Showing posts with label Sophisticated User Defense. Show all posts
Showing posts with label Sophisticated User Defense. Show all posts

Wednesday, April 13, 2011

Article Published in SCDTAA Publication "The Defense Line"

I am pleased to announce that my article entitled "Limits on the Duty to Warn in South Carolina Products Liability Law" was recently published in the Spring 2011 edition of The Defense Line, which is published by the South Carolina Defense Trial Attorneys' Association. You can find a .pdf of the article here.

As background, South Carolina Lawyer was kind enough to publish my article, "South Carolina Products Liability Law: What is South Carolina's Law on Warnings?" in its January 2011 edition. (See my post about this publication here). The original draft of the article was intended to be a comprehensive review of South Carolina warnings law, with the exception of the doctrine of preemption (which is a topic for an entirely different article by itself). The problem was that the article was extremely long and nearly double the word limitations requested by South Carolina Lawyer. To prepare it for publication, I had to cut a substantial amount of material from the section dealing with exceptions to and limitations on the duty to warn. My hope was that I could use this material to create a separate article and have it published in a different publication.

Fast forward to the Spring edition of The Defense Line, and there you have it: the "lost material" from the original article. This article has substantially more information on limitations/exceptions to the duty to warn in South Carolina than what was in the original South Carolina Lawyer article, with more case law and analysis. Enjoy.

This post is subject to the DISCLAIMER AND TERMS OF USE of this website.

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 Druganddevicelaw.blogspot.com (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.

This post is subject to the DISCLAIMER & TERMS OF USE of this website.

Wednesday, May 27, 2009

Case Brief: Bragg v. Hi-Ranger

By Brian A. Comer and Felicia Sampson

Today's brief is of Bragg v. Hi-Ranger, Inc., 319 S.C. 531, 462 S.E.2d 321 (Ct. App. 1995). Along with Young v. Tide-Craft, Inc., 270 S.C. 453, 242 S.E. 2d 671 (1978), Bragg is probably the most important products liability law case in South Carolina. Therefore, my apologies that this "brief" is not that short, but again...there's a lot to this case.

Special thanks to Felicia Sampson, a summer associate who just completed her first year of law school at the University of South Carolina School of Law, who took the lead on writing this case brief.

FACTUAL BACKGROUND: The decedent, a lineman employed by Y.C. Ballenger Electrical Contractor ("Ballenger"), died as a result of injuries sustained from jumping out of an aerial bucket manufactured by Hi-Ranger, Inc. ("Hi-Ranger") when the bucket caught on fire. Bragg v. Hi-Ranger, Inc., 319 S.C. 531, 534, 462 S.E.2d 321, 323 (1995). The decedent had been using a hydraulically-driven wrench that was being fed hydraulic fluid under pressure by two hoses. Id. at 535, 462 S.E.2d at 324. The bucket caught fire when the conductive tool hose attached to the wrench came in contact with energized power lines. Id. "Quick disconnect couplings" used for connecting hydraulic tools were installed near the bucket. Id. at 536, 462 S.E.2d at 324. Once a tool is disconnected, the couplings prevented the hydraulic fluid from flowing. Id. at 535, 462 S.E.2d at 324. However, before the accident, a Ballenger mechanic had improperly installed a black conductive hose rather than the proper orange non-conductive hose. Id. Several linemen testified that they knew non-conductive hoses should be used on the aerial bucket, but that they did not know orange hoses were non-conductive and black hoses were conductive. Id. 535-36, 462 S.E.2d at 324.

PROCEDURE: The Plaintiff, personal representative of the decedent’s estate, brought an action against Hi-Ranger alleging claims based on strict liability, implied warranties, and negligence. Bragg, 319 S.C. at 534, 462 S.E.2d at 323. At trial, the Plaintiff presented expert evidence regarding design and warning defects. Id. at 535-36, 462 S.E.2d at 324. Hi-Ranger asserted defenses of contributory negligence, assumption of risk, intervening negligence, substantial change in the product after sale, open and obvious danger, and misuse of the product under S.C. Code Ann. § 15-73-20 (1976). Id. at 534, 462 S.E.2d at 323. Hi-Ranger moved for a directed verdict on each cause of action. Id. The trial court granted Hi-Ranger a directed verdict on the strict liability and warranty claims, and the jury returned a verdict in favor of Hi-Ranger on the negligence claim. Id. The Plaintiff appealed, arguing that the court’s decision to grant the motion for directed verdict on the strict liability claim—while denying the motion for directed verdict on the negligence claim—was illogical. Id. at 538, 462 S.E.2d at 325. The Plaintiff also appealed several portions of the trial court's jury charge. Id. at 534, 462 S.E.2d at 323.

ISSUES: The court analyzed whether strict liability and negligence are mutually exclusive theories of recovery such that failure to prove one theory would preclude proving the other. Bragg, 319 S.C. at 538-39, 462 S.E.2d at 325-26. The court also addressed the sufficiency of certain jury charges, including (1) whether a manufacturer has a duty to warn previous-purchasers about safety devices developed after the time of sale, or (2) whether a manufacturer has a duty to retrofit products with later-developed safety devices if the products were not defective based on the standards existing at the time of manufacture or time of sale. Id. at 547-49, 462 S.E.2d at 330-31. Finally, the court addressed whether the sophisticated user defense is appropriate where the manufacturer, regardless of the intermediary's actual knowledge, reasonably assumed that the intermediary would know the danger involved in using the product and take steps to protect its employees. Id. at 549-51, 462 S.E.2d at 331-32.

