Sixth Circuit: Duty to Warn Limited to Risks Known – By Somebody

Generally, manufacturers have a duty to warn users about non-obvious, known dangers.  But, what steps must a manufacturer take to discover potential hazards?  The legal standard is for manufacturers to warn of dangers that could have reasonably been discovered.  Obviously, this alleviates the duty to discover a soothsayer in a distant land prophesying about the inherent dangers of a product.  But, what about sources that are more apparent, like medical journals?  Recently, the Sixth Circuit tackled this very issue. In Rodriguez v. Stryker Corp., No. 11-5335 (6th Cir. May 21, 2012), the Sixth Circuit held that a pain pump manufacturer did not have a duty to warn of a danger based on 13 articles published at various times in the 70 years before the pump was used.  In 2008, the plaintiff discovered that he had developed chondrolysis, a condition which left him with no cartilage in his shoulder.  According to the plaintiff, he developed the condition after using a pain-pump manufactured by Stryker Corporation to infuse his shoulder with an anesthetic known as bupivicaine for two-days following a 2004 surgery.

How could the plaintiff make such a claim?  Digging up articles from 1933 medical journals, that’s how.

The plaintiff did not claim Styker had actual knowledge in 2004 that the pump could cause chondrolysis.  After all, the first reported case of chondrolysis linked to anesthetics didn’t pop up until 2005.  Rather, the plaintiff alleged that Stryker should have known of the dangers based on 13 articles that “document [ ] significant damage to articular cartilage after prolonged exposure to foreign solutions.”

As the Court noted, the plaintiff’s argument is a stretch given what the articles say.

For example, the plaintiff produced one article from 1933 that shows injecting rabbits with water and saline solutions over a period of weeks produces chronic arthritis.  Four other articles are used to link chondrolysis to dyes and antiseptics – not anesthetics.  Three articles discuss the use of bupivicaine within a joint, but none of which say bupivicaine is unsafe.  One article from 2004 did describe a patient who developed chondrolysis after using a pain pump with bupivicaine, but that article offered no conclusions linking chondrolysis to pain pumps.  When looking at the articles in total, the Court stated:

[N]ot one of Rodriguez’s thirteen articles shows that medical experts understood in 2004 that infusing a joint with bupivicaine for two days could cause irreversible cartilage damage.  Stryker had no duty to understand what the relevant medical literature did not.

We here at Abnormal Use must applaud the Sixth Circuit for its holding.  To be clear, the holding does not imply that manufacturers have no duty to discover relevant medical literature.  Rather, they do not have a duty to piece together articles over several decades to make medical conclusions that the literature has not made.  Medical literature has plenty of value and should be reviewed.  The most-respected researchers in any field are cautious about drawing conclusions. Why should we impose a duty on manufacturers to jump to conclusions the researchers haven’t made?  Manufacturers should not be expected to have a heightened level of understanding beyond that of the medical research. A manufacturer’s duty to warn is limited to risks that are known – by somebody.  As long as that somebody isn’t the mountaintop oracle of a foreign land.

Sixth Circuit Prefers A Bourbon On The Porch To A Margarita On The Beach

“All bourbon is whiskey, but not all whiskey is bourbon.”  So begins an especially amusing opinion in which the the Sixth Circuit gives Jose Cuervo a history lesson on one of the pillar’s of American society: bourbon.  It is an especially American concoction, Judge Martin of Kentucky observes, one that has been enjoyed since 1774 by everyone from Elijah Craig to Ulysses S. Grant, who apparently had a preference for Old Crow.

Plaintiff Maker’s Mark Distillery, Inc. has been sealing its bottles with red wax since the 1950’s, which it registered as trademark in 1985 (Reg. No. 1469925).  In 1997, the parent company for Jose Cuervo began using a red sealing wax on its special edition “Riserva de la Familia” tequila, shown here.  Maker’s Mark took exception to the use of the red sealing wax and, after Jose Cuervo refused to change the design, filed suit for trademark infringement in 2003.

