How a law firm races to repair its Vioxx files

How a law firm races to repair its Vioxx files
Wednesday, February 15, 2006By Heather Won Tesoriero, The Wall Street Journal
Hurricane Katrina destroyed a lot of things, but some of the most difficult to replace are legal files.
That is the dilemma facing the New Orleans law firm of Herman, Herman, Katz & Cotlar. The firm oversees a repository for 10 million documents relating to federal litigation of Merck & Co.'s painkiller drug Vioxx -- including medical reports, depositions and emails -- that plaintiffs' lawyers are permitted to use. Those documents were housed on the 43rd floor of an unharmed office building during the hurricane and stayed dry.
But many of Herman's own 125 federal Vioxx cases were waterlogged, and the firm is scrambling to recreate those documents to meet a court deadline Thursday to turn over files for 90 of those cases to Merck's defense team. That means using a private investigator to track down many plaintiffs whose homes were destroyed, and for whom litigation is the last thing on their minds.
A typical response from plaintiffs once they are found: "'I hadn't even thought about that. I've been busy trying to get things like shoes,'" recalls private investigator Anthony Valenti, a 67-year-old retired police officer.
The law firm is operating with half of its 65-person staff since it returned to temporary offices in the Big Easy in early January. Several employees lost everything, including Leonard Davis, a partner at the firm, and his paralegal.
"We're having a hell of a time," says partner Russ Herman. "We've got medical records destroyed at three hospitals that don't exist anymore."
Merck withdrew Vioxx from the market in Sept. 2004 after it was linked to an increased risk of heart attacks and strokes. The Whitehouse Station, N.J., drug giant faces 9,650 Vioxx cases in state and federal courts.
Katrina has caused other serious problems for the 4,350 federal cases consolidated under U.S. District Court Judge Eldon E. Fallon in New Orleans. The first federal Vioxx trial was relocated to Houston after the hurricane, and ended in a mistrial in December. The retrial started in New Orleans on Feb. 6.
The Herman firm plays a critical role in the federal Vioxx litigation at large. It was appointed by Judge Fallon to serve as an intermediary between the court and plaintiffs' attorneys around the country.
After the storm, the Louisiana governor extended the deadline for filing a case. After that, lawyers have 75 days to turn over files that include questionnaires filled out by plaintiffs and their medical records. The deadline for the Herman firm to submit completed forms to Merck is Thursday -- otherwise, Merck can ask the court to dismiss the cases. Merck liaison counsel Phil Wittmann says Merck has "routinely granted extensions to Mr. Herman and other Louisiana counsel in cases where they've had trouble completing the forms due to Katrina....If Mr. Herman calls me and explains what his problem is, we will grant his extension."
Following the storm, Herman sent letters to clients asking them to send information on their new locations. Almost no one responded. Mr. Valenti started tracking them down using credit card numbers, motor vehicle records and cellphone numbers. He located one plaintiff by obtaining the name of the man's auto insurer from motor vehicle records. The client had been in a car accident and was found living in Brookhaven, Miss.
Since many doctors' and hospitals' records were destroyed in the storm, Herman has been reaching out to third party companies that archive medical records, and even photocopy companies to see if they have them.
Mr. Herman says he is frustrated that he's been unable to locate Allen Rosenzweig, his jury consultant. Mr. Herman told Mr. Valenti, the private investigator, that Mr. Rosenzweig's father was a tailor named Murphy and his mother was named Florence, and he joked that the jury consultant "was crazy enough to be on the top of a roof someplace." Mr. Valenti, the private investigator, came up with a post office box in Kenner, La., and a phone number. The voice on the answering machine said it was Mr. Rosenzweig, but the jury consultant still hasn't been found.
A week after the storm, Herman staffers returned to the damaged office and pulled out essential files -- even those that were yellowed and moldy, Mr. Davis says. "We pick ourselves up and we move on and keep doing what we know how to do," he says.
Mr. Davis recounts a humbling moment when he called Judge Fallon to tell him: "Judge, I'm not going to be able to file that brief today. I don't even have a stapler." Mr. Davis says he and Judge Fallon laughed about the predicament.

Merck's first witness testifies in Vioxx trial

NEW ORLEANS Merck began its defense of its once-popular pain reliever Vioxx in a New Orleans courtroom yesterday, discussing internal studies that suggested the drug would not cause heart trouble.Merck research doctor Briggs Morrison said while Vioxx seemed to reduce an enzyme that keeps blood flowing, Merck studies on rabbits injected with Vioxx showed that enzyme was not present in blood vessels, and therefore would not lead to heart attacks.
Testimony will continue today in first federal Vioxx lawsuit, after an earlier trial over the death of Floridian Richard "Dickie" Irvin ended in a hung jury.
Irvin's widow claims Merck rushed Vioxx to market and hid its dangers from the public.
Merck says Irvin had a history of cardiac trouble.

