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.

Okay, one more try.

So my test post revealed that my feedburner function is not working. So I "resynced" it (whatever that means) and hopefully it will now. Unfortunately, it requires yet another test post.

Test Post and Feedback

Sorry for this, but I need to do a test post, as I think that my subscriber function may not be sending out updates.

While I'm at it, if anyone has suggestions for the site, please comment. Always looking for ways to improve it.

State Settlement with Pfizer

I missed this when it ran, but stumbled across it when looking for recent verdicts, settlements, etc. The below ran in the Post and Courier on April 3, 2010, and while it lasts you can find it here. I have cut and pasted the article below.

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Pfizer, S.C. settle dispute over off-label promotions

By MEG KINNARD • Associated Press • April 3, 2010

COLUMBIA, S.C. — South Carolina is to receive $11 million under an agreement with Pfizer Inc. over the company's disputed sales tactics for certain drugs, double the amount the state said Friday it would have gotten under a multistate deal struck last year.

Under the deal finalized Thursday and confirmed by Pfizer, the New York-based pharmaceutical giant also is to give South Carolina more than $1.5 million in medications for use in its free clinics.

In September, federal prosecutors hit Pfizer with $2.3 billion in fines over what they called the improper promotion of drugs -- including painkiller Bextra and the schizophrenia medicine Geodon -- that included plying doctors with free golf, massages, and resort junkets.

Use of drugs for so-called "off-label" medical conditions is not uncommon, but manufacturers are prohibited from marketing drugs for uses that have not been approved by the Food and Drug Administration. Prosecutors said junkets and other company-paid perks were designed to promote the drugs to doctors for unapproved uses and dosages, backed by false and misleading claims about safety and effectiveness.

Bextra, for instance, was approved for arthritis, but prosecutors had said Pfizer promoted it for acute pain, and in dosages above the approved maximum. In 2005, Bextra was pulled from the U.S. market amid mounting evidence it raised the risk of heart attack, stroke and death.

In addition to a $1.2 billion criminal fine, the company also agreed to pay $1 billion in civil penalties, the Justice Department said in September. Of that amount, $331 million was to be split among 49 states and the District of Columbia.

South Carolina Attorney General Henry McMaster -- who is seeking his state's Republican nomination for governor -- sparked controversy when that deal was announced, saying he had opted out of the multistate agreement to pursue his own case against Pfizer to seek a better deal for the state.

That gamble seems to have paid off.

McMaster spokesman Mark Plowden says the state would have gotten about $5.5 million if it had participated in the multistate deal, according to a formula set by the court system.

In a statement, Pfizer acknowledged no wrongdoing and said it was pleased with the deal.

Under the individual agreement, South Carolina is getting a combined $12.68 million in money and prescription drugs. Plowden said the deal has been a year in the making.

It will take South Carolina about a month to receive the money, which Plowden said will go to the state's Medicaid coffers and state health care plan.

Happy Easter!

Happy Easter to any followers of the South Carolina Products Liability Law Blog!

I will be attending the DRI Products Liability Committee meeting this week in Las Vegas, Nevada (details here). I am flying in on Tuesday, staying for all of the conference, and staying a couple of extra days to see and enjoy Las Vegas with my wife, who is joining me.

If anyone else will be attending, please let me know! I would love to have the opportunity to meet you.

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: Watson v. Ford Motor Co.

By Brian A. Comer

UPDATE: The South Carolina Supreme Court has re-filed this opinion as of September 13, 2010, and the below brief was based on the first opinion, and not the re-filed one. Please see this post for more details and links to the current opinion. The new opinion upholds the reversal and deals with the same issues (expert testimony and admission of other incidents), but it also includes additional language concerning Ford's motion for judgment notwithstanding the verdict.

