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Date: 07-13-2023

Case Style:

Amy Licht v. Merck & Co., Inc., et al.

Case Number: 1:22-cv-10515-

Judge: Allison D. Burroughs

Court: United States District Court for the District of Massachusetts (Suffolk County)

Plaintiff's Attorney: Kimberly Lewis Beck, Lynne M. Kizis, Paula S. Bliss

Defendant's Attorney: Craig A. Thompson, Matthew W Webb, Stephen E. Marshall, Michelle M. Byers,
Michelle I. Schaffer

Description: Boston, Massachusetts personal injury lawyers represented Plaintiff who sued Defendants on product liability theories.

Plaintiff Amy Licht (“Plaintiff” or &ldquo ;Licht”) brings the instant action against Merck & Co., Inc., Merck Sharp & Dohme Corp., Organon & Co., and Organon, LLC (collectively, “Merck” or “Defendants”) for claims arising from neuropsychiatric injuries allegedly incurred after ingesting the prescription pharmaceutical product, Singulair. Before the Court is Merck's motion to dismiss Count I and Count III, insofar as Count III states a claim for negligent design. [ECF No. 13]. For the following reasons, the motion is GRANTED.


A. Factual Background

The following facts are taken primarily from the complaint, [ECF No. 2-1 (“Compl.”)]. The Court assumes the factual allegations in the complaint to be true when considering a motion to dismiss. Ruivo v. Wells Fargo Bank, N.A., 766 F.3d 87, 90 (1st Cir. 2014).

Merck began selling the prescription drug Singulair in 1998. [Compl. ¶ 2]. The active ingredient in Singular is montelukast, the anti-asthmatic properties of which Merck discovered and subsequently patented in 1996.[1] [Id. ¶¶ 2, 27, 53]. When Merck's patent and its exclusive right to sell the drug expired in 2012, the FDA approved multiple generic forms of Singulair, although Merck continued to manufacture and sell the branded version. [Id. ¶¶ 27, 86].

In 1998, when Merck began selling Singulair, it did not include any warnings about the drug's possible effects on the brain. [Compl. ¶ 53]. Licht contends that montelukast causes adverse neuropsychiatric events as a result of its ability to cross the blood-brain barrier and accumulate in the central nervous system. [Id. ¶¶ 32, 38, 39]. She further alleges that “Merck knew that Singulair crosses the blood-brain barrier from pre-clinical trials” and that “Merck Defendants misled the FDA” about the amount of the drug detected in the brain. [Id. ¶¶ 51-52]. In the years following Singulair's initial FDA approval, Merck made several changes and additions to Singulair's label that, over time, communicated an ever-higher degree of risk associated with ingesting the medication. [Id. ¶¶ 54-78].

In 2001, Defendants added to Singulair's label a warning that “‘dream abnormalities and hallucinations, drowsiness, irritability, agitation including aggressive behavior, restlessness [and] insomnia' have been observed.” [Compl. ¶ 54 (alteration in original)]. At another unspecified point, Merck also “added the term ‘suicide'” to the label and replaced the previously added term “psychomotor hyperactivity” with “anxiousness.” [Id. ¶¶ 59, 61]. And in 2010, “disorientation” was added to the warnings, precautions, and adverse events section of the label. [Id. ¶ 69]. In 2017, a collection of patient advisory organizations petitioned the FDA to require Singulair's label to include stronger warnings about neuropsychiatric events. [Id. ¶ 75]. FDA committees ultimately held a hearing on the petition in 2019 after which they required Merck to add a “black box warning”[2] to Singulair's label. [Id. ¶¶ 76-77].

;Licht was prescribed and took Singulair from 2008 to 2012, during which time her prescriptions were filled with branded Singulair.[3] [Compl. ¶ 8]. She alleges that “[a]s a direct and proximate result of ingesting Singulair, [she] suffered neuropsychiatric injury including depression, anxiety and [obsessive compulsive disorder].” [Id.].

In the present suit, Licht brings counts against Defendants that relate to her use of branded Singulair and generic equivalents. [Compl. ¶¶ 106-215]. She asserts that Defendants, as the brand-name manufacturer of the drug, “controlled the contents of the Singulair label as well as the labels on the generic equivalents of Singulair[,]” [id. ¶ 192], because manufacturers of the generics “have only the duty to ensure their labels for generic bioequivalent to Singulair are the same as the label used by the brand[,]” [id. ¶ 88]. Therefore, Licht argues, Defendants “knew that any deficiencies in the label . . . would be perpetuated in the label of its generic bioequivalent.” [Id. ¶ 89].

;Licht further argues that because of information obtained through “post-marketing information[,] . . . reanalysis of existing data and scientific literature[,] . . . reanalysis of preclinic and clinical trials[,] . . . the increasing body of publicly available scientific literature regarding montelukast[,] . . . [and] post-marketing surveillance information available to the Merck Defendants[,]” the revisions to Singulair's label should have come earlier and been more pronounced. [Id. ¶¶ 79-82]. She further claims that if she had known about the “defects in Singulair, [she] would not have taken [it]” and instead “would have taken a safer alternative . . . that would not have exposed [her] to neuropsychiatric events.” [Id. ¶ 143].[4]

B. Procedural Background

;Licht filed her five-count complaint against Merck in Bristol Superior Court on March 3, 2022 alleging design defect strict liability (Count I), failure to warn (Count II), negligence (Count III), misrepresentation (Count IV), and breach of express warranty (Count V). [Compl. ¶¶ 106-215]. On April 7, 2022, Merck removed the action to this Court, [ECF No. 1], and then on April 14 moved to dismiss Count I and Count III, insofar as Count III states a claim for negligent design, [ECF No. 13]. Plaintiff filed an opposition, [ECF No. 21], and Defendants replied, [ECF No. 24].
Licht v. Merck & Co. (D. Mass. 2023)

Outcome: Motion to dismiss granted.

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