Knowlton v. Deseret Medical, Inc.
| Decision Date | 05 March 1991 |
| Docket Number | No. 89-2139,89-2139 |
| Citation | 930 F.2d 116 |
| Parties | Prod.Liab.Rep.(CCH)P 12,804 Mark T. KNOWLTON, et al., Plaintiffs, Appellees, v. DESERET MEDICAL, INC., Defendant, Appellant. . Heard |
| Court | U.S. Court of Appeals — First Circuit |
Jeffrey S. Stern with whom Tina M. Traficanti, Ellen K. Wade and Sugarman, Rogers, Barshak & Cohen were on brief, Boston, Mass., for defendant-appellant.
Terrence D. Garmey with whom Smith & Elliott were on brief, Saco, Me., for plaintiffs-appellees.
Before CYR, Circuit Judge, COFFIN and BOWNES, Senior Circuit Judges.
The main issue on this appeal requires us to determine under Massachusetts law the duty to warn imposed on the manufacturer-seller of medical devices used during open-heart surgery and the closely related question of causation. Plaintiffs-appellees Mark Knowlton and his mother, Bonnie B. Tetrault, brought suit for injuries from chemical burns incurred by Knowlton during open-heart surgery at Children's Hospital in Boston. The jury found that defendant-appellant Deseret Medical, Inc. was liable for failing to adequately warn the surgeon-user of the danger involved in the manner in which the surgeon used the devices.
The purpose of the surgery was the insertion of two artificial heart valves to replace the natural valves which had been damaged by disease. Part of the surgical procedure required placing catheters, small hollow flexible tubes, directly into the left and right atria of the heart. 1 The catheters are called atrial lines. This case concerns only the right atrial line, which was used to carry a drug Nitroprusside (Nipride) into the right atrium during the immediate post-operative period. In order for the catheter to infuse the drug into the heart, it had to be attached to the container holding the solution of Nipride. The focus of this case is the method used by the surgeon to ensure that the Nipride solution flowed from its container through the catheter tubing into the right atrium of the patient's heart.
One end of the catheter was inserted directly into the right atrium by the surgeon during the open-heart part of the operation. A hollow needle with sharp beveled edges near the point was inserted through the chest wall. When the surgeon was able to see the point of the needle in the chest cavity, he inserted the other end of the catheter into the point of the needle and threaded it into the needle from the point to the hub. This is called retrograde threading. The needle and catheter were then pulled back through the chest wall. The catheter was then cut and tied so that enough protruded from the chest wall to allow it to be attached to another tube leading to the container of Nipride solution.
On the day following the surgery, a nurse noticed that the gauze on the patient's chest dressing was wet. She called the attending physician, Dr. Richard Jonas, who removed the catheter, found a small hole in it and discarded it. Dr. Jonas was not a member of the operating team. It was subsequently determined that Nipride had leaked from the catheter onto the chest and abdominal walls of the patient causing extensive and intensive chemical burns. There was significant scarring and substantial plastic surgery was required. At the time of the open-heart surgery, the plaintiff Mark Knowlton was fifteen years old.
The plaintiffs sued Deseret Medical, Inc., the manufacturer-seller of the catheter and needle used during the open-heart surgery. They alleged: (1) breach of warranty and negligence in the design of the catheter and needle; (2) breach of warranty and negligence in the manufacture of the catheter and needle; and (3) breach of warranty and negligence in failing to give an adequate warning of the danger involved in the use of the catheter and needle. Under Massachusetts law, a count for breach of warranty is "intended to be fully as comprehensive as the strict liability theory of recovery that has been adopted by a great many other jurisdictions." Back v. Wickes Corp., 375 Mass. 633, 378 N.E.2d 964, 968 (1978).
The plaintiffs also brought medical malpractice claims against Dr. William Norwood, the chief surgeon during the operation, and two other doctors involved in the open-heart surgery, Dr. Robert Emery and Dr. William Parks. Dr. Richard Jonas was also sued. Malpractice claims were also brought against Children's Hospital and three nurses. Prior to trial, the claims against Dr. Jonas, Children's Hospital and the three nurses were dropped.
