Nolan v. Dillon

Singley, J., delivered the opinion of the Court. In January 1968, Dr. David M. Nolan, a Montgomery County obstetrician, admitted Mrs. Linda Dillon, at that time 19 years of age, as his patient at Holy Cross Hospital in Silver Spring, where she was delivered of her first child. Mrs. Dillon was given two injections. The first, in preparation for delivery, was given at 12:45 a.m. and is only peripherally at issue.

At 1:50 a.m., prior to delivery, when Mrs. Dillon became unmanageable and had to be restrained, Dr. Nolan gave Mrs. Dillon a second injection — an intravenous injection of Sparine, or promazine hydrochloride, a drug compounded and sold by Wyeth Laboratories Division of American Home Products Corporation (American Home) for use in allaying apprehension and anxiety. 1 Immediately following the injection, Mrs. Dillon’s left hand became discolored and then cyanotic. Two anaesthesiologists attempted, without avail, to correct this by the use of stellate ganglion and brachial plexus blocks. Ultimately gangrene set in, and it became necessary to amputate the distal phalanges of Mrs. Dillon’s index, ring and little fingers. Mrs. Dillon and her husband sued Dr. Nolan in the Circuit Court for Montgomery County for negligence and American Home for negligence and breach of warranty, but dismissed the suit against American Home immediately prior to the commencement of trial.

Mr. Dillon had withdrawn from the case when he and his wife separated. Dr. Nolan filed a cross-claim against American Home, sounding in negligence and breach of warranty. 2 The case came on for trial before Levine, J., and a jury. At the conclusion of Dr. Nolan’s case American Home’s ⁵²⁰ motion for a directed verdict in its favor was granted. The jury returned a verdict of $72,500 against Dr. Nolan.

Dr. Nolan’s motion for a judgment n.o.v. or alternatively, for a new trial, was denied. From a judgment entered on the verdict and a judgment in favor of American Home for costs, Dr. Nolan has appealed. There are really only two crucial issues in this case, both questions of law. The first is whether there wag sufficient evidence of Dr. Nolan’s negligence to go to the jury.

The second is whether the warnings which American Home gave regarding the use of Sparine were adequate to warrant the granting of a directed verdict in its favor. We think, as did the trial court, that both questions should be answered in the affirmative. There was testimony that Sparine was prepared by American Home and was available in the Holy Cross Hospital delivery suite in two concentrations: one a 10 cubic centimeter ampule containing 25 milligrams of the drug per cubic centimeter. The other, also a 10 cubic centimeter ampule, contained 50 milligrams of the drug per cubic centimeter, and was clearly labelled in large red letters, “For Intramuscular Use Only.” Each package contained an insert which described the drug, its uses, and dosage and administration.

The insert said, in part: “It is important to make sure that intramuscular injections are given deeply into large muscle masses, i.e., gluteal region, and intravenous injections are given in diluted solutions (25 mg./cc. or less) into the lumen of the vein. Under no circumstances should intra-arterial injections be given. “Sparine (Promazine Hydrochloride, Wyeth) when used intravenously should be used in a concentration no greater than 25 mg. per cc. The injection should be given slowly. Suitable dilution of the more concentrated solution, 50 mg. per cc., with an equivalent volume of physiological saline is advised if used intravenously.

Under ⁵²¹ such circumstances of use, the parenteral administration of Sparine (Promazine Hydrochloride, Wyeth) is well tolerated. Its use is not usually attended by local discomfort or irritation provided correct techniques are employed to insure injection into the lumen of the vein; care should be exercised during intravenous administration not to allow perivascular extravasation since under such circumstances chemical irritation may be severe. The intravenous administration of Sparine (Promazine Hydrochloride, Wyeth) in a concentration of 50 mg. per cc. has resulted in localized thrombophlebitis or vascular spasm and localized cellulitis in an extremely small number of cases. In nine cases, arteriolar spasm of the digital vessels with resulting gangrene has been reported, some of which have required amputation of the digits.

Hazards such as this may be avoided provided that: 1) A concentration of no greater than 25 mg. per cc. be used; 2) The whole contents of the syringe be injected into the lumen of the vein; 3) That injections be made only into vessels previously undamaged by multiple injections or trauma.” (Emphasis in original.) In his pre-trial deposition, the transcript of which he had been given an opportunity to examine and correct, which was introduced in evidence at trial, Dr. Nolan said that he had injected Sparine “just as I got it from the ampule, (50 mgs) ” 3 using a 2ya cubic centimeter syringe, clearly implying that he had used the 50 milligram concentration. The note on the hospital record, signed by Dr. Nolan, “Sparine 100 mgm I. [ntra] v. [enously] at 1:50 a.m.” although not a contemporaneous one, would seem, if read in the light of the deposition, to bear this out. At trial, Dr. Nolan testified that he had used the 25 ⁵²² milligram per cubic centimeter concentration in a 5 cubic centimeter syringe to inject 100 milligrams of Sparine. The testimony with regard to the site of the injections was somewhat conflicting.