Scientists cross-examined in Vioxx retrial

Using a big black, red and yellow chart labeled "Merck Knew But No Warning" to emphasize his points, a plaintiff's attorney cross-examined a top scientific executive for the drug company Thursday, as the first federal Vioxx trial neared its second closing.
U.S. District Judge Eldon E. Fallon, who is retrying a case that ended with a hung jury, told jurors that attorneys hoped to wind up evidence Thursday. In this case, Evelyn Irvin Plunkett contends that taking the drug for a month caused the heart attack which killed her husband Richard "Dickie" Irvin in May 2001, and that manufacturer Merck & Co. hid the drug's dangers.
For nearly four hours, Andy Birchfield asked Alise Reicin, vice president of clinical research at Merck, about two studies in which patients taking Vioxx had more heart attacks than those in comparison groups, and about related events.

The first study, called VIGOR, was reported to the U.S. Food and Drug Administration in 2000, but the heart attack information was not added to the Vioxx label until 2002. The second study, called APPROVe, prompted Merck to pull the drug from the market in September 2004.
The New England Journal of Medicine criticized VIGOR's authors in an editorial published online the day that the first jury began deliberations, saying they failed to mention three heart attacks among patients who were taking Vioxx.
Reicin said the company did report them to the FDA, but didn't feel it had to tell the journal because they didn't significantly change the results. With either set of figures, she said, rounding would have made the "relative risk" figure the same.
The figures reported to the journal were 17 heart attacks among patients on Vioxx and four among those taking another drug, called naproxen, or 4 1/4 times as many. The additional three changed that to 20 and four, or five times as many.
Merck, saying that the difference was probably because naproxen kept blood clots from forming, framed it as a reduction in the likely risk. Rounding off made that the same in either case, Reicin said: "a fivefold difference."
"And we highlighted those results in that paper," she said.
In earlier videotaped testimony, the journal's executive editor, Dr. Gregory Curfman, said the numeric difference was of great interest to the journal and its readers, and should have been reported to keep the article up to date.
"You withheld these three myocardial infarctions from the New England Journal of Medicine," Birchfield said.
That was "mischaracterization," Reicin said.
"You never gave it to them," Birchfield said.
That was because the earlier analysis already showed a significant difference, Reicin said. "Had these changed the conclusions, I think we would have thought differently about it. But it didn't change the conclusions."
She also repeated Merck's contention that it asked the FDA that year to approve a new label, but the approval process took two years.
A plaintiff's expert testified earlier that a label's warning can be strengthened without getting approval first from the FDA. Reicin said she wasn't aware of that.

Industry Insider: Merck takes the offensive to lay civility ground rules

Merck sure picked a funny way to ask that its opponents observe rules of civility in an upcoming Vioxx trial in Atlantic City.
In a motion filed earlier this month, the drugmaker slagged Houston attorney Mark Lanier's conduct last summer during the Ernst trial in Texas, the first Vioxx case to go to a jury. Lanier won a $253.4 million judgment against Merck, although that amount is expected to fall to $26 million on appeal.
He will be lead attorney again in a dual trial in New Jersey Superior Court involving plaintiffs Thomas Cona and Robert McDarby, which is scheduled to begin early next month.
In its brief, Merck listed 14 "infractions" by Lanier in the earlier trial. The alleged sins included arguing with witnesses, offering personal views on the truthfulness of certain witnesses and references to Lanier's out-of-court roles as a part-time preacher and family man.
The pharmaceutical company's defense team also cited a recent ruling by U.S. District Court Judge Eldon Fallon, who is overseeing federal Vioxx cases, that denied the live playback of a deposition Lanier took. "It's just the tone and the smirking and the laughter that has no place in federal court," the judge said.
Merck attorneys seemed to recognize that pummeling an opponent preemptively was an odd way to promote rules of decorum. In their motion to Superior Court Judge Carol Higbee, they offered "apologies for the undesired (but, Merck believes, necessary) itemization of infractions."
For his part, Lanier said he could have filed similar citations on the behavior of Diane Sullivan, one of Merck's co-counsels in a Vioxx case brought by Frederick Humeston, which the drugmaker won in Atlantic City last fall. Sullivan clashed with Higbee several times, and once with a member of her own legal team.
"Merck doesn't need to worry, because I'm going to conduct myself within the rules of the court," Lanier said in a phone interview. "Different judges have different rules."
-- Jeff May
Who let the dogs in? In a victory for animal rights activists, the Securities and Exchange Commission ruled this week that Pfizer must allow a vote on an animal testing resolution at its stockholder meeting this spring.
People for Ethical Treatment of Animals has asked Pfizer to adopt resolutions that call for stepped-up protections for animals used in laboratory testing. Pfizer asked the SEC to declare the resolution ineligible for consideration.
"We're thrilled that the SEC agreed that shareholders have a right to vote on this issue," said PETA's director of regulatory testing, Jessica Sandler.
Over the past year, PETA has used shareholder meetings as a protest forum. Its resolutions typically lose by wide margins, but the group is happy just to get its issues before shareholders and the media.
In a letter to the SEC, Pfizer said PETA's request was "vague and indefinite" and that "the animals cannot communicate to Pfizer" that their "psychological, social and behavioral needs be met."
-- George E. Jordan

