Mass Tort Litigation Blog

Medicare Won't Cover Stents for Neck Arteries

Article in the New York Times -- In a Reversal, U.S. Says Medicare Won’t Cover Stents for Neck Arteries, by Barnaby J. Feder.  Here's an excerpt:

Responding to criticism from surgeons, the government has dropped its previously announced plans to expand Medicare coverage for the use of stents to prop open neck arteries to prevent strokes.

Instead, Medicare will stick with definitions that restrict eligibility for such stents to fewer than 10 percent of the 150,000 to 200,000 Americans who annually undergo surgery to clear blockages that restrict blood flow to the brain and raise stroke risks.

That is a far more conservative stance on stenting than has been taken by the Food and Drug Administration, which determines when a device is safe and effective enough to be sold commercially. And it is likely to slow the expansion of coverage among private insurers.

The decision, which Medicare regulators published online on Monday night, was an unexpected reversal for stent makers and many doctors who have promoted stenting as a less invasive alternative to neck surgery.

BGS

Vaccines for Humans and Cattle as Way to Battle E.Coli

Article in the New York Times -- Scientists Look to Vaccines in the War on E. Coli, by Andrew Pollack.  Here's an excerpt:

Shousun C. Szu, a scientist at the National Institutes of Health, says the best way to prevent people from being poisoned by deadly E. coli would be to vaccinate all infants against the bacteria.

Graeme McRae, a Canadian biotechnology executive, says it would be more practical to inoculate cows instead.

Vaccines for people and for cattle are just two approaches under development to prevent or treat food poisoning by the strain E. coli O157:H7.

Right now, scientists can do little medically to fight the pathogen, which was responsible for two severe outbreaks last fall, one from contaminated bagged spinach and a second from tainted lettuce served in chain taco restaurants.

The main approach has been to try to prevent contamination through careful handling, rigorous inspections and government regulation.

BGS

Melamine Found in Pet Food Unlikely to Pose Threat to Humans

Article in the New York Times -- Pet Food Chemical Unlikely to Pose Threat to Humans, Experts Say, as U.S. Continues Inquiry, by Donald G. McNeil, Jr.  Here's an excerpt:

Toxicologists monitoring the American food supply for traces of melamine after it was found in imported ingredients in the contaminated pet food that has killed at least 16 dogs and cats and sickened thousands of others said yesterday that even if there were small amounts of it in the American food supply, it would be unlikely to pose much of a threat to humans.

Sampling thus far by the Food and Drug Administration for melamine, which has also been detected in chicken feed on some farms in Indiana, has not turned up the chemical in food meant for humans, and the trace amounts found in some poultry feed — and hog feed — would presumably be excreted or broken down by the animals before they were slaughtered, scientists and federal officials said.

Also, a survey of poison control centers, veterans’ hospitals and a sample of private hospitals across the country by the federal Centers for Disease Control and Prevention has found no increase in reports of kidney diseases, the most likely indicator of melamine poisoning, said Bernadette Burden, a C.D.C. spokeswoman.

BGS

Restyled Federal Rules of Civil Procedure

Today the Supreme Court sent the package of "restyled" Federal Rules of Civil Procedure to Congress, which means that the new rules will go into effect December 1, 2007 unless Congress affirmatively acts to reject them.  Here's the link to the notice on the federal courts rulemaking page.  The Advisory Committee on Civil Rules worked on the restyling project for several years, with the goal of making the rules clearer and more readable without changing their substantive meaning.  That last point has been a subject of controversy, with some civil procedure scholars arguing that changing the language of the rules inevitably will change how those rules are interpreted and used.  In any event, it appears likely that come Dec. 1, we'll be using the new improved FRCPs.

HME

FDA Proposes Expanded Suicide Warning for Antidepressants for Young Adults

Article in the New York Times -- FDA Seeks Antidepressant Warning, by the Associated Press.  Here's an excerpt:

Young adults beginning treatment with antidepressants should be warned about an increased risk of suicidal thoughts and behavior, federal health officials said Wednesday.

The Food and Drug Administration proposed labeling changes that would expand a warning now on all antidepressants. The current language applies only to children and adolescents. The expanded warning would apply to adults 18-24 during the first month or two of treatment with the drugs, the FDA said.

The proposed labeling changes also would note that studies have not shown this increased risk in adults older than 24, and that adults 65 and older taking antidepressants have a decreased risk of suicidal thoughts and behavior, it said.

The proposed expanded warnings emphasize that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide.

BGS

Calls for More FDA Screening Based on Adulterated Pet Food from China

Article in the Washingon Post -- Pet Deaths Spur Call for Better FDA Screening:Imports Raise Concern About Human Foods, by Rick Weiss and Ariana Eunjung Cha.  Here's an excerpt:

Amid growing revelations that suppliers in China frequently spike pet food and other food ingredients with contaminants to boost profits, momentum is building in Washington to bolster the Food and Drug Administration's capacity to detect and screen out adulterated imports.

Several Chinese suppliers conceded over the weekend that adding melamine to pet food ingredients -- now blamed for the deaths of many animals in the United States and possible contamination of the human food supply -- is but the latest technique for fooling U.S. companies into thinking they are purchasing a high-quality product.

Before melamine there was urea, Chinese traders said -- another nitrogen-rich chemical that was used to give false high scores on tests of protein content but was abandoned after it made animals ill.

The task of guarding against contaminants in imports has become far more complicated because an increasing portion of the tens of billions of dollars in Chinese food and agricultural imports involves powders and concentrates for the processed-food industry -- including the wheat gluten and rice protein at the center of the pet food scandal. Animal feed imports alone grew sevenfold from 2001 to 2006, the Commerce Department says.

BGS

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.”

BGS

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.

BGS

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.

HME

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.

BGS

Blog Roundup

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.

BGS

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.

BGS

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.

BGS

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.

BGS

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.

BGS

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.

BGS

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.

BGS

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.

HME

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.

BGS

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. ...

HME