Lyman v. Pfizer, Inc.

COLLEEN AND STEVE LYMAN Plaintiffs,

v. PFIZER, INC., WYETH, INC., SCHWARZ PHARMA, INC., TEVA PHARMACEUTICALS USA, INC., PLIVA USA, INC.,ACTAVIS-ELIZABETH, L.L.C. Individually and as a subsidiary of ACTAVIS, INC.and as successor TO PUREPAC PHARMACEUTICAL, INC, Defendants.

Case No. 2:09-cv-262

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF VERMONT

Dated: February 3, 2012

Opinion and Order

Plaintiffs Colleen and Steve Lyman have brought suit against the brand name and generic manufacturers of metoclopramide for injuries arising from Colleen Lyman's ingestion of the drug. They allege that the medication caused her to develop tardive dyskinesia, a severe neurological disorder causing involuntary repetitive tic-like movements. Following the United States Supreme Court's decision in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), Defendants Actavis Elizabeth LLC and PLIVA, Inc. (collectively "Generic Defendants") have moved for judgment on the pleadings pursuant to Federal Rule of Civil Procedure 12(c) contending that all claims against them are preempted by federal law. For the reasons that follow, the motion, ECF No. 182, is granted in part and denied in part.

I. Background

The Food and Drug Administration ("FDA") approved metoclopramide in tablet form for the treatment of gastrointestinal disorders under the brand name Reglan in 1980.¹ Generic manufacturers received approval to produce metoclopramide in 1985. According to the Lymans' Complaint, the Generic Defendants knew or should have known that the labeling for metoclopramide substantially understated the risk of developing tardive dyskinesia, particularly as a result of long-term use of the drug.

Warnings included in labeling for metoclopramide have been modified and strengthened over the years, in 1985, in 2004, and in 2009. Mensing, 131 S. Ct. at 2572-73. In 2004, the FDA approved a change to the label to add that "[t]herapy should not exceed 12 weeks in duration." Id. at 2573; see also Kellogg v. Wyeth, 612 F. Supp. 2d 421, 427 (D. Vt. 2008). In 2009, the FDA required the addition of a "black box warning," stating that "Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. . . . Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases." Mensing, 131 S. Ct. at 2573.

Colleen Lyman was prescribed and took metoclopramide from2003 until at least 2006. The Lymans filed suit against the name brand and generic manufacturers of metoclopramide on November 25, 2009. Their Complaint alleges claims against the Generic Defendants for negligence; strict liability; breach of an implied warranty of merchantability; breach of an implied warranty of fitness for a particular purpose; misrepresentation, suppression of evidence and fraud; and gross negligence. In their Statement of Facts, they assert that Colleen Lyman's injuries

came about as a foreseeable and proximate result of Defendants' dissemination of inaccurate, misleading, materially incomplete, false and otherwise inadequate information concerning the potential effects of exposure to and long-term ingestion of Reglan/metoclopramide to the medical community, Colleen Lyman, and other foreseeable users of the drug.

Compl. ¶ 3.19, ECF No. 1. In essence, the Lymans' claims arise from the Defendants' "failure to warn doctors and patients of information within their knowledge or possession which indicated that the subject Reglan/metoclopramide, when taken for long periods of time, caused serious, permanent and debilitating side effects, including tardive dyskinesia." Id. ¶ 3.22.

Specifically, the Lymans' Complaint alleges that the Generic Defendants disseminated false and misleading information about the risks of metoclopramide through their package inserts. Id. ¶¶ 3.67-69. They also allege that the Generic Defendants failed to review and report on adverse drug event information, relevant scientific literature and material safety information; and failedto conduct and report post-market safety surveillance on metoclopramide. Id. ¶¶ 3.72-77. They allege that the Generic Defendants knowingly concealed from physicians material facts pertaining to the risk of serious side effects resulting from use of the drug for longer than twelve weeks. Id. ¶¶ 3.78-81.

