As we age, we sometimes forget how things used to be.  It is not just age-related deterioration of the synapses in our hippocampi.  (We do question why hippocampi and hippopotamuses are the preferred plural forms these days and why more anatomic structures are not named for things like seahorses.)  There is also a recency effect.  In our area of the law, we do not often pine for the “good old days,” at least on this side of the v.  While not as pronounced as in civil rights, where there clearly was a time when the law of the land was a travesty, the old days of defending drug and device product liability was not better, at least in terms of the law on the books and how it was applied.  For instance, we recall defending cases in Texas court over alleged cardiac injuries when (1) the chances of successful removal were slim, (2) motions to dismiss on adequacy of pleadings were useless, and (3) the substantive Texas law was pretty plaintiff-friendly, especially as applied by elected state judges and many appointed federal judges (who often used to be elected state judges).  Harris v. Medtronic, Inc., No. 3:20-CV-1407-S, 2021 U.S. Dist. LEXIS 178827 (N.D. Tex. Sept. 20, 2021), shows how things have changed for the better.

Harris is a case where the plaintiff had an aortic valve replacement surgery and, subsequently, was placed on defendant’s temporary external pacemaker, specifically something called an external pulse generator (“EPG”).  We can surmise that the EPG was necessary because the plaintiff’s heart rhythm was not otherwise stable, creating a risk of various problems like atrial fibrillation, stroke, sudden cardiac death, and cardiac arrest.  Unfortunately, despite the EPG, he suffered the last of these, from which he survived but claimed continuing injuries.  About two years after his cardiac arrest, he sent a notice of claim to the out-of-state manufacturer and he and his wife sued it and some non-diverse defendants (healthcare providers, we assume) in Texas state court.  After the non-diverse defendants were dismissed a bit less than a year later, the manufacturer successfully removed the fully diverse case to the Northern District of Texas.  The removal may seem pretty rote now, but it was not so in the 1990s and early 2000s.  Those non-diverse defendants tended to get dismissed more than a year after the case had been filed and many federal courts in Texas were disinclined to find fraudulent joinder of even the most obviously bogus defendants.  But, in 2020, this case stuck in federal court.  Then the plaintiffs amended their complaint twice and the remaining defendant teed up a TwIqbal motion.

Twombly was decided in 2007 and Iqbal in 2009.  Together, they changed things a bit.  On the plus side, boilerplate allegations should not be enough to get past a 12(b)(6) motion in federal court.  We have not seen data on this, but we strongly suspect the success rate of such motions after Iqbal is probably twice what it was before Twombly.  On the downside, many plaintiffs file crazy long and confusing complaints to try to overwhelm courts and suggest that they have specific factual allegations to back up their claims.  In addition, courts tend to give plaintiffs multiple chances before dismissing cases (or even some of the claims) with prejudice.  The rule of thumb seems to be three strikes and you’re out.

The other change relates to Texas law.  Although the Texas Product Liability Act dates to 1993, there were major changes in 2003, including damages caps.  Again, this is our speculation based on anecdote and observation, but there appears to be far less drug and device product liability litigation in Texas these days and it seems that the application of legal requirements for such claims is tighter.  One might think that an overloaded court system, as Texas state courts were often labeled pre-2003, would lead to higher bars for getting to trial, but the opposite seems to be the case.  Accuse us of being defense hacks if you wish, but we tend to like strict application of the rules and requirements (e.g., evidence supporting each element of a cause of action to get past summary judgment).  Harris gave us that, starting with a recitation of the TwIqbal requirements and a dive into the three versions of strict liability available under Texas statute.

First up was manufacturing defect.  Texas law requires deviations from specifications that render the product unreasonably dangerous.  Id. at **6-7.  Rather than identify a specific defect present in plaintiff’s device, the operative complaint offered a few possibilities of general things that “may have” happened in manufacturing the device, without ever specifying the actual specifications.  Id. at *7.  This was insufficient in terms of defect, deviation, and causation.  In essence, this was an attempt to pervert the res ipsa loquitur doctrine to establish a manufacturing defect from an alleged malfunction.  That does not fly under Texas law these days.

Next up was “marketing defect,” which is really just a warnings claim.  Plaintiffs were required to plead specific inadequacies in the warnings to doctors and that such inadequacies caused the alleged injuries.  Instead, plaintiffs offered a laundry list of possible failure mechanisms (combining their manufacturing defect and design defect lists) and claimed the “user” was insufficient warned of them.  Id. at **9-10.  These “conclusory” allegations were insufficient, as plaintiffs never identified what warnings were included and how they were presented to allow an assessment of their inadequacy.  Similarly, the causation allegation was just that the doctor would have picked another product without any factual allegations to back it up.  Id. at *11.  The court went a step further and concluded that the warnings actually provided with the device were adequate as to the risk of the harm allegedly suffered by plaintiff.  Id. at **11-12.  It is unusual for a court to reach such a conclusion in the 12(b)(6) context, but the court here explained that it could do so based on the record before it (without converting to Rule 56 motion).  Id. at *11 n.1.

For design defect, Texas requires the plaintiff to prove defect, unreasonable dangerousness, causation, and the existence of a safer alternative design.  Have only a laundry list of possible failure mechanisms, plaintiffs did not get off the ground.  “Plaintiffs have pleaded the EPG malfunctions without pleading a design defect.”  Id. at *13.  Alleging that the device could have been designed without these alleged design defects was not enough either.  (The court did not need to go further, but we found the allegation of “degradation” to be particularly dubious in this case where the injury occurred a day after use began.  We guess it is just standard now to throw in some “degradation” theory with every medical device these days.)

The TPLA does not abrogate common law negligence, but logic still applies.  If plaintiffs could not articulate supported claims for any defect in manufacture, design, or warnings, then re-casting the same stuff as “negligent” was not going to work either.  Id. at **15-16.

Last was the claim for breach of implied warranty of merchantability.  That had two problems.  The first was that plaintiffs based their claim on the same allegations of manufacturing, design, and marketing (warnings) defect.  Id. at *17.  That failing was just as fatal to implied warranty as it was to the negligence claim.  The second and independent problem was that Texas requires timely notice of such a claim and plaintiffs waited almost two years.  They tried to claim “they were not aware of the malfunction” until an unspecified time after their injury, but that directly conflicted with plaintiffs’ attempt to apply res ipsa.  For that, they argued, essentially, “that the defects in the EPG were so clear that nothing could explain what happened to Mr. Harrison except that the EPG was defective.”  Id. at *19 (emphasis in original).  They could not have it both ways and the court found that notice was not timely.

That brings us to the part of the decision we do not like.  Without any analysis, the court granted plaintiffs leave to file an amended complaint within three weeks.  No limit was imposed on its content.  There are two problems with that from our perspective.  First, the court dismissed the plaintiffs’ third complaint.  They had enough swings to assert something more than conclusory allegations that a cardiac arrest during use of a product designed to help prevent cardiac arrest must equate to liability.  Second, the court made two affirmative findings that further amendment cannot undo.  The warnings with device were adequate, which should end the strict liability marketing defect claim and parts of the negligence and implied warranty claims.  Not that any of the implied warranty claim should still be viable given the finding on untimely notice.  So, if plaintiffs were going to get another shot at a complaint, then the available claims should have been limited.  Maybe the plaintiffs will not try again, saving the defendant from having to prepare another motion to dismiss and the court from having to write up another order granting it.