Friday, July 6, 2007
Article in the New York Times -- Judge Rejects Merck’s View on F.D.A. Issue, by the Associated Press. Here's an excerpt:
Food and Drug Administration approval of a drug label does not clear the manufacturer of claims that its warnings were inadequate, a judge ruled in a decision that could potentially affect thousands of federal suits against Merck over the painkiller Vioxx.
“The F.D.A.’s current view on the question of immunity for prescription drug manufacturers is entirely unpersuasive,” Judge Eldon E. Fallon of Federal District Court wrote in the opinion, handed down Tuesday.
Had Judge Fallon sided with Merck, the drug company could have challenged claims brought by thousands of other plaintiffs who say it is to blame for heart attacks and other cardiovascular problems.
Wednesday, June 6, 2007
Judge Eldon Fallon (E.D. La.), who is overseeing the Vioxx MDL, yesterday ordered remittitur in the Barnett case. Last year, the plaintiff won a verdict of $51 million ($50 million compensatory plus $1 million punitive). The court found the amount excessive and, last August, ordered a new trial on damages. Yesterday, the court amended its order. At plaintiff's request, the court granted remittitur (obviously it's unusual for a plaintiff to ask for remittitur, but in this case the alternative was a new trial on damages). Specifically, the court ordered a new trial unless the plaintiff accepted a reduced damage award of $1.6 million ($600,000 compensatory plus $1 million punitive); the judge determined that $600,000 was the highest amount a jury could reasonably have awarded for compensatory damages. Here's the AP story in the Houston Chronicle -- Vioxx Plaintiff Can Get Damages or Retry.
Friday, June 1, 2007
The wrongful death case of Plunkett v. Merck simply won't end. The first Vioxx case to go to trial in federal court, it resulted in a hung jury in 2005. At the retrial in 2006, Merck won an important defense victory. But two days ago, Judge Fallon granted a new trial based on the revelation that one of Merck's expert witnesses had misrepresented his qualifications. Here's an excerpt from the story in the Houston Chronicle by Janet McConnaughey of AP -- Judge Orders New Vioxx Trial:
A federal judge has ordered a third trial in a lawsuit by a woman who blamed Merck & Co.'s painkiller Vioxx for the heart attack that killed her husband. A cardiologist who testified for Merck misrepresented his qualifications in the second trial last year, U.S. District Judge Eldon Fallon ruled. Jurors in that trial ruled in favor of Merck and against Evelyn Irvin Plunkett, whose first husband, Richard "Dickie" Irvin, died of a heart attack after taking Vioxx for less than a month.
Tuesday, April 24, 2007
Article in the New York Times -- Medicine and the Drug Industry, a Morality Tale, by Abigail Zuger, M.D. Here's an excerpt:
Less familiar may be some of industry’s other friendly overtures: the lavish junkets and cash rewards for some “high-prescribing” doctors; the subtle manipulations of research data; the way-too-generous financing of postgraduate medical education; the very cozy relationship with the Food and Drug Administration and its physician consultants; and a casually Orwellian interference with the average physician’s prescription pad.
A drug salesman recalls for Dr. Brody the time his company asked a local doctor to evaluate various sales presentations for a particular drug: “He’d been selected because our data showed that he was a relatively low prescriber. ...Basically, the company was willing to bet $500 or $750 that if he heard the same drug pitch all day, by the end of the day he’d be so brainwashed that he could not possibly prescribe any other drug but ours.”
All this mutual back-scratching would be fine if patients’ interests were indeed being served. But ample data indicates quite the reverse. Patients, after all, are the ones who pay for expensive drugs when cheaper would do as well, and the ones who swallow dangerous drugs nudged to market by their manufacturers.
The epitaph of the recently withdrawn painkiller Vioxx, whose virtues were subtly spun to the medical community in prestigious research journals, is still being written in litigation around the country.
