MacSwan v. Merck & Co., 1:20-cv-1661

CourtUnited States District Courts. 2nd Circuit. United States District Court of Western District of New York
Writing for the CourtChristina Reiss, District Judge United States District Court
PartiesJOANNE MACSWAN, Plaintiff, v. MERCK & CO., INC., Defendant. v.
Docket Number1:20-cv-1661
Decision Date04 May 2022


MERCK & CO., INC., Defendant.

No. 1:20-cv-1661

United States District Court, W.D. New York

May 4, 2022


Christina Reiss, District Judge United States District Court

Plaintiff Joanne MacSwan brings this action against Defendant Merck & Co., Inc. alleging that, as a result of taking FOSAMAX® (“Fosamax”), a medication for the prevention and treatment of osteoporosis, she suffered serious and debilitating injuries, On October 6, 2020, Plaintiff filed a complaint in New York Supreme Court alleging six causes of action against Defendant: negligence (Count I); strict liability (Count II), breach of express warranty (Count III), breach of implied warranty (Count IV), fraudulent misrepresentation (Count V), and fraudulent concealment (Count VI) (the “Complaint”). Plaintiff seeks compensatory damages and punitive damages. On November 12, 2020, Defendant removed the case to this court and, on November 19, 2020, filed an answer.

Pending before the court is Defendant's September 10, 2021 motion for judgment on the pleadings seeking dismissal of Counts I and II, to the extent they are based on design defect theories, and Counts III, IV, V, and VI in their entirety. (Doc. 17.) Plaintiff opposed the motion on September 24, 2021 and Defendant replied on October 1, 2021, at which time the court took the motion for judgment on the pleadings under advisement.


Plaintiff is represented by Alexandria N. Rowen, Esq. and Hugh M. Russ, III, Esq. Defendant is represented by Michael L. Hecht, Esq., Robert G. Scumaci, Esq., and Stephen E. Marshall, Esq.

I. Allegations in the Complaint.

Plaintiff is a New York resident. Defendant is a New Jersey corporation with its principal place of business in West Trenton, New Jersey. This action “arises out of Defendant's designing, manufacturing, marketing, distributing, and selling” of Fosamax, which is Defendant's brand name for the compound alendronate, a nitrogenous bisphosphonate drug used “primarily to mitigate or reverse the effects of osteoporosis.” (Doc. 1-1 at 4-7, ¶¶ 1, 9, 20.) Bisphosphonates are a class of drugs “used for treating bone conditions” and some, though not Fosamax, “are also used for chemotherapy and for adjunct chemotherapy[.]” Id., at 7, ¶ 17.

In September 1995, the United States Food and Drug Administration (“FDA”) approved Fosamax for the treatment of osteoporosis. At all relevant times, Defendant was the “designer, manufacturer, marketer, distributor, and seller” of Fosamax, which was a top selling drug for Defendant, averaging over $3 billion in annual sales. Id. at 5-6, ¶ 9. From the 1990s to the present, “medical articles and studies” reported “the frequent and common occurrence” of “osteonecrosis of the jaw as a result of nitrogenous bisphosphonates used for chemotherapy” and “atrial fibrillation as result of bisphosphonates use.” (Doc. 1-1 at 7, ¶¶ 18-19.)

Defendant allegedly knew or should have known that Fosamax, like all bisphosphonates, “increasefs] the release of inflammatory cytokines which are associated with, and cause, atrial fibrillation[, ]” which “is a risk factor and/or predisposition for stroke(s).” Id. at 8, ¶¶ 23-24. In addition, because Fosamax is a nitrogenous bisphosphonate, Defendant allegedly knew or should have known that it “shared a similar adverse event profile to other drugs within this specific subclassf, ]” id. at 7, ¶ 20, including that these drugs “inhibit endothelial cell functionf, ]” “inhibit vascularizationf, ]” and “induce ischemic changes specific to patients' mandibles (lower jaws) and maxillae (upper jaws)[.]” Id. at 7-8, ¶ 21. Defendant allegedly further knew or should have known.


that “these factors combine to create a compromised vascular supply in the affected area” and “a minor injury or disease . . . can progress to widespread necrosis (bone death) and osteomyelitis (inflammation of bone marrow)-together, osteonecrosis.” Id. at 8, ¶ 22.

Defendant allegedly “concealed its knowledge” of Fosamax's “unreasonably dangerous risks[, ]” and “failed to conduct adequate and sufficient post-marketing surveillance.” Id. at 4-5, ¶¶ 2-3. “As a result of the defective nature” of Fosamax, Plaintiff “suffered and may continue to suffer severe and permanent personal injuries, including osteonecrosis of the jaw and other irreversible damage to the jaw, and atrial fibrillation, stroke, and other irreversible damage to the brain.” Id. at 5, ¶ 4.

