A couple of months ago we were sufficiently impressed by a guest post we received concerning Iowa and the learned intermediary rule.that we invited counsel familiar with the other states that lacked state-court appellate authority to give us their best pitch for the rule in those states. We had volunteers for South Carolina and Wisconsin (Idaho, Maine, New Hampshire, North Dakota, Puerto Rico, Rhode Island, South Dakota, and Vermont are still available if anyone wants to volunteer). Here’s the first one to be completed, South Carolina – authored by Jim Rogers, Joe Fornadel, and Shannon Coy, all of Nelson Mullins. We thank them for stepping forward. As always, our guest posters deserve 100% percent of the credit (and any blame) for what follows.
The current state of South Carolina law remains largely unchanged from the Blog’s 2007 coverage [ed. note the 2007 post is regularly updated]: it remains true that no South Carolina state appellate court has adopted the learned intermediary doctrine (“LID”) in a prescription medical product case against a product manufacturer. There is an abundance of examples of federal courts taking their best Erie guess that the South Carolina Supreme Court would do so if presented squarely with the issue and some bread crumbs left by state court appellate decisions indicating the same. Indeed, since 1984, the Fourth Circuit has held that the LID should be applied in the prescription product context under South Carolina law (with no contrary state precedent in the interim), making the issue largely academic for federal court practitioners. Nevertheless, the LID has not crossed the goal line yet via a clear state appellate court decision, though there is little reason to believe that it will not at some point in the future.
History of the LID in South Carolina State Courts
The first South Carolina appellate court decision to mention the LID was Bragg v. Hi-Ranger, Inc. There, the intermediate Court of Appeals considered the trial court’s instruction on the sophisticated user defense, which likened a sophisticated user to a “learned intermediary.” 462 S.E.2d 321, 331 (S.C. Ct. App. 1995). Indeed, the current model jury charges contain this same language. See Anderson, S.C. Requests to Charge – Civil, 32-8 (“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”). Neither the Bragg decision nor the model charge go into any detail on the LID, but the recognition of the overlap between these doctrines is informative, particularly in the absence of any appellate caselaw expressly adopting the LID, let alone any declining to do so.
Almost a decade later, the South Carolina Supreme Court favorably discussed the LID in Madison v. American Home Prods. Corp., but the facts of the case did not put the issue squarely before the court. 595 S.E.2d 493, 494 (S.C. 2004). There, the plaintiff ingested an anti-depressant and subsequently harmed her son and herself. Following a criminal conviction related to the assault and battery of her son, the plaintiff sued both the drug manufacturer and the pharmacy that filled the prescription. Ultimately, and for reasons not bearing further discussion here, the trial court never considered the substance of the claims against the manufacturer and there was no express appellate determination that the LID applied in this context. Nevertheless, the pharmacy successfully sought dismissal of the claims stated against it. In upholding this dismissal, the Supreme Court held that, among other things, “impos[ing] strict liability on pharmacists” was inappropriate, as “‘strict liability is inconsistent with the learned intermediary doctrine, which places the duty to warn on the prescribing physicians, and not pharmacists.’” Id. at 496 (citing David J. Marchitelli, Liability of Pharmacist Who Accurately Fills Prescription for Harm Resulting to User, 44 A.L.R. 5th 393, 419, § 2(a)(1996)).
In short, the South Carolina Supreme Court’s discussion of the LID in Madison is helpful and can be read as holding that the LID would apply in the context of a failure to warn claim stated against a prescription product manufacturer (as can the model charge regarding the sophisticated user defense). A plaintiff may argue that the court set forth multiple grounds for affirming the grant of summary judgment for the pharmacy in Madison, thus making the LID endorsement mere dicta in an opinion that did not expressly address failure to warn claims directed at a manufacturer. A defendant would call it an alternative holding. Either way, this is a narrow objection to the LID, and potentially impossibly so, in light of the persuasive federal case law interpreting this doctrine.
