Monday, April 30, 2007
Use of Deceptive Pet Food Filler in China
Article in the New York Times -- Filler in Animal Feed Is Open Secret in China, by David Barboza and Alexei Barrionuevo. Here's an excerpt:
As American food safety regulators head to China to investigate how a chemical made from coal found its way into pet food that killed dogs and cats in the United States, workers in this heavily polluted northern city openly admit that the substance is routinely added to animal feed as a fake protein.
For years, producers of animal feed all over China have secretly supplemented their feed with the substance, called melamine, a cheap additive that looks like protein in tests, even though it does not provide any nutritional benefits, according to melamine scrap traders and agricultural workers here.
“Many companies buy melamine scrap to make animal feed, such as fish feed,” said Ji Denghui, general manager of the Fujian Sanming Dinghui Chemical Company, which sells melamine. “I don’t know if there’s a regulation on it. Probably not. No law or regulation says ‘don’t do it,’ so everyone’s doing it. The laws in China are like that, aren’t they? If there’s no accident, there won’t be any regulation.”
April 30, 2007 in Food Poisoning | Permalink | Comments (0) | TrackBack (0)
Friday, April 27, 2007
Congress, Politics, and Tort Litigation
Op-ed in the Wall Street Journal -- Tort Tribute, by Kimberley Strassel. Here's an excerpt:
Using hearing and subpoena power to aid the trial bar is an old play, and was common when Democrats were last in control. Remember the 1998 Big Tobacco settlement, one of the biggest paydays in trial-lawyer history? The groundwork was initially laid in Congress with Mr. Waxman's 1994 hearings, in which he lined up tobacco executives to accuse them of adding nicotine to their products and of lying in their testimony. These fishing expeditions helped to publicly vilify the industry, softening it up for a later legal collapse.
When Democrats lost power in 1994, the "investigatory" role passed to liberal state attorneys general such as New York's Eliot Spitzer, who used their own power to embarrass companies and leak details that helped their trial-lawyer friends. Which industries will receive the most congressional summonses in the next 18 months? The very same the trial bar has been trying hardest to crack in recent years: MTBE manufacturers, pharmaceutical companies, oil giants. Bet on it.
Meanwhile, as companies are dragged in to explain past actions, Democrats will be working on their second strategy: ensuring industries' future actions are also more open to lawsuits. This will come in the form of small, seemingly innocuous additions or subtractions to legislation -- what might best be termed "trial lawyer earmarks." For a sense of how these work, consider the current $120-plus billion Iraq war supplemental, which includes a section about chemical security.
April 27, 2007 in Tobacco | Permalink | Comments (0) | TrackBack (0)
Seton Hall Announces New Center on Pharmaceutical Law
Seton Hall Law School announced a new Center for Health and Pharmaceutical Law, endowed by Schering-Plough Corporation, sanofi-aventis, Johnson & Johnson, and Bristol-Myers Squibb, as well as an expansion of the law school's Institute of Law, Science, and Technology, endowed by the Gibbons law firm. Here's the press release.
April 27, 2007 in Pharmaceuticals - Misc. | Permalink | Comments (0) | TrackBack (0)
Thursday, April 26, 2007
NEJM Article on Physician-Industry Relationships
Article in the New England Journal of Medicine -- A National Survey of Physician–Industry Relationships, by Eric G. Campbell, Ph.D., Russell L. Gruen, M.D., Ph.D., James Mountford, M.D., Lawrence G. Miller, M.D., Paul D. Cleary, Ph.D., and David Blumenthal, M.D., M.P.P. Here's an excerpt from the abstract:
Results Most physicians (94%) reported some type of relationship with the pharmaceutical industry, and most of these relationships involved receiving food in the workplace (83%) or receiving drug samples (78%). More than one third of the respondents (35%) received reimbursement for costs associated with professional meetings or continuing medical education, and more than one quarter (28%) received payments for consulting, giving lectures, or enrolling patients in trials. Cardiologists were more than twice as likely as family practitioners to receive payments. Family practitioners met more frequently with industry representatives than did physicians in other specialties, and physicians in solo, two-person, or group practices met more frequently with industry representatives than did physicians practicing in hospitals and clinics.
Conclusions The results of this national survey indicate that relationships between physicians and industry are common and underscore the variation among such relationships according to specialty, practice type, and professional activities.
Here's a link to the related Wall Street Journal story, Gifts to Doctors are Widespread, by Joseph Pereira.
April 26, 2007 in Pharmaceuticals - Misc. | Permalink | Comments (0) | TrackBack (0)
Wednesday, April 25, 2007
Drug and Device Law Blog has an interesting post on causation in failure-to-warn cases, and another post elaborating after reader comment.
