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,
It is important initially to set this products liability case in its proper pеrspective. 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.
1
Courts also have been deluged with claims of injury resulting from the use of defective medical devices. See,
e.g., Terhune v. A.H. Robbins Co.,
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 *299 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 fоr 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).
2
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 avoids any liability for failure to warn. See
Reyes v. Wyeth Laboratories,
The Illinois Supreme Court recently adopted this principle in
Kirk v. Michael Reese Hospital and Medical Center,
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.,
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 еvidence. 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 *300 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 interpretation of Indiana law.
Rush Presbyterian St. Luke’s Medical Center v. Safeco Ins. Co. of America,
Probably the principal and most interesting issue pressed on appeal — the one that deserves the greatest attention — concerns Phelps’ primary claim that Sherwood had a duty to warn users of the catheter “down-line” (defendants’ terminology) from Dr. Rubush, the operating surgeon. Ru-bush was warned by the label on the container that the catheter was not to be removed while its needle was in place. Neither Phelps’ counsel's brief nor his oral argument attacks the adequacy of that warning. Instead he contends that the trial court erred by instructing the jury in a strict products liability action under Indiana law that the “user” of the catheter employed in Phelps’ open-heart surgery was Rubush so that he was the sole person entitled to a warning. At the close of the evidence, the district court gave portions of Sherwood’s instructions numbers two and five and refused Phelps’ tendered instruction number ten. The court instructed the jurors:
If you find from the evidence in this case that Doctor Rubush had knowledge, in his intended use of this Defendants’ catheter, that there was danger of breaking of said catheter upon attempted removal because of the route and obstructions existent in the application of this catheter, then you are instructed that the Defendants had no duty to warn with respect to such potential properties since they were already known to the user, the operating surgeon. (Emphasis added) (Sup.App. 72-73).
The court further instructed the jury that: In this case the user of the product is the operating surgeon, Doctor Rubush (Sup. App. 74).
The court thus limited Sherwood’s duty to warn to Rubush as the “user” or consumer of the product. Phelps contends the duty extended at least to Nurse Vaught, who attempted to remove the catheter, and perhaps even to Phelps, whose body is unfortunately “using” the catheter to this day. He argues that there was no Indiana law supporting the district court’s instruction and that a warning by Sherwood, if required, should have a broader scope and should not merely be limited to the “operating surgeon,” Rubush. Sherwood responds that it had the duty to warn only Rubush, who, as a “learned intermediary,” should then have passed on any potential dangers of catheter use to Vaught and Phelps. Sеe
Ortho Pharmaceutical Corp. v. Chapman,
180 Ind,App. 33,
*301 Initially this Court must examine Indiana strict products liability law in order to determine Phelps’ burden of proof in his action for strict liability. In 1978, the Indiana legislature codified the doctrine of strict products liability in Indiana Code § 33-1-1.5-3. Section 33-1-1.5-3 states:
Sec. 3. Codification and Restatement of Strict Liability in Tort. Thе common law of this state with respect to strict liability in tort is codified and restated as follows:
(a) One who sells any product in a defective condition unreasonably dangerous to any user or consumer or to his property is subject to liability for physical harm thereby caused to the user or consumer or to his property if that user or consumer is in the class of persons that the seller should reasonably foresee as being subject to the harm caused by the defective condition, and, if:
(1) the seller is engaged in the business of selling such a product, and
(2) the product is expected to and does reаch the user or consumer without substantial change in the condition in which it is sold.
(b) The rule stated in Subsection (a) applies although:
(1) the seller has exercised all possible care in the preparation and sale of this product, and
(2) the user or consumer has not bought the product from or entered into any contractual relation with the seller.
Ind.Code § 33-1-1.5-3 (1983 Supp.). Thus, to establish liability on Sherwood's part, Phelps is required to demonstrate that Sherwood sold a “product in a defective condition unreasonably dangerous to any user.” Ind.Code § 33-l-1.5-3(a) (1983 Supp.). In
Bemis Company, Inc. v. Rubush,
Under the present statute adopted in 1978, Indiana law defines “user” of a product as follows:
“User or consumer” means a purchaser, any individual who uses or consumes the product, or any other person who, while acting for or on behalf of the injured party, was in possession and control of the product in question, or any bystander injured by the product who would reasonably be expected to be in the vicinity of the product during its reasonably expected use.
