Ignacuinos v. Boehringer Ingelheim Pharm. Inc., No. 3:19-cv-672 (SRU)

CourtUnited States District Courts. 2nd Circuit. United States District Court (Connecticut)
Writing for the CourtStefan R. Underhill, United States District Judge
Citation490 F.Supp.3d 533
Parties Carl IGNACUINOS and Pamela Davis, on behalf of themselves and all others similarly situated, Plaintiffs, v. BOEHRINGER INGELHEIM PHARMACEUTICALS INC., Defendant.
Docket NumberNo. 3:19-cv-672 (SRU)
Decision Date23 September 2020

490 F.Supp.3d 533

Carl IGNACUINOS and Pamela Davis, on behalf of themselves and all others similarly situated, Plaintiffs,

No. 3:19-cv-672 (SRU)

United States District Court, D. Connecticut.

Signed September 23, 2020

490 F.Supp.3d 535

Stephen M. Bourtin, The Boyd Law Group, Stamford, CT, Eric M. Teszler, C.K. Lee, Lee Litigation Group, PLLC, New York, NY, for Plaintiffs.

Emily Sarah Ullman, Shankar Duraiswamy, Covington & Burling LLP, Washington, DC, James T. Shearin, Pullman & Comley, Bridgeport, CT, for Defendant.


Stefan R. Underhill, United States District Judge

This purported class action seeks monetary and injunctive relief for injuries caused by the alleged deceptive design, manufacturing, and marketing of Boehringer Ingelheim Pharmaceuticals, Inc.’s ("Boehringer") pharmaceutical drug, Combivent Respimat ("Combivent"). Combivent is a metered dose inhaler that is prescribed to alleviate symptoms of chronic obstructive pulmonary disease ("COPD"). Carl Ignacuinos ("Ignacuinos") and Pamala Davis ("Davis") (collectively "the Plaintiffs") allege that Boehringer falsely represents that each Combivent inhaler ("the Product") contains 120 doses. The Plaintiffs bring a seventeen-count class action complaint seeking damages and an injunction prohibiting Boehringer from marketing and selling the Product with the alleged defects and misrepresentations. See generally Third Am. Compl. (Doc. No. 23). In addition, the Plaintiffs

490 F.Supp.3d 536

seek changes to the Product's design and labeling. Id.

Boehringer moves to dismiss the Third Amended Complaint in its entirety, primarily arguing that: (1) the Plaintiffs lack Article III standing; and (2) the Plaintiffs’ state law claims are preempted by federal law. See Def's Mem. in Supp. Mot. to Dismiss ("Def's Mem.") (Doc. No. 24-1) at 1. On September 2, 2020, I held oral argument and took the motion under advisement. See Minute Entry, Doc. No. 39.

For the following reasons, Boehringer's motion to dismiss (doc. no. 24) is granted .

I. Standard of Review

A motion to dismiss for failure to state a claim pursuant to Rule 12(b)(6) is designed "merely to assess the legal feasibility of a complaint, not to assay the weight of evidence which might be offered in support thereof." Ryder Energy Distrib. Corp. v. Merrill Lynch Commodities, Inc. , 748 F.2d 774, 779 (2d Cir. 1984) (quoting Geisler v. Petrocelli , 616 F.2d 636, 639 (2d Cir. 1980) ).

When deciding a motion to dismiss pursuant to Rule 12(b)(6), the court must accept the material facts alleged in the complaint as true, draw all reasonable inferences in favor of the plaintiff, and decide whether it is plausible that plaintiffs have a valid claim for relief. Ashcroft v. Iqbal , 556 U.S. 662, 678–79, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) ; Bell Atl. Corp. v. Twombly , 550 U.S. 544, 555–56, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) ; Leeds v. Meltz , 85 F.3d 51, 53 (2d Cir. 1996).

Under Twombly , "[f]actual allegations must be enough to raise a right to relief above the speculative level," and assert a cause of action with enough heft to show entitlement to relief and "enough facts to state a claim to relief that is plausible on its face." 550 U.S. at 555, 570, 127 S.Ct. 1955 ; see also Iqbal , 556 U.S. at 679, 129 S.Ct. 1937 ("[w]hile legal conclusions can provide the framework of a complaint, they must be supported by factual allegations."). The plausibility standard set forth in Twombly and Iqbal obligates the plaintiff to "provide the grounds of his entitlement to relief" through more than "labels and conclusions, and a formulaic recitation of the elements of a cause of action." Twombly , 550 U.S. at 555, 127 S.Ct. 1955 (quotation marks omitted). Plausibility at the pleading stage is nonetheless distinct from probability, and "a well-pleaded complaint may proceed even if it strikes a savvy judge that actual proof of [the claims] is improbable, and ... recovery is very remote and unlikely." Id. at 556, 127 S.Ct. 1955 (quotation marks omitted).

