Presto v. Sandoz Pharmaceuticals Corp.

• Decision Date: 13 May 1997
• Docket Number: No. A97A0196,A97A0196
• Citation: 487 S.E.2d 70,226 Ga.App. 547
• Parties: , 65 USLW 2832, 33 UCC Rep.Serv.2d 418, Prod.Liab.Rep. (CCH) P 14,951, 97 FCDR 1944 PRESTO et al. v. SANDOZ PHARMACEUTICALS CORPORATION et al.
• Court: Georgia Court of Appeals

Page 70

487 S.E.2d 70

226 Ga.App. 547, 65 USLW 2832, 33 UCC

Rep.Serv.2d 418,

Prod.Liab.Rep. (CCH) P 14,951, 97 FCDR 1944

PRESTO et al. v. SANDOZ PHARMACEUTICALS CORPORATION et al.

No. A97A0196.

Court of Appeals of Georgia.

May 13, 1997.

Reconsideration Denied May 28, 1997.

Certiorari Denied Jan. 5, 1998.

Chamberlain, Hrdlicka, White Williams & Martin, Richard N. Hubert, Dan B. Wingate, Atlanta, for appellants.

Hawkins & Parnell, Lawrence J. Myers, Charles R. Beans, Love & Willingham, Robert P. Monyak, Alston & Bird, Lawrie E. Demorest, Troutman Sanders, Amy S. Lettes, Atlanta, for appellees.

BLACKBURN, Judge.

In this prescription-drug products liability case, plaintiffs appeal the trial court's grant of defendant Sandoz's motion to dismiss plaintiffs' complaint, which alleges that the defendants are tortiously liable for the suicide of Greg Presto, for failing to warn him of the dangers of discontinuing the use of the drug Clozaril. The trial court held that the complaint failed to state a claim as to Sandoz, the manufacturer, as its duty to warn was limited to providing such notice only to the prescribing physician, Dr. Warren. Plaintiffs also appeal the trial court's grant of summary judgment on plaintiffs' tort and warranty claims to defendant Caremark, whose limited duty it was to dispense the drug, draw the patient's blood, review his lab results, and provide them to Dr. Warren. Neither Dr. Warren nor Peachford Behavior Health Systems, d/b/a Charter Peachford Hospital, is a party to this appeal.

Greg Presto, the adult son of plaintiffs Charles and Mary Presto, committed suicide in September 1991. The Prestos claim that Greg committed suicide because he suddenly stopped taking Clozaril, a prescription anti-psychotic drug manufactured by defendant Sandoz Pharmaceuticals Corporation, distributed by defendant Caremark, Inc., and prescribed by defendant Dr. Warren.

The Prestos allege the defendants should have warned Greg of the dangers he faced if he discontinued use of the drug. They appeal from the trial court's rulings which found: (1) that defendant Sandoz had no duty to warn Greg of the dangers of discontinuing the use of Clozaril; (2) that defendant Caremark was not subject to liability for professional negligence because the Prestos did not attach the required expert affidavit to their complaint; and (3) that Caremark was not liable under a warranty theory for an "inadequately labeled" drug.

Greg had previously been treated for mental illness with Clozaril, which had been prescribed to him by defendant Dr. Warren. Because Clozaril can damage a patient's immune system, defendant Caremark was hired to perform certain tests on Greg, monitor the results of those tests, and dispense the medication to him.

The Clozaril helped Greg's condition, but it had undesirable side effects. In August 1991, Greg and his mother requested he be taken off the medication and be prescribed a different drug. Dr. Warren agreed, the plaintiffs allege. According to the Prestos' complaint, neither Greg nor his parents were told of a warning included in the Clozaril packaging. This warning recommended that patients be removed from the drug by gradually reducing the dosage over a one- or two-week period and stated, "[s]hould a patient's medical condition require abrupt discontinuation ..., the patient should be carefully observed for the recurrence of psychotic symptoms."

