Longs v. Wyeth

Decision Date20 March 2009
Docket NumberCase No.: 1:03 CV 2042.
Citation621 F.Supp.2d 504
PartiesRamona LONGS, as Executor of the Estate of Mary Buchanan, Plaintiff v. WYETH, et al., Defendants.
CourtU.S. District Court — Northern District of Ohio

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

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

ORDER

SOLOMON OLIVER, JR., District Judge.

Plaintiff Ramona Longs ("Plaintiff" or "Longs") brings the above-captioned law-suit as executor of the estate of decedent Mary Buchanan ("Buchanan"), alleging product liability claims regarding the diet pill Redux against Defendants Wyeth, et al. (collectively, "Defendants" or "Wyeth"). Now pending before the court are Plaintiff's Motion to Vacate Order and Judgment (ECF No. 151) and Plaintiff's Motion to Alter Judgment Pursuant to Federal Rule of Civil Procedure 59(e) (ECF No. 152). For the reasons discussed below, both Motions are denied.

I. FACTS AND PROCEDURAL HISTORY

A more detailed discussion of the facts appears in the court's Order of February 28, 2008. (Order, ECF No. 29.) In that Order, the court granted summary judgment in favor of Defendants on all of Plaintiffs claims, finding that the strict liability and negligence claims related to pre-FDA approval were preempted by federal law and that the claims that were not preempted failed on their merits. Specifically, the court held that Plaintiffs strict liability design defect claim failed because Plaintiff had neglected to provide evidence to refute Defendants' showing that the Redux warnings were adequate as a matter of law. The court also held that Plaintiff's negligence claims failed because Plaintiff had neglected to provide evidence of proximate cause. The court then denied Defendants' Motions for Summary Judgment on Plaintiffs request for punitive damages as moot. By the same Order, the court also dismissed Plaintiff's failure to warn claim with prejudice on the ground that Plaintiff had voluntarily dismissed this claim. As a result of these rulings, the court dismissed Plaintiff's case in its entirety.

On March 10, 2008, Plaintiff filed the two pending Motions. In her Motion to Vacate Order and Judgment (ECF No. 151), Plaintiff requests that the court vacate its Order dismissing Plaintiff's case as well as its Judgment Entry for Defendants so that the court could consider Plaintiff's Motion to Alter Judgment (ECF No. 152). In her Motion to Alter Judgment, Plaintiff raises the following arguments: (1) Plaintiff's claims are not preempted; (2) Defendants bear the burden of proof regarding whether the warnings were inadequate; (3) Defendants did not properly raise the argument that Plaintiff lacked evidence of the inadequacy of warnings with regard to her design defect claim; and (4) Defendants did not properly raise the issue that Plaintiff lacked evidence of proximate cause related to her negligence claims.

II. STANDARD FOR ALTERING OR AMENDING JUDGMENT

Rule 59(e) motions may be granted in the following instances: (1) clear error of law; (2) newly discovered evidence; (3) an intervening change in controlling law; or (4) to prevent manifest injustice. E.g., GenCorp, Inc. v. Am. Int'l Underwriters, 178 F.3d 804, 834 (6th Cir. 1999). Although the court has authority to do so, a court will only reconsider its prior ruling in rare and unusual circumstances. As the court stated in Dana Corp. v. United States, 764 F.Supp. 482, 489 (N.D.Ohio 1991):

Although `motions to reconsider are not ill-founded step-children of the federal court's procedural arsenal,' they are `extraordinary in nature and, because they run contrary to notions of finality and repose, should be discouraged.' In re August, 1993 Regular Grand Jury, 854 F.Supp. 1403, 1406 (S.D.Ind.1994). To be sure, `a court can always take a second look at a prior decision; but `it need not and should not do so in the vast majority of instances,' especially where such motions `merely restyle or re-hash the initial issues.' Id. at 1407. It is not the function of a motion to reconsider either to renew arguments already considered and rejected by a court or `to proffer a new legal theory or new evidence to support a prior argument when the legal theory or argument could, with due diligence, have been discovered and offered during the initial consideration of the issue.' Id. at 1408. Where, as is the case with much of the instant motion, `defendant views the law in a light contrary to that of this Court,' its `proper recourse' is not by way of a motion for reconsideration `but appeal to the Sixth Circuit.'

