Marciniak v. Miles-Cutter

• Citation: 874 F. Supp. 772
• Decision Date: 16 December 1994
• Docket Number: No. 1:93-CV-442.,1:93-CV-442.
• Parties: Roman MARCINIAK, Julie Marciniak and Troy Marciniak, individually, and Julie Marciniak, as next friend of Heather Marciniak, a minor, Plaintiffs, v. MILES-CUTTER, an Indiana corporation, and Lederle Laboratories, a division of American Cyanamid Company, a New York corporation, jointly and severally, Defendants, Blue Cross Blue Shield of Michigan, Intervening Plaintiff.
• Court: U.S. District Court — Western District of Michigan

874 F. Supp. 772

Roman MARCINIAK, Julie Marciniak and Troy Marciniak, individually, and Julie Marciniak, as next friend of Heather Marciniak, a minor, Plaintiffs, v. MILES-CUTTER, an Indiana corporation, and Lederle Laboratories, a division of American Cyanamid Company, a New York corporation, jointly and severally, Defendants Blue Cross Blue Shield of Michigan, Intervening Plaintiff.

No. 1:93-CV-442.

United States District Court, W.D. Michigan, Southern Division.

December 16, 1994.

COPYRIGHT MATERIAL OMITTED

John C. Buchanan, Kevin J. O'Dowd, Buchanan & Bos, Grand Rapids, MI, for plaintiffs.

Jack E. Vander Male, Feikens, Vander-Male, Stevens, Bellamy & Gilchrist, P.C., Detroit, MI, for Miles-Cutter.

Wallson G. Knack, Warner, Norcross & Judd, Grand Rapids, MI, for Lederle.

MEMORANDUM OPINION

McKEAGUE, District Judge.

This diversity action presents claims of negligence against defendant Miles-Cutter, and negligence and breach of implied warranty against defendant Lederle Laboratories. Specifically, plaintiff¹ alleges an actionable failure to warn by both defendants relative to their respective products: Konyne, a Factor IX complex manufactured by Miles-Cutter; and Amicar (chemical name, epsilon aminocaproic acid), an inhibitor of fibrinolysis manufactured by Lederle. Now before the Court are defendants' motions for summary judgment on all claims.

I

Plaintiff suffers from a mild form of hemophilia B, a condition characterized by insufficient levels of a blood clotting factor known as Factor IX. In 1990, while in the hospital for surgical repair of a bilateral inguinal hernia, Dr. Mani Kurien, the hospital's hematologist, erroneously administered Konyne and Amicar concurrently to plaintiff, with dire results. Consequently, plaintiff filed a medical malpractice and negligence action in Muskegon County Circuit Court. After receiving a settlement of approximately $2.5 million in that case, plaintiff filed this products liability action.

The basis of plaintiff's claim is the allegation that the warnings contained in the package inserts for Konyne and Amicar were inadequate and directly responsible for Dr. Kurien's misuse of the products. Plaintiff argues that the "very heart of this issue is that Dr. Kurien looked to the product inserts specifically wondering whether he could co-administer Konyne and Amicar together." Plaintiff's Br. in Opposition, p. 4. Plaintiff acknowledges the generally held opinion among medical experts that these two products "absolutely should never be used together," but argues that Dr. Kurien "remembered that in certain circumstances, the two drugs had been used together." However, plaintiff concedes that even those who advocate the co-administration of the two products warn that it requires "great caution" and is limited to cases of "dental surgery, brain surgery and circumstances where the patient is bleeding excessively." Plaintiff's Br. in Opposition, p. 4 and n. 5. The record contains no evidence that such caution was exercised or that any of the alleged exceptions existed in plaintiff's case.

Plaintiff argues that Dr. Kurien's misuse of Konyne was foreseeable because the warning, which expressly states "epsilon aminocaproic acid should not be administered with Factor IX Complex as this may increase the risk of thrombosis," was found in the PRECAUTIONS section rather than the CONTRAINDICATIONS section.

Plaintiff correctly notes that the Amicar product insert does not address the issue of co-administration of Amicar and Konyne. Therefore, plaintiff argues, Dr. Kurien's reliance on a medical textbook edited by William J. Williams (hereinafter "Williams textbook") as the authority for his belief that the two products could be co-administered made Dr. Kurien's misuse foreseeable. However, the Williams textbook's discussion of such coadministration is strictly limited to "dental extractions" and, even then, instructs that the combined use of the products must be done serially, not concurrently (as was done by Dr. Kurien). On the very next page of the Williams textbook, in a subsection entitled "ADVERSE EFFECTS ASSOCIATED WITH FACTOR IX THERAPY," is the following warning: "Epsilon aminocaproic acid should not be administered with prothrombin complex concentrates," which is the generic definition of Konyne.

