Longs ex rel. Estate of Buchanan v. Wyeth, No. 1:03 CV 2042.

• Decision Date: 29 February 2008
• Docket Number: No. 1:03 CV 2042.
• Citation: 536 F.Supp.2d 843
• Parties: Ramona LONGS, as Executor of the ESTATE OF Mary BUCHANAN, Plaintiff v. WYETH, et al., Defendants.
• Court: U.S. District Court — Northern District of Ohio

536 F.Supp.2d 843

Ramona LONGS, as Executor of the ESTATE OF Mary BUCHANAN, Plaintiff v. WYETH, et al., Defendants.

No. 1:03 CV 2042.

United States District Court, N.D. Ohio, Eastern Division.

February 29, 2008.

COPYRIGHT MATERIAL OMITTED

Benjamin H. Anderson, Anderson Law Office, Cleveland, OH, Linda C. Love, Michael L Williams, Williams Love O'Leary Craine & Powers, Portland, OR, .for

Eric L. Alexander, Reed Smith, M. Sean Laane, Arnold & Porter, Washington, DC, George E. McDavid, Melissa G. Graff, Reed Smith, Princeton, NJ, David R. Cooper, Cooper & Walinski, Toledo, OH, for Defendants.

ORDER

SOLOMON OLIVER, JR., District Judge.

Plaintiff Ramona Longs¹ ("Plaintiff" or "Longs") brings the above-captioned lawsuit as executor of the estate of decedent Mary Buchanan ("Buchanan"), alleging product liability claims against Defendants Wyeth, et al. (collectively, "Defendants" or "Wyeth").² Now pending before the court are Defendants' Motion for Partial Summary Judgment Based on Federal Preemption (ECF No. 34); Defendants' Motion for Summary Judgment Based on Lack of Evidence of Proximate Causation (ECF No. 31); and Defendants' Motion for Partial Summary Judgment Relating to Punitive Damages (ECF No. 33). For the reasons stated below, the Motions are denied as moot to the extent that they address Plaintiffs failure to warn claim, which Plaintiff has withdrawn. Consequently, Plaintiffs failure to warn claim is hereby dismissed with prejudice. Furthermore, Defendants' Motion for Partial Summary Judgment Based on Federal Preemption (ECF No. 34) is granted in part and denied in part; Defendants' Motion for Summary Judgment Based on Lack of Evidence of Proximate Causation (ECF No. 31) is granted, and Defendants' Motion for Partial Summary Judgment Relating to Punitive Damages (ECF No. 33) is denied as moot. As a result of the above rulings, Plaintiffs case is hereby dismissed in its entirety.

I. FACTS AND PROCEDURAL HISTORY

According to Plaintiff, Buchanan ingested the diet pill Redux for several months during 1996 and 1997. (Am. Compl.¶ 6.) In November, 2001, Buchanan was diagnosed with primary pulmonary hypertension ("PPH"). (Id. ¶ 7.) Buchanan died on December 18, 2003, allegedly as a result of PPH. (Id.)

Defendants marketed and sold the drug Redux. (Answer 2-3, 8, ECF No. 4.) Redux was approved by the FDA in April, 1996. (See FDA Approval Letter, Defs.' Ex. A, ECF No. 33.) Redux became available to the public in June, 1996 (4/30/96 Letter, Defs.' Ex. E, ECF No. 31) and was taken off the market on or about September 15, 1997. (Answer ¶ 26.)

Plaintiffs Amended Complaint alleges the following claims: (1) product liability, which encompasses both design defect, pursuant to O.R.C. § 2307.75, and failure to warn, pursuant to O.R.C. § 2307.76; (2) negligence; and (3) wrongful death, pursuant to O.R.C. § 2125.01 et seq. (Am. Compl.¶¶ 14-22.) Plaintiff seeks economic and non-economic damages (id. at 9), as well as punitive damages, pursuant to O.R.C. § 2307.80(C). (Id. ¶ 13.) On October 3, 2007, Plaintiff filed a Notice of Withdrawal of Claim of Failure to Warn. (ECF No. 35.) In the Notice, Plaintiff stated that she intended to pursue only her design defect and negligence claims, and that she continued to seek punitive damages. (Id. at 1-2.)

The court held oral arguments on January 17, 2008, at which the parties addressed Defendants' Motion for Partial Summary Judgment Relating to Punitive Damages and Defendants' Motion for Summary Judgment Based on Lack of Evidence of Proximate Causation. At oral argument, both parties indicated that they rested on their briefs as to Defendants' Motion for Partial Summary Judgment Based on Federal Preemption. (1/17/08 Oral Argument Tr. ("1/17/08 Tr.") at 44) (on file.)

II. SUMMARY JUDGMENT STANDARD

Federal Rule of Civil Procedure 56(c) governs summary judgment motions and provides:

The judgment sought shall be rendered forthwith if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law....

