We’ve mentioned our Drug and System Legislation Weblog elder care duties earlier than and the way it has educated us about well being points confronted by the senior inhabitants.  Shingles is one well being danger that will increase as you grow old.  It’s typically described as a painful rash, however “painful rash” doesn’t actually seize how unhealthy shingles may be.  “Intense burning sensation” with ache that “can final for months and even years after the rash goes away” is nearer, however nonetheless falls wanting the acute actuality of the expertise.

Shingles is brought on by the varicella-zoster virus, the identical virus that causes chickenpox. When you’ve had chickenpox, you might have the varicella-zoster virus in your physique and, if it reactivates as you age, it is going to manifest as shingles.  Happily, vaccines can present safety. 

However the place there are vaccines, there will probably be litigation, and we’ve written earlier than about litigation involving one of many shingles vaccines, Zostavax.  From a protection perspective, the In re Zostavax MDL has had its ups and downs, however largely ups. 

On the draw back, the MDL choose lately gave 43 plaintiffs a move for failing to serve their complaints inside 90 days as Federal Rule of Civil Process 4(m) requires.  See In re Zostavax (Zoster Vaccine Reside) Prods. Liab. Litig., 2023 U.S. Dist. LEXIS 138412, 2023 WL 5044944 (E.D. Pa. Aug 8, 2023).

However on the upside, the MDL choose has not all the time indulged plaintiffs who fail to observe via on their procedural obligations.  He dismissed—with prejudice—the claims of a plaintiff who did not well timed serve discovery (the ever-problematic “plaintiff reality sheets” discovered solely in MDLs).  See In re Zostavax (Zoster Vaccine Reside) Merchandise Legal responsibility Litigation, 2022 U.S. Dist. LEXIS 143883, 2022 WL 3309471 (E.D. Pa. Aug. 11, 2022).

In actual fact, Zostavax has made our year-end “better of” lists twice, in 2022 (#10) and 2021 (honorable point out).  The Court docket entered a Lone Pine order with tooth in In re Zostavax (Zoster Vaccine Reside) Merchandise Legal responsibility Litigation, 2022 U.S. Dist. LEXIS 57935, 2022 WL 952179 (E.D. Pa. March 30, 2022), and In re Zostavax (Zoster Vaccine Reside) Merchandise Legal responsibility Litigation, 2022 U.S. Dist. LEXIS 219261, 2022 WL 17477553 (E.D. Pa. Dec. 6, 2022), requiring all plaintiffs alleging one sort of damage (vaccine-induced shingles) to reveal the outcomes of a genetic take a look at distinguishing between wild varicella virus and the weakened, vaccine pressure, and dismissing the claims of plaintiffs who lacked proof their shingles was from the vaccine pressure. The MDL Court docket additionally entered abstract judgment in 2021 towards 5 bellwether plaintiffs after excluding all their specialists on Rule 702 grounds.  See In re Zostavax (Zoster Vaccine Reside) Merchandise Legal responsibility Litigation, 579 F. Supp. 3d 675 (E.D. Pa. 2021).

Earlier this 12 months, the MDL Court docket additionally dismissed some claims on “warning causation” grounds.  Sure California plaintiffs claimed there was a failure to warn in regards to the danger of peripheral neuropathy, however the prescribing doctor “by no means mentioned that data of such a danger would have modified her determination to prescribe it” and plaintiffs’ specialists mentioned they solely cared about “widespread” unwanted effects and provided no opinion about “the incidence of peripheral neuropathy as a aspect impact of Zostavax.”  In re Zostavax (Zoster Vaccine Reside) Merchandise Legal responsibility Litigation, 2023 U.S. Dist. LEXIS 45440, 2023 WL 2562981 (E.D. Pa. March 16, 2023).  In different phrases, these plaintiffs hadn’t proven that the alleged failure to offer the peripheral neuropathy warning would have mattered.

And that brings us to the most recent Zostavax order, In re Zostavax (Zoster Vaccine Reside) Merchandise Legal responsibility Litigation, 2023 WL 6465837 (E.D. Pa. Oct. 4, 2023), and it’s one other good one.  It concerned a bellwether plaintiff who’s alleged Zostavax damage was “persistent day by day headache” (or “PDH”), which she described as gentle complications lasting “fifteen to thirty seconds.”  Id. at *2.  

To assist her case, this plaintiff provided the testimony of Dr. Joseph Jeret, apparently a frequent-flyer skilled witness out there to cowl any variety of medical specialties and alleged accidents.  Dr. Jeret opined that Zostavax may cause PDH (basic causation) and actually did trigger PDH on this plaintiff (particular causation). 

However Dr. Jeret by no means met or examined the plaintiff, and developed his opinion based mostly on a overview of a choose 44 pages of her medical data and two depositions.  Suffice to say the opinion already had a shaky basis.

Subsequent, Dr. Jeret’s basic causation opinion (that Zostavax may cause PDH) was based mostly on, in Daubert and Common Electrical Co. v. Joiner, 522 U.S. 136, 146 (1997), phrases, ipse dixit.  His chain of not-really-connected hyperlinks was as follows:

First, it’s undisputed that Zostavax is a live-attenuated virus vaccine, which might trigger infections and complications. The Zostavax warning label confirms that complications may result. Second, essentially the most generally recognized set off of PDH is “an infection and flu-like sickness.” Id. Dr. Jeret notes that 22% of the instances of PDH are a results of an infection. Third, the percentages of contracting PDH from an an infection will increase in people with immunosenescence, that’s, people whose immune methods have weakened with age, and in people with prior trauma. Fourth, Dr. Jeret concludes Zostavax may cause PDH in older individuals.

Id. at *3.

Because the Zostavax choose shortly surmised, Dr. Jeret’s basic causation conclusion was not dependable as a result of:

It doesn’t observe that just because Zostavax may cause an an infection and complications in older individuals or folks that have skilled head trauma, that it will probably trigger PDH.

Id. at *4.  No epidemiology supported the conclusion that Zostavax causes PDH.  The Zostavax label reporting complications as a standard antagonistic occasion doesn’t imply that Zostavax causes PDH, a definite medical situation.  Notably, Dr. Jeret’s opinion that “any an infection from Zostavax may lead to PDH is merely a concept based mostly on organic plausibility” and “is not any extra dependable than an opinion that moonlight may cause pores and skin most cancers merely as a result of there’s a research that daylight may cause pores and skin most cancers.”  Id. 

Dr. Jeret’s particular causation opinion additionally fell wanting the admissibility mark.  His PDH prognosis didn’t match the accepted diagnostic standards, and he did not account for the plaintiff’s pre-vaccination historical past of migraine headache in reaching his PDH prognosis.  He mainly determined Zostavax induced PDH within the plaintiff based mostly on temporal proximity, and by no means carried out a differential prognosis. 

As a result of Dr. Jeret didn’t make use of dependable strategies in reaching his basic or particular causation opinions, his testimony was excluded.  Assuming this plaintiff has no different skilled testimony on medical causation, we are able to solely assume that abstract judgment will probably be forthcoming.