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.