Rosenstern v. Allergan, Inc.

• Decision Date: 25 October 2013
• Docket Number: No. 13 C 4416,13 C 4416
• Citation: 987 F.Supp.2d 795
• Parties: Klaus Rosenstern, individually and as Executor of the Estate of Janet Rosenstern, Plaintiff, v. Allergan, Inc., and Allergan USA, Inc., Defendants.
• Court: U.S. District Court — Northern District of Illinois

987 F.Supp.2d 795

Klaus Rosenstern, individually and as Executor of the Estate of Janet Rosenstern, Plaintiff,

v.Allergan, Inc., and Allergan USA, Inc., Defendants.

No. 13 C 4416

United States District Court, N.D. Illinois, Eastern Division.

October 25, 2013

James A. Karamanis, Barney & Karamanis, LLP, Chicago, IL, for Plaintiff.

Stephen J. O'Neil, Molly K. McGinley, Nicholas William Marietti, Noah I. Eisner, K & L Gates LLP, Chicago, IL, Brendan Mathieu Ford, Caitlin Comstock Blanche, Ellen Lynn Darling, K & L Gates LLP, Irvine, CA, for Defendants.

Memorandum Opinion and Order

Honorable Thomas M. Durkin, United States District Judge

Klaus Rosenstern (“Plaintiff”), individually and as Executor of the Estate of Janet Rosenstern, deceased (“Rosenstern”), brings this action against Allergan, Inc. and Allergan USA, Inc. (“Allergan”), manufacturers of the prescription drug Botox, alleging that Allergan caused Rosenstern's death by failing to warn of Botox's risks and negligently designing and marketing Botox, among other alleged violations of state law. R. 1–1. Plaintiff originally filed his complaint in the Circuit Court of Cook County, after which Allergan removed the case to this Court. R. 1. Allergan has moved to dismiss all counts pursuant to Federal Rule of Civil Procedure 12(b)(6). R. 11. For the following reasons, Allergan's motion is granted as to Counts VI, VIII and IX, and denied as to Counts I, II, III, IV, V and VII.

Background

The following facts, taken from the complaint, are accepted as true, and all reasonable inferences are drawn in Plaintiff's favor. Mann v. Vogel, 707 F.3d 872, 877 (7th Cir.2013).

Botox is Allergan's name for Botulinum Type A, a potent neurotoxin. The federal Food and Drug Administration (“FDA”) has approved certain therapies that involve injecting Botox into localized muscle areas to paralyze the muscle. R. 1–1 ¶¶ 13–14. One risk of Botox, however, is that it “can migrate outside the injected muscles and cause side effects including botulism and severe autoimmune reactions with resulting brain damage.” Id. ¶ 14.

Plaintiff alleges that Allergan touted Botox as a “miracle drug” and “sponsored ... conferences for doctors [at which Allergan] represent[ed] that Botox is ‘well-tolerated,’ ‘safe,’ and ‘effective.’ ” Id. ¶ 15. Allergan “heavily promote[d] Botox for a wide variety of off-label uses including [Temporomandibular Joint Syndrome (“TMJ”) ].” Id. ¶ 16. Allergan created and funded several organizations to distribute electronic and printed promotional materials and to educate doctors about off-label uses for Botox. Id. ¶ 17. Allergan “specifically trained” its sales representatives to “refer doctors” to this promotional material and “encourage [d] off-label use by teaching injecting physicians and their staff how to get reimbursed for these nonapproved uses by third-party payers.” Id. According to Plaintiff, Allergan knew that this information was false, and Allergan distributed it with the intent of inducing physicians to prescribe Botox to treat off-label conditions. Id. ¶¶ 55–56. Allergan recently pled guilty to off-label promotion in violation of the federal Food, Drug and Cosmetic Act, resulting in civil and criminal penalties. Id. ¶ 17.

Rosenstern's physicians recommended Botox treatment for her TMJ disorder. Id. ¶ 20. On May 25, 2011, Rosenstern received 75 units of Botox. Id. ¶¶ 3, 20. Rosenstern and her physicians decided to treat her TMJ with Botox in reliance on Allergan's representations that this was an appropriate use of Botox. Id. ¶ 57.

Plaintiff alleges that as “a consequence of Rosenstern's Botox treatment, she suffered from severe debilitating pain in her back and neck, muscle weakness, increased anxiety, depression and migraines.” Id. ¶¶ 20, 22. The Botox also exacerbated Rosenstern's preexisting anxiety and depression. Id. ¶ 23. “Her condition eventually progressed into severe acute immune reaction, resulting in a[n] ... injury to her brain, resulting in death” on April 23, 2013. Id. ¶¶ 21, 25. According to Allergan, the Sarasota, Florida Medical Examiner determined that Rosenstern's cause of death was suicide, R. 12 at 5, but Plaintiff alleges that Rosenstern's suicide was precipitated by her “Botox poisoning.” R. 20 at 6.