Ind.Code § 33-1-1.5-2 (emphasis added). This term is further explained by comment 1 to Restatement of Torts (Second) § 402(A), which reads, in part, as follows:
User or consumer. In order for the rule stated in this Section to apply, it is not necessary that the ultimate user or consumer have acquired the product directly from the seller, although the rule applies equally if he does so. He may have acquired it through one or more intermediate dealers. It is not even necessary that the consumer have purchased the product at all. He may be a member of the family of the final purchaser, or his employee, or a guest at his table, or a mere donee from the purchaser. The liability stated is one in tort, and does not require any contractual relation, or privi *302 ty of contract, between the plaintiff and the defendant.
“Consumers” include not only those who in fact consume the product, but also who prepare it for consumption; and the housewife who contracts tularemia while cooking rabbits for her husband is included within the rule stated in this Section, as is also the husband who is opening a bottle of beer for his wife to drink. Consumption includes all ultimate uses for which the product is intended, and the customer in a beauty shop to whose hair a permanent wave solution is applied by the shop is a consumer. “User” includes those who are passively enjoying the benefit of the product, as in the cаse of passengers in automobiles or airplanes, as well as those who are utilizing it for the purpose of doing work upon it, as in the case of an employee of the ultimate buyer who is making repairs upon the automobile which he has purchased.
Restatement (Second) of Torts § 402(A), comment 1 (1977) (emphasis added). Further, a product is considered defective, pursuant to Indiana law, if the seller fails to:
[G]ive reasonably complete instructions on proper use of the product; when the seller, by exercising reasonable diligence, could have made such warnings or instructions available to the user or consumer.
Ind.Code § 33-l-1.5-2.5(b)(2). By law, the catheter in this case could only be sold to physicians; thus Sherwood claims that only Rubush, and not Sherwood, should have warned either Vaught or Phelps, neither of whom was the “user or consumer.”
Physician as User or Consumer.
Should Rubush be considered a “consumer” or “user” of the catheter for purposes of this case? There are no reported Indiana cases directly on point, but
Chapman
holds that a prescription drug manufacturer need only warn the patient’s physician and by analogy controls here (see
supra,
p. 301 and
infra,
p. 304). Similarly, in treating a physician as the “consumer” of a drug, the California appеllate court in
Carmichael v. Reitz,
Here Rubush stood in a similar position. He received the label warning from Sherwood and thus should certainly be considered as a “user” of the catheter. Ru- *303 bush also fits into the Restatement’s definition of “consumer” since he prepared and employed the catheter for ultimate “consumption” by Phelps. Even more significantly, he utilized the catheter for the purpose of surgery. This characterization of Rubush as “user” requires a discussion of his role as a “learned intermediary.”
Physician as Learned Intermediary.
Sherwood correctly contends that the intervention of a professional intermediary— here Rubush — affects its duty to warn of potential dangers of its catheter’s use. Indiana courts have held that the “duty to warn of hazards associated with prescription drugs is part and parcel of the physician-patient relationship.”
Ingram v. Hook’s Drugs, Inc.,
In
Chapman,
the prescription drug manufacturer discharged its duty to warn by warning a patient’s physician.
In judging Phelps’ challenge to the particular jury instruction that Rubush was the “user” or “consumer” of the catheter (quoted
supra,
p. 300), it must be determined whether the instructions overall conveyed the “correct message” to the jury.
Liquid Air Corp. v. Rogers,
1. Sherwood attempted to avail itself of the “open and obvious” defense. As a matter of law in Indiana, an open and obvious danger bars an action under the Product Liability Act, §§ 33-1-1.5-4,
et seq.
See
Ruther v. Robins Engineering and Constructors,
The facts developed at trial showed that the suturing of Sherwood’s catheter to a patient presented the danger of separation. In his deposition, Rubush testified that he knew of this potential hazard: specifically the suture of the catheter to Phelps’ pulmonary vein and its routing could obstruct its removal. Phelps, however, contends otherwise, viz., that the possible сatheter breakage was not open and obvious.
While Sherwood would not be liable for obvious dangers associated with the risks of catheter use, it was bound to avoid any hidden defects or concealed dangers in its product.
