Rosewolf v. Merck & Co.

• Docket Number: Case No. 22-cv-2072,Case No. 22-cv-02138-JSW,Case No. 22-cv-02260,Case No. 22-cv-2263
• Decision Date: 12 October 2022
• Citation: 635 F.Supp.3d 830
• Parties: Joshua ROSEWOLF, Plaintiff, v. MERCK & CO., INC., et al., Defendants. Mark Starr, Plaintiff, v. Merck & Co., Inc., et al., Defendants. Tyler Skinner, Plaintiff, v. Merck & Co., Inc., et al., Defendants. Shauna Gibson, Plaintiff, v. Merck & Co., Inc., et al., Defendants.
• Court: U.S. District Court — Northern District of California

635 F.Supp.3d 830

Joshua ROSEWOLF, Plaintiff, v. MERCK & CO., INC., et al., Defendants.

Mark Starr, Plaintiff, v. Merck & Co., Inc., et al., Defendants.

Tyler Skinner, Plaintiff, v. Merck & Co., Inc., et al., Defendants.

Shauna Gibson, Plaintiff, v. Merck & Co., Inc., et al., Defendants.

Case No. 22-cv-2072

Case No. 22-cv-02138-JSW

Case No. 22-cv-02260

Case No. 22-cv-2263

United States District Court, N.D. California

Signed October 12, 2022

Kevin Peter Roddy, Wilentz Goldman & Spitzer, PA, Woodbridge, NJ, Kimberly Lewis Beck, Pro Hac Vice, Beck Law Center, Cincinnati, OH, Shehnaz M. Bhujwala, Boucher, LLP, Woodland Hills, CA, for PlaintiffsJoshua Rosewolf, Mark Starr, Shauna Gibson.

Kevin Peter Roddy, Wilentz Goldman & Spitzer, PA, Woodbridge, NJ, Kimberly Beck, Beck Law Center, Cincinnati, OH, Shehnaz M. Bhujwala, Boucher, LLP, Woodland Hills, CA, Kimberly Lewis Beck, Pro Hac Vice, Beck Law Center, Cincinnati, OH, for PlaintiffTyler Skinner.

Shannon Beamer, Venable LLPVenable LLP, Los Angeles, CA, Alexander Gerard Calfo, Julia E. Romano, King & Spalding LLP, Los Angeles, CA, Nicole Norma King, Bryan Cave, LLP, Santa Monica, CA, Steven Edward Swaney, Venable LLP, San Francisco, CA, Jennifer Taylor Stewart, King & Spalding LLP, San Francisco, CA, for DefendantsMerck & Co., Inc., Merck Sharp & Dohme Corp., Organon & Co., Organon LLC.

Julia E. Romano, Alexander Gerard Calfo, King & Spalding LLP, Los Angeles, CA, Shannon Beamer, Venable LLPVenable LLP, Los Angeles, CA, Steven Edward Swaney, Venable LLP, San Francisco, CA, Jennifer Taylor Stewart, King & Spalding LLP, San Francisco, CA, for DefendantsMerck & Co., Inc., Merck Sharp & Dohme Corp., Organon & Co., Organon LLC.

ORDER GRANTING, IN PART, AND DENYING, IN PART, MOTIONS TO DISMISS AND SETTING DEADLINES AND CASE MANAGEMENT CONFERENCE

Re: Dkt. Nos. 18(Rosewolf), 8 (Starr and Skinner), and 9 (Gibson)

JEFFREY S. WHITE, United States District Judge

Now before the Court for consideration are motions to dismiss filed by DefendantsMerck & Co., Inc., Merck Sharp & Dohme Corp., Organon & Co., and Organon, LLC("Defendants").The Court has considered the parties' papers, relevant legal authority, and the record in this case, and it HEREBY GRANTS, IN PART, AND DENIES, IN PART, Defendants' motions.

BACKGROUND¹

A.Regulatory Background for New and Generic Drugs.

In order to place Plaintiffs' claims in context, the Court begins with some background of the law and regulations relating to the manufacture and sales of new and generic drugs.When a drug manufacturer wants to market a new drug, it must submit a New Drug Application ("NDA") to the FDA and then "undergo a long, comprehensive, and costly testing process[.]"FTC v. Activis, Inc., 570 U.S. 136, 141, 133 S.Ct. 2223, 186 L.Ed.2d 343(2013).When a manufacturer wants to market a generic version of an FDA approved new drug, it can file an Abbreviated New Drug Application ("ANDA") and "piggy-back" on the brand-name manufacturer's NDA by "show[ing] that the generic drug has the same active ingredients as, and is biologically equivalent to, the brand-name drug."Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S. 399, 405, 132 S.Ct. 1670, 182 L.Ed.2d 678(2012)(citing21 U.S.C. §§ 355(j)(2)(A)(ii), (iv)).

As part of the NDA process, the manufacturer of the new drug must submit and the FDA must approve "the exact text in the proposed label."Wyeth v. Levine, 555 U.S. 555, 568, 129 S.Ct. 1187, 173 L.Ed.2d 51(2009);see also21 U.S.C. § 355;21 C.F.R. § 314.105(b).Under the ANDA process, the manufacturer of a generic drug must "show that the safety and efficacy labeling proposed . . . is the same as the labeling approved for the brand-name drug."PLIVA, Inc. v. Mensing, 564 U.S. 604, 612-13, 131 S.Ct. 2567, 180 L.Ed.2d 580(2011)(internal alterations and quotations omitted).Thus, "[a] brand-name manufacturer seeking new drug approval is responsible for the accuracy and adequacy of its label[,]" whereas a generic manufacturer "is responsible for ensuring that its warning label is the same as the brand name's" label.Id. at 613, 131 S.Ct. 2567(citations omitted).Although any drug manufacturer can apply to the FDA to change an existing drug label, only the manufacturer of the branded drug can "add or strengthen a contraindication, warning, precaution, or adverse reaction" warning without waiting for FDA approval.Wyeth, 555 U.S. at 568, 129 S.Ct. 1187(citing21 C.F.R. § 314.70(c)(6)(iii)(A), (C)).

