What could be more complicated than explaining why an attorney’s errors doomed a generic drug defect products liability case, based upon medical malpractice in the prescribing of the generic allegedly defective drug in which there were nationwide class actions and federal preemption claims?

Schwartz v Oshman & Mirisola, LLP 2024 NY Slip Op 31592(U) May 3, 2024 Supreme Court, New York County Docket Number: Index No. 155780/2023 Judge: Dakota D. Ramseur was dismissed, in part, for failure to explain it all in a way that convinced the judge.

“In or around 2001, Dr. Steven Rubin started prescribing plaintiff Reglan (the brand drug of metoclopramide) or a generic version of the drug manufactured by PLIVA, Inc. to treat her gastroparesis. Metoclopramide was first approved by the Food and Drug Administration (“FDA”) in 1980 pursuant to a New Drug Application (“NDA”) as a “short-term (4-12 weeks) therapy for adults with symptomatic documented gastroesophageal reflux who fail to respond to conventional therapy.” (See NYSCEF doc. no. 15, 1987 Physicians’ Desk Reference for Reglan; NYSCEF doc. no. 17 at 26, Dr. David Feigal Expert Report dated 10/11/2019.) In 1988, the FDA approved PLIVA’s Abbreviated New Drug Application (“ANDA”) to manufacture a generic metoclopramide. To be approved pursuant to an ANDA, the generic drug must be bioequivalent to the FDA-approved brand drug, the administration, dosage form, and strength of the generic must be identical, and the information contained on its label must be the same. (NYSCEF doc.
no. 17 at 16.)

Since Reglan was first approved by the FDA, its brand label/package insert has contained a warning that using metoclopramide could cause tardive dyskinesis, a neurological disorder that is potentially irreversible and causes the individual to suffer involuntary, repetitive movements. Specifically, the label warned that “[b]oth the risk of developing the syndrome and the likelihood that it will become irreversible are believed to increase with the duration of treatment and the total cumulative dose.” (NYSCEF doc. no. 15.) In addition, the section of the label entitled “Doses and Administration” warns that “[t]herapy longer than 12 weeks has not been evaluated and cannot be recommended.” (Id.) There is no dispute that PLIVA’s generic drug label contained these two warnings throughout the entire period of time that plaintiff was taking this
medication. In 2004, the FDA approved a change in the Reglan label as applied for by the owner of its NDA. The language added to the “Indication and Usage” section states, “the use of Reglan tablets is recommended for adults only. Therapy should not exceed 12 weeks in duration.” (NYSCEF doc. no. 17 at 24.) Similar language was also included in the “Doses and Administration” section. Even though the changes were made to Reglan, PLIVA did not update its generic drug’s label/package insert to reflect the FDA-approved changes.

Litigation Against Metoclopramide Makers
In 2009, the FDA required both Reglan and generic metoclopramide manufacturers to
include a “black box warning” that the use of the drug could cause tardive dyskinesia if taken for longer than 12 weeks. Thereafter, plaintiffs throughout the country brought class action suits in various state courts, alleging that the makers metoclopramide had undersold the risk of significant neurological disorders in taking metoproclamide. In Pliva, Inc. v Mensing (564 U.S. 604 [2011]), the Supreme Court found that these plaintiffs’ state-law claims against generic manufacturers were preempted by federal law under the Supremacy Clause to the extent that state-law failure-to-warn statutes required generic drugs to provide more stringent, safer warning labels. To the Court, since generic drug manufactures are required by FDA regulations to maintain identical labels as their brand counterparts, it would be impossible for them to change its label (even to strengthen a warning) in response to state-law tort suits. (Id. at 618-619.) In In
Re Reglan Litigation, the New Jersey Supreme Court found that the class claims of nearly 1,000 users of generic metoclopramide manufacturers were not preempted as in Mensing because the generic manufacturers like PLIVA had not, in fact, matched their labels to that of the brand. (226 N.J. 315, 335-338 [2016].)

The Underlying Claims and Present Action
In her complaint, plaintiff alleges that, in 2009, she approached defendants to represent her in litigation against the makers of Reglan/Metoclopramide after she started suffering from neurological disorders including tardive dyskinesis due to her longtime use of the drug from 2001 to 2009. (NYSCEF doc. no. 1 at ¶ 10, 14; NYSCEF doc. no. 21, plaintiff’s medication history.) She alleges that she joined a class action against both Reglan and the generic manufacturers. As a class member, she acknowledges that she was a part of a global settlement against the brand maker of Reglan (NYSCEF doc. no. 1 at ¶¶ 25,75, 115) but alleges that she was pressured by defendants into opting out of the settlement with PLIVA—one of only eight individuals (out of approximately 6,000) to do so (id. at ¶ 26-28.) In her affidavit, she avers that
defendants informed her they would no longer represent her if she did not opt out and that they would have a chance of a greater recovery if she did. (NYSCEF doc. no. 33 at ¶ 4, Schwartz affidavit.)”

“In the instant action, plaintiff alleges that defendants committed malpractice in failing to oppose PLIVA’s summary judgment motion (NYSCEF doc. no. 1 at ¶ 47, 51, 86, 96, and 124) and to timely file a motion to vacate (id. at ¶ 42, 48, 87, 97, 125). In addition, in her opposition to this motion, plaintiff indicates that, if defendants were aware that she could not win her case against PLIVA (the position that defendant’s take in this motion), then it was also malpractice for them to advise her to opt out of the global settlement against PLIVA in the first place. (See NYSCEF doc. no. 27 at ¶ 5-7.)

In this motion sequence, defendants move to dismiss plaintiff’s complaint pursuant to
CPLR 3211 (a) (1) and (a) (7), arguing that plaintiff cannot establish that their conduct was the proximate cause of any loss she sustained since, in their view, she cannot demonstrate—for numerous reasons—that she would have obtained a favorable judgment against PLIVA in the underlying action. Plaintiff’s opposition, as will be discussed below, does little if anything to refute this argument; instead, plaintiff essentially contends that it is premature to dismiss her claim pre-answer since no discovery has been taken and plaintiff is allegedly not in possession of her entire file from defendants. (See NYSCEF doc. no. 27 at ¶ 37, 50, 54, 55.) Since this
argument has no merit, the Court must dismiss plaintiff’s complaint.”