Friday, May 17, 2013

A Not So Bad Blast from The Past


            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.

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