Almond v. Janssen Pharm., Inc., CIVIL ACTION NO. 20-2183

LEONARD ALMOND, Plaintiff, v. JANSSEN PHARMACEUTICALS, INC.and JOHNSON & JOHNSON, Defendants.

CIVIL ACTION NO. 20-2183

UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA

November 6, 2020

OPINION

Plaintiff Leonard Almond was prescribed Elmiron, a medication designed, marketed, and distributed by Defendant Janssen Pharmaceuticals, Inc.¹ to treat his interstitial cystitis. Elmiron has been identified as a cause of pigmentary maculopathy, a medical condition that affects vision. Though Plaintiff does not allege that he has developed maculopathy as a consequence of using Elmiron, he contends Defendants' negligence has exposed him—and the people he seeks to represent as a class—to a higher risk of visual injury. Specifically, he alleges that Defendants negligently failed to conduct adequate safety testing, notify the Federal Drug Administration ("FDA") of the link between Elmiron and maculopathy, and alert consumers to the risks of taking the drug.

Plaintiff is seeking a declaratory judgment, pursuant to the Declaratory Judgment Act, 28 U.S.C. § 2201, et seq., that Elmiron is defective as it is unsafe for its intended use. He also demands that Defendants pay for ongoing medical monitoring of Plaintiff and prospective class members on the basis that early diagnosis achieved through a monitoring regime will lead tobenefits in treatment, management, rehabilitation, or mitigation of long term health consequences.

The Amended Complaint sets forth three separate putative classes—the "Proposed Illinois Class," the "Proposed Pennsylvania Class," and "the Proposed Nationwide Class"—each of which includes only people who "were prescribed and took Elmiron who are currently asymptomatic for pigmentary maculopathy and have not received a diagnosis of retinal toxicity due to Elmiron use." Defendants have filed a Motion to Strike only the Proposed Nationwide Class Allegations Under Federal Rules of Civil Procedure 23(d)(1)(D), 23(c)(1)(A), and 12(f).²

I. FACTS

A short foray into the alleged facts is necessary to put Plaintiff's claim into context. In 1996, the Food and Drug Administration ("FDA") approved Defendants' New Drug Application ("NDA") for Elmiron—otherwise known as pentosan polysulfate sodium—for use in treating interstitial cystitis. Beginning in 2018, however, a series of scientific studies identified long-term users of Elmiron who developed maculopathy, a medical condition that can result in significant vision loss. Multiple published studies recommended visual examinations to monitor Elmiron patients for drug toxicity that could result in maculopathy. Despite these studies that identified a link between Elmiron and maculopathy, Defendants "have made no change to [Elmiron's] label or taken any steps to warn the medical community and users of the drug regarding these risks," though Defendants "made label changes in other countries to warn ofthese injuries." The prescription label on Elmiron sold in the United States has never warned of a risk of maculopathy or vision loss.³

II. DISCUSSION

By Plaintiff's own account this is not a case where he is endeavoring to certify a nationwide class to be adjudicated under the various fifty state laws. Instead, he is seeking to certify a Proposed National Class in which each of the class members' claims are resolved under Pennsylvania law regardless of whether they live in Pennsylvania or elsewhere. He acknowledges that the parties' dispute over whether Pennsylvania law governs the Proposed National Class is a "purely legal issue" that can be resolved on a motion to strike.

Defendants agree that the matter to be decided here is one of law arguing that Pennsylvania's choice-of-law rules will necessarily require application of any one of each state's laws. The individualized factual and legal considerations, amplified by complex variations in state law, would, in Defendants' view, be fatal to the viability of class treatment of Plaintiff's medical monitoring claim.

Plaintiff acknowledges—as he must—that variations in state law pose significant hurdles "in certain context" to certification of nationwide classes. But, according to Plaintiff, this is not that context. Here, his argument, which is premised on the Pennsylvania Supreme Court's 2018 decision Danganan v. Guardian Prot. Servs., 179 A.3d 9 (Pa. 2018), is that Danganan by extension of its holding provides that a national class as proposed here is appropriate because both Pennsylvania residents and out of state plaintiffs can avail themselves of Pennsylvania lawwhen suing a Pennsylvania defendant. A closer analysis of Danganan and of Pennsylvania's choice-of-law rules, leads to the contrary conclusion. While Plaintiff's position is correct in some regards, it ignores a key component of the Pennsylvania Supreme Court's decision which ultimately requires the Court to conduct a choice-of-law analysis which analysis yields the result that variations in state law render the Proposed National Class uncertifiable under Federal Rule of Civil Procedure 23.

