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Last week we posted about the Daubert decision in Lowery v. Sanofi-Aventis LLC, that tossed out both plaintiff’s medical causation expert and FDA expert.  As promised, that was just the first blow.  The knockout came in its companion decision granting summary judgement not just on medical causation but also on the grounds of preemption.

First a quick reminder that the product at issue is a Class III medical device that is a gel-like substance that is injected into the knee to reduce pain.  It is undisputed that plaintiff’s injection came from a product lot that was later found to be contaminated.  Lowery v. Sanofi-Aventis, 2021 WL 871344, *1 (N.D. Ala. Mar. 9, 2021).  So, “[o]n the surface, this claim may seem meritorious.  After all, the device was contaminated with bacteria.  But that is not the whole story.”  Id.  Indeed, it is just the beginning.  Because while “some cases seem viable upon their initial presentment, they can fall apart when the legal standards affecting expert testimony are applied and Congress’s policy choices come in to play.”  Id.  And that is the part of the story we are most interested in.

This story is told in two chapters.  First, plaintiff’s claims fail under Alabama law for lack of medical causation.  As pointed out in our prior post, plaintiff’s medical expert was not qualified to render his opinions and his opinions themselves were unreliable because they were not based on generally accepted scientific methodologies (they were largely based on temporal proximity and parroting the medical records).  So, on summary judgement plaintiff was left with no expert evidence that he actually suffered from the condition known as septic arthritis or that the contaminant causes septic arthritis generally or caused plaintiff’s septic arthritis specifically.  Id. at *8.  Instead, plaintiff tried to rely on defendant’s internal company documents and the testimony of plaintiff’s treating physician.  “Even if Defendant’s documents can be said to be a legally sufficient substitute for expert testimony to establish general causation,” at most those documents identified septic arthritis as a potential risk of the bacteria.  Id.  A mere possibility, “does not reliably establish general causation.”  Id.

As for plaintiff’s treating physician, he was asked at his deposition if a “reasonable physician [could] conclude tat this was . . .  septic arthritis from a contaminated lot of [the device].”  Id. at *9.  The assented to that statement.  That testimony does not come close to satisfying Daubert.

[The treater’s] statement that it was possible Plaintiff suffered from septic arthritis does not indicate that it is [the treater’s] medical opinion that Plaintiff had septic arthritis, much less what caused it. Nor does [the treater’s] statement that a “reasonable physician” could conclude Plaintiff suffered from septic arthritis indicate what [his] medical opinion about Plaintiff’s condition actually was. . . [N]othing supports the assertion that [the treater] concluded that Plaintiff suffered septic arthritis because of Defendant’s product—let alone that he conducted an analysis that would withstand Daubert scrutiny.

Id.  (citations omitted, emphasis in original)

This story could have ended there, but wanting to be efficient, the court wrote chapter two.

[E]ven if Plaintiff’s state-law claims were viable (and, to be clear, they are not), Plaintiff’s claims are preempted because they impose requirements in addition to, or different from, those required by the FDA under federal law.

Id. at *7.  The injection at issue here was subject to the device-specific requirements of its PMA and the generally applicable requirements of the FDA’s Good Manufacturing Practices (GMPs).  Id. at *14.  We would normally take issue with GMPs being found sufficient to form the basis of a parallel violation claim, but this is the Eleventh Circuit and therefore controlled by Godelia v. Doe 1, 881 F.3d 1309 (11th Cir. 2018), which just happens to be one of our top ten worst cases of 2018.  And it didn’t impact the court’s conclusion:

To assert a parallel claim, a plaintiff must “set forth” evidence of “specific violations” of “specific regulations.” Importantly, not only must a plaintiff show that a federal requirement has been violated but he must also “causally connect the simultaneous violations of federal and state law … to the alleged injury.”

Id. at *15 (citations omitted, emphasis in original).  Plaintiff failed to connect Defendant’s conduct to any “specific binding regulation.”  Id. at *16.  Plaintiff could not rely on the criticisms of his FDA expert because she was excluded.  He was left to point to only FDA guidance documents and regulations applicable to pharmaceuticals.  Id.  Plaintiff is correct that the FDA has offered “guidance” on certain applicable processing and testing procedures.  But guidance documents are non-binding, as stated in the documents themselves.  They are not final agency actions, but rather reflect the FDA’s “current thinking” on the given topic.  Id. at *17. While informative in some contexts, a deviation from the practices suggested in an FDA guidance, do not support a parallel violation claim.  Id.

So, while plaintiff alleged defendant violated the FDA’s GMP Guidance on Endotoxin Testing, what plaintiff failed to do was cite “a single specific GMP that the allegedly deficient endotoxin testing violated.”  Id. at *18 (emphasis in original).  Further, the one GMP that plaintiff does allege defendant violated is applicable to pharmaceuticals not medical devices.  The FDA defines and regulates pharmaceuticals and medical devices differently.  The GMPs applicable to one cannot be applied by the courts to the other. Failure to demonstrate any violation of GMPs was also fatal to plaintiff’s claim that defendant’s product was adulterated.  Id. at *20 (adulteration requires a finding of non-conformity with applicable requirements).  And plaintiff’s argument that defendant was not prohibited from doing additional testing is “of no moment.”  A state cannot make obligatory a federal requirement that is merely permissive.  Such a state requirement would be different from or in addition to federal requirements.  Id.

Even if there were evidence of a parallel violation “(and, to be clear, there is not),” plaintiff’s claims would still be preempted because there is no evidence that defendant’s conduct caused plaintiff’s injury.  Id. at *16.  For example, plaintiff offers no evidence that if the endotoxin testing had been done differently it would have led to different results that would have meant plaintiff would never have received an injection from the contaminated lot.  Id. at *19.  Without a causal link, plaintiff’s claims are preempted.

Without expert evidence, causation evidence, or a parallel violation – plaintiff’s claims went down for the count.