TortsProf Blog flags another story on Zyprexa from Alex Berenson of the New York Times.
Products Liability Prof Blog posts a link to a story on a meager punitive verdict in a Ford rollover case, delivered after Ford noted its layoffs and losses.
Civil Procedure Prof Blog has a post on the 2007 U.S. Chamber of Commerce rankings of states for tort law climate.
Point of Law has a post celebrating a California opinion questioning the oursourcing of government lawsuits to plaintiffs lawyers.
April 25, 2007 in Zyprexa | Permalink | Comments (0) | TrackBack (0)
FDA Awareness of Dangers to Food Prior to Outbreaks
Article in the Washington Post -- FDA Was Aware of Dangers To Food: Outbreaks Were Not Preventable, Officials Say, by Elizabeth Williamson. Here's an excerpt:
The Food and Drug Administration has known for years about contamination problems at a Georgia peanut butter plant and on California spinach farms that led to disease outbreaks that killed three people, sickened hundreds, and forced one of the biggest product recalls in U.S. history, documents and interviews show.
Overwhelmed by huge growth in the number of food processors and imports, however, the agency took only limited steps to address the problems and relied on producers to police themselves, according to agency documents.
Congressional critics and consumer advocates said both episodes show that the agency is incapable of adequately protecting the safety of the food supply.
FDA officials conceded that the agency's system needs to be overhauled to meet today's demands, but contended that the agency could not have done anything to prevent either contamination episode.
April 25, 2007 in E Coli, FDA, Food Poisoning | Permalink | Comments (0) | TrackBack (0)
FDA to Test Imported Food Additives to Detect Melamine
Article in the Washington Post -- FDA to Test Imported Additives for Melamine, by Marc Kaufman and Rick Weiss. Here's an excerpt:
Concerned that a wide variety of Chinese vegetable protein products may be contaminated with the harmful compound melamine, the Food and Drug Administration said yesterday that it will begin testing batches of six imported ingredients used in pet foods and livestock feed, as well as additives to human food.
Officials have not found the substance in food products for people but detected it in two imported ingredients widely used in pet food: wheat gluten and rice protein. The agency said that imported corn gluten, corn meal, soy protein and rice bran will also be tested. The vegetable proteins are used in bread, pizza, baby food and many vegetarian dishes.
April 25, 2007 in FDA, Food Poisoning | Permalink | Comments (0) | TrackBack (0)
Tuesday, April 24, 2007
Pharmaceutical Industry Influence on Doctors
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.
April 24, 2007 in FDA, Vioxx | Permalink | Comments (2) | TrackBack (0)
NY Appellate Tobacco Statute-of-Limitations Decision
As noted by Michael Kraus at Point of Law, interesting article on law.com -- N.Y. Court Refuses to Revive Smoking Suit Filed Years After Limitations Period, by Joel Stashenko. Here's an excerpt:
A man who started smoking when he was 9 and did not quit until he underwent throat cancer surgery 30 years later is time barred from suing cigarette companies for his disease, a New York Appellate Division, 3rd Department, panel has ruled.
A four-justice panel denied Warren Robare's attempt to invoke the doctrine of equitable estoppel to prevent the defendant tobacco companies from successfully asserting the three-year statute of limitations as a defense. Citing Putter v. North Shore Univ. Hosp., 7 NY3d 553-554 (2006), the court said Robare had "timely awareness" of his cancer and its possible link to cigarettes since, at the latest, May 1991.
"The record establishes that plaintiff quit smoking on May 13, 1991, the day of his throat surgery, because he realized he was addicted to cigarettes and he knew they were generally harmful to his health," Justice Carl J. Mugglin wrote for the court.
April 24, 2007 in Procedure, Tobacco | Permalink | Comments (0) | TrackBack (0)
Richard Epstein on the Kennedy FDA Bill
Commentary in the Wall Street Journal -- Risky Drug Business, by Richard Epstein. Here's an excerpt:
Sen. Edward Kennedy fired the latest shot in the battle over pharmaceutical regulation last week with the introduction of his FDA Revitalization Act. And, surprisingly, those who want to speed up the drug approval process will cheer the centerpiece of his bill: A "Sense of the Senate" that declares the Prescription Drug User Free Act (PDUFA) a success.
PDUFA, which was first adopted in 1992, uses funds from a tax on drug companies to speed up FDA internal procedures. Set to expire in September, Sen. Kennedy's support for it now is an indication that the Senate will not get hung up on the criticism that has emerged in the past -- that it turns the agency into a tool of the drug industry. PDUFA does not guarantee drug approval, which continues to be judged under regular agency rules. But on average it has shortened the unfortunate (and deadly) delays in reviewing new drug applications by six months. And it has done so without reducing the quality of the approvals.
