June 23, 2008

Fen-phen, wrapping it up

Concluding arguments in the Kentucky fen-phen trial are set for today in a Covington federal courtroom, the issue being whether three attorneys who won a class-action case ripped off their clients when they took $51 million out of the $200 million settlement.

The Cincinnati Enquirer has a wrap-up story, Fen-phen case nears climax," with all its strange elements: The lawyers buying a race horse, the machinations of Cincinnati class-action guru Stan Chesley - granted immunity - and the pain suffered by the clients. (The Enquirer has published a special section: "Prescription for Scandal" featuring all the coverage so far.)

Meanwhile, Florida A&M Law School defends a $1 million contribution from one of the accused, Shirley Cunningham, endowing a chair for himself. Horsehide?

May 30, 2008

Did Merck settle too generously?

The drug company's stunning victory yesterday in two Vioxx appeals has led to speculation that it may have been too generous in reaching a $4.85 billion settlement with many other claimants last November. But the WSJ law blog talks to Kirkland & Ellis product liability specialist David Bernick, who emphatically disagrees:

Bernick explained that at the time Merck made the settlement, it was staring down a flood of cases nearing trial that threatened to overwhelm the company. "At that point, there was a shared incentive to reach a global deal," he says. For that reason, says Bernick, "you can't look at a track record that precedes or follows a settlement because it doesn't capture the dynamic facing a company at that point, which is that it won't be able to defend itself" against an onslaught of cases.

Shorter version: when it comes to mass torts and their settlement value, quantity is its own kind of quality. Can anyone still be confident that such a system yields optimal incentives for either defendants or the lawyers suing them? More: Jane Genova has some interesting thoughts from another defense attorney, this one anonymous.

May 29, 2008

Breaking: Merck wins two more Vioxx reversals on appeal

AP reports a Texas court has thrown out the infamous Ernst $26 million judgment; a New Jersey court has tossed part of the judgment in McDarby. More details 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). The New Jersey court also affirmed Merck's victory in the Cona case against Mark Lanier.

May 14, 2008

Breaking: Merck wins reversal of Garza v. Merck Vioxx $32 million verdict

Per exactly the grounds I predicted, a Texas appellate court has reversed in its entirety the $32 million verdict/$7.75 million judgment in Garza v. Merck (Apr. 23, 2006; Apr. 21, 2006; Aug. 8, 2006 NY Sun op-ed), holding that the expert specific causation evidence was lacking under Merrell Dow Pharmaceuticals, Inc. v. Havner, 953 S.W.2d 706 (Tex. 1997). (Merck & Co. v. Garza (Tex. App. May 14, 2008) and WSJ via Beck). The Ernst oral arguments recently occurred, and one can expect a similar reversal there in the long run.

Garza was one of the plaintiffs intentionally omitted from the Vioxx settlement, so he will take nothing unless the Texas Supreme Court reverses, an unlikely scenario. (Even under the settlement, he would not have been eligible for more than a token $5000 payment, because of the lack of evidence of Vioxx usage.)

That said, the attorneys who brought this meritless, and likely fraudulent, case will likely suffer no disciplinary consequence for inflicting millions of dollars of legal expense upon Merck. It was the nuisance of these legal expenses that forced Merck shareholders to spend $4.85 billion to extract themselves from the meritless litigation.

More: Bloomberg; Reuters; WSJ Health Blog (which has inaccurate trial statistics); WSJ Law Blog.

As I previously noted, plaintiffs had won only 5 out of 32 Vioxx cases scheduled for trial; the Garza reversal reduces that number to 4 out of 32, with the likely promise that the other Texas plaintiffs' verdict will be thrown out as well.

The Shannon Brownlee and Jeanne Lenzer "List"

Shannon Brownlee and Jeanne Lenzer write for Slate and bemoan that Peter Pitts, a former FDA official, and head of Center for Medicine for the Public Interest, was able to speak on a program broadcast on many NPR affiliates that failed to mention his ties to industry. Brownlee and Lenzer identify nothing that Pitts said that was scientifically inaccurate; they just object to the fact that CMPI receives funding from pharmaceutical companies. (In contrast, they lionize the Center for Science in the Public Interest, though CSPI apparently colluded with the plaintiffs' bar in support of bogus lawsuits.)

Brownlee and Lenzer write:

In hopes of making reporters' jobs a little easier, we've created for journalists an international list of prestigious and independent medical experts who declare they have no financial ties to drug and device manufacturers for at least the past five years. We have nearly 100 experts from a wide array of disciplines. E-mail us at Brownlee.Lenzer@gmail.com, and we'll be happy to name names.

Of course, financial ties from "drug and device manufacturers" are not the only source of potential conflicts of interest; many "medical experts" who take no money from drug and device manufacturers are instead receiving substantial money manufacturing quack expert testimony for the plaintiffs' bar falsely condemning pharmaceutical companies for profit. I took Brownlee and Lenzer up on their public offer to share the list and asked to see it, because I thought it would be interesting to see how many of their "nearly 100" could be cross-referenced against testifying experts for plaintiffs, but Brownlee and Lenzner refused to submit the list to independent scrutiny because I work for AEI. Students of game theory know what the refusal to disclose to skeptical sources indicates about the quality of the hidden information; the refusal tells you you can safely assume the worst about the list.

