Nolan v. Dillon

• Decision Date: 14 April 1971
• Docket Number: No. 376,376
• Citation: 261 Md. 516,276 A.2d 36
• Parties: David M. NOLAN v. Linda A. DILLON et al.
• Court: Maryland Court of Appeals

Page 516

261 Md. 516

276 A.2d 36

David M. NOLAN v. Linda A. DILLON et al.

No. 376.

Court of Appeals of Maryland.

April 14, 1971.

William A. Ehrmantraut, Rockville (Donahue & Ehrmantraut, Rockville, on the brief), for appellant.

Joseph S. McCarthy, Rockville (Thomas F. Hogan and McCarthy & Wharton, Rockville, on the brief) for Linda A. Dillon.

Hugh L. Reilly, Hyattsville

(Edward C. Bell and Bell & Reilly, Hyattsville, on the brief), for American Home Products Corporation.

Argued before HAMMOND, C. J., and BARNES, McWILLIAMS, FINAN, SINGLEY, SMITH and DIGGES, JJ.

SINGLEY, Judge.

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 his 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 Dillon had withdrawn from the case when he and his wife separated.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 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 was 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 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) is 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 2 1/2 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 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 pre-trial 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 Pharma ceutical 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 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. Walter Kided & 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 § 402A 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 § 402A 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.Rptr. 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...