Kellogg v. Wyeth

• Decision Date: 20 October 2010
• Docket Number: Case No. 2:07–cv–82.
• Citation: 762 F.Supp.2d 694
• Parties: Ethel KELLOGG, Plaintiff,v.WYETH, Individually and as Successor–in–Interest to A.H. Robins Company, Inc. and American Home Products Corporation; Schwarz Pharma, Inc.; Actavis, Inc.; Actavis–Elizabeth, L.L.C.; Alpharma, Inc.; Purepac Pharmaceutical Company, Inc.; Teva Pharmaceuticals, USA, Inc.; Bar Pharmaceuticals, Inc.; Pliva, Inc.; and Drug Company Does 1 Through 10, inclusive, Defendants.
• Court: U.S. District Court — District of Vermont

762 F.Supp.2d 694

Ethel KELLOGG, Plaintiff,

v.WYETH, Individually and as Successor–in–Interest to A.H. Robins Company, Inc. and American Home Products Corporation; Schwarz Pharma, Inc.; Actavis, Inc.; Actavis–Elizabeth, L.L.C.; Alpharma, Inc.; Purepac Pharmaceutical Company, Inc.; Teva Pharmaceuticals, USA, Inc.; Bar Pharmaceuticals, Inc.; Pliva, Inc.; and Drug Company Does 1 Through 10, inclusive, Defendants.

Case No. 2:07–cv–82.

United States District Court, D. Vermont.

Oct. 20, 2010.

Jerome F. O'Neill, Esq., O'Neill Kellner & Green, Burlington, VT, Leslie A. Brueckner, Trial Lawyers for Public Justice, P.C., Louis M. Bograd, Washington, DC, Ralph D. Pittle, Esq., Medical Legal Consultants of Washington, Bellevue, WA, for Plaintiff.Robert B. Hemley, Ross A. Feldmann, Gravel and Shea, Kristina MacBeth Roomet, Esq., Stephen J. Soule, Paul Frank Collins P.C., Matthew S. Borick, Downs Rachlin Martin PLLC, John D. Monahan, Jr., Dinse, Knapp & McAndrew, P.C., Burlington, VT, Charles Leroy Casteel, Esq., Jeffrey R. Pilkington, Esq., Davis Graham & Stubbs LLP, Denver, CO, Philip H. Butler, Esq., Bradley Arant Boult Cummings LLP, Montgomery, AL, Henry E. Billingsley, II, Esq., Richard A. Dean, Tucker Ellis & West, Cleveland, OH, Richard A. Oetheimer, Esq., U. Gwyn Williams, Goodwin Procter LLP, Boston, MA, Joseph P. Thomas, Matthew V. Brammer, Thomas G. McIntosh, Ulmer & Berne LLP, Cincinnati, OH, Rex A. Littrell, Esq., Ulmer & Berne LLP, Columbus, OH, for Defendants.

OPINION AND ORDER

WILLIAM K. SESSIONS III, Chief Judge.

Plaintiff Ethel Kellogg brings suit against the brand name and generic manufacturers of metoclopramide (“MCP”) for strict product liability, breach of express and implied warranties, negligent misrepresentation, fraud and fraud by concealment. She alleges that the medication caused her to develop tardive dyskinesia, a neurological disorder causing involuntary repetitive tic-like movements. Defendants Wyeth and Actavis, Inc. have moved for summary judgment. For the reasons that follow, the motions, ECF Nos. 204 & 211, are denied.

Factual Background

The following facts are either undisputed or presented in the light most favorable to Kellogg, as the non-moving party. MCP is a prescription drug approved by the Federal Drug Administration (“FDA”) for the treatment of symptoms associated with gastroesophageal reflux when a patient fails to respond to conventional therapy. MCP has been available for prescription use under the name brand Reglan® since the late 1970's.

Reglan® was originally developed and marketed by A.H. Robins Company (“AHR”). An oral tablet form of Reglan® was approved in 1980 for the treatment of hospitalized patients with acute diabetic gastroparesis. See Nelson Decl. ¶ 25, ECF No. 223–11. In 1984, Reglan® was approved for treatment of gastroesophageal reflux in the general population. See id. ¶ 26.

In 1985, AHR filed for bankruptcy. In 1989, AHR merged into AHP Subsidiary (9) Corporation, and ceased to exist. AHP Subsidiary (9) Corporation, a wholly-owned subsidiary of American Home Products Corporation, was renamed A.H. Robins Company, Inc., and carried on the surviving aspects of AHR's business. In 1998, A.H. Robins Company, Inc. merged into American Home Products Corporation, and became an unincorporated division of that company. On March 11, 2002, American Home Products Corporation changed its name to Wyeth.

In acquiring AHR, Wyeth acquired the rights to Reglan®, and manufactured and distributed it from 1989 through 2001. In December 2001, Wyeth transferred the rights to Reglan® tablets to Schwarz Pharma, Inc.,¹ and ceased to manufacture and distribute Reglan®.

Since the mid–1980's, Reglan® tablets have also been available in generic form. Several companies, including Wyeth and its co-defendant Actavis, have manufactured and sold generic MCP tablets. Wyeth has not manufactured or distributed generic MCP tablets since December 27, 2001.

