Willett v. Baxter Intern., Inc.

Decision Date01 May 1991
Docket NumberNo. 90-3418,90-3418
Citation929 F.2d 1094
PartiesProd.Liab.Rep.(CCH)P 12,816 Gene Earl WILLETT, And All Patients Who Have Received Implants of the Edwards Duromedics Aortic Bileaflet Valve, Model, 3160, Plaintiffs-Appellants, Mrs. Albert Spriggins, Intervenor-Appellant, v. BAXTER INTERNATIONAL, INC., and Edwards Duromedics, a/k/a Edwards Division of Baxter International, Inc., and Baxter Healthcare Corp., Defendants-Appellees.
CourtU.S. Court of Appeals — Fifth Circuit

James E. Uschold, David Oestreicher, II, Oestricher, Whalen & Hackett, New Orleans, La., for plaintiffs-appellants.

Donna Guinn Klein, Stephanie M. Lawrence, McGlinchey, Stafford, Cellini & Lang, New Orleans, La., Lee David Thames, J. Carter Thompson, Jr., Jackson, Miss., for Baxter Intern.

William F. Bologna, Habans, Bologna & Carriere, New Orleans, La., for Edwards Duromedics.

Appeal from the United States District Court for the Eastern District of Louisiana.

Before WISDOM, KING, and JOLLY, Circuit Judges.

WISDOM, Circuit Judge:

The plaintiff, Gene Earl Willett, sued the defendants, Baxter Healthcare Corporation ("Baxter") and Carbomedics, Inc., seeking to recover for his fear that his allegedly defective heart valve, manufactured by the defendants, would fail. 1 Mrs. Albert Spriggins, and her husband, intervened in the action, seeking the same recovery. Upon the motion of the defendants, the district court granted summary judgment in favor of the defendants holding that the valves of the plaintiff and the intervenor were not defective and that Louisiana did not recognize a right of recovery for the fear that the valves may fail in the future. While we disagree with some of the reasoning of the district court, we AFFIRM because the plaintiff, and the intervenor, have failed to present sufficient evidence to enable a reasonable jury to find that the valves were defective.


In January of 1988, Dr. White E. Gibson III, a New Orleans cardiovascular surgeon, replaced deteriorating heart valves in both Willett and Mrs. Spriggins with artificial heart valves manufactured by the defendants. 2 In June of 1988, Willett read an article in his local paper that discussed Baxter's voluntary suspension of the marketing of the valves. Willett filed this action less than a week later. After reading of the lawsuit in the paper, Mrs. Willett and her husband intervened.

Each artificial heart valve has two leaves, made of pyrolitic carbon, that control the flow of blood through the valve. The voluntary recall was prompted by several reports of a phenomenon known as "leaflet escape". Leaflet escape refers to the in vivo escape of one of the two leaflets that controls the flow of blood through the valve.

The plaintiff and the intervenor alleged that their valves were defective in that pyrolitic carbon was not well-suited for use in heart valves because of the possibility of stress fractures in the material. The plaintiff and the intervenor do not deny that their valves are currently functioning properly. Instead, they seek damages for their fear that their valves will fail in the future.

After a suitable time for discovery, the defendants moved for summary judgment. To support the motion, the defendants filed the affidavits of Dr. Gibson, the surgeon who performed the operations, and Mr. William G. Swartz, an epidemiologist employed by Baxter. The plaintiff, and the intervenor, responded with sealed documents obtained from another court case involving the valves. 3 The plaintiff and the intervenor argue that these documents establish that pyrolitic carbon is an inappropriate material for use in heart valves.

Taken together, the summary judgment evidence established that approximately 19,614 patients received these valves between 1982 and the first quarter of 1990. Since the valves were first implanted, only seventeen cases of leaflet escape have been reported. Of the seventeen reported cases, fifteen involved mitral valves, and two involved aortic valves. All seventeen cases occurred in valves manufactured before April of 1986. The valves of both the plaintiff and the intervenor were manufactured after April of 1986. Of the valves manufactured since April of 1986, no failures have been reported. 4

From the evidence, a reasonable jury could conclude that leaflet escape is caused by stress fractures in the pyrolitic carbon. From the evidence, it appears that pyrolitic carbon is very resistant to the start of a stress fracture. But once a stress fracture has begun, the fracture will grow at a fairly steady rate, and may eventually lead to leaflet escape.