“Research that is driven by marketing rather than by scientific aims would seem, in the end, to be low-quality research,” Dr. Brody comments mildly about the Vioxx fiasco.
Thursday, April 19, 2007
Article in the Washington Post -- Merck Net Jumps 12 Percent, by Linda A. Johnson of the Associated Press. Here's an excerpt:
Merck & Co. Inc. said Thursday its first-quarter profit jumped 12 percent, as the drugmaker posted sharply higher sales of its asthma and cholesterol drugs, plus one-time gains from product divestitures.
Meanwhile, the number of personal injury lawsuits in the massive litigation over the painkiller Vioxx, which Merck withdrew from the market in September 2004 due to increased risk of heart attack and stroke, declined slightly for the first time.
Merck said it now faces 27,250 personal injury lawsuits over Vioxx, including 45,700 plaintiff groups. That's actually down slightly from the 27,400 Merck reported in January. The company said more than 4,600 lawsuits had been dismissed as of March 31, although 3,550 of them could be refiled later.
Merck also has agreements with 13,700 claimants halting the statute of limitations for them to sue. The company has been fighting lawsuits individually, and in cases that have reached verdicts, it has won 10 and lost five.
Tuesday, April 17, 2007
According to this article in the Houston Chronicle -- Judge Casts Doubt on Vioxx Point -- Texas judge Randy Wilson plans to dismiss Ruby Ledbetter's failure to warn claim against Merck, while allowing her to proceed on other claims such as negligence and product defect. Judge Wilson has all of the Texas state court Vioxx cases, so the ruling has broad implications:
If a Harris County judge is right, a 2003 Texas law could not only gut the nearly 900 Vioxx cases pending in this state, but it could raise the bar for pharmaceutical cases of any kind here.
State District Judge Randy Wilson, who oversees all state Vioxx claims, told lawyers in the case of Ruby Ledbetter versus Merck & Co. that he plans to issue an order later this week to dismiss a part of her case. She was due to go to trial in May and be the next jury test of a user of the painkiller claiming it caused serious side effects that they weren't warned about — in her case a heart attack.
Her lawyer, Tommy Fibich, said the judge plans to put all the state Vioxx cases in limbo until he hears from the appellate courts about whether Texas law might keep the Vioxx users from claiming they weren't fairly warned. According to the court Web site, there are 888 Vioxx cases pending before Wilson.
Even if she loses on the issue of whether she was fairly warned of side effects, Ledbetter could still go to trial on other potentially harder to prove complaints — like that the company was negligent or the drug was defectively designed.
But the fair warning question is the one lawyers know resonates with juries.
The anticipated dismissal would be based on a 2003 Texas tort reform statute that creates a presumption of adequate warnings based on FDA approval. Although most of the nation's Vioxx cases are pending in New Jersey state court and in the federal MDL in New Orleans, Texas has played a significant role as well, with hundreds of pending claims and two of the most significant plaintiffs' victories to date.
Friday, April 13, 2007
Article in the Wall Street Journal -- Merck's Vioxx Troubles May Ebb With Ruling Poised to Aid Defense, by Heather Won Tesoriero. Here's an excerpt:
A ruling from a Texas judge coming as soon as Monday is expected to undercut the legal foundation for all 1,000 Vioxx cases brought against Merck & Co. by Texas plaintiffs, providing a potentially significant boon to Merck's defense efforts.
The judge has informed both sides in a state-court Vioxx case that he will dismiss it based on a recently finalized Food and Drug Administration rule, according to a person familiar with the matter. He then told attorneys involved in some of the other 1,000 Vioxx cases in Texas state courts that his ruling could affect the whole group.
Judge Wilson said he was granting Merck's motion to dismiss Ms. Ledbetter's case, citing an FDA policy rule issued in February 2006. That rule says the agency's approval process trumps state law in how manufacturers of health-care products must warn consumers about their potential risks. It hasn't been clear how or if the rule would apply to Vioxx, which was approved long before 2006, and this case could prove to be an important test.
