It is not as if this qualifies as a profound insight, but whenever we watch a drug or device trial (easier and easier to do now with various internet services) we walk away thinking that the two key prongs to any defense are context and the doctor's choice of treatment. Plaintiff lawyers are skilled at seizing on isolated bits of awkwardness – a bad study, a bad document, a bad complication – and making a defendant look … bad. Defendants can carp about cherry-picking, but that is no way to woo a jury. The chief assignment of the defense lawyer is to show the rest of the picture.
(Now here comes the inevitable digression. Several years ago we were in a product liability trial against a smart, energetic, eloquent plaintiff lawyer. Note that we did not add “fair” to that litany of adjectives. The case was brought on behalf of a woman who had allegedly died from using our client’s product. In his opening statement, the plaintiff lawyer showed the jury a picture of the decedent. She looked like a very nice lady. But the picture was cropped. Somehow, even though it had been months since we scanned the hundred or so photographs of plaintiff produced in discovery, we remembered that there was something else in that photograph. Over the lunch break, we got to work. Then came our opening statement, where we told the jury that the plaintiff lawyer had showed them only a part of the picture. We were going to show the jury the rest of the picture. Literally. We reshowed the picture of the plaintiff. Then, with a theatrical flourish, we unwrapped the uncropped version, which showed the decedent using another product. At least two members of the jury gasped. We’re not saying we won the case right there and then, but it was a nice start.)
The doctor's choice of treatment modality is another important concept in our cases. There is no overall perfect drug or medical device. What works well for one patient might be ineffective or even catastrophic for another. Doctors need to choose the right treatment for the right patient, and it is crucial that doctors have a range of options. Plaintiff lawyers should not be choosing what devices doctors can and cannot choose. Neither should juries. Jurors themselves must know that is true. If we can get the jury to understand the concepts of context and the doctor's need to choose, we feel we have a decent prospect of success.
It turns out that context and doctor choice can also play roles in obtaining summary judgment. In Kordek v. Becton, Dickinson & Co., 2013 WL 420332 (E.D. Pa. Feb. 4, 2013), Judge McLaughlin authored an insightful opinion showing how context and doctor choice are relevant to a claim of design defect. In Kordek, the plaintiff claimed that a scalpel shield was defectively designed. The plaintiff was a surgical technician responsible for preparing operating rooms. Part of that preparation involved placement of surgical instruments. One of the surgical instruments she handled was a disposable scalpel with a fully removable shield covering the blade. The plaintiff had a difficult time removing the scalpel’s shield. She wrapped her fingers around the shield and pulled. In the course of removing the shield, the plaintiff lacerated her hand and arm.
The defendant manufactured a range of scalpel products, including:
- a conventional disposable scalpel, and
- a protected disposable scalpel.
Conventional scalpel blades are protected by a flexible, tube-like vinyl shield, which is fully removed from the scalpel before use. A person must use two hands to remove the scalpel shield from a conventional disposable scalpel. This is the type of scalpel that the plaintiff handled when she injured herself.
Beginning in 2000, the defendant began developing a new protected disposable scalpel. Unlike the conventional disposable scalpel, which has a fully removable vinyl shield, the protected disposable scalpel has a shield that can be retracted for use and then pushed back over to protect the blade. As a result of the retraction device, a person can “remove” the shield using only one hand. The defendant designed these scalpels to minimize the risk of surgical blade injuries.
The market’s reaction to the protected (retractable) shield scalpel was mixed. Some customers continued to demand the conventional scalpel due to the different “feel” of the retractable shield products. One study reported that 84% of doctors surveyed stated that they did not like the feel of retractable scalpels and that more than 68% were concerned with their line of sight. Statements from OSHA also make reference to concerns regarding the “feel” of the instruments. By contrast, the nurse manager of the plaintiff’s unit testified that the staff “really liked” the retractable shield scalpels. 2013 WL 420332 at *2-3.
The defendant in Kordek filed a motion for summary judgment, and the issue was whether the conventional scalpel was defectively designed, especially in light of the alternative scalpels with the retractable shield. As a preliminary matter, Judge McLaughlin visited the vexing issue of whether the Second or Third Restatement of Torts should govern the case. As we have mentioned before (here, for example), the Pennsylvania courts have resisted any impulse toward lucidity on this point. In Kordek, Judge McLaughlin laid out the legal landscape as clearly as possible. In June 2011, the Third Circuit directed federal district courts to apply the Restatement (Third) to design defect claims arising under Pennsylvania law. Covell v. Bell Sports, Inc. 651 F.3d 357, 360 (3rd Cir. 2011). District courts are bound by that Third Circuit holding unless and until the state supreme court issues a contrary decision or it appears from a subsequent decision of the appellate courts that the court of appeals erred. Since Covell, the Pennsylvania Supreme Court has neither affirmed nor rejected the Third Circuit’s application of the Restatement (Third). It was given an opportunity to make such a decision in Beard v. Johnson & Johnson, Inc., 31 A.3d 823, 836 (Pa. 2012), in which the appellee invited the Supreme Court to adopt the Restatement (Third), but the Pennsylvania Supreme Court declined the invitation, although it did acknowledge the “continuing state of disrepair” in this area. So the Pennsylvania Supreme Court spotted the mess, but kept eyes aimed ahead and kept walking. The bottom line is that Judge McLaughlin was bound by Covell to follow the Third Restatement, although she believed the final result would be the same under either the Second or Third.
