Meade v. Parsley

SHIRLEAN MEADE and ELMER MEADE, Plaintiffs,

v. DEIDRE E. PARSLEY, D.O.; WYETH, INC., doing business as Wyeth;SCHWARZ PHARMA, INC.; PLIVA, INC.; and JOHN DOE DEFENDANTS #1-6 Defendants.

Civil Action No. 2:09-cv-00388

UNITED STATES DISTRICT COURT

SOUTHERN DISTRICT OF WEST VIRGINIA

AT CHARLESTON

Date: November 24, 2010

MEMORANDUM OPINION AND ORDER

Pending is defendant PLIVA, Inc.'s ("PLIVA") motion to dismiss based on federal preemption and its motion for summary judgment, both filed September 10, 2010.

I. Factual Background

This action arises out of PLIVA's alleged failure to warn plaintiff Shirlean Meade ("Mrs. Meade") of the potential adverse side-effects of the drug metoclopramide. PLIVA manufactures, labels, sells, and distributes metoclopramide, the generic equivalent of the brand name drug Reglan.¹ (Compl. ¶ 12). Since its approval by the Food and Drug Administration ("FDA") in 1980, metoclopramide has been widely used to treat gastroesophageal reflux disease ("GRD"), nausea, and gastroparesis. (Pl.'s Resp., Ex. 18).

On January 18, 2006, defendant Dr. Deidre Parsley prescribed metoclopramide to Mrs. Meade in order to treat her GRD, nausea, and loss of appetite. (Def.'s Mot. Summ. J., Ex. 2, Williamson Memorial Hospital Records, 5MEADE00031; Compl. 5 34). Mrs. Meade continued taking metoclopramide until February 2007. (Def.'s Mem. Supp. Mot. Summ. J. 5). The parties do not dispute that PLIVA manufactured the metoclopramide ingested by Mrs. Meade.

It is undisputed that, during the period when Mrs. Meade used the drug, PLIVA's metoclopramide packages included package inserts that contained the following warnings:

Under the heading "DOSAGE AND ADMINISTRATION"

Therapy longer than 12 weeks has not been evaluated and cannot be recommended.

Under the heading "INDICATIONS AND USAGE" and the subheading "Symptomatic Gastroesophageal Reflux"

Metoclopramide tablets are indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy.

Under the heading "WARNINGS" and the subheading "Tardive Dyskinesia":

Tardive Dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with metoclopramide. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to predict which patients are likely to develop the syndrome. Both 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.

Less commonly, the syndrome can develop after relatively brief treatment periods at low doses; in these cases, symptoms appear more likely to be reversible.

There is no known treatment for established cases of tardive dyskinesia although the syndrome may remit, partially or completely, within several weeks-to-months after metoclopramide is withdrawn.

Metoclopramide itself, however, may suppress (or partially suppress) the signs of tardive dyskinesia, thereby masking the underlying disease process. The effect of this symptomatic suppression upon the long term course of the syndrome is unknown. Therefore, the use of metoclopramide for the symptomatic control of tardive dyskinesia is not recommended.

(See Pl.'s Resp., Ex. 5, metoclopramide tablets label, 2; Def.'s Mem. Supp. Mot. Summ. J. 14).

Mrs. Meade, who is 77 years of age, filled her metoclopramide prescriptions at the Sav-Rite Pharmacy in Kermit, West Virginia. (Id.). She never read any written materials accompanying her metoclopramide prescriptions. (Def.'s Mot. Summ. J., Ex. 11, Meade Dep. 86-87). Dr. Parsley likewise did not read PLIVA's metoclopramide package insert or any other written materials produced by PLIVA before prescribing the drug to Mrs. Meade.² (Id., Ex. 16, Dr. Parsley Dep. 191-95). Dr. Parsley did, however, read the Physician's Desk Reference ("PDR") for Reglan, which contained the same warnings as the PLIVA metoclopramide package insert. (See id., Dr. Parsley Dep. 194; Pl.'s Resp. 12).

Between February 2007 and February 2008, Mrs. Meade began experiencing involuntary facial tremors. (Pl.'s Resp., Ex. 2, Dr. Patnaik Dep. 58). Although several physicians observed these tremors, the first doctor to diagnose Mrs. Meade with metoclopramide-induced tardive dyskinesia was Dr. Douglas Deitch, a neurologist. Based on his two examinations of Mrs. Meade — one in December 2008 and another in March 2009--Dr. Deitch testified as follows:

Q. Okay. Now, based on your two visits with Mrs. Meade, did you ever make any type of diagnosis of her involuntary movement disorder?

