Photo of Michelle Yeary

Last month we told you about two great preemption victories for St. Jude Medical in implantable cardioverter defibrillator (“ICD”) lead litigation (see post).  In one of those cases, plaintiffs decided they wanted to sing a different song – “Don’t Let Me Be Misunderstood.”  But, once again the court said “Na Na Hey Hey . . . Goodbye.”

In Pinsonneault v. St. Jude Medical, Inc., 2014 U.S. Dist. LEXIS 104994 (D. Minn. Jul. 30, 2014), plaintiffs sought leave to file a motion for reconsideration of the summary judgment ruling that tossed out almost all of their claims.   Their sole basis for reconsideration was that the court misunderstood one of their claims.  There are lots of misunderstandings in life.  What time were we supposed to meet?  I thought you were picking up something for dinner?  And, of course, keeping with our musical theme – there are a whole host of misunderstood or misheard lyrics.  For instance, Elton John’s “Tiny Dancer” isn’t a love song to Tony Danza and Credence Clearwater Revival isn’t offering directions to the restroom in “Bad Moon Rising.”  In Pinsonneault, the court makes it abundantly clear that it heard what plaintiffs were saying and that it wasn’t very happy with plaintiffs’ attempt at revisionist history.

The sole issue previously decided by the court was whether any of plaintiffs’ claims withstood preemption.  And, within that context the only real issue was whether plaintiff had alleged any claims for violations of any manufacturing specifications in the device’s PMA (potentially parallel claims that would not preempted).  Id. at *4.  One of the dismissed claims was, as pleaded, that the defendant violated a federal requirement that the ICD lead’s insulation be manufactured with a consistent diameter.  Id. at *2-3.  But the allegation is ambiguous as to whether plaintiffs are referring to the diameter of the entire lead body or just to the thickness of the surrounding insulation.  There is a PMA specification as to the former, but not the latter.   Id. at *4.  So, it was fairly important for plaintiffs to make their allegation clear.

And, it sounds like they did – they were clear that their claim was about the insulation not the lead body.  Plaintiffs were given several opportunities to clarify their position and at each turn failed to include the diameter of the lead body among their allegations.  First, during discovery, one of defendant’s witnesses explained to plaintiffs’ counsel that “insulation thickness” and “body diameter” were different things.  But even though it was “very much in plaintiffs’ interest to make sure that everyone understood” their claim, plaintiffs’ counsel did nothing to clarify their position but rather focused the rest of the deposition on insulation thickness.  Id. at *5.

Then, at the oral argument on the motion for summary judgment, because their claim remained ambiguous, the court specifically asked plaintiffs’ counsel to clarify.  Which they did:  “Plaintiffs were not alleging that their leads failed to comply with the lead-body diameter specification, but instead were alleging that there was insufficient insulation between the lumens and the outer wall of the lead body.”  Id. at *6.  Plaintiffs’ counsel even acknowledged that the PMA specification about lead body diameter wasn’t directly on point to the claim they were making.  Id.

After all that, plaintiffs claimed they were simply misunderstood and that they were actually also alleging that the leads violated the lead-body diameter PMA specification.  But no way was the court allowing plaintiffs to backtrack to their original ambiguous complaint allegations:

Plaintiffs had multiple opportunities and every incentive to clarify that they were attacking both the thickness of the insulation and the diameter of the lead body. Having failed to do so, they cannot now credibly assert that they were somehow misunderstood.

Id. at *7.  One of our only complaints about the original Pinsonneault summary judgment ruling was that it wasn’t a motion to dismiss ruling; that the defendant had to bear the expense of discovery to achieve the result.  So, now we’ll take the upside of that situation – there was a substantial body of work to demonstrate that plaintiffs hadn’t pursued the lead body diameter claim.  Enough so that the court had no choice to but consider plaintiffs’ motion for reconsideration really a motion to assert a new claim.  Way too late for that now.

So, Pinsonneault stands.  Now, can someone explain why Bob Dylan was singing about ants blowing in the wind?