One of the problems with so-called Lone Pine orders in MDLs is timing – they are usually entered way too late, more as vehicles to enforce settlements than as any genuine effort to weed out the large number of bogus cases that everyone, including plaintiffs, admits are present in MDLs.
We can’t say that the Lone Pine order recently entered in the Zostavax MDL, In re Zostavax (Zoster Vaccine Live) Products Liability Litigation, 2022 WL 952179 (E.D. Pa. March 30, 2022), was timely entered, but at least it’s primary purpose was to weed out worthless claims instead of herding plaintiffs into a global settlement (forced at least partially by large numbers of bogus claims).
The Zostavax decision explains what happened to warrant a Lone Pine order. The product under assault in that litigation is a vaccine to prevent shingles – a disease caused by the same virus that also causes chicken pox. Almost everyone gets chicken pox as a child, but the adult disease shingles is a lot more dangerous. As the name of the MDL indicates, the active ingredient in this vaccine is an enervated live virus. “It includes the Oka strain of the VZV, a live-attenuated virus that is a weakened form of the natural or wild-type virus found in the body of someone who has had chicken pox.” 2022 WL 952179, at *2.
As we’ve discussed before, federal preemption under the Vaccine Act has done an excellent job of protecting the nation’s vaccine supply from being overwhelmed by litigation. Zostavax is an exception, since the Vaccine Act only covers childhood vaccines, while this product is exclusively for adults. Plaintiffs’ theory is that, instead of preventing shingles, the vaccine can cause it instead, due to the use of the live virus. Id. In the Zostavax MDL the plaintiffs did what they always do and solicited many hundreds of claimants (some 1700) without regard to whether any of them actually had a case. And, as we explained here, that came back to bite them because of a serious causation problem – having had chicken pox as a kid is “an obvious alternative cause,” because the virus can linger for a lifetime and cause shingles many years later:
Because shingles occurs from reactivation of the virus that causes chicken pox and almost everyone over 30 in the U.S. has had chicken pox, approximately 1/3 of adults develop shingles during their lifetimes. The reactivation apparently happens randomly or can be brought on by a variety of stressors. Thus, the court’s statement that “There is no doubt that defendants have presented an obvious alternative cause of the plaintiffs’ shingles, that is, the activation of the natural wild-type virus latent in their bodies.”
Blogpost (quoting and citing In re Zostavax (Zoster Vaccine Live) Products Liability Litigation, 2021 WL 5631687 (E.D. Pa. Dec. 1, 2021)). As we discussed in that prior post, all of the Zostavax bellwether plaintiffs’ experts simply ignored this obvious alternative in formulating patently invalid “differential diagnoses” and were therefore excluded under F.R. Evid. 702.
Moreover, as we discussed in that prior post, the wild chickenpox virus that we encounter in childhood has a different genetic makeup from the “Oka strain” that was used to create the vaccine that the Zostavax plaintiffs are suing over. A “simple” genetic test existed that could tell them apart, and thus eliminate or establish the alternative cause. Not surprisingly, not one of the five bellwether plaintiffs was willing to take the test and thereby establish whether or not there was a real case:
“A simple PCR test?” one might ask. “Then why, pray tell, don’t we just look at the test results for each plaintiff?” Well, these five did not have them. Why not? We do not know.
Blogpost (similarly quoting 2021 WL 5631687). And so all five Zostavax bellwether plaintiffs had their experts excluded and summary judgment entered against them.
Well, what about the 1700 or so remaining Zostavax plaintiffs?
That’s what the Zostavax Lone Pine order is about. The defendant sought an order requiring all of these remaining plaintiffs to get themselves tested.
[Defendant] now seeks to require the remaining Group A plaintiffs to produce specific testing evidence that the Zostavax virus as opposed to the virus from latent chicken pox caused their shingles-related injuries. What [defendant] requests is known as a Lone Pine order. . . .
Zostavax, 2022 WL 952179, at *2 (description of Lone Pine order concept omitted). Helpfully, the controlling court of appeals had “approved” use of Lone Pine orders in MDLs less than a year before. Id. (discussing Hamer v. LivaNova Deutschland GmbH, 994 F.3d 173 (3d Cir. 2021)) (see our discussion of the same decision, here).
Thus, an MDL-wide Lone Pine order as an “essential tool” to help an MDL “court weed out non-meritorious claims” was just what the doctor (or, here, the Third Circuit) ordered. Id. (Hamer-related quotation marks omitted).
[A] district court . . . may impose a Lone Pine order so as to require plaintiffs to furnish specific evidence like proof of a medical diagnosis, with the goal of winnowing non-compliant cases from the MDL. This is exactly what [defendant] seeks here.
Id. (Hamer-related quotation marks omitted).
Zostavax then discussed the disproportion between the massive MDL discovery the defendant had been forced to provide over the last “three years,” versus the MDL plaintiffs’ obviously concerted failure to be “tested for the type of virus present.” Id. In light of that disparity, the Lone Pine order that the MDL defendants sought was “not unreasonable.”
There is compelling medical authority that a laboratory test of the shingles rash of a person who has had chicken pox is the only way to tell whether the shingles was caused by the virus strain contained in Zostavax or by the wild-virus strain from chicken pox latent in a person’s body. . . . [Plaintiffs have] not cited any medical literature or expert medical opinion explaining how it can be determined that Zostavax caused a person to contract shingles other than, as defendants have shown, through a testing of that person’s rash.
Id. at *2-3 (citations omitted). Thus the court ordered the 1700 remaining plaintiffs claiming vaccine-caused shingles “to come forward with the Laboratory Reports or other documentation [defendant] requests to enable the court to weed out non-meritorious from meritorious claims.” Id. *3.
This Lone Pine order does seem to be precisely the right tool (if a little late) for the job of vetting the cases of the plaintiffs in this particular MDL. But its importance goes beyond just purpose and timing – Zostavax is not the usual order to produce medical records and related documents. Rather it orders plaintiffs to undergo a form of genetic testing to identify a particular type of viral DNA.
Given that genetic testing for all kinds of DNA sequences is becoming both cheaper and more accurate all the time, Zostavax is an important precedent that courts have the power to require litigants to undergo such tests. Appropriate genetic testing has the potential to prove − and more importantly from our perspective, to disprove − many types of claimed injury. That’s why we’ve collected precedent and written about cases involving pharmacogenomic discovery. We’ve even proposed that the Federal Rules should be amended to address “provision of blood or tissue sampling for genetic testing.”
Given Moore’s Law and the pace of scientific progress, we would not be at all surprised in a few years for genetic testing orders to be routine practice in MDLs. We can even envision the results of such mass-tort testing − properly redacted to ensure individual privacy − harnessed as part of the “big data” push to find genetic cures for what ails the human race. That would be a socially beneficial use for MDL discovery. Will wonders never cease?
Note: We are informed, by someone with more knowledge of the Zostavax litigation than we do, that the genetic testing required by the Lone Pine order must occur at the time the infection is active. Thus all of the 1700 plaintiffs either had the testing done at the time they suffered from shingles or they cannot now satisfy the terms of the Lone Pine order, which means that their cases will be dismissed for inability to establish causation. Thus, while this order does not mandate new testing, it has even more teeth, in terms of culling meritless cases, than we previously thought.