A. Danganan

In Danganan, a California resident sued Guardian Protection Services, a company headquartered in Pennsylvania, on behalf of himself and a putative nationwide class of persons. His contention was that Guardian's customer contracts—which it purported authorized continued billing of customers regardless of their cancellation attempts—violated Pennsylvania's Unfair Trade Practices and Consumer Protection Law ("UTPCPL"). 73 P.S. § 201-3, et seq. The agreement contained a choice-of-law provision which provided that the "Agreement shall be governed by the laws of Pennsylvania."

On a motion to dismiss the complaint, the federal district court in which the matter was pending held that the UTPCPL is restricted to protecting the rights of the citizens of Pennsylvania; that Guardian's headquarters in Pennsylvania did not establish a sufficient nexus between the out of state resident and Pennsylvania; and, that the choice-of-law provision in the consumer contract could not be employed to broaden the limited scope of the UTPCPL. Danganan, 179 A.3d at 11 (citing Danganan v. Guardian Prot. Servs., 2016 WL 3977488, at *3 (W.D. Pa. July 25, 2016)).

The matter was appealed to the U.S. Court of Appeals for the Third Circuit which certified two questions to the Pennsylvania Supreme Court: (1) "[w]hether a non-Pennsylvaniaresident may bring suit under the [UTPCPL], against a business headquartered in and operating from Pennsylvania, based on transactions which occurred outside of Pennsylvania?"; and, (2) "[i]f the UTPCPL does not allow a non-Pennsylvania resident to invoke its protections, whether the parties can, through choice-of-law provision, expand its protections to parties to the contract who are non-Pennsylvania resident consumers?" Id. at 11-12 (citing Danganan v. Guardian Prot. Servs., 170 A.3d 981 (Pa. 2017)).

With respect to the first question, the Pennsylvania Supreme Court focused on whether there was a textual basis in the statute for any geographical or residency limitations. Delving down into the plain meaning of the words "person," "commerce," and "trade" it decided that, by its terms, the UTPCPL does not contain any such limitations. Id. at 16. Accordingly, it held that "the Law's prescription against deceptive practices employed by Pennsylvania-based businesses may encompass misconduct that has occurred in other jurisdictions." Id. at 16-17.

Moving to the second certified question, the Court emphasized the distinction between a choice-of-law provision which "pertains to a contractual agreement between the parties as to which jurisdiction's laws will govern the parties' relationship," and which was the focus of the second certified question, and choice-of-law rules which "refer[] to the precepts used to select which jurisdiction's laws to apply in a lawsuit. . . ." Id. at 14 n.7. Finding the second question regarding the choice-of-law provision moot in light of its decision on the first question it thus did not address the issue of whether a choice-of-law provision could expand the reach of the UTPCPL. However, addressing Guardian's concern that its decision could be read to allow "any person around the globe" to file a cause of action under the UTPCPL, the Court specifically stated that it was not addressing how choice-of-law rules may limit the scope of the UTPCPL's reach in a given matter. Id. at 17 ("jurisdictional principles and choice-of-law rules" may offerlimitations to the reach of the UTPCPL). Indeed, any choice-of-law analysis would be left for the trial court to decide on remand "within the context of [the] specific litigation" before it. Id. (citing SUMMARY OF PA. JURISPRUDENCE 2d §1:10).

Thus, a close reading of Danganan establishes that "both Pennsylvania residents and out of state plaintiffs can avail themselves of Pennsylvania law when suing a Pennsylvania defendant." But, that principle does not necessarily extend beyond the particular statute at issue in Danganan—the UTPCPL—and does not mandate that a national class is appropriate here. Whether one is or is not must be decided by conducting a traditional choice-of-law-analysis.

B. Choice-of-Law Analysis

The choice-of-law rules of the forum state—here, Pennsylvania—apply to litigation before a federal court sitting in diversity. See Hammersmith v. TIG Ins. Co., 480 F.3d 220, 226 (3d Cir. 2007) (citing Klaxon v. Stentor Elec. Mfg. Co., 313 U.S. 487 (1941)). Under Pennsylvania's choice-of-law analysis rules, "courts first consider whether a true conflict exists between the two states. This is because in some instances the purported conflict is ultimately revealed to be a false conflict—meaning that the laws of both states would produce the same result, or that one of the states has no meaningful policy-based interest in the issue raised." Melmark, Inc. v. Schutt by & Through Schutt, 206 A.3d 1096, 1104 (Pa. 2019) (internal quotation marks and citations omitted). Accordingly, "the first...