underwent surgery and was required to warn his surgeon of this potential.
A manufacturer is under a continuing obligation to warn of a product's potential dangers of which it knew or should have known. A manufacturer is generally in the best position to discern and correct dangerous product defects, justifying placing this responsibility on it. See Baker v. St. Agnes Hospital, 70 A.D.2d 400, 421 N.Y.S.2d 81, 85 (App. Div. 1979). Nevertheless, a manufacturer is not under a duty to warn of each and every defect in a product -- the law properly limits the duty to dangerous defects that are not obvious.
Bravman primarily relies on New York cases requiring drug manufacturers to notify the medical community of their products' side effects in making this argument. From this, he appears to imply that a heart valve is an unavoidably unsafe product and that Baxter had an obligation to warn his surgeon of the noise potential. See Restatement (Second) of Torts § 402A comment k. Because Baxter failed to warn of this effect, the argument goes, it cannot avail itself of comment k's defense. See Lindsay v. Ortho Pharmaceutical Corp., 637 F.2d 87, 90 (2d Cir. 1980).
Comment k is applied most commonly to drugs because, unlike other products, "drugs may cause untoward side effects despite the fact that they have been carefully and properly manufactured". Lindsay v. Ortho Pharmaceutical Corp., 637 F.2d 87, 90 (2d Cir. 1980); see Restatement (Second) of Torts § 402A comment k (discussing Pasteur's rabies vaccine). Under its terms, an unavoidably unsafe product, "properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous". Id. (emphasis in original); see Baker, 421 N.Y.S.2d at 85.
A product is unavoidably unsafe if it has the potential to inflict a physical harm. See Lindsay, 637 F.2d at 93-94 (oral contraceptives that can cause stroke); Wolfgruber, 423 N.Y.S.2d at 96 (antibiotic with side effects of diarrhea and colitis); Baker, 421 N.Y.S.2d at 83 (anticoagulant with ability to cross placental barrier and cause fetal death); Restatement (Second) of Torts § 402A(1) ("physical harm thereby caused to the ultimate user of consumer"). The insertion of a mechanical heart valve indeed can have such side effects, including stroke and myocardial infarction. The record shows, however, that Bravman's surgeon knew of these risks and discussed them fully with Bravman. The two also discussed the difference between porcine valves and mechanical valves, with the surgeon recommending the insertion of the more durable mechanical valve.
The record also shows that Baxter and its predecessor knew that there were complaints about the noise generated by the Edwards-Duromedics Heart Valve. There was some concern over this effect, but no evidence that it could cause direct physical harm. In comparison, upon learning of relatively few instances of leaflet escape, Baxter took immediate action in warning the market and withdrawing the valve. This prudent action no doubt help save lives, given the low percentage of patients who have died from valve failure since the warning was circulated.
Life-threatening side effects readily fall within comment k's scope. A manufacturer is expected to warn about the possibility of danger so that doctors, as intermediaries, and others can make intelligent judgments concerning the risks associated with a product. See Willett, 929 F.2d at 1099. A noisy prosthetic device, however, does not pose such a threat. There is no evidence showing that the Edwards-Duromedics Heart Valve has inflicted any physical harm on Bravman, nor that a failure to warn him of the noise has placed him in physical danger, see Gerardi, 566 N.Y.S.2d at 1005. Indeed, the clicking indicates that the Edwards-Duromedics Heart Valve continues to regulate the flow of blood through Bravman's heart, as intended.
Whatever harm may exist in a noisy heart valve is far outweighed by the life-sustaining benefit the device confers. Bravman's proposed cause of action is novel and finds little support in New York law. Allowing Bravman to recover for his alleged injury would extend that law far beyond its present limits, a step this federal court is not prepared to take. See Garland v. Herrin, 724 F.2d 16, 20 (2d Cir. 1983). Baxter is therefore entitled to summary judgment against Bravman's claims as a matter of law.
II. Loss of Consortium
Mrs. Bravman's alleged claim for loss of consortium is derivative. Because her husband has failed to establish a claim, Baxter is entitled to summary judgment on her claim as well. See Jones v. United States, 720 F. Supp. 355, 369 (S.D.N.Y. 1989); Liff v. Schildkrout, 49 N.Y.2d 622, 427 N.Y.S.2d 746, 749, 404 N.E.2d 1288 (1980).
For the reasons set forth above, Baxter's motion for summary judgment is granted, and the Amended Complaint dismissed. Settle judgment on notice.
It is so ordered.
New York, N.Y.,
May 18, 1992
ROBERT W. SWEET