September 30, 2007
Civil Procedure Law Prof has a post on Jennifer Wolsing's article, Daubert's Erie Problem.
Food Law Prof Blog has a post on meat recalls increasing (with link to Marlerblog).
Health Law Prof Blog has a post on the FDA and Clinical Trials.
Products Liability Prof Blog has several interesting posts: Senators Brown and Casey Introduce the Food and Product Responsibility Act of 2007; CPSC Announces Massive Crib Recall with Simplicity, Inc.; Mattel Issues Apology to China Over Recalls; and Rhode Island Wants $2.4 Billion for Lead Paint Cleanup.
September 13, 2007
Drug and Device Law Blog discusses in detail the recent New Jersey Supreme Court Operating Engineers opinion, decertifying a third-party-payer, consumer fraud class involving Vioxx.
Food Law Prof Blog has a post on the FDA Statement on the Strategic Framework Document on Import Safety.
August 01, 2007
FDA Announces Voluntary Food Standards, Looks to States
Article in the Wall Street Journal -- Strapped FDA Turns to States: Amid Food-Safety Scares, Agency Asks for Help With Inspections, by Jane Zhang. Here's an excerpt:
For several months, amid food scares ranging from tainted pet food to canned chili with botulism, the Food and Drug Administration's cash-strapped food program has been struggling to demonstrate that it can police the nation's food supply. Now, it is taking steps to rely more heavily on the states for help.
Yesterday, the FDA announced new voluntary standards that it said would lead to uniform, high-quality state food-safety programs. Margaret Glavin, associate commissioner for regulatory affairs, called the shift a significant step toward "integrating our food-safety system."
The move amounted to an acknowledgment, increasingly discussed within the FDA in recent months, that federal and state officials need to combine forces to combat food-safety problems.
May 31, 2007
U.S. Manufacturing Plant Found to Have Used Melamine in Feed
Article in the New York Times -- Melamine From U.S. Put in Feed, by Andrew Martin. Here's an excerpt:
Ever since pet food contaminated with an industrial chemical was traced to shipments of wheat flour from China, American officials have concentrated on cracking down on imports.
It turns out the problem was closer to home, too.
Yesterday, federal officials announced that a manufacturing plant in Ohio was using the same banned substance, melamine, to make binding agents that ended up in feed for farmed fish, shrimp and livestock.
The problem surfaced after a distributor, concerned about what was in its feed binders after the reports from China, sent the product to a private laboratory for testing.
The melamine was used by Tembec BTLSR, a Canadian forest products company with a small chemical plant in Toledo, to make binding agents that keep pellets of animal feed together, said Dr. David Acheson, assistant commissioner for food protection at the Food and Drug Administration.
May 09, 2007
Non-Economic Damages for Injured Pets?
Commentary in the Wall Street Journal -- Pet Plaintiffs, by Steve Malanga. Here's an excerpt:
In the wake of the tainted pet-food scandal, some pet owners, aided by trial lawyers and advocacy groups, are trying to achieve human-like status for their animals in our civil courts. If they succeed, it may become much more costly -- and risky -- to own a pet in America.
Many of America's estimated 65 million dog and cat owners are justifiably outraged at the news that popular brands of pet food were contaminated by the chemical melamine. Although the Food and Drug Administration has attributed only 16 dog and cat deaths to the contamination, veterinarians have reported thousands of cases of renal distress and failure since shortly after a large maker of pet foods began importing wheat gluten and rice concentrate from China. FDA inspectors are now investigating whether Chinese importers purposely spiked the food with melamine because the chemical shows up as protein on nutritional tests.
The crisis has prompted some 50 class action lawsuits against domestic pet-food brands by trial lawyers who are recruiting owners of stricken pets as clients. Under traditional legal precedent, the damages in these cases are limited to what you paid for your pet and what you've spent in food and vet care, plus any additional bills for having your pet treated for food poisoning. But trial lawyers and some animal-rights activists are hoping to persuade legislators and the courts to allow judgments for noneconomic damages, including awards that take into account the pain and suffering of owners.
May 03, 2007
Fallout from Pet Food Contamination Affects Whole Industry
Article in the Washington Post -- Crisis Over Pet Food Extracting Healthy Cost: Owners, Manufacturers, Suppliers All Feel Fallout, by Rick Weiss and Nancy Trejos. Here's an excerpt:
While the Food and Drug Administration pursues what is sure to be a long investigation into how pet food became contaminated with an ingredient for making plastics, and while Congress begins the months-long process of haggling over food-safety amendments, pet food companies, their suppliers and their customers do not have the luxury of waiting.
They have to cope with the crisis immediately, and for most, that is already proving expensive.