Baxter published at least three Clinical Reports documenting the leaflet escape problem in January of 1987, November of 1987, and January of 1988. The articles described the failures that had occurred to date. While the reports stated that the cause (or causes) of the failures was uncertain, the articles suggested that the problem may have been caused by improper surgical technique. Specifically, the reports suggested that, during the surgical procedure, a valve may have been scratched or improperly exposed to certain chemicals. This scratch or improper exposure created a weak spot in the leaflet, where a stress fracture could begin.

In contrast, the plaintiff and the intervenor argue that the manufacturing process inevitably leads to weak spots in the leaflets. They rely on the deposition testimony of one Dr. Harvey Miller Flower, taken from the sealed court records. According to Dr. Flower, soot pockets can form in pyrolitic carbon during manufacture. If not discovered, the soot pocket might weaken the leaflet sufficiently that a stress fracture can begin. Notably, the expert did not testify that another material was more suitable than pyrolitic carbon for use in the valves, or that a different manufacturing or quality control process could have reduced a theoretical soot pocket problem. Dr. Flower also did not testify as to how often undiscovered soot pockets would develop given the manufacturing and quality control process used by the defendants.

The plaintiff and the intervenor provided no evidence that their particular valves actually suffered from a soot pocket problem, and no evidence that their valves were not performing as designed. On the contrary, their surgeon, Dr. Gibson stated, in his affidavit, that the valves implanted in both Willett and Mrs. Spriggins were functioning normally. He also stated that, to a reasonable degree of medical certainty, the valve replacement had saved their lives and greatly improved their quality of life.

The district court granted summary judgment in favor of the defendants. The district court held that the valves were functioning normally and were therefore not defective, and that Louisiana did not recognize a cause of action for the fear that the valves would become defective. The plaintiff and the intervenor have appealed arguing that the valves can be defective even though they have not yet failed, and that their fear and mental anguish should be recognized as a cognizable injury under Louisiana law.


To recover under Louisiana products liability law, a plaintiff must show: (1) that the product was defective and (2) that the defective aspect of the product caused a legally cognizable injury to the plaintiff. 5 A plaintiff may show that a product is defective by showing that:

(1) the product is unreasonably dangerous per se ; or

(2) the product was defectively manufactured; or

(3) the product was defectively designed; or

(4) the manufacturer failed to warn of a non-obvious danger inherent in the normal use of the product. 6

While the question of whether a product is defective is ordinarily one of fact, 7 to avoid summary judgment, the plaintiff and the intervenor must point to sufficient evidence in the record to make the fact issue a genuine one. 8 If there is insufficient evidence to enable a reasonable jury to find that the heart valves were defective, then we must affirm the district court's decision. We consider each possible defect theory in turn.

First, to establish that a product is unreasonably dangerous per se, a plaintiff must show that the likely harm of the product outweighs its benefit. 9 Based on the summary judgment evidence, a reasonable jury could not find that the pyrolitic carbon heart valves are unreasonably dangerous per se. The undisputed evidence establishes that the valves have extended over nineteen thousand lives. While the valve replacement was not successful in every case, the undisputed evidence established that, even with the risk of leaflet escape, a patient has a much greater chance for life with the valve replacement than without the replacement. From the record, the only reasonable conclusion is that the clear life-saving benefits of the heart valve outweigh its risks.

Second, the plaintiff and the intervenor argue that the existence of soot pockets in some valves is sufficient to create a factual issue as to whether their valves have soot pockets. While we agree that a soot pocket may be a manufacturing defect, the mere possibility of a manufacturing defect is not sufficient to establish the fact of a manufacturing defect in the valves implanted in the plaintiff and the intervenor. 10

Third, the plaintiff and the intervenor argue that pyrolitic carbon is not suited for use in a heart valve, and that its use establishes a defect in the design of the product. The use of a pyrolitic carbon heart valve can be considered a design defect under Louisiana law if:

(1) A reasonable person would conclude that the danger-in-fact, whether foreseeable or not, outweighed the utility of the product;

(2) The defendants knew, or should have known, of another product that would serve the same need with less risk; 11 or

(3) The defendants knew, or should have known, of a material more suitable than pyrolitic carbon at the time they manufactured the valves. 12

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