[Drug and Device Law] Specific Causation + General Verdict = Pain Pump Defense Win
Today’s newsflash: winning is good. Winning is better than losing. Winning at trial is especially good. Winning at trial enhances the chance of winning on appeal. But are there ways to win at trial that improve the odds of winning on appeal? Funny you should ask. A recent unpublished California appellate opinion, In Re Infusion Pump Cases, Super. Ct. No. JCCP 4615 (Cal. 4th App. Dist. March 2, 2015), offers an interesting object lesson. The plaintiff claimed a chondrolysis shoulder injury from the pain pump. We’ve heard that before. There were causes of action for, inter alia, strict liability and negligence. We’ve heard that before. The jury returned a verdict for the defendant. We’ve heard that before. The plaintiff appealed and argued that the court had wrongly excluded certain evidence. We’ve heard that before. But the appellate court’s reasoning in affirming the defense verdict causes us to think more about how to try cases, causes us to think more about how to frame verdict forms , and causes us to think more about causation.
The plaintiff underwent shoulder surgery in 2002. The doctor used the defendant’s pain pump to control plaintiff’s post-operative pain. The pain pump was connected by a catheter to the plaintiff’s shoulder for about two days after the surgery. Between 2002 and 2008, the plaintiff rode dirt bikes and all-terrain-vehicles, played golf, and went snowboarding and skiing. In 2008, after he could not finish painting a room in his house due to shoulder pain, the plaintiff visited several physicians. One orthopedist diagnosed him with arthritis. Another, who later became the plaintiff’s expert witness, concluded that the pain pump had caused chondrolysis.
One of the plaintiff’s claims at trial was that the defendant had not warned about the unreasonable risks of using a pain pump in the shoulder joint. The plaintiff contended that the defendant should have warned physicians that its pain pump had not been cleared for intra-articular or orthopedic uses. The plaintiff alleged that the defendant unsuccessfully tried to secure the FDA’s clearance to include orthopedic use in the pain pump’s indication for use statement. According to the plaintiff, the FDA refused such clearance due to safety concerns. Nevertheless, the court excluded evidence concerning the defendant’s submission to, and contact with, the FDA for clearance to market defendant’s pain pump. Meanwhile, the parties’ expert orthopedic surgeons disagreed on the cause of the plaintiff’s problems. As referenced above, the plaintiff’s expert opined that the plaintiff had chondrolysis. By contrast, the defendant’s expert opined that the plaintiff had needed a shoulder replacement due to arthritis.
The jury returned a general verdict in defendant’s favor on all of plaintiffs’ claims. The plaintiff’s argument on appeal was that the court had abused its discretion by excluding evidence of the defendant’s communications with the FDA, “communications that should have put [defendant] on notice of potential safety risks associated with the use of its pumps in orthopedic surgeries, and particularly of use inside the shoulder joint.” The plaintiffs asserted that the improperly excluded evidence included (1) documents exchanged between defendant and the FDA during the regulatory clearance process, and (2) the deposition testimony of an FDA staff person who reviewed the defendant’s regulatory submissions. That strikes us as proper, given how the plaintiff sought to use that evidence. We’ve blogged several times (here, for example) about FDA regulatory status and informed consent, and the rule is that FDA regulatory status is not something that a doctor is obligated to discuss with a patient. Rather, informed consent covers only medical risks and benefits of proposed treatment. But the appellate court did not need to reach the evidentiary question. It found a much easier way to affirm.
The excluded evidence would have been relevant only to the defendant’s failure to warn claim. But such evidence would have in no way dislodged or erased the substantial evidence adduced at trial supporting a finding that the defendant’s pain pump did not cause any injury whatsoever. Thus, if the jury based its verdict on a lack of causation, the failure to warn goes nowhere. Because the jury returned a general verdict that simply found for the defendant on the two claims of (1) “Negligence – Manufacturer or Supplier – Duty to warn” and (2) “Strict Liability – Failure to Warn,” the appellate court was required to infer that the jury by its general verdict found for the defendant on every issue submitted. One of the issues submitted by the defendant at trial was lack of specific medical causation – that its pain pump did not cause any harm to the plaintiff. The defendant presented substantial evidence at trial supporting a finding that the plaintiff did not suffer from chondrolysis, and thus the failure to warn of the risk of chondrolysis was not a substantial factor in causing the plaintiff’s harm. This evidence included the defense expert’s opinion that the plaintiff never had chondrolysis and that the plaintiff’s eventual total shoulder replacement was made necessary because he developed secondary arthritis. Remember how, between 2002, when the plaintiff underwent the surgery in which the pain pump was used, and 2008, when he sought medical help after being unable to finish painting a room, the plaintiff had engaged in enough sporting activities to fill a Cabela’s catalogue?
In closing argument to the jury, defense counsel stated: “[T]his may be obvious, but I’m going to say it anyway. If the plaintiffs haven’t proven that Scott McKenna had chondrolysis, then they haven’t proven that anything Breg did at all was related to any harm of Scott McKenna.” Just so. That very well might have been the winning argument. Given the general verdict form, the appellate court had to assume that the defense medical causation argument had won the jury over. The record showed that lack of causation was a primary defense theory at trial. It does not matter that there was also substantial contrary evidence. We are not applying the summary judgment standard at this point. Once the court necessarily presumes that the jury found that the pain pump had not caused the plaintiff’s injury, the failure to warn claim goes by the boards, and whether or not certain evidence might have suggested warning adequacy is a big who-cares.
As we said above, winning is good. Winning with a general verdict is even better. That is a point that gives us pause, because so often we defense lawyers fight hard for special interrogatories, thinking they will either steer the jury in our direction or will enhance the chance of attacking a bad verdict. But it turns out that a general verdict is the best way to uphold a good verdict. Another lesson in this pain pump case is that one should not give up on medical causation without a very good reason. As the defense lawyer told the jury in closing, medical causation can be the be-all end-all.
We offer a tip of the cyber-cap to the folks at Bowman & Brooke, who must be very pleased with the outcome they achieved in this case on behalf of the defendant.
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Posted By Steve McConnell to Drug and Device Law at 3/10/2015 07:30:00 AM --
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