Bryant v. Hoffmann-La Roche, Inc., No. A03A0661.

585 S.E.2d 723

262 Ga. App. 401

BRYANT et al. v. HOFFMANN-LA ROCHE, INC.

No. A03A0661.

Court of Appeals of Georgia.

July 16, 2003.

Bird & Associates, Wendell R. Bird, Richard L. Brittain, Jonathan T. McCants, Atlanta, for appellants.

Nelson, Mullins, Riley & Scarborough, Richard B. North, Jr., Matthew B. Lerner, Atlanta, for appellee.

ADAMS, Judge.

Clyde C. Bryant filed suit against Hoffmann-La Roche, Inc. in his capacity as executor of the estate of his late wife, Carolyn Bryant, as well as on his own behalf. Hoffmann-La Roche is a pharmaceutical manufacturer, and Bryant's suit arose out of his wife's use of Posicor, one of the company's products.¹

In 1997, Carolyn Bryant was being treated for cardiac problems, including hypertension and atrial fibrillation by Dr. Harold D. Carlson. In connection with that treatment, Carlson prescribed a number of medications for Mrs. Bryant, including Betapace, a beta blocking drug. On August 18, 1997, Dr. Carlson increased the Betapace dosage and on August 25, he prescribed Posicor, a heart medication that Hoffmann-La Roche had recently placed on the market. Posicor is a calcium channel blocker medication used to treat high blood pressure and angina. On August 26, 1997, Mrs. Bryant took the Betapace at approximately 7:00 a.m., and again at noon, and took Posicor for the first time at approximately 10:00 a.m. that day. That afternoon, her husband found her at the bottom of the stairs in her home, and it was later determined that she had suffered severe brain injuries.

Bryant subsequently brought this suit asserting claims of negligence, breach of warranty, strict liability, and loss of consortium against Hoffmann-La Roche and alleging that his wife's injuries were linked directly to the use of Posicor and its interaction with Betapace. The trial court, without explanation, granted Hoffmann-La Roche's motion for summary judgment as to all of Bryant's claims, and Bryant appeals that ruling as well as the trial court's order granting Hoffmann-La Roche's motions in limine to exclude the testimony of his expert witnesses.

1. As an initial matter, we must address Hoffmann-La Roche's argument that Bryant's claims are preempted by federal law. The company asserts that Bryant's allegations actually set forth a claim that Hoffmann-La Roche committed fraud upon the Food and Drug Administration in submitting Posicor for approval, and that claim is preempted by federal law under the authority of Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001). Hoffmann-La Roche bases its argument on Bryant's allegations that the company rushed Posicor to market without fully testing the product.

In Buckman, the plaintiffs actually asserted a fraud on the FDA claim, and the United States Supreme Court held that preemption applied because "the existence of ... federal enactments is a critical element" of the claim. 531 U.S. at 353, 121 S.Ct. 1012. And the Court noted the claim arose "solely by virtue" of the disclosure requirements of the Food, Drug, and Cosmetic Act. 52 Stat. 1040, as amended by the Medical Device Amendments of 1976, 90 Stat. 539, 21 USC § 301 (1994 ed. and Supp. V). Id. Thus, we would agree that to the extent that Bryant's claims could be construed as asserting a fraud-on-the-FDA claim or a claim arising solely by virtue of federal law, such claims would be preempted.

But Bryant does not assert a fraud claim or a violation of federal law; rather he asserts that Hoffmann-La Roche violated duties arising under state statutory and common law. And we do not construe Buckman as holding that such claims are preempted. The U.S. Supreme Court, in fact, drew a distinction between the fraud-on-the-agency claim asserted in that case and its prior decisions involving "traditional state law tort principles" that were not subject to preemption. See Buckman Co., 531 U.S. at 352-353, 121 S.Ct. 1012 (distinguishing Silkwood v. Kerr-McGee Corp., 464 U.S. 238, 104 S.Ct. 615, 78 L.Ed.2d 443 (1984), and Medtronic, Inc. v. Lohr, 518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996)). Accordingly, Hoffmann-La Roche was not entitled to summary judgment on the basis of preemption. See also Lance v. American Edwards Laboratories, 215 Ga.App. 713, 715-716, 452 S.E.2d 185 (1994) (FDCA and MDA do not preempt state strict liability and negligence claims arising from use of medical device); Caraker v. Sandoz Pharmaceuticals Corp., 172 F.Supp.2d 1018 (S.D.Ill.2001) (for a comprehensive discussion of preemption in this context after Buckman and holding that state law claims for pharmaceutical design defect, failure to warn, and negligence claims are not preempted by federal law).

