Vioxx class action in Australia

Australians are launching a class action against Merck over Vioxx:

More than 400 Australians have launched a class action for personal damages from the manufacturers of the anti-arthritis drug, Vioxx.

The drug has been found to increase the risk of stroke and heart attacks, and was globally recalled in September last year.

Law firm Slater and Gordon is bringing the class action against Merck and Co, the American manufacturer of Vioxx and its Australian subsidiary.

Special counsel Richard Meeran says clients have a compelling case for compensation.

“This drug is a defective drug - it increases the risk of heart attack and stroke by a very significant amount,” he said.

“It had been marketed and promoted by the company as being safer than the the alternative drug, when in fact the opposite seems to have been the case.”

Mr Meeran says there is evidence the drug’s manufacturers knew Vioxx posed a risk.

“Vioxx was recalled last year at the end of September by the company because the company’s own study has shown that users of Vioxx has a significantly increased rate of cardiovascular problems,” he said.

“We’re not seeking specific amounts for any body - as I said the amounts will vary and I wouldn’t want to put figures on the amounts of damages for that reason because they’ll be so variable,” he said.

Source: ABC News Online

Pfizer starting huge Celebrex study

BusinessWeek Online is reporting that Pfizer is searching for a definitive answer on celebrex by funding a “multiyear, $100 million study to finally find out if the painkiller is safe.”

“The study, being run independently by the clinic, will compare three drugs: Celebrex (the Cox-2 drug from Pfizer), ibuprofen (sold under the brand name Motrin), and naproxen, sold under brand names such as Alleve.”

The study should answer a big question: Were the cardiovascular problems seen with the withdrawn painkiller Vioxx unique to that drug or a common problem for all so-called Cox-2 inhibitors? Merck pulled Vioxx from the market in the fall of 2004 after a study confirmed it was linked to a higher risk of cardiovascular problems, including heart attacks.

Celebrex fell under similar suspicion in December, 2004, when one Pfizer’s studies showed a possible link to increased cardiovascular risk at higher doses. Those fears have hammered the drug’s sales. This year Celebrex is expected to bring in just $1.7 billion in revenue, according to SG Cowen analyst Stephen M. Scala, vs. $3.3 billion in 2004.

The study should provide a wealth of information to individuals wrestling with how to treat their arthritis. The trial will focus on people with heart disease or at high risk for it. All patients will be given low-dose aspirin, which is a typical treatment for people with heart problems, as well as the drug Prilosec, to reduce stomach acid.

It’s “a risky study for Pfizer. It could find that Celebrex does pose a cardiovascular risk, and that would doom the product.”

Vioxx study data knowingly skewed

An editorial in the New England Journal of Medicine claims that “authors of a study funded by Vioxx maker Merck & Co. failed to disclose in a report published in the New England Journal of Medicine in 2000 that three additional patients in a clinical study suffered heart attacks while using the now-withdrawn painkiller,” according to AP Business writer Linda A. Johnson.

The editorial, written by the journal’s editor in chief, Dr. Jeffrey M. Drazen, executive editor Dr. Gregory D. Curfman and managing editor Stephen Morrissey, also alleges the study’s authors deleted other relevant data before submitting their article for publication.

“Taken together, these inaccuracies and deletions call into question the integrity of the data on adverse cardiovascular events in this article,” the doctors wrote. Excluding the three heart attacks “made certain calculations and conclusions in the article incorrect.”

For the rest of the article, click the above link.

News on the upcoming Vioxx trial

Vioxx users will challenge safety claims, according to Yahoo! News:

HOUSTON - Whether the once-popular painkiller Vioxx can be lethal if taken for just a few weeks will be the crux of the first federal trial concerning the drug’s safety, plaintiff’s lawyers said Wednesday.

Jere Beasley and Andy Birchfield, the Montgomery, Ala., lawyers representing the widow of a man who had a fatal heart attack a month after taking Vioxx, said they intend to skewer Vioxx-maker Merck & Co.’s contention that the drug can’t cause heart hazards unless taken for 1 1/2 years or more.

“The 18-month myth is something Merck has manufactured to avoid liability,” Birchfield said.

“Beasley and Birchfield aim to show a jury some of Merck’s own studies among 58 clinical trials conducted before Vioxx went on the market in 1999 that revealed increases in heart attacks or other cardiovascular problems after a few weeks’ use.”