The vast majority of pharmaceutical product-liability cases hinge on whether or not a drug maker adequately warned of a drug's risks -- as have most of the Vioxx trials to date, of which Merck has won 10 and lost five.
Article in the Wall Street Journal -- Merck Shares Jump as Outlook, Tossed Case Trump Arcoxia News, by Peter Loftus. Here's an excerpt:
Merck & Co. shares jumped nearly 9%, hitting a 52-week high Friday, after the company raised its earnings outlook and said a federal judge had dismissed a class-action suit over disclosures related to its pain reliever Vioxx.
This came a day after a Food and Drug Administration panel recommended against approval of Merck's Arcoxia arthritis drug. Normally, such news might have hurt Merck shares, because the company had assumed a 2007 Arcoxia launch in its previous full-year sales forecast.
But the setback was soon overshadowed by the double whammy of good news for Merck.
A little more than two hours after Arcoxia was shot down by the FDA panel, Merck announced its first-quarter and 2007 earnings would come in higher than expected. Merck cited "strong revenue performance across the company's range of products." It's scheduled to report full results Thursday.
Also, Merck scored a couple of victories on its Vioxx litigation front. On Friday morning, Merck said a federal judge in New Jersey had dismissed a securities class-action lawsuit against the company in connection with its disclosures regarding Vioxx. A Texas judge might issue a ruling soon that could undercut the legal foundation for all 1,000 Vioxx product-liability lawsuits brought in the state against Merck, The Wall Street Journal reported Friday. Merck withdrew its Vioxx painkiller from the market in 2004 after a study linked it to higher risk for heart attack and stroke.
Wednesday, April 11, 2007
Point of Law's Walter Olson has a post criticizing the upcoming Roger Williams conference on Genuine Tort Reform as only representing pro-plaintiff perspectives.
Point of Law's Ted Frank has a post on Vioxx class actions.
Civil Procedure Prof's Jeremy Counseller has a post with more links on E-Discovery.
Products Liability Prof's Michael Steenson has a post on assessing damages on pet deaths from recent pet-food poisonings.
As noted by Torts Prof Blog's William Childs, Anthony Sebok has posted on Findlaw the second part of his article examining the expansion of the 9/11 fund.
Article in the Wall Street Journal -- FDA's Position on New Drugs May Hurt Merck's Arcoxia Bid, by Jennifer Corbett Dooren. Here's an excerpt:
The Food and Drug Administration said proposed prescription painkillers should fill an unmet medical need for patients who have no other "relatively safer" alternatives, suggesting Merck & Co.'s bid to have a Vioxx-like successor drug approved in the U.S. faces a tough road.
The FDA's view was outlined in a March 21 memo posted on the agency's Web site ahead of a meeting tomorrow of outside medical experts who are being asked to weigh in on whether the agency should approve Arcoxia. The Merck drug falls into the same class as Vioxx, which was widely used to treat arthritis and other painful conditions.
Vioxx was pulled off the market in September 2004 after it was linked to an increased risk of heart attacks and strokes, and in 2005, the FDA asked Pfizer Inc. to pull Bextra off the market. Pfizer was allowed to keep its other so-called Cox-2 painkiller, Celebrex, on the market with warnings.
Tuesday, April 10, 2007
Article in the New York Times -- FDA Weighs Risk of Vioxx Successor Drug, by the Associated Press. Here's an excerpt:
New painkillers in the same class as Vioxx that increase the risk of stroke and heart attack shouldn't be approved if safer alternatives are available, according to federal documents released Tuesday.
That opinion came as a panel of government advisers prepares to weigh Merck & Co. Inc.'s proposed successor to its now-withdrawn Vioxx.
That puts the cardiovascular safety of the drug, called Arcoxia, front and center Thursday, when the panel of Food and Drug Administration advisers discusses whether to make a nonbinding recommendation that the prescription painkiller receive agency approval. Merck voluntarily pulled Vioxx from the market in 2004 after it was linked to a higher risk of stroke and heart attack when compared to dummy pills.