The case was tried to a jury over a period of four and one-half weeks with Magistrate Robert B. Collings presiding by agreement of counsel. Thirty interrogatories were submitted to the jury. After eight days of deliberation, the jury returned the following verdicts. It found Dr. Emery and Dr. Parks not liable. There were two separate claims of medical malpractice against the chief surgeon, Dr. Norwood. The jury found that Dr. Norwood was not negligent in the manner in which he inserted the catheter into the right atrium and withdrew it through the chest wall during the open-heart surgery. The jury did find that Dr. Norwood was negligent in suturing the implant valves into Mark's heart. The jury awarded $20,000 in damages to the plaintiff-patient and $32,337.03 to his mother against Dr. Norwood, who is not an appellant in this case.
The jury made the following findings as to the liability of Deseret. It found that Deseret was neither negligent nor liable for breach of warranty in the design of the catheter and needle. The jury found that Deseret had not breached its warranty in respect to the manufacture of the catheter and needle. It found that Deseret was negligent in the manufacture of the devices but that this negligence was not a proximate cause of the injury. As to warning, however, the jury found liability. It found that Deseret breached its warranty because it failed to provide an adequate warning of the danger inherent in the use of the catheter and needle or properly instruct foreseeable users of the catheter and needle. It also found that Deseret was negligent in respect to warning and proper instruction. The jury further found that this breach of warranty and negligence were proximate causes of the injury sustained by Mark Knowlton. It awarded him $337,500 in damages and his mother, $37,455.06.
Deseret has appealed from the denial of its motion for judgment n.o.v. or, in the alternative, for a new trial. In addition to the warning-causation issue, Deseret assigns two other errors to the trial court: refusal to instruct the jury that expert testimony on failure to warn was required; and an evidentiary ruling excluding certain testimony by Dr. Norwood.
The standard for reviewing the denial of a motion for judgment n.o.v. has been stated as follows:
When considering an appeal from the denial of motions for directed verdict and judgment n.o.v., this court must view all the evidence in the light most favorable to the plaintiff, and draw all reasonable inferences in the plaintiff's favor. To overrule the denial of defendant's motions we must find that the facts and the inferences drawn from the facts can reasonably lead to only one conclusion.
Payton v. Abbott Labs, 780 F.2d 147, 156 (1st Cir.1985). See also Santiago Hodge v. Parke Davis & Co., 909 F.2d 628, 634 (1st Cir.1990); Venturelli v. Cincinnati, Inc., 850 F.2d 825, 833 (1st Cir.1988).
The first question is whether the evidence was sufficient for the jury finding that defendant failed to warn or instruct adequately foreseeable users of its catheters and needles.
Defendant manufactured and sold to hospitals and doctors a catheter placement unit known as Intracath, which had the following component parts: tubing (also called the catheter), a needle with sharp beveled edges leading to the point, a needle guard, a flow control plug in the needle hub, a wire eyelet and a bevel cover. The directions for use were printed on a rolled-up sheet of paper that was inserted into the package containing the Intracath. The directions on the insert make it clear that the primary use of the Intracath was for venipunctures: the insertion of the needle and catheter tubing into a vein. There is no mention or suggestion in the directions that the catheter could also be used for insertion into the atrium of the heart during open-heart surgery and that the needle could be used to withdraw the catheter through the chest wall, as was done in this case. The only warning given in the insert stated:
There was testimony, however, from which it could be found that Jacqueline Fraley, manager, Quality Assurance Professional Services of Deseret, knew that catheters and needles from the Intracath unit were used as atrial lines during open-heart surgery. Glen Kazanowski, a field representative and salesman for Deseret, testified that he learned that the Intracath was being used in open-heart surgery at Massachusetts General Hospital. Deseret's manager of catheter products, Brad Bell, disclaimed any knowledge of such use, but he and the two other employees acknowledged that retrograde threading of the catheter through the needle point to the hub posed a significant risk that the catheter tube might be cut or nicked in the process. Dr. David Lentz, vice-president in charge of research and development for Deseret's medical products, was aware that catheters had been nicked or shredded due to "retrograde passage." He acknowledged that retrograde threading of the catheter into the needle posed a danger of damaging the catheter. Dr. Lentz further testified that Deseret took no steps to warn surgeons that retrograde threading should not be done.
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