Upcoming Webinar: "Warnings - Scope of and Exceptions to Duty to Warn"

My firm is a member of the Primerus network of law firms, and on July 21, 2011 at 2 p.m. ET, I am going to be presenting in a webinar entitled "Warnings - Scope of and Exceptions to Duty to Warn."  I am one of three speakers who will be discussing the various limitations on the duty to warn in a products liability case.  We anticipate that the webinar will last between an hour and an hour-and-a-half.  It will include a powerpoint presentation of the various topics discussed, and my co-presenters include Rick Quinlivan and John Brydon.  Both of these gentlemen also have extensive experience in products liability cases and warnings cases (in particular).

I have written numerous blog posts and articles about South Carolina's limitations on the duty to warn , so this is a topic that is fairly familiar to me.  (See, e.g., this post, this post, this article, and this article).  This webinar takes a more general, national approach to this topic so as to provide the audience with some high-level guidance for application in various jurisdictions.

Although I try to keep this blog fairly "even keel" in terms of plaintiff and defense themes/perspectives, this webinar is presented as part of the Primerus Defense Institute, so it is primarily focused on defense strategies in a warnings case.  If you are interested in registering for this webinar, go to this link for more information.  I hope you will join us for what should be an informative presentation.

South Carolina Bar CLE Presentation on Warnings Goes "Live"

You probably recall from a previous post that I recently participated in the South Carolina Bar's "Distance Learning" program by taping a one-hour presentation on South Carolina warnings law.  I received an email today that my presentation has gone "live" on the website. 

So...if you want to watch my ugly mug and some slides for an hour-long, fun-filled warnings extravaganza, check out this link.

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.

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SC Lawyer Article on Warnings Published

My apologies for the length of time since my last post. January was rough for the South Carolina Products Liability Law Blog, as your beloved author got sidetracked by one kid getting sick...for a week...then a second kid getting sick...for the entire next week....and then yours truly getting the flu this past week (most likely thanks to aforementioned kids). So basically, when I haven't been working, I've been helping tend to sick kids or trying to get myself healthy again. Fun stuff, people, fun stuff. But better days are ahead, as Punxsutawney Phil did NOT see his shadow this week, meaning spring is on the way!

But enough about all that. Let's talk about something that really gets the juices flowing...like South Carolina's law on warnings. South Carolina Lawyer was kind enough to publish my article entitled Products Liability Claims in South Carolina: What is South Carolina's Law on Warnings? in its January 2011 edition, and you can find a copy of it here (give it a couple seconds to load). This article started out as a very exhaustive look at South Carolina warnings law (with the exception of the doctrine of preemption...which is a big enough topic to be its own article). However, because of space constraints, I had to cut it down a fair amount for publication. The section on exceptions to the duty to warn was originally much longer and had a great deal of additional case law and information. Because much of this information had to be cut out, I plan to use it as the basis for a new article that focuses specifically on this area of South Carolina warnings law, and I hope to submit it for publication in the near future.

Hopefully you will find it to be of interest, and I welcome any comments or feedback.

A couple of other blog-worthy developments from the last month. The South Carolina Defense Trial Attorneys Association asked if I would co-chair the Products Liability Substantive Law Committee, which I was very happy to accept for this year. My co-chair is Nick Gladd, and we will be responsible for providing updates to the organization on developments in products liability law in South Carolina, as well as helping plan for certain breakout sessions at the SCDTAA's meetings this year. If any followers of the blog are members of the SCDTAA and have suggestions for breakout topics, then please let me know.

Finally, my firm has asked me to chair our Products Liability Practice Group. The outgoing chairperson is Gray Culbreath, who also happens to be the Managing Partner of Collins & Lacy, P.C. and serves as the current President of the SCDTAA. Needless to say, Gray is wearing many different hats these days, so I appreciated my firm asking me to take over this duty so as to free him up a bit. I look forward to serving in this role.

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

'Tis the Season for Good Food...And Warnings

During this time of year when we enjoy turkey, turkey ala king, turkey sandwiches, turkey soup, turkey casserole, and crazy delicious holiday food (see above classic example from National Lampoon's "Christmas Vacation"), it is a good time to reflect on...warnings. Yes, that's right, there is even a body of law concerning warnings about food.

You are probably saying to yourself right now, "I've always thought that the turkey packaging should warn about L-Tryptophan and the danger of driving after Christmas lunch." Whether sleepiness after excessive turkey consumption is an open and obvious risk (and therefore constitutes an exception to the duty to warn) is an issue that will be debated for eons among the most sophisticated jurists.

But I digress. The reality is that food warnings law is set forth fairly clearly in comment J. to section 402A of the Restatement (Second) of Torts. As you will recall, South Carolina has incorporated this comment by reference into its strict liability statute as the legislative intent of the chapter. See S.C. Code Ann. § 15-73-30 (1976) (“Comments to § 402A of the Restatement of Torts, Second, are incorporated herein by reference thereto as the legislative intent of this chapter.”). Comment j. includes certain exceptions to the duty to warn, and it just so happens that two such exceptions deal with warnings about food.

(1) Common Allergies

The first exception to the duty to warn set forth in comment j. is that “the seller may reasonably assume that those with common allergies, as for example to eggs or strawberries, will be aware of them, and he is not required to warn against them.” Restatement (Second) of Torts § 402A cmt. j. Although this exception to the duty to warn may be straightforward when the consumer’s conduct relates to avoiding individual food products, it becomes more problematic when these food products are ingredients in other dishes. Comment j. therefore qualifies this exception with additional language.

Where, however, the product contains an ingredient to which a substantial number of the population are allergic, and the ingredient is one whose danger is not generally known, or if known is one which the consumer would reasonably not expect to find in the product, the seller is required to give warning against it, if he has knowledge, or by the application of reasonable, developed human skill and foresight should have knowledge of the presence of the ingredient and the danger.