In reviewing summary judgment motions, this court must view the evidence in a light most favorable to the non-moving party to determine whether a genuine issue of material fact exists. Adickes v. S.H. Kress & Co., 398 U.S. 144, 153, 90 S.Ct. 1598, 26 L.Ed.2d 142 (1970); White v. Turfway Park Racing Ass'n, Inc., 909 F.2d 941, 943-44 (6th Cir.1990). A fact is "material" only if its resolution will affect the outcome of the lawsuit. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). Determination of whether a factual issue is "genuine" requires consideration of the applicable evidentiary standards. Thus, in most civil cases the Court must decide "whether reasonable jurors could find by a preponderance of the evidence that the [non-moving party] is entitled to a verdict." Id. at 252, 106 S.Ct. 2505. However, "[c]redibility judgments and weighing of the evidence are prohibited during the consideration of a motion for summary judgment." Ahlers v. Schebil, 188 F.3d 365, 369 (6th Cir.1999).

Summary judgment is appropriate whenever the non-moving party fails to make a showing sufficient to establish the existence of an element essential to that party's case and on which that party will bear the burden of proof at trial. Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). Moreover, "the trial court no longer has a duty to search the entire record to establish that it is bereft of a genuine issue of material fact." Street v. J.C. Bradford & Co., 886 F.2d 1472, 1479-80 (6th Cir.1989) (citing Frito-Lay, Inc. v. Willoughby, 863 F.2d 1029, 1034 (D.C.Cir.1988)). The non-moving party is under an affirmative duty to point out specific facts in the record as it has been established that create a genuine issue of material fact. Fulson v. City of Columbus, 801 F.Supp, 1, 4 (S.D.Ohio 1992). The non-movant must show "mere than a scintilla of evidence to overcome summary judgment"; it is not enough to show that there is slight doubt as to material facts. Id.

When a motion for summary judgment is made and supported as provided in this rule, an adverse party may not rest upon the mere allegations or denials of the adverse party's pleading, but the adverse party's response, by affidavits or as otherwise, provided in this rule, must set forth specific facts showing that there is a genuine issue for trial.

Fed.R.Civ.P. 56(e).

III. MOTION FOR PARTIAL SUMMARY JUDGMENT BASED ON FEDERAL PREEMPTION

Defendants argue that Plaintiff's claims are preempted by the Federal Foci!, Drug, and Cosmetic Act ("FDCA" or the "Act"), 21 U.S.C. § 391 et seq., which is enforced by the Food and Drug Administration ("FDA"), 21 U.S.C. § 393(b). Initially, Defendants primarily argued in support of their Motion that Plaintiff's failure to warp claim was preempted, anticipating, that Plaintiff would seek to introduce evidence that Defendants' warnings about the risk of PPH from Redux should have been stronger, or should have contained a "black box" warning. In support of this argument, Defendants cited the FDA's new drug labeling rules, which were issued in January, 2006. The preamble to these rules states that the "FDA believes that under existing preemption principles, FDA approval of labeling under the act, whether it be in the old or new format, preempts conflicting or contrary State law." 71 Fed. Reg. 3922, 3934. The court notes that because Plaintiff has withdrawn her failure to warn claim, this argument is no longer pertinent. Thus, this portion of Defendants' Motion is denied as moot.

Defendants also argued that all of Plaintiff's claims are preempted because they conflict with the FDA regulatory process. As discussed below, the court finds that the FDCA preempts some, but not all, of Plaintiff's claims.

The purpose of the FDA is to

(1) promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner;

(2) with respect to such products, protect the public health by ensuring that —

. . . . .

(B) human ... drugs are safe and effective;....

21 U.S.C. § 393(b). In other words, the FDA is responsible for regulating which drugs are on the market and the warnings such drugs must provide. As such, Plaintiffs strict liability and negligence claims that Redux was an "unreasonably dangerous" drug for which no warning would have been adequate directly conflicts with the FDA's authority to determine which drugs are sufficiently safe and effective to be, marketed. Although Plaintiff asserts that she alleges only that Defendants should not have marketed Redux, and that she does not argue that the FDA did anything wrong, the court finds that her claim that Redux should never have been placed on the market interferes with the FDA's objectives.. Consequently, all claims relating to pre-FDA approval are preempted by the FDA. In addition, to the extent that Plaintiff alleges fraud-on-the-FDA or that Defendants concealed or misrepresented information to the FDA, these claims are preempted, as well.

However, the FDCA does not preempt all product liability claims. Congress has expressly stated that the FDCA is not intended to preempt a state law unless it directly conflicts with the Act:

Nothing in the amendments made by this Act to the Federal Food, Drug, and Cosmetic Act shall be construed as invalidating any provision of State law which would be valid in the absence of such amendments unless there is a direct and positive conflict between such amendments and such provision of State law.

Section 202 of the Drug Amendments of 1962 (Public Law 87-781, Title II, section 202, 76 Stat. 780, 793) (Oct. 10, 1962). Furthermore, in its most recent regulations, the FDA expressly stated...