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Heisner v. Genzyme Corp.

April 30, 2009

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



The opinion of the court was delivered by: Honorable David H. Coar

MEMORANDUM OPINION AND ORDER

Before this Court is Defendant Genyzme's ("Defendant") Motion to Dismiss Plaintiff Elmer Heisner's ("Plaintiff") Second Amended Complaint. On September 3, 2008, Plaintiff filed his Second Amended Complaint containing four counts: strict liability (Count I), negligence (count II), negligence per se (Count III), and breach of express warranty (Count IV). For the reasons stated below, Defendant's Motion to Dismiss on all counts is GRANTED.

I. Alleged Facts

On January 19, 2006, Jayne Heisner, wife of Elmer Heisner, underwent surgery to remove an ovarian cyst. To prevent potential post-surgical adhesions, a Seprafilm barrier, made and marketed by Defendant, was placed into her body. Seprafilm is a Class III medical device approved by the United States Food and Drug Administration ("FDA") pursuant to its premarket approval (PMA) process. Seprafilm is composed of chemically modified hyaluronic acid and carboxymethylcellulose. Individuals who have an allergy to the source animal or microorganism that synthesized the hyaluronic acid may have an increased risk of side effects and the potential to develop an allergic response. Mrs. Heisner developed an intense fibrous reaction of the small intestines with collections of foreign body cells [concrete intestines], and died on February 22, 2006.

On January 28, 2009, Plaintiff filed a seven-count complaint against Defendant seeking damages in connection with the death of his wife. After Defendant filed a motion to dismiss the original complaint, Plaintiff filed a five-count amended complaint. Defendant argued that Plaintiff's claims were preempted by the Medical Device Amendments (MDA) to the federal Food, Drug, and Cosmetics Act (FDCA). 21 U.S.C. § 360c et seq. On July 25, 2008, this Court granted Defendant's motion to dismiss, but allowed Plaintiff to replead. See Heisner v. Genzyme, No. 08-CV-593, Mem. Op. and Order (July 25, 2008) (hereinafter "July 2008 Memorandum Opinion"). Plaintiff filed his Second Amended Complaint, the subject of the instant motion to dismiss, on September 3, 2008.

II. Standard of Review

In ruling on a motion to dismiss under Federal Rule of Civil Procedure 12(b)(6), the Court will assume that all facts alleged in the Complaint are true and construe the allegations in the Plaintiff's favor. Tamayo v. Blagojevich, 526 F.3d 1074, 1081 (7th Cir. 2008). A party's claim should only be dismissed if it is clear that no set of facts in support of the claim would entitle the party to relief. Ledford v. Sullivan, 105 F.3d 354, 356 (7th Cir. 1997) (quoting Hishon v. King & Spalding, 467 U.S. 69, 73 (1984)). "In ruling on a 12(b)(6) motion, a district court may take judicial notice of matters of public record." Anderson v. Simon, 217 F.3d 472, 474-75 (7th Cir. 2000).

III. Analysis

Defendant's motion to dismiss is premised in part on the MDA's preemption clause. That clause provides:

Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement ---

(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and

(2) which relates to the safety and effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.

21 U.S.C. § 360k(a). The MDA therefore preempts any claim that is different from, or in addition to, federal requirements. See Riegel v. Medtronic, 128 S.Ct. 999, 1011 (2008); Mitchell v. Collagen Corp., 126 F.3d 902 (7th Cir. 1997). The Supreme Court has clarified that "ยง 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 ...


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