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 , 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.