Nelson v. F. Hoffmann-La Roche, Inc.

642 F.Supp.3d 1115

John NELSON, Plaintiff, v. F. HOFFMANN-LA ROCHE, INC., et al., Defendants.

Case No. 21-cv-10074-TLT

United States District Court, N.D. California

Signed November 28, 2022

Benjamin Widlanski, Pro Hac Vice, Kozyak Tropin & Throckmorton, Miami, FL, David J. Todd, Moore & Lee, LLP, McLean, VA, Erica W. Rutner, Pro Hac Vice, Moore & Lee, LLP, Fort Lauderdale, FL, Gail A. McQuilkin, Pro Hac Vice, Kozyak Tropin & Throckmorton, Coral Gables, FL, Yano Lee Rubinstein, Rubinstein Law Limited, San Francisco, CA, for Plaintiff.

Kathryn Elizabeth Cahoy, Covington & Burling LLP, Palo Alto, CA, for Defendant F. Hoffmann-La Roche, Inc.

Kathryn Elizabeth Cahoy, Covington & Burling LLP, Palo Alto, CA, Andrew J. Soukup, Emily Sarah Ullman, Pro Hac Vice, Covington and Burling LLP, Washington, DC, Matthew Quinn Verdin, Covington & Burling LLP, San Francisco, CA, for Defendants Roche Laboratories, Inc., Genentech, Inc., Genentech USA, Inc.

Andrew J. Soukup, Covington and Burling LLP, Washington, DC, Kathryn Elizabeth Cahoy, Covington & Burling LLP, Palo Alto, CA, Matthew Quinn Verdin, Covington & Burling LLP, San Francisco, CA, for Defendant Hoffmann-LaRoche Inc.

ORDER GRANTING DEFENDANTS' MOTION TO DISMISS PLAINTIFF'S COMPLAINT

Re: ECF Nos. 54-56, 60-66, 71

TRINA L. THOMPSON, United States District Judge

Pending before the Court is a motion to dismiss pursuant to the Federal Rules of Civil Procedure 12(b)(1) and 12(b)(6) filed by Defendants F. Hoffman-La Roche, Inc., Roche Laboratories, Inc., Genentech, Inc. and Genentech USA, Inc. The motion came on regularly for hearing before the Court on November 15, 2022. Upon consideration of the parties' submissions and the arguments of counsel, the Court finds that Plaintiffs' claims may not be adjudicated under California law. Accordingly, defendants' motion to dismiss is GRANTED.

I. BACKGROUND

A. Plaintiff John Nelson

Plaintiff filed his first amended medical monitoring class action complaint against Defendants based on allegations that they failed to warn of the substantial and irreversible dangers of certain antimalarial drugs. ECF No. 43, First Amend. Complaint ("FAC"). The complaint further asserts that, as a result of Defendants' alleged tortious and fraudulent conduct, Plaintiff sustained, and continues to sustain, neuropsychiatric side effects. Id., para. 6. Plaintiff brings causes of action for (1) negligent failure to warn; (2) negligent design; (3) strict liability failure to warn; (4) strict liability design defect; (5) negligent misrepresentation; and (6) fraudulent misrepresentation.

Plaintiff entered the U.S. military in 2005, and throughout his service, he was a citizen of Kentucky, Oregon, and Tennessee. Id., para. 12. He is currently a citizen of Florida. Id. The plaintiff was deployed to Afghanistan in February 2008 and the military prescribed him Mefloquine—a generic version of Defendants' drug, Lariam. He started ingesting the generic medication two weeks before. Id., paras. 17, 72. At the time of his first dose, in early February, Plaintiff was residing on a miliary base in Kentucky. Thereafter, he took Mefloquine once per week while in Afghanistan until April 2009. Id., paras. 69, 71-72. Plaintiff claims that he started experiencing symptoms immediately after his first dose of Mefloquine in 2008. Id., para. 73.

Plaintiff was placed into military retirement and was honorably discharged in 2015. Id., para. 79. He then moved to Oregon for five years, and thereafter lived in Tennessee for one to two years. Plaintiff moved to Florida in 2019 where he is a current resident. Id., para. 12.

B. Lariam and Mefloquine

Researchers affiliated with the Walter Reed Army Institute of Research reported the initial synthesis of Mefloquine in the late 1960's. Id., para. 19. The military transferred its intellectual property rights of the drug to Defendant Roche, Ltd.¹ Id. In 1989, Defendant Hoffman-La Roche Inc. ("Roche, Inc.") applied for and obtained approval for Mefloquine under the brand name Lariam from the U.S. Food and Drug Administration ("FDA"). Id., para. 20. Roche, Inc. was the official holder of the New Drug Application for Lariam until 2002. Id. paras. 21, 23.

Roche, Ltd. subsequently manufactured Lariam. Id. para. 14. Defendant Roche Laboratories was listed on Lariam's FDA labelas its distributor. Id. para. 14. As the distributor, Roche Laboratories marketed and sold Lariam to the Defense Logistics Agency ("DLA"), an agency within the U.S. Department of Defense. Id., para. 22.