For example, the Food Allergen Labeling and Consumer Act (“FALCA”) went into effect in 2006 to require that packaged foods containing milk, eggs, fish, crustacean shellfish, peanuts, tree nuts, wheat and soy must display them prominently in the ingredient list. See 21 U.S.C. § 201 et. seq. According to FALCA, these “Big Eight” food allergens account for 90 percent of all food-allergic reactions, and federal law requires their disclosure on packaged foods. Id. at § 201(2). Comment j. provides some of the rationale for this disclosure: a substantial number of the population is allergic to these ingredients, and the consumer may not know if one of the ingredients is in a food product without the disclosure.

Neither South Carolina state nor federal courts have interpreted this specific aspect of comment j. in the context of a food products failure to warn case. However, in Vaughn v. Nissan Motor Corp., 77 F.3d 736, 738 (4th Cir. 1996), the court stated in dicta that the “ordinary consumer” standard for determining if a product is unreasonably dangerous does not necessarily apply in the case of products associated with allergic reactions in an appreciable number of consumers.

(2) Products Consumed Over a Long Period of Time

Comment j. also carves out an exception to the duty to warn if the potential danger of a product relates to its use over a long period of time or in excessive quantities: “[A] seller is not required to warn with respect to products, or ingredients in them, which are only dangerous, or potentially so, when consumed in excessive quantity, or over a long period of time, when the danger, or potentiality of danger, is generally known and recognized.” Restatement (Second) of Torts § 402A cmt. j. As examples, the comment cites to alcoholic beverages and foods containing substances such as saturated fats. A seller has no duty to warn about the risks associated with such products from extended or excessive consumption.

Neither South Carolina state nor federal courts have interpreted this exception in comment j. In Aldana v. R.J. Reynolds Tobacco Co., No. 2:06-3366-CWH, 2008 WL 1883404 (D.S.C. Apr. 25, 2008), the court cited to this portion of comment j. to support that the warnings for defendant’s cigarette products were not required to make the product itself “safe,” but the court did not otherwise apply it to excessive or extended use of cigarettes. Id. at *2.

From the South Carolina Products Liability Law Blog, here's wishing you and your friends/families a very Merry Christmas and happy holiday season.

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Drilling Down: Proving the Duty to Warn

By Brian A. Comer

Although I have never made it official, I have been doing a series of posts on warnings as a result of some research I have done lately for a case. It started with an analytical framework for warnings, followed by some commentary on the duty to warn and the "obvious risk" posed by cell phone use while driving, and then a more detailed post on when the duty to warn arises.

As stated in a prior post, Gardner v. Q.H.S., Inc., 448 F.2d 238 (4th Cir. 1971) supports that the duty to warn arises when (a) the reasonably foreseeable risks of a product – either from its intended use or from the environment in which it is used – pose a potential danger, and (b) the user may not realize the potential danger. In such cases, the manufacturer and supplier has a duty to warn the user. Gardner, 448 F.2d at 242-43.

The question that follows is: how does a plaintiff prove this duty in the context of a manufacturer seller? A plaintiff must produce evidence from which a jury can conclude that a manufacturer or seller has reason to believe that a warning is necessary. Livingston v. Noland Corp., 293 S.C. 521, 525, 362 S.E.2d 16, 18-19 (1987) (holding that supplier and manufacturer had no way of knowing and no reason to foresee that failed refrigerator compressors would be unreasonably dangerous unless a warning was provided). Gardner also addressed this issue by discussing the means by which to determine foreseeability and whether a duty to warn arises. As stated by the court:

Where the issue is one of foreseeability, evidence of what has actually been experienced in the same or comparable situations constitutes proof of the greatest probative value. The only other way foreseeability can be proved is by expert testimony and in most instances it, too, will depend upon actual experience developed by laboratory or everyday experience.

Id. at 244. In this context, the court in Gardner determined that depositions and complaint letters of other product users who had similar experiences with the hair rollers at issue were admissible to show the manufacturer’s knowledge of the problem. Id. The court also believed that certain expert testimony should have been admitted to show the nature of the danger. Id.

Gardner's analysis correlates with my own experience in warnings cases concerning the method of proof. There are multiple sources of information that should be reviewed to determine if there is an actual or potential risk with a product, creating a duty to warn:

• Interviewing manufacturer and/or seller representatives about the product and whether there was any knowledge of an actual or foreseeable risk, and when the individuals had this knowledge. From an efficiency standpoint, this is usually my first source (if I represent the manufacturer/seller).
• After interviews, reviewing internal company documents relating to prior incidents involving the product and the risk at issue, adverse event reports (in drug/medical device cases), testing of the product (and their results), memoranda and emails concerning any risks with the product, and other documents. This is typically where a plaintiff is trying to find a "smoking gun" where the manufacturer or seller indicates knowledge of a potential issue.
• Review of non-company documents and information, such as scientific literature concerning the product, case reports in literature of the potential risk at issue, trade literature, information from any regulatory bodies (FDA, CPSC, etc.), recall information, etc. Evaluating this information is important because even if there was not anything in the company documents or interviews to indicate knowledge of a potential risk, these sources can inform as to whether the company should have known of a potential risk. Although it may vary depending on the jurisdiction, companies frequently are held to the standard of being an "expert," meaning they are expected to know about the most current literature and findings concerning their product.
• Interviews and consultation with industry and scientific experts. These individuals, in my experience, usually provide their opinion -- putting together all of the above information -- as to whether there was a duty to warn.

These sources only focus on the duty to warn, and not the adequacy of the warning (which involves other sources of information that should be reviewed, and other kinds experts, including regulatory and human factors experts). Furthermore, the above list is certainly not exhaustive by any means. However, whether there was a duty to warn can be a simple issue (e.g., warning that a surface is hot) or a contentious one (whether a pharmaceutical manufacturer should have warned of a potential, disputed risk in its labeling), and all this information is important with regard to proving any duty to warn.

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

Drilling Down: The Duty to Warn

By Brian A. Comer

I have been doing some research on South Carolina warnings law lately, and now is as good a time as any to provide some further explanation on this area of products liability law. I always enjoy cases involving warnings, primarily because I never cease to be amazed at how different sides of the bar can have totally divergent views on whether a specific warning is "adequate."