Federal Courts & the LID
When Applying South Carolina Law
Though there may be some gap into which an enterprising state court plaintiff’s counsel could build an argument that the LID has not been recognized under South Carolina law, no such gap exists within the Fourth Circuit. Federal courts have routinely reached the same conclusion when making their Erie guess as to whether the LID should apply in the prescription product context: it should.
In 1984, and predating Bragg by over a decade, the Fourth Circuit stated that, “[a]lthough the South Carolina Supreme Court has not addressed the issue, we conclude that it would expressly adopt the [LID], generally accepted and supported by sound policy, restricting the manufacturer’s duty to warn the prescribing physician.” Brooks v. Medtronic, Inc., 750 F.2d 1227, 1231 (4th Cir. 1984). Brooks involved a cardiac pacemaker and the Fourth Circuit held that the manufacturer of that prescription medical device had no duty to warn the patient of the risks associated with the device under the LID. Id.
Since Brooks, the Fourth Circuit and the District Court for the District of South Carolina have applied the LID faithfully and repeatedly when interpreting South Carolina law. See Bean v. Upsher-Smith Pharms., Inc., 765 F. App’x 934, 936 (4th Cir. 2019) (citing Brooks and affirming application of LID in context of prescription drugs), aff’g 2017 WL 4348330, at *7-*8 (D.S.C. Sept. 29, 2017); Odom v. G.D. Searle & Co., 979 F.2d 1001, 1003 (4th Cir. 1992) (citing Brooks and applying the LID in prescription device context), aff’g No. D:90–0845–8, 1991 WL 11695212, at *1 (D.S.C. Dec. 11, 1991); McLeod v. Sandoz, Inc., No. 4:16-CV-01640-RBH, 2018 WL 1456739, at *3 (D.S.C. Mar. 23, 2018) (citing Odom and applying LID in prescription drug context); Harrison v. Davol, Inc., No. 8:17-1033-TMC, 2017 WL 10109447, at *3 (D.S.C. Nov. 8, 2017) (citing Brooks and Odom and applying the LID in the prescription device context); McLeod v. Sandoz, Inc., No. 4:16-CV-01640-RBH, 2017 WL 1196801, at *9-*10 (D.S.C. Mar. 31, 2017) (citing Brooks and Odom and applying LID in the prescription drug context); Luberda v. Purdue Frederick Corp., No. 4:13–cv–00897–RBH, 2014 WL 1315558, at *5 (D.S.C. Mar. 28, 2014) (citing Brooks and Odom and applying LID in the prescription drug context); Carnes v. Eli Lilly & Co., No. CA 0:13-591-CMC, 2013 WL 6622915, at *3 (D.S.C. Dec. 16, 2013) (citing Brooks and Odom and applying LID to prescription drugs); Sauls v. Wyeth Pharms., Inc., 846 F.Supp.2d 499, 502 (D.S.C. 2012) (citing Brooks and Odom and applying LID in prescription drug context); King v. Stryker Corp., No. 2:10-cv-3069-RMG, 2012 WL 12981763, at *5 (D.S.C. Apr. 3, 2012) (citing Brooks and applying LID in prescription device context); Fisher v. Pelstring, 817 F.Supp.2d 791, 811 (D.S.C. 2011) (citing Brooks and Odom and applying LID in prescription drug context); Jones v. Danek Med., Inc., No. 4:96–3323–12, 1999 WL 1133272, at *7 (D.S.C. Oct. 12, 1999) (citing Brooks and applying LID in prescription device context); see also Cribbs v. Beaufort Memorial Hosp., No. 9 05 415-PMD, 2005 WL 8166096, at *3 (D.S.C. Oct. 5, 2005) (in context of claims that hospital failed to warn of certain risks, holding that “‘virtually every jurisdiction considering the issue, including the Fourth Circuit, has concluded that the learned intermediary doctrine should apply not only to prescription drugs, but also to medical devices, which are prescribed or inserted by a physician’”) (quoting Pleasant v. Dow Corning Corp., No. 3:92–3180–17, 1993 WL 1156110, at *6 (D.S.C. Jan. 7, 1993) (citing Brooks)).