At the times relevant to this lawsuit, prescriptions of Reglan® and generic MCP tablets were accompanied by an FDA-approved label and package insert that contained instructions concerning the drug's use and warnings about risks associated with its use. According to this information, MCP was “indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented esophageal reflux who fail to respond to conventional therapy.” Physicians' Desk Reference (“PDR”) 2604 (54th ed. 2000), ECF No. 205–1. The information also included warnings that

extrapyramidal symptoms, manifested primarily as acute dystonic reactions, occur in approximately 1 in 500 patients treated with the usual adult dosages.... These usually are seen during the first 24–48 hours of treatment with metoclopramide, occur more frequently in pediatric patients and young adults, and are even more frequent at the higher doses used in prophylaxis of vomiting due to cancer chemotherapy.

Id. The package insert also warned that tardive dyskinesia is a possible side effect of MCP, and 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.” Id. With respect to using the drug for relief of symptoms of gastroesophageal reflux, the package insert advised that “[t]herapy longer than 12 weeks has not been evaluated and cannot be recommended.” Id. at 2605. Until 2002, when Wyeth ceased marketing Reglan®, this information for Reglan® was also published in the PDR, an annual compilation of manufacturers' prescribing information distributed to doctors. See, e.g., id. 2603–2605.

According to Kellogg's expert, Dr. Robert C. Nelson, from the mid–1970's through the mid–1980's, AHR pursued an aggressive marketing strategy for Reglan®, and underplayed or concealed the risks involved in the use of the drug for prolonged treatment of chronic gastrointestinal ailments. For example, AHR encouraged the use of Reglan® for “vague gastrointestinal complaints.” Nelson Decl. ¶ 15, ECF No. 223–11. It promoted Reglan® as safe for long-term use, although it was aware that there were concerns that Reglan® tablets should not be used for longer than four to six weeks. Id. ¶ 12. It acknowledged that gaining approval for treatment of heartburn “would place the drug on the market for acute and chronic indefinite intermittent usage. Actual clinical usage should easily exceed the initially approved labeled indications.” Id. ¶ 11. It advised its sales force, when marketing the drug to doctors, to refer to a study showing that Reglan® was safe for long-term use, but cautioned its sales people not to allow access to the study data. Id. ¶ 17. In sum, Nelson's review of the Wyeth and AHR files on Reglan® shows a company bent on increasing the market for its drug by encouraging off-label use and fostering the impression among the medical community that the drug was relatively safe to administer for longer than the recommended duration of therapy.

Kellogg has a history of gastrointestinal disorders, which have been treated with a variety of prescription and nonprescription medications. In May 2000, Kellogg's physician, Dr. Meghan B. Cook, prescribed MCP tablets for her gastrointestinal condition. Dr. Cook testified that she prescribed MCP rarely, but had experience with it before she prescribed it for Kellogg. She was aware of some of the benefits and some of the side effects. Her sources of information included generally journal articles, lectures, the PDR and perhaps colleagues. Dr. Cook thought that extrapyramidal symptoms—in particular acute dystonic reactions—were rare, and she relied on the manufacturers to supply accurate information and to inform her if the information available to doctors about the drug was no longer accurate. Dr. Cook had referred to the Reglan® entry in the PDR in the past, but did not recall reviewing it before prescribing MCP for Kellogg, and did not regard it as the chief source of her information about MCP. She did not recall whether she knew about or thought about the recommended four to twelve-week duration of therapy. She did not recall whether she discussed the potential side effects of MCP with Kellogg. Cook Dep. 56:12–64:10, 91:21–94:25, 100:5–11, Apr. 14, 2010, ECF No. 223–8.

Dr. Bradford Armstrong, Kellogg's physician from October 2001 through 2009, did not recall reviewing or relying on any label, package insert or PDR reference for MCP during or before the time he prescribed MCP for her. Nor did he recall receiving any information from sales representatives or conferences. He believed that he may have consulted a medical text, or learned about the drug in pharmacology class, or gotten his information from instructors during his medical training. He believed he was familiar with the risks of the drug. He believed that extrapyramidal effects were relatively rare, and that tardive dyskinesia was a very uncommon side effect. He did not recall whether he knew about the recommended four to twelve-week duration of therapy. He did expect, however, that new information would be brought to his attention, especially information indicating that the risk of a side effect was substantially greater than had been reported. Dr. Armstrong testified that had he been aware of the information that now accompanies MCP, he would have taken Kellogg off the medication. Armstrong Dep. 11/18/2009, 22:16–19, 24:25–25:16, 60:23–61:1, 113:22–118:9, 122:3–123:15, 127:7–128:15, 131:5–24, 133:16–24, 135:19–136:15, 148:20–25, Nov. 18, 2009, ECF No. 223–7.

Kellogg took MCP from May 2000 through mid-June 2004. She did not read or rely upon the drug labeling or package insert for her information about the drug, but relied on her physicians to inform her. Her MCP prescriptions were filled exclusively with generic MCP tablets.² She never received or ingested Reglan® tablets. Two of Kellogg's prescriptions, from May 8, 2000 and January 1, 2001, were filled with...