Leathers v. Pfizer, Inc.

233 F.R.D. 687, 2006 U.S. Dist. LEXIS 11381, 2006 WL 708571
CourtDistrict Court, N.D. Georgia
DecidedMarch 10, 2006
DocketNo. CIV.A.1:04CV00615
StatusPublished
Cited by60 cases

This text of 233 F.R.D. 687 (Leathers v. Pfizer, Inc.) is published on Counsel Stack Legal Research, covering District Court, N.D. Georgia primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Leathers v. Pfizer, Inc., 233 F.R.D. 687, 2006 U.S. Dist. LEXIS 11381, 2006 WL 708571 (N.D. Ga. 2006).

Opinion

ORDER

ORINDA D. EVANS, District Judge.

This toxic tort diversity action is currently before the Court on Defendants’ Motion to Exclude the Opinions of Mark R. Firth, M.D. [# 72], Defendants’ Motion for Leave to File Excess Pages [# 70], Defendants’ Motion for Summary Judgment [# 71], Defendants’ Motion to File Under Seal Certain Portions of Exhibits to Their Motion for Summary Judgment [# 75], Defendants’ Motion for Scheduling Order [# 78], Defendants’ Motion for Leave to File Excess Pages [# 95], Defendants’ Motion to Strike [#98], Defendants’ Motion for Leave to File Response to Plaintiffs Notice of Subsequent Authority [# 113]; Defendants’ Motion for Ruling on the Record [# 124]; and Defendants’ Motion for Leave to File a Response to Plaintiffs Supplemental Brief Document [# 129].

On February 1, 2006, United States District Judge William S. Duffey, Jr. conducted a Daubert hearing on Defendants’ Motion to Exclude the Opinions of Dr. Mark R. Firth, M.D. [#72]. The hearing also addressed issues related to Defendants’ Motion to Strike. Counsel for both parties delivered oral arguments on the matter. Neither Dr. Firth nor the subjects of Defendants’ Motion to Strike were in attendance. After the hearing but prior to ruling on Defendants’ motions, Judge Duffey recused himself and the case was transferred to the undersigned judge.

For the following reasons, Defendants’ Motion to Exclude the Opinions of Dr. Mark R. Firth, M.D. [# 72] and Defendants’ Motion for Summary Judgment [# 71] are GRANTED. Defendants’ Motion to Strike [# 98] is GRANTED IN PART and DISMISSED AS MOOT IN PART. Defendants’ Motions for Leave to File Excess Pages [# 70 & # 95], Defendants’ Motion to File Under Seal [# 75], and Defendants’ Motion for Leave to File a Response to Plaintiffs Supplemental Authority [# 113] are GRANTED NUNC PRO TUNC. Defendants’ Motion [690]*690for Scheduling Order [# 78] and Defendants’ Request for Ruling on the Record [# 124] are DISMISSED AS MOOT.

I. Background

The following facts are undisputed unless otherwise noted. Defendant Pfizer, Inc. (“Pfizer”) is a foreign corporation in the business of pharmaceutical manufacturing, marketing, and sales. Pfizer makes Lipitor, the prescription medication at issue in this lawsuit. Defendant Warner-Lambert Company (“Warner-Lambert”) is a subsidiary of Pfizer. Through an unincorporated division called Parke-Davis, Warner-Lambert manufactures and sells Lipitor in the United States and, more specifically, in Georgia. According to the Complaint, Defendants began selling Lipitor in the United States in 1997 after garnering approval from the Food and Drug Administration (“FDA”).

Lipitor is in a class of drugs called statins, which inhibit a certain enzyme in the liver from producing the kind of cholesterol responsible for clogging blood vessels. Lipitor is commonly prescribed to reduce cholesterol levels, thereby reducing the risk of heart attack, stroke, and other related maladies. By virtue of being a statin, Lipitor has certain widely recognized side effects. Defendants freely admit that physicians have long been aware of “certain muscle-related adverse events [that] have been associated with statin drugs.” Defs.’ Mot. 3. Defendants also acknowledge that “in some class or some subset of people they can basically have [rhabdomyolysis], renal failure and death ... with respect to statins.” Firth Trans. 35:8-12. Plaintiff and Defendants, however, dispute whether Lipitor can cause the permanent, milder form of diffuse muscle ailment that Plaintiff claims to have. Plaintiff and Plaintiffs doctors refer to Plaintiffs alleged injury as “statin-induced myopathy.”

Plaintiffs first exposure to Lipitor was in August of 2001. He was 69 years old at the time. Dr. Mark R. Firth, Plaintiffs general internist, prescribed 10 milligrams of Lipitor per day to Plaintiff. A few months later (on or about February 20, 2002 according to Plaintiffs Complaint), Plaintiffs dosage increased to 20 milligrams of Lipitor per day. According to Dr. Firth’s expert report,1 “within a few weeks [of the increase in dosage, Plaintiff] developed signs and symptoms consistent with myopathy including extreme fatigue, weakness and diffuse muscle pain.”

Plaintiff discontinued Lipitor and underwent tests. Dr. Firth did a blood test which showed that Plaintiffs creatine phosphokinase levels were normal, indicating that Plaintiff did not have rhabdomyolysis. Dr. Firth referred Plaintiff to Dr. Linker, a rheumatologist, and Dr. Novey, a neurologist. After brief consultations, both doctors concluded that Plaintiffs ailments were linked to Lipitor.

Plaintiff claims that his muscle pain did not abate when he discontinued Lipitor. He claims that as a result of taking Lipitor, he has suffered from “grievous injuries, including, but ... not limited to, muscular weakness, severe muscle pain, multiple myalgias, myositis, a myopathic syndrome, and permanent disability.” Compl. H 3. Plaintiff alleges that Defendants knew that Lipitor had the potential to cause these permanent side effects, but that Defendants inadequately warned the FDA, doctors, and consumers of these risks. Plaintiffs claims include defective design, failure Oto warn, negligence, breach of express warranties, breach of implied warranties, and unjust enrichment. He seeks compensatory, punitive, and exemplary damages.

II. Toxic Tort Litigation & Causation

Toxic tort litigation is a subset of products liability in which “cases ... are won or lost on the strength of the scientific evidence presented to prove causation.” Rider v. Sandoz Pharm. Corp., 295 F.3d 1194, 1197 (11th Cir.2002). Recently, the United States Court of Appeals for the Eleventh Circuit noted that “toxic tort cases usually come in two broad categories: first, those cases in which the medical community generally recognizes the toxicity of the drug or chemical at issue, and second, those cases in which the medical community does not generally recognize the agent as both toxic and causing the [691]*691injury plaintiff alleges.” McClain v. Metabolife Int'l Inc., 401 F.3d 1233, 1239 (11th Cir.2005). In the first type of toxic tort case, the Court “need not undertake an extensive Daubert analysis on the general toxicity question when the medical community recognizes that the agent causes the type of harm a plaintiff alleges.” Id. In other words, general causation2 is already established, leaving only specific causation at issue for trial. In the second type of case, the plaintiff bears the burden of establishing both general and specific causation.

The parties dispute which category the instant case falls into. Plaintiff argues that because the medical community recognizes that Lipitor (and statins in general) cause muscle-related ailments, general causation is already established. Defendants, on the other hand, insist that while the medical community recognizes that statins can cause certain maladies, the medical community also believes that discontinuing the medication will correct the problems.

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233 F.R.D. 687, 2006 U.S. Dist. LEXIS 11381, 2006 WL 708571, Counsel Stack Legal Research, https://law.counselstack.com/opinion/leathers-v-pfizer-inc-gand-2006.