Vioxx Case

December 19, 2006

The other side of the Lilly/Zyprexa story

What the New York Times left out: Lilly's side of the story (and second press release), essentially corresponding to what anyone reading between the lines of the Times' hit piece would conclude:

[T]he Times failed to mention that these leaked documents are a tiny fraction of the more than 11 million pages of documents provided by Lilly as part of the litigation process. They do not accurately portray Lilly's conduct. As part of Lilly's commitment to patients and healthcare professionals, many high-level Lilly physicians and researchers -- along with researchers from outside Lilly -- were engaged for a number of years to study the issue of Zyprexa and diabetes. Leaked documents involving these discussions do not represent an accurate view of company strategy.

And, finally, Lilly deplores the illegal release of select confidential documents. Our concern is that this illegal and selective disclosure of incomplete information will cause unwarranted concern among patients that may cause them to stop taking their medication without consulting a physician. This is the unfortunate result we saw when plaintiffs' lawyers aggressively advertised about Zyprexa in recent years while searching for clients.

Lilly also notes that the labeling does warn about weight-gain and the incidence of diabetes adverse events, and further argues that studies have not shown a causal link between the drug and diabetes. Earlier: Dec. 18.

Posted by Ted Frank at 12:46 AM | TrackBack (0)

December 18, 2006

Mass tort document leaks

This Sunday, the New York Times ran a standard "plaintiffs' lawyer feeds to the Times a cherry-picked set of documents and opening statement alleging a heinous conspiracy that we repeat credulously with a one-line disclaimer saying the defendant denies it" story, this one about Lilly and weight-gain from the anti-schizophrenia drug Zyprexa. Because the Times only gave one side of the story, we can't evaluate it; the evidence adduced seemed much more to me like 20/20 hindsight rather than a smoking gun. But we noticed a striking procedural detail that the Times elided; so did the two defense attorneys behind the new Drug and Device Law Blog. To wit, Lilly claims that the documents were released in violation of a protective order. It's far from clear that this is necessarily so, as James Beck & Mark Herrmann acknowledge, but they note:

Doesn't this happen in virtually all of the mass torts? Courts enter protective orders; defendants produce documents subject to the protective orders; documents are leaked to the press; night follows day.

What surprises us is how infrequently courts seem to care about this. Although documents are often leaked in violation of mass tort protective orders, courts rarely conduct full-scale investigations to find and punish the person who violated the court's order. Why not?

We'd like to see an academic (who might have the time to pursue this) research the mass tort cases (since about 1985 or so, when modern mass torts sprung into being) to determine the percentage of cases in which protective orders have been violated and the number of times courts have tracked down and punished the violator. If, as we suspect, protective orders are routinely ignored, but violators are rarely punished, that fact should influence how courts conduct future cases.

Let me further note that if there is an academic out there interested in studying this empirical question, they should contact me at the AEI Liability Project; I'd be interested in hearing their proposal and possibly funding and/or co-writing a paper.

Posted by Ted Frank at 12:46 PM | TrackBack (0)

December 15, 2006

Merck victory in Alabama Albright case

Gary Albright had multiple risk factors for a heart attack including a 30-year history of hypertension, diabetes, obesity and untreated high cholesterol. An Alabama state-court jury took 90 minutes to decide Vioxx wasn't the cause of his 2001 heart attack. Merck pled a statute of limitations defense, but AP press coverage is unclear how that played out. (h/t) The Merck press release appears to be misdated, since the verdict came today. That's nine out of thirteen jury verdicts for Merck (with one such victory overturned by Judge Higbee).

Posted by Ted Frank at 03:21 PM | TrackBack (0)

December 14, 2006

Merck wins Dedrick federal case

The Dedrick case Michael mentions is the fifth jury victory for Merck in six cases, but, of course, when juries are allowed to award tens of millions of damages, trial lawyers can profitably bring meritless cases if juries get it wrong 15% of the time.

Of the seventeen cases that have been tried or scheduled for trial and are no longer pending, only four have resulted in a plaintiff's verdict. In my opinion, all four plaintiffs' victories suffered from reversible errors at trial, particularly in the admission of conclusory expert evidence. Juries have decided in Merck's favor in eight cases (one of which was overturned and will be retried) and five cases have been dismissed.

Another five cases, previously scheduled for trial, have been withdrawn from the trial calendar by the plaintiffs before the claims could reach trial. More than eleven hundred other plaintiff groups' claims have been dismissed with prejudice. [Bloomberg; WSJ; Merck press release]

Note that Dedrick sought only $200,000 in damages. In "bellwether trials", plaintiffs and defendants each pick their preferred cases to try, and, given the unsavory criminal past of the plaintiff (he had been convicted of bouncing checks) this was likely a case that Merck picked. The comparatively modest damages request was likely an attempt to get a victory so plaintiffs could stem the momentum Merck seems to be obtaining in these cases, a momentum that will only accelerate when appellate courts start ruling on the few plaintiffs' verdicts obtained to date. The question is where the tipping point is when plaintiffs start asking for nuisance settlements for their inventory of increasingly worthless Vioxx cases—or whether plaintiffs can get a jackpot verdict in a state-court jurisdiction that turns the tide.

Posted by Ted Frank at 07:30 AM | TrackBack (0)

Merck wins yet another Vioxx suit

This AP report
summarizes another Merck victory. A Tennessee man's claim that the maker of the withdrawn painkiller should compensate him for his 2003 heart attack has been rejected by a federal jury in New Orleans, the company's fourth victory in five federal trials.

