“Pharmaceutical company Biopure Corp.’s defamation and trade libel case against a National Institutes of Health official for his statements in an article co-authored for the Journal of the American Medical Association raises concerns about the litigation risks of scientific discourse.” (Sheri Qualters, “Suit Against Scientific Journal Raises Litigation Issues”, National Law Journal, Oct. 31; MassHighTech; Pharmalot).
Gary Charbonneau had a gambling history, including substantial wins, which devolved into compulsive gambling in 2002. He blames this on his Parkinson’s disease medication, Mirapex, which he started taking in 1997. Mirapex changed its warning label to include reports of a correlation while Charbonneau was taking the drug; Charbonneau’s doctor kept prescribing the drug. Nevertheless, Charbonneau was able to persuade a jury that the failure to warn was what was responsible for his $200,000 gambling losses (much of which came from gambling illegally) and resulting marital troubles. The jury verdict even awarded $8 million in punitive damages, giving a whole new meaning to jackpot justice (though one would expect the trial court to reduce this substantially). The only press coverage of this lawsuit, aside from a handful of blogs (Pharmalot; TortsProf; InjuryBoard), is in an op-ed I wrote for today’s Examiner about the case and about how a Supreme Court case and Congressional legislation could affect it. (Theodore H. Frank, “Jackpot justice gets new meaning,” DC Examiner, Aug. 19).
Tim Sandefur asks this only half-facetiously as he reviews mass torts. Of course, as a must-read comment letter to FASB (via the indispensable Beck/Herrmann) submitted by six pharmaceutical companies notes, “A mass tort occurs when the plaintiffs’ bar decides to invest in it.”
The nurse gave the child at least twice as much as the dosage was supposed to be. “Plaintiffs sued everyone in sight” including the manufacturer of the little medicine cup. Would redesigning the little graduated markings on the cup have made a difference? (Beck & Herrmann, Drug & Device Law Blog, Jul. 30).
Justinian Lane crows: Pfizer fined by an Australian trade group! Indeed it was; drug reps went off the reservation of what they were supposed to talk about without telling managers, and exaggerated the health effects of a competing drugs for personal profit. (Note that there was no need for a regulator or plaintiffs’ attorneys to get involved; this was entirely an Australian free-market self-policing arrangement through contractual agreements that fined Pfizer. Lane forgets to mention that part.)
Lane thinks this is a just result worth noting. So let us consider that trial lawyers do the same thing every day: lie about or exaggerate health effects of drugs for profit (just Google the name of any prescription drug to get a lawyer’s ad)–and without the intermediating effects of doctors to assess the claims and correctly inform patients, so it is clearly worse. But the lawyers do so with impunity, with no consequences for the adverse health effects on patients. (E.g., POL June 2007; POL Feb. 12.) There’s no private cause of action; and the trial bar and its professional organizations lionize such tactics, rather than punish them. All we can do is criticize plaintiffs’ lawyers for putting profits before people.
Mark Herrmann has details of Sinclair v. Merck. The decision also suggests that the New Jersey Supreme Court is going to affirm the intermediate McDarby decision rejecting the use of consumer-fraud law for product-liability claims in New Jersey.
Mark Lanier and other plaintiffs lawyers are giving a series of interviews where they complain that the Ernst v. Merck decision (discussed yesterday) is “judicial activism that reinterprets the evidence.” (E.g., in Texas Lawyer.) This is nonsense. Ernst follows well-stated precedent. Indeed, I predicted precisely this result and precisely the case the appellate court would use to strike down the decision the week of the jury’s verdict.
AP reports a Texas court has thrown out the infamous Ernst $26 million judgment; a New Jersey court has tossed $9 million of the judgment in McDarby. More details on Point of Law as available.
Ernst was the first Vioxx suit to go to trial. A jury awarded $253 million. Mark Lanier waited months before asking for a final judgment; at the time, I suggested that this was because he knew the case would be reversed on appeal, and did not want the bad publicity. Indeed, the appellate decision perhaps comes too late for Merck: the number of lawsuits increased from 6000 to 60000 in the months following publicity over the jury verdict, costing Merck billions of dollars in the later extortionate settlement.
With these two decisions, only three plaintiffs’ verdicts in favor of Merck remain.
Update: I still haven’t seen the McDarby decision, but an updated AP story indicates that it upheld the compensatory damages of $4.5 million, overturned the $9 million punitive damages verdict, and overturned the consumer-fraud judgment (which also saves Merck millions of dollars in plaintiffs’ attorneys’ fees).
One of the justifications for FDA preemption is the fear of overwarning; warning overload can be counterproductive, causing people to ignore important warnings. Thus, failure-to-warn litigation impedes safety. See “Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products,” 71 Fed. Reg. 3922 (Jan. 24, 2006); Larkin v. Pfizer, Inc., 153 S.W.3d 758, 764 (Ky. 2004).
Further evidence comes from a CNNMoney.com report (Aaron Smith, “Consumers tune out FDA warnings”, Feb. 25) suggesting that the FDA’s post-Vioxx caution has already caused the agency to be at the point of diminishing returns, as it is averaging 50% more safety alerts a year for 2005-2007 than it did in 2004, the year Vioxx was withdrawn from the market.
I discussed overwarning in other contexts on Overlawyered in Sep. 2006.
Erin Brockovich, the real-life character who brings fictional lawsuits, thinks my criticism of her trolling for clients in Avandia lawsuits is “shameful”. She should know from shameless.
I was very amused by Brockovich’s remark “It is no coincidence that thousands on Avandia now have heart attacks.” Really? Thousands of people who saw Erin Brockovich in the theaters have had heart attacks, and many others have had strokes. Some even contracted cancer! Coincidence, or has Ms. Brockovich put movie royalties ahead of safety?
(Updating and bumping Feb. 4 post about to roll off bottom of page because of new comment activity)
Update, Feb. 8: separately, Merck yesterday settles for $650 million different Medicaid fraud allegations over the marketing of Vioxx and other drugs. The qui tam relator will get a jackpot award of $68 million. [WaPo; DOJ; Merck] The pricing theories at the center of these lawsuits—which hold Merck liable for purportedly charging too little—definitely deserve longer discussion another time.
(Re-posted from Point of Law.)
Point of Law Volokh