The FDA said its focus in evaluating Merck's application for Arcoxia, and all other drugs from that class, will be specifically on its risks to the cardiovascular system. Any nonsteroidal anti-inflammatory drugs, or NSAIDs, merit approval only if they fill an unmet need for a particular group of patients who have no relatively safer options available, the FDA said in a March 21 memorandum released Tuesday.
Wednesday, April 4, 2007
Monday, April 2, 2007
Whatever you want to call it -- plaintiff-friendly venue, renegade jurisdiction, or judicial hellhole -- it takes time for a forum's reputation to change. Madison County, arguably the most notorious plaintiff-friendly and class-action-friendly jurisdiction of the past decade, has changed in recent years. But will the recent defense verdict in a Vioxx case help the county finally shed its reputation? This AP story in Insurance Journal -- Ill. Vioxx Verdict Helps Madison County Shed Pro-plaintiff Reputation -- suggests that this verdict is a big step, but that these things take time:
Judicial watchdog Ed Murnane long has been critical of Madison County's reputation as a plaintiff's paradise in big-money lawsuits, and he knew changing that would take baby steps. So it was little wonder that the chief of the Illinois Civil Justice League, which sides with business and the insurance industry in fighting for caps on damages and other lawsuit reforms, was encouraged when a jury rejected a widower's request for tens of millions of dollars in damages against Merck & Co. in the death of his wife. ...
Murnane acknowledged Wednesday that jurors might have sided with Merck because Frank Schwaller's case wasn't persuasive enough _ not to prove this county just east of St. Louis didn't deserve being stigmatized by some as a "judicial hellhole.'' Even so, Murnane believes the verdict may be a "watershed"' for Madison County and the nation's perception of it. "This is just a good, positive sign. There is no doubt,'' he said. While "it certainly doesn't erase all of the concern and distrust people have had,'' the county needs to sustain the momentum and "the image of fairness.''
For years, Madison County has been known as a place where lawyers from across the country file cases hoping for big payouts involving everything from asbestos exposure to medical malpractice. ...
Under the watch of Ann Callis, Madison County's chief judge since last May, reforms cheered by Murnane and others are under way. Murnane said recent local rules adopted by Madison County judges that make it tougher for plaintiffs, particularly from out-of-state, to file cases here and moving some cases to arbitrators have weeded out frivolous lawsuits and helped speed cases along. ...
Numbers show improvement. Major civil cases _ those seeking at least $50,000 _ last year totaled 1,145, down from 1,297 in 2005, 1,439 in 2004 and 2,102 in 2003. Asbestos lawsuits dropped to 325 last year, nearly one-third of the 953 such cases in 2003. There were three class-action filings in 2006; just three years before that, there were 106.
Even the American Tort Reform Association has taken notice. In announcing its yearly "judicial hellholes'' ranking, the group in December put Madison County fifth, improved from fourth the previous year after two years atop the list. The association credited the county with "extraordinary changes'' in the past two years that significantly improved fairness, warranting the county's move from "from the worst-of-the-worst to purgatory.'' ...
But shedding the hellhole image doesn't appear imminent. "Such a reputation does not fade fast,'' the group's Web site reads, "and civil defendants still shiver at the prospect of facing a lawsuit in Madison County.''
Tuesday, March 27, 2007
Article in the Wall Street Journal -- Merck Wins First Midwest Case Over Former Painkiller Vioxx, by Heather Won Tesoriero. According to the WSJ's updated trial scorecard, Merck has now won 10 trials and lost 5. Here's an excerpt:
A Madison County, Ill. jury cleared Merck & Co. of responsibility in the fatal heart attack of a woman who took its Vioxx painkiller.
