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Heisner v. Genzyme Corp.

March 8, 2010

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: David H. Coar United States District Judge

Honorable David H. Coar

MEMORANDUM OPINION AND ORDER

Before this Court is Defendant Genyzme's ("Defendant") Motion to Dismiss Plaintiff Elmer Heisner's ("Plaintiff") Third Amended Complaint. On May 21, 2009, Plaintiff filed his Third Amended Complaint containing three counts: strict liability (Count I), negligence (count II), and negligence per se (Count III). For the reasons stated below, Defendant's Motion to Dismiss on all counts is GRANTED.

I. Background

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. Jayne Heisner developed an intense fibrous reaction of the small intestines with collections of foreign body cells. She 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. See Heisner v. Genzyme, No. 08-CV-593, Mem. Op. and Order (July 25, 2008). The Court concluded that Plaintiff's allegations could not form the basis of his claims because their lack of specificity prevented the Court from determining whether his claims were preempted under 21 U.S.C. § 360k(a). In the interests of justice, Plaintiff was granted leave to replead.

Plaintiff filed his Second Amended Complaint on September 3, 2008. In his amended pleadings, Plaintiff supplemented his tort claims with allegations that Defendant failed in its annual reporting requirements in the years following Jayne Heisner's death. Defendant moved to dismiss on September 17, 2008. Upon review, the Court found that Plaintiff failed to state a claim for strict liability, negligence, or negligence per se because the alleged omissions, occurring after Mrs. Heisner's death, could not have proximately caused her injury. Plaintiff's breach of warranty claim was preempted by the MDA, and his remaining allegations consisted of the same vague statements contained in his earlier complaints. As a result, on April 30, 2009, this Court again granted Defendant's motion to dismiss, permitting Plaintiff to replead only Counts I, II, and III. See Heisner v. Genzyme, No. 08-CV-593, Mem. Op. and Order (Apr. 30, 2009). Plaintiff filed his Third Amended Complaint, the subject of the instant motion to dismiss, on May 21, 2009.

II. Standard of Review

The purpose of a motion to dismiss under Federal Rule of Civil Procedure 12(b)(6) is to test the sufficiency of a complaint. Weiler v. Household Finance Corp., 101 F.3d 519, 524 n. 1 (7th Cir.1996). To survive the motion, a complaint need only describe the claim in sufficient detail to give the defendant fair notice of the claim and its basis. Fed. R. Civ. P. 8(a)(2); Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555, (2007). A plaintiff's factual allegations must suggest a plausible, rather than merely speculative, entitlement to relief. Tamayo v. Blagojevich, 526 F.3d 1074, 1083 (7th Cir. 2008); Ashcroft v. Iqbal, 129 S.Ct. 1937, 1949 (2009); Twombly, 550 U.S. at 555. That is, the complaint must present "enough facts to raise a reasonable expectation that discovery will reveal evidence" supporting the plaintiff's allegations. Twombly, 550 U.S. at 556. In ruling on a motion to dismiss, the court must construe the complaint in the light most favorable to the plaintiff, accepting as true the well-pleaded allegations, and drawing all reasonable inferences in plaintiff's favor. Tamayo, 526 F.3d at 1081. "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

The preemption clause of the Medical Device Amendments ("MDA") to the federal Food, Drug, and Cosmetic Act ("FDCA") 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 alleging requirements different from, or in addition to, federal requirements. See Riegel v. Medtronic, 552 U.S. 312, 329-30 (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 ...


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