The following facts are undisputed: Dr. Kurien prescribed dosages of Konyne far in excess of the recommended levels, in direct contravention of the Konyne product insert and relevant medical literature; and Dr. Kurien prescribed Amicar without obtaining a definite laboratory diagnosis that plaintiff was suffering from primary fibrinolysis, again in direct contravention of the product insert. In fact, Kurien testified that he did not even think plaintiff had primary fibrinolysis.

In support of its motion for summary judgment, Miles-Cutter points to the express prohibition in its package insert against co-administration of these two products. Miles-Cutter also argues that the allegations in plaintiff's complaint that the product inserts misled Dr. Kurien to believe that co-administration of the two products was permissible are belied by Kurien's own testimony that he did so based on the Williams textbook.²

Both defendants, in support of their motions, rely heavily on the arguments put forth by plaintiff, through the same attorneys representing him in this action, in their prior medical malpractice and negligence action against Dr. Kurien, et al. in Muskegon County Circuit Court.³ Defendants correctly point out that plaintiff's arguments and characterization of Dr. Kurien's professional behavior in that prior action are the exact opposite of the arguments put forth in this action. In various documents filed in the Muskegon County Circuit Court, plaintiff claimed that his injuries were directly and proximately caused by the negligent actions of Dr. Kurien, that it "is simply unthinkable, and in this case unforgivable that both drugs were administered simultaneously, to a patient undergoing an elective, minor surgery for hernia repair;" that "Dr. Kurien prescribed and administered Konyne and Amicar simultaneously, which should never be done under any circumstances, which was the direct and proximate cause of Roman Marciniak's injuries;" that had Dr. Kurien "performed proper research into the medications, he would have recognized that the combined use of Konyne and Amicar is clearly improper and a breach of the standard of care;" that "all the experts agree that it was a breach of the standard of care for Dr. Kurien to co-administer Konyne and Amicar, which are incompatible;" and that

Nothing in the medical literature allows the simultaneous use of Amicar and Konyne. In fact, the package insert for Konyne ... clearly states:

Aminocaproic acid Amicar should not be administered with Factor IX complex Konyne as this may increase the risk of thrombosis.

The only, narrow, exception, is limited to certain dental surgeries, and, even in the context of that extremely narrow exception, administration of the two drugs is serial and not simultaneous. Even then, there is a school of thought which opposes even the serial administration of the two drugs in that limited context. Even the hospital's own expert in this case could not find any authority to permit the simultaneous administration of Konyne and Amicar.

Miles-Cutter's Br. in Support, pp. 6-7; Lederle's Br. in Support, pp. 11-12. See also Lederle's Br. in Support, Ex. D.

II

Summary judgment is appropriate when the record reveals that there are no issues as to any material fact in dispute and the moving party is entitled to judgment as a matter of law. Fed.R.Civ.P. 56(c); Celotex Corp. v. Catrett, 477 U.S. 317, 322-23, 106 S.Ct. 2548, 2552, 91 L.Ed.2d 265 (1986); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 2510, 91 L.Ed.2d 202 (1986). The standard for determining whether summary judgment is appropriate is "whether the evidence presents a sufficient disagreement to require submission to a jury or whether it is so one-sided that one party must prevail as a matter of law." Liberty Lobby, 477 U.S. at 251-52, 106 S.Ct. at 2512. "By its very terms, this standard provides that the mere existence of some alleged factual dispute between the parties will not defeat an otherwise properly supported motion for summary judgment; the requirement is that there be no genuine issue of material fact." Id., 477 U.S. at 247-48, 106 S.Ct. at 2510 (emphasis in original).

The Court must consider all pleadings, depositions, affidavits, and admissions on file, and draw all justifiable inferences in favor of the party opposing the motion. Matsushita Elec. Ind. Co. v. Zenith Radio Corp., 475 U.S. 574, 587, 106 S.Ct. 1348, 1356, 89 L.Ed.2d 538 (1986). However, the moving party is not required to expressly negate the opponent's claim. Celotex, 477 U.S. at 323, 106 S.Ct. at 2552. The movant satisfies its initial burden merely "by pointing out to the court that the respondent, having had sufficient opportunity for discovery, has no evidence to support an essential element of his or her case." Street v. J.C. Bradford & Co., 886 F.2d 1472, 1479 (6th Cir.1989).

Once the movant makes a sufficient showing of an absence of evidence to support the non-moving party's case, the non-moving party then assumes the burden of coming forward with evidence demonstrating a genuine issue of material fact. Celotex, 477 U.S. at 324-25, 106 S.Ct. at 2553. The non-moving party may not rest on the mere allegations contained in the pleadings, but, rather, must set forth specific facts showing that there is a genuine issue for trial. Fed. R.Civ.P. 56(e). "The mere existence of a scintilla of evidence in support of the non-moving party's position will be insufficient." Liberty Lobby, 477 U.S. at 252, 106 S.Ct. at 2512. The non-moving party "cannot rely on the hope that the trier of fact will disbelieve the movant's denial of a disputed fact, but must present...