The seven-member jury answered "no" on a verdict questionnaire when asked if evidence showed that Merck failed to adequately warn Anthony Dedrick's doctors of any known risk posed by Vioxx, or that the lack of such a warning was a cause of Dedrick's heart attack.

Merck lawyers had attacked the credibility of Dedrick, 50, of Waynesboro, Tenn., who was seeking $200,000 from the company. Dedrick's own lawyer acknowledged in his closing statement that Dedrick had other risk factors for his heart attack, including tobacco use, high blood pressure, high cholesterol, diabetes and cocaine use...

Merck has reserved nearly $1.6 billion for legal costs related to Vioxx, but has resisted setting aside money to pay jury awards or settlements with plaintiffs. This reminds me of the Bendectin litigation, won by the defendant but nonetheless leading to withdrawal of the product because of the costs of successfully defending it. Stronger arguments for loser-pays rules are pretty hard to come by.

Posted by Michael Krauss at 07:22 AM | TrackBack (0)

November 22, 2006

Vioxx discovery to date

"Merck has produced approximately 22 million pages of documents and a terabyte of data to the [Plaintiffs' Steering Committee], more than 310 depositions have been noticed relating to 168 witnesses, depositions have been taken for more than 145 days and now comprise over 35,000 pages of testimony." — Judge Fallon's November 22, 2006 Order at 3 n. 4.

That order, as expected by even the plaintiffs, refused to certify a nationwide personal-injury class and hinted that even state-wide personal-injury classes could not be certified as a class because of the predominating individualized issues. (Of course, because of the dozens of pre-CAFA class actions that have been filed in various state courts, plaintiffs will get more than one bite at this apple; while Judge Easterbrook's landmark Firestone opinion holds that this would be improper and that such state-court flouting of the federal order could be enjoined, it is unclear whether Judge Fallon will follow that precedent.)

For you complex civil procedure mavens out there, the Plaintiffs' Steering Committee, apparently anticipating defeat in the Fifth Circuit, has taken the interesting and unprecedented tack of asking that the MDL remand the 23(f) appeal back to the transferor courts for resolution by various other circuit courts of appeals, hoping to roll the dice in the Ninth Circuit or a fortuitous three-judge panel elsewhere. Such an extraordinary step would almost certainly violate the law for reasons too arcane to go into without putting the vast majority of readers to sleep, but Judge Fallon has not yet dismissed the idea out of hand.

Public Citizen's Brian Wolfman and Professor Erichson also comment. Class certification issues are still pending for classes seeking medical monitoring relief and "consumer fraud" damages.

Posted by Ted Frank at 05:11 PM | TrackBack (0)

November 15, 2006

Merck Wins Another Vioxx Suit

As the W$J reports, Merck has won another one.

A federal jury on Wednesday cleared Merck of liability for a 2003 nonfatal heart attack suffered by a Utah bank manager who had taken Vioxx for more than 10 months.

Charles Mason, a 64-year-old from Salt Lake County, Utah, switched to Vioxx after years of taking anti-inflammatory drugs because of back pain. He was seeking about $690,000 in lost wages and other damages.

Merck attorneys, in closing arguments Wednesday, said Vioxx had nothing to do with Mr. Mason's heart attack because he took the once-popular painkiller for less than a year and stopped taking it four days before his heart attack.

Mr. Mason's attorney, Ed Blizzard, countered that the drug's effects didn't go away between the Monday that Mason began taking a different painkiller for chest pains and the Friday of his heart attack.

Posted by Michael Krauss at 06:27 PM | TrackBack (0)

November 12, 2006

Study: Naproxen has anticlotting effect similar to aspirin

Maggie Fox has the story for Reuters. You may recall that plaintiffs' lawyers have been dragging Merck over the coals for daring to suggest that a likely hypothesis for the statistically significant difference between Vioxx and naproxen in its VIGOR study was because of the cardioprotective effect of naproxen.

Posted by Ted Frank at 12:42 AM | TrackBack (0)

November 09, 2006

Vioxx litigation update

You might not know that there have been twenty Vioxx cases scheduled for trial by now—nearly every press account scorecard lists only the ten that have gone to verdict or those ten minus the Humeston defense verdict that was mysteriously overturned by Judge Higbee. The real total is 16-4: five cases were dismissed with prejudice by Judge Fallon, and five more were withdrawn by plaintiffs' attorneys before they could result in losses, six resulted in defense jury verdicts, and four in plaintiff jury verdicts, though all of those have strong appellate grounds for, among other things, violations of state and federal expert testimony standards. The West Virginia Record has an excellent interview with Merck defense attorney Ted Mayer. ("Vioxx cases not all big payoffs," Nov. 8).

Posted by Ted Frank at 07:11 AM | TrackBack (0)

October 25, 2006

FDA pre-emption update

As we noted on Mar. 21, the much ballyhooed FDA statement on pre-emption in the preamble of its warnings regulations had no more force of law than the amicus briefs it had been filing for several years, and thus could continue to be disregarded by judges indifferent to the public policy implications. Attorney Stephanie A. Scharf, writing for, notes that that is precisely what has happened in several cases, as courts disagree on whether to apply the FDA position. The matter could go to the Supreme Court, as the differing positions percolate up the appellate ladder. The first appellate court to rule, the Second Circuit, decided against applying the FDA standards in Desiano v. Warner-Lambert et al.

Posted by Ted Frank at 07:40 AM | TrackBack (0)