The complaint includes nine substantive counts.¹ In Count I, Plaintiff alleges that “Allergan failed to warn Janet Rosenstern and others” and “her health care providers” that Botox could cause the harm Rosenstern suffered. R. 1–1 ¶¶ 27, 29. In Count II, Plaintiff alleges that the “Botox given to Janet Rosenstern contained a defect in its manufacture,” id. ¶ 33, and that this defect caused Rosenstern's injuries. Id. ¶ 36. And in Count III, Plaintiff alleges that “Allergan was negligent in designing and marketing Botox,” causing Rosenstern's injuries. Id. ¶ 38.

In Counts IV and V, Plaintiff alleges that Allergan breached implied and express warranties that Botox could safely be used to treat TMJ. Id. ¶¶ 16–17, 42, 49.

Count VI is captioned as a claim for “negligent misrepresentation.” Id. at 13. Plaintiff alleges that Allergan made “false representations ... to Janet Rosenstern, her health care providers, and the general public, ... that Botox was safe, fit, and effective for human consumption.” Id. ¶ 52. Plaintiff alleges that Allergan “willfully deceived Janet Rosenstern, her health care providers, and the general public as to the health risks and consequences of the use of Botox.” Id. ¶ 53.

Count VII is a wrongful death claim brought by Plaintiff in his individual capacity. And in Count VIII, Plaintiff seeks to recover “certain sums of money for the funeral costs of the Decedent,” in a “survival action.” Id. ¶ 68.

Plaintiff has disavowed his claim for punitive damages in Count IX, R. 20 at 15, and, thus it is dismissed with prejudice.

Legal Standard

A Rule 12(b)(6) motion challenges the sufficiency of the complaint. See, e.g.,Hallinan v. Fraternal Order of Police of Chi. Lodge No. 7, 570 F.3d 811, 820 (7th Cir.2009). A complaint must provide “a short and plain statement of the claim showing that the pleader is entitled to relief,” Fed. R. Civ. P. 8(a)(2), sufficient to provide defendant with “fair notice” of the claim and the basis for it. Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). This “standard demands more than an unadorned, the-defendant-unlawfully-harmed-me accusation.” Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009). While “detailed factual allegations” are not required, “labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do.” Twombly, 550 U.S. at 555, 127 S.Ct. 1955. The complaint must “contain sufficient factualmatter, accepted as true, to ‘state a claim to relief that is plausible on its face.’ ” Ashcroft, 556 U.S. at 678, 129 S.Ct. 1937 (quoting Twombly, 550 U.S. at 570, 127 S.Ct. 1955). “ ‘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.’ ” Mann, 707 F.3d at 877 (quoting Iqbal, 556 U.S. at 678, 129 S.Ct. 1937). In applying this standard, the Court accepts as true all well-pleaded facts as true and draws all reasonable inferences in favor of the non-moving party. Mann, 707 F.3d at 877.

Analysis

Count I: Products Liability—Failure to Warn

“To recover in a product liability action, a plaintiff must plead and prove that the injury resulted from a condition of the product, that the condition was an unreasonably dangerous one, and that the condition existed at the time the product left the manufacturer's control.” Sollami v. Eaton, 201 Ill.2d 1, 265 Ill.Dec. 177, 772 N.E.2d 215, 219 (Ill.2002). The “unreasonably dangerous” standard can be met through either “a physical flaw, a design defect, or a failure of the manufacturer to warn of the danger or instruct on the proper use of the product.” Id. When proceeding under a failure to warn theory, a plaintiff must demonstrate that the manufacturer did not disclose an unreasonably dangerous condition or instruct on the proper use of the product as to which the average consumer would not be aware. Id.

Allergan contends that Plaintiff's claim is barred by the learned intermediary doctrine, R. 12 at 4, which “excuses the manufacturer of a prescription drug from having to warn consumers of the drug's adverse side effects; it need warn only physicians, so that armed with the warning they can make a medical decision to prescribe or not to prescribe the drug for a particular patient.” Walton v. Bayer Corp., 643 F.3d 994, 999–1000 (7th Cir.2011). But since Plaintiff has alleged that that Allergan failed to warn “Rosenstern or her health care providers ” about the risks associated with Botox injections, R. 1–1 ¶ 29 (emphasis added), Allergan cannot seriously argue that the learned intermediary doctrine is applicable here. Allergan's real argument is that Rosenstern's reference to “health care providers” is not specific enough as to the physicians' identities. R. 12 at 5 n.1. But Plaintiff has named Dr. Steven Dayan and the True Skin Care Center as respondents in discovery who have “information regarding the Botox injection procedures which gave rise to the instant cause of action.” R. 1–1 ¶¶ 74–83. This information is sufficient to give Allergan fair notice regarding the identity of Rosenstern's physicians.

Allergan also argues that Plaintiff fails to allege the following: what risks associated with Botox Allergan failed to warn Rosenstern's physicians about, R. 21 at 3; that “Allergan knew of the alleged risks of Botox at the time of production,” or “injection,” R. 12 at 5; R. 21 at 3; that “the alleged risks were not already known to the prescribing physician or the medical community,” R. 12 at 5; R. 21 at 3; that “the alleged risks were not in the package insert for Botox,” R. 21 at 3; and, “that Allergan's alleged failure...