New South Carolina Products Liability Case

Like I said in my last post, I have been a bit behind on blogging as a result of taking a vacation and having a fairly busy August.  However, on August 8, 2012, the South Carolina Supreme Court issued its opinion in Weston v. Kim's Dollar Store, No. 27155 (S.C. filed Aug. 8, 2012).  You can find the decision here.

As you may recall, I briefed the South Carolina Court of Appeals decision in this case, Weston v. Kim's Dollar Store, 385 S.C. 520, 684 S.E.2d 769 (Ct. App. 2009).  My brief of the court of appeals case can be found here.  The South Carolina Supreme Court granted a writ of certiorari to review the court of appeals decision, and it affirmed the court's decision. 

This is a preemption case, so it is significant in the world of drug/medical device litigation.  I will try in the next couple of days to do a case brief that supplements the earlier brief of this case, and I will post a hyperlink to it once it is completed.

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Holiday Season Food Law (Part IV): The food poisoning cases

(This is the fourth post in my holiday series in which I am surveying South Carolina's products liability case law involving food/beverage.  See also part I, part II, and part III). 

As Christmas is behind us and New Year's Day is around the corner, it seems appropriate to begin bringing this series to a conclusion by talking about food that just flat out makes you sick. 

This Saturday evening, people around the world will ring in 2012 with all sorts of food and beverage, and undoubtedly some of them will just become sick for no apparent reason (other than maybe imbibing a bit too much).  There is another line of cases in South Carolina where the lawsuit relates to food that just made someone sick...no fragments of glass, no exploding bottles, no animal carcasses in the food.  The plaintiff just eats/drinks something and gets food poisoning of some variation.  If you are one of these unfortunate individuals, this post is dedicated to you.

In Gantt v. Columbia Coca-Cola Bottling Co., 193 S.C. 51, 7 S.E.2d 641 (1940), a man became sick after drinking a soft drink he believed contained some kind of poisonous substance.  Only after analysis by some chemists was it determined that the soft drink contained copper sulphate (which apparently is used by farmers to protect crops from rust).  7 S.E.2d at 642.  The plaintiff sued for negligence (in bottling of the soft drink, inspection, etc.), and the jury awarded $2,000.  Id.  On appeal, the defendant argued (1) there was no evidence it bottled the drink or that it contained the substance at the time of bottling, and (2) there was no evidence from which a jury could conclude it was negligent.  Id. at 643.  In a detailed opinion, the court pointed out that the only evidence of negligence was a violation of the applicable Pure Food Statute at the time (i.e., making it negligence per se if there is some poisonous or deleterious substance in the food).  Id.  It did not matter that the plaintiff failed to plead the statute in his Complaint, and "neither knowledge of the contamination nor negligence in fact is a material element of the offense."  Id.  It is negligence per se under the law, and this alone is sufficient for consideration by the jury.  Id. at 645.  However, the court reversed the case and remanded for a new trial.  Id. at 645-46.  Why?  Because the trial judge excluded testimony by the defendant the instance at issue was the only time that copper sulphate had been found in the soft drink bottled by the defendant.  Id. at 646.  In short, if the plaintiff can get the case to the jury by just showing violation of the statute, the defendant also should be able to offer testimony relevant to the standard of care, and failure to allow this testimony required a new trial.

Yummy processed and potted meat.  Love it.  My dad's generation sure did, as I often heard stories of "eating Vi-enner sausages in the field" while growing up.  I will pass, thank you very much (especially after reading Upton Sinclair's The Jungle in my high school history class).  Nevertheless, there are three South Carolina cases I have found involving potted/processed meat, and reading them is pure entertainment.  

Housand v. Armour & Co., 173 S.C. 268, 175 S.E. 516 (1934) involved consumption of "oil sausage" sold in 50-pound cans and retrieved via "an old fork which hung from the counter" in the retail shop."  175 S.E. at 517.  This is a strange case in which the "defendant" Armour was found to not actually be the right defendant, but they answered and went to trial anyway.  Ultimately, the judgment against the defendant corporation was reversed based on lack of evidence of negligence and improper expert testimony.  Id. at 518.  The court affirmed the judgment against the local defendants based on how they handled the meat (i.e., not keeping it refrigerated).  Id. at 518-20.  Hollis v. Armour & Co., 190 S.C. 170, 2 S.E.2d 681 (1939) also involved oil sausages, and the offending sausages in this case were sold from cans that had rusted.  The concept of preemption rears its head in this early case, as one of the defendant's arguments was that the State Pure Food Statute interfered with federal acts and regulations.  2 S.E.2d at 684-85.  The court disagreed, and it also believed the plaintiff had adequately pled a violation of the State Pure Food Statute so as to sustain the $1,500 award by the jury to the plaintiff.  Id. at 685.  Finally, Boylston v. Armour & Co., 196 S.C. 1, 12 S.E.2d 34 (1940) involved a ham that had a "bluish-greenish cast" that is "not unusual" in a cooked, smoked ham.  12 S.E.2d at 37.  (Uhhh...okay).  Contrary to the holding in Hollis, the Boylston court reversed the trial court and remanded the case for a new trial on grounds that the applicable State Pure Food Statute did not apply; it only applied to manufacture or sale or offer for sale of food within the state, and there was evidence that the meat at issue was prepared and sold out of state.  Id. at 38. 