New pain relievers boost blood pressure more

ISLAMABAD: Arthritis drugs known as COX-2 inhibitors raise blood pressure more than older pain relievers, which may explain why the newer medicines have been linked to heart attacks, Australian researchers reported.
The increases were small and varied among the different COX-2 drugs. The risk seemed highest with Merck & Co. Inc.’s Vioxx, the researchers said after reviewing data from more than 45,000 people in 19 studies. Merck pulled Vioxx from the market last September.
The study was published online on Monday by the Archives of Internal Medicine.
The safety of pain relievers is under scrutiny from regulators. A U.S. advisory committee will review the medicines at a three-day meeting starting on Wednesday.
The Archives of Internal Medicine said it released the findings early because they were relevant to the meeting.
One of the authors of the new study, Henry Krum, said the blood pressure increases seen with the COX-2 drugs were small, but they may be enough to help spur heart attacks.
"One could draw the conclusion the elevations in blood pressure are contributing to the increase in cardiovascular risk," said Krum, director of the National Health and Medical Research Council of Australia’s Center of Clinical Research Excellence in Therapeutics.
Some COX-2 inhibitors, as well as older pain relievers called nonsteroidal anti-inflammatory drugs or NSAIDs, had already been linked to higher blood pressure.
The new study was designed to determine if the widely used COX-2 drugs raised blood pressure more than NSAIDs such as ibuprofen and naproxen. The COX-2 drugs studied were Merck’s Vioxx and Arcoxia and Pfizer Inc.’s Celebrex.
On average, systolic blood pressure -- the upper number of a blood pressure measurement -- was 2.83 millimeters of mercury higher with COX-2 inhibitors than with NSAIDs. Diastolic pressure -- the lower number -- was 1.34 millimeters of mercury higher with the COX-2 drugs.
Vioxx "clearly is the most dramatic in elevating blood pressure," while Celebrex "looks pretty clean," Krum said.
The data on Arcoxia, which is approved in some countries but not the United States, were too limited to draw conclusions, Krum said.
Merck spokeswoman Casey Stavropoulos noted the study was an analysis of previously published research. "There will be a more complete review of selective COX-2 inhibitors and blood pressure at the (Food and Drug Administration) committee meeting later this week," she said.
COX-2 inhibitors were developed with the hope they would reduce pain as much as NSAIDs while being gentler on the stomach. NSAIDs can cause potentially fatal stomach and intestinal bleeding.
Only Vioxx has been shown to produce fewer serious gastric problems than NSAIDs. Vioxx was pulled after a study showed the drug doubled heart attack and stroke risk in patients who took it for at least 18 months.
"Clinicians need to weigh the risks of improved gastrointestinal safety versus potential hazards of developing elevated blood pressure when considering the use of these agents, especially in the elderly population," Krum and his colleagues wrote.
The research was funded by grants from Australia’s National Health and Medical Research Council and the Royal Australasian College of Physicians.
Krum has received consulting fees from Pfizer, Merck and Novartis -- all makers of COX-2 inhibitors. Another of the study’s authors was a consultant to Pfizer.

