Wasting Time Looking For A Dime

We are unabashedly pro-science.  In our cases, we are usually on the side of good science against bad or no science.  In discussing large-scale product liability litigation, we have said many times how bad science and the risk of attendant litigation can negatively impact the development of new products.  Even if we were so naïve as to believe that good science always wins out in product liability litigation, it is clear that misleading legal advertising and uncritical media coverage can spread and emphasize bad science to the detriment of public health.  The FTC noted as much in 2019 when it took minimal steps to limit “deceptive” and “unfair” advertising from certain “legal practitioners and lead generators . . . that solicit clients for personal injury lawsuits against drug manufacturers.”  (If you think a government action from five years ago is ancient history, then just wait for the rest of the post.)  Of course, product liability litigation is not the only kind of litigation against medical product manufacturers that often relies on bad science and unscientific conclusions.  False Claims Act litigation can not only be high stakes, but it can take years to get from the filing of a sealed complaint by a relator to an ultimate conclusion.

When we think of litigation involving vaccines, a couple of things come to mind.  The first is how the widespread use of childhood vaccines was one of the great successes of science in the 20^th century.  For instance, before the availability of vaccines for measles, mumps, and rubella, combined for decades into the “MMR” vaccine, many thousands died annually in the U.S. from these viruses and many multiples more were hospitalized or suffered permanent disabilities such as deafness from them.  Until some recent anti-science-driven drops in vaccination rates, serious complications from these diseases had become exceedingly rare in the U.S.  The second thing we think about with vaccine litigation is how the Childhood Vaccine Act created an alternative system for compensation for alleged vaccine-related complications for “table” vaccines such as MMR.    The flip side is that, under Bruesewitz, many product liability claims involving vaccines will be preempted.  We do not usually think about the False Claims Act with regard to vaccines, in part because the U.S. government, which has to receive a claim for payment to trigger the FCA, is so heavily involved with the common vaccines administered to children in the U.S.

Much like civil RICO and state consumer protection statutes, the FCA is widely overused by plaintiffs and plaintiff lawyers who initiate suits about medical products.  These suits routinely assert that FDA was somehow misled in fulfilling its regulatory function.  Because of the risk that the government will intervene in a case brought by a relator and the possibility that an adverse judgment will result in a bar from participation in government reimbursement programs, these cases present the manufacturer with the choice of settling for too much or expending significant resources in fighting this particular variant of blackmail.  While some FCA relators are legitimate whistleblowers relying on non-public information to expose a real issue, many more are anything but.  In U.S. ex rel. Krahling v. Merck & Co., Inc., No. 23-2553, 2024 WL 3664648 (3d Cir. Aug. 6, 2024) (unpublished), the relators did report information about an alleged impropriety to FDA back in 2001 and one of their counsel firms is named Whistleblower Partners, but the case itself seemed like a giant waste of time and resources particularly in light of the purpose of the old Lincoln Law.

Doing our best to summarize the highly technical stuff without misrepresenting it, the case involved certain lots of the MMR vaccine that may or may not have been purchased by the CDC before February 2000 and that FDA-approved labeling describing shelf-life and potency that were theoretically overstatements for some doses within those lots.  FDA was well-aware of the issues in with these lots based on an inspection and back-and-forth with the company in 2000 and 2001.  2024 WL 3664648, *2.  The FDA was also aware of the issue the relators raised in 2001, which related to the conduct of a clinical study (started before the lot issues) to change the label in relation to end-expiration potency.  Id. at *3.  So, the non-public information the relators had back in 2001 had at best a tangential relationship to the alleged falsity of the claims for payment from CDC.  Instead, the alleged falsity was based on information obtained in a decade of discovery about preliminary data from lot testing that had not been shared with FDA during the back-and-forth that resulted in the inspection observations being closed in April 2001 without adverse regulatory action.  What does any of that FDA history have to do with CDC’s decision to buy MMR vaccine from the company that was, at the time, the only manufacturer of an MMR vaccine approved in the U.S.?  Preciously little.  To link things up, plaintiffs would have had to allege that the vaccine was only on the market when CDC maybe bought some of the affected lots.  But plaintiffs did not allege any fraud on FDA, perhaps because that might have implicated the primary jurisdiction doctrine.  (Preemption applies to state law claims and the FCA is federal.)

In April 2010, nine years after the events above, plaintiff sued the manufacturer based on the claim that it misled the CDC.  After two years, the U.S. declined to intervene and the complaint was unsealed.  Over the next seven years, plaintiffs burdened not just the defendant but the government with discovery, only to turn up no evidence that CDC was misled by anything that the manufacturer allegedly misrepresented to or withheld from the government.  In FCA parlance, this is an issue of materiality, the standard for which the Supreme Court addressed a few years ago in Escobar.  The nine years that the case lingered until the defendant was able to move for summary judgment worked to the plaintiffs’ detriment, because they had insisted that FDA and CDC be informed of their allegations and evidence along the way.  Once the district court decided summary judgment, it had to look no farther than the lack of materiality to get rid of the case in a decision that was an honorable mention for our ten best list last year. 

Because a decision from a circuit court, even unpublished, carries more weight and because the appellate court’s review was de novo, Krahling merits a look.  Like the court below, the Third Circuit needed only to address materiality to conclude that the plaintiffs failed to establish a prima case.  In fact, none of the factors identified in Escobar supported that any purported misrepresentation or omission by the manufacturer was material to CDCs decision to purchase the only approved MMR vaccine.  First, there was no identified representation that was a condition of payment.  CDC did have conditions of payment, but they were all met even under plaintiffs’ view of the facts.  Id. at *7.  The plaintiffs’ allegations about vaccine potency and shelf life being misrepresented did not matter because the CDC did its own real-world research on efficacy and required a shelf life that was not longer than the alleged shortened shelf life indicated by the testing on the lots with potency issues.  Id.  Second, the identified alleged misrepresentations were minor and insubstantial given that CDC made its purchasing decisions based on advisory committee that did not rely on the alleged misrepresentations.  Third, the government did not change its practices upon learning the information at issue.  FDA knew about both issues identified by plaintiff back in 2001 and DOJ, CDC, FDA, and HHS knew about everything plaintiffs said mattered—in part because plaintiffs insisted on it.  Yet, CDC has never changed its purchasing practices or its position that the vaccine is effective, even once another MMR vaccine became available.  Id. at *8.

So, absent an unlikely reversal by the Supreme Court, the plaintiffs’ case is finally gone after a mere fourteen years.  The core issue was lots of an essential vaccine made more than twenty-four years ago that may have never resulted in doses lacking in potency being available for use after purchase by CDC.  Given the burden on the manufacturer and the U.S. government and the lack of any real public harm to redress, even if plaintiffs had been right about some aspect of the claims for payment from CDC for the vaccine being false, it does not seem like a good use of resources.  Perhaps such a case will not be allowed to linger so long and get so much leeway before getting kicked.  Deterring lawsuit abuse with sanctions, however, might be too much to expect.