ALLEN v. JANSSEN PHARMACEUTICALS INC.

CourtDistrict Court, E.D. Pennsylvania
DecidedNovember 6, 2020
Docket2:20-cv-02183
StatusUnknown

This text of ALLEN v. JANSSEN PHARMACEUTICALS INC. (ALLEN v. JANSSEN PHARMACEUTICALS INC.) is published on Counsel Stack Legal Research, covering District Court, E.D. Pennsylvania primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
ALLEN v. JANSSEN PHARMACEUTICALS INC., (E.D. Pa. 2020).

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA

LEONARD ALMOND, CIVIL ACTION Plaintiff,

v.

JANSSEN PHARMACEUTICALS, INC. and JOHNSON & JOHNSON, NO. 20-2183 Defendants.

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 to

1 Janssen, a Pennsylvania corporation with its principal place of business in Pennsylvania, is a wholly-owned subsidiary of Defendant Johnson & Johnson, a New Jersey corporation with its principal place of business in New Jersey. Plaintiff Almond is a citizen and resident of Pennsylvania. benefits 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 of

2 Defendants do not seek to strike the class allegations that pertain to the Proposed Pennsylvania Class. And, with respect to the Proposed Illinois Class, shortly before the issuance of this opinion Plaintiff opted not to proceed with the Illinois class allegations in light of a recent case of the Supreme Court of Illinois holding that an Illinois plaintiff cannot bring a negligence action for medical monitoring based only on increased risk of injury. See Berry v. City of Chicago, 2020 IL 124999, __ N.E.3d __ (Ill. 2020).

2 these 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 law

3 Plaintiff’s brief in opposition to the pending motion asserts that Defendants did, in fact, update the labeling for Elmiron to warn of potential vision damage, but only after the first lawsuit asserting claims against Defendants for their role in the distribution of Elmiron was filed in 2020. Defendants’ motion papers assert that, to the contrary, Janssen sought permission from the FDA to update the label in 2019. This factual dispute is outside of the scope of the present motion. 3 when 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.

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ALLEN v. JANSSEN PHARMACEUTICALS INC., Counsel Stack Legal Research, https://law.counselstack.com/opinion/allen-v-janssen-pharmaceuticals-inc-paed-2020.