The other day we learned that the U.S. Supreme Court will decide Vaccine Act preemption in Bruesewitz v. Wyeth.  We’ll have plenty of time to obsess about the Bruesewitz case itself in the coming months, so today we’ll just use it as a convenient excuse to get a couple of things out of the way.

Good-Bye Colacicco

Remember Colacicco v. Apotex?  At one point it was all the rage – indeed the surge in interest about the original 2006 district court opinion, Colacicco v. Apotex, Inc., 432 F. Supp.2d 514 (E.D. Pa. 2006), in which Bexis was involved as local counsel, was one factor that motivated creation of this blog.  For a while we thought that Colacicco would be the case the Supreme Court would take to decide prescription drug preemption.  But for a bunch of reasons, not the least of which was consolidation with another case, the wheels of appellate practice ground exceedingly slowly in Colacicco, and it got overtaken by Wyeth v. Levine.  The rest, as they say, was history.

We still thought that we might at least get another crack at preemption post-Levine back in the district court in Colacicco.  The plaintiff in the case did too, and didn’t like that prospect one bit. So really late in the game, he tried to be slick, sever some claims, and get out of Dodge (or at least Judge Baylson’s courtroom).  No such luck.  See Colacicco v. Apotex, Inc., 2009 WL 4729883 (E.D. Pa. Dec. 10, 2009) (denying transfer).

Well, Colacicco’s now gone bye-bye. On March 8, Judge Baylson approved a stipulation of dismissal entered into by the parties.  So that long-running show is over.  Too bad. With a few more breaks – and a speedier appellate process – the case coulda been a contender.  Thanks to Dave Alden at Jones Day for the heads up.

Now Bruesewitz is a contender.

A Timely Reminder Why We Need The Vaccine Act

Bruesewitz, of course, involves the Vaccine Act, which was passed in 1986, to address a liability crisis that had developed in the vaccine sector and that was threatening the nation’s vaccine supply.  The biggest problem was that vaccines were the sort of public good that most companies did as much out of public service as to make money.  A lot of vaccines were sold to the government and other public or quasi-public entities for not much profit margin.

But the explosive growth of product liability threatened all that. Vaccines, like every other kind of prescription medication, have risks.  Some of those risks, though rare, are quite grave.  Beyond that, a lot of vaccines are routinely given to children at young ages to prevent childhood diseases that used to kill many thousands of babies annually.  Vaccines are a major reason why life expectancy in this country increased by over 20 years in the 20th Century.

But age of inoculation is a problem, too.  Vaccines are given at the same time that a variety of developmental disorders – these days, most notoriously autism – begin to manifest themselves in very young children.  Thus, a lot of vaccine manufacturers got sued simply because they were in the neighborhood, temporally, when the diagnosis was made.

One seven-figure verdict could wipe out a the profit, such as it was, from a great deal of vaccine. The litigation expense was as bad or worse.  Hence, the country was down to about two manufacturers of vaccines by the time Congress acted.

That’s more than 20 years in the past, and people tend to forget how messed up things were, and why Congress was willing to expressly preempt personal injury litigation.  A very recent case, however, serves as a stark reminder of what that pre-preemption regime was like. Last month, a trial court in New York denied post-trial motions and let stand a verdict of more than 20 million dollars for a single vaccine-related injury.  Tenuto v. Lederle Laboratories, 2010 WL 625223 (N.Y. Sup. Feb. 17, 2010).  Amazingly, Tenuto was a pre-Vaccine Act case – and not by a little bit – involving the consequences of a polio vaccination given in May, 1979 – more than thirty years ago.  Suit was timely filed in 1981.

This real life version of Jarndyce and Jarndyce is at least partially testament to the willingness of the New York Court system to allow unlimited interlocutory appeals, as the trial court felt the need to explain up front the “long and contentious history” of the case.  2010 WL 625223, at *1.

Be that as it may, Tenuto is a stark reminder of the “bad old days” before the Vaccine Act, and why unchecked litigation would have destroyed the country’s ability to prevent childhood (and other) diseases.  Had the litigation industry succeeded in taking down the vaccine manufacturers, the upsurge in morbidity and mortality would have dwarfed the current increase in teen suicide caused by the more recent misguided suicide warnings that have deterred use of anti-depressants in that population.

The most troubling thing about Tenuto – beyond the jaw-dropping size of the verdict – is the imposition of a duty to warn about an exceedingly rare risk.  Even the opinion justifying the verdict, which must resolve disputes in favor of the plaintiff as the winner, estimates the risk of an adult catching contact polio (here, resulting in paraplegia) from a vaccinated child at literally one in a million. 2010 WL 625223, at *3 (quoting defendant’s warning).  In other words, the vaccine maker was held liable in Tenuto for a one-in-a-million risk.  And as will become clear, liability was imposed even though it had warned about the risk.