Nonetheless, these new procedures might lead to other significant reforms. One would reward with cash, not burden with paperwork, the physicians, who report adverse incidents to the government, on the grounds that carrots get more information than sticks. Second, the FDA might let up a bit on its hostility toward allowing new drugs on the market, as evidenced by last week's resounding 20-1 decision by an FDA advisory committee to reject Merck's Arcoxia, a Cox-2 inhibitor in Vioxx's class of drugs. More than 60 other countries have already approved Arcoxia for sale. If only the FDA had stated that it would be more receptive to letting Arcoxia and other drugs onto the market once post-marketing review procedures are improved.
But neither Congress nor the FDA has mastered the fundamental lesson of risk analysis. Keeping drugs off the market deprives all informed patients the opportunity to correct FDA errors. Letting new drugs on the market leaves individual patients the option to decline their use. In the long term, Congress must wean the FDA from its misapplied "first, do no harm" principle, which causes far more harm than it prevents.
April 24, 2007 in FDA | Permalink | Comments (0) | TrackBack (0)
Monday, April 23, 2007
Amgen Earnings and Concerns on Aranesp & Epogen
Article on cnn.com -- Amgen earnings meet forecasts: Biotech's income surges 19% in latest quarter; 15% gain in revenue just below expectations; future uncertain for Aranesp sales, by Aaron Smith. Here's an excerpt:
Amgen (up $0.22 to $62.19, Charts, Fortune 500) reported a 19 percent surge in non-GAAP first-quarter earnings, or earnings that do not include certain charges, to $1.08 per share for 91 cents a year earlier. That met the analyst consensus from Thomson First Call.
Amgen, based in Thousand Oaks, Calif., reported a 15 percent jump in total revenue to $3.69 billion from $3.22 billion in the prior year. Analysts surveyed by First Call projected revenue of $3.73 billion.
George Morrow, chief of global commercial operations, said Amgen won't be able to provide a clearer picture of future revenue before weighing the impact on insurers from heightened FDA warnings regarding anemia drugs Aranesp and Epogen.
Aranesp and Epogen are often used in conjunction with chemotherapy, which can cause anemia, a condition caused by the reduction in red blood cells produced. Recent studies showed these drugs may increase the risk of death in cancer patients, according to the FDA.
The Food and Drug Administration required heightened safety warnings for Aranesp and Epogen, as well as for Procrit from Johnson & Johnson (down $0.37 to $64.75, Charts, Fortune 500).
Here's a link to the Associated Press story, Amgen’s Profit Rises, but Does Not Meet Expectations, which appeared in the New York Times.
April 23, 2007 in Pharmaceuticals - Misc. | Permalink | Comments (0) | TrackBack (0)
Pet Food Class Action Lawsuits
In-depth article in yesterday's Philadelphia Inquirer about the mounting litigation concerning contaminated pet food -- Chasing Justice in Pet Food Lawsuits. The article by Emilie Lounsberry notes that at least 50 class actions have been filed, largely in New Jersey where primary defendant Menu Foods has a plant. In addition to lawyers specializing in animal rights, according to the article, "[t]he recall also has drawn lawyers who specialize in class-action and mass-tort cases involving injury to complainants of the two-legged variety, such as the gargantuan litigation over the diet drug fen-phen and the pain reliever Vioxx." Indeed, it sound like the litigation is shaping up much like other mass tort litigation, with claims for medical expenses, medical monitoring, and emotional distress (which would require a significant shift in the law's treatment of animals). Here's an excerpt:
Attorneys for hundreds of pet owners nationwide already have taken aim at some of the companies that have recalled more than 120 varieties of dog and cat food since March 16. By far, the target of choice is Menu Foods Inc., the Canada-based manufacturer of about 100 of the tainted product lines.
As of Friday, at least 50 class-action lawsuits had been filed in federal courts; most are in New Jersey, where Menu has a Pennsauken plant. State courts are likely to be hit, too. For while the Food and Drug Administration has confirmed only 16 deaths, informal tallies by veterinary groups and pet Web sites put fatalities above 3,000, with possibly 10,000 more sickened after eating batches made with melamine-tainted wheat gluten from China.
Only days ago, panic struck again with the recall of rice protein, also from China, shipped to U.S. pet-food makers. The importer said it, too, might contain melamine, used in fertilizers and plastics.
