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What Dangers Require Disclosure in Failure-to-Warn Claims?

By Robyn Hagan Cain | Last updated on

Lawyers make the worst surgical patients, because we tend to review lists of complications and ask our doctors about the likelihood of each one. (So my odds of not waking up after anesthesia are 1 in 100,000? How many patients have you treated? Have you already met your statistical loser?)

Doctors and medical device manufacturers have a duty to warn patients about likely side effects and glitches, but what kinds of harms does that duty include? The Sixth Circuit Court of Appeals weighed in on the issue this week.

In November 2004, Dr. John Kuhn implanted a pain-pump catheter in plaintiff Andrew Rodriguez’s shoulder following arthroscopic surgery. Over the next two days, a Stryker pain pump delivered a regular dose of bupivicaine, a local anesthetic, to Rodriguez’s shoulder joint. Rodriguez’s condition improved after surgery but worsened over time; in 2008, he learned he no longer had any cartilage remaining in his shoulder, a condition called chondrolysis. Rodriguez sued Stryker, alleging strict liability, negligence and breach of warranty.

Under Tennessee law, a manufacturer must warn users about non-obvious dangers caused by its product. Here, Rodriguez claims that Stryker should have known of the risk, and warned doctors. He submitted 13 articles published at various times during the 70 years before the surgery, which allegedly put Stryker on notice about the danger of using its pain pumps inside a joint.

Stryker moved for summary judgment, and to exclude or limit the testimony of Rodriguez's experts on Daubert grounds. Even accepting the admissibility of the expert testimony for the sake of argument, the district court concluded that Stryker could not reasonably have known about the risk of chondrolysis in 2004, and thus had no duty to warn of the risk. (The court also held that Rodriguez failed as a matter of law to prove causation.)

The Sixth Circuit Court of Appeals agreed.

The Court pointed out that none of Rodriguez’s 13 articles showed that medical experts understood in 2004 that infusing a joint with bupivicaine for two days could cause irreversible cartilage damage, so Stryker had no duty to understand what the relevant medical literature did not. According to the appellate court, “the state of scientific and technological knowledge available to the manufacturer ... at the time the product was placed on the market,” defeated Rodriguez’s failure-to-warn claim as a matter of law under Tennessee Code § 29-28-105(b).

Rodriguez clearly suffered an injury that will cause him long-term pain, but the courts have ruled that neither his doctor, nor Stryker should have anticipated that harm based on the available evidence. What do you tell clients in similar situations where a failure-to-warn claim fails?

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