In 2002, Roche, Ltd., Roche, Inc. and Roche Laboratories (collectively the "Roche entities") lost the exclusive rights to Mefloquine. During the same year, generic manufacturers began to manufacture, distribute, and sell generic Mefloquine. Id., paras. 23, 29. The Roche entities continued to market and manufacture Lariam until 2005. Id., para. 29; see also Motion, 3. The last lots of Lariam were manufactured in 2005 and expired in 2008. FAC, paras. 14-15, 24.

The Roche entities merged with Genentech, Inc. and Genentech USA, Inc. in March 2009. Id., para. 15. Genentech USA, Inc. is a subsidiary of Genentech, Inc. and Genentech, Inc. is a subsidiary of the Roche entities. Id., paras. 15-16. Roche's U.S. marketing authorization for Lariam was officially withdrawn several months after the merger. Id., paras. 14-15, 25.

In July 2013, the FDA started requiring that Mefloquine be labeled with a black-box warning, its strictest form of warning. Id., paras. 5, 37. The new warning advised of "the potential for development of neurologic and psychiatric adverse reactions in patients using the drug" and that Mefloquine's neurologic side effects "can last for months to years after the drug is stopped or can be permanent." Id., paras. 38-37. After the FDA's change to the warning label on Mefloquine, the military re-designated Mefloquine as a drug of last resort to be taken only after other malaria prevention drugs were found to be ineffective. Id., para. 40.

Plaintiff experienced neuropsychiatric side effects after taking Mefloquine which presently continue. He did not learn about the medical literature supporting a causal link between Mefloquine and his symptoms until February 2020. Id., para 7. As a consequence, Plaintiff underwent medical evaluations and test to determine the cause of his symptoms. Id. "It is currently believed that Plaintiff[']s symptoms are attributed to Mefloquine, however he is still undergoing further medical evaluation necessary to provide a proper diagnosis." Id. Plaintiff alleges that, by 1994, "Defendants knew or should have known that these adverse reactions were permanent and irreversible." Id., para. 3.

The generic form of Mefloquine is still on the market today and the military continues to prescribe it as a drug of last resort. Id., paras. 14, 40.

II. JURISDICTION

This Court has diversity jurisdiction pursuant to 28 U.S.C. § 1332(a). Plaintiff is a resident of Florida. Roche, Inc. is incorporated under the laws of New Jersey. Id., para. 13. Roche Laboratories, Genentech, Inc. and Genentech USA, Inc. are Delaware corporations. As of March 2009, the headquarters for Defendants are in California. Id., paras. 14-16.

This Court has jurisdiction under 28 U.S.C. § 1332(d) as plaintiff alleges a class action with the matter in controversy exceeding the sum or value of $5,000,000. Id., para. 9.

III. REQUEST FOR JUDICIAL NOTICE

As a preliminary matter, the Court GRANTS IN PART and DENIES IN PART Defendants' request for judicial notice.² ECF No. 56, 64.

The Court may take judicial notice of matters that are either "generally known within the trial court's territorial jurisdiction" or "can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned." Fed. R. Evid. 201(b). Judicial notice is appropriate for facts "not subject to reasonable dispute." Id.; Lee v. City of Los Angeles, 250 F.3d 668, 690 (9th Cir. 2001).

As a general rule, on a motion to dismiss under Federal Rule of Civil Procedure 12(b)(6), a court may not consider matters outside the complaint. See Hal Roach Studios, Inc. v. Richard Feiner & Co., 896 F.2d 1542, 1555 n. 19 (9th Cir. 1989). As an exception to the general rule, however, a court may consider documents referenced in the complaint that are "central" to the claims, and as to which no party questions the authenticity of the copies provided. See Knievel v. ESPN, 393 F.3d 1068, 1076 (9th Cir. 2005).

A. Exhibits 1-3

Defendants request that the Court take judicial notice of the FDA-approved labels for Lariam and generic Mefloquine from 1989, 2002, and 2013. A court may consider documents "whose contents are alleged in a complaint and whose authenticity no party questions," despite such documents not being physically attached to the pleadings. Id. The policy concern underlying such a rule is to "[p]revent[ ] plaintiffs from surviving a Rule 12(b)(6) motion by deliberately omitting references to documents upon which their claims are based." Abrego Abrego v. Dow Chem. Co., 443 F.3d 676, 681 (9th Cir. 2006).

Exhibits 1 through 3 are incorporated by reference in Plaintiff's amended complaint. FAC, paras. 14, 20, 37-39, 44. Plaintiff did not oppose Defendants' request as to these exhibits so the court GRANTS Defendants' request as to Exhibits 1 through 3.

B. Exhibit 4-5

Exhibits 4 and 5 include a copy of the Center for Disease Control and Prevention webpage titled "FDA Revises Mefloquine Labeling; Drug Still Recommended," dated October 29, 2020 and a copy of FDA's webpage titled "FDA Drug Safety Communication: FDA approves label changes for antimalarial drug mefloquine hydrochloride due to risk" dated July 29, 2013.

The Court may take judicial notice of public documents, records, and reports of government bodies. Barron v. Reich, 13 F.3d 1370, 1377 (9th Cir. 1994). Judicial notice may be taken of publications introduced to "indicate what was in the public realm at the time, not whether the contents of those articles were in fact...