Photo of Michelle Yeary

Make no mistake about it – the result of Dunn v. Genzyme Corp., 2021 Mass LEXIS 84 (Mass. SJC Jan. 29, 2021) – is what we want.  Dismissal of all of plaintiff’s claims for failure to plead them with the necessary factual support.  But sometimes results need context and sometimes that context is not all positive.  Enter the asterisk and its varied uses.  An asterisk is most commonly used to draw attention to a notation, like a footnote.  It is often also used to censor offensive words.  In the legal arena we use it to cite to caselaw.    And thanks to baseball, it has also come to be associated with marking a tainted result.

It was 1961 and Roger Maris was about to break Babe Ruth’s 34-year-old single season homerun record.  The Sultan of Swat had hit 60 homeruns in 154 games; the 1961 season was scheduled for 162.  Ford Frick, the Baseball Commissioner and a friend of Ruth’s, decided that if Maris took longer than 154 games to break the record, it would be denoted with some “distinctive mark.”  If you aren’t familiar with the story, Billy Crystal directed an HBO movie, 61*, that does a nice job and you don’t have to be a baseball fanatic to enjoy.  As it turns out, MLB really had no direct control over the “record books,” and within a few years the controversy died down and Maris was listed as the single-season record holder.  That is until the late 1990s – Sosa, McGwire, Bonds – and illegal steroids.  Fans and sportswriters, considering themselves purists, called for asterisks again.   The asterisk was resurrected as recently as 2017 when the Houston Astros won the World Series but were investigated for their involvement in a sign-stealing scheme, leading to the nickname the Houston Asterisk.

So that is why we called today’s case Dunn*.  A tainted defense win, but a win nonetheless.

Plaintiff underwent injections for her osteoarthritis and suffered side effects that she alleges caused her to suffer multiple injuries.  Id. at *5-6.  Plaintiff brought five claims against the device manufacturer – failure to warn, breach of warranty, negligence, products liability, and consumer protection.  Id. at *6-7.  The injected material is considered a medical device, and in this case, a PMA medical device.  So, it should come as no surprise that defendant filed a motion to dismiss on the grounds of preemption, as well as failure to adequately plead.  The trial court denied the motion, emphasizing the limited information available to plaintiff at this stage.  Id. at *8.  From what we can gather from the decision, this means the trial court essentially let plaintiff get away with pleading nothing.  Defendant’s request for an interlocutory appeal was granted, but before the intermediate appellate court could hear the case, the Massachusetts Supreme Judicial Court decided to take the issue for itself.

The court correctly determined that the preemption analysis was governed by Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), and therefore only a parallel claim would survive preemption.  Here is the part of the opinion we consider tainted.  Before considering the sufficiency of the allegations, the court ruled that claims such as failure to warn, negligent manufacture, and breach of warranty “all can be interpreted as coextensive with the comprehensive Federal requirements imposed on [defendant] under the MDA.”  Id. at *12.  The court determined that the state law duties “parallel rather than add to” federal duties. Id.  How the court determined that without reference to any specific federal duty is what confuses us.   What about the alleged violation of the state law duty?  Does that not matter either?  Unfortunately, the court seems to think not:

We will not require plaintiffs who are asserting parallel State law claims to plead specific facts, such as the precise Federal regulations purportedly violated or the precise relationship between State and Federal requirements, to meet our ordinary, notice-pleading standard. “Although the complaint would be stronger with such detail, we do not believe the absence of those details shows a failure to comply” with the requirements.

Id. at *12.  Insert giant asterisk.

But, if a plaintiff alleges that a medical device’s warning should have contained something more than what it did but the warning contains exactly what it is supposed to contain per its PMA – how does enforcing state law parallel federal law?  It doesn’t.  True, the Supreme Court has said that states have “the right to provide a traditional damages remedy for violations of common-law duties when those duties parallel [F]ederal requirements.”  Id. (quoting Lohr).  But determining whether a claim is parallel requires more.

Moving on, the court next turned to the sufficiency of the pleadings.  To the extent the court interpreted the defendant as seeking to impose a heightened pleading standard to survive preemption, the court rejected that argument.  But no court has ever so held.  Unfortunately, the court determined that requiring plaintiff to identify the federal regulations allegedly violated and how they were violated would be a heightened requirement that it was unwilling to impose.  Id. at *15.  Without this level of specificity, we return to the question of how do you determine parallelism, which is required for plaintiff to have a right to relief in a PMA medical device case?

The complaint, however, does need to meet Massachusetts’ plausibility standard.  Sufficient facts must be alleged “to raise the right to relief above the speculative level.”  Id. at *14 (citing state law precedent adopting TwIqbal).  The Dunn complaint was entirely boilerplate, containing no “factual allegations” to support its conclusions.  Id. at *16-17.  Unlike the trial court, the most the Supreme Judicial Court could find was temporally proximity between the injections and the injuries, which it was unwilling to substitute for “sufficient factual assertions that plausibly establish causality.”  Id. at *17.  Meaning that the order denying the motion to dismiss was reversed.  So you could say that all’s well that ends well, but . . .*