At trial, Dr. Nolan and the attending nurse testified that the first injection, a “cocktail” of Demorol, Scopolamine and Sparine, was given Mrs. Dillon at 12:45 a.m. in her right arm. In his pretrial deposition, Dr. Nolan had been much less certain about this. Dr. Nolan was sure that the second injection of Sparine was given at 1:50 a.m. in the antecubital vein of the left arm. Mrs. Dillon testified that she remembered only one injection, the first, and said it had been given in her left arm.

This contradiction was one of consequence, for as will later appear, had both injections been given in the same arm, the chances of extravasation of the drug, or escape from the vein, would have increased. In his deposition and in the clinical note which he dictated for the hospital record, Dr. Nolan attributed Mrs. Dillon’s reaction to the possibility that the drug had extravasated or that some of the medication had been injected outside the vein. He explained this by saying that Mrs. Dillon was “thrashing about” in bed while he was giving the injection. Dr. John Kuhn, called as an expert by Dr. Nolan, testified that the warnings given on the package insert provided reasonable directions as to dosage and concentration of Sparine and represented the standard of care followed by physicians practicing in Montgomery County.

Dr. Kuhn said that the same instructions appeared in Physicians’ Desk Reference to Pharmaceutical Specialties and Biologicals (PDR) published annually by Medical Economics, Inc., and distributed among physicians. Dr. Nolan admitted that PDR was available to him, that he was familiar with it, and when asked whether it was the “Bible”, replied that it was “a good volume.” Dr. Donald Levitt, called as a witness by Mrs. Dillon, testified that an injection of Sparine in a 25 milligram concentration could cause a vascular spasm and cyanosis if injected into an artery, injected into the wall of an ⁵²³ artery or injected into a vein in such fashion that it extravasated. From what we have said it seems clear that American Home’s package insert and the label on the 50 milligram concentration fully discharged its duty to warn. The duty is to give a reasonable warning, not the best possible one, Levin v. Walker Kidde & Co., 251 Md. 560, 563 , 248 A. 2d 151 (1968) ; Annot., 76 A.L.R.2d 9 (1961) ; see, Noel, Products Defective Because of Inadequate Directions or Warnings, 23 Sw.

L.J. 256 (1969) ; Dillard and Hart, Product Liability: Directions For Use and the Duty to Warn, 41 Va.L.Rev. 145 (1955) ; Prosser, Torts § 96 at 665 (3d ed. 1964). See also, 1 Frumer and Friedman, Products Liability § 8.01 at 143 (1968) ; 1 Hursh, American Law of Products Liability § 2.40 at 186 (1961). Even in jurisdictions which have espoused the doctrine of strict liability, Restatement, Torts 2d § 402 A at 347 (1965), and Maryland has not, Myers v. Montgomery Ward & Co., 253 Md. 282 , 252 A. 2d 855 (1969) ; Telak v. Maszczenski, 248 Md. 476 , 237 A. 2d 434 (1968), American Home’s warning would have protected it. See Comment K to § 402 A and Davis v. Wyeth Laboratories, Inc., 399 F. 2d 121, 127 (9th Cir. 1968).

For cases holding the warning which appeared in the Sparine package insert to be adequate, see Magee v. Wyeth Laboratories, Inc., 214 Cal.App.2d 340 , 29 Cal. Reptr. 322 (1963), where the court held that the warning protected the manufacturer of Sparine against a claim for death from agranulocytosis, grounded on breach of warranty, when it was possible to infer that the death resulted from the physician’s failure to take precautions against infection as urgently recommended in the package insert and Schrib v. Seidenberg, 80 N. M. 573, 458 P. 2d 825 (1969) where a judgment entered against a physician who injected Sparine into an artery was affirmed, as was a judgment in favor of American Home on the ground that the warning was adequate. See also Buchanan v. Downing, 74 N. M. 423, 394 P. 2d 269 (1964) which dealt with an intramuscular injection of Sparine, holding neither the ⁵²⁴ physician nor American Home answerable in damages for a skin infection which developed. Compare, however, Yarrow v. Sterling Drug, Inc., 263 F. Supp. 159 (D.S.D. 1967), aff’d 408 F. 2d 978 (8th Cir. 1969) (80% blind patient permitted to recover when manufacturer’s warning in 1958 was simply that Aralen had produced “visual disturbances” and in 1963 that it caused “certain ocular complications” and so advised doctor).