McConocha v. Blue Cross and Blue Shield Mut. of Ohio, 930 F.Supp. 1182, 1184 (N.D.Ohio 1996). Motions to reconsider are "not designed to give an unhappy litigant an opportunity to relitigate matters already decided, nor is it a substitute for an appeal." Sherwood v. Royal Ins. Co. of Am., 290 F.Supp.2d 856, 858 (N.D.Ohio 2003).

III. LAW AND ANALYSIS
A. Preemption
1. Pre-FDA Approval Claims

The court previously granted in part and denied in part Defendants' Motion for Partial Summary Judgment Based on Federal Preemption. (See Order, ECF No. 148, at 4-8.) Specifically, the court held that "all claims relating to pre-FDA approval are preempted by the FDA [or FDCA]. 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." (Id. at 6.) The court's conclusion was based on its finding that "Plaintiff's 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." (Id.) However, the court also found that "Plaintiff's post-FDA approval design defect claims, under strict liability and negligence, are not preempted." (Id. at 7) (emphasis added.)

Plaintiff now argues that the court erred in finding that her claims relating to Defendants' conduct prior to the FDA's approval of Redux were preempted. In support of her argument for reconsideration, Plaintiff asserts that two recently decided Supreme Court cases bear on the preemption issues in the instant case. As discussed below, the court finds that these cases do not warrant a reconsideration of the court's original ruling on preemption.

In Riegel v. Medtronic, Inc., ___ U.S. ___, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008), the plaintiff sued a medical device manufacturer for wrongful death, arguing that the device was defectively designed and labeled. The Court held that the Medical Device Act, 21 U.S.C. § 360k(a), expressly preempted common law claims regarding the safety and effectiveness of the device. The Court also noted that

State requirements are pre-empted under the MDA only to the extent that they are "different from, or in addition to" the requirements imposed by federal law. § 360k(a)(1). Thus, § 360k does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case "parallel," rather than add to, federal requirements. Lohr [v. Medtronic, Inc.], 518 U.S., [470] at 495, 116 S.Ct. 2240, 135 L.Ed.2d 700 [(1996)]; see also id., at 513, 116 S.Ct. 2240 (O'Connor, J., concurring in part and dissenting in part).

Id. at 1009 (internal quotations omitted). The Court only addressed the effect of the MDA on claims premised on violations of FDA regulations and did not address the extent to which tort claims are preempted by the FDCA. Furthermore, the Court expressly stated that, "[i]t has not been established (as the dissent assumes) that no tort lawsuits are pre-empted by drug or additive approval under the FDCA." Id. The Court left open the possibility that tort lawsuits are preempted to some extent under the FDCA, but declined to fully address it as this was not an issue before the Court. Accordingly, Riegel did not establish whether Plaintiffs pre-FDA approval claims are preempted by the FDCA, as this issue was not before the Court.

In Warner-Lambert Co., LLC v. Kent, ___ U.S. ___, 128 S.Ct. 1168, 170 L.Ed.2d 51 (2008) (per curiam), the court affirmed, without opinion, the decision in Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir.2006). Kent was affirmed by a 4-4 vote in which the Chief Justice abstained. As Defendants correctly note, "[a]ffirmance by an equally divided Court is entitled to no precedential weight." In re Aredia & Zometa Prods. Liab. Litig., No. 3:06-MD-1760, 2008 WL 913087 at *2 n. 2, 2008 U.S. Dist. LEXIS 26859 at *5 (M.D.Tenn. Apr. 2, 2008) (citing Neil v. Biggers, 409 U.S. 188, 192, 93 S.Ct. 375, 34 L.Ed.2d 401 (1972)). Accordingly, neither Riegel nor Kent are controlling in the instant case.

Furthermore, the Supreme Court's recently issued case, Wyeth v. Levine, ___ U.S. ___, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009), also does not support Plaintiff's Motion for Reconsideration. In Wyeth, the Court considered the narrow issue of "whether the FDA's drug labeling judgments preempt state law product liability claims premised on the theory that different labeling judgments were necessary to make drugs reasonably safe for use." Id. at 1193 (internal quotation omitted). The Court held that the FDA's approval of the defendant-drug manufacturer's label did not provide it a complete defense to the plaintiff's failure to warn claim, as the claim was not preempted by federal law. Id. In reaching its holding, the Court emphasized that it was Congress' intent to have state law complement federal drug regulation because "manufacturers have superior access to information about their drugs, especially in the...

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