Poor Armour.  These cases are a mixed-up potted mess, and reading them can be exhausting.  The above summary does not do them justice.  If you have an interest in potted meat cases, I encourage you to read them for yourself.

Last but not least, Fowler v. Coastal Coca-Cola Bottling Co., 252 S.C. 579, 167 S.E.2d 572 (1969) involved a three-year-old child who became sick after drinking a soft drink that contained something "dark in color and slick and slimy to the touch."  A pathologist determined that the substance was yeast, and he testified that certain yeasts can cause certain diseases.  Id. at 582, 167 S.E.2d at 574.  The problem was that the plaintiff's doctor testified there had been a rash of viruses at the time, and he could not say whether the plaintiff's sickness was from the virus or from the yeast in the soft drink.  Id. at 583, 167 S.E.2d at 574.  Although the court recognized a violation of the Pure Food and Drug Act in effect at the time constituted negligence per se, the plaintiff still had to show proximate causation. 

We have held that where the cause of plaintiff's injury may be as reasonably attributed to an act for which the defendant is not liable as to one for which he is liable, the plaintiff has failed to carry the burden of establishing that his injury was the proximate result of defendant's negligence.

Id. at 575, 167 S.E.2d at 584.  Based on this law, the court reversed the judgment because plaintiff failed to prove proximate causation.

This is the last group of cases in this series.  In my next (concluding) post for this series, I will do my best to synthesize my blogs on food and beverage case law and bring some "order" to them.

Happy New Year!

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New Products Liability Decision in This Week's Advance Sheets

The South Carolina Supreme Court today issued its decision in Priester v. Ford Motor Co., et al. The decision can be found here and beginning on page 12 here. A quick cut and paste of the lead-in paragraph provides a good synopsis of its holding, and I will try and get a briefing posted that goes into more detail. As Justice Kittridge states in the lead-in paragraph:

This case concerns whether Federal Motor Vehicle Safety Standard 205 (49 C.F.R. § 571.205 (1971)) preempts a state law products liability claim premised solely on a manufacturer's choice of tempered glass for a vehicle's side windows. Federal Motor Vehicle Safety Standard 205 (Regulation 205) mandates that "[g]lazing materials[1] for use in motor vehicles … shall conform" to the American National Standard Institute "safety code for safety glazing materials." Courts across the country faced with this issue have struggled with the preemptive effect, if any, of Regulation 205 and have reached opposite conclusions. Pending resolution from the United States Supreme Court, we join those jurisdictions finding the federal regulation preempts state law, and therefore, we affirm the trial court's grant of summary judgment in favor of Ford Motor Company.

Case Brief: State v. Astra Zeneca

By Brian A. Comer

This case brief involves an action brought by South Carolina Attorney General Henry McMaster against a pharmaceutical company, captioned State v. Astra Zeneca Pharmaceuticals, LP, 2009 WL 1227848 (D.S.C. May 5, 2009). It is significant because it discusses off-label promotion and preemption, and the extent to which they can serve as a basis for federal question jurisdiction.

FACTUAL BACKGROUND: Defendants manufactured an anti-psychotic drug known as Seroquel. The State sued Defendants to recover funds expended by South Carolina to provide medical treatment to certain Medicaid and state employee participants who experienced Seroquel-related illnesses, as well as to recover funds spent in purchasing Seroquel for off-label uses not covered by certain state programs. The State alleged causes of action for submission of false and fraudulent claims under the Medicaid program, violations of the South Carolina Unfair Trade Practices Act, negligence, breach of warranty, fraud and misrepresentation, and unjust enrichment in connection with Defendants' marketing of Seroquel.

PROCEDURE: The State filed its case in state court on January 9, 2009. Defendants removed the case to federal court (D.S.C., Spartanburg Division) based on federal question jurisdiction. Defendants also moved to stay the case pending transfer by the Judicial Panel on Multi-District Litigation. The State moved to remand on February 18, 2009, and it filed a motion to transfer the case to Judge Henry Herlong on February 23, 2009. The MDL Panel issued a conditional transfer order on February 26, 2009 transfering the action to the Middle District of Florida as part of the Seroquel MDL. On March 12, 2009, the Court granted in part Defendants' motion to stay the case, staying all issues except the pending motions to remand and transfer.

