In the past two years, Johnson & Johnson and its subsidiary Janssen Pharmaceuticals were successfully sued for $257.7 million in Louisiana and $327 million in South Carolina. More recently, J&J has been levied a $1 billion charge in connection with Federal probes into the marketing of Risperdal.

On January 10th 2012, the State of Texas launched its case against J&J, claiming that the company had defrauded the state of $579 million. They are seeking over $1 billion in restitution and penalties. This case is potentially much larger than it seems because what is on trial is not just Medicaid fraud perpetrated by one company for one drug in one state, but the system of influence that has molded a reliable pipeline for creating blockbuster markets as readily out of unworthy as worthy drugs.

There is no easy synopsis of the combined commercial and medical history of the “atypical” or second generation antipsychotic (SGA) medicines of which Risperdal is one—except to say that it is the commercial more than the medical side that dominates the story (Healy 2002 is a good place to start). Testimony of this may lie in the bizarre fact that for several years running this ostensibly rarefied group of drugs—how many psychotic people do you know?—has been the best-selling class of pharmaceuticals in America. In 2010, a small number of SGAs (including principally Risperdal, Zyprexa, Seroquel, Abilify, and Geodon) sold $14.6 billion in the US alone, or 1.5 times the public expenditure for all health care in India.

Risperdal earned J&J $34 billion during its 17-year patent period. The size and complexity of the machinery necessary to generate revenues on that scale cannot be easily summarized. Those who don’t have firsthand knowledge of how mega corporations work cannot easily comprehend what’s involved.

Explaining this is the very challenge facing the Texas Attorney General’s office in the coming weeks. They have gathered millions of bits of data but have only a handful of hours to make their case to a jury as to how they think J&J could have defrauded the state of $579 million. It is of course too early to tell how they will build their case, but in the plaintiff’s opening statement, attorney Tom Melsheimer accused J&J/Janssen of implementing a “systematic scheme…not a one-time event, not an accident” to turn a drug designated for narrow use in the treatment of schizophrenia into a $34 billion pill, with a 97% profit rate, he said, and to defraud the Texan taxpayers of hundreds of millions of dollars along the way.

Melsheimer asked the court how the company could have accomplished this feat of unnatural expansion. He alleged four ways: They (1) influenced usage guidelines by bribing Texas officials; (2) illegally promoted the drug for use in children—he added that half the patient population for the drug is under the age of thirteen; (3) made false claims that Risperdal is safer than other antipsychotic drugs; and (4) made claims that, despite costing 45 times as much as generic competitors against which Risperdal could show no superiority, it was cost effective to the tax payer.

If the prosecution is able to demonstrate these claims, as they aimed to do starting in the first testimonies in the afternoon, then J&J will be able to add Texas to the growing number of states winning retribution for illegal marketing activities associated with the drug. (Similar cases have been won against Eli Lilly, AstraZeneca, and Pfizer for their atypical antipsychotics; see http://www.psychsearch.net/lawsuits.html)

Signaling the type of evidence that would come to light, Mr. Melsheimer referred to warning letters sent to Janssen by the FDA challenging the company’s marketing claims that its drug was superior to first generation antipsychotics (such as Haldol, which was developed by Janssen in the 1950s), or safer. He alleged that bribes in the form of “unrestricted educational grants” and honoraria were given to Texas medical officials serving on the influential Texas Medicines Algorithm Project (TMAP; see Healy 2006, 2008). He argued that the company “seeded” the scientific literature with ghostwritten articles claiming the drug’s superiority. Finally, he alleged that the company illegally promoted off-label prescription for child and adolescent use.

Melsheimer concluded his peroration by saying, “Our jury system empowers us…to refuse to let corporate greed feast on taxpayer’s dollars.”

I was not in the gallery for cases tried against J&J/Janssen in other states, but it seems to me that Texas is a particularly hospitable place for the company’s defense lawyers to draw upon rhetorical rather than factual flourishes.

Defense attorney Steve McConnico appealed to jurors’ common sense, their trust in doctors’ judgment, and their faith in the American free market system. Instead of drawing on the type of expert witnesses the plaintiff has chosen—people who write “awrticles” (said derisively, so I reproduce it here) or who only read court documents, but do not treat patients—the defense would introduce witnesses who treat people with schizophrenia every day, and who also “treat vets.” These medical men and women know firsthand that the second generation antipsychotics such as Risperdal “are far superior.”

McConnico listed the debilitating side effects of first generation antipsychotics, more than implying that Risperdal doesn’t cause these and other side effects. (This is untrue, of course.) “You talk about cost effectiveness? Get rid of these [side effects].”

He then said that while the first generation drugs treat just the positive symptoms of schizophrenia (psychosis, delusion, hearing voices, e.g.), Risperdal also treats the negative symptoms (inexpressiveness, lack of interest in life, monosyllabic speech) so that people can go back to work and lead more normal lives. Independent research regards this more as advertising than scientific truth, but that’s precisely the point. The defense is redeploying its old Risperdal marketing messages that worked so well on doctors and other stakeholders— this time on the jurors.

In contrast to the prosecution, the defense attorney spoke in folksy down home speech about “the real world” (as against the academic or legal ones) and what fit common sense and what didn’t. For instance,

“The idea that we’re puppet masters over doctors isn’t common sense.”

“[Millions] of prescriptions have been written for [Risperdal]. The theory that we pulled a smokescreen over the whole medical community makes no sense.”

“The idea that a drug rep tells a doctor what to prescribe and then the doctor prescribes it is just plain wrong—you betcha!”

Finally, McConnico applied to the jurors’ presumed acceptance of the Market doctrine of value and truth:

“The marketplace proved that the drugs were superior… The marketplace knows the truth.”

After years of marketing muddying of the waters of objective scientific and clinical evaluation of the utility of Risperdal, the full truth of it is hard for anyone to know. The suit is about Medicaid money and not product liability per se, which makes the State’s case a bit easier, I think:

For 10% of the population taking the drug to be under six years of age, as the plaintiff showed, “makes no sense.”

Suggesting that Risperdal is 45 times more cost effective than the first generation drugs, and therefore deserved its designation by TMAP as the first line treatment  “isn’t common sense.” Different patients respond variously to different drugs, or not at all. Internal research that Janssen allegedly concluded in 1994 but did not share, confirmed just this point.

And to claim that the marketing machinery of drug companies, starting with Key Opinion Leaders and ending with hordes of drug reps bearing ghostwritten articles and gifts, has no influence “is just plain wrong—you betcha!”

The marketplace sometimes only knows the truth promulgated by its biggest manipulators and propagandists, and this is what ought to be on trial in Texas.

Cited:

Healy, David   2002. The Creation of Psychopharmacology. Harvard University Press.

Healy, David   2006. “Manufacturing Consensus.” Culture, Medicine and Psychiatry 30:135-156.

Healy, David   2008.  Mania: A Short History of Bipolar Disorder. Johns Hopkins University Press.