Gardley-Starks v. Pfizer, Inc., Civil Action No. 4:10–CV–099–SA–JMV.

• Decision Date: 10 January 2013
• Docket Number: Civil Action No. 4:10–CV–099–SA–JMV.
• Citation: 917 F.Supp.2d 597
• Parties: Lirlene GARDLEY–STARKS, Plaintiff v. PFIZER, INC., et al., Defendants.
• Court: U.S. District Court — Northern District of Mississippi

917 F.Supp.2d 597

Lirlene GARDLEY–STARKS, Plaintiff

v.PFIZER, INC., et al., Defendants.

Civil Action No. 4:10–CV–099–SA–JMV.

United States District Court,

N.D. Mississippi,

Greenville Division.

Jan. 10, 2013.

Terrence Joseph Donahue, Jr., McGlynn Glisson & Mouton, Baton Rouge, LA, Christopher Paul Williams, Gerald J. Diaz, Jr., James Russell Segars, III, The Diaz Law Firm, PLLC, Madison, MS, Edward Blackmon, Jr., Blackmon & Blackmon, Canton, MS, for Plaintiff.

John Simeon Hooks, Adams and Reese, Ridgeland, MS, Leigh Davis Vernon, Walter T. Johnson, Watkins & Eager, Eugene R. Naylor, Wise, Carter, Child & Caraway, J. Carter Thompson, Jr., Baker, Donelson, Bearman & Caldwell, Charles R. Wilbanks, Jr., Wells, Moore, Simmons & Neeld, Jackson, MS, Habib Nasrullah, Wheeler Trigg & Kennedy, PC, Andrew Myers, Stephanie Reedy, Wheeler Trigg O'Donnell LLP, Denver, CO, for Defendants.

MEMORANDUM OPINION

SHARION AYCOCK, District Judge.

In this diversity action, PlaintiffLirlene Gardley–Starks asserts numerous causes of action under Mississippi law, arguing that her ingestion of the prescription drug metoclopramide caused her to develop a neurological disorder known as tardive dyskinesia.Before the Court is a Motion for Summary Judgment[81] filed by DefendantSchwarz Pharma, Inc., and a Motion for Partial Summary Judgment[83]¹ filed by DefendantsPfizer, Inc., and Wyeth Inc.(collectively, the “Brand Defendants”).Also before the Court is a Joint Motion to Dismiss for Failure to State a Claim[111] filed by DefendantsActavis Elizabeth, LLC; McKesson Corporation; Northstar RX, LLC; and PLIVA, Inc.(collectively, the “Generic Defendants”).

FACTS & PROCEDURAL HISTORY

Metoclopramide is a prescription drug approved by the FDA for short term treatment of gastroesophageal reflux disease and diabetic gastroparesis.The FDA approved metoclopramide in 1980 under the brand name Reglan.In 1985, generic drug manufacturers began producing metoclopramide.Brand name Reglan was manufactured by Defendant Wyeth ² from 1989 to 2001.Defendant Schwarz acquired the rights to Reglan in December 2001, and manufactured and distributed the drug until 2008.The Generic Defendants, beginning in the mid–1980s, manufactured, sold and distributed generic metoclopramide.

Long term use of metoclopramide can cause a serious and permanent neurological condition known as tardive dyskinesia.In 1985, the drug's label was modified to warn that “tardive dyskinesia ... may develop in patients treated with metoclopramide,” and the drug's package insert added that “[t]herapy longer than 12 weeks has not been evaluated and cannot be recommended.”In 2003, another labeling change was approved regarding metoclopramide use in geriatric patients.In 2004, the label was again changed to add that “[t]herapy should not exceed 12 weeks in duration.”In 2009, the FDA ordered a boxed warning on metoclopramide—its strongest—which states: “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.”Plaintiff alleges that Defendant PLIVA, a generic manufacturer, never updated its product labeling to reflect the 2003 and 2004 changes.

Between 2002 and 2008, Plaintiff was prescribed metoclopramide to treat her acid reflux, ulcers, and heartburn.Plaintiff alleges that her prescribing doctor relied upon information published in the package inserts for the drug and/or information published in the Physicians' Desk Reference (PDR).Plaintiff alleges that as a result of her long-term use of metoclopramide, she developed tardive dyskinesia.Plaintiff commenced the instant suit on August 9, 2010.

On February 28, 2011, this Court held a case management conference and stayed the case pending the United Supreme Court's decision in PLIVA, Inc. v. Mensing,––– U.S. ––––, 131 S.Ct. 2567, 180 L.Ed.2d 580(2011).Mensing was decided on June 23, 2011, and as will be discussed more fully below, held that respondents' state-law failure to warn claims against generic manufacturers were preempted by federal law.Id. at 2572–73.