1. Sandoz, the manufacturer, moved to dismiss the complaint for failure to state a claim, on the ground that it was required to give any warnings only to Greg Presto's physician. The record shows the trial court granted this motion after considering matters outside the pleadings, specifically documents provided by the plaintiffs and the deposition of Mary Presto. Thus, the motion is construed as one for summary judgment, upon which the parties were given a hearing. See Christensen v. State of Ga., 219 Ga.App. 10, 12(4), 464 S.E.2d 14 (1995).

The Prestos acknowledge the settled "learned intermediary rule" of Georgia law that the manufacturer of a prescription drug is not normally required to directly warn the patient of dangers in its use. "Ordinarily, in the case of prescription drugs, a warning as to possible danger in its use to the prescribing physician is sufficient." (Citations and punctuation omitted.) Singleton v. Airco, Inc., 169 Ga.App. 662, 664, 314 S.E.2d 680 (1984); see also Hawkins v. Richardson-Merrell, Inc., 147 Ga.App. 481, 482-483(1), 249 S.E.2d 286 (1978); Parke, Davis & Co. v. Mayes, 124 Ga.App. 224, 183 S.E.2d 410 (1971).

The plaintiffs mistakenly claim that Carter v. E.I. DuPont de Nemours & Co., 217 Ga.App. 139, 456 S.E.2d 661 (1995) weakens this rule. Carter involved plaintiffs who purchased clothing available to the general public without warnings regarding the fabric's flammability. Carter is not applicable to this case, which involves a prescription drug, available only through a licensed, skilled physician. As we stated in Hawkins, supra at 483(1), 249 S.E.2d 286, "[t]his special standard for prescription drugs is an understandable exception to the ... general rule that one who markets goods must warn foreseeable ultimate users of dangers inherent in his products. Prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect. 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." (Citation and punctuation omitted.)

The Prestos make no claim that Sandoz failed to warn Greg's physician, Dr. Warren, of this potentially adverse effect of Clozaril. In fact, they point to such a warning included with the medication's packaging, and the record shows Dr. Warren signed a document stating he was familiar with all Clozaril package labeling. They make no argument that the warning given Dr. Warren was inadequate. Thus, the "learned intermediary" rule of Hawkins applies here, and Sandoz had no duty to directly warn Greg or the Prestos of the potential hazards of the use of Clozaril.

The Prestos, however, claim Sandoz should have warned Greg directly because it did give some direct information in the form of a pamphlet entitled "Understanding Clozaril (clozapine) Therapy: A Guide for Patients and Their Families." Plaintiffs cite the principle that "[w]here one undertakes an act which he has no duty to perform and another reasonably relies on that undertaking, the act must generally be performed with ordinary or reasonable care." Stelts v. Epperson, 201 Ga.App. 405, 407, 411 S.E.2d 281 (1991); see also Mixon v. Dobbs Houses, 149 Ga.App. 481, 484, 254 S.E.2d 864 (1979). Because Sandoz voluntarily undertook to provide some information directly to patients, the Prestos argue, it should also have warned patients of the dangers of discontinuing use of the medication.

This argument fails because the Prestos could not, as a matter of law, have "reasonably relied" on this pamphlet for such a warning. See Stelts, supra. The pamphlet does not constitute an effort to inform patients of all the dangers of Clozaril and does not purport to do so. The booklet states that it "provides answers to many common questions about CLOZARIL" but cautions the reader: "If there are any other questions about CLOZARIL therapy, be sure to ask the doctor, nurse, or pharmacist." As the pamphlet covers only general issues concerning the drug, and as the Prestos relied on Dr. Warren to prescribe and supervise Greg's use of the drug, this theory of liability is without merit.

2. The trial court also granted summary judgment to Caremark on the Prestos' claims. The complaint alleged that Caremark "possessed actual or constructive knowledge of the dangers inherent in using and abruptly terminating the use of Clozaril" but did not inform Greg Presto of those dangers. A Caremark employee testified that the company's only role in Greg Presto's treatment...