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A couple of weeks ago, we featured Medtronic’s Connecticut Supreme Court win in Hurley v. The Heart Physicians, P.C., ___ A.3d ___, 2010 WL 3488962 (Conn. Sept. 14, 2010).
Yesterday, we blogged about Medtronic’s defeat of a qui tam action based upon allegations of promotion of off-label use, and the significant ruling that off-label promotion alone cannot support a False Claims Act action.
Well, Medtronic’s on a roll.  Yesterday we received from John Lavelle at Morgan Lewis an opinion that completed Medtronic’s trifecta.  This case is William Beaumont Hospital v. Medtronic, Inc., No. 09-11941, slip op. (E.D. Mich. Oct. 8, 2010).  Interestingly, none of these three Medtronic wins involved preemption, which has become the company’s signature issue.
The William Beaumont case was one of open-and-shut liability to the original plaintiff patient (something we don’t see very often) – for medical malpractice.  All Medtronic did was (through a sales representative) offer to supply free samples catheter “refill kits” to a one of the physicians at the plaintiff hospital.  Proving that no good deed goes unpunished, the company also included an “Access Port Kit” along with the refill kits.  There’s a difference between the two kits, and both were separately labeled and packaged in different colored containers.  After receiving the Medtronic package, here are the undisputed (on summary judgment, the judge resolved all disputes in favor of the plaintiff hospital) facts about what happened:

  • Somebody at the hospital failed to deliver the Medtronic package to the doctor to whom it was addressed.
  • Brain-dead hospital employee number one put all of the kits (both kinds) in the same storage cabinet.
  • Brain-dead hospital employee number two failed to read an explicit warning that the access kit was not intended for use in refill procedures and selected the access kit for use in a refill procedure, despite the package being the wrong color.
  • Brain-dead hospital employee number three, after receiving the access kit from brain-dead hospital employee number two, also failed to read the explicit warning and decided to use the access kit in a refill procedure.
  • Brain-dead hospital employee number three persisted in using the access kit in a refill procedure even though it was not working properly for this unintended (and warned against) use – with fatal results for the patient.

Slip op. at 2-4.  Not surprisingly, the patient sued the hospital, and did not (as far as we can tell) sue Medtronic.  Not surprisingly, the hospital chose to settle rather than litigate the case – we assume for a substantial sum (at least large enough to justify what happened after that).
After what had happened, the hospital (probably its carrier), had the chutzpah to demand that Medtronic contribute to the settlement.  In a gutsy move, Medtronic told the hospital to pound sand (politely, of course).
So the hospital sued Medtronic, claiming that none of this would have happened if the company hadn’t included the access kit in a package that (so the hospital claimed – the facts were disputed on this point so the court took the hospital’s position as true) was supposed to contain only refill kits.
The court granted summary judgment, holding that, even if Medtronic had been (a little) negligent in including the free access kit along with the others (the good deed that got punished), the catastrophic result was not foreseeable.  Instead, the court found superseding cause as a matter of law – which is not an easy defense to win.  The court stated:

Even if [Medtronic’s] acts breached a duty of care to the decedent in some general sense, the sort of severe injury that occurred cannot be rationally said to be a “natural and probable” result of that nebulous breach.  It would have been possible to speculate, ex ante, that such a result could occur, but “possible” ought not be read where “probable” properly belongs.  Probable results would include the incurrence of additional shipping costs to replace the [access kit] with a Refill Kit or harm caused by delay upon the discovery that the item was not that which [the hospital] expected to receive.  At most, [Medtronic’s] action in sending the unexpected kit “furnished the condition” necessary for the subsequent negligence.  A new, independent, and unlikely act of negligence on the part of [brain-dead hospital employees] was needed for any injury to result. [Medtronic’s] ostensible negligence had come to rest without injury; it did not sit dormant, like a ticking bomb, waiting only for a victim.  It had been extinguished by the superceding gross negligence of failing to read even the label of the product about to be used in the presumably routine medical procedure.
Viewed in the light most favorable to Plaintiffs, the facts nonetheless evince reckless disregard for the potential for injury from using the wrong medical kit, as well as a willful blindness to the patently obvious. . . .

Slip op. at 10-11 (much additional bashing of the hospital’s actions omitted).  There are some situations, that court held, that failure of health care professionals to read and follow product labels can be so egregious as to constitute superseding cause.  Id. at 13.  Medtronic’s alleged knowledge of a “possibility of confusion” was not enough to make what happened “foreseeable”:

Mistakes are to be expected as a natural concomitant of life.  However, they are not the natural and probable result of all negligent acts.  In fact, it appears from the record that the intervening actors would have disregarded virtually any warning, contraindication, label, or direction that could have been given.  That the occasional misidentification had occurred in the past does not make total nonidentification a foreseeable result.  Such evidence merely moderates the extreme attenuation of the causal connection between Defendant’s misrepresentation and decedent’s injury.  The facts before this court show that there is no genuine issue of material fact with respect to causation. . . .  No reasonable jury could find the facts such that [Medtronic] would be required to foresee that its clearly-labeled medical products would be identified by literate medical professionals by merely looking at the picture on the front of the boxes and guessing as to the contents.

Slip op. at 14-15.
Moral of story (other than we wouldn’t want to be treated at that hospital)?  It’s simple – don’t bring indemnity/contribution actions when you’re the actively negligent party.