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Heisner v. Genzyme Corp.

July 25, 2008

ELMER HEISNER, INDIVIDUALLY AND ON BEHALF OF JAYNE HEISNER, PLAINTIFF,
v.
GENZYME CORPORATION, A MASSACHUSETTS CORPORATION, DEFENDANT.



The opinion of the court was delivered by: David H. Coar United States District Judge

HONORABLE DAVID H. COAR

MEMORANDUM OPINION AND ORDER

Plaintiff Elmer Heisner ("Plaintiff" or "Heisner") brought this action against Defendant Genzyme Corporation ("Genzyme" or "Defendant") for violations of state law surrounding the death of his wife, Jayne Heisner ("Decedent"). Now before this Court is Defendant's motion to dismiss pursuant to Federal Rule of Civil Procedure 12(b)(6) (Docket No. 8). For the reasons stated below, Defendant's motion is GRANTED.

1. FACTS*fn1

As an initial matter, Defendant requests that this Court take judicial notice of the fact that "Seprafilm is a Class III device approved through the PMA [premarket approval] process." (Def.'s Reply at 2-4.) The Complaint references Seprafilm's approval by the FDA on December 20, 2000, but does not make clear what approval process or category was applied to the device.

It is certainly possible to "take judicial notice of matters of public record without converting the 12(b)(6) motion into a motion for summary judgment." Anderson v. Simon, 217 F.3d 472, 474-75 (7th Cir. 2000) (citing Henson v. CSC Credit Servs., 29 F.3d 280, 284 (7th Cir. 1994)). However, this can be done only where "an undisputed fact in the public record establishes that the plaintiff cannot satisfy the 12(b)(6) standard." Gen. Elec. Capital Corp. v. Lease Resolution Corp., 128 F.3d 1074, 1081 (7th Cir. 1997).

Plaintiff argues against taking judicial notice of facts surrounding the FDA's approval, stating that "disputable findings exist concerning the Defendant's compliance with the FDA's Medical Device Amendments (MDA) and Premarket approval process in the manufacturing of their product, Seprafilm." (Pl.'s Resp. at 3.) However, this does not contradict the putative fact in question, which is only that the FDA approved Seprafilm as a Class III device pursuant to the PMA process. Whether that process was properly followed by the FDA, or whether Defendant fulfilled its obligations over the course of that process, are disputed issues that cannot be resolved at this early stage. However, neither of these questions contradict the clear, undisputed, and publicly available fact put forward by Defendant; that the FDA approved Seprafilm as a Class III device. As a matter of law, this approval is granted only upon completion of the PMA process. See 21 U.S.C. § 360c(a)(1)(C). Therefore, this Court takes judicial notice of the fact that "Seprafilm is a Class III device approved by the FDA pursuant to the PMA process," and leaves open any additional questions regarding the adequacy of that process as applied in this case.

Plaintiff's wife underwent surgery to remove an ovarian cyst on January 19, 2006. A Seprafilm adhesion barrier manufactured and sold by the Defendant was inserted into her body to prevent post-surgical adhesions from forming between her internal organs and tissue. Plaintiff alleges that Jayne Heisner died on February 22, 2006 as a proximate result of the insertion of Seprafilm into her body. (Compl. ¶ 2.)

Plaintiff's Complaint contains seven counts, generally alleging that Genzyme was negligent in the design, manufacture, and labeling of Seprafilm and that Seprafilm was not fit for its intended use. Defendant has moved to dismiss all seven counts of the Complaint. In his Response to the Defendant's Motion to Dismiss, Plaintiff has asked this Court to dismiss without prejudice Count II, which claimed a failure to disclose under Massachusetts General Law Ch. 93A § 2(a). (Pl.'s Resp. to Def.'s Mot. to Dismiss 14-15.) Dismissal of Count II is GRANTED without prejudice. The remaining counts are:

I. Breach of Implied Warranty of Merchantability under Massachusetts General Law § 2-314.

III. Strict Liability under Illinois tort law, as product was unreasonably dangerous for normal use.

IV. Negligence under Illinois tort law in testing, inspection, design, manufacture, warning, and/or labeling.

V. Negligence per se under Illinois tort law due to adulteration and/or misbranding in violation of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, the Sherman Food, Drug and Cosmetic Law, and "other applicable laws, statutes, and regulations," including standards for care and labeling set by 21 C.F.R. §§ 201.56 and 201.57.

VI. Breach of Express Warranty under Illinois tort law

VII. Breach of Implied Warranty under Illinois tort law

2. STANDARD OF REVIEW FOR MOTION TO DISMISS

When considering a motion to dismiss for failure to state a claim under Federal Rule of Civil Procedure 12(b)(6), courts take the allegations in the complaint as true, drawing all possible inferences in favor of the plaintiff. Killingsworth v. HSBC Bank Nevada, N.A., 507 F.3d 614, 618 (7th Cir. 2007).

To state a claim under federal pleading standards, a plaintiff need only provide a "short and plain statement of the claim showing that the pleader is entitled to relief," sufficient to provide the defendant with "fair notice" of the claim and its basis. Fed. R. Civ. P. 8(a)(2); Bell Atlantic Corp. v. Twombly, 127 S.Ct. 1955, 1964 (2007). In Twombly, however, the Supreme Court seemingly raised the level of factual development required to state a claim, requiring a complaint to contain more than ...


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