It is not as if this qualifies as a profound insight, butwhenever we watch a drug or device trial (easier and easier to do now withvarious internet services) we walk away thinking that the two key prongs to anydefense are context and the doctor's choice of treatment. Plaintiff lawyers are skilled atseizing on isolated bits of awkwardness – a bad study, a bad document, a badcomplication – and making a defendant look … bad. Defendantscan carp about cherry-picking, but that is no way to woo a jury. Thechief assignment of the defense lawyer is to show the rest of thepicture.
(Now here comes the inevitable digression. Severalyears ago we were in a product liability trial against a smart, energetic,eloquent plaintiff lawyer. Note that we did not add “fair” to that litanyof adjectives. The case was brought on behalf of a woman who hadallegedly died from using our client’s product. In his opening statement,the plaintiff lawyer showed the jury a picture of the decedent. Shelooked like a very nice lady. But the picture was cropped. Somehow,even though it had been months since we scanned the hundred or so photographsof plaintiff produced in discovery, we remembered that there was something elsein that photograph. Over the lunch break, we got to work. Then cameour opening statement, where we told the jury that the plaintiff lawyerhad showed them only a part of the picture. We were going to show thejury the rest of the picture. Literally. We reshowed thepicture of the plaintiff. Then, with a theatrical flourish, we unwrappedthe uncropped version, which showed the decedent using another product. At least two members of the jury gasped. We’re not saying we won the caseright there and then, but it was a nice start.)
The doctor's choice of treatment modality is another important concept in ourcases. There is no overall perfect drug or medical device. Whatworks well for one patient might be ineffective or even catastrophic foranother. Doctors need to choose the right treatment for the right patient,and it is crucial that doctors have a range of options. Plaintiff lawyersshould not be choosing what devices doctors can and cannot choose. Neither should juries. Jurors themselves must know that is true. Ifwe can get the jury to understand the concepts of context and the doctor's need to choose, wefeel we have a decent prospect of success.
It turns out that context and doctor choice can also playroles in obtaining summary judgment. In Kordek v. Becton, Dickinson &Co., 2013 WL 420332 (E.D. Pa. Feb. 4, 2013), Judge McLaughlin authored aninsightful opinion showing how context and doctor choice are relevant to aclaim of design defect. In Kordek, the plaintiff claimed that a scalpel shieldwas defectively designed. The plaintiff was a surgical technicianresponsible for preparing operating rooms. Part of that preparationinvolved placement of surgical instruments. One of the surgicalinstruments she handled was a disposable scalpel with a fully removable shieldcovering the blade. The plaintiff had a difficult time removing the scalpel’s shield. She wrapped her fingers around the shield and pulled. Inthe course of removing the shield, the plaintiff lacerated her hand and arm.
The defendant manufactured a range of scalpelproducts, including:
- a conventional disposable scalpel, and
- a protected disposable scalpel.
The market’s reaction to the protected (retractable) shield scalpel was mixed. Some customers continued to demand the conventional scalpeldue to the different “feel” of the retractable shield products. One studyreported that 84% of doctors surveyed stated that they did not like the feel ofretractable scalpels and that more than 68% were concerned with theirline of sight. Statements from OSHA also make reference to concernsregarding the “feel” of the instruments. By contrast, the nurse managerof the plaintiff’s unit testified that the staff “really liked” the retractableshield 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 retractableshield. As a preliminary matter, Judge McLaughlin visited the vexingissue of whether the Second or Third Restatement of Torts should govern thecase. As we have mentioned before (here, for example), the Pennsylvania courts have resistedany impulse toward lucidity on this point. In Kordek, Judge McLaughlinlaid out the legal landscape as clearly as possible. In June 2011, theThird Circuit directed federal district courts to apply the Restatement (Third)to design defect claims arising under Pennsylvania law. Covell v. BellSports, Inc. 651 F.3d 357, 360 (3rd Cir. 2011). District courts are boundby that Third Circuit holding unless and until the state supreme court issues acontrary decision or it appears from a subsequent decision of the appellatecourts that the court of appeals erred. Since Covell, the PennsylvaniaSupreme Court has neither affirmed nor rejected the Third Circuit’s applicationof the Restatement (Third). It was given an opportunity to make such adecision 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, althoughit did acknowledge the “continuing state of disrepair” in this area. Sothe Pennsylvania Supreme Court spotted the mess, but kept eyes aimed ahead andkept walking. The bottom line is that Judge McLaughlin was bound byCovell to follow the Third Restatement, although she believed the final resultwould be the same under either the Second or Third.