On the testimony as a whole, whether Dr. Nolan was negligent, and whether his negligence caused Mrs. Dillon’s injury were clearly jury questions. Dr. Nolan assigns eight reasons why we should overturn the jury’s verdict, arguing that each amounted to prejudicial error on the part of the lower court: (i) The refusal to allow Dr. Nolan to proceed against American Home on the theory of strict liability and to establish that a person not a party to the suit was responsible for the injury. (ii) The refusal to permit Dr. Nolan to proceed against American Home for indemnification. (iii) The admission into evidence of photographs of Mrs. Dillon’s hand “in combination with” testimony concerning her marital problems and financial difficulty. 4 (iv) The denial of Dr. Nolan’s motion to strike the testimony of Dr. Levitt given in response to a question which assumed that a 50 milligram concentration had been administered.

(v) The denial of Dr. Nolan’s motions for a directed verdict at the close of Mrs. Dillon’s case and at the close of all the evidence. (vi) The refusal to admit into evidence Dr. Nolan’s exhibits 2, 3, 4 and - 5 (four articles from medical journals). (vii) The refusal to permit Dr. Trenholm Fisher to testify. (viii) The giving of three instructions to the jury. ⁵²⁵ We propose to consider each of these arguments, expanding the recitation of such facts as may be germane to each issue.

(i) The court’s refusal to allow Dr. Nolan to proceed against American Home on the theory of strict liability and to establish that a person not a party to the suit was responsible for the injury Maryland Rule 504 provides that a trial court may, at the request of a party or on its own motion, schedule a pre-trial conference to achieve, inter alia, a simplification of issues. Rule 504 c contemplates the entry of a pre-trial order: “c. Order of Court — Amendment. The Court may make an order which recites the action taken at the conference, the amendments allowed to the pleadings, and the agreements made by the parties as to any of the matters considered, and which limits the issues for trial to those not disposed of by admissions or agreements of counsel.

Such order may thereafter be modified, either before or during the trial, as justice may require.” (Emphasis supplied.) On 6 April 1970, Judge Levine held a pre-trial conference in which counsel for all parties participated. On 15 April, Judge Levine circulated among counsel a draft of a pre-trial order consisting of 12 typewritten pages, which had been carefully drafted. It seems to be conceded that in his letter of transmittal, he asked that changes or corrections be submitted before 20 April, and suggested that the order be signed by counsel on 22 April. The order, signed by counsel, was entered on 24 April.

At the pre-trial conference, in outlining the case which he proposed to present, Dr. Nolan denied that he was guilty of negligence, and maintained that Sparine had been injected in accordance with the instructions given in the package insert prepared by American Home. In ⁵²⁶ support of his third-party claim against American Home, Dr. Nolan took the position that the warning given by American Home was inadequate, that American Home knew that intravenous administration of Sparine in accordance with its instructions could result in gangrene, and that Sparine should not be suggested for intravenous injection. All of this sounded in negligence. At the trial of the case, counsel for Dr. Nolan attempted to make an end run around Myers v. Montgomery Ward & Co., supra, 253 Md. 282 and Telak v. Maszczenski, supra, 248 Md. 476 , and to advance a claim against American Home on grounds of strict liability.

He also endeavored to prove that the negligent act which proximately caused the injury was that of the nurse who prepared the injection for Dr. Nolan. Judge Levine ruled that Dr. Nolan was limited to the issues formulated in the pre-trial order. Dr. Nolan says that this was error. While he concedes that our Rule 504 was modelled on Federal Rule 16, and that the two rules are virtually identical, he takes comfort from the fact that the first sentence of the Federal equivalent of our Rule 504 c contains an additional phrase: “* * * • and such order when entered controls the subsequent course of the action, unless modified at trial to prevent manifest injustice.” American Home counters with the suggestion that pretrial is not intended to be an academic exercise; that the Maryland Rule, like the Federal Rule, is intended to achieve a simplification of the issues and, we might add, to minimize the element of surprise; that unless the parties are held to the issues as simplified, the purpose of the Rule is frustrated, and that the power of the court to modify the order necessarily implies that the order is intended to control the course of the trial.