Despite FDA reports of osteonecrosis and atrial fibrillation among users of Fosamax after its release, Defendant “failed to implement further studies” of these issues and instead “sought to extend the exclusivity period with the FDA through 2018.” Id., at 8-9, ¶¶ 25-27. On August 25, 2004, the FDA issued a review of bisphosphonates that concluded the risk of osteonecrosis to the jaw were not limited to those used for chemotherapy and required Defendant to update Fosamax's label to warn of the risks of osteonecrosis of the jaw. Notwithstanding this directive, Defendant allegedly “continued to . . . minimize . . . unfavorable findings” and did not update Fosamax's warning label until 2005. (Doc. 1-1 at 10, ¶ 34.) Because Defendant “did not adequately and sufficiently warn consumers, including [Plaintiff], or the medical community” about the “significant” risks of “dental and oral complications” and “atrial fibrillation and resulting stroke” associated with Fosamax, Plaintiff and other consumers continued to use Fosamax despite “several alternative safer products available to treat their conditions.” Id. at 10 ¶ 36-38.

Plaintiff “was prescribed and began taking” Fosamax in January 2009. Id. at 11, ¶ 40. Through “affirmative misrepresentations and omissions, ” Defendant allegedly “actively concealed” from Plaintiff and her doctors “the verified and significant risks” of Fosamax. Id. at 11, ¶ 45. Had the associated risks been properly disclosed, Plaintiff would have ceased using Fosamax. As a result of Defendant's “actions and omissions, ” Plaintiff asserts she was “permanently and severely injured, having suffered serious


consequences from the ingestion of F[osamax]” and “has required and will continue to require ongoing medical care and treatment.” Id. at 10-11, ¶ 39.

For each of the six counts in the Complaint, Plaintiff alleges she suffered “significant and permanent injuries[, ]” “diminished quality of life, ” and “other losses and damages” as a result of Defendant's “actions, omissions, and misrepresentations[.]” Id. at 12-14, 16, 18-19, 21 ¶¶ 53, 66, 74, 85, 95, 107. She seeks punitive damages on all counts because Defendant allegedly acted knowingly and “with conscious, wanton, willful, and deliberate disregard for the value of [her] life[.]” (Doc. 1-1 at 13, 15-16, 18, 20, 21-22 ¶¶ 55, 68, 76, 87, 97, 109.)

II. Judicial Notice.

In deciding a motion for judgment on the pleadings, the court may consider documents and information incorporated by reference or integral to a complaint, as well as facts subject to judicial notice. See Glob. Network Commc'ns, Inc. v. City of New York, 458 F.3d 150, 156 (2d Cir. 2006). Defendant asks the court to consider the warnings regarding osteonecrosis in Fosamax's FDA-approved label and in Defendant's Patient Information Sheet. Because the Complaint “relies heavily upon [the] terms and effect” of Fosamax's label and warnings distributed to patients, they are integral to the Complaint. Chambers v. Time Warner, Inc., 282 F.3d 147, 153 (2d Cir. 2002) (quoting Int'l Audiotext Network, Inc. v. Am. Tel. & Tel. Co,, 62 F.3d 69, 72 (2d Cir. 1995) (per curiam)).

Defendant also requests the court take judicial notice of the dates Fosamax's patent rights expired, the market effects of the expiration of those rights, and FDA safety studies on bisphosphonates. Plaintiff criticizes Defendant's allegedly “liberal use of carefully chosen quasi-public documents” but does not oppose Defendant's requests for judicial notice. (Doc. 18-2 at 6.) “The court may judicially notice a fact that is not subject to reasonable dispute because it: (1) is generally known within the trial court's territorial jurisdiction; or (2) can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned.” Fed.R.Evid. 201(b). The court “must take


judicial notice if a party requests it and the court is supplied with the necessary information.” Id. at (c)(2).

The court takes judicial notice of patent expiration dates and the safety studies cited by Defendant because they can be “accurately and readily” determined from FDA sources “whose accuracy cannot reasonably be questioned.” Id. at (b)(2); see also In re Zyprexa Prod. Liab. Litig., 549 F.Supp.2d 496, 501 (E.D.N.Y. 2008) (“Public documents issued by government agencies such as the Food and Drug Administration (“FDA”) may also be [judicially noticed].”). The court declines to take judicial notice of the effect of generic competition on Defendant's market share as Defendant has not supplied the court with the court “with the necessary information[, ]” Fed.R.Evid. 201(c)(2), and the impact of generic competition is subject to reasonable dispute.

III. Conclusions of Law and Analysis.

A. Standard of Review.

“The standard for granting a Rule 12(c) motion for judgment on the pleadings is identical to that for granting a Rule 12(b)(6) motion for failure to state a claim.” Lively v. WAPPA Inv. Advisory Grp., Inc., 6 F.4th 293, 301 (2d Cir. 2021) (internal quotation marks omitted) (quoting Lynch v. City of New York, 952 F.3d 67, 75 (2d Cir. 2020)). To survive a motion to dismiss filed pursuant to Fed. R. Civ. P. 12(b)(6), “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 (2009)...

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