A. Well, other than what I've stated as far as the tardive dyskinesia.

Q. Did you determine a cause for her tardive dyskinesia?

A. Well, I felt it was secondary to the Reglan [metoclopramide] she used in the past.

(Pl.'s Resp., Ex. 1, Dr. Deitch Dep. 17). Dr. Deitch also ruled out other potential causes of Mrs. Meade's symptoms:

Q. Now, were there any things you were able to rule out in regard to Mrs. Meade's tardive dyskinesia?

A. Well, yeah, I ruled out stroke, I ruled out aneurysm, I ruled out brain tumor, I ruled out Parkinson's disease, those things.

(Id. 19).

On February 26, 2009, the FDA required manufacturers of metoclopramide to insert a black box warning on the drug's labeling that would "alert physicians of the risk of tardive dyskinesia with chronic use of metoclopramide." (Pl.'s Resp., Ex. 7, Letter from Public Health Service, Food and Drug Administration, 2). PLIVA complied with this directive and changed its metoclopramide package insert accordingly. (Def.'s Reply 10). The black box warning states as follows:

WARNING: TARDIVE DYSKINESIA

Chronic treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with the duration of treatment and the total cumulative dose. The elderly, especially elderly women, are most likely to develop this condition.

Metoclopramide therapy should routinely be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia; however, in some patients symptoms may lessen or resolve after metoclopramide treatment is stopped.

Prolonged treatment (greater than 12 weeks) with metoclopramide should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risks to the patient of developing tardive dyskinesia.

By way of comparison, the PLIVA package insert noted that the risks of usage increased with the duration of treatment and total dosage, that metoclopramide is indicated as short term (4 to 12 weeks) therapy for GRD, and that usage beyond 12 weeks has not been evaluated and is not recommended. The 2009 FDA warning is somewhat more specific as to duration of use by directing that prolonged treatment greater than 12 weeks should be avoided in all but rare cases. It also directs that the warning be displayed in bold type in a box rimmed with a black border. Save for the placement of the warning in a black box, the length of usage warning given by PLIVA largely approaches that of the 2009 FDA warning.³

II. Procedural History

Mrs. Meade and her husband Elmer Meade ("Mr. Meade") (collectively "plaintiffs") initiated this action in the Circuit Court of Mingo County, West Virginia on February 25, 2009. Defendants removed on April 20, 2009, invoking the court's diversity jurisdiction. Plaintiffs assert 13 counts (Nos. 2 through 14) against PLIVA in their complaint, all of which are based on the following material allegations: (1) defendants "fail[ed] to warn doctors and patients of information within its knowledge or possession or both, which indicated... [that metoclopramide], when taken for long periods of time, caused serious, permanent, and debilitating side effects, including Tardive Dyskinesia and Akathisia"; and (2) defendants "marketed, manufactured and distributed [metoclopramide] and encouraged the long term use of these drugs, misrepresented the effectiveness of the drugs and concealed the drugs's dangerous side effects." (Compl. 55 23-24) (emphasis in original).⁴

Counts 2 through 14 are asserted against the "manufacturing defendants," which includes PLIVA. Count 2 is a strict products liability claim; Count 3 is a manufacturing defect strict liability claim; Count 4 is a design defect strict liability claim; Count 5 is a breach of express warranty claim; Count 6 is a breach of implied warranty claim; Count 7 is a negligence claim; Count 8 is a negligent misrepresentation claim; Count 9 is a claim for breach of undertaking a special duty; Count 10 is a fraud and misrepresentation claim; Count 11 is a constructive fraud claim; Count 12 is a fraud by concealment claim; Count 13 is a claim for violation of the West Virginia Unfair Trade Practices Act; and Count 14 is an intentional infliction of emotional distress claim. (Id. 55 108-199).

Plaintiffs seek recovery for actual damages, punitive damages, loss of consortium, and reasonable costs and attorneys fees. (Id. ¶¶ 200-208).

On September 10, 2010, PLIVA filed a motion to dismiss pursuant to Federal Rule of Civil Procedure 12(c) and a motion for summary judgment pursuant to Rule 56. In its motion for summary judgment and supporting memorandum, PLIVA contends there are no genuine issues of material fact inasmuch as (1) plaintiffs cannot establish causation; (2) Dr. Parsley was aware of the risks of using metoclopramide when she prescribed the drug to Mrs. Meade; (3) PLIVA satisfied any alleged duty to warn by providing a package insert explaining potential side effects of metoclopramide; (4) PLIVA's product was reasonably safe for its intended use; (5) plaintiffs have not satisfied their burden of proof on their claims for breach of warranty, fraud, violation of West Virginia Unfair Trade Practices Act, and emotional...