In the posture of the case before us, we need not reach the basic issue. Judge Levine gave all counsel an opportunity to modify the pre-trial order, and took the precaution of having them endorse the order which was ⁵²⁷ filed. As we see it, from that moment, the order controlled the course of the trial, subject to the court’s discretionary power to permit modification as justice may require. Under the circumstances here, we find no abuse of discretion.

Dr. Nolan argues that even if this is the case, the court permitted a modification when it allowed Mrs. Dillon to argue that she had been injected with a 50 milligram concentration rather than a 25 milligram concentration. This overlooks the fact that one of the specific acts of negligence asserted by Mrs. Dillon in the pre-trial order was the administration of “an improper dosage” of Sparine. (ii) The refusal to permit Dr. Nolan to proceed against American Home for indemnification We think that this question might have been more precisely phrased as “was it error for the court to have granted American Home’s motion for a directed verdict at the close of Dr. Nolan’s case?” Here again, Dr. Nolan’s contention is in part a reprise of the argument for the imposition of strict liability, to which reference has already been made. The pre-trial order clearly indicated that Dr. Nolan’s case against American Home would be in negligence.

As we have previously determined, on the facts American Home met the burden of its duty to warn, and under Magee v. Wyeth Laboratories, Inc., supra, 214 Cal.App.2d 340 and Schrib v. Seidenberg, supra, 80 N. M. 573, it would not have been held answerable either in an action sounding in breach of warranty or in negligence. (iii) The admission into evidence of photographs of Mrs. Dillon’s hand “in combination with” testimony concerning her marital problems and financial difficulty Exceptions taken to the admission of three color photo ⁵²⁸ graphs of Mrs. Dillon’s hand prior to the amputation of the fingers were overruled, and we think properly. There was no contention that these did not fairly and accurately depict the condition of the hand at that time, and photographs which meet this test are not impermissibly inflammatory. Such matters must be left largely to the trial court’s discretion.

Garozynski v. Daniel, 190 Md. 1, 5 , 57 A. 2d 339 (1948) ; Kirsch v. Ford, 170 Md. 90, 94 , 183 A. 240 (1936). We have examined the photographs and find no abuse of discretion here. Mrs. Dillon was permitted to testify, over Dr. Nolan’s objection, that she had been separated from her husband since October, 1968 and that he was not contributing to the support of their child. She testified without objection that her abilities as a typist had been adversely affected by her injury.

It was made clear to the jury that it was not Mrs. Dillon’s contention that the domestic situation was a result of the injury. The testimony was properly admitted as proof of the fact that Mrs. Dillon’s earning capacity had been permanently impaired by the injury. See Ihrie v. Anthony, 205 Md. 296, 305-07 , 107 A. 2d 104 (1954). We do not understand whether the thrust of Dr. Nolan’s argument on appeal is that the photographs and the testimony were improperly admitted, or improperly admitted “in combination with” each other.

If the latter is the case, since the objection was not made at trial, it cannot be raised here. Rules 522 d 2 and 885. (iv) The denial of Dr. Nolan’s motion to strike the testimony of Dr. Levitt, given in response to a question which assumed that a 50 milligram concentration had been administered Dr. Donald Levitt, called as an expert by Mrs. Dillon, testified on direct examination without objection: “Q. Now, do you have an opinion based on reasonable medical certainty as to the cause of ⁵²⁹ this immediate reaction cyanosis and ultimate gangrene? A. Yes. “Q. Could you tell us what your opinion is as to its cause?

A. The artery was thrown into an intractable very severe spasm and prevent [ed] blood supply to the lower extremity. The cause of the spasm most probably was one of three things; the material was injected into the artery, the material was injected into the wall of the artery, or the material extravasated or spilled out from the vein and surrounded the artery throwing it into severe spasm. “Q. Are we to understand that any one of those things, an injection into the artery, or an injection around the wall of the artery, or an injection into the vein in which it got out of the vein would have set the artery in motion or attacked the wall of the artery? A. That is correct. “Q. Pathologically, what happens when either one of those three things occur? A. Well, because of the irritating nature of the medication, the artery goes into spasm.

It constricts and permits no blood supply. “Q. What is the effect of lack of blood? A. You get a disorder which we call chemia. It is a loss of warmth, a change in color, the normal pink to a bluish discoloration and the bluish discoloration occurs in patches. It usually proceeds from the point of most severe loss and proceeds onward to the point of blockage. “Q. Is the time element that Doctor Nolan testified to the time development of significance to you in reaching your opinion?

A. Yes. I think the time element would probably indicate that it got into the artery or damaged the wall