Opinion ID: 2341867
Heading Depth: 1
Heading Rank: 9

Heading: failure to direct a verdict on medical malpractice claim

Text: Dr. Armstrong argues that he was entitled to a directed verdict because the Gundersons failed to show that his treatment of Mary Gunderson violated the applicable standard of care. It is Dr. Armstrong's position that there was insufficient evidence that he violated the standard of care owed to Mrs. Gunderson because the evidence established that: Parlodel was approved by the FDA for PPLS in 1993; the prescription for Parlodel for Mrs. Gunderson was not in violation of the contraindications in the package insert; Parlodel's use for PPLS was per a standing order of Suburban Hospital in 1993; Dr. Armstrong's partner had prescribed Parlodel to Mrs. Gunderson for PPLS after her previous pregnancy in 1989 with no adverse reaction; and Dr. Armstrong had prescribed Parlodel for PPLS for years in his practice with no adverse results. Citing Prewitt v. Higgins, 231 Ky. 678, 22 S.W.2d 115, 117 (1929), Dr. Armstrong asserts that, even assuming that the decedent died as a result of a Parlodel-induced seizure, it does not necessarily follow that he was negligent in prescribing the drug because [i]njury may result from the use of the drug even when the doctor has proceeded with the utmost care and skill. We agree that [i]t is necessary... in order to make out a case [for medical negligence], that something more be shown than mere injury by the drug. Id. In a medical malpractice case, the plaintiff must prove that the treatment given was below the degree of care and skill expected of a reasonably competent practitioner and that the negligence proximately caused the injury or death. Reams v. Stutler, 642 S.W.2d 586 (Ky.1982). A physician has the duty to use the degree of care and skill expected of a competent practitioner of the same class and under similar circumstances. Grubbs ex rel. Grubbs v. Barbourville Family Health Ctr., P.S.C., 120 S.W.3d 682 (Ky.2003); Mitchell v. Hadl, 816 S.W.2d 183, 185 (Ky. 1991); Cordle v. Merck & Co., Inc., 405 F.Supp.2d 800 (E.D.Ky.2005). Appellees presented the testimony of Dr. Jay Patrick Lavery, a board-certified obstetrician/gynecologist who practiced in Louisville from 1975-1987. During that time, he had a private practice in Louisville and, from 1980-1987, was Director of Obstetrics at University Hospital. From 1987 to the present, he has operated an obstetrics practice in Michigan specializing in high risk pregnancies. Dr. Lavery stated that in his opinion, it was not a breach of the applicable standard of care in 1989 to prescribe Mrs. Gunderson Parlodel for PPLS after the birth of her first child. In Dr. Lavery's opinion it was, however, a deviation of the standard of care for Dr. Armstrong to prescribe Mrs. Gunderson Parlodel for PPLS in 1993. Dr. Lavery explained that by 1993, there was information available in the medical literature indicating that Parlodel had adverse vascular properties and was ineffective for PPLS because of its rebound propensity. Dr. Lavery specifically noted two articles, one in the green journal and one in the American Journal of Obstetrics and Gynecology, questioning the safety of Parlodel's use for PPLS because of an association between Parlodel and postpartum hypertension, strokes, seizures, and heart attacks. Dr. Lavery testified that given Mrs. Gunderson's gestational hypertension in 1993, he would not have prescribed Parlodel for PPLS because of the high risk of an adverse vascular event and low potential benefit of the drug. Dr. Lavery testified that he ceased prescribing Parlodel for PPLS in 1984 or 1985, when he was still practicing in Louisville, and since that time, he has successfully treated postpartum breast pain and engorgement with traditional therapies such as breast binding and analgesics. When confronted on cross-examination with the fact that prescribing Parlodel to Mrs. Gunderson in 1993 was not contraindicated by the information in the FDA-approved package insert, Dr. Lavery testified that it was nevertheless a breach of the standard of care to prescribe the drug to Mrs. Gunderson at that time. Dr. Lavery testified that even though a drug is approved by the FDA for a certain use and may not be contraindicated by the package insert, a reasonably prudent doctor still has to weigh the risks and benefits of the drug relative to a particular patient. This testimony is consistent with the majority view that while the information about the drug in the package insert and the PDR is relevant and useful information regarding the prescribing physician's standard of care, it is not the sole determinant of the standard of care. Richardson v. Miller, 44 S.W.3d 1, 16-17 (Tenn.Ct.App.2000); Spensieri v. Lasky, 94 N.Y.2d 231, 701 N.Y.S.2d 689, 723 N.E.2d 544, 548 (N.Y. 1999); Morlino v. Med. Ctr. of Ocean County, 152 N.J. 563, 706 A.2d 721, 728-30 (1998); Craft v. Peebles, 78 Hawai'i 287, 893 P.2d 138, 150-52 (1995). [3] The information in the package insert and PDR can only be analyzed in the context of the medical condition of the individual patient. Spensieri, 701 N.Y.S.2d 689, 723 N.E.2d at 548; Morlino, 706 A.2d at 730. As a medical expert, the prescribing physician can take into account the propensities of the drug, as well as the susceptibilities of his patient. His is the task of weighing the benefits of any medication against its potential dangers. The choice he makes is an informed one, an individualized medical judgment bottomed on a knowledge of both patient and palliative. Larkin, 153 S.W.3d at 763 (quoting Reyes v. Wyeth Labs., 498 F.2d 1264, 1276 (5th Cir.1974)). Relative to the claim that Dr. Armstrong could not have violated the standard of care when he prescribed Parlodel to Mrs. Gunderson in 1993 because she had taken the drug with her first pregnancy in 1989 with no adverse reaction, Dr. Nichols testified that it is not uncommon for a patient to not have an adverse reaction to a drug the first time they take it, and then suffer an adverse or paradoxical reaction upon the second or subsequent administration of the drug. Moreover, as emphasized by Dr. Lavery, Mrs. Gunderson did not have gestational hypertension with her first pregnancy. Thus, the vascular risks of the drug were more significant for Mrs. Gunderson in 1993. As stated earlier, Dr. Armstrong admitted in his deposition that he had not read the 1987 updated package insert for Parlodel. Although he maintained that he regularly read the green journal and the PDR addendums, Dr. Armstrong denied having knowledge of the potential vascular risks of Parlodel and testified that the only side effects he was aware of were headaches and nausea. Dr. Armstrong testified that had he known about the information in the Dear Doctor letters sent by Sandoz, he would not have prescribed Parlodel for Mrs. Gunderson in 1993. Incorporated in a physician's duty of reasonable care to his patient is the duty of requisite knowledge. Jones v. Furnell, 406 S.W.2d 154, 156 (Ky.1966), overruled on other grounds, 459 S.W.2d 166 (Ky.1970). Drawing all reasonable inferences in favor of Appellees, we believe the Appellees presented sufficient evidence that Dr. Armstrong breached his standard of care, by failing to have knowledge of the vascular risks of Parlodel in 1993 and prescribing the drug to Mrs. Gunderson for PPLS, to withstand the motion for directed verdict. See Thomas v. Greenview Hosp., Inc., 127 S.W.3d 663, 673 (Ky.App.2004), overruled on other grounds, 171 S.W.3d 14 (Ky. 2005). Dr. Lavery's expert testimony was evidence that the standard of care for an obstetrician in Louisville in 1993 was such that a reasonably prudent doctor would have known not to prescribe Parlodel to a woman with gestational hypertension. Accordingly, Dr. Armstrong's motion for directed verdict was properly denied.