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Yesterday, the South Carolina Supreme Court reversed an $18 million jury verdict against Ford Motor Co. on grounds that the trial court erred in admitting certain expert testimony, as well as in admitting evidence of other incidents. The case can be found here . It provides some great guidance on South Carolina's law concerning the admissibility of expert testimony and the responsibility of the trial court to act as a "gatekeeper" for same. It also sets forth certain factors that can be applied in the products liability context to determine whether evidence of other incidents should be admitted.

FACTUAL BACKGROUND: In December of 1999, Plaintiff Sonya Watson ("Watson") was driving a 1995 Ford Explorer with three other passengers, including Patricia Carter ("Carter"). After entering the interstate, Watson lost control of the vehicle, and it rolled for times. Watson and Carter were ejected from the vehicle. Watson was rendered a quadriplegic, and Carter died.

PROCEDURE: Plaintiffs filed a products liability lawsuit against Ford, D&D Motors, Inc. and TRW Vehicle Safety Systems, Inc., alleging that the cruise control system and seatbelts were defective and seeking actual and punitive damages. Plaintiffs' theory was that the Ford Explorer's cruise control system was defective because it allowed electromagnetic interference ("EMI") to affect it. Plaintiffs presented an electrical engineer, Dr. Antony Anderson, to support their theory. He testified that EMI can interfere with the speed component of a cruise control system and cause a vehicle to suddenly accelerate. He also testified that Ford could have used "twisted pair wiring" to prevent EMI so that the accident would not have occurred. Plaintiffs also presented the testimony of Bill Williams as an expert on "cruise control diagnosis," as well as evidence from four witnesses who testified about other incidents in which their Ford Explorers suddenly accelerated. Ford presented its own cruise control expert, Karl Passeger, who testified that EMI signals have no effect on cruise control. Ford also presented evidence that the floor mats could have caused the acceleration, as they had on prior occasions. The jury awarded compensatory damages of $15 million to Watson and $3 million to Carter's Estate.

ISSUES: The South Carolina Supreme Court addressed three issues presented by Ford on appeal:

1. Did the trial court err in qualifying Plaintiffs' expert Bill Williams as an expert in cruise control systems?
2. Did the trial court err in allowing Dr. Anderson's expert testimony regarding EMI and alternative feasible design?
3. Did the trial court err in allowing evidence of other incidents of sudden acceleration in Explorers?

DISPOSITION: Reversed.

RULES AND OPINION: The Court reviewed South Carolina's law of admission of expert testimony, which is governed by South Carolina Rule of Evidence 702. The trial court must make three key preliminary findings before presenting the testimony to the jury:

First, the trial judge must find that the subject matter is beyond the ordinary knowledge of the jury, thus requiring an expert to explain the matter to the jury. Next, while the expert need not be a specialist in the particular branch of the field, the trial court must find that the proffered expert has indeed acquired the requisite knowledge and skill to qualify as an expert in the particular subject matter. Finally, the trial court must evaluate the substance of the testimony and determine whether it is reliable.

(Citations omitted). The Court analyzed the three appellate issues in this context.

Issue Number 1: The Court found that the trial court erred in qualifying Mr. Williams as an expert on cruise control diagnosis. A trial court's inquiry into the qualifications of an expert should be "broad in scope." Although Williams testified that he had worked in the automotive industry as a trainer, consultant, software developer, and a writer, his qualifications were lacking in other respects.

• He had no professional experience working on cruise control systems prior to the litigation.
• He had not conducted any comparison of the Explorer's cruise control system to any other system.
• He had never taught or published papers on cruise control systems.
• "Williams had no knowledge, skill, experience, training or education specifically related to cruise control systems." Instead, he "taught [him]self" about the Explorer's system prior to trial.

The Court found that the trial court failed to properly evaluate Williams' qualifications specific to cruise control systems and erred in qualifying him as a cruise control expert. However, Williams' testimony was primarily descriptive of the cruise control system, its scope was controlled by the trial court, and he was subject to extensive cross examination to impeach his credibility. Therefore, the error did not prejudice Ford.