Here’s some background:

The first federal case involves the May 2001 death of Richard “Dicky” Irvin, a 53-year-old manager of a wholesale seafood distributor in St. Augustine, Fla. He got a prescription for Vioxx from his son-in-law, an emergency room doctor, to alleviate back pain and had a fatal heart attack about a month later.

His wife, Evelyn Irvin Plunkett, contends the drug caused a blood clot to form in one of his coronary arteries, leading to the heart attack. She also alleges that Merck knew years before Vioxx went on the market that the drug could be dangerous but downplayed those concerns to profit from the $2.5 billion seller.

Merck claims in court papers that Vioxx couldn’t be responsible for Irvin’s death because he took the drug for such a short time. The company also says it believed Vioxx to be safe until the 2004 study prompted the drug’s withdrawal.

Birchfield said plaintiffs expect Merck to focus on Irvin’s autopsy, which notes he had moderate to severe clogged arteries. Birchfield said one of those coronary arteries, near where the clot was found, was 60 percent blocked.

Class action kings move to NY

TheLawyer.com is reporting that “Houston-based Lanier Law Firm has launched in New York with four lawyers, with the aim of expanding the presence to eclipse its headquarters within three years.”

Officially opened today (16 November), the mid-town Manhattan office of the class action specialists will be overseen by resident head Richard Meadow, who will be supported by three attorneys and five administration staff.

Founding partner Mark Lanier said the firm hoped to rapidly increase the size of the office, with the “expectation to have that eclipse the size of our Houston office within three years.” The Houston office consists of 24 lawyers and 50 additional support staff.

Lanier plans to divide his time between Houston and New York to facilitate this expansion, which will focus on increasing the firm’s client litigation practice, including pharmaceutical, product liability and toxic tort claims.

The New York office is the firm’s second presence, after its Houston headquarters was launched in 1990.

Lanier shot to fame earlier this year, after winning a $253m verdict (the first in the US) against Merck & Co, the maker of Vioxx, an arthritis drug that was found to increase the risk of heart attack.

Next Vioxx case will be tough for Merck, lawyers say

AP Business Writer Linda A. Johnson reports:

TRENTON, N.J. - The next Vioxx product-liability case to come to trial in New Jersey will likely be a tougher battle for manufacturer Merck & Co., which last week got its first courtroom victory in a case involving short-term use of the now-withdrawn painkiller.

New Jersey Superior Court Judge Carol Higbee, who is overseeing about 3,500 Vioxx lawsuits filed in New Jersey — half the suits filed to date — has told attorneys she wants the next group of trials to involve plaintiffs who took the drug for 18 months or more. Plaintiff lawyers said the judge appears to want to determine how such cases will play out in an attempt to encourage the settlement of some lawsuits.

Whitehouse Station-based Merck has admitted Vioxx doubled risk of heart attacks and strokes after use for 18 months or longer; it pulled the blockbuster arthritis pill from the market in September 2004 after its own research showed that.

Cases with such long-term use will be harder for Merck to defend, although plaintiffs still have the heavy burden of proving Vioxx caused them harm, plaintiff lawyers say.

“If there’s any case that should truly be indefensible, it’s the 18 months and over (case) because Merck has conceded that,” said lawyer Chris Seeger.

Cases involving long-term use of Vioxx make up about 60% of the cases on Higbee’s docket. One lawyer was quoted as saying he still thinks “cases involving short-term Vioxx use are winnable, partly because one Harvard study showed cardiac risks developed within 30 days of Vioxx use.”

Asbestos bill meeting next Thursday

Here’s the latest on the asbestos bill, from TheHill.com:

An upcoming Senate Judiciary Committee hearing on asbestos-injury-liability reform will give Chairman Arlen Specter (R-Pa.) a chance to counter a critical report about his bill and rejuvenate his effort to move the legislation forward.

The hearing, scheduled for next Thursday, could be viewed as a response to a recent report by the economics-consulting firm Bates White, which concluded that Specter’s proposed trust fund to pay asbestos claims will go bankrupt.

[…]

Specter’s decision to call a hearing on a bill his committee has already marked is a break with the Senate’s usual practice. He could be seeking to repair any damage the Bates White report may have inflicted on his legislation’s future.

If the trust fund were to run dry, the legislation would allow claimants to file lawsuits. Politically, however, it could prove difficult for Congress to allow a trust fund to disappear. The federal government could be left to foot the bill itself or squeeze additional money from the private sector.

