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Phelps v. Sherwood Medical Industries and Argyle Associates

decided: December 17, 1987.


Appeal from the United States District Court for the Northern District of Indiana, South Bend Division. No. 85 C 281 - Robert L. Miller, Jr., Judge.

Cummings, Cudahy and Kanne, Circuit Judges.

Author: Cummings

CUMMINGS, Circuit Judge.

This diversity strict products liability tort action for $2,000,000 presents various claims of error by the plaintiff involving the district court's giving and refusal to give several jury instructions tendered by the parties. Viewing the instructions provided by the court as a whole, United States v. Grier, 823 F.2d 177, 178 (7th Cir. 1987), we hold that the charges to the jury concerning both the defendants' duty to warn as well as their defenses to negligence and strict liability accurately led the jury to a proper understanding of the relevant Indiana law. Because those instructions treated the issues fairly and accurately, we affirm the judgment for defendants.

It is important initially to set this products liability case in its proper perspective. In recent years, litigation dealing with the use and side effects of potentially dangerous products such as prescription drugs has increased considerably, creating a greater public awareness of the problems inherent in protecting consumers.*fn1 Courts also have been deluged with claims of injury resulting from the use of defective medical devices. See, e.g., Terhune v. A.H. Robins Co., 90 Wash. 2d 9, 577 P.2d 975 (1978) (Dalkon Shield litigation). The medical-device industry is a multi-billion dollar enterprise; yet until recently, few medical-device cases were litigated. Foote, Loops and Loopholes: Hazardous Devise Regulation Under the 1976 Medical Device Amendments to the Food, Drug and Cosmetic Act, 7 ECOLOGY L.Q. 101, 103 (1978). This is surprising, given that the public has been made aware of the problem for at least fifteen years. In 1970, a federal survey of the preceding ten-year period revealed some 512 deaths and 300 injuries connected with heart-valve implants, 89 deaths and 186 injuries from pacemakers, 47 deaths and a number of injuries from anesthesia machines, 28 deaths and 171 injuries from the use of catheters, more than 8,000 injuries caused by intrauterine devices (IUD) - this was before the most recent IUD revelations - more than 2,000 injuries associated with radiation equipment, and scores more injuries related to other devices. See Hearings on Medical Device Amendments Before Subcommittee on Health of the Senate Committee on Labor and Public Welfare, 93d Cong., 1st Sess. 877-878 (1973).

By definition in the Food, Drug and Cosmetic Act, a "medical device" includes the catheter at issue because it is -

an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is -

(1) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,

(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

(3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes.

21 U.S.C. § 321(h) (1970). However, plaintiff does not allege that this catheter was misbranded within 21 U.S.C. § 352 for want of adequate labeling.

In the prescription drug area, which has been the focus of substantially more attention than the medical-device industry, manufacturers are required by law to warn the medical profession of all known dangers involved in the use of their products in order to prevent adverse drug effects. 21 C.F.R. § 201.57 (1983).*fn2 This requirement compels the physician to act as a "learned intermediary," advising his or her patient of the benefits as well as the inherent risks in the use of a particular product. By adequately warning the doctor, the manufacturer fulfills its duty and avoid any liability for failure to warn. See Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th Cir. 1974), certiorari denied, 419 U.S. 1096, 42 L. Ed. 2d 688, 95 S. Ct. 687 .

The Illinois Supreme Court recently adopted this principle in Kirk v. Michael Reese Hospital and Medical Center, 117 Ill. 2d 507, 111 Ill. Dec. 944, 513 N.E.2d 387 (1987), reversing 136 Ill. App. 3d 945, 483 N.E.2d 906, 91 Ill. Dec. 420 (1985), thus joining the majority position regarding prescription drug warnings. A minority of jurisdictions, however, have held that the manufacturer's duty to warn extends beyond the prescribing physician to the consumer. See, e.g., Lindsay v. Ortho Pharmaceutical Corp., 637 F.2d 87 (2d Cir. 1980); Lukaszewicz v. Ortho Pharmaceutical Corp., 510 F. Supp. 961 (E.D. Wis. 1981), amended by 532 F. Supp. 211 (E.D. Wis. 1981). Those cases requiring warnings to consumers have involved oral contraceptives: since the dispenser of those products may not be a physician (as in a clinic), the careful balancing of risks to the individual patient may not occur, and therefore an extended warning is appropriate.

There is a dearth, however, of reported decisions regarding the manufacturer's duty to warn physicians about dangers in the use of medical devices. This case concerns applying the principles of medical-device defect liability to the allegedly defective heart catheter used here. The essential facts, construed as favorably to the defendant (since it won a jury verdict) as the record permits, see Tippecanoe Beverages, Inc. v. S.A. El Aguila Brewing Co., 833 F.2d 633, slip op. at 1 (7th Cir. 1987), are as follows: Plaintiff Roger N. Phelps, a resident of Indiana, underwent a single coronary artery bypass operation at Memorial Hospital in South Bend, Indiana, on May 18, 1983. During open-heart surgery, Dr. John Rubush inserted a catheter manufactured by the defendants, Sherwood Medical Industries and Argyle Associates ("Sherwood"),*fn3 into the left atrium of Phelps' heart to monitor his post-operative condition. This catheter was held in place by a "purse-string" suture*fn4 and pursued a serpentine path to the left atrial cavity.

After the surgery Nurse Lydia Vaught encountered some resistance in attempting to remove the catheter. The catheter broke and a portion remained inside Phelps' heart. Vaught then contacted Rubush's partner, Dr. Ross Gardner. Vaught later testified at trial that had she known the catheter was sutured to Phelps' pulmonary vein, she would not have tried to remove it. Dr. Rubush's deposition was read into evidence. He testified that before this surgery, he had heard of a similar breakage and that the suture to a patient's superior pulmonary vein and the catheter's routing might prevent removal of the catheter.

When Phelps learned about the breakage, he went to the Cleveland Clinic Foundation. After an examination, Dr. Bruce W. Lytle determined that the risks of removing the catheter remnant outweighed the risks of leaving it in his heart, stating: "Our conclusions are that we do not think that it is in the patient's interest to have anything done about this foreign body at this time" (Pl. Ex. 9).

Both sides produced demonstrative evidence and expert testimony at trial. Phelps contended that Sherwood was liable because its catheter broke upon Nurse Vaught's attempted removal. Phelps claims that this was due to an alleged defect in the catheter's inability to stretch before separating. Furthermore, he alleged that Sherwood failed to warn of this potential hazard. All these issues went to the jury, which ultimately found for Sherwood. On appeal, Phelps attacks the giving of five of Sherwood's instructions and the refusal of four of his proposed instructions. In reviewing the trial court's actions, some deference should be accorded to that court's intepretation of Indiana law. Rush Presbyterian St. Luke's Medical Center v. Safeco Ins. Co. of America, 825 F.2d 1204, 1206 (7th Cir. 1987). Moreover, regarding Phelps' claims of erroneous instructions, ...

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