Novotney v. Walgreen Co.

• Court: U.S. District Court — Northern District of Illinois
• Writing for the Court: JORGE ALONSO, United States District Judge
• Citation: Novotney v. Walgreen Co., 683 F.Supp.3d 785 (N.D. Ill. 2023)
• Docket Number: 22 C 3439
• Decision Date: 20 July 2023
• Parties: Jim NOVOTNEY, Plaintiff, v. WALGREEN CO., Defendants.

683 F.Supp.3d 785

Jim NOVOTNEY, Plaintiff, v. WALGREEN CO., Defendants.

No. 22 C 3439

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

Signed July 20, 2023

Spencer Sheehan, Sheehan & Associates, P.C., Great Neck, NY, Peter S. Lubin, Patrick Doyle Austermuehle, Lubin Austermuehle, P.C., Oakbrook Terrace, IL, for Plaintiff.

Christopher W. Carmichael, Henderson Parks, LLC, Chicago, IL, Jonathan Lawrence Lewis, Lowenstein Sandler LLP, Washington, DC, for Defendants.

ORDER

JORGE ALONSO, United States District Judge

Defendant Walgreen Co.'s motion to dismiss [15] is granted. This case is dismissed with prejudice.

STATEMENT

Plaintiff, Jim Novotney, brings this putative class action against defendant, the Walgreen Co., asserting state-law claims of fraud, breach of warranty, negligent misrepresentation and unjust enrichment. The Court has subject matter jurisdiction under the Class Action Fairness Act, 28 U.S.C. § 1332(d)(2).

Plaintiff's claims are rooted in defendant's practice of selling 3% hydrogen peroxide solution while representing that it is a "first aid antiseptic" to be used for "treatment of minor cuts and abrasions." In fact, plaintiff claims, hydrogen peroxide is ineffective in treating minor cuts and abrasions because, contrary to popular belief, it does not reduce rates of wound infection. While hydrogen peroxide may kill some potentially harmful bacteria, plaintiff claims, it does more harm than good because it also destroys beneficial bacteria and healthy cells that promote healing.

Defendant moves to dismiss under Federal Rule of Civil Procedure 12(b)(6), arguing that plaintiff's claims are preempted and he fails to plead sufficient facts to meet his pleading burden. For the following reasons, the Court agrees that dismissal is appropriate because plaintiff's claims are preempted.

I. Applicable Law

"A motion under Rule 12(b)(6) tests whether the complaint states a claim on which relief may be granted." Richards v. Mitcheff, 696 F.3d 635, 637 (7th Cir. 2012). Under Rule 8(a)(2), a complaint must include "a short and plain statement of the claim showing that the pleader is entitled to relief." Fed. R. Civ. P. 8(a)(2). The short and plain statement under Rule 8(a)(2) must " 'give the defendant fair notice of what . . . the claim is and the grounds upon which it rests.' " Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) (quoting Conley v. Gibson, 355 U.S. 41, 47, 78 S.Ct. 99, 2 L.Ed.2d 80 (1957)). Under federal notice-pleading standards, a plaintiff's "[f]actual allegations must be enough to raise a right to relief above the speculative level." Id. Stated differently, "a complaint must contain sufficient factual matter, accepted as true, to 'state a claim to relief that is plausible on its face.' " Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (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." Id. (citing Twombly, 550 U.S. at 556, 127 S.Ct. 1955).

A. Preemption

"The preemption doctrine is grounded in the Constitution's Supremacy Clause." Wis. Cent., Ltd. v. Shannon, 539 F.3d 751, 762 (7th Cir. 2008). The Supremacy Clause declares that federal law "shall be the supreme Law of the Land . . . any Thing in the Constitution or Law of any State to the Contrary notwithstanding." U.S. Const. Art. VI., cl. 2. "Where state and federal law directly conflict, state law must give way." PLIVA, Inc. v. Mensing, 564 U.S. 604, 617, 131 S.Ct. 2567, 180 L.Ed.2d 580 (2011) (internal quotation marks omitted).

"Preemption is an affirmative defense, and pleadings need not anticipate or attempt to circumvent affirmative defenses." Bausch v. Stryker Corp., 630 F.3d 546, 561 (7th Cir. 2010) (internal citation omitted). The preferred procedure for raising a preemption defense is to assert it in the answer and move for judgment on the pleadings under Federal Rule of Civil Procedure 12(c), rather than raising the issue in a motion to dismiss. Id.; see Benson v. Fannie May Confections Brands, Inc., 944 F.3d 639, 645 (7th Cir. 2019). But granting a Rule 12(b)(6) motion to dismiss based on an affirmative defense such as preemption is "appropriate . . . 'where the allegations of the complaint itself set forth everything necessary to satisfy the affirmative defense.' " Sidney Hillman Health Ctr. of Rochester v. Abbott Lab'ys, Inc., 782 F.3d 922, 928 (7th Cir. 2015) (quoting Chicago Bldg. Design, P.C. v. Mongolian House, Inc., 770 F.3d 610, 614 (7th Cir. 2014)). If the plaintiff affirmatively pleads himself out of court by presenting "all relevant facts," Brownmark Films, LLC v. Comedy Partners, 682 F.3d 687, 690 (7th Cir. 2012), such that he has essentially "admit[ted] all the ingredients of an impenetrable defense," Xechem, Inc. v. Bristol-Myers Squibb Co., 372 F.3d 899, 901 (7th Cir. 2004), then the Court need not insist that the defendant prepare and file two documents (an answer and a Rule 12(c) motion) where a Rule 12(b)(6) motion alone would do just as well. See Wardingley v. Ecovyst Catalyst Techs., LLC, No. 2:22-CV-115-PPS-JEM, 639 F.Supp.3d 803, 805-07 (N.D. Ind. Nov. 4, 2022) (analyzing preemption issue raised in Rule 12(b)(6) motion to dismiss because the Court had before it "all that is 'needed in order to . . . rule on the defense' ") (quoting Carr v. Tillery, 591 F.3d 909, 913 (7th Cir. 2010)).