Frank Schwaller, of Granite City, Ill. sued the drug maker over the death of his wife, Patricia. She had taken Vioxx for 20 months and died in 2003. Mrs. Schwaller had a number of cardiovascular risk factors, including morbid obesity, high cholesterol and high blood pressure. The jury deliberated for about six hours before returning the verdict in favor of the defense.
Merck withdrew Vioxx from the market in September 2004 following a study that linked the drug to an increased risk of heart attacks and strokes. The Whitehouse Station, N.J., drug maker now faces some 28,000 lawsuits.
Monday, March 26, 2007
The first Vioxx trial in Madison County, Illinois, is coming to a close. Newsday has the AP story on today's closing arguments:
Attorneys for a widower who claims the painkiller Vioxx contributed to his wife's 2003 death urged jurors on Monday to punish the maker of the once-blockbuster drug for allegedly failing to adequately warn consumers about potentially deadly side-effects. During closing arguments, Mikal Watts argued that Merck & Co. ignored or stifled credible warnings that Vioxx could cause cardiovascular problems, including warnings that came well before Patty Schwaller collapsed and died of a heart attack after taking Vioxx for about 20 months. ...
Schwaller -- who died suddenly Aug. 8, 2003 after returning home with groceries -- "shall not have died in vain," Watts told the Madison County jury in the Midwest's first trial involving Vioxx. Citing the company's own internal e-mails, Watts said Merck failed to adequately study Vioxx's possible side-effects on people at risk of heart disease and publicly downplayed worries by outside researchers that Vioxx could put users at greater risk of heart attacks or strokes. ...
Attorneys for Merck, based in Whitehouse Station, N.J., were expected to summarize their cases later Monday before jurors began deliberating.
Monday, March 19, 2007
Article on cnn.com -- Merck appeals potentially costly NJ suit: Merck wants to strike down class-action lawsuit in New Jersey, vows to keep fighting cases individually, from Reuters. Here's an excerpt:
Merck & Co. made its latest case Monday to decertify a class-action lawsuit involving pain drug Vioxx, which opposition attorneys said could cost the drugmaker up to $27 billion.
Attorneys made oral arguments before the New Jersey Supreme Court after Merck had earlier failed to persuade a lower appeals court that the suit should not be allowed to go forward as a class action on behalf of health insurers and others who paid for people to use Vioxx.
Merck (up $0.33 to $43.42, Charts) withdrew its once $2.5 billion-a-year drug from the market in September 2004 after a study found it doubled the risk of heart attack and stroke in long-term users. The company is facing more than 27,000 lawsuits from people who claim to have been harmed by the arthritis medicine.
Chris Seeger, an attorney for plaintiff the International Union of Operating Engineers Local 68 Welfare Fund, said insurers and other third parties paid between $8 billion and $9 billion to Vioxx users during the five years it was on the market.
Under New Jersey's Consumer Fraud Act, a court must award three times the amount spent on any product whose maker is found to have violated the law.
The plaintiffs in the class-action suit claim that Merck misrepresented Vioxx and concealed facts about its heart risks, which led the payers to reimburse users for the drug.
Tuesday, March 13, 2007
In the retrial of the Humeston Vioxx case in New Jersey, the jury yesterday afternoon found Merck liable for punitive damages, adding $27.5 million of punitives to the $20 million compensatory damages verdict it had rendered earlier in the day. Here are excerpts from the AP story in the Houston Chronicle -- Vioxx Jury Awards $47.5M to Idaho Couple:
Merck & Co.'s painkiller Vioxx contributed to an Idaho postal worker's heart attack, a jury in Atlantic City ruled Monday, reversing the verdict in the man's first trial and hitting Merck with a total of $47.5 million in damages.
In one of Merck's biggest losses over the drug so far, the jurors awarded the man and his wife $20 million in compensatory damages Monday morning, then later said Merck should pay $27.5 million in punitive damages.