No South Carolina state court (that I have found) explicitly sets forth when the duty to warn arises in a products liability case. However, in Gardner v. Q.H.S., Inc., 448 F.2d 238 (4th Cir. 1971), the Fourth Circuit Court of Appeals provided extensive guidance on the duty to warn in an appeal of a South Carolina products liability action arising in diversity, and the South Carolina Supreme Court cited to Gardner’s rationale in its negligent failure to warn analysis in Livingston v. Noland Corp., 239 S.C. 521, 362 S.E.2d 16 (1987). Gardner supports that the duty to warn arises when (a) the reasonably foreseeable risks of a product – either from its intended use or from the environment in which it is used – pose a potential danger, and (b) the user may not realize the potential danger. In such cases, the manufacturer and supplier has a duty to warn the user. Gardner, 448 F.2d at 242-43; Livingston, 293 S.C. at 525, 362 S.E.2d at 18.

Gardner involved the ignition of hair rollers when the water in which they were heating boiled out of the pot. Id. at 240-41. After putting the rollers on the stove to heat, the user fell asleep in the bathtub. Id. at 241. The resulting fire substantially destroyed the apartment building, and the building owner sued the hair roller manufacturer to recover his losses. Id. at 240. One of his theories for recovery was that the manufacturer’s warning about the flammability of the rollers was inadequate. Id. The warning at issue stated as follows: “Use plenty of water. Do not let water boil away. Cautionary note: Rollers may be inflammable only if left over flame in pan without water. Otherwise Q.H.S. Setting/Rollers are perfectly safe.” Id. at 241.

The district judge granted a directed verdict in favor of the manufacturer on grounds that the hair rollers were not “inherently dangerous.” Id. at 240. Therefore, the manufacturer had no duty to provide a more extensive warning than the one provided. Id. On appeal, the Fourth Circuit rejected the district judge’s focus on the inherent danger of the rollers as the determinative factor for the manufacturer’s duty to warn. Id. at 242. Instead, the court suggested that the duty to warn arises if a supplier and manufacturer “(a) . . . know or have reason to know that the chattel is or is likely to be dangerous for the use for which it is supplied, [and] (b) they lack reason to believe that the user will realize the potential danger. . . . “ Id. at 242 (citing Restatement (Second) of Torts §§ 388 and 295 (1965)). The court elaborated that the duty is determined through an analysis of foreseeability, and it cited to Mickle v. Blackmon, 252 S.C. 202, 166 S.E.2d 173 (1969) as the applicable South Carolina law. Gardner, 448 F.2d at 242-43. The court quoted from Mickle as follows:

Normally a seller or manufacturer is entitled to anticipate that the product he deals in will be used only for the purposes for which it is manufactured and sold: thus he is expected to reasonably foresee only injuries arising in the course of such use. However, he must also be expected to anticipate the environment which is normal for the use of his product and where, as here, that environment is the home, he must anticipate the reasonably foreseeable risk of the use of his product in such an environment. These are risks which are inherent in the proper use for which his product is manufactured.

Id. (quoting Mickle, 252 S.C. at 233, 166 S.E.2d at 187).

Using this framework, the court determined that a jury could conclude that a momentary interruption that results in water boiling away is so common that the manufacturer should have foreseen that it could occur while its product was being used. Id. at 243. The court also concluded that a jury could find that the manufacturer knew or should have known that the heat to which the product would be subjected during those occasions could exceed the normal ignition point of the hair roller’s contents. Id. Therefore, the court concluded that the jury could have found that there was a duty to warn of these risks. Id.

I will continue to post on when the duty to warn arises as I continue to research warnings law. However, from my research to date, no other case summarizes when the duty arises better than Gardner.

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

Case Brief: Moore v. Barony House Restaurant

By Brian A. Comer

Today's case brief is Moore v. Barony House Restaurant, LLC, 382 S.C. 35, 674 S.E.2d 500 (Ct. App. 2009). This is (predominantly) a warnings case, and its significance relates to the concept that there is no duty to warn of open and obvious dangers associated with use of a product.

FACTUAL BACKGROUND: A doctor hosted a Christmas party in 2004 in which folks had socialized at one section of his property and then were transported to a different section across a public road for dinner. 382 S.C. at 38, 673 S.E.2d at 502. The deceased worked for the caterer and was in charge of transporting party-goers to the dinner section of the property via a golf cart. Id. Plaintiff attempted to cross the road in a golf cart that was not equipped with lights. Id. An SUV was approaching, did not see the golf cart in time, struck the cart, and killed the driver. Id. at 39, 673 S.E.2d at 502.

PROCEDURE: The deceased's estate ("Plaintiff") brought suit against the various parties responsible for the party (the doctor, caterer, golf cart manufacturer, etc.). 382 S.C. at 39, 674 S.E.2d at 502. Against the manufacturer, Plaintiff alleged causes of action for strict liability based on the manufacturer's used fleet golf cars being unreasonably dangerous in light of their foreseeable use and based on inadequate warnings. Id. Plaintiff also alleged negligence based on a failure to warn. Id. The trial court granted summary judgment in favor of the manufacturer on these claims, and Plaintiff appealed. 382 S.C. at 40, 674 S.E.2d at 503.

ISSUES: Whether the trial court erred in granting summary judgment on Plaintiff's strict liability and negligence claims relating to the manufacturer's alleged failure to warn. 382 S.C. at 40, 674 S.E.2d at 503.

DISPOSITION: The South Carolina Court of Appeals affirmed the grant of summary judgment by the trial court. 382 S.C. at 43, 674 S.E.2d at 504.

