Thursday, May 28, 2009

The Learned Intermediary Doctrine in South Carolina

By Brian A. Comer

I have done a significant amount of work on drug and medical device cases over the years, and one of the most important concepts in that products liability arena is whether or not a state has adopted the "learned intermediary" doctrine. In the prescription drug context, the learned intermediary doctrine provides that manufacturers of prescription drugs and medical devices discharge their duty of care to patients by providing warnings to the prescribing physicians. Restatement (Third) of Torts: Products Liability § 6 cmt. d, reporters’ note (1997). The justification in this particular context is that consumers cannot buy prescription drugs directly from a manufacturer. As stated by the Fourth Circuit Court of Appeals:
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. The choice he makes is an informed one, an individualized medical judgment bottomed on a knowledge of both patient and palliative. Pharmaceutical companies then, who must warn ultimate purchasers of dangers inherent in patent drugs sold over the counter, in selling prescription drugs are required to warn only the pre scribing physician, who acts as a "learned intermediary" between manufacturer and consumer.

Talley v. Danek Med., Inc.
, 179 F.3d 154, 163 (4th Cir. 1999).

South Carolina state courts have not explicitly adopted the learned intermediary doctrine in the drug and medical device context. Only two state court cases (that I have found) cite to the rule at all, Bragg v. Hi-Ranger, Inc., 319 S.C. 531, 462 S.E.2d 321 (Ct. App. 1995) and Madison v. American Home Prods. Corp., 358 S.C. 449, 595 S.E.2d 493 (1995). Madison only mentions the rule in dicta (i.e., "strict liability is inconsistent with the learned intermediary doctrine, which places the duty to warn on the prescribing physicians, and not pharmacists...."). Madison, 358 S.C. at 455, 595 S.E.2d at 496. In Bragg, one of the issues on appeal was whether or not the trial court had correctly charged the jury on the "sophisticated user defense." The charge at issue was as follows:

Now, ladies and gentlemen, under South Carolina law, a manufacturer has no duty to warn of potential risks or dangers inherent in a product if the product is distributed to what we call a learned intermediary or distributed to a sophisticated user who might be in a position to understand and assess the risks involved, and to inform the ultimate user of the risks, and to, thereby, warn the ultimate user of any alleged inherent dangers involved in the product. Simply stated, the sophisticated user defense is permitted in cases involving an employer who was aware of the inherent dangers of a product which the, the employer purchased for use in his business. Such an employer has a duty to warn his employees of the dangers of the product.

Bragg, 319 S.C. at 549, 462 S.E.2d at 331-32 (emphasis added). The South Carolina Court of Appeals concluded that the trial court properly charged the jury concerning the sophisticated user defense. Id.

Other practitioners have stated unequivocally that South Carolina has adopted the learned intermediary defense, sometimes citing Bragg or Madison as support. See, e.g., the July 2007 "Headcount: Who's Adopted the Learned Intermediary Rule" at (citing to Madison as support that South Carolina has adopted the rule in the non-prescription medical product case); Lynn H. Gorod, "The Evolving Duty of Pharmacists: To Warn or Not to Warn?" 16 S. Carolina Lawyer 14, 16 (July 2004) ("The basis for not extending this duty has widely been premised on the "learned intermediary doctrine." This doctrine, which has been accepted in many jurisdictions, including South Carolina, provides that manufacturers of prescription drugs have a duty to warn prescribing physicians of a drug's known dangerous propensities.") (Emphasis added).

There is no question that Bragg provides support that South Carolina has adopted the learned intermediary doctrine (perhaps relabeled as the sophisticated user defense). However, there is a dearth of South Carolina case law in comparison to other states on this issue, and any "adoption" of the doctrine at the state level is likely to be subject to greater argument than in other states, where adoption in the drug and medical device context is often more explicit. See, e.g. Stone v. Smith, Kline & French Laboratories, 447 So. 2d 1301 (Ala. 1984); Hawkins v. Richardson-Merrell, Inc., 249 S.E.2d 286 (Ga. Ct. App. 1978); Pittman v. Upjohn Co., 890 S.W.2d 425 (Tenn. 1994) (all explicitly adopted the learned intermediary doctrine in the prescription drug context).

South Carolina's federal courts, on the other hand, have been more explicit and have predicted that South Carolina state courts would apply the learned intermediary rule, and specifically in the drug and medical device context. In Brooks v. Medtronic, Inc., 750 F.2d 1227, 1232 (4th Cir. 1984), the Fourth Circuit Court of Appeals, hearing an appeal from the District of South Carolina, stated that "Although the South Carolina Supreme Court has not addressed the issue, we conclude it would adopt the [learned intermediary] rule, generally accepted and supported by sound policy, restricting the manufacturer's duty to warn to the prescribing physician." Id. at 1231. Brooks was a medical device case involving a pacemaker, and one of the issues on appeal was whether a pacemaker manufacturer has a duty to warn a consumer directly or whether warnings to the physician are sufficient. Id. at 1230. After reviewing South Carolina strict liability law, the court pointed out that other jurisdictions had adopted the learned intermediary rule, and it believed that South Carolina would as well. Id. at 1231. This rule was again cited as the law in Tarallo v. Searle Pharmaceutical, Inc., 704 F. Supp;. 653, 659 n.2 (D.S.C. 1988), Odom v. G.D. Searle Co., 979 F.2d 1001, 1003 (4th Cir. 1992) (involving an appeal from the District of South Carolina), and Pleasant v. Dow Corning Corp., 1993 U.S. Dist. LEXIS 21488 (Jan. 7, 1993, D.S.C.).

This is the case law that I have found that interprets this area of the law in South Carolina. If anyone knows of others, please comment and let me know.

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1 comment:

  1. While you're technically correct that Madison wasn't called upon actually to apply the LIR, the citation to it by the court was sufficiently favorable that subsequent courts have taken it as demonstrating South Carolina's adherence to the LIR. The Texas Supreme Court cited Madison for that proposition in Centocor v. Hamilton, 372 SW3d 140, at note 17.