Court Opinion

ID: 9621017
Source: CourtListenerOpinion
Date Created: 2023-08-22 05:50:37.193915+00
Date Added: 2024-06-11T14:58:08.000110
License: Public Domain

Dissenting opinion by
Justice WINTERSHEIMER.
I respectfully dissent from the majority opinion because the decision to adopt the so-called learned intermediary doctrine as an exception to the clear and unambiguous provisions of the Product Liability Act, KRS 411.300, is a matter solely within the discretion of the General Assembly, and not the judiciary. The so-called learned intermediary doctrine provides a type of summary immunization for pharmaceutical manufacturers and makes the adequacy of warnings to the ultimate consumer a question of law for the court and not a question of fact for the jury.
In Kentucky, the Product Liability Act applies to all damage claims arising from use of products, regardless of legal theory advanced. KRS 411.300(1). See Monsanto Co. v. Reed, Ky., 950 S.W.2d 811 (1997). The majority has attempted to supersede statutory law with the common law. Our sister court in Oregon was faced with substantially similar facts and arrived at the proper conclusion that statutes, not the common law, govern strict products liability claims and defenses to those claims. See Griffith v. Blatt, 334 Or. 456, 51 P.3d 1256, 1261 (2002). There, the Oregon Supreme Court declined to incorporate the learned intermediary doctrine into the statutory scheme of strict products liability because the defense was a common law defense but the underlying claim was brought by the statutory action. Likewise, by enacting the Product Liability Act, the Kentucky Legislature has preempted the field of strict products liability claims by defining “any action” in KRS 411.300(1). Nowhere in the Product Liability Act is there an incorporation of the common law defense of the learned intermediary doctrine. Instead, the majority has made such legislation by judicial fiat, but it is an unfortunate addition for the reasons below.
This Court should take notice of the abundantly obvious fact that the development of direct to consumer pharmaceutical *771advertising has indelibly changed the realities of physician/patient relationships. Anyone who watches television is regtilarly bombarded with a variety of pharmaceutical products which suggest that the ultimate consumer ask his physician to prescribe a particular advertised product.
This case provides a scenario where the application of the so-called learned intermediary doctrine involves an allegation that the manufacturer of a prescription drug failed to warn the ultimate consumer of the risks associated with that drug, even though the manufacturer advised the prescribing physician of such risks.
A review of the legislative approach to product liability indicates that by the clear and unambiguous language of the Act, the legislature did not intend that such a doctrine be an exception to product liability. Cf. Reda Pump Co. v. Finch, Ky., 713 S.W.2d 818 (1986). Reda Pump Co., supra, is an example of the Legislature, not this Court, adjusting the Product Liability Act. Only three years after that decision, effective July 15, 1988, the Legislature enacted a revised KRS 411.182, which statutorily overruled Reda Pump Co. and KRS 411.320(3) thereby incorporating comparative negligence into the Product Liability Act where previously there was none. See Ingersoll-Rand Co. v. Rice, Ky.App., 775 S.W.2d 924 at 930 (1989).
Strict liability for defective products of any kind was codified in the Restatement (Second) of Torts § 402A in 1964. This Court adopted a form of strict liability in Dealers Transport Co. v. Battery Distributing Co., Ky., 402 S.W.2d 441 (1966). In some states, product liability law has been developed through judicial decisions. Some states have taken a statutory approach. In 1978, the Kentucky General Assembly codified the common law product liability and since that time the court has generally held that any major changes or additions to that law is within the province of the legislature. See Reda Pump Co.
This Court has previously recognized that manufacturers of products have a nondelegable duty to warn consumers of the dangers connected with the use of their products. See Grayson Fraternal Order of Eagles Aerie No. 3738, Inc. v. Claywell, Ky., 736 S.W.2d 328 (1987). There is really no logical reason for determining that the generally applicable non-delegable duty does not apply to prescription medicine. It must be remembered that the legislature has the sole responsibility for determining public policy where a statutorily established right is in question. Commonwealth v. Wilkinson, Ky., 828 S.W.2d 610 (1992); Surrogate Parenting Associates v. Commonwealth, Ky., 704 S.W.2d 209 (1986).
The comparative fault amendments adopted in 1998 did not incorporate the so-called learned intermediary doctrine as an exception to liability. There is no question that pharmaceutical manufacturers believe they have very effective methods to communicate directly with consumers. In the first four months of year 2000, pharmaceutical manufacturers’ spending has increased 58% when compared to the first four months of 1999. Caroline L. Nadel, The Societal Value of Prescription Drug Advertisements in the New Millennium: Targeted Consumers Become the Learned, 9 J.L. and Pol’y 451, 480 (2001). Consumer marketing has made the pharmaceutical industry the 13th largest advertiser in the United States. See Mitchell S. Berger, A Tale of Six Implants: The Perez v. Wyeth Laboratories Norplant Case and the Applicability of the Learned Intermediary Doctrine to Direct-To-Consumer Drug Promotion, 55 Food & Drug Law Journal 525 (2000). One study cited by a recent commentary on this subject noted that *772“patients may make appointments for the sole purpose of requesting a new ‘miracle drug’ they have seen on television, having no knowledge of whether the drug is truly appropriate for their particular situation.” See Andrea M. Greene, Pharmaceutical Manufacturers’ Liability for Direct Marketing and Over-promotion of Prescription Drugs to Product Users, 26 Am. J. Trial Advoc. 661 (2003). This same study found that as many as a third of the patients asked for information on the drug while one in four asked for the drug itself. Id., at note 6. Three quarters of those patients that asked their doctor to write the prescription for the drug received one. Id. Such direct demand for drug products is due to the manufacturer’s direct-to-consumer promotion. Given that the manufacturers are now directly marketing and benefiting by increased sales, they must also assume increased share in the risks and duties pertinent to selling a product.
Pharmaceutical companies are in the best position to ensure that adequate warnings are provided to customers. As noted in Perez v. Wyeth Labs., Inc., 161 N.J. 1, 734 A.2d 1245 (1999):
Our medical-legal jurisprudence is based on images of health care that no longer exist. At an earlier time, medical advice was received ... from a physician.... [Today,] medical services are in large measure provided by managed care organizations. Medicines are purchased in the pharmacy department of supermarkets and often paid for by third-party providers. Drug manufacturers now directly advertise products to consumers on radio, television, the internet, billboards on public transportation, and in magazines.
Perez, supra, 734 A.2d at 1246.
This case can have a profound effect on the health and well being of individuals in this Commonwealth. It is an important matter of public policy that should be properly decided by the legislature. The matter needs public and legislative debate which is supported by evidence of its value or otherwise. Such' a process can best be obtained through legislative investigative hearings as a matter of public policy. Kentucky product liability law is statutory and amendments to the law are within the discretion of the General Assembly.
LAMBERT, C.J., and STUMBO, J., join this dissent.