, in a suit for breach of contract)” without converting a motion to dismiss to a motion for summary judgment, Tierney v. Vahle, 304 F.3d 734, 738 (7th Cir. 2002), so the Court considers these materials here. On August 11, 2021, Aeropres sent a letter to Beiersdorf notifying it of potential benzene contamination in the Propellant A-31 it supplied. [Id., ¶35; Dkt. 15-5.] Classified as a human carcinogen at certain levels, the FDA has advised

manufacturers to avoid using benzene in drug manufacturing processes because benzene cannot be removed from Propellant A-31 once contamination has occurred. [Dkt.s 1, ¶¶37−38; 15-3.]4 Aeropres’s letter to Beiersdorf stated that “the nature of the [ ] materials precludes our ability to assure that there are no residual [benzene] solvents in the finished product,” and that it “regret[ed] this development as it is not in keeping with Aeropres’[s] standards of product manufacture.” [Dkts. 1, ¶¶35−36;

15-5.] Two days later, Beiersdorf informed Bayer about the benzene contamination issues. [Dkt. 1, ¶39.] Upon discovering the benzene contamination, both Beiersdorf and Bayer tested samples of unexpired Lotrimin and Tinactin products; Beiersdorf’s September 2021 test results confirmed benzene levels above the FDA’s threshold in some products. [Id., ¶¶40−41.] Bayer’s testing of certain samples manufactured beginning in September 2018—the date of manufacture of the oldest unexpired lots—also

showed benzene contamination. [Id., ¶41.] Bayer alleges that as a direct consequence

4 The CDC and FDA webpage hyperlinks in Bayer’s Complaint at footnotes 1, 2, and 3—which are also attached to Aeropres’s motion to dismiss as Exhibits 15-3, 15-4 and 15-6, respectively—are incorporated by reference. See Brownmark Films, LLC v. Comedy Partners, 682 F.3d 687, 690 (7th Cir. 2012) (“[T]he incorporation-by-reference doctrine provides that if a plaintiff mentions a document in his complaint, the defendant may then submit the document to the court without converting defendant’s 12(b)(6) motion to a motion for summary judgment.”). of Aeropres’s supply of benzene-contaminated Propellant A-31, it announced a recall on October 1, 2021 of certain Lotrimin and Tinactin products. [Id., ¶42; Dkt. 15-6.] In February 2023, Bayer informed Aeropres that the benzene contamination

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Bayer HealthCare LLC v. Aeropres Corporation, Counsel Stack Legal Research, https://law.counselstack.com/opinion/bayer-healthcare-llc-v-aeropres-corporation-ilnd-2024.