Specter’s hearing will include analysts who will no doubt impugn the Bates White study, which the conservative American Legislative Exchange Council commissioned. Other independent reports have drawn more optimistic conclusions about the fiscal soundness of the fund.

[…]

Specter originally scheduled the hearing for Monday. Sources said he moved it back amid complaints that committee members and others would sparsely attend a hearing on a Monday — a day Senate committees rarely convene.

For the entire article, visit Judiciary panel to revisit asbestos by Jeffrey Young at TheHill.com.

Merck heads to the feds over Vioxx

Here’s the latest on the Vioxx debacle:

HOUSTON - With Merck & Co. now 1-and-1 in state lawsuits over its Vioxx painkiller, the nation’s No. 5 drug maker may face higher stakes later this month in the first federal trial of charges that it knowingly rushed a potentially lethal drug to market to pocket billions in profits.

“They have a fresh crack at it in a court that is a very important court,” said Benjamin Zipursky, a professor at Fordham Law School in New York. “For Merck, reputationally, investors will look at what happens in federal courts as a signal of the strength of the goods on Merck.”

The federal Vioxx trial is scheduled to begin Nov. 29 in Houston, just 40 miles north of the state court where Texas jurors last August slapped Merck with a $253 million verdict in the first Vioxx trial in the nation. Texas caps on punitive damages will cut that amount to no more than $26.1 million.

This is from Yahoo! News. Here’s more from CNN.com.

Breakdown of Vioxx suits

Here’s a breakdown of the Vioxx-related suits filed so far:

More than 5,000 product liability lawsuits, nearly all of them personal injury lawsuits, have been filed against Merck. They include:

_1,811 federal lawsuits consolidated for pretrial coordination to streamline steps common to the cases, such as document gathering and witness depositions.

_More than 290 federal lawsuits pending but not yet consolidated with the others in what’s called multidistrict litigation.

_More than 250 cases pending in California state courts.

_About 2,475 cases pending and coordinated under one judge in Atlantic County, New Jersey.

_More than 200 cases pending in state courts elsewhere.

The above categories include 148 potential class-action cases, which could eventually include many plaintiffs if judges certify them as class actions. A handful of those cases involve union health plans, insurers and other third-party payers to seek reimbursement of money they paid for Vioxx for their prescription plan members. One such class action suit filed by a New Jersey union has been certified.

Class Action Could Mean Billion-Dollar Exposure for Merck

A new Law.com article (reprinted from the New Jersey Law Journal) is discussing how NJ’s Consumer Fraud Act will be bad news for Merck:

After Merck & Co.’s devastating loss in Texas several weeks ago in the first Vioxx case to go to a jury, the nation’s eyes now turn to Atlantic City, where New Jersey’s first case is set for trial on Sept. 12.

There are about 5,000 personal injury suits filed nationwide, about half in New Jersey, over the Merck painkiller that has been linked to increased risk of heart attack or stroke, but lurking behind those thousands of cases is a single one that could pose the greatest danger to America’s third-largest drug company.

On July 29, in the midst of the trial in Texas, New Jersey Superior Court Judge Carol Higbee certified a national class action covering every private third-party payer that allowed members of its health benefits plan to buy Vioxx.

With 20 million Vioxx users in the United States alone since 1999, Merck’s exposure could be well into the billions if it loses the case, International Union of Operating Engineers Local 68 Welfare Fund v. Merck & Co. Inc.

The majority of Vioxx purchases were through plans run by insurance companies and health maintenance organizations.

Unlike the thousands of individual personal injury claimants, Local 68 lawyers don’t have to prove that anyone suffered injury. The suit was filed under New Jersey’s plaintiff-friendly Consumer Fraud Act, under which all that need be proved is that the third-party payers were influenced by unconscionable Merck business practices — primarily deceptive marketing and promotion of Vioxx, either affirmatively or by omitting data such as the possibility of heart attacks.

The Consumer Fraud Act does not require proof that the buyer relied on the allegedly false advertising or that there is a specific causal link between a purchase and the marketing: only that there was a “causal nexus between the concealment of the material and the loss.”

If the engineers’ union wins, all third-party payers nationwide can recoup payments to the company, and under the CFA they are entitled to collect treble damages as well as attorney fees.

For the rest of the article, click here.

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