"It's just getting bigger and bigger," said Casey Srogoncik, a Northeast Philadelphia lawyer who is gathering up clients.
The owners' lawsuits seek compensation for costs ranging from burials to ongoing care of survivors. State Rep. Mark Cohen and his wife, Mona, of Northeast Philadelphia, nearly lost their Yorkie bichon, Cookie. They've joined a federal class-action lawsuit that, while typically not stating a specific dollar amount, asks for such relief as a fund for medical monitoring and treatment of lingering health problems.
But the big-ticket question is not who will pay the vet bills, legal experts say. It's whether owners will be entitled to damages for emotional distress.
April 23, 2007 in Class Actions, Food Poisoning | Permalink | Comments (12) | TrackBack (2)
Thursday, April 19, 2007
Merck Profit Jumps, Vioxx Lawsuits Decline Slightly
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.
April 19, 2007 in Vioxx | Permalink | Comments (0) | TrackBack (0)
10 Years for Louis Robles
Article in today's Daily Business Review -- Asbestos Attorney Accepts 10-Year Term in Plea Deal:
Louis Robles, a nationally prominent Miami plaintiffs attorney who was charged with stealing millions of dollars from thousands of asbestos clients nationwide, has accepted a plea deal that calls for him to serve 10 years in prison and provide full restitution to his victims.
According to sources within the U.S. Attorney's office in Miami, Robles, 59, accepted the plea deal Monday. He is scheduled to appear Friday before U.S. District Judge Alan Gold to enter a guilty plea.
The plea deal is the latest chapter in the spectacular fall of the class action and mass tort lawyer, who was a star in the South Florida legal community. Robles at one time had 40 lawyers on his staff and more than 12,000 class action clients around the country. He focused on asbestos cases, traveling around the country in a van with a doctor and X-ray machine, signing up clients and advertising on national television.
In 2002, the Daily Business Review was the first to report on a four-year investigation into Robles by the Florida Bar. The Bar had received numerous complaints about Robles paying clients little or nothing on their asbestos settlements, charging contingency fees of more than 50 percent and having clients pay for his airfare, food, phone bills and other costs not previously disclosed. He abruptly closed his downtown Miami office in 2002 and soon after filed for bankruptcy.
Robles was disbarred by the Florida Supreme Court in May 2003. About a year later, the Review disclosed that a federal grand jury was looking into an indictment against Robles. ...
April 19, 2007 in Asbestos, Ethics | Permalink | Comments (2) | TrackBack (0)
Tuesday, April 17, 2007
Charleston Law School Conference on Punitive Damages, Due Process, and Deterrence -- The Debate After Williams
On Friday, September 7, 2007, Charleston School of Law is hosting a conference entitled, "Punitive Damages, Due Process, and Deterrence: The Debate After Williams." Confirmed panelists include Theodore Boutrous (Gibson Dunn), Elizabeth Cabraser (Lieff Cabraser), Robin Conrad (US Chamber of Commerce), Thoedore Eisenberg (Cornell), Andrew Frey (Mayer, Brown), Murray Garnick (Arnold & Porter), Lauren Rosenblum Goldman (Mayer, Brown), John Gotanda (Villanova), Laura Hines (Kansas), Keith Hylton (Boston U.), John Mulderig (Altria), Robert Peck (Center for Constitutional Litigation), Steve Rissman (Altria), Michael Rustad (Suffolk), Victor Schwartz (Shook, Hardy), Anthony Sebok (Brooklyn), Catherine Sharkey (Columbia), Neil Vidmar (Duke), and Judge William Wilkins (4th Cir.). I will be the moderator for a panel on the relationship between punitive damages and class actions. The conference chair is Professor Sheila Scheuerman of Charleston School of Law.
April 17, 2007 in Conferences, Punitive Damages | Permalink | Comments (0) | TrackBack (0)
Texas Vioxx Judge Plans to Dismiss Failure-To-Warn Claim
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.
April 17, 2007 in Vioxx | Permalink | Comments (0) | TrackBack (0)
Friday, April 13, 2007
Merck Expected to Win Vioxx Preemption Ruling from Texas Judge
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.
April 13, 2007 in Vioxx | Permalink | Comments (0) | TrackBack (1)
Merck Shares Rise on Vioxx Legal Wins
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.
April 13, 2007 in Vioxx | Permalink | Comments (0) | TrackBack (0)
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.
April 11, 2007 in 9/11, Conferences, Vioxx | Permalink | Comments (0) | TrackBack (0)
FDA Position Makes More Difficult Approval of Merck's Arcoxia
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.
April 11, 2007 in FDA, Vioxx | Permalink | Comments (0) | TrackBack (0)