Section 2(b) of the Restatement (Third) of Torts explicitlyrequires an inquiry into the existence of a reasonable alternativedesign. Not surprisingly, the plaintiff argued that the retractableshield scalpel was a reasonable alternative design. That seems like aperfectly obvious argument to make. It even seems like low-hangingfruit. Nevertheless, the court concluded that the retractable shieldproducts were not reasonable alternatives because “they create additionalhazards which do not occur with the use of the conventional scalpel.” 2013 WL 420332 at *7. Comment f to section 2(b) states that “whenevaluating the reasonableness of a design alternative, the overall safety ofthe product must be considered. It is not sufficient that the alternativedesign would have reduced or prevented the harm suffered by the plaintiff if itwould also have introduced into the product other dangers of equal or greatermagnitude.” In other words, the court must consider the broader contextof the device and “must not limit its analysis to the particular injurysustained by the plaintiff.” 2013 WL 420332 at *7.
The advantage of the retractable shield isunanswerable. That shield makes an accidental cut much less likely. But the court cannot stop its analysis there. There was alsoevidence that the retractable shield offered safety costs as well as safetybenefits. First, the defendant’s expert testified that the retractableshield scalpel products are bulkier. Second, government regulatory bodiesdo not ban conventional scalpel products and instead allow their use where theyare medically necessary. Third, there is no statistical evidenceindicating that the conventional scalpel has a dangerously high rate of injury. Id. at *8.
The contextual analysis employed by the Kordek court foundan 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 HIVwhen stuck with an intravenous catheter needle brought a products liabilityaction against the defendant-manufacturer. The nurse argued that areasonable alternative was available in the form of a catheter with aretractable needle that was at that time manufactured and marketed by thedefendant. Id. at 886. The Riley court disagreed, pointing toevidence from the hospital at issue and in healthcare publications suggesting that the retractable needles had safety and pragmatic problems. The Rileycourt concluded that the substitute may not be “safer overall when otheraspects of the alternative design are considered.” So the Riley case washelpful and on-point. It was also a case that Bexis worked on during hissalad days.
Viewing all the pluses and minuses of the conventionalscalpel and the newer version with the retractable shield, it appearsindisputable 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 toargue? Put it this way: if your surgeon tells you that he or she simplyfeels more comfortable using an older version of a scalpel, wouldn’t you wantthat surgeon to use the scalpel they prefer?
Remember that the Kordek case involves a motion for summaryjudgment. Even in the face of Riley and the contextual analysis, theplaintiff argued that she had established genuine issues of material factsufficient to defeat a motion for summary judgment. There is no doubtthat the plaintiff’s laceration would likely not have happened with theretractable shield scalpel. Moreover, the “staff really liked” theretractable shield scalpel. But it was not clear whether that "staff" referred to those who prepared the rooms for operations or those who actuallyperformed these operations. It makes a difference. The plaintifftried to minimize the ‘feel’ point by citing the defendant’s advertisements, which claimed that the scalpels were “virtually” the samein size and shape. But such claims are of “limited relevancy to theactual experience of medical professionals.” Id. at *9.
The best piece of evidence that the plaintiff had was thestatement by her expert witness, Dr. Benda, that the retractable scalpel was asafer alternative because it would have protected the plaintiff from theinjuries she suffered. But again, that expert opinion was devoid of theappropriate context. Dr. Benda’s conclusion did “not consider theopinions of medical professionals. He did not consider whether theretractable shield scalpel posed any risks that are not posed by theconventional scalpel. He did not consider the cost of retractable shieldscalpels as compared to the conventional ones.” Id. It isinteresting and useful that the court included cost as a valid factor in assessingreasonable 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 haveconcluded that the retractable shield scalpel is a “reasonable alternative” ashe defined it, “the scope of his analysis is far narrower than that which mustbe conducted by the Court.” Thus, the court ultimately held that “noreasonable jury could find that the retractable shield scalpel is a reasonablealternative design.” Id. at *10.
The Kordek opinion offers healthy doses of clarity andreality. It is as if a judge actually wanted to engage with how medicineis actually practiced and how doctors actually make choices. Thereasoning in Kordek is sharp and the result is right.
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