Court Opinion

ID: 9855588
Source: CourtListenerOpinion
Date Created: 2023-09-24 06:27:46.104373+00
Date Added: 2024-06-11T09:36:13.785966
License: Public Domain

Eldridge, Judge,
dissenting.
In the absence of evidence showing that the Synthes defendants warned McCombs’ surgeon of danger associated with the implant in issue, whether known before its implantation or acquired thereafter as here,4 McCombs correctly argues that a jury question remains on the issue. It is well settled that the “learned intermediary” rule of Hawkins v. Richardson-Merrell, Inc., 147 Ga. App. 481 (249 SE2d 286) (1978), is applicable to medical devices implanted in patients under the supervision of a physician as it is to drugs to be taken by prescription upon a rationale applicable in common, i.e., that the duty to warn the patient should rest, not with the manufacturer, designer, or distributor, but solely with the treating physician in that “the decision to employ prescription medication involves professional assessment of medical risks in light of ... a patient’s particular needs and susceptibilities. Walker v. Jack Eckerd Corp., 209 Ga. App. 517, [521 (2) (434 SE2d 63) (1993)].” Lance v. American Edwards Laboratories, 215 Ga. App. 713, 716 (452 SE2d 185) (1994). Ordinarily, a warning to the learned intermediary is sufficient to satisfy the manufacturer’s duty of care before a prescription drug is sold or a medically prescribed implant is installed. See generally Presto v. Sandoz Pharmaceuticals Corp., 226 Ga. App. 547, 549 (487 SE2d 70) *549(1997). However, after a drug has been prescribed or after a device has been implanted under a doctor’s care, the learned intermediary rule should lie only to the extent that the manufacturer warned the physician and that the warning, as given, was adequate. Id. Otherwise, manufacturers have a duty to directly warn patients by all practicable means5 of danger as to such prescription drugs as they may he taking or such implants in them under a doctor’s care. Id.; compare Davis v. Wyeth Laboratories, 399 F2d 121, 130 (9th Cir. 1968) (manufacturer of polio vaccine required to warn consumers of risks attendant to the use of the vaccine because vaccine distributed in the absence of a physician serving as learned intermediary).
This result is not inconsistent with the duty to exercise ordinary care to warn of a known or reasonably foreseeable risk of injury or death which applies to products after they are sold notwithstanding the statute of repose abolishing such duty, a duty to warn which is distinguishable from the duty to warn before sale. See OCGA § 51-1-11 (c); Chrysler Corp. v. Batten, 264 Ga. 723, 724 (1), 727 (4) (450 SE2d 208) (1994); see also Love v. Whirlpool Corp., 264 Ga. 701, 703 (1) (449 SE2d 602) (1994); Mack Trucks v. Conkle, 263 Ga. 539, 544 (4) (436 SE2d 635) (1993); DeLoach v. Rovema Corp., 241 Ga. App. 802, 804, n. 3 (527 SE2d 882) (2000); Bishop v. Farhat, 227 Ga. App. 201, 206 (6) (489 SE2d 323) (1997). That such a duty to warn of danger applies to ordinary products, such a duty to warn attaches to require manufacturers to warn of danger identified by post-sale knowledge acquired after the first sale of such product, particularly as to prescription drugs or implanted medical devices — this because the probability of risk of injury or death attendant to the continued use of the same is necessarily greater than that associated with products used less intimately.
The duty to warn of a reasonably foreseeable danger arising out of knowledge acquired about a product after it is first sold differs from the duty to warn before such sale for several reasons. In the period before implantation, for example, time may elapse before the product is first sold; learned intermediaries may choose not to use the product; or patients may choose not to grant informed consent after being advised of the risks involved by their learned intermediaries. However, after an implant has been sold and is in use, the nature of the danger is imminently more real and palpable *550in that the risk now co-exists with the patient, not unlike an unstable explosive awaiting a detonating jar or charge. Stated otherwise, before a medical device is implanted, the learned intermediary is the gatekeeper who assesses the risk and informs the prospective patient-recipient who then must give his or her consent to the implant. After implantation, the learned intermediary no longer acts as gatekeeper, because the autonomy a patient-recipient enjoys in choosing what happens to his or her body determines whether to accept the risk of surgical removal versus the risk of danger from continuing to live with the implant, physical and mental pain, as well as the cost of removal in terms of time, pain in recuperation, and money. Neither is it assured after a medical device is implanted that the learned intermediary is the best means by which to warn the patient-recipient of after-acquired knowledge of danger associated with the implant’s continued use. The patient’s surgeon may have died, retired, moved, or changed HMO, PPO, or other health insurance. There may be no continuing surgeon-patient relationship. Such relationship may have been terminated; the patient may have been referred back to his or her primary care physician; the patient may have changed his or her HMO, PPO, or other health insurance; or the patient may have moved away. In each instance, the learned intermediary ceases to be the best means to convey the warning to the recipient patient, requiring that manufacturers give notice of post-sale danger by the means set out above. Thus, a jury issue exists.
Decided July 13, 2001
Webb, Stuckey & Lindsey, James H. Webb, Jr., Martin C. Jones, Sharon S. Whitwell, for appellant.
Kilpatrick Stockton, Susan A. Cahoon, Jeffrey J. Toney, for appellees.

 In opposition to summary judgment, McCombs tendered the deposition of Dr. Kenneth A. Pettine, a board-certified orthopedic surgeon specializing in the spine. Dr. Pettine deposed that in November 1993 he notified the Synthes defendants by letter that he and his partner had experienced a six percent breakage rate using the implant in issue, ten of 170 such implants having failed. The complained-of surgery was performed more than a year after the November 1993 letter was sent. There also is evidence the Synthes defendants failed to investigate Dr. Pettine’s reports, failed to duplicate the tests he had performed, and failed to warn treating physicians as learned intermediaries of the fracture problem.

 Notice of this sort contemplates the necessity for direct notice to a known recipient, notice to hospitals or health care providers supplying the product, the surgeons involved, if known (and, if not known, then all surgeons) by advertising in the medical journals of all colleges of surgery, notice to all primary care physicians through advertisement in their professional journal or journals, or any other exercise of ordinary care required to give actual notice to the patient taking a prescribed medication or who is the recipient of a prescription implant.