RULES AND OPINION: The Court first addressed Plaintiff's strict liability claim. 382 S.C. 40, 674 S.E.2d at 503. Plaintiff contended that the golf car was defective and unreasonably dangerous because the manufacturer marketed the used fleet golf cars for operation on public roads without affixing lights and reflective devices or without providing warnings. Id. at 41, 674 S.E.2d at 503. The Court disagreed and stated that while lights and reflectors would make the carts more safe, the absence of such optional safety features did not make the cart defective. Id. "'Most any product can be made more safe . . . . [A] bicycle is more safe if equipped with lights and a bell, but the fact that one is not so equipped does not create the inference that the bicycle is defective and unreasonably dangerous." Id. (quoting Marchant v. Mitchell Distrib. Co., 270 S.C. 29, 35-36, 240 S.E.2d 511, 513 (1977)). The Court also disagreed with Plaintiff's contention that the golf cart was defective and unreasonably dangerous because the manufacturer failed to provide adequate warnings regarding operation at night and on public roads. Id. The Court acknowledged that a product may be defective and unreasonably dangerous if it is not accompanied by an adequate warning. Id. at 41, 674 S.E.2d at 503-04. However, the Court recognized that a seller is not required to warn of dangers or potential dangers that are generally known and recognized. Id. "[O]peration of an unlighted golf car on a public highway at night presents an open and obvious risk." Id. at 42, 675 S.E.2d at 504. Therefore, the golf cart was not defective and unreasonably dangerous for failure to include a warning about nighttime operation. Id.

With regard to Plaintiff's negligence claim, the Court reiterated that there is no duty to warn of dangers that are open and obvious. Id. at 42, 674 S.E.2d at 504. Furthermore, the Court stated that although questions of negligence are often for the jury, "when the risk complained of is open and obvious to consumers, there is no duty to warn of that risk as a matter of law." Id. The Court also believed that the deceased's negligence in operating the golf cart would prohibit a recovery under a negligence theory as a matter of law. Id. at 43, 674 S.E.2d at 504.

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

Drilling Down: The Duty to Warn and the "Obvious Risk" Associated With Cell Phone Use While Driving

By Brian A. Comer

There has been a great deal of press lately concerning cell phone use while driving, including a recent settlement in a South Carolina case involving a driver who was using her cell phone when she struck and killed two cyclists. The case and settlement prompted me to wonder one morning, "Will we ever see a warning on a cell phone advising not to use it while driving? Or to be careful using it while driving?" As ridiculous as the proposal may sound, I looked at the fast food coffee cup I was holding that said "Caution: Contents Are Extremely Hot" and began to wonder...

So what is the law?

South Carolina courts have held that seller is not required to warn of dangers or potential dangers that are generally known and recognized by users. Anderson v. Green Bull, Inc., 322 S.C. 268, 270, 471 S.E.3d 708, 710 (Ct. App. 1996). In such cases, the product is not defective or unreasonably dangerous because these dangers are contemplated by the ultimate user. Id. (citing Restatement (Second) of Torts § 402A cmt. g. (1965) for the principle that “a product is defective only ‘where the product is, at the time it leaves the seller’s hands, in a condition not contemplated by the ultimate consumer, which will be unreasonably dangerous to him.”) (emphasis in original). These dangers are frequently referred to as “obvious risks,” which include matters that should be common sense to the user.

For example, in Dema v. Shore Enterprises, Ltd., 312 S.C. 528, 435 S.E.2d 875 (Ct. App. 1993), the South Carolina Court of Appeals held that an Aqua-Cycle water recreational vehicle was not defective for failure to include a warning label cautioning the user to “watch out for swimmers” and to “avoid strong current, wind, or waves.” In reaching its conclusion, the court stated as follows:

[U]sers of the Aqua-Cycle would be aware, as a matter of common sense, that they should be careful around swimmers in the surf. Because it is obvious that an Aqua-Cycle can cause injury to a swimmer, [the manufacturer] did not have a duty to warn Aqua-Cycle users of that risk.

Id. at 531-32, 435 S.E.2d at 876. South Carolina courts have used similar analysis to determine that there is no duty to warn about overtightening of lug nuts so as to avoid cracking them. Claytor v. General Motors, Corp., 277 S.C. 259, 286 S.E.2d 129 (1982). The general notion is that a person should know-- from common sense -- that if you tighten something too much, you could break it.

In this blogger's opinion, this is the area of law that is applicable to cell phones and whether there is a duty to warn about cell phone use while driving. It is pretty obvious (and a matter of common sense in my opinion) that there is a risk associated with looking at a cell phone, fumbling with it, holding it, trying to press those small numbers on it, or otherwise trying to use it while doing a dangerous activity, such as driving. Why? Because the user is devoting attention to the cell phone instead of the potentially dangerous activity in which they are engaged: driving a 4,000 pound vehicle at a rate of speed and on a road with other vehicles, cyclists, etc.

So, is there a duty to warn a cell phone user not to use their cell phone while driving, or to use caution? Though I am sure that someone may try and make this argument (if they have not already), this seems to be a classic case of "obvious risk."

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

Drilling Down: The Analytical Framework for Warnings

By Brian A. Comer

I have a five-year-old daughter who is my "spirited child." She would make an excellent lawyer because she is an absolute bulldog when it comes to negotiating, and she hates to lose. However, I find that we frequently run into some variation of the following scenario when it comes to matters of discipline.

Me: "Honey, if you are not going to do what I say, then you are going to have to go to bed early."
Daughter: [Does exactly the opposite of what I told her to do].
Me: "Okay, then time for you to go to bed."
Daughter: "But what about family movie night?"
Me: "You will not be watching family movie night, because you will be in bed."
Daughter: "BUT I DIDN'T REALIZE THAT IS WHAT YOU MEANT!!!" (followed by uncontrollable sobbing).

In her own way, my daughter tries to convince me that I did not provide her with an adequate warning...one that sufficiently conveys the risks of performing or not performing certain actions. She does not succeed very often (as I know that she is very smart and that she understood exactly what I said), but this does not stop her from trying.

Similarly, in the realm of products liability litigation, a central focus is frequently whether a manufacturer or seller had a duty to warn the user of a product about potential dangers, and if so, whether the warning was adequate to convey the risks. So I want to write a bit about South Carolina warnings law.

South Carolina law recognizes that many products cannot be made completely safe for use. Claytor v. General Motors Corp., 277 S.C. 259, 264, 286 S.E.2d 129, 132 (1982). However, these products may still be useful, desirable, and serve a purpose. Id. In such cases, if the product is properly designed, manufactured, and packaged with accompanying adequate warnings and instructions, then they are not defective. Id. Otherwise, manufacturers and sellers may be discouraged from marketing many products solely because some danger accompanies the use of the product. Id.