Dudley Sports Co. v. Schmitt,
2. An unforeseeable misuse of a product also bars an action under Indiana law. Such a defense to liability is contained in Indiana Code § 33-1-1.5-4. See
Ruther,
3. Phelps was not required to prove that the alleged defect he attributes to Sherwood was the sole cause of his injury; it would be sufficient under Indiana law if the defect, combined with other reasonable or foreseeable intervening forces, constituted a proximate cause of his injuries. Modification of the catheter, however, if unforeseeable, could constitute an efficient intervening cause of Phelps’ injuries. Under Indiana law, Phelps could prevail under strict products liability theory only if he could demonstrate that the allegedly defective product reached him “without substantial alteration in the condition in which it is sold” and that his injuries were caused as a result of the defective product. Ind.Code § 33-1-1.5-3 (1983 Supp.). The Indiana courts have held that “any change which increases the likelihood of a malfunction ...
is a substantial change." Cornеtte v. Searjeant Metal Products, Inc.,
Sherwood asserted that its catheter was substantially altered by being connected to Phelps’ heart with a “purse-string” suture, and that this method and routing of the catheter increased the likelihood of a malfunction such as the separation of the catheter’s tubing upon any attempted removal. If the particular modifications were foreseeable and did not unforeseeably render the catheter unsafe, the alterations would be a non-intervening cause leading to Phelps’ injury.
Craven v. Niagara Machine and Tool Works,
4. The jury was instructed on the “state of the art defense” provided in Indiana Code § 33 — 1—1.5—4(b)(4):
Whenever the physical harm is caused by the plan or design of the product, it is a defense that the methods, standards, or techniques of designing and manufacturing the product were prepared and applied in conformity with the generally recognized state of the art at the time the product was designed or manufactured.
*305
Phelps claimed that Sherwood’s catheter was defective in both design and manufacture. In arguing that the court erred in giving its charge, he relies on a statemеnt by the Indiana Court of Appeals: “The fact that a particular product meets or exceeds the requirements of its industry is not conclusive proof that the product is necessarily safe.”
Dudley Sports Co. v. Schmitt,
5. The subject matter of Phelps’ remaining proposed instructions regarding negligence, “environmental use” of the product, and strict liability were adequately covered in the court’s various jury charges. “It is not necessary to give a proposed instruction ‘where the essential points are covered in another instruction.’ ”
Liquid Air Corp. v. Rogers,
Finally, Phelps contends that the trial court did not properly instruct the jury on the failure to warn under strict products liability. In
Black v. Henry Pratt Co.,
Sherwood only had a duty to warn of those dangers which it knew or should have known at the time it distributed its catheter. Cf.
Woodill v. Parke, Davis & Co.,
Phelps fails to demonstrate that the court erred in either giving Sherwood’s or refusing his own tendered instructions. The court appropriately adhered to the principles of
Erie R. Co. v. Tompkins,
Affirmed.
Notes
. The majority of cases have involved the drug MER/29 (used in the treatment of high cholesterol), see,
e.g., Roginsky v. Richardson-Merrell,
.As far as we are advised, no comparable regulation governs medical devices.
.Sherwood has its principal place of business in Missouri, and Argyle, a division of Sherwood, has its principal place of business in New York. Diversity of citizenship is thus proper under 28 U.S.C. § 1331. See
Rush Presbyterian St. Luke's Medical Center v. Safeco Ins. Co. of America,
.This type of suture "is placed around [the catheter] to hold it in place, not tightly, but [to] hold it there so it doesn’t get pulled out and so that [the physician] can easily dislodge it” (Ru-bush Dep. at pp. 14, 56).
. Within the last several years an innovative theory of liability has been successfully maintained against manufacturers of drugs and medical devices. These manufacturers have been held liable to doctors for the economic and emotional injuries they suffered as a result of harm caused to their patients by the manufacturers’ products. See,
e.g., Conlee v. McGhan Medical,
No. 81-4062 (Tex., Nuecas County District Court, Dec. 15, 1983) (Texas jury returned a $11.1 million award, including $10 million in punitive damages, against the manufacturer of inflatable breast prostheses, finding it liable for the mental anguish caused and income lost by a doctor who replaсed forty-eight defective prostheses in his patients without charge);
Kennedy v. McKesson Co.,