Opinion
No. 3-02-CV-2072-L.
March 4, 2005
MEMORANDUM OPINION AND ORDER
Defendant Wyeth f/k/a American Home Products Corporation ("Wyeth") has filed a motion for summary judgment in this drug products liability action. For the reasons stated herein, the motion is granted.
The parties have agreed to let the magistrate judge make final rulings on all case-dispositive motions while reserving their right to trial before the district judge. (Jt. Stat. Rep., 10/8/03 at 2, ¶ 4). By order dated December 15, 2004, defendant's motion for summary judgment was referred and transferred to the magistrate judge for final determination pursuant to 28 U.S.C. § 636(c).
I.
Plaintiff Sue McNeil, age 71, suffers from a variety of medical problems, including gastroesophageal reflux disease ("GERD"). In August 2000, her doctor prescribed Reglan after plaintiff complained of spitting up blood. (Def. App. at 017). Reglan is a "prokinetic" drug manufactured by Wyeth that helps control GERD by blocking dopamine receptors in the brain and throughout the body, thus enhancing movement or contractions of the esophagus, stomach, and intestines. ( Id. at 104, ¶ 8; see also Plf. App. at 215-24). Like all prescription medications, Reglan and its generic equivalent, metoclopramide, have potential adverse side effects, some of which may be severe. Among the known side effects of the drug are extrapyramidal symptoms ("EPS"), or abnormal movements of various parts of the body, and tardive dyskinesia, a disfiguring and potentially irreversible neurological disorder typically characterized by involuntary movements of the mouth, tongue, lips, and extremities. (Def. App. at 005, 068).As required by FDA regulations, Wyeth developed package labeling and a product description for Reglan. The package insert, which appears in the Physician's Desk Reference, states that "Reglan Tablets and Syrup are indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy." ( Id. at 005). The Reglan label also warns against potential adverse side effects of the drug. With respect to EPS and tardive dyskinesia, the warning label states:
The FDA requires a prescription drug label to contain "a summary of the essential scientific information needed for the safe and effective use of the drug." 21 C.F.R. § 201.56(a). The labeling must be "informative and accurate and neither promotional in tone nor false or misleading in any particular." Id. § 201.56(b). Specific labeling requirements are found at 21 C.F.R. § 201.57.
Extrapyramidal symptoms, manifested primarily as acute dystonic reactions, occur in approximately 1 in 500 patients treated with the usual adult dosages of 30-40 milligrams per day of metaclopramide. These are usually seen during the first 24-48 hours of treatment with metoclopramide, occur more frequently in pediatric patients and adult patients less than 30 years of age and are even more frequent at the higher doses[.] . . . These symptoms may include involuntary movements of limbs and facial grimacing, torticollis, oculogyric crisis, rhythmic protrusion of tongue, bulbar type of speech, trismus, or dystonic reactions resembling tetanus . . .
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 this syndrome is unknown. Therefore, the use of metoclopramide for the symptomatic control of tardive dyskinesia is not recommended.
* * * *
ADVERSE REACTIONS
In general, the incidence of adverse reactions correlates with the dose and duration of metoclopramide administration. The following reactions have been reported, although in most instances, data do not permit an estimate of frequency.
* * * *
Extrapyramidal Reactions (EPS)
Acute dystonic reactions, the most common type of EPS associated with metoclopramide, occur in approximately 0.2% of patients (1 in 500) treated with 30 to 40 milligrams of metaclopramide per day . . . Symptoms include involuntary movements of limbs, facial grimacing, torticollis, oculogyric crisis, rhythmic protrusion of tongue, bulbar type of speech, trismus, opisthotonous (tetanus-like reactions), and, rarely, stridor and dyspnea possibly due to laryngospasm; . . .
* * * *
Tardive dyskinesia most frequently is characterized by involuntary movement of the tongue, face, mouth, or jaw, and sometimes by involuntary movements of the trunk and/or extremities; movements may be choreoathetotic in appearance (see WARNINGS).
( Id. at 005-06) (emphases in italics added).
Plaintiff was prescribed Reglan by three different physicians over a 14-month period. (Plf. App. at 001, ¶¶ 1-2). None of these doctors ever warned plaintiff of the potential adverse side effects of the drug or told her that she may be at an increased risk of developing tardive dyskinesia if she stayed on Reglan for more than three months. ( Id. at 2, ¶ 5). On October 14, 2001, plaintiff was taken to the emergency room of a local hospital complaining of shortness of breath, anxiety, and a "chewing motion" of her mouth that started several months ago. ( Id. at 031-32). The nurse noted that plaintiff was constantly fidgeting, appeared nervous, and had an unsteady gait. ( Id. at 031). Upon examination, the emergency room doctor determined that plaintiff was exhibiting a "likely extra-pyramidal reaction to Reglan." ( Id. at 033). This diagnosis was confirmed by plaintiff's primary care physician who discontinued the medication and prescribed a replacement drug for GERD. ( Id. at 036, 113-14). When her symptoms did not improve, plaintiff consulted a neurologist and two movement disorder specialists. All three doctors have concluded that plaintiff suffers from Reglan-induced tardive dyskinesia. ( See id. at 037-39, 047-48, 051-53).