Another medical source at the time estimated the risk as one in ten million. Id. (quoting the “Red Book” guide for pediatricians).

We find liability for this type of remote risk alone shocking.  Yet it used to happen with unnerving frequency in vaccine cases.

One in a million (let alone one in ten million) is considered a trivial risk – even by notoriously cautious governmental regulators.  “EPA is generally not concerned about cancer risks at or below the range of 1 x 10-6, or 1 in a million.”  73 Fed. Reg. 64229, 64237 (EPA Oct. 29, 2009).  If everybody in this country has a one-in-a-million chance of dying in an automobile accident, the number of fatalities in a year would be a little over 300.  In reality, the traffic fatality rate is 100 times greater than that – even with seatbelts and airbags.

In fact, in Tenuto, the doctor who administered the vaccine – and who didn’t pass along the manufacturer’s warning – escaped liability because the risk was “too remote”:

Notwithstanding the duty to warn the parents of [the vaccinated child] of the risks of incurring contact polio recognized by the New York Court of Appeals, the defendant [prescriber] maintained in the medical malpractice and negligence causes of action against him that the standard of care was not to warn parents of the risks because they were too remote. . . . The jury apparently adopted [the prescriber’s] argument because it did not find [him] liable for his failure to warn the parents of the risks of contact polio.

2010 WL 625223, at *3.

It is a measure of the extent to which the product liability system gets out of control in vaccine cases, that while one jury let the prescribing doctor skate for not warning at all of a one-in-a-million risk, another jury tagged the vaccine manufacturer – which did warn – for over $20 million on the same facts.  Why?  Because the warnings could have been “more expansive.”  2010 WL 625223, at *3.  How?  According to the opinion, the manufacturer could have “disseminating a warning . . . through drug sales representatives . . . as well as through written warning notices that are occasionally sent to doctors and hospitals known as ‘Dear Doctor letters.’”  Id. at *7.

This is a one-in-a-million – at best – risk we’re talking about here. What the court holds was “reasonably necessary,” id. at 14, if anybody ever did it, would deluge doctors in letters about trivial risks and would have sales reps doing nothing but talking about risks that the average doctor would likely never see an entire lifetime of practice.

If a doctor saw 50 patients a day (that’s less than 10 minutes each for an 8 hour day), five days a week, with no vacations, that doctor would need 2000 weeks, or more than 77 years, to see a million patients.  Doesn’t happen.

Then the doctor would have to – as the doctor in Tenuto did not – think that the one-in-a-million warning was important enough to bring up during the less than ten minutes s/he saw the hypothetical patient.

The court held that this utterly impractical warning duty was not preempted – because the defendant in fact did revise its warnings (after the fact, of course) to include the information. Unfortunately, Vaccine Act preemption had not kicked in yet.  2010 WL 625223, at *7-8.

Tenuto is an excellent reminder why we needed the Vaccine Act. With a severely injured (we do not in the least question the plaintiff’s injuries), one-in-a-million plaintiff before them, neither the court nor the jury was capable of keeping liability within sensible bounds.

Another inherent problem with vaccine litigation, present in Tenuto in spades, is letting the jury decide whether the defendant complied with notoriously complex and arcane FDA regulations about vaccine manufacture.  The court in Tenuto allowed several experts to testify at some length about this sort of regulatory gobbledygook – such as “monkey neurovalence” – even though it recognized that New York does not allow common-law standards of care to be dictated by mere regulations.  E.g., Elliott v. City of New York, 747 N.E.2d 760, 763-64 (N.Y. 2001); Long v. Forest-Fehlhaber, 433 N.E.2d 115, 117 (N.Y. 1982). See Tenuto, 2010 WL 625223, at *8-14.

Amazingly, in this whole long discussion, the only case that the court substantively discussed wasn’t even from New York. Instead, it was the Strong case from Missouri (a state apparently with no compunction to allowing negligence per se on mere regulations) – a case that the FDA felt strongly enough was wrongly decided to intervene as amicus precisely against the admission of this sort of testimony, as we discussed earlier.

Finally, in the discussion of the warning claim in Tenuto, there’s notably nothing at all about warning causation (medical causation was not contested), despite this being a one-in-a-million risk.  Who’s to say that the prescriber would have done anything different with the supposedly better warning?  No evidence mentioned in the opinion supports the proposition that the doctor would either have given the warning or would have otherwise changed his practice.  No evidence suggests that the plaintiff would have done anything different either.  The opinion simply ignores causation.

Tenuto is a timely reminder why we need Vaccine Act preemption in the first place.  Most courts and most juries are simply not capable of dealing with remote risks in a rational fashion when faced with a victim of such a risk.  Tenuto’s straight-faced suggestion that Dear Doctor letters be required for one-in-a-million risks is proof enough of that.  This is an opinion that would make perfect sense if the risk were one in a thousand or perhaps even one in ten thousand.  But it’s a result that’s perfectly absurd when the risk is one in a million.