Section 2(b) of the Restatement (Third) of Torts explicitly requires an inquiry into the existence of a reasonable alternative design. Not surprisingly, the plaintiff argued that the retractable shield scalpel was a reasonable alternative design. That seems like a perfectly obvious argument to make. It even seems like low-hanging fruit. Nevertheless, the court concluded that the retractable shield products were not reasonable alternatives because “they create additional hazards which do not occur with the use of the conventional scalpel.” 2013 WL 420332 at *7. Comment f to section 2(b) states that “when evaluating the reasonableness of a design alternative, the overall safety of the product must be considered. It is not sufficient that the alternative design would have reduced or prevented the harm suffered by the plaintiff if it would also have introduced into the product other dangers of equal or greater magnitude.” In other words, the court must consider the broader context of the device and “must not limit its analysis to the particular injury sustained by the plaintiff.” 2013 WL 420332 at *7.
The advantage of the retractable shield is unanswerable. That shield makes an accidental cut much less likely. But the court cannot stop its analysis there. There was also evidence that the retractable shield offered safety costs as well as safety benefits. First, the defendant’s expert testified that the retractable shield scalpel products are bulkier. Second, government regulatory bodies do not ban conventional scalpel products and instead allow their use where they are medically necessary. Third, there is no statistical evidence indicating that the conventional scalpel has a dangerously high rate of injury. Id. at *8.
The contextual analysis employed by the Kordek court found an antecedent in the case of Riley v. Becton Dickinson Vascular Access, Inc., 913 F. Supp. 879 (E.D. Pa. 1995). In Riley, a nurse who contracted HIV when stuck with an intravenous catheter needle brought a products liability action against the defendant-manufacturer. The nurse argued that a reasonable alternative was available in the form of a catheter with a retractable needle that was at that time manufactured and marketed by the defendant. Id. at 886. The Riley court disagreed, pointing to evidence from the hospital at issue and in healthcare publications suggesting that the retractable needles had safety and pragmatic problems. The Riley court concluded that the substitute may not be “safer overall when other aspects of the alternative design are considered.” So the Riley case was helpful and on-point. It was also a case that Bexis worked on during his salad days.
Viewing all the pluses and minuses of the conventional scalpel and the newer version with the retractable shield, it appears indisputable that a surgeon might choose the former over the latter. Sure, maybe most technicians like the convenience of the retractable shield, but if the ‘feel’ of the scalpel really matters to a surgeon, who’s going to argue? Put it this way: if your surgeon tells you that he or she simply feels more comfortable using an older version of a scalpel, wouldn’t you want that surgeon to use the scalpel they prefer?
Remember that the Kordek case involves a motion for summary judgment. Even in the face of Riley and the contextual analysis, the plaintiff argued that she had established genuine issues of material fact sufficient to defeat a motion for summary judgment. There is no doubt that the plaintiff’s laceration would likely not have happened with the retractable shield scalpel. Moreover, the “staff really liked” the retractable shield scalpel. But it was not clear whether that "staff" referred to those who prepared the rooms for operations or those who actually performed these operations. It makes a difference. The plaintiff tried to minimize the ‘feel’ point by citing the defendant’s advertisements, which claimed that the scalpels were “virtually” the same in size and shape. But such claims are of “limited relevancy to the actual experience of medical professionals.” Id. at *9.
The best piece of evidence that the plaintiff had was the statement by her expert witness, Dr. Benda, that the retractable scalpel was a safer alternative because it would have protected the plaintiff from the injuries she suffered. But again, that expert opinion was devoid of the appropriate context. Dr. Benda’s conclusion did “not consider the opinions of medical professionals. He did not consider whether the retractable shield scalpel posed any risks that are not posed by the conventional scalpel. He did not consider the cost of retractable shield scalpels as compared to the conventional ones.” Id. It is interesting and useful that the court included cost as a valid factor in assessing reasonable alternatives. (Bexis reminds us that cost was a major issue in the Riley case, as the alternative design there was two or three times the price of the simple catheter.) In short, while the plaintiff’s expert may have concluded that the retractable shield scalpel is a “reasonable alternative” as he defined it, “the scope of his analysis is far narrower than that which must be conducted by the Court.” Thus, the court ultimately held that “no reasonable jury could find that the retractable shield scalpel is a reasonable alternative design.” Id. at *10.
The Kordek opinion offers healthy doses of clarity and reality. It is as if a judge actually wanted to engage with how medicine is actually practiced and how doctors actually make choices. The reasoning in Kordek is sharp and the result is right.