Therefore, “[i]n order to prevent a product from being unreasonably dangerous, the seller may be required to give a warning on the product concerning its use.” Anderson v. Green Bull, Inc., 322 S.C. 268, 270, 471 S.E.2d 708, 710 (1996); see also Claytor v. General Motors Corp., 277 S.C. 259, 264, 286 S.E.2d 129, 132 (1982). If a product includes a warning that – if followed – makes it safe for use, then the product is not defective or unreasonably dangerous. Anderson, 322 S.C. at 270, 471 S.E.2d at 710; Allen v. Long Mfg. NC, Inc., 332 S.C. 422, 427, 404 S.E.2d 354, 357 (Ct. App. 1998). This foundation of South Carolina warnings law is discussed at length in comment j. to section 402A of the Restatement (Second) of Torts, and South Carolina has incorporated this comment by reference into its strict liability statute as the legislative intent of the chapter. See S.C. Code § 15-73-30 (“Comments to § 402A of the Restatement of Torts, Second, are incorporated herein by reference thereto as the legislative intent of this chapter.”).

A review of comment j. and the case law interpreting it reveals that the warnings analysis is based on a twofold inquiry: (1) whether there is a duty to warn to begin with, and (2) whether the warning provided is “adequate” so that (if followed) the product is safe for use. See, e.g., Allen v. Long Mfg. NC, Inc., 332 S.C. 422, 427-28, 505 S.E.2d 354, 357 (Ct. App. 1998) (separating the warnings analysis into a determination of duty to warn and adequacy of the warning).

Check back for more on warnings. I hope to make this a new series.

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

Case Brief: Weston v. Kim's Dollar Store

By Brian A. Comer

NOTICE: PLEASE SEE BOTH BRIEFS BELOW.  THE FIRST BRIEF IS OF THE SOUTH CAROLINA COURT OF APPEALS DECISION ISSUED JULY 15, 2009. 

THE SOUTH CAROLINA SUPREME COURT GRANTED A WRIT OF CERTIORARI TO REVIEW THE COURT OF APPEALS DECISION, AND IT ISSUED ITS DECISION ON AUGUST 8, 2012.  THE BRIEF FOR THAT CASE FOLLOWS FURTHER BELOW.

SOUTH CAROLINA COURT OF APPEALS CASE BRIEF

This case brief is of the July 15, 2009 South Carolina Court of Appeals decision, Monica Weston v. Kim's Dollar Store and CIBA Vision, a division of Novartis Company. It is currently only available as a slip opinion. When it is published, I will try and circle back around to drop in the reporter citations. This case is noteworthy because a South Carolina court assesses whether state tort claims are preempted by federal law in the context of a medical device case.

FACTUAL BACKGROUND: Plaintiff purchased two pairs of contacts manufactured by Defendant CIBA Vision ("CIBA") from Defendant Kim's Dollar Store ("Kim's"). Plaintiff had no prescription for the "prescription only" lenses. Plaintiff was given no instructions for usage of the lenses, and she was not informed of the need for a prescription. After wearing the contact lenses, Plaintiff developed an eye infection that caused her to temporarily lose vision in her left eye.

PROCEDURE: Plaintiff brought suit against Defendants alleging six causes of action:(1) negligence per se for selling misbranded contact lenses; (2) negligence in the manufacture, sale and/or distribution of contact lenses, and in failing to provide adequate warnings and instructions; (3) breach of implied warranty of merchantability and fitness because the lenses were not safely labeled; (4) strict liability for placing defectively labeled products into the stream of commerce; (5) sale of a defective product due to inadequate warnings; and (6) violation of the South Carolina Unfair Trade Practices Act by committing an unfair or deceptive act or practice, including inadequate labeling and warnings, in the conduct of trade or commerce. CIBA moved for summary judgment on the basis that the majority of Plaintiff's claims were subject to federal preemption pursuant to the Medical Device Amendments of 1976 ("MDA") to the Federal Food, Drug, and Cosmetic Act ("FDCA"). The circuit court granted CIBA's motion and found that CIBA was entitled to summary judgment on the basis of federal preemption on all actions depending on warning, labeling, design, marketing, misbranding, or other similar claims. The circuit court stated that CIBA could file additional motions to test the viability of the remaining causes of action, and the circuit court restricted Plaintiff from pursuing additional discovery on the aforementioned topics.

ISSUES: "[Plaintiff argue[d] the circuit court erred in granting summary judgment because (1) the circuit court lacked jurisdiction to determine whether the contact lenses at issue were federally regulated medical devices, (2) a genuine issue of material fact existed, and (3) there was neither a showing nor a finding that any South Carolina law conflicted with federal law."

DISPOSITION: The South Carolina Court of Appeals affirmed the decision of the circuit court.

RULES AND OPINION: With regard to the first issue, the court found that the circuit court properly interpreted federal statutes to determine whether the MDA preempted South Carolina law in this matter. "' The interpretation of a statute is a question of law for the [c]ourt.'" (Quoting In re Campbell, 379 S.C. 593, 599, 666 S.E.2d 908, 910-11(2008)). Tort claims are within the jurisdiction of the circuit court, and "[w]hen federal law seats exclusive jurisdiction over a particular type of claim in the federal courts, South Carolina courts must examine the federal law to determine whether it preempts state law." (Citing McCullar v. Estate of Campbell, 381 S.C. 205, 206, 672 S.E.2d 784, 784 (2009), and Griggs v. S.C. Elec. & Gas Co., 320 S.C. 127, 129, 463 S.E.2d 608, 609 (1995)). The circuit court did not err in interpreting the federal law because doing so is an essential step in determining whether the federal law preempts the state law.

With regard to the second issue, the court found that the circuit court correctly concluded no genuine issue existed as to whether CIBA's contacts were federally regulated as medical devices. The court reviewed the history of medical device and contact lense regulation, as well as the standard for summary judgment. From the evidence, the contact lenses fit the FDCA's definition of a "device," and CIBA presented uncontradicted evidence that the lenses were Class III medical devices subject to and approved by the FDA pursuant to the pre-market approval process. This evidence included:

• FDA approval letters that set forth the appropriate warnings and regulations pertaining to the lenses.
• Expert testimony that CIBA always treated the contact lenses as medical devices and that they were always approved through the pre-market approval process.
• The "Rx only" symbol on the packaging substantiated that the contact lenses at issue were medical devices that should only be sold pursuant to prescription.
• The contacts included a package insert that was drafted by CIBA and reviewed and approved by the FDA.
• There was evidence that he contact lenses had medical or therapeutic purposes (e.g., ultra-violet radiation protection).