Now, most people might be reluctant to challenge the strength and recognition of Maker’s Mark’s trade dress in a U.S. District Court in western Kentucky; but hey, too much tequila can make a man do strange things sometimes.  At least Jose Cuervo was sophisticated enough to request a bench trial, taking out of play the risk that it would end up with 12 bourbon-loving Kentucky jurors.  In a shocking turn of events, the district court found that Maker’s Mark’s registered trademark consisting of its signature trade dress element – a red dripping wax seal – was valid and infringed and enjoined Jose Cuervo from using any similar design.  The Sixth Circuit agreed and upheld the district court’s award of costs to Maker’s Mark.

Trade dress is an often unnoticed, but highly valuable form of intellectual property.  Recognized as a “symbol” or “device” under the Lanham Act (15 U.S.C. § 1052), trade dress typically encompasses the actual shape or design of a product or its packaging.  Some famous examples include the Coca-Cola bottle or Tiffany’s blue box.  Unlike traditional trademarks, trade dress must have acquired distinctiveness and it cannot be “functional.”  For example, if you see a small blue box wrapped in white ribbon, you don’t have to see the Tiffany’s mark before knowing where it came from.  Showing this level of recognition at trial can require a substantial amount of evidence. In this case, the Court found that Maker’s Mark’s fifty years of advertising and substantial sales were enough to satisfy the requirement.  It also did not hurt that in 2002 Business Week declared the Maker’s Mark’s seal “one of the most recognizable in the world.”

So next time you go to buy bourbon be rest assured that if you get the bottle sealed in red wax, it’s going to be a Maker’s Mark.


Sixth Circuit Allows State Law Negligence Claims

Last year, the Supreme Court decided Wyeth v. Levine [PDF], stating that Congress, through the FDCA, did not intend to preempt state law failure to warn claims. The Sixth Circuit extended Levine in Wimbush v. Wyeth, No.09-3380, 2010 WL 3256029 (6th Cir. Aug. 18, 2010) [PDF], and reasoned that a plaintiff could pursue negligence claims relating to a manufacturer’s decision to bring a drug to market, i.e., a pre-labeling, pre-approval claim.

Mary Buchanan, the Plaintiff’s decedent, developed primary pulmonary hypertension, allegedly caused by her ingestion of Redux, a weight-control drug pulled from the market in 1997. The pulmonary hypertension was the alleged cause of death. It’s unlikely, at least in Ohio, that there would be many more claims like the plaintiff’s. Ohio statutory law would now preempt any negligence claims based on products liability, but Buchanan filed her claim before the statute became effective. Therefore, Wimbush brings us into a strange scenario where, although the drug manufacturer can successfully defend the failure to warn claim, there are other state law claims that are not preempted and allowed by state tort law.

After explaining why the state law negligence claim would be allowed under state law, the Sixth Circuit reversed the district court’s grant of summary judgment in favor of Wyeth. The Court, leaning heavily on Levine, noted that Congress had never enacted an express preemption provision throughout the 70-year history of the FDCA. In light of the history of the scheme, there could be no preemption of state law claims, express or implied. Nevertheless, the Sixth Circuit acknowledged that its decision was breaking new ground:

Finally, we are aware of no federal appeals court decision since Levine concluding that FDA regulation preempts any aspect of state tort law, though we admit that, until today, there is also no post-Levine court of appeals authority for the proposition that the Levine rationale extends beyond the realm of failure-to-warn claims to apply to all pre-approval state law claims.

Wimbush may be used to open a door in other jurisdictions to allow other state law negligence claims in jurisdictions where the standards, statutes of limitations, or venire may be plaintiff-oriented. Look for plaintiffs’ attorneys to test the state law waters with inventive tort actions. I’m sure that there are all manner of pre-approval state law claims that are about to be manufactured.