Once again, a drugmaker is challenging a lawsuit filed by a state attorney general and, specifically, the use of a private law firm that has a contingency fee arrangement. The latest instance involves GlaxoSmithKline, which filed its lawsuit late last week against Louisiana Attorney General Buddy Caldwell, who last year filed a lawsuit that charged the drugmaker with fraudulently marketing its controversial Avandia diabetes pill (
back story).Over the past couple of years, a growing number of drugmakers have filed countersuits as a tactic to blunt efforts by the states to recover funds that were allegedly misspent by state programs for medications that later became the subject of allegations over improper marketing or undisclosed side effects. In their view, the drugmakres believe the outside counsel have improper incentives and limits are required. So far, the notion is gaining traction.
For instance, a federal court judge recently ruled that Merck can proceed with a lawsuit against the Kentucy Attorney General for violating its constitutional due process rights, because the state struck a contingency fee arrangement with two outside law firms to help pursue a lawsuit alleging the drugmaker violated the state consumer protection act in its marketing of Vioxx (read here).
And earlier this year, a South Carolina state court judge denied a motion by state Attorney General Alan Wilson to dismiss a lawsuit that AstraZeneca filed last year. The drugmaker filed that lawsuit in response to a 2009 lawsuit brought by Wilson, who sought to recover funds spent to treat Seroquel side-effects and for reimbursements for alleged off-label uses (see this).
In Louisiana, the drugmaker offers the same argument as Merck. Glaxo "believes that the Attorney General’s engagement of private counsel, on a contingency-fee basis, violates Louisiana statutes and Glaxo’s constitutional rights to due process. Glaxo is entitled under Louisiana and federal law to an unbiased prosecutor who has no financial interest in the outcome of the prosecution and who has been retained in accordance with statutory and constitutional legal requirements," according to a statement sent us by a spokesman (here is the Glaxo lawsuit).
Whether such maneuvers will prevail, of course, remains to be seen. The states have retained outside law firms because, in an era of limited staffing, they believe they lack the resources and expertise to pursue these cases otherwise. By offering a contingency fee, the state attorneys general hope to get the best of both worlds - a recovery without straining their staffs. However, this sort of outcome may be in jeopardy if one or more drugmakers win in court. We asked the Louisiana Attorney General for a comment and will update you accordingly.
7 Comments
I am asking myself where, on this planet, one would find an "unbiased prosecutor." Are not all prosecutors, by definition, biased? Don't they all have incentives, public and private (e.g., personal career), to win a case?
But somehow many seem to think that when there is a profit motive, that is a completely different sort of COI that needs to be singled out for special treatment.
Of course, there are exceptions in both directions, but the pattern is, I think, definitive.
In any event, there are some apples/oranges in the comparison. A privately highered law firm may have more incentive, of a specific kind, to win a case. But, in the courtroom, there is also an opposing legal team, judge, and/or jury to balance however motivation translates into action.
I don't think there is anything equivalent even in "peer reviewed" journals (which we know can mean a lot of different things).
I partly, and maybe even mostly agree with your implied belief that the conflict between the results of industry-funded studies and non-industry funded studies is due to bias in the former and not the latter. But realistically, who wants to publish a paper with the following statement in the abstract? And how likely would such a paper be to generate additional grant funding?
"We performed a meta analysis of 17 published clinical trials of gabapentin in neuropathic pain. Based on these data, we conclude that the safety and efficacy of the drug are essentially identical to those reported previously by Pfizer".
While this is admittedly a separate (and therefore irrelevant) issue, I think there is also bias in the form of subject matter chosen. One hundred thousand patients die each year in the US from hospital acquired infections, and recent surveys (when you can find them) indicate that handwashing by hospital physicians between patients is about 50%. Imagine the response of your peers to an article written about this subject in the scathing tones of a typical NEJM editorial about the pharmaceutical industry. If you search for studies of this subject in pubmed, I think you'll find that few are published in first tier journals, and none are accompanied by morally judgmental editorials.
Lastly, do you know many trial lawyers who really believe that the outcome of jury trials is determined by superior reasoning and a stronger grasp of the facts?
No disrespect intended, I deliberately gave you a poke because I figured you would have something interesting to say.
I am not a lawyer (or plaintiff) so I feel I can answer without self-incrimination!
I'll answer with a quote from one of Bayer's lawyers in the context of the Baycol litigation. I learned from a very "well placed soure" that he said that "juries usually get it right." Not always, obviously. And there are certainly undeserving claims that find their way to compensation.
Anyway, no, I don't think trial lawyers believe in superior reasoning any more than most pols do. But juries have a way of ferreting out the BS that comes from both sides.
Again, without suggesting the "purity" of civil litigation (I am far from believing that!), I have been struck by the fact that there is only one case on record when a drug that turned out to be safe was pulled because of lawyer pile-on. This was Bendectin, a drug for morning sickness (as you probably know) both of the active ingredients of which were available OTC at the time of withdrawal (vit. B6 and doxylamine succinate). Indeed, there were even ob-gyns who created hand-outs for pts about how to "make your own Bendectin."
Compare that with the number of drugs that have been withdrawn by FDA. Of course, it is true that, for most of these, the data was not available at the time of approval. But for some it clearly was--fen-phen, arguably Vioxx if all studies had surfaced, that flu inhaler the name of which escapes me, and others.
BTW, your example of gabapentin and neuropathic pain is a great one because, as I recall, the drug was never approved for NP (even though virtually every internist thinks it was). And we later learned (again through litigation) that most of the off-label promoted uses for gabapentin had either no evidence or negative evidence. Thus the famous "witches' brew" sales slide and the internal documents in which Pfizer's own marketing people referred to Neurontin as "snake oil."
Don't know about handwashing editorials, so I'll grant you that until proven otherwise!
"As the 2009 influenza A(H1N1) virus expands its reach, health officials continue to stress the importance of hand washing as the first line of defense in prevention. Particularly in health care settings, hand antisepsis has long been recognized as a key factor in minimizing the spread of pathogenic microorganisms and limiting health care–associated infections. Yet getting health care workers, including physicians and nurses, to wash their hands remains a problem. In response, new patient safety programs from the Joint Commission and the World Health Organization (WHO) are placing their initial focus on improving compliance with hand hygiene standards.
.On September 10, the Joint Commission launched its Center for Transforming Healthcare, which seeks to identify effective quality and safety practices that can be implemented at a broad range of institutions, said Mark R. Chassin, MD, MPH, Joint Commission president. Its first target: hand cleanliness. “We conducted a little poll giving institutions about 35 of the nastiest quality problems they now face and asked them to identify for themselves what their top problems were,” Chassin said. “The problem receiving the most votes was hand hygiene.” .