2. Bryant asserts that the trial court erred in granting summary judgment on his strict liability claims because he asserts that there are factual issues as to whether Posicor was a defective drug, whether it had a design defect, and whether Hoffmann La Roche issued inadequate warnings for the drug. Hoffmann-La Roche asserts, however, that pharmaceutical manufacturers should be exempt from liability for design defects. Hoffmann-La Roche further argues that if this Court determines that a claim for pharmaceutical design defect can exist, we should adopt a special standard of strict liability for drug manufacturers that would insulate them from claims for design defect unless the plaintiff can show that the drug was not suitable for any class of patients.

To date, no Georgia case has specifically addressed the issue of design defects in the context of pharmaceutical products. And our review of the case law from other jurisdictions demonstrates that the treatment of design defect claims for prescription drugs varies widely among the states to have considered the issue.

Hoffmann-La Roche argues that in the absence of prior Georgia authority, we should follow the approach of the California Supreme Court holding that prescription drug manufacturers are insulated from all design defect claims. Brown v. Superior Court &c. of San Francisco, 44 Cal.3d 1049, 245 Cal. Rptr. 412, 751 P.2d 470 (1988). In reaching that conclusion, the California court relied upon Comment k to § 402A of the Restatement (Second) of Torts. Id. at 1061, 245 Cal.Rptr. 412, 751 P.2d 470. That comment provides:

There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs.... Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. It is also true in particular of many new or experimental drugs as to which, because of lack of time and opportunity for sufficient medical experience, there can be no assurance of safety, or perhaps even of purity of ingredients, but such experience as there is justifies the marketing and use of the drug notwithstanding a medically recognizable risk. The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.

(Emphasis omitted.) The California court interpreted this provision as providing that no prescription drug manufacturer can ever be strictly liable for design defect, but could only be liable for negligent manufacturing defects and for failure to warn of known or reasonably knowable side effects. Brown, 44 Cal.3d at 1069, n. 12, 751 P.2d 470.

In support of this interpretation, the California Supreme Court noted:

If drug manufacturers were subject to strict liability, they might be reluctant to undertake research programs to develop some pharmaceuticals that would prove beneficial or to distribute others that are available to be marketed, because of the fear of large adverse monetary judgments.

Brown, 44 Cal.3d at 1063, 245 Cal.Rptr. 412, 751 P.2d at 479.

But the Brown decision reflects the minority view among those jurisdictions to have considered the language of Comment k.² See Winchester, Note: Section 8(c) of the Proposed Restatement (Third) of Torts: Is It Really What the Doctor Ordered?, 82 Cornell L. Rev. 644, 655 (1997). Most of the states that have adopted Comment k have applied it in a more limited fashion and on a case-by-case basis. See Freeman v. Hoffman-La Roche, Inc., 260 Neb. 552, 560-563(IV)(1)(a)(ii), 618 N.W.2d 827 (2000);

Tansy v. Dacomed Corp., 890 P.2d 881, 886, n. 2 (Okla.1994). And most of those jurisdictions have held that a risk-utility analysis must be conducted before Comment k will bar recovery under products liability. Tansy, 890 P.2d at 886. The cases that have taken this approach have determined that Comment k requires that the benefits of the product must outweigh its known risks on the date the product is distributed before the manufacturer can avoid strict liability. Adams v. G.D. Searle & Co., 576 So.2d 728, 733 (Fla.App. 1991). This application of Comment k also includes a consideration of whether the risks were unavoidable, that is whether at the time of manufacture and distribution there was any "feasible alternative design which on balance accomplishe[d] the subject product's purpose with a lesser risk." Toner v. Lederle Laboratories, 112 Idaho 328, 337, 732 P.2d 297 (1987). In addition, Comment k, by its own terms, provides protection against strict liability only where the product is "properly prepared, and accompanied by proper directions and warning." Thus, it does not...