In her pro se complaint, plaintiff alleges that she also suffers from an enlarged heart, shortness of breath, bronchitis, and difficulty swallowing. ( See Def. App. at 9, 11-12). To the extent that plaintiff contends her heart problems were caused by Reglan, there is no evidence to support such a claim. Plaintiff does argue that she suffers from respiratory dyskinesia, manifested by "noisy breathing" and "difficulty swallowing," secondary to her exposure to Reglan. ( See Plf. MSJ Resp. at 23-25; Plf. App. at 312, ¶ 6). However, her own expert testified that these problems are related to Reglan-induced tardive dyskinesia. ( See Plf. App. at 261-64).
On August 9, 2002, plaintiff, proceeding pro se, filed this products liability action in Texas state court. The gravamen of her complaint is that Wyeth failed to adequately warn physicians and consumers of the increased risk of developing tardive dyskinesia with long-term use of Reglan which renders this inherently unsafe product unreasonably dangerous. After Wyeth removed the case to federal court, plaintiff retained counsel and the parties conducted extensive discovery. Wyeth now moves for summary judgment as to all claims and causes of action. The issues have been fully briefed by the parties and the motion is ripe for determination.
Federal subject matter jurisdiction is proper because plaintiff and Wyeth are citizens of different states and the amount in controversy exceeds $75,000, exclusive of interest and costs. See 28 U.S.C. § 1332(a)(1).
II.
Summary judgment is proper when there is no genuine issue as to any material fact and the movant is entitled to judgment as a matter of law. FED. R. CIV. P. 56(c); Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 2552, 91 L.Ed.2d 265 (1986). A dispute is "genuine" if the issue could be resolved in favor of either party. Matsushita Electric Industrial Co. v. Zenith Radio Corp., 475 U.S. 574, 586, 106 S.Ct. 1348, 1356, 89 L.Ed.2d 538 (1986); Thurman v. Sears, Roebuck Co., 952 F.2d 128, 131 (5th Cir.), cert. denied, 113 S.Ct. 136 (1992). A fact is "material" if it might reasonably affect the outcome of the case. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 2510, 91 L.Ed.2d 202 (1986); Matter of Gleasman, 933 F.2d 1277, 1281 (5th Cir. 1991).A summary judgment movant who does not have the burden of proof at trial must point to the absence of a genuine fact issue. Duffy v. Leading Edge Products, Inc., 44 F.3d 308, 312 (5th Cir. 1995); Tubacex, Inc. v. M/V Risan, 45 F.3d 951, 954 (5th Cir. 1995). The burden then shifts to the nonmovant to show that summary judgment is not proper. Duckett v. City of Cedar Park, 950 F.2d 272, 276 (5th Cir. 1992). The nonmovant may satisfy this burden by tendering depositions, affidavits, and other competent evidence. Topalian v. Ehrman, 954 F.2d 1125, 1131 (5th Cir), cert. denied, 113 S.Ct. 82 (1992). All the evidence must be viewed in the light most favorable to the party opposing the motion. Rosado v. Deters, 5 F.3d 119, 122 (5th Cir. 1993); Reid v. State Farm Mutual Automobile Insurance Co., 784 F.2d 577, 578 (5th Cir. 1986). However, conclusory statements and testimony based merely on conjecture or subjective belief are not competent summary judgment evidence. Topalian, 954 F.2d at 1131.
III.
Both parties agrees that Texas law governs the substantive legal issues in this diversity case. Texas courts have adopted Section 402A of the Restatement (Second) of Torts for products liability claims. See Nobility Homes of Texas, Inc. v. Shivers, 557 S.W.2d 77, 79-80 (Tex. 1977). Section 402A provides, in pertinent part:
[O]ne who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer, or to his property, if:
(a) the seller is engaged in the business of selling such a product, and
(b) it is expected to and does reach the user or consumer without substantial change in the condition in which it is sold.
RESTATEMENT (SECOND) OF TORTS § 402A (1965); see also Lucas v. Texas Industries, Inc., 696 S.W.2d 372, 377 (Tex. 1984). A product may be unreasonably dangerous because of a manufacturing defect, a marketing defect, or a design defect. Lucas, 696 S.W.2d at 377. In order to establish a claim, a plaintiff must show: (1) the defective and unreasonably dangerous condition of defendant's product; and (2) a causal connection between such condition and plaintiff's injuries or damages. Id.