DISPOSITION: The court affirmed the judgment in favor of Hi-Ranger. Bragg, 319 S.C. at 551, 462 S.E.2d at 332.

RULES AND OPINION: The theory of strict liability and the theory of negligence are not mutually exclusive, and failure to prove one does not preclude proving the other. Bragg, 319 S.C. at 539, 462 S.E.2d at 326. In order to prove any products liability theory, the plaintiff must prove (1) the product injured him, (2) the injury was a result of the product's defective condition which rendered the product unreasonably dangerous to the user, and (3) at the time of the accident, the product was in the same condition as it was when it left the defendant's control. Id. Under a negligence theory, the plaintiff must also prove that the defendant failed to exercise due care. Id. The conduct of the seller or manufacturer is at issue in a negligence theory, whereas a strict liability theory focuses on a product's condition. Id. at 539-40, 462 S.E.2d at 326. It is possible for a manufacturer to be liable under a negligence theory without being liable under a strict liability theory because under strict liability, the manufacturer is not responsible for all losses caused by the product, but only for losses caused by the product's failure to perform to a standard of reasonable safety within its normal environment. Id. at 541, 462 S.E.2d at 327. Therefore, it is not inconsistent to grant a directed verdict on a strict liability claim while allowing a negligence claim to go to the jury. Id.

The fact that a product can be made safer does not mean that it is unreasonably dangerous and subject to a strict liability claim. Id. at 543, 462 S.E.2d at 328. Similarly, the fact that a product malfunctions does not demonstrate a manufacturer's negligence or that a product was defective. Id. There are two tests that determine whether a product is unreasonably dangerous for its intended use. Id. The first test asks "whether the product is unreasonably dangerous to the ordinary consumer or user given the conditions and circumstances that foreseeably attend the use of the product." Id. Under the second test, the product is unreasonably dangerous "if the danger associated with the use of the product outweighs the utility of the product." Id. To determine whether a product is unreasonably dangerous under one of these tests, the court balances "the utility of the risk inherent in the design of the product with the magnitude of the risk," thus establishing the reasonableness of the manufacturer in designing the product. Id. at 544, 462 S.E.2d at 328. Relevant factors include the usefulness and desirability of the product, the cost for added safety, likelihood and potential seriousness of injury, and the obviousness of the danger. Id.

The court found that the testimony of the Plaintiff's expert was insufficient to prove that the aerial device, as designed and manufactured in 1984, was defective and unreasonably dangerous at the time of sale. Id. at 544, 462 S.E.2d at 329. At the time of sale, the aerial device was "merchantable and fit for the purpose for which it was sold, but caused injury due to its improper use by a third party" (i.e., due to the incorrect installation by the Ballenger mechanic of the conductive hose). Id. at 545-46, 462 S.E.2d at 329. The fact that there had been no mishaps for six years after the time of sale was additional evidence that the aerial device was not unreasonably dangerous. Id. The court found that "considering the aerial device's characteristics, risks, dangers and uses, together with the knowledge, training, and experience possessed by the intended user," and because the Plaintiff did not introduce evidence that there was a feasible design alternative for the couplings that would be useful beyond demonstration purposes, failure to use different "quick disconnect couplings" did not make the device defective and unreasonably dangerous for the intended user; therefore, Hi-Ranger was not liable for a design defect based on a strict liability claim. Id. at 546-47, 462 S.E.2d at 330. The court also found that because the evidence established that the aerial device met warning standards at the time of manufacture and sale, Hi-Ranger was not liable for a warning defect based on a strict liability claim. Id.

Plaintiff also contended that there were four jury instructions that were erroneously excluded and two charges that were erroneously given. The court also disagreed with this contention. Id. at 547, 462 S.E.2d at 330. The court found that it had accurately and completely charged the jury on assumption of risk, contributory negligence, and intervening or superseding negligence. Id. With regard to a charge concerning a manufacturer's post-sale duties, the court found that a product must be measured against the standards of care that exist at the time of sale or against the reasonable consumer expectations at the time of sale. Id. at 548-49, 462 S.E.2d at 331. The court found that because the evidence suggested that the aerial device met all appropriate standards at the time of manufacture, the trial court properly charged the jury with the law regarding the manufacturer's duty to retrofit or recall its products. Id. With regard to the sophisticated user defense, the court found that the defense applies where the manufacturer reasonably assumes that the employer knows of the danger of the product and will take measures to protect its employees, regardless of the specific knowledge of the employer. Id. at 549-51, 462 S.E.2d at 331-32. Because there was substantial evidence that Ballenger was a large electric contractor, was very familiar with bucket trucks and aerial devices, and was aware that conductive hoses should not be used in aerial buckets, the trial court properly charged the jury regarding the sophisticated user defense. Id.

This post is subject to the DISCLAIMER & TERMS OF USE of this website.