Issue Number 2: The Court found that the trial court abused its discretion in admitting Dr. Anderson's testimony. First, the Court rejected the notion that technical evidence is not subject to the same reliability requirements as scientific evidence. "The trial court must examine the substance of the testimony to determine if it is reliable, regardless of whether the expert evidence is scientific, technical, or other specialized knowledge."

Next, the Court examined Dr. Anderson's qualifications and the reliability of his testimony (applying the reliability factors articulated in State v. Council, 335 S.C. 1, 19, 515 S.E.2d 515, 517 (1999)). The Court found that with regard to his opinions concerning alternative feasible design, Dr. Anderson failed to meet Rule 702's rule that the witness be qualified in the particular area of expertise. Dr. Anderson's experience was in working with large generators with different electrical wiring systems and voltage levels. He had no experience in the automotive industry, never studied a cruise control system, and never designed any component of such a system. Plaintiffs also failed to illustrate that his testimony that twisted pair wiring would have cured the EMI defect was reliable, or how it could be incorporated into a cruise control system. There was also a lack of evidence to support the economic feasibility of this alternative.

The Court also found that Dr. Anderson's testimony about EMI and its effect on the cruise control system was unreliable. He admitted that his theory had not been peer-reviewed, he had never published papers on it, and he had never tested it. He also could not pinpoint where the EMI that caused the malfunction originated, or the system in the Explorer that it affected. His only document to support his theory was a 1975 National Highway Safety Administration report, which had been superseded in 1989. The Court focused on the fact that Dr. Anderson had never published his theory, never tested it, and that his theory had been rejected in the scientific community. Admission of Dr. Anderson's testimony was prejudicial error because it was the only evidence presented by Plaintiffs to support their theory of defect.

Issue Number 3: The Court found that the trial court's admission of evidence of other incidents of sudden acceleration was prejudicial error. Evidence of similar incidents is admissible where there is some special relation between the accidents tending to prove or disprove some fact in dispute. (Citing Whaley v. CSX Transp., Inc., 362 S.C. 456, 483, 609 S.E.2d 286, 300 (2005)). The Court also cited to a District of North Carolina case, Buckman v. Bombardier Corp., 893 F. Supp. 547, 552 (E.D. N.C. 1995), for factors to consider regarding admissibility of similar incidents to prove defect, including (1) similarity of the products, (2) similarity of defects, (3) causation related to defect in the other incidents, and (4) exclusion of other reasonably secondary explanations for the cause of the other incidents. Plaintiffs failed to show that the incidents were substantially similar and failed to establish a special relation between the other incidents and Plaintiffs' accident. The products were not similar because the other incidents involved Explorers made in different years and of a different model type. Plaintiffs failed to show a similarity of causation between the incidents, and they failed to excluse reasonable explanations for the cause in the other incidents. Therefore, this evidence was irrelevant. The admission of this evidence was highly prejudicial, especially in light of the fact that Plaintiffs' counsel highlighted it in his closing argument and "thereby possibly induced the jury to speculate as to other causes of the accident not supported by any evidence."

CONCURRING OPINION: Justice Pleicones wrote the concurring opinion for Justices Waller, Beatty, Kittredge, and Pleicones. The concurring opinion focuses primarily on the framework for analyzing the admissibility of expert testimony. It disagrees with the first inquiry in the framework articulated in the majority opinion, "Is the subject matter of the testimony beyond the knowledge of a layperson, thus requiring and expert to explain it?" Instead, the concurring opinion cites to the framework cited in State v. Council, 335 S.C. 1, 515 S.E.2d 508 (1999), which is (1) is the underlying science reliable?; (2) is the expert qualified?; and (3) would the evidence assist the trier of fact to understand the evidence or to determine a fact in issue? The concurring opinion also disagreed that the model and manufacture year of the Explorers in the other incidents were meaningful distinctions for purposes of excluding this evidence.

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.

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