"Preemption can take on three different forms: express preemption, field preemption, and conflict preemption." Aux Sable Liquid Prod. v. Murphy, 526 F.3d 1028, 1033 (7th Cir. 2008). This case concerns express preemption, which is when Congress "define[s] explicitly the extent to which its enactments pre-empt state law." English v. Gen. Elec. Co., 496 U.S. 72, 78, 110 S.Ct. 2270, 110 L.Ed.2d 65 (1990).

B. Federal Law Governing Content of Over-The-Counter Drug Labels

The Food, Drug, and Cosmetics Act ("FDCA") regulates the marketing and labeling of drugs. See 21 U.S.C. § 301 et seq. The FDCA provides that no state may "establish . . . any requirement . . . that is different from or in addition to, or that is otherwise not identical with, a requirement" of the FDCA. 21 U.S.C. § 379r(a).

The Secretary of Health and Human Services has "authority to promulgate regulations for the efficient enforcement" of the FDCA, 21 U.S.C.A. § 371(a), which he accomplishes through the Food and Drug Administration ("FDA") and its Commissioner, 21 U.S.C. § 393(a), (b), (d)(2). Drug manufacturers must apply to the FDA for approval before marketing their products, so that the FDA may determine whether the drugs are safe and effective for use as labeled. 21 U.S.C. § 355(a), (b), (j); see Wyeth v. Levine, 555 U.S. 555, 566, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009).

The FDA regulates over-the-counter ("OTC") drugs via its "Over the Counter Drug Review" process, which the Second Circuit has described as follows:

Commenced in 1972, the OTC Drug Review established FDA's "monograph" system for regulating over-the-counter drugs. See 21 C.F.R. § 330.10; 37 Fed. Reg. 9464 (May 11, 1972). While FDA must [typically] approve drugs as [generally recognized as safe and effective ("GRAS/E")] individually, the monograph system allows manufacturers to bypass individualized review. See 21 U.S.C. § 355; 21 C.F.R. § 330.10. Under this system, FDA issues a detailed regulation—a "monograph"—for each therapeutic class of OTC drug products. Like a recipe, each monograph sets out the FDA-approved active ingredients for a given therapeutic class of OTC drugs and provides the conditions under which each active ingredient is GRAS/E.

NRDC v. FDA, 710 F.3d 71, 75 (2d Cir. 2013); see In re Tylenol (Acetaminophen) Mktg., Sales Practices & Prod. Liab. Litig., 144 F. Supp. 3d 699, 708-11 (E.D. Pa. 2015) (describing the "monograph system" as "essentially an expanded version of administrative notice-and-comment rulemaking" for drugs with active ingredients in longtime use).

The FDA regulates 3% hydrogen peroxide solution for antiseptic use under a 1991 "tentative final monograph," Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for First Aid Antiseptic Drug Products, 56 Fed. Reg. 33644 (July 22, 1991) ("1991 TFM"); see 21 C.F.R. § 330.10(a)(7)(i) ("After reviewing all comments, reply comments, and any new data and information or, alternatively, after reviewing a panel's recommendations, the Commissioner shall publish in the Federal Register a tentative order containing a monograph establishing conditions under which a category of OTC drugs or specific OTC drugs are generally recognized as safe and effective and not misbranded."). The 1991 TFM became final under the Coronavirus Aid, Relief and Economic Security Act in 2020. See 21 U.S.C. § 355h(b)(8)(A). The monograph states as follows, in pertinent part:

The submission forwarded by the manufacturer (Ref. 3) included labeling for a currently marketed product containing hydrogen peroxide solution U.S.P. 3 percent, which states: "First aid antiseptic" "For treatment of minor cuts and abrasions." The submission also included safety and effectiveness data from published articles and unpublished studies. These data indicate that hydrogen peroxide inhibits S. aureus, Salmonella typhosa, Escherichia coli (E. coli), Proteus vulgaris, Klebsiella pneumoniae, Streptococcus hemolyticus, and P. aeruqinosa. The manufacturer also provided in vitro data to show that 3 percent hydrogen peroxide reduced the number of S. aureus ATCC 6538P by 3 logs (3 log10) within 5 minutes and completely inhibited all bacteria within 10 minutes.

In a separate OTC drug rulemaking, for OTC oral mucosal injury drug products, the agency found hydrogen peroxide (3 percent in aqueous solution) safe for short-term use up to 7 days. (See the Federal Register of July 26, 1983, 48 FR

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