From all of the evidence, CIBA carried its burden of demonstrating that no genuine issue of material fact existed as to whether the contact lenses underwent the pre-market approval process and were, therefore, subject to regulation by the FDA.

With regard to the third issue, the court found that any jury verdict imposing different requirements than the federal law would constitute an impermissible conflicting state law. Having found that the contact lenses were subject to FDA regulation as Class III medical devices, the court had to assess whether Plaintiffs' claims were subject to federal preemption, thereby entitling CIBA to judgment as a matter of law. "Whether a federal statute preempts state law is a question of law for the court to decide." (Citing Campbell, 379 S.C. at 599, 666 S.E.2d at 910-11). Pre-market approval of a medical device by the FDA results in device-specific requirements that preempt inconsistent state requirements, including those sought to be imposed through tort claims.

Specifically, the MDA prohibits States from imposing on devices intended for human use "any requirement (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter."

(Quoting 21 U.S.C.A. section 360k(a)). This clause has been read to extend to attempts to impose state tort liability. The court found that the circuit court correctly applied the doctrine of federal preemption because "a jury's acceptance of the disputed claims could result in different or additional requirements from the federal requirements. . . . This is not permissible." The court reasoned that such jury findings would be in addition to or contrary to to federal requirements. Therefore, the circuit court correctly granted summary judgment on all actions dependent on warning, labeling, design, marketing, misbranding, or similar claims.

SOUTH CAROLINA SUPREME COURT CASE BRIEF

FACTUAL BACKGROUND: Plaintiff purchased a pair of prescription decorative, colored contact lenses without a prescription from Defendant Kim's Dollar Store, an unauthorized seller.  Defendant CIBA Vision manufactured the lenses.  Plaintiff developed an eye infection, resulting in loss of vision in her left eye.

PROCEDURE:  Plaintiff brought an action against Kim's Dollar Store and CIBA Vision.  The trial court granted partial summary jdugment in CIBA's favor as to three of six causes of action based on federal preemption.  The South Carolina Court of Appeals affirmed, and the South Carolina Supreme Court granted certiorari.

ISSUES:  On certiorari, Plaintiff conceded the lenses she purchased were Class III medical devices but argued her claims were not preempted because CIBA failed to show the lenses were approved by the Food and Drug Administration ("FDA") through the pre-market approval ("PMA") process.

DISPOSITION:  The court found the lenses were approved through the PMA process and affirmed the court of appeals to the extent partial summary judgment was granted on claims that would impose common-law requirements "different from, or in addition to" applicable FDA requirements.  As to the remaining causes of action, it remanded the matter for further proceedings consistent with the opinion.

RULES AND OPINION:  The court reviewed briefly the factual and procedural history set forth in greater detail in the court of appeals decision.  (See case brief above).  The court stated that the sole issue before it was Plaintiff's claim that a genuine issue of material fact exists as to whether the lenses were subject to FDA approval through the PMA process.

After reviewing the standard for granting summary judgment, the court provided its analysis.  Congress provided an express preemption provision in the Medical Device Amendments of 1976 ("MDA").  Citing to National Meat Ass'n v. Harris, 132 S.Ct. 965 (2012), the court emphasized that the United States Supreme Court has held that express preemption provisions should be construed broadly, and the decision was instructive with regard to how to construe express preemption provisions where the federal regulatory scheme at issue does not contain a saving clause.

After reviewing the applicable law in Riegel v. MEdtronic, Inc., 552 U.S. 312, 322 (2008) concerning the device-specific requirements contemplated by the MDA and the PMA process, the court set forth the process to follow in a preemption inquiry.  The first step is to determine whether the federal government has established requirements applicable to the device through the PMA process.  If so, the next step is to determine whether state common-law claims paralellel the federal requirements.  If so, the state claim is not preempted.  However, if the state common-law claims are "different from or in addition to" the federal requirements (as outlined in Riegel), then the state claim is preempted. 

The court found there was no genuine issue of material fact that the lenses purchased by Plaintiff were subject to device-specific federal requirements by virtue of the PMA process.  Prior correspondence between CIBA and the FDA established that the lenses went through the PMA process and were approved, triggering express preemption.  On the second question in the inquiry, the court referenced Plaintiff's claim that CIBA knew or should have known its lenses were being marketed and sold unlawfully without a prescription and by unauthorized sellers.

The court reviewed the trial court's grant of summary judgment and vacated any summary judgment granted with regard to negligence.  CIBA’s counsel conceded that negligence survived summary judgment.  The court also held that any grant of summary judgment based on sufficiency of FDA-approved requirements imposed by PMA process was proper.  Requirements different from or in addition to them are preempted, and any claim that is parallel may proceed.

The court noted that it could not be more specific with regard to claims that survived summary judgment due to lack of specificity in that court order.  Therefore, it affirmed partial grant of summary judgment to the extent it was granted on claims that would impose common law requirements “different from, or in addition to” applicable FDA requirements.

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Case Brief: Allen v. Long Mfg. NC, Inc.

Today's case brief is of Allen v. Long, Mfg. NC, Inc., 332 S.C. 422, 505 S.E.2d 354 (Ct. App. 1998). This is a warnings case, and it is significant because it discusses the adequacy of warnings, rejects that compliance with industry standards is conclusive evidence of adequacy, and establishes the heeding presumption in South Carolina.

FACTUAL BACKGROUND: Otis Allen, Sr. ("Allen") was using a portable grain auger to load grain onto a grain drill. 332 S.C. at 424, 505 S.E.2d at 355. The auger's center of gravity could change when grain was conveyed to the top of the auger without replacing the material at the bottom (which kept it stable and prevented it from becoming top heavy). Id. Allen was standing beneath the auger's discharge end when it became unstable and struck him in the head, killing him. Id. He had not anchored the lower end or supported the discharge end. Id. The auger contained a warning label with the word "CAUTION" preceding eleven different instructions. 332 S.C. at 425, 505 S.E.2d at 356.