The jurors, after deliberating for about five hours over two days, awarded Humeston $18 million in compensatory damages for pain and suffering and gave $2 million to his wife, Mary. Then, after brief arguments over punitive damages, the jury deliberated briefly late Monday afternoon and decided to assess $27.5 million in punitive damages against Merck.
Humeston lost his first trial against the pharmaceutical giant in 2005, but New Jersey Superior Court Judge Carol Higbee granted him a second trial because new evidence surfaced that short-term Vioxx use could also be risky; Humeston took the drug on and off for about two months. Merck insists Vioxx didn't increase cardiac risks until after 18 months of use, but many doctors say research disproves that.
Monday, March 12, 2007
In the retrial of Mike Humeston's Vioxx lawsuit against Merck, the jury this morning awarded $20 million in compensatory damages. Here's an excerpt from Linda Johnson's AP story in the Houston Chronicle -- Vioxx Jury Awards $20M to Idaho Couple:
Merck & Co.'s painkiller Vioxx contributed to the heart attack of an Idaho postal worker, a state jury in Atlantic City ruled Monday. The jury awarded Frederick "Mike" Humeston and his wife $20 million in compensatory damages.
The verdict at the end of the eight-week trial means Merck has now won nine cases and lost five in the mushrooming litigation over its former blockbuster arthritis pill.
Humeston, 61, of Boise, Idaho, suffered a heart attack in September 2001, several months before Merck _ under pressure from federal regulators _ put a stronger warning about the cardiovascular risks of Vioxx on the drug's detailed package insert.
Humeston, a decorated veteran, had taken Vioxx intermittently for about two months for knee pain from a Vietnam War shrapnel wound.
The five-man, three-woman jury ruled on March 2 that Merck was negligent and did not provide adequate warning about those risks prior to Humeston's heart attack. That set the stage for a second phase of the trial, with the jury last week hearing evidence on whether Vioxx contributed to Humeston's heart attack, entitling him to damages.
The jurors awarded Humeston $18 million in compensatory damages and gave another $2 million to his wife, Mary.
New Jersey Judge Carol Higbee established a phased trial structure for this joint trial, which now moves to the punitive damages phase.
Tuesday, March 6, 2007
Article in the Wall Street Journal -- New Jersey Judge Denies Plaintiff 'Do Over' Motion in Vioxx Trial, by the Associated Press. Here's an excerpt:
The judge presiding over a Vioxx personal injury trial in Atlantic City on Monday rejected a motion to give one of the two plaintiffs a second shot at winning damages from drug maker Merck & Co.
The jury on Friday ruled that Merck was not negligent in the case of Brian Hermans of Waupaca, Wis., who died at age 44 after a September 2002 heart attack. That meant his family could not collect damages.
However, the jury did find that Merck violated New Jersey's consumer fraud law, so Mr. Hermans' family could recoup three times what he paid for Vioxx prescriptions, plus about $2 million in costs and fees his lawyer requested.
The lawyer, Mark Lanier, late Friday asked Superior Court Judge Carol Higbee to overturn the jury's ruling that Merck wasn't negligent in the Hermans' case. Mr. Lanier argued Mr. Hermans had started taking Vioxx before April 2002, when Merck put a stronger warning about the drug's cardiac risks in the detailed package insert, and he hadn't seen his doctor since then. Judge Higbee rejected the motion Monday.
Saturday, March 3, 2007
Article in the Wall Street Journal -- Merck Receives a Split Verdict From New Jersey Jury in Vioxx Trial, by Heather Won Tesoriero. Here's an excerpt:
A New Jersey state court jury delivered a split verdict in the first phase of the latest Vioxx trial, finding that Merck & Co. adequately warned doctors of the drug's heart-attack risks in the case of one plaintiff but not of another.
The eight-person jury found that in the case of both plaintiffs the drug maker violated a state consumer-protection statute by misrepresenting the drug's cardiovascular risks in marketing.
The Wall Street Journal also provides an updated trial scorecard for the Vioxx litigation.