Wyeth seeks summary judgment with respect to plaintiff's marketing defect and design defect claims. More particularly, Wyeth contends that: (1) the warnings about movement disorders, including tardive dyskinesia, contained in the Reglan label are adequate as a matter of law; (2) there is no evidence that any inadequacy in the Reglan warning caused plaintiff's injuries; and (3) prescription drugs accompanied by adequate warnings are immune from defective design claims. The court will consider these arguments in turn.
A.
Under Texas law, a manufacturer has a duty to warn of foreseeable risks arising from the use of a product, and the lack of adequate warnings or instructions renders an otherwise adequate product unreasonably dangerous. See McLennan v. American Eurocopter Corp., Inc., 245 F.3d 403, 427 (5th Cir. 2001), citing Coleman v. Cintas Sales Corp., 40 S.W.3d 544, 549-50 (Tex.App.-San Antonio 2001, no writ). In prescription drug cases, the duty to warn is satisfied if the manufacturer properly discloses to the physician, a "learned intermediary," the dangerous propensities of its product. See Hurley v. Lederle Laboratories Div. of American Cynamid Co., 863 F.2d 1173, 1178 (5th Cir. 1988); Wyeth-Ayerst Laboratories Co. v. Medrano, 28 S.W.3d 87, 91 (Tex.App.-Texarkana 2000, no writ); Rolen v. Burroughs Wellcome Co., 856 S.W.2d 607, 609 (Tex.App.-Waco 1993, writ denied). This is reasonable because the physician understands the potential dangers involved in the use of a given drug and, as the prescriber, stands between the drug and the ultimate consumer. Medrano, 28 S.W.3d at 91. As the Fifth Circuit explained:
This special standard for prescription drugs is an understandable exception to the Restatement's general rule that one who markets goods must warn foreseeable ultimate users of dangers inherent in his products. Prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect. As a medical expert, the prescribing physician can take into account the propensities of the drug, as well as the susceptibilities of his patient. His is the task of weighing the benefits of any medication against its potential dangers. The choice he makes is an informed one, an individualized medical judgment bottomed on a knowledge of both patient and palliative.Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1276 (5th Cir. 1974) (citation omitted).
Although it is reasonable for the manufacturer to rely on a physician to pass on its warnings to the ultimate consumer, the learned intermediary doctrine does not absolve a prescription drug manufacturer of liability every time a warning is given. The warning still must be adequate. "[If] the warning to the intermediary is inadequate or misleading, the manufacturer remains liable for injuries sustained by the ultimate user." Medrano 28 S.W.3d at 91, quoting Alm v. Aluminum Company of America, 717 S.W.2d 588, 592 (Tex. 1986). In general, the adequacy of a warning is a question of fact for the jury. See Alm, 717 S.W.2d at 591-92; Bituminous Casualty Corp. v. Black Decker Manufacturing Co., 518 S.W.2d 868, 873 (Tex.Civ.App.-Dallas 1974, writ ref'd n.r.e.). However, when a warning specifically mentions the circumstances complained of, it is adequate as a matter of law. Rolen, 856 S.W.2d at 609-10; see also Carter v. TAP Pharmaceuticals Inc., 2004 WL 2550593 at *2 (W.D. Tex. Nov. 2, 2004); Brumley v. Pfizer, Inc., 149 F.Supp.2d 305, 310 (S.D. Tex. 2001).
In this case, the Reglan label plainly states that the drug is to be used for "short-term (4 to 12 weeks)" treatment of GERD symptoms. (Def. App. at 005). It also warns that movement disorders, including tardive dyskinesia, are known adverse side effects of the drug. Among the possible symptoms associated with these disorders are "involuntary movements of the limbs and facial grimacing, torticollis, oculogyric crisis, rhythmic protusion of tongue, bulbar type of speech, trismus, or dystonic reactions resembling tetanus[,]" all of which may be irreversible. ( Id.). These are the very circumstances of which plaintiff complains. Moreover, the Reglan label states that "the prevalence of [tardive dyskinesia] appears to be highest among the elderly, especially elderly women," and "[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." ( Id.). Thus, plaintiff's treating physicians were on notice that an elderly woman had an increased risk of developing tardive dyskinesia by taking Reglan for more than 12 weeks, and that the risk increased the longer the patient stayed on the drug.
