We saw the news yesterday about DePuy discontinuing two of
their lines of hip implants, which have been involved in some litigation. While we are not ignorant of the impact of
litigation on business or the impact of discontinuation/withdrawal/recall on
litigation, we do hate to see situations where the availability of useful
medical products can be affected by the number of lawsuits drummed up through
waves of lawyer advertising. We do not
know the merits of the cases involving these products, except to the extent we
have seen some decisions on pleading and preemption, but we do know we see ads
to bring suit about these products everywhere we turn, even as annoying pop-ups
on “free” apps. We ran across a case
approaching consideration of the merits on a case involving another one of
DePuy’s hip implant products. In Rydzewski v. DePuy Orthopedics, Inc.,
No. 11-80007-Civ-Williams, 2012 U.S. Dist. LEXIS 187963 (M.D. Fla. Aug. 14,
2012), most but not all of plaintiff’s claims were kicked on summary
judgment. (You ask why we post now on a
decision from 9 months ago. Well, first,
we do what we want, and, second, it was just “published” by Lexis last week.)
When we
started reading the Rydzewski
decision, we thought we were not going to like it. As we have said before, the language the
court uses to describe the plaintiff and his/her injury often foretells the
result. Here, the plaintiff was
described as “6’1” in height and 230 pounds in weight, and [] a physically
active police officer,” and his alleged injury was described as “when the
femoral stem of the device fractured, disabling him and causing severe pain . .
. [and s]ince that time [plaintiff] has
experienced constant pain and significant physical limitations.” We say “alleged injury,” but the court did not
use that qualifier. Nor did it need to
describe extent of plaintiff’s damages to rule on a fairly straightforward
motion for summary judgment based on whether plaintiff had established a prima
facie case for any of his asserted causes of action.
When the
court denied the motion as to design defect without any explanation of the
proffered evidence, we thought we had read the omens correctly. (We are not sure if this process is more like reading entrails,
tea leaves, bird flight patterns, thrown bones, or some other esteemed method
of prognostication.) The plaintiff
alleged that the design defect related to the product’s “unacceptably low
safety strength factor” and had two experts to say that “a design defect caused
the device to undergo premature fatigue failure,” “that there was no practical
justification for the defective design” and “that alternative safer designs
were available.” Id. at **4 & 9. The court did not mention the experts’
qualifications, basis, reasoning, or even whether the defect they opined on was
that “unacceptably low safety strength factor” thing. As we see later in the decision, the issue
really seems to be whether the product was strong enough for someone with
plaintiff’s size and activity level. We
cannot tell from the decision whether the plaintiff’s experts actually
supported a defect along those lines, but the court said they did − not only enough to create a genuine issue of
material fact as to a design defect under the risk utility test, but also to overcome
any presumption against defect from the Florida statutory Government Rules
Defense. Id. The court did not decide
whether that defense applied to the case.
Nor did it decide whether “the consumer expectation test is still an
independent basis for finding a design defect under Florida law” given that the
test was dropped in the Third Restatement—it merely “assume[d]’ that it
was. It did, however, conclude that the
consumer expectation test did not apply for a complex implantable medical
device, which may be helpful in other cases.
Id. at **8-9.
After this
shaky start, the court proceeded to knock out a manufacturing defect
claim. That was largely because the
plaintiff did not try to justify the claim in his summary judgment response. Then the court turned to claims for implied
warranty. Florida requires privity,
which you typically do not have for medical devices. Plaintiff tried to say that the privity requirement
was satisfied because he was a third-party beneficiary of some sales contract, but
the court pointed to Florida law requiring that “the parties to the contract
clearly express . . . an intent to primarily and directly benefit the third
party or a class of persons to which that party claims to belong.” Id.
at * 12. Plaintiff—and, we suspect, the
vast majority of device plaintiffs--could not satisfy that standard, so the
implied warranty claims were gone. The
tea leaves for the remaining negligence claim were not looking so grim (or Grim).
The main
hurdle in evaluating the negligence claim seemed to be determining what
negligence was being asserted, challenged by defendant, and argued by
plaintiff. The count seems to have been
drafted like the typical kitchen sink negligence claim, with parts sounding in
negligent design, negligent failure to test, negligent failure to warn, and
negligent manufacturing. Defendant said
they were only moving on the warnings part and then plaintiff took the position
that he had not asserted and did not really resist summary judgment on
warnings. The court proceeded to grant
summary judgment on negligent failure to warn without addressing other
negligence theories. We do not quite get
it, particularly how negligent manufacturing could survive where plaintiff did
not even try on manufacturing defect, but that is what happened. The warnings analysis was pretty solid. Contrary to what we saw with the discussion
of the expert evidence on design defect, the court did what it was supposed to
and looked closely at the proffered evidence.
The same expert who helped carry design defect could not raise a genuine
issue on the adequacy of warnings because his affidavit amounted to
“unsupported factual assertions” due to lack of citations and detail. Id.
at *18. The court even went to the
expert’s report, maybe sua sponte, to
spot inconsistencies with his affidavit.
In a clear statement of how warnings claims should be analyzed, the
court found:
The warnings quoted above accurately,
clearly, and unambiguously provide that excess body weight and activity level
can adversely affect the device, and that the largest device possible should
therefore be used. The Plaintiffs offer
no explanation as to how the warnings in this case were inaccurate, unclear, or
ambiguous, and in this respect they correctly acknowledge that the adequacy of
warnings can be a question of law. Thus
the Court finds that the Plaintiff have not produced sufficient evidence to
create a genuine issue of material fact regarding the adequacy of the warnings
provided to [the surgeon.]
Id.
at **19-20 (citation omitted).
Not
surprisingly, the plaintiff also failed on proximate cause. The experienced surgeon knew all the
pertinent risks and never read the package insert, so there were two problems
for plaintiff. He did “not explain what
additional warnings not within [the surgeon’s] independent knowledge should
have been provided” and “it is unclear how the inclusion of additional warnings
in the insert would have prevented the incident.” Id.
at *21. We certainly appreciate it when
courts take proximate cause seriously and do not let plaintiffs get by on
speculation and assumption. So, the
negligent warnings claim was gone too.
With
a nod towards old SNL, now is the time on “Sprockets” when we
second-guess. We have not checked the
briefs or docket here, so our three hindsight observations should be taken as
such. We are not sure why the attack on
the negligence claim was not broader.
Plaintiff clearly did not have negligent manufacturing evidence, and the
failure-to-test theories (even if cognizable) were going to run into the same
proximate cause problems as the warnings claim, which was largely based on
failure to test evidence anyway. Also,
we are not sure why some of this was not sorted out on a motion to dismiss. Clearing out counts or portions of counts
that were impermissibly vague or not allowed under Florida law might have
narrowed the target for summary judgment.
And, lastly, this may be the only summary judgment decision we have read
on an implantable surgical device that does not mention preemption. We are not saying how that would have gone
here—Class II, we think, in the Eleventh Circuit—but design defect under a risk
utility test can smack up against preemption.
Anyway, not so bad as is. And,
no, you cannot touch our monkey.