PROCEDURE: Allen's estate ("Plaintiff") brought a wrongful death and pain and suffering action against Defendant Long Mfg. NC, Inc. ("Long", the manufacturer of the auger) and Glen Kinard, the auger's owner. 332 S.C. at 424-25, 505 S.E.2d at 355. The theories of recovery were strict liability and negligence. Id. at 424, 505 S.E.2d at 355. The trial court granted Long's motion for summary judgment. Id. Plaintiff appealed to the South Carolina Court of Appeals.

ISSUES: The questions on appeal were whether genuine issues of material fact existed regarding (1) whether the auger was in a "defective condition unreasonably dangerous" to Allen, (2) whether Long breached its duty of care by failing to provide an adequate warning, and (3) whether Allen's failure to follow the warning was the proximate cause of his injuries. 332 S.C. at 425-26, 505 S.E.2d at 356.

DISPOSITION: The Court of Appeals reversed the trial court's grant of summary judgment. 332 S.C. at 426, 505 S.E.2d at 356. It found that the sufficiency of the auger's warnings was a question of fact for the jury. Id.

RULES AND OPINION: With regard to whether the auger was in a defective condition, unreasonably dangerous to the user, the court pointed out that "[i]f a warning is given which, if followed, makes the product safe for use, the product cannot be deemed defective or unreasonably dangerous." 332 S.C. at 427, 505 S.E.2d at 357 (citing Restatement (Second) of Torts section 402A cmt. j (1965)). Whether a warning is adequate is a question of fact for the jury as long as evidence has been presented that the warning was not adequate. Id. at 428, 505 S.E.2d at 357. Plaintiff's expert provided testimony regarding the auger's warning that created a genuine issue of material fact. 332 S.C. at 429, 505 S.E.2d at 358. There was nothing in the auger's warnings to explain that the machine's center of gravity could change as it emptied. Id. Furthermore, the court disagreed with the trial court's interpretation of Bragg v. Hi-Ranger, Inc., 319 S.C. 531, 462 S.E.2d 321 (Ct. App. 1996) as establishing that a warning is adequate as a matter of law if it complies with industry standards. 332 S.C. at 430-31, 505 S.E.2d at 358-59 ("We reject this principle as unsound since it would allow the industry to set its own standard of safety, a proposition which finds no support from other jurisdictions, and which is antithetical to the underlying premise of strict liability."). Finally, the court stated that it need not address whether a feasible design alternative must be presented to survive summary judgment. Id. at 431, 505 S.E.2d at 359. The court agreed that Plaintiff failed to present a factual issue on this point, but it concluded that the court erred in ruling upon it because Long conceded that the auger required a warning to be made safe. Id. This concession foreclosed Plaintiff's argument that the auger could have been redesigned to be made safer and rendered the trial court's holding moot. Id. at 431-32, 505 S.E.2d at 359.

With regard to Long's duty of care, the court reversed the trial court's determination that Long satisfied its duty of care because its determination was premised on the legal adequacy of the auger's warning, which the Court of Appeals (supra) held was an issue of fact for the jury. Id. at 432, 505 S.E.2d at 359.

Finally, the court reversed the trial court's finding that the Plaintiff failed to introduce evidence of causation. 332 S.C. at 432-33, 505 S.E.2d at 359-60. At trial, Long successfully argued that Allen's failure to heed the auger's warning was the proximate cause of his injuries because Plaintiff's expert stated that if Allen had followed the warnings, the accident would not have occurred. Id. at 432, 505 S.E.2d at 359-60. The court stated that when an adequate warning is given, the manufacturer may assume that it will be heeded by the product user. Id. at 432-33, 505 S.E.2d at 360. However, the testimony by Plaintiff's expert created a factual issue as to whether a different, adequate warning could have changed Allen's conduct. Id. at 433, 505 S.E.2d at 360.

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Case Brief: Anderson v. Green Bull, Inc.

By Brian A. Comer

Today's case brief is Anderson v. Green Bull, Inc., 322 S.C. 268, 471 S.E.2d (Ct. App. 1996). This is a warnings case, and it stands for the principle that a seller is not liable for injuries caused by a product if there is an an adequate warning and the user fails to follow it. Furthermore, there is no duty to warn of common or obvious dangers.

FACTUAL BACKGROUND: Joe McLees ("Deceased") was working with another employee of Tucker Roofing ("Tucker") to replace a roof on a house. 322 S.C. at 270, 471 S.E.2d at 710. Two high-voltage power lines ran over the top of the house. Id. While they were moving an aluminum conveyor ladder, the Deceased was electrocuted and the other employee was injured. Id. Green Bull sold the ladder to Tucker, and Tucker assembled it, without modifications. Id. The ladder contained a red warning label that read, "KEEP ENTIRE UNIT CLEAR OF ALL UTILITY AND ELECTRICAL WIRING." Id.

PROCEDURE: The Deceased's personal representative ("Plaintiff") brought a strict liability action against Green Bull. 322 S.C. at 269, 471 S.E.2d at 709-10. At the close of evidence, Green Bull moved for directed verdict, which was denied. Id. at 269, 471 S.E.2d at 710. The jury returned a $50,000 verdict for the Plaintiff. Id. Green Bull moved for a judgment notwithstanding the verdict, which the trial court also denied. Id. Green Bull then appealed to the South Carolina Court of Appeals. Id.

ISSUES: Whether the trial court should have granted Green Bull's motions for directed verdict and judgment notwithstanding the verdict. 322 S.C. at 269-70, 471 S.E.2d at 710.

DISPOSITION: The South Carolina Court of Appeals reversed the decision of the trial court. 322 S.C. at 269, 471 S.E.2d at 710.

