Wednesday, October 31, 2012

Qui Tam Off-label Trick or Treat

This week is scary through and through.  We in the mid-Atlantic region have confronted Frankenstorm, which turned our frontyard into a postapocalyptic scene.  We would not be a bit surprised to espy a zombie lurking behind the overturned pink flamingos.  Then there's the new jobs report, slated to come out in a few days.  That could be deadly for one of the presidential candidates. There will be a Million Muppet March on Washington this weekend.  Grover always frightened us.  Plus, as you may have heard, Big Bird has lately been on the warpath.  But we'd rather be pecked to death by Big Bird than endure yet another country music award show, which graces a network's airwaves this week. (Honestly, can we ever go a fortnight without another of those silly congrat-fests with big hair, bad jokes, and twangy jingoism?  Just asking).  And today is Halloween. 

We're not fans of the modern slasher flicks.  But in our tyke-dom we watched the Creature Features on Saturday nights.  The old Universal Pictures monster movies were our favorites.  Frankenstein, The Wolfman, Dracula, etc. offered good, clean, mildly spooky fun.   Improbable terrors threatened and were inevitably defeated, but there was usually a hint at the end that the ghouls might return.  "We belong dead," the monster says at the end of Bride of Frankenstein, but he would visit us many times, even to pal around with Abbott and Costello. Dracula was always arising again from the grave.  And poor Lawrence Talbot would once more stare at the full moon and feel his hair and nails grow lupine.  The Blob, which was filmed in Philly suburbs, transforms the scripted "The End" into a big question mark. 

Today's case is like a near death experience.  The theory of the plaintiff (in a qui tam suit the proper nomenclature is "the relator") in United States ex rel. Watson v. King-Vassel et al, 2012 U.S. Dist. LEXIS 152496 (E.D. Wisconsin Oct. 23, 2012), is that a doctor can be liable under the False Claims Act for prescribing a drug off-label.  The court ends up dismissing the case, but does not quite administer the authoritative stake in the heart we'd like to see.   As with Freddie or Jason, we might not have seen the last of this nasty apparition. 

The relator, Dr. Watson, filed a qui tam action alleging that another doctor, named King-Vassel, violated the federal False Claims Act by prescribing medications off-label.   Dr. Watson also named other medical providers on a respondeat superior theory, though there was not an ounce of evidence to support that theory (more on that later).  The case was initially sealed while the United States and the state of Wisconsin determined whether to intervene.  They decided not to do so, which is usually, though not always, indicative of a weak case.  It certainly was the case here. 

The relator in this case did some, er, interesting things to construct this lawsuit.   He met an attorney through the International Society for Ethical Psychology and Psychiatry.  Remember that "Ethical" part.  Dr. Watson did further research on bringing a qui tam claim through the website PsychRights.org.  Then the good doctor placed an ad in the Sheboygan newspaper soliciting Medicaid patients who had received certain medications.  A mother of a child-patient responded to the ad.  Dr. Watson then procured medical records for the child via a release stating that the information was "for the purpose of providing psychological services and for no other purpose whatsoever." In reality, Dr. Watson obtained the records "only to bring the immediate suit." Id. at 3-4.  How disappointing. 

The court ultimately granted the defendants summary judgment and dismissed the complaint because the relator did not prove that the defendant doctor "knowingly caused" a false claim.  Oddly, there is no discussion at all about whether the defendant doctor ever uttered a false statement.  We bet she did not. What is pernicious about the current crop of qui tam pharma false claims act cases is that people and companies are being sued even if they never said anything false.  The Watson case is especially frightening because it suggests that a doctor can be prosecuted for practicing good medicine. Off-label use can be, in many circumstances, the standard of care.

Dr. Watson never showed that the defendant doctor received any Medicaid  reimbursement, or that the doctor knew there would be a Medicaid submission.  The relator offered no expert witness and, according to the court, the absence of expert testimony created a "grand mystery between the time of the prescription and the claim being made to Medicaid.  In many ways, that mystery is like a black box - perhaps Dr. King-Vassel's signature on the prescription set off a series of reactions that on the other side of the box resulted in a false claim, but the churning mechanism on the inside is still a mystery." Id. at 20.  The court also pointed out that Dr. Watson did not offer an expert who would testify that the use of the medicine was off-label or not recognized in the drug compendia. 

Of course, finding an expert to supply such testimony would be relatively easy to do.  To take comfort from the Watson holding would be like whistling past the graveyard.  The problem with the opinion is that it does not foreclose any opportunistic person from transforming a malpractice case - even one where is no real malpractice - into a federal qui tam case.  If you log onto the PsychRights.org website, you will see that the plan is to do precisely that.  We are not merely witnessing an accidental mangling of legal principles; it is premeditated murder. 

Perhaps the court took what it thought to be the easy way out in the Watson case because it was particularly offended by the conduct of Dr. Watson.  Indeed, the court imposed sanctions on Dr. Watson.   First, Dr. Watson had learned early on that Dr. King-Vassel was an independent contractor, so the respondeat superior theory was untenable.  Nevertheless, Dr. Watson still dragged the corporate defendant through the discovery process and made it file a summary judgment brief before Dr. Watson would give up the ghost on the respondeat superior claim.  That amounted to torture via litigation, wasting party and court resources, and it could easily have been avoided with a decent amount of pre-complaint investigation. Second, the court was mightily irked at how Dr. Watson conjured up the case by obtaining medical records "in a manner that could best be described as borderline-fraudulent." Id. at 27.  Dr. Watson's "attack here on a single doctor's prescriptions to a single patient does not provide the government with substantial valuable  information, as intended by the qui tam statutes. Instead of providing the government with valuable information, Dr. Watson seemingly sought only to cash in on a fellow doctor's attempts to best address a patient's needs."  Id. at 28. 

That conclusion is right as far as it goes. It simply does not go far enough. If the treating doctor really was trying to practice good medicine, she should not be vulnerable to a false claims action, even if the relator lines up a willing expert and offers the expected incantations.  The Watson court dismissed a bad case. But it should have interred a bad theory.




3 comments:

Cocaine Princess said...

I like the old school horror films too but some of the modern day ones aren't that bad either and are quite frightful.

We were very lucky and missed Hurricane Sandy.

Happy Halloween!!

Sam said...

Hi, Cocaine Princess! You are very lucky indeed. My mom lives in New York but in Fresh Meadows, so they weren't hit hard.

Online Pharmacies said...

Glad to see that you are safe. I also like horror movies, Zombies etc..