May the holidays treat you well.  We trust that none of you got burnt by any of the many hot things loitering around this time of year: yule logs, candles, figgy puddings, overloaded electrical outlets, and Aunt Sally’s line dancing after she downs a third eggnog. 

Today’s case is not exactly hot, but it’s got enough good bits to warm our flinty, defense-hack hearts. It’s like a two-fer present under the tree, with one present being considerably more fun than the other. Think of unwrapping a box that ends up containing a bottle of scotch and a pair of socks. Lin v. Solta Med., Inc., 2021 U.S. Dist. LEXIS  228901 (N.D. Cal. Dec. 18, 2024), is a to-be-published decision granting summary judgment against warning claims in a long-running product liability case. The plaintiff claimed that she got burned by a bad product.  But it was her case that got burned by a straightforward application of California’s learned intermediary rule.

 The plaintiff, a California resident, had gone abroad to obtain a cosmetic surgical laser skin treatment that was apparently not available in the US (probably for FDA reasons).  She claimed injury in the form of second degree burns and blamed the medical devices used.  She filed a complaint in Alameda County (the darling of plaintiff lawyers) alleging the usual litany of product liability claims (failure to warn, design defect, manufacturing defect, and breach of warranties) against a couple of companies.  The case was removed to federal court. One defendant got out on jurisdictional grounds.  One did not.  The California manufacturer remaining in the case filed a motion for summary judgment.  The plaintiff punted on the manufacturing defect and warranty claims. What was left was a phalanx of warning and design defect claims (in both strict liability and negligence versions). The defendant won on warning but lost on design defect.

As a preliminary matter, the Lin court applied California law.  Why?  The medical procedure took place in Taiwan.  Be that as it may, the court applied California law.  Maybe the parties agreed.  Maybe Taiwan’s law is similar (though that would surprise us – Taiwan seems pretty smart about most things).  We bet the federal judge was happy not to have to undertake an exploration of Taiwanese tort law.

The court applied the learned intermediary rule to the warning claims.  Following a nicely reasoned analysis, the court held that the warning was adequate as a matter of law and there was no warning causation.  The treatment involved general anesthesia, which increased the risk of burns (because a patient under general anesthesia is less sensitive to pain and less able to alert the treaters) and the successive use of two different devices, which also increased the risk. The plaintiff argued that the device manual was unduly vague about these risks, but the undisputed record showed that the plaintiff’s doctor knew them. The treater was not only aware of the relevant risks, but had the plaintiff sign a consent form reciting them. Moreover, it was the doctor, not the defendant, who was responsible for the dual use. 

The court rejected the claim that the defendant had a duty to warn “specifically about greater risk when a different medical device is also used. The duty to warn about the “enhanced” risk when also using a different product was “too much” because it proposed that a “defendant must warn with specificity about every conceivable element that might” increase an already warned-of risk.

The best part of the Lin court’s opinion is its conclusion that the plaintiff’s theory was, in practicality,  that “any warning short of a complete contraindication or ban is insufficient as a matter of law.” That often ends up being the theory in most of our failure to warn cases.  What is wanted is not a warning that would truly help a doctor weigh risks; rather, the plaintiff wants a ‘warning” that essentially says, “Don’t use this product.”  The Lin court held that the plaintiff’s theory “would require the jury to go beyond what is permitted by California law and find that a defendant must not only inform but also explicitly limit the usage of a product, thereby eliminating the consumer’s option to ‘avoid the danger by careful use.'” Adios, warning claims.  Summary judgment was granted. 

By contrast, the design defect analysis did not quite go the manufacturer’s way. The manufacturer did get its way by persuading the court to apply the risk-benefit test, as opposed to the consumer expectation test. The Lin court reasoned that the consumer expectation test for design defect was not applicable to a prescription-only medical device that is used only by specialized physicians. Such devices are beyond the understanding or expectations of lay jurors. So far so good. But the Lin court denied summary judgment on risk/utility because defendant did not adequately address factors other than the relative rarity of this adverse event and its warnings.  To be sure, the defendant had a strong point that the actual rate of adverse event reports of product involvement with burns was approximately 0.007% of treatments. But the court concluded that the jury could look to other factors, such as feasibility and cost of the plaintiff’s proposed safer alternative design, in considering the negligence and strict liability design claims. 

It is possible that those other factors will end up working out in the defendant’s favor. For example, the strict liability design defect claim should fail because California law does not permit strict liability design claims against prescription products.  It’s just going to take more litigation to get there. Sometimes the best presents do not show up until after the New Year.