Negligence is not to be presumed, but is a matter for affirmative proof. The expression res ipsa loquitur means that the transaction speaks for itself. It is a rule of evidence which allows an inference of negligence to arise from the happening of an event causing an injury to another where it is shown that the defendant owned, operated, and maintained, or controlled and was responsible for the management and maintenance of the thing doing the damage and the accident was a kind which, in the absence of proof of some external cause, does not ordinarily happen without negligence. The principal basis for application of the rule of res ipsa loquitur is that the occurrence involved would not have occurred but for negligence, and this negligence may properly be charged to the person in exclusive control of the instrumentality.
(Citations and punctuation omitted.) U. S. Fidelity &c. Co. v. J. I. Case Co., 209 Ga. App. 61, 64-65 (3) (432 SE2d 654) (1993).
Here, the device was not under the exclusive control of the manufacturer. In addition, there is evidence that the tubing could have disconnected for causes unrelated to any negligence of AMS. For instance, as previously noted, Dr. Harrison testified that Williams was a diabetic and, therefore, his incisions were slow to heal. As a result, it was possible that the infection spread from the incision, causing swelling which forced the tubing apart. Therefore, because res ipsa loquitur does not apply in this case, the trial court correctly granted summary judgment on these issues.
3. The trial court correctly granted summary judgment to AMS on Williams’s claim for failure to warn him of the danger that the tubing could disconnect.3 This issue is controlled adversely to Williams by Lance v. American Edwards Laboratories, 215 Ga. App. 713, 716 (452 SE2d 185) (1994). In Lance, this Court held that when a device can be prescribed and inserted only by a physician, that treating physician has sole responsibility for advising the patient of dangers associated with the use of the device. The designer, manufacturer, and distributor are under no duty to the patient. Id. at 716. Indeed, any information supplied to Williams by AMS regarding dangers associated with the device could compromise the doctor-patient relationship. Id. Therefore, AMS did not have the responsibility or the means to warn Williams of any dangers associated with the implant. Id.
3
We note that the package insert does contain the warning that there is a risk of infection with surgery to implant the device and men with diabetes have an increased risk of infection. It also states that product wear, component disconnection, or other mechanical problems may occur.