Indeed many federal court plaintiffs have not even disputed that the LID applies in the prescription product context. E.g., Bean, 2017 WL 4348330, at *7–*8; Odom, 979 F.2d at 1003; McLeod, 2018 WL 1456739, at *3. Some still choose to contest the issue, but the authors are not aware of any successful attempts in that regard. Carnes, 2013 WL 6622915, at *4 (“Plaintiffs have not identified, and the court is unaware of, any decision from the South Carolina Supreme Court or Court of Appeals rejecting the learned intermediary doctrine in a prescription drug case”).
The most recent opinion from the Fourth Circuit on the issue, Bean, provides several interesting updates on the LID under South Carolina law (at least within the Fourth Circuit). First, the Fourth Circuit read Madison as having “proven” the Fourth Circuit’s prediction in Brooks as “correct.” 765 F. App’x at 936. This reading should foreclose any wiggle room potentially allowed by the fact that the Supreme Court was not squarely presented with a classic application of the LID in Madison. Second, the Fourth Circuit also recognized that, even though the FDA requires direct-to-consumer warnings for some prescription products, this requirement does not impact to whom the manufacturer’s duty to warn runs for the purposes of a failure to warn claim. Id. at 937. The Fourth Circuit explained that to hold otherwise would contravene the FDA’s intent that the requirements for such direct-to-consumer warnings do not “alter the duty or set the standard of care for manufacturers.” Id. (quoting 63 Fed. Reg. 66378, 66384 (Dec. 1, 1998)).
Looking beyond the Fourth Circuit, the Texas Supreme Court included South Carolina among the “highest courts of at least thirty-five states [that] have adopted some form of the [LID]” on the strength of Madison. Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 173 n.17 (Tex. 2012). Federal courts applying South Carolina law in other jurisdictions also have found that South Carolina follows the LID. See Nodine v. Shiley Inc., No. SA CV 97-431-GLT EEX, 1999 WL 1487423, at *2 (C.D. Cal. Jan. 28, 1999) (involving application of the LID in the context of a fraud claim against the manufacturer of an artificial heart valve), aff’d, 240 F.3d 1149 (9th Cir. 2001) (affirmed on statute of limitations grounds without discussion of the substantive claim); Purnell v. United States, No. CIV.A. 86-4475, 1987 WL 11212, at *1 (E.D. Pa. May 21, 1987) (citing Brooks and applying LID in prescription drug context). Additionally, the District Court for the Eastern District of Texas listed South Carolina in a table of forty-eight jurisdictions that either apply or recognize the LID without exception to prescription drugs. See In re Norplant Contraceptive Prod. Liab. Litig., 215 F. Supp. 2d 795, 806 (E.D. Tex. 2002) (citing Brooks and Odom).
Thus, it is settled that, at least in federal courts, the LID should be applied when analyzing South Carolina law. This nearly 30-year body of caselaw should be persuasive, though admittedly not binding, on any state court presented with the issue.
As reported on the Blog back in 2007 [ed. note the 2007 post is regularly updated], the issue of whether the LID applies under South Carolina law remains on the goal line. The South Carolina Supreme Court’s holding in Madison implies that the LID is viable and, indeed, in the eyes of the Fourth Circuit, this opinion was enough to push the issue over the goal line. Bean, 765 F. App’x at 936. Further, a review of the remaining published opinions involving the LID reveals no reason to suspect that the LID would not be adopted. More broadly, most jurisdictions have adopted the LID at this point and the latest Restatement section regarding the same recognizes as much. Restatement (Third) of Torts: Prods. Liab. § 6, cmt. b (Am. Law. Inst. 1998) (“The obligation of a manufacturer to warn about risks attendant to the use of drugs and medical devices that may be sold only pursuant to a health-care provider’s prescription traditionally has required warnings directed to health-care providers and not to patients”) (emphasis added). There is little reason to believe the South Carolina Supreme Court will not cross the goal line at the first opportunity to do so, but, until then, the issue remains unsettled in South Carolina state courts.