The District Judge in Lin v. Solta Medical, Inc. is evidently on a year-end push. We reported just the other day on the court’s order granting summary on the plaintiff’s warnings-based claims, but denying summary judgment on design defect. A few days later, the court ruled on the parties’ motions to exclude expert opinions. This is quite the holiday treat, although the court’s order on experts delivers more lumps of coals for these parties than sugar plums. On the whole, the defendant medical device manufacturer is probably looking forward to happier new year.
To recap, a California resident traveled to Taiwan for cosmetic laser skin treatment and claims that she suffered second-degree burns as a result of the treatment. The treating physician used the defendant’s device, so the plaintiff filed a product liability lawsuit—in California. Each side filed motions to exclude expert opinions offered by the other side. Lin, No. 21-cv-05062, 2024 WL 5199905 (N.D. Cal. Dec. 23, 2024).
The outcome reflected a vigilant approach to the “gatekeeping” function mandated by the Rule 702. Although the district court relied on Daubert and many older opinions, it is clear that the court applied the new rule, exemplified by the exclusion of several opinions in instances when earlier courts may have ruled incorrectly that objections “go to the weight.”
How exactly did this play out? First, the court granted the plaintiff’s motion to exclude most of the defendant’s medical expert’s opinions. The parties in this lawsuit dispute whether the device used to treat the plaintiff was, in fact, an authentic device manufactured by this defendant. Thus, the defense medical expert offered the opinions that the plaintiff had not established the authenticity of the device and that there was “no available evidence” that certain parts of the device were defective or counterfeit. These opinions, however, were not based on any reliable methodology, but were instead based on the physician’s factual interpretation of deposition testimony. The expert “simply characterized the state of the evidence,” which usurped the jury’s function. Id. at *2-*3.
The court also excluded the defense expert’s opinion that the treating physician breached the standard of care and caused the plaintiff’s alleged injuries. The standard of care for physicians is determined by medical experts under similar circumstances, including geography in some cases. Here, the defense expert could not address the standard of care in Taiwan, and he offered only general statements regarding “safety and efficacy” that were too value to be helpful. The defendant’s medical expert will be allowed to opine on the plaintiff’s current condition and possible treatment options, and little else. Id. at *3-*4.
Second, the defendant’s engineering experts were likewise limited. The court excluded one engineer’s opinion that the device was safe because it was completely derivative of the fact that the FDA approved the product. He offered no opinion based on his expertise or knowledge, and thus did not employ any reliable methodology. The FDA’s review of the product “can be presented to the jury in a number of ways,” which would make the opinion redundant and unhelpful, too.
The defendant’s engineers, however, will be allowed to rebut engineering opinions offered by the plaintiff. These experts did not submit written reports, but because they were longtime employees of the defendant—and not retained experts—they did not have to. Rule 26(1)(2)(B) requires a report from a witness “retained or specially employed to provide expert testimony,” which did not include witnesses “employed [by the defendant] for business purposes, not to regularly give expert testimony.” Id. at *4-*5.
Third, the district court denied the defendant’s motion to exclude the plaintiff’s damages expert. Sure, she assumed liability and was just doing arithmetic. But experts (especially damages experts) are given assumptions all the time, and while she was performing mere arithmetic, it was “somewhat complex arithmetic.” Id. at *5-*6.
Fourth, the court granted the defendant’s motion to exclude the plaintiff’s regulatory expert. Because the court already granted summary judgment on the plaintiff’s warnings claims and on manufacturing defect, his testimony could not help the trier of fact and was irrelevant. Id. at *6. Given the mischief that plaintiff-side regulatory experts can cause, this is a good ruling.
Fifth, the court largely gutted the plaintiff’s medical expert. On causation, the expert could not describe a reliable methodology and could not describe what other causes she considered. She agreed that she did not “consider other potential alternatives” or perform a “specific analysis” as to the cause of the plaintiff’s burn. She agreed that the treating physician’s decision making contributed to the plaintiff’s outcome, but she did not consider potential malpractice as a contributing factor. The plaintiff’s medical expert will be allowed to say that the treating physician was using the defendant’s device or a copycat device when the plaintiff was burned, and virtually nothing else. Id. at *6-*9.
The court also excluded the plaintiff’s medical expert’s opinion that the plaintiff’s burns were “most likely caused by” the defendant’s device, as opposed to a counterfeit device. In forming this opinion, the expert was merely parroting the treating physician’s description of the device, which is not a reliable methodology. The other purported bases for her opinion were equally unreliable, nothing more than ipse dixit, and statements with “no indication at all as to what information supports that conclusion.” Id. at *9-*11. The medical expert’s opinions on the adequacy of the warnings, the defendant’s purported “failure to train,” and an earlier version of the device were irrelevant and unhelpful; and her opinions on the defendant’s “knowledge and intent” were similarly irrelevant, but also “pure speculation” with “no methodical basis.” Id. at *11-*12.
Sixth, the court also largely gutted the plaintiff’s engineering expert. His testimony on how the device works was not an expert opinion, and he was not qualified to offer opinions on design alternatives. The expert had worked in research and development in the medical device industry and had experience with wound closure and cardiac devices. But he never used the device at issue here, or even seen one before consulting with another of plaintiff’s experts for this litigation. He admitted that he “did not quite understand the magic” of one device and that he has “no expert knowledge concerning the relevant market, how competing products are designed, how those design features work, and what tradeoffs they entail.” The expert was likewise not qualified to offer opinions on “preferred safety features” and “displayed warnings” for the device, since “[h]e is an engineer, not a physician.” Id. at *13-*14.
The court also excluded the plaintiff’s engineering expert’s opinions that it would be difficult to make a counterfeit device and that the device warnings were not adequate because the court was “unable to determine what method [the expert] even claims to use,” leaving the court “unable to discern any basis for finding that the opinions are reliable or trustworthy.” And, of course, having granted summary judgment on warnings, opinions on the warnings were unhelpful and irrelevant, too. Finally, the court excluded the engineer’s opinion that physicians have a financial incentive to work quickly. Talk about ending with a whimper. Id. at *15-*16.
As we said at the top, this order shows the hallmarks of the new Rule 702 in a couple of ways. The court clearly placed the burden of demonstrating admissibility on the party offering the opinions, and the court applied that burden evenhandedly going both ways. Moreover, rather than defaulting to the mantra that objections “go to the weight,” the court excluded opinion where qualifications or methodology was lacking. Another judge might have ruled improperly that an expert’s experience with other medical devices went “to the weight.” This judge excluded the opinions. Same with a causation methodology that failed to consider alternative causes. This judge excluded the causation opinions. Both sides took their lumps, but we think the defendant came out better here.