ISSUES: Pending before the court was the State's motion to remand the case to state court and its motion to transfer the case to Judge Herlong.

DISPOSITION: The court granted the State's remand motion, which rendered moot its motion to transfer.

RULES AND OPINION: Although the State did not assert a federal cause of action in its Complaint, Defendants maintained that the Court should exercise federal question jurisdiction because the case raises substantial questions of federal law, e.g. an examination of the Food, Drug and Cosmetic Act and other federal statutes. Defendants relied on the rule in the United States Supreme Court decision of Grable & Sons Metal Prod. v. Darue Eng'g & Mfg., 545 U.S. 308, 312 (2005) as the applicable law, as follows:

[D]oes a state law claim necessarily raise a stated federal issue, actually disputed and substantial, which a federal forum may entertain without disturbing any congressionally approved balance of federal and state judicial
responsibilities."

The Court rejected Defendants' argument that the State's off-label promotion allegations implicated significant federal questions. First, the Court pointed out that this same argument was rejected by Judge Henry Herlong in State v. Eli Lilly & Co., Inc., 2007 WL 2261693 (D.S.C. Aug. 3, 2007) and State v. Janssen Pharmaceutica Inc., 2007 WL 2022173 (D.S.C. July 10, 2007). Second, the Court did not believe that the the State's claims had anything to do with "off-label" uses, as that term is defined in federal law. Finally, the Court did not believe that -- in applying the Grable test -- any references to "off-label" uses in the case were "substantial enough" to justify the exercise of federal question jurisdiction. "As alleged, the State could establish a prima facie case of Medicaid fraud under state law without having to establish that Defendants' communications were 'off-label' in violation of federal law."

The Court also rejected Defendants' arguments that the case raised substantial federal questions under federal Medicaid law. These arguments were also rejected by Judge Herlong in the above-referenced cases, and the Court quoted extensively from Judge Herlong's Janssen opinion as support for its decision. Judge Herlong's decision on this issue focused on the fact that (i) Defendants' liability depended on their breach of duties defined by state law, and (ii) the Federal Medicaid Act does not provide a private right of action, which further supports that there is no federal question jurisdiction.

Finally, the Court rejected Defendants' argument that the federal preemption issues implicated by Plaintiff's failure to warn claims raised a federal question. "Defendants concede that a failure to warn preemption defense has never been held sufficient to convey federal jurisdiction."

Based on its decision to grant Plaintiff's remand motion, it determined that the Plaintiff's motion to transfer the case to Judge Herlong was rendered moot.

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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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The Obama Administration's View on Preemption

By Brian A. Comer

On Wednesday, President Obama's administration released a two page memorandum that sets forth the current administration's view on preemption and the interaction of federal and state laws. A .pdf file of the memorandum can be found at the following link (I had to open this in a new window for it to work):

http://wsj.com/public/resources/documents/20090520preemption.mem.rel.pdf

In addition, the Wall Street Journal did a nice write-up of the implications of the memorandum and how the current administration's stance differs from the previous administration. That article can be found at the following link:

http://online.wsj.com/article/SB124285702885340713.html

In a nutshell, the memorandum recognizes that executive departments and agencies during the previous administration have sometimes announced that their regulations preempt State law, including the common law, without explicit preemption by Congress or "an otherwise sufficient basis under the applicable legal principels." Memorandum at 1. As stated by the current administration in the memorandum, "the general policy of [President' Obama's] administration [is] that preemption of State law by executive departments and agencies should be undertaken only with full consideration of the legitimate prerogatives of the States and with sufficient legal basis for preemption." Id. (emphasis added). The memorandum directs that heads of departments and agencies should not include in regulatory preambles statements that they intend to preempt State law through a regulation except where such provisions are also included in the regulation. Id. Furthermore, such provisions should not be included "except where such provisions would be justified under legal principles governing preemption." Memorandum at 2. Finally, the memorandum directs heads of departments and agencies to review regulations issued in the past 10 years to determine whether any statements concerning preemption are justified. Id. If they are not, then the appropriate department or agency head should "initiate appropriate action, including amending the relevant regulation. Id.

In short, this administration is putting its own stamp on the preemption issue, and from the memorandum, it appears to be the opposite of the prior administration's views on this legal principle. What does this mean for products liability litigation in general? State law tort claims that were previously deemed "preempted" under federal law are more likely to be recognized as viable claims. Only time will tell, but it will be interesting to see the stance taken by the courts in light of the current administration's views.

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