The last baseball player to reach a .400 batting average for a season was Ted Williams in 1941.  In a sport that probably keeps more stats than any other, baseball sees records broken and milestones reached all the time.  Some marks, however, appear to be set in stone.  One of these is Ted Williams’s 1941 season.  Some consider it the best offensive season in baseball ever.  That the record has stood for 78 years seems to support that.  Some of the best to play the game in those 78 years have come close – Tony Gwynn’s .394 (1994), George Brett’s .390 (1990), Rod Carew’s .388 (1977), Stan Musial’s .376 (1948) – but they’ve come up shy.  It’s a monumental feat.  But what does .400 mean anywhere else outside of baseball.  It means 40%.  And 40% can mean different things in different scenarios.  In baseball, it means you’re going to the Hall of Fame.  A 40% return on investment probably means you’re going to be investigated by the SEC.  A 40% on an algebra test probably means you didn’t study.  And, if you win 40% of the motions you bring.  It’s not Cooperstown, but it’s not failing either.

That’s what Bayer won in Goodell v. Bayer Healthcare Pharmaceuticals Inc., 2019 WL 4771136 (D. Mass. Sep. 30, 2019).  It went 2 for 5 on its motion to dismiss.  Plaintiff underwent an MRI in 2010 during which he was administered a gadolinium-based contrast agent.  Risks of retained gadolinium in people with impaired kidneys was known around that time.  Several years later, scientific evidence led to the FDA to change the drug’s labeling to include warnings about gadolinium retention in patients with normal kidney function.  Id.  Plaintiff alleges he continues to have detectable levels of gadolinium in his body.

First up – motion to dismiss for lack of personal jurisdiction.  Plaintiff is a resident of Massachusetts, defendant is not.  In his complaint, plaintiff alleged only that defendant is authorized to do business in Massachusetts, derives income from sales of its products in Massachusetts, and in fact sells, markets and distributes the product in Massachusetts.  Id. at *3.  Plaintiff contends that is sufficient to establish specific jurisdiction – that his claim arises out of defendant’s in-state activities.  But he’s missing any allegations about the actual transaction at issue.  Plaintiff failed to allege where he was prescribed the drug, where the drug was administered, or where he suffered his alleged injuries.  Without those facts, the court concluded plaintiff had not met his burden and granted defendant’s motion.  Plaintiff is going to be given the chance to re-plead his jurisdictional allegations.  Not a homerun, but a decent infield single.

Next – preemption.  Defendant argued that plaintiff’s failure to warn claim was preempted because it could not have amended its label without FDA approval.  Plaintiff relied on the CBE regulation which allows a manufacturer to amend its label to add “newly acquired information” without prior FDA approval.  But, it’s not enough to point to the CBE regulation, plaintiff has to “provide plausible allegations of newly acquired information that manifested after the FDA’s approval of the [drug’s] label but before Plaintiff’s injury.”  Id. at *4.   Missing from plaintiff’s complaint was any allegation that there was any new information to support a CBE label change prior to plaintiff being administered gadolinium.  Id.  The court would not “merely accept Plaintiff’s conclusory allegations that such information existed.”  Id.  Therefore, the claim is preempted.  Again, plaintiff gets a chance to re-plead but we think this is at least a double that could get stretched to a triple.

Now we have to move on to the misses.  Defendant argued that plaintiff’s claims should be dismissed because he had not alleged a cognizable injury.  Retention of gadolinium is not enough in the absence of any current physical symptoms.  The court disagreed finding retained gadolinium “is a health risk and that the nature of the risk it creates is still being ascertained.”  Id. at *5.  Ultimately, the court concludes the nature of the injury is a fact question that can’t be resolved at the motion to dismiss stage.  While this motion wasn’t granted, we refer you back to an excellent Daubert win in another gadolinium case that points to this win being temporary as it’s hard to prove an injury that “is still being ascertained.”

Next was plaintiff’s claim under Massachusetts’ Consumer Protection Law (Ch. 93A).  Ch. 93A has an exemption for “transactions or actions otherwise permitted under law as administered by any regulatory board . . . acting under statutory authority of . . . the United States.”  As this provision has been interpreted, “a defendant must show that such [regulatory body] affirmatively permits the practice which is alleged to be unfair or deceptive.”  Id. Since plaintiff is alleging defendant’s warning was improper and the FDA approved that warning, the exemption seems to apply.  But the court was unwilling to find that the FDA permitted the warning given the availability of the CBE process.  This, however, seems contrary to the court’s prior conclusion that plaintiff had failed to plead facts sufficient to show defendant could have used the CBE process.  At a minimum, we think it would have been more logical to dismiss this claim on the same grounds.  Instead, the court found it was an issue for trial.  Perhaps there will another chance to take a swing at this one after the court’s sees plaintiff’s amended CBE allegations.

Finally, plaintiff’s complaint also included an allegation that he was entitled to permanently enjoin defendant from continuing its unlawful business practices. Id. at *6.  Defendant moved to dismiss the injunctive relief claim on standing grounds.  Because plaintiff hadn’t sought preliminary relief, the court considered the issue premature and denied the request to dismiss.

There was a statute of limitations motion that was also denied and that we are opting not to count in our analysis as we usually only address limitations issues when they are significant or compelling (and it would have reduced our batting average analogy to .333 which while still pretty darn good – only 25 players have ever had a higher career batting average – we liked the Ted Williams record better).