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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Medical Device Review Under Scrutiny

Though not specific to South Carolina, I have been reading recently about how the FDA is planning to take a closer look at its 510K review process for medical devices. This is the abbreviated process for obtaining medical device approval. There is a good article in the Wall Street Journal today summarizing what is going on, and if you do medical device work, this should be of interest.

FIRMS WARN OF DELAYS FROM FDA SCRUTINY
(September 30, 2009 edition of the Wall Street Journal)

By ALICIA MUNDY

Medical-device makers including Johnson & Johnson are warning of delays in device approvals after the Food and Drug Administration announced a major review of the process that has allowed quick clearance for thousands of products.

An internal FDA memo suggests that the tightening of the abbreviated process known as 510k is beginning already, before the review has been completed.

"It's Autumn, and change is in the air. This is particularly true for our 510k program," said Donna-Bea Tillman, head of the device evaluation office, in an email to her staff late Friday that was reviewed by The Wall Street Journal.

Dr. Tillman said in the memo that she needed to "get a better lay of the land" and called on branch chiefs to inform her when they were asked to clear a new "indication" or use "that you have never cleared for that device type." FDA reviewers typically don't run such individual applications by an official at Dr. Tillman's level, according to two FDA scientists.

Dr. Tillman didn't respond to requests for comment. The FDA said in a statement that her memo "reflects and is a furtherance of [FDA head Peggy Hamburg's] new direction."

The FDA's action came after it found "definite threats" to the integrity of its approvals in the case of a knee device approved last year that was the target of intensive lobbying by Democratic politicians. Dr. Tillman's role in the approval was critiqued in the FDA report on the episode.
The FDA has also commissioned an outside group to look into the issue.

The reviews "could have an impact now, in that they may lead FDA reviewers to be more conservative or more cautious in 510k reviews," said Jeffrey Gibbs, a Washington lawyer who advises device makers on FDA issues. "It's a very nervous time for the device industry."

A Johnson & Johnson spokeswoman defended the current 510k process, which streamlines clearance for products deemed "substantially equivalent" to devices already on the market. Carol Goodrich said the process "builds on ever-expanding knowledge" and accelerates innovation. Requiring more evidence for approval through the 510k process "would raise development costs substantially while also creating barriers to market entry that would reduce competition," she said.

At J&J, about $23 billion of the company's $64 billion in world-wide sales in 2008 came from the medical devices and diagnostic equipment division.

The FDA's Dr. Tillman said in her memo that the agency has set up a working group on 510k matters in her unit, and she called for extra scrutiny of certain applications.
She said the new scrutiny is "just the first of what I am sure will be many things that we will be doing to strengthen the 510k and all of our other programs in the months ahead."

The FDA's moves came in the wake of other potentially bad news for the industry in Washington. Leading Democrats have included a tax on device makers in health-overhaul legislation that would raise $40 billion over 10 years. Companies are fighting on Capitol Hill to stop or reduce those taxes.

Companies have valued the 510k process because it doesn't normally require lengthy clinical trials, allowing them to get their products to market sooner. Some members of Congress and some FDA device reviewers say the process is used too often for complex products that need more testing for safety and efficacy.

The Advanced Medical Technology Association, the industry's lobbying group, has met with members to discuss how to get their concerns reflected in the reviews at the FDA.

The association's executive vice president, David Exon, said the industry supports the reviews and is open to changes, so long as the "standards are reasonable and applied with consistency and transparency."

But Mr. Exon said he fears the multiple reviews could have a "chilling effect now" on FDA staff.—Nomaan Merchant contributed to this article.

Write to Alicia Mundy at alicia.mundy@wsj.com

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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