Despite the apparent adequacy of this warning, plaintiff criticizes Wyeth for failing to revise its label in light of the published medical literature showing a significantly higher risk of tardive dyskinesia and other movement disorders in patients with long-term exposure to Reglan. In 1989, two researchers, Dr. Lucinda Miller and Dr. Joseph Jankovic, studied 1,031 patients and concluded that the actual prevalence of metoclopramide-induced movement disorders is probably greater than Wyeth's estimate of 1 in 500, or 0.2%. ( See Plf. App. at 064). Another article, published by Dr. Linda Ganzini and others in 1993, involved a case-control study in which 29% of the patients exposed to metoclopramide met the case definition of tardive dyskinesia. The average duration of exposure to the drug was 2.6 years. According to Dr. Ganzini:
Dr. Jankovic is one of the movement disorder specialists who treated plaintiff.
These data clearly suggest that both the prevalence and severity of metoclopramide-induced acute EPS and tardive dyskinesia have been underestimated and underrecognized and are approximately 100 times more prevalent than previously reported.
( Id. at 070). A similar case-control study conducted by Dr. Daniel D. Sewell in 1994 found that 27% of the patients exposed to metoclopramide for longer than 30 days met the case definition of tardive dyskinesia. ( Id. at 073-74).
Prior to the publication of the Ganzini and Sewell studies, a 1992 article by Dr. Ron B. Stewart and others drew attention to the common practice of long-term treatment with metoclopramide. The study involved 4,515 elderly patients at the Florida Geriatric Research Program. Of the patients who reported using metoclopramide, 32% had used the drug for more than one year. This led the authors to conclude that long-term treatment with metoclopramide is "quite common" and that other prescription drugs were effective and safer to treat GERD:
The routine use of metoclopramide for gastroesophageal reflux should be questioned in light of the availability of safer, more effective drugs such as histamine-receptor blocking agents cimetidine and ranitidine, and omeprazole. The long-term efficacy and symptomatic benefit of metoclopramide have not been documented.
( Id. at 077).
Plaintiff contends that the Reglan label is misleading because it does not specifically quantify the risk of tardive dyskinesia and warn physicians that the risk significantly increases with use of the drug for more than three months. Stated differently, plaintiff believes that the failure to quantify the relative risk of developing tardive dyskinesia with long-term exposure to Reglan renders the warning inadequate. The court disagrees. Plaintiff cites no case imposing such a burden on a prescription drug manufacturer. As long as the warning specifically mentions the circumstances complained of, it is adequate as a matter of law. Here, the Reglan label specifies that the drug is intended for short-term use of 12 weeks or less, warns against the potential risk of tardive dyskinesia and other movement disorders, and discloses that the risk of developing tardive dyskinesia is highest among elderly women and increases with the duration of treatment and the total cumulative dose. (Def. App. at 005). The label also describes the possible symptoms associated with movement disorders caused by the drug-the very symptoms of which plaintiff complains. Thus, Wyeth is entitled to summary judgment on plaintiff's marketing defect claim. See Carter, 2004 WL 2550593 at *2; Brumley, 149 F.Supp.2d at 310; Dickerson v. Abbott Laboratories, 1999 WL 93117 at *2-3 (Tex.App.-Dallas 1999, no writ); Medrano, 28 S.W.3d at 91; Rolen, 856 S.W.2d at 609-10. But cf. Anderson v. Sandoz Pharmaceuticals Corp., 77 F.Supp.2d 804, 807-08 (S.D. Tex. 1999) (fact issue precluded summary judgment where drug label specifically mentioned reaction suffered by plaintiff, but did not connect the reaction to plaintiff's particular diagnosis); Jordan v. Geigy Pharmaceuticals, 848 S.W.2d 176, 181-82 (Tex.App.-Fort Worth 1992, no writ) (summary judgment not proper where package insert warned of kidney problems, but not "acute" and "irreversible, permanent" renal failure).
The resolution of this issue pretermits consideration of whether any inadequacy in the Reglan warning caused plaintiff's injuries.
B.
Plaintiff also claims that Reglan is unreasonably dangerous as designed. Under Texas law, all FDA-approved prescription drugs are unavoidably unsafe as a matter of law. See Carter, 2004 WL 2550593 at *2; Hackett v. G.D. Searle Co., 246 F.Supp.2d 591, 595 (W.D. Tex. 2002). An unavoidably unsafe product "properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous." Hackett, 246 F.Supp.2d at 595, quoting RESTATEMENT (SECOND) OF TORTS § 402A, cmt. k (1965). Such is the case here. Reglan is a prescription drug approved for sale by the FDA. The court has already determined that the accompanying warnings are adequate. Consequently, Wyeth is entitled to summary judgment on plaintiff's design defect claim. See id. ("To allow plaintiffs to sue for defective design of prescription drugs would provide a disincentive to companies to develop new drugs and would allow juries to second-guess the FDA's approval of the drugs for marketing.").CONCLUSION
Defendant's motion for summary judgment is granted. The court will dismiss this case with prejudice by separate judgment issued today.
SO ORDERED.