RULES AND OPINION: For any strict liability claim, a plaintiff must prove that the injury occurred because the product was in an unreasonably dangerous, defective condition. 322 S.C. at 270, 471 S.E.2d at 710. To prevent a product from being unreasonably dangerous, a seller may be required to provide a warning on the product concerning its use. Id. As stated by the court:

A product bearing a warning that the product is safe for use if the user follows the warning is neither defective nor unreasonably dangerous; therefore, the seller is not liable for any injuries caused by the use of the product if the user ignores the warning. Further, a seller is not required to warn of dangers or potential dangers that are generally known or recognized. It follows, then, that a product cannot be deemed either defective or unreasonably dangerous if a danger associated with the product is one that the product's users generally recognize.

Id. at 270-71, 471 S.E.2d at 710 (citations omitted). On this basis, there was no evidence to infer that the roofers' injuries were caused by a defect in the ladder. Id. at 271, 471 S.E.2d at 710. It is commonly known that aluminum ladders should be kept away from power lines. Id. at 271, 471 S.E.2d at 711. Plaintiff also argued that the jury could have reasonably found that the accident resulted from "arcing" (i.e., where an electrical current "jumps" into a conductive source without direct contact), and that arcing is not common knowledge. Id. at 272, 471 S.E.2d at 711. However, the court said that there was no evidence from which a jury could reasonably conclude that arcing most probably took place. Id. For these reasons, the trial court erred in denying Green Bull's motions for directed verdict and judgment notwithstanding the verdict. Id.

CONCURRING OPINION (Cureton, J.): Judge Cureton concurred with the majority, but stated that the question presented was "whether Green Bull, knowing the foreseeable use of the ladder, had a duty to warn its users against the hazard of bringing the ladder into contact with electrical lines, and if so, whether the warning it placed on the ladder was adequate." 322 S.C. at 273, 471 S.E.2d at 712. Judge Cureton agreed that Green Bull had a duty to warn, but found that the warning provided by Green Bull was adequate. Id. at 273-74. 471 S.E.2d at 712.

DISSENTING OPINION (Howell, C.J.): Chief Judge Howell framed the issue as "not whether the trial judge considers the product unreasonably dangerous, but what the evidence reflects may reasonably be regarded as unreasonably dangerous." 322 S.C. at 275, 471 S.E.2d at 713. He reviewed the evidence concerning the use of fiberglass, how it would change the composition, utility and weight of the ladder, and the state of the art. Id. at 276-77, 471 S.E.2d at 713-14. Based on the evidence, Chief Judge Howell dissented because he believed that "there was ample competent evidence in the record for the trial judge to submit the issue of whether the ladder was defective by design to the jury." Id. at 277, 471 S.E.2d at 714.

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Case Brief: Dema v. Shore Enterprises, Ltd.

By Brian A. Comer

Today's case brief is of Dema v. Shore Enterprises, Ltd., 312 S.C. 528, 435 S.E.2d 875 (Ct. App. 1993). The case is most often cited for for the principle that "a product is not defective for failure to warn of the obvious." Id. at 530, 435 S.E.2d at 876. This is a short case, and you can probably read it in its entirety in about as much time as it takes to read this brief.

Factual Background: Plaintiff Dema was body surfing on a public beach and collided with a recreational vehicle known as an Aqua-Cycle. 312 S.C. at 529, 435 S.E.2d at 875-76.

Procedure: Plaintiff and his wife brought a products liability action against various individuals and entities, including the Aqua-Cycle manufacturer. 312 S.C. at 529, 435 S.E.2d at 876-77. At trial, Plaintiffs claimed that the failure to place certain warnings on the watercraft (to "watch out for swimmers" and to "avoid strong current, wind or waves") made the craft defective and unreasonably dangerous. Id. at 530, 435 S.E.2d at 876. The trial court granted a directed verdict in favor of the manufacturer as to the Plaintiffs' claims for strict liability, breach of implied warranty, and negligence because it found that failure to place a warning on the watercraft was not the proximate cause of the injuries. Id. Plaintiffs also claimed at trial that the town was negligent in allowing Aqua-Cycles to be used on the beach in the vicinity of swimmers. Id. at 531, 435 S.E.2d at 876. The trial court granted a directed verdict on the ground that there was no evidence that the town had actual notice of a defective or dangerous condition as required under the South Carolina Tort Claims Act. Id. The jury found in favor of the remaining defendants on the remaining claims. Id. at 530, 435 S.E.2d at 875.

Issues: The Plaintiffs appealed from the directed verdicts in favor of the (1) manufacturer, and (2) the Town of Hilton Head. 312 SC. at 530, 435 S.E.2d at 875.

Disposition: The South Carolina Court of Appeals affirmed the trial court. 312 S.C. at 530, 435 S.E.2d at 875.

Rules and Opinion: With regard to the first issue, the South Carolina Court of Appeals first reviewed the three elements that a plaintiff must establish in any products liability claim. 312 S.C. at 530, 435 S.E.2d at 876. The only element in dispute was whether "the injury occurred because the product was in a defective condition unreasonably dangerous to the user." Id. The court reviewed the evidence to determine, in the light most favorable to the nonmoving party, whether the evidence was susceptible to the reasonable inference that the Aqua-Cycle was defective. Id. "A product is not defective for failure to warn of the obvious." Id. (citing Koester v. Carolina Rental Ctr., Inc., 311 S.C. 115, 427 S.E.2d 708 (Ct. App. 1993)). The evidence was indisputable that Aqua-Cycle users would be aware, based on common sense, that they should be careful around swimmers in the surf. Id. at 530-31, 435 S.E.2d at 876. Because of the obviousness of the risk, the manufacturer did not have a duty to warn users of the Aqua-Cycle of the risk. Id. It affirmed the trial court's directed verdict in favor of the manufacturer. Id.

With regard to the second issue, the South Carolina Court of Appeals stated that it did not need to determine whether the town had notice of a dangerous condition. 312 S.C. at 531, 435 S.E.2d at 876. Instead, because the jury found that the franchisee (Shore Enterprises) was not negligent in renting Aqua-Cycles, it could not have found the town liable for allowing the franchisee to rent the Aqua-Cycle that Plaintiff Dema collided with. Id. at 531, 435 S.E.2d at 877.

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