Within their negligence claim, the Lymans assert failure to exercise reasonable care in the design, manufacture, marketing and testing of metoclopramide, as well as failure to provide adequate warnings. Id. ¶¶ 4.02-03. In their strict product liability claim, the Lymans assert that metoclopramide was defective in design and marketing and unreasonably dangerous, and failure to provide adequate warnings rendered the drug "unreasonably dangerously defective as designed and marketed." Id. ¶ 4.08. The Lymans' breach of an implied warranty of merchantability claim asserts that metoclopramide was not merchantable as fit for safe use because, as designed, it was capable of causing serious injury as suffered by Colleen Lyman. Id. ¶ 4.11. Their breach of an implied warranty of fitness for a particular purpose asserts that they relied on the Generic Defendants' skill and judgment when purchasing metoclopramide, which was not fit for its particular purpose. Id. ¶ 4.14. Within their fraud and misrepresentation claim, the Lymans assert that the Generic Defendants made false material representations and omitted material information concerning the risk of seriouspermanent side effects, the inadequacy of testing, and the inadvisability of use for longer than twelve weeks. Id. ¶ 4.17-23. The Lymans also assert that the Generic Defendants' negligent acts or omissions amount to gross negligence, warranting exemplary damages. Id. ¶ 4.26-27.

On February 15, 2011, this Court granted a partial stay of proceedings in anticipation of a decision by the United States Supreme Court in the consolidated cases of Mensing v. Wyeth, Inc., 588 F.3d 603 (8th Cir. 2009), and Demahy v. Actavis, Inc., 593 F.3d 428 (5th Cir. 2010), rev'd sub nom. PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011). The Supreme Court issued its decision on June 23, 2011. See Mensing, 131 S. Ct. at 2567.

In PLIVA, Inc. v. Mensing, the United States Supreme Court held that federal law preempted state laws imposing a duty on generic drug manufacturers to provide adequate warning labels for their products. 131 S. Ct. at 2572, 2581. Like Colleen Lyman, the plaintiffs in the cases before the Court were prescribed and took generic metoclopramide. After taking the drug for several years, these women developed tardive dyskinesia. Id. at 2573. Their lawsuits alleged "that long-term metoclopramide use caused [their] tardive dyskinesia and that the [generic manufacturers] were liable under state tort law . . . for failing to provide adequate warning labels." Id.

The Mensing Court first identified a state tort duty towarn, that allegedly would require the generic manufacturers to use a stronger, safer label than the one approved by the FDA. The Court then summarized the different labeling requirements for brand-name and generic drug manufacturers, observing that under the Drug Price Competition and Patent Term Restoration Act of 1984,² a generic drug manufacturer "is responsible for ensuring that its warning label is the same as the brand name's." Id. at 2574.

The Supreme Court rejected the suggestions that generic drug manufacturers have opportunities to strengthen their warnings, either (1) through the FDA's "changes-being-effected" process, or (2) through the delivery of "Dear Doctor" letters to healthcare professionals. Id. at 2575-76. It assumed, without deciding, that generic drug manufacturers have a duty to propose that the FDA require stronger warning labels, but concluded that complying with such a duty would not satisfy a state-law duty to provide adequate labeling. Id. at 2576-78. Consequently, the Court concluded that it is impossible for generic manufacturers to comply both with state requirements to supply an adequate warning label and federal requirements that their labels be the same as the brand name's label. Id. at 2577-78. Given that the Supremacy Clause establishes that federal law prevails in casesof direct conflict with a state law, the Court held that the plaintiffs' failure to warn claims against the generic manufacturers were preempted. Id. at 2577, 2581.

In their motion, the Generic Defendants argue that Mensing requires dismissal of all of the Lymans' claims against them. The Lymans concede that they cannot pursue claims against the Generic Defendants for failure to add new or strengthened warnings to their labeling for metoclopramide that did not appear in the labeling for Reglan. Nevertheless, they argue that their complaint also alleges viable claims that the Generic Defendants failed to correct the label for metoclopramide to reflect that therapy with the drug should not exceed twelve weeks, actively concealed information that metoclopramide was not safe for long-term use, and failed to perform their duties to monitor and report information on the safety of metoclopramide to the FDA. These allegations, they contend, are not preempted.

II. Discussion

A. Rule 12(c) Motion

"'To survive a Rule 12(c) motion, [plaintiffs'] complaint must contain sufficient factual matter, accepted as true, to state a claim to relief that is plausible on its face.'" Hayden v. Paterson, 594 F.3d 150, 160 (2d Cir. 2010) (quoting Johnson v. Rowley, 569 F.3d 40, 44 (2d Cir. 2009) (per curiam)). The Court accepts as true all well-pleaded factual allegations, and drawsall reasonable inferences in plaintiffs' favor. L-7 Designs, Inc. v. Old Navy, LLC, 647 F.3d 419, 429 (2d Cir. 2011).

In considering a motion for judgment on the pleadings, a court may first identify pleadings that, being no more than conclusions, are not entitled to the presumption of truth. Id. at 430; see Ashcroft v. Iqbal, 129 S. Ct. 1937, 1950 (2009). Assuming the truth of...