B.Factual Background.

Defendants manufacture and sell the brand-name drug "Singulair," and each Plaintiff alleges that Singulair's active ingredient, montelukast, causes neuropsychiatric injury by crossing the blood-brain barrier.Plaintiffs also allege that Defendants knew montelukast could cause these types of injuries but failed to warn of those risks and failed to maintain the accuracy and adequacy of Singulair's warning label.(See, e.g., Starr Compl.¶¶ 32-85.)Defendants held patent rights on montelukast until August 2012, when the patent expired.(Id.¶¶ 2, 27.)At that point, other companies began to manufacture and sell generic montelukast.(Id.¶ 86.)Plaintiffs allege that Defendants"engaged in an extensive campaign to educate physicians in California about the alleged benefits of Singulair" but misrepresented its safety in that campaign.(Id.¶ 19.)

Plaintiffs also allege that on March 4, 2020, the FDA required Defendants to add a Black Box Warning to Singulair's label and required a new medication guide.(Id.¶ 3.)The Black Box Warning states:

Serious neuropsychiatric events have been reported in patients taking Singulair.These include:

agitation, aggressive behavior or hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, dysphagia (stuttering), hallucinations, insomnia, irritability, memory impairment, obsessive-compulsive symptoms, restlessness, somnambulism, suicidal thoughts and behavior (including suicide), tic, and tremor . . . Psychiatric disorders: agitation including aggressive behavior or hostility, anxiousness, depressions, disorientation, dream abnormalities, hallucinations, insomnia, irritability, restlessness, somnambulism, suicidal thinking and behavior (including suicide), tremor [see Warnings and Precautions (5.4)].

(Id.¶ 4(emphasis in original)).The Black Box Warning also states that "the benefits of Singulair may not outweigh the risks, and the FDA issued a press release in which it stated that "many patients and health care professionals are not fully aware of these risks."(Id.)

Plaintiffs allege they were prescribed Singulair during various periods after 2012, which "were filled with branded and/or generic Singulair."²(Starr Compl.¶¶ 7-8;Skinner Compl.¶¶ 7-8;Gibson Compl.¶¶ 7-8.)According to Plaintiffs, if they or their physicians had known that Singulair "could cause [them] to suffer neuropsychiatric events, [their physicians] would not have prescribed Singulair," and they would not have ingested it.(StarrComp. ¶ 11;Skinner Compl.¶ 10;Gibson Compl.¶ 11.)Based on these and other allegations that the Court shall address as necessary, Plaintiffs assert the following claims for relief: Count I - strict liability (design defect); Count II - strict liability (failure to warn); Count III - negligence; Count IV - negligent misrepresentation; Count V - breach of express warranty; and Count VI - breach of implied warranty.

The Court will address additional facts as necessary in its analysis.

ANALYSIS

A.The Court Concludes It Has Personal Jurisdiction Over Defendants.

1.Applicable Legal Standards.

Defendants move to dismiss Plaintiffs' claims for lack of personal jurisdiction, under Federal Rule of Civil Procedure 12(b)(2).Due process requires that a defendant have "minimum contacts" with the forum state "such that the maintenance of the suit does not offend 'traditional notions of fair play and substantial justice.' "Int'l Shoe Co. v. Washington, 326 U.S. 310, 316, 66 S.Ct. 154, 90 L.Ed. 95(1945)(quotingMilliken v. Meyer, 311 U.S. 457, 463, 61 S.Ct. 339, 85 L.Ed. 278(1940)).The Court's focus when evaluating personal jurisdiction is on the "nature and extent of 'the defendant's relationship to the forum state.' "Ford Motor Co. v. Montana Eighth Judicial Dist. Ct., — U.S. —, 141 S.Ct. 1017, 1024, 209 L.Ed.2d 225(2021)(quotingBristol-Myers Squibb Co. v. Super. Ct. of California, 582 U.S. —, 137 S. Ct 1773, 1779, 198 L.Ed.2d 395(2017))("Ford");see alsoWalden v. Fiore, 577 U.S. 277, 290, 134 S.Ct. 1115, 188 L.Ed.2d 12(2014)("The proper question is not where the plaintiff experienced a particular injury or effect but whether the defendant's conduct connects him to the forum in a meaningful way.").

Plaintiffs argue the Court has specific jurisdiction over Defendants, which requires them to show: (1)Defendants purposefully directed their activities at California or purposefully availed themselves of California's laws; (2)Plaintiffs' claims arise out of or relate to Defendants' activities in California; and (3) exercising jurisdiction would be reasonable.See, e.g., Schwarzenegger v. Fred Martin Motor Co., 374 F.3d 797, 802(9th Cir.2004).In Ford, the Court addressed the meaning of the phrase "arise out of or relate to" and concluded that

[t]he first half of that standard asks about causation; but the back half, after the "or," contemplates that some relationships will support jurisdiction without a causal showing.That does not mean anything goes.In the sphere of specific jurisdiction, the phrase "relate to" incorporates real limits, as it must to adequately protect defendants foreign to a forum.But again, we have never framed the specific jurisdiction inquiry as always requiring proof of causation—i.e., proof that the plaintiff's claim came about because of the defendant's in-state conduct.

Ford, 141 S.Ct. at 1026.

Plaintiffs bear the burden of proving the first two prongs.Schwarzenegger, 347 F.3d at 802.If Plaintiffs...