On August 3, 2011, the Court lifted the stay to allow limited discovery regarding the issue of product identification.That discovery revealed that Plaintiff ingested generic metoclopramide manufactured by ESI Lederle, Northstar, PLIVA, and Purepac; however, there is no evidence that Plaintiff ever ingested brand name Reglan.

Thereafter, Defendants filed dispositive motions.The Brand Defendants argued that they were entitled to summary judgment due to the fact that Plaintiff never ingested brand name Reglan.The Generic Defendants sought judgment on the pleadings, asserting that Plaintiffs claims were preempted in light of Mensing.In response, Plaintiff filed a motion for leave to file an amended complaint, which was granted.On April 12, 2012, Plaintiff filed her first amended complaint, alleging that:

This case involves Defendants' failure to warn physicians that use of metoclopramide should not exceed 12 weeks in duration ... their sale of a defective product, their breach of express and implied warranties, and their negligence in continuing to market and sell Reglan/metoclopramide without complying with federal and state laws designed to protect consumers and in spite of their knowledge that numerous physicians were engaging in dangerous prescribing practices likely to result in injury to those who consumed the drug.

Plaintiff asserts the following claims under Mississippi law: (1) negligence, (2) strict liability, (3) breach of warranties, (4) misrepresentation, fraud, and suppression of evidence, and (5) gross negligence.

DISCUSSION

I.Brand Defendants

The Brand Defendants argue that, because it is undisputed that the Plaintiff never ingested their product (brand name Reglan), they are entitled to summary judgment.The Court agrees.

A.Summary Judgment Standard

“The court shall grant summary judgment if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.”Fed.R.Civ.P. 56(a).“An issue of material fact is genuine if a reasonable jury could return a verdict for the nonmovant.”Agnew v. Wash. Mut. Fin. Group, LLC,244 F.Supp.2d 672, 675(N.D.Miss.2003)(citingAnderson v. Liberty Lobby, Inc.,477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202(1986)).

“A party asserting that a fact cannot be or is genuinely disputed must support the assertion by: (A) citing to particular parts of materials in the record, including depositions, documents, electronically stored information, affidavits or declarations, stipulations (including those made for purposes of the motion only), admissions, interrogatory answers, or other materials; or (B) showing that the materials cited do not establish the absence or presence of a genuine dispute, or that an adverse party cannot produce admissible evidence to support the fact.”Fed. R. Civ. P. 56(c)(1).“Conclusional allegations and denials, speculation, improbable inferences, unsubstantiated assertions, and legalistic argumentation do not adequately substitute for specific facts showing a genuine issue for trial.”Oliver v. Scott,276 F.3d 736, 744(5th Cir.2002).

The Court is not to weigh the evidence or engage in credibility determinations.Anderson,477 U.S. at 249, 106 S.Ct. 2505;Deville v. Marcantel,567 F.3d 156, 164(5th Cir.2009).“[T]he court must view the facts in the light most favorable to the non-moving party and draw all reasonable inferences in its favor.”Deville,567 F.3d at 164.

B.Analysis

The Brand Defendants argue that no matter how Plaintiff labels her claims, they are ultimately products liability claims, and because it is undisputed that Plaintiff never ingested a Brand Defendant product, her claims fail as a matter of law.Plaintiff responds that it is immaterial whether Plaintiff actually ingested name brand Reglan.Instead, she contends that her injury is due to her physician's reliance on false and misleading information disseminated by the Brand Defendants.Plaintiff asserts that she may still pursue claims against the Brand Defendants sounding in common law negligence and misrepresentation.³

By federal law, the manufacturer of a generic version of a drug must use the same label as that approved for the brand name drug.SeeMensing,131 S.Ct. at 2574, 180 L.Ed.2d 580.Plaintiff argues that, because the manufacturers of generic metoclopramide are required to use a warning label identical to that approved for brand name Reglan, and that physicians rely upon the Brand Defendants' label when prescribing metoclopramide, regardless of whether a prescription is ultimately filled with a generic product, the Brand Defendants owe a duty of care towards the consumers of generic formulations of metoclopramide.The Brand Defendants respond that all of plaintiffs claims, however styled, must fail as it is undisputed that plaintiff never consumed brand name Reglan.Moreover, the Brand Defendants argue that no duty to warn the users of a competitor's product exists under Mississippi law.

The Mississippi Products Liability Act (“MPLA”) provides in pertinent part, that:

(a) The manufacturer or seller of the product shall not be liable if the claimant does not prove by the preponderance of the evidence that at the time the product left the control of the manufacturer or seller:

(i) 1.The product was defective because it deviated in a material way from the manufacturer's specifications or from otherwise identical units manufactured to the same manufacturing specifications, or

2.The product was defective because it failed to contain adequate warnings or instructions, or

3.The product was designed in a defective manner, or

4.The product breached an express warranty or failed to conform to express factual representations upon which the claimant justifiably relied in electing to use...