We’ve been following all this Pain Pump litigation for some time – our “Pain Pump” topic has 31 posts in it − and with some trepidation. The trepidation has primarily derived from the Pain Pump defendants’ rather powerful state of the art defense in many of the current cases (mostly involving older surgeries). As always, when the defendants have a solid defense, we see plaintiffs resorting to a variety of more-or-less novel and expansive causes of action in attempt to circumvent it. In Pain Pump we’ve seen duty to test, post-sale duty to warn, off-label promotion, and “no good deed goes unpunished” FDA-related allegations that amount to private FDCA enforcement. As to the latter, a word to the wise: If you’ve already received a general use indication from the FDA for your device, anything you do to seek a more precise indication, especially if you aren’t successful, might be used against you by plaintiffs improperly trying to impose their peculiar view of the FDCA
Well, with the plaintiffs unsuccessful (twice) in getting a federal MDL, they haven’t all been able to pile on in one forum. Instead, it’s been the legal equivalent of guerilla warfare in various courts – state and federal – around the country. Some of those cases have been approaching the trial stage. As veterans of the Baycol and Vioxx wars (among others), we know how important early trial wins can be.
Well, on February 6, 2013, the defense won a big one – in a difficult jurisdiction (California), but not in the worst parts of it (Orange County), which is where hundreds of California state Pain Pump (against all defendants) cases have been “coordinated.” This bellwether case, the first to be tried in California, was called McKenna and the target defendant was Breg. Previously, other Pain Pump defendants also won a trial in federal court in Oregon, and we believe another in Wyoming.
Unlike the other most prominent California defendant (I-Flow), Breg has not settled more than a few of its cases, opting instead for the gutsier and more risky path of trying cases. Our intelligence tells us that, because McKenna had relatively favorable facts, Breg decided to push it to trial. We’ve heard that the trial judge, Hon. Gail Andler, made some very favorable rulings for Breg in motions in limine and during the trial – we’d love to get copies of anything in writing – but denied nonsuit on the statute of limitations, which would have meant no trial. Shades of Paveklo. Judge Andler presides over all of the California pain pump cases, so perhaps her other rulings, combined with the favorable verdict, will give plaintiffs second thoughts about going to the mat on more of these cases.
The allegations sound like an ordinary Pain Pump case – not surprising, since it was picked as a bellwether – shoulder surgery in July 2002, followed by use of an infusion pump (a “Pain Care 3000” for those of you wanting product details). The usual Pain Pump injury, chondrolysis, was claimed. The plaintiff’s causes of action were warning-related and sounded in negligence and strict liability.
Although mooted by the verdict, the statute of limitations grounds were solid. Plaintiff McKenna’s subsequent treating doctor (who has even worked for plaintiffs in other Pain Pump cases) actually sent plaintiffs an email stating that he had chondrolysis from pain pump use – and still the plaintiffs blew the statute by four days. But evidently, the jury didn’t see it that way after the judge put the issue to them. Oh well, conceivably Judge Andler could revisit it, but that's not particularly necessary anymore.
Beyond the usual state of the art defense, Breg also asserted that the plaintiff didn’t have chondrolysis at all. Instead he had secondary osteoarthritis, an injury which was not caused by the pump or the drug that it administered. This injury-based defense is why McKenna was a better than usual defense case.
The McKenna trial lasted three and a half weeks. The jury found for the defense on both the negligence and strict liability claims. We’ve heard the verdict was unanimous on strict liability and 9-3 for the defense on negligence. We wonder if the difference was caused by the plaintiff trying to squeeze some novel claim (such as duty to test) into the negligence count. In any event, it didn’t work.