II. Background

A. The Product

Combivent is a bronchodilator designed to provide relief to individuals suffering from COPD, a chronic inflammatory lung disease that constricts airflow to the lung's passageways. See Third Am. Compl. at ¶ 28. By delivering a combination of ipratropium bromide and albuterol through the Product, Combivent relaxes muscles in the lungs and expands air passageways so that it becomes easier to breathe. Id. at ¶ 29. The Product consists of the inhaler equipped with a mouthpiece and a cartridge that contains the medication itself. See Def's Mem. at 2. Boehringer represents that each use, or "actuation," of the Product will deliver a set, metered dose: "[e]ach actuation from the COMBIVENT RESPIMAT inhaler delivers 20 mcg ipratropium bromide (monohydrate) and 100 mcg albuterol (equivalent to 120 mcg albuterol sulfate) in 11.4 mcL of solution from the mouthpiece." Third Am. Compl. at ¶ 33. The recommended dose of the Product is "one inhalation four times a day, not to exceed six inhalations in 24 hours," and

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each Product is reported to contain 120 metered doses.1 Id. at ¶¶ 35–36. In addition, Boehringer represents that the Product "will deliver 120 puffs and last 30 days if used 1 puff [actuation] four times daily." Id. at ¶ 37.

In 2016, the FDA reviewed and approved an updated version of the labeling of the Product, including the package insert for physicians, patient information, and carton packaging, that remains in effect today. See Def's Mem. at 3. In a section of the labeling entitled "Answers to Common Questions," the Instructions for Use note the possibility that "[t]he dose indicator on the COMBIVENT RESPIMAT reaches zero too soon" under certain circumstances involving user error. Ex. 1 to Third Am. Compl. at 14.

B. The Plaintiffs’ Allegations

Ignacuinos, a Florida resident, is a long-time sufferer of COPD. See Third Am. Compl. at ¶ 22. Beginning in 2016, he was prescribed Combivent to alleviate his COPD symptoms. Id. Since he was first prescribed Combivent, Ignacuinos noticed that he was not receiving the full, or even close to, the 120 metered doses from the Product during each use. Id. at ¶ 24. Ignacuinos began logging the total number of doses he derived from each Combivent inhaler he was prescribed. Id. at ¶ 45. Over the course twenty-tour inhalers, Ignacuinos's inhalers delivered on average only 61 metered doses before each inhaler's dosage meter reached "0" and automatically locked, notwithstanding Boehringer's representations that each Product delivers 120 metered doses. Id. at ¶ 46.

Because the Product only delivers about half its advertised number of doses, Ignacuinos states that Combivent can only be used in accordance with Boehringer's one puff instruction, four times daily for approximately two weeks each month. Id. As a result, Ignacuinos uses less than four puffs daily so that he can preserve the lifespan of his Combivent inhaler for an entire month, until he is prescribed another inhaler by his health care provider after 30 days have lapsed. Id. Due to the Product's alleged defects, Ignacuinos routinely experiences bodily injury in the form of episodes with acute difficulty breathing because he does not have enough medication to alleviate his COPD symptoms. Id. at ¶ 48. In addition, Ignacuinos alleges that he is deprived of the benefit of the bargain each time he pays for the Product. Id. at ¶ 49.

Davis, an Indiana resident, is a COPD patient who was first prescribed and purchased Combivent in 2016 to treat her COPD symptoms. Id. at ¶ 23. After using approximately 30 Combivent inhalers since 2016, Davis reports that each Product delivers only about 70 doses. Id. at ¶ 52. Because her medication runs low well in advance of the date of her next available prescription, Davis takes less than the daily amount of puffs recommended by Boehringer to extend the lifespan of her inhaler. Id. at ¶ 53. Davis alleges that she has trouble breathing due to the Product's defects, which causes mental and emotional distress. Id. at ¶ 55.

The Plaintiffs note that other users of the Product have also complained about a shortfall in dosage. See, e.g. , User Reviews & Ratings—Combivent Respimat inhalation , WEBMD, https://www.webmd.com/drugs/drugreview-161259-Combivent +Respimat (last visited September 16, 2020)) ("I have had continuing problems

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with Combivent Respimat. It is supposed to have 120 doses for the month but has typically not lasted a full month. Last year 2017 it averaged less than 25 days. For May and June of 2018 it barely lasts two weeks and I am left without medication for the remainder of the month. Something is wrong with this product. I have talked to the company, sent them the defective inhalers but the problem persists."). The Plaintiffs further allege that "[t]he shortfall in dosage is not due to variance or any natural fluctuation in the manufacturing process. Instead, the consistent shortfall is based on the random sampling for each [Product he] receives, demonstrating a common scheme...

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