RIAA et al. says CD ripping, backups not fair use

If anyone has any doubts about the content industry's resolve to destroy fair use and usher in new ways of charging you for uses that were previously both free and fair, look no further. As part of the triennial review of the effectiveness of the DMCA, a number of content-related industries have filed a joint reply (PDF) with the government on the effectiveness of the DMCA and the challenges that lay ahead for copyright. As you might expect, the document is a celebration of the DMCA, and the industries are pushing for even more egregious abuses of technology to fatten up their bottom lines.
With regards to the argument that the DMCA is bad law because it prevents users from making backups, the joint reply dismissed such arguments as "uncompelling." First, they argue that there is no evidence that "any of the relevant media are 'unusually subject to damage in the ordinary course of their use.'" This "cart-before-the-horse" argument suggests that people do not need to backup anything that does not have a high failure rate—a view that fundamentally misunderstands the purpose of backups. Furthermore, they argue that the success of DVD sales vis-à-vis VHS demonstrates that whatever problem there might be, it's not big enough to matter to consumers, because DVD sales are skyrocketing while VHS isn't. Thus high sales volumes are indicators that the consumer are well served, which is an argument that we'll hope never takes hold in the pharmaceutical industry (Vioxx sure did sell well!).
Such are the lengths they will go through in order to keep the anti-circumvention provisions of the DMCA intact. But supporting the status quo isn't in their interest. No, the idea is to embrace and extend. To wit, the joint reply also argues that making backups of your CDs is also not fair use.
The [submitted arguments in favor of granting exemptions to the DMCA] provide no arguments or legal authority that making back up copies of CDs is a noninfringing use. In addition, the submissions provide no evidence that access controls are currently preventing them from making back up copies of CDs or that they are likely to do so in the future. Myriad online downloading services are available and offer varying types of digital rights management alternatives. For example, the Apple FairPlay technology allows users to make a limited number of copies for personal use. Presumably, consumers concerned with the ability to make back up copies would choose to purchase music from a service that allowed such copying. Even if CDs do become damaged, replacements are readily available at affordable prices. Similar to the motion picture industry, the recording industry has faced, in online piracy, a direct attack on its ability to enjoy its copyrights. (emphasis added)
As you can see, the argument is hinged partially on the cost of replacements. Why should you be allowed to make backups of CDs you've purchased when you can replace them? And why should CD backups be legal when users can already decided to purchase from (DRM-laden) services that do allow the limited copying of lossy music files? Here, again, we see the way in which the RIAA et al. would like to see contract law take over the domain of fair use. "Leave it up to DRM, you big dummies!"
But they're not done with that argument. The real kicker is buried in a footnote, where the joint reply suggests the unthinkable: that making copies of CDs for any purpose may, in fact, be infringement.
Nor does the fact that permission to make a copy in particular circumstances is often or even "routinely" granted, see C6 at 8, necessarily establish that the copying is a fair use when the copyright owner withholds that authorization. In this regard, the statement attributed to counsel for copyright holders in the Grokster case, is simply a statement about authorization, not about fair use.
Allow me to translate: just because people have been copying CDs in the past doesn't mean that that they had the authorization to do so, and a general trend does not override such explicit authorization. But as the EFF has picked up, the RIAA is engaging in a little historical revision. Their last comment about the Grokster case is attempting to change the substance of comments that were uttered by their own legal counsel. Why they would do this is abundantly clear when you see the statement in question:
"The record companies, my clients, have said, for some time now, and it's been on their website for some time now, that it's perfectly lawful to take a CD that you've purchased, upload it onto your computer, put it onto your iPod."
It looks like someone is having a change of heart.
In the world of the joint reply, if and when the RIAA and its member studios say that copying your CDs is not permitted, then it's not permitted. Forget fair use. Forget historical precedent. The joint reply here is arguing that copyright owners have the authority to deny what has become fair use—what their own lawyers have admitted is fair use in front of the Supreme Court of the United States. The upshot is that this argument suggests that the most common form of CD "copying"—namely ripping CDs for use on computers and portable players—is not necessarily fair use. The joint reply adds:
Similarly, creating a back-up copy of a music CD is not a non-infringing use, for reasons similar to those the Register canvassed in detail in her 2003 determination that back-up copying of DVDs cannot be treated as noninfringing. [Ed note: see above arguments.] While we recognize that access controls may in some circumstances affect copying, the fact remains that there is no general exception to the reproduction right to allow back-up copying (except the limited exception in § 117 for computer programs) and thus no justification for allowing circumvention of access controls for this purpose.
Inasmuch as the joint reply was grafted in defense of the DMCA, it remains unclear if the RIAA has any plans to take up this line of argument in front of legislators or the public. It does mark, however, yet another development in the erosion of fair use, and it demonstrates that the insidious notion of "customary historic use" stems from part of the industry's campaign to legislate new business models that fly in the face of fair use, the doctrine of first sale, and limited copyrights.