Read all the way to the bottom of the Slate piece for an amusing exchange between Bill Lichtenstein (who reveals that Lenzer only blasted his program on Slate after he refused to profile them on air) and Lenzer complaining that Lichtenstein dared to mention the scandal that forced BMJ to retract a Lenzer hit piece on Eli Lilly at the same time she makes ad hominem attacks on Peter Pitts and Trevor Butterworth without addressing the substance of their comments. To wit, Butterworth notes:

Lenzer, a former physician's assistant turned freelance writer, appears to be of the "industry money corrupts" school of medical reporting. This has its place, but only if an accusation of vested interests can be shown in faulty research methodology and poor statistical methods, or that the drug is pointless or has a greater risk profile than similar drugs without any greater benefit. Otherwise, it's a way of reporting whose bias is at least as bad as the bias it purports to expose precisely because it's unscientific in method; it insinuates corruption without demonstrating it in the data.

Lenzer's bias is evident in her attack on Butterworth. And, speaking of bias, we somehow doubt that Lenzer will ever have the problem that she will write an article that BMJ has to retract in its entirety and apologize for because it was mistakenly too favorable to industry.

Since Brownlee and Lenzer will point this out if they respond at all, my employer, AEI, receives a small portion of its annual budget from pharmaceutical companies. I have previously performed legal work or consulting work for pharmaceutical companies. None of this has previously prevented me from taking public-policy positions opposed by the pharmaceutical industry. Neither AEI nor any of its donors has dictated or sought to dictate the conclusions of any of my work.

May 12, 2008

May 21 at AEI: Off-Label Uses of Approved Drugs: Medicine, Law, and Policy

An important all-day conference at AEI next week:

In the last several years, nearly every major pharmaceutical company has paid hundreds of millions of dollars to settle allegations of illegal "off-label" marketing of drugs. There has been a growing trend of actions by federal prosecutors, state attorneys general, and cooperating trial lawyers to litigate against pharmaceutical manufacturers for allegedly doing too much to promote off-label use of prescription products. Citing recent legal changes mandating exclusion from federal programs after a conviction, many manufacturers say they are forced to settle rather than risk defending themselves--even as prosecutions against individual executives have foundered in front of juries.

At this AEI Legal Center event, experts on both law and health care will present papers on the law, economics, medicine, and public policy of off-label marketing, discussing everything from the abuse of class action mechanisms to implications for the First Amendment and medical malpractice. Speakers include former Food and Drug Administration chief counsel Daniel Troy; former Cephalon general counsel John Osborn; former deputy attorney general George Terwilliger; principal deputy assistant attorney general and acting assistant attorney general for the Civil Division Jeffrey Bucholtz; attorneys Brian Anderson, James Beck, Mark Herrmann, Richard Samp, and Kyle Sampson; law professor Margaret Johns; and AEI scholars John E. Calfee, Theodore H. Frank, and Scott Gottlieb.

Panel I: Off-Label Marketing, R&D, and Medical Practice

Panel II: The Legal Environment from Federal Regulation and Enforcement

Panel III: Distortions from State and Private Enforcement

Panel IV: Legal Implications for Commercial Speech and Medical Practice

Register here. Earlier discussion on POL: Feb. 1; Feb. 19; Mar. 24; Dec. 17; Aug. 31; Aug. 22 (Richard Epstein); Aug. 1, 2006 (state AGs); Mar. 19 (InterMune indictment).

April 24, 2008

Dr. Egilman responds

Our post on the JAMA articles provoked a response by Dr. David Egilman in the comments-section at Shop Floor:

Continue reading   Dr. Egilman responds

April 23, 2008

Warning of Risk is Unavailing to Drug Maker

News inferno reports that Kamie Kendall, a 24-year-old Utah hairdresser has been awarded $10.5 million by a New Jersey jury for damages to her colon following use of the anti-acne drug Accutane. The trial judge refused to allow the jury to consider punitive damages.

Kendall is the third Accutane plaintiff to successfully sue Hoffman-LaRoche over inflammatory bowel disease. In May, another New Jersey jury awarded $2.62 million in damages to a patient who needed to have his colon and most of his rectum removed after taking the drug Accutane. In October, A Florida jury awarded $7 million in damages to another Accutane user who developed the disorder and said Hoffman-LaRoche failed to adequately warn of the drug's risks.

Kendall started taking Accutane at age 12. She was diagnosed with ulcerative colitis at the age of 14, and in 2006 she had her colon removed and now suffers from debilitating diarrhea.

Hoffman-LaRoche is apparently appealing all three verdicts, and insisted that the link between Accutane and inflammatory bowel disease has not yet been proven. In a possibly contradictory statement, however, the company also said that "the Accutane labeling has contained a warning about IBD for more than 20 years."

Accutane may well go the way of Bendectin....

April 17, 2008

The circle of life (Ortho Evra edition)

• Plaintiffs' lawyers make fictional allegation;
• Friendly New York Times reporters who work in conjunction with plaintiffs' lawyers report fictional allegation as fact, ignoring the underlying facts;
• Plaintiffs' lawyers use bootstrapped New York Times article to argue against sensible preemption policies that would benefit consumers but would hurt lawyers.

April 16, 2008

Vioxx: JAMA publishes litigation-support for trial lawyers

The latest issue of Journal of the American Medical Association publishes two pieces by plaintiffs'-side experts (including the infamous Dr. David Egilman (e.g., Oct. 2007; Dec. 2005; Jul. 2005)) slamming Merck over Vioxx studies. Ross/Hill/Egilman/Krumholz accuse scientists of ghostwriting studies for Merck, but as Merck and Reuters note, Egilman et al. are smearing dozens of scientists without factual basis. As one tells the Washington Post:

Continue reading   Vioxx: JAMA publishes litigation-support for trial lawyers