Stephen S. Miller, chief executive of ChemNutra of Las Vegas, was sued last week by a pet food company to which it had sold tainted Chinese wheat gluten. He now faces legal fees and the costs of extra on-site inspections he plans to impose on his Chinese suppliers.
Producers of brand-name pet foods, several of which were revealed by the recall to use the same ingredients that economy chow makers use, stand to lose once-loyal customers, many of whom are saying they would not return to their former brands.
And some pet owners like Mitzner, fed up with worrying about poisoning their animals, can expect to pay up to three times as much for organic or other specialty chows.
If there is one player that may benefit from the still-spreading disaster -- federal officials said yesterday that millions of chickens that ate the contaminated food were sold for human consumption -- it is the U.S. wheat gluten industry, which has been struggling for years to compete against cheaper Chinese imports.
May 02, 2007
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.
Here's a link to a related article in the Washington Post -- Millions Of Chickens Fed Tainted Pet Food: Risk to Consumers Minimal, FDA Says, by Rick Weiss.
May 01, 2007
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.
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 25, 2007
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.
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 23, 2007
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 08, 2007
Senate Inquiry Into FDA Oversight of Tainted Pet Food
Article in the L.A. Times -- Senate panel to question FDA response to tainted pet food: Sen. Durbin says the agency should be able to order a recall rather than rely on companies to do so voluntarily, by Chuck Neubauer. Here's an excerpt:
Seeking ways to ensure that pet food is safe, a Senate subcommittee plans to question Food and Drug Administration officials as soon as Thursday about their response to the contamination that has killed pets and led to the recall of more than 100 brands.
On Saturday, Sen. Richard J. Durbin (D-Ill.), a leading advocate of improving food safety, criticized the federal inspection process for both human and pet food. "The system is broken-down," he said.
Durbin, the second-ranking Democrat in the Senate, called for the hearing last week. He said he would like to see the FDA set national standards and inspection rules for pet food manufacturing facilities.
"The FDA is like a fire department that is only called after the house has burned," Durbin said in a telephone interview.
He also said he would like to see federal law changed to allow the FDA to order a recall of food intended for human or pet consumption rather than rely on companies to do it voluntarily.
The agriculture appropriations subcommittee plans to schedule a hearing for Thursday or sometime next week. Durbin said he expects to hear from FDA Commissioner Dr. Andrew C. von Eschenbach, veterinarians and representatives of the pet food industry.
April 03, 2007
FDA Blocks Chinese Wheat Gluten Imports After Pet Food Deaths
Article in the Wall Street Journal -- FDA Blocks Wheat Gluten Imports From Chinese Firm After Pet Recall, by the Associated Press. Here's an excerpt:
The U.S. government has blocked imports of wheat gluten from a company in China because of contamination, acting after the recent pet-food-related deaths of cats and dogs.
The Food and Drug Administration took action against wheat gluten from Xuzhou Anying Biologic Technology Development Co. in Wangdien, China, after the U.S. recall of nearly 100 brands of pet food. Tainted pet food apparently has resulted in kidney failure in animals across the country.
March 31, 2007
FDA Finds Pet Food Contained Chemical Found in Plastic
Article in the New York Times -- Pet Food Contained Chemical Found in Plastic, F.D.A. Says, by Brenda Goodman. Here's an excerpt:
The Food and Drug Administration said yesterday that it had not found rat poison in pet food that has been killing animals, but that it had found melamine, a chemical commonly used to make plastic cutlery that is also used in fertilizer.
Hours after the announcement, the nationwide pet food recall, which had involved only so-called wet foods — all manufactured by Menu Foods and sold under a variety of brand names — was expanded to include one brand of dry cat food, Prescription Diet m/d Feline, made by Hills Pet Nutrition.
The brand was found to have been made with a batch of wheat gluten shipped to the United States from China that the F.D.A. said was laced with melamine.
Here's a link to the article in the Washington Post.
March 18, 2007
FDA Voluntary Guidelines for Fresh Food
Article in the New York Times -- F.D.A. Offers Guidelines to Fresh-Food Industry, by Marian Burros. Here's an excerpt:
The Food and Drug Administration yesterday offered new, nonbinding guidelines to food processors to try to reduce the risk of food poisoning in fresh-cut produce like bagged spinach leaves, sliced tomatoes and imported melons, but acknowledged that it could not say with certainty what caused the recent outbreaks connected to E. coli and salmonella, or how to stop them.
It has taken the F.D.A. seven years to issue advice to the produce industry on how to reduce the risk of food poisoning in fresh-cut produce. The industry can choose to follow it or not: compliance is voluntary. But the agency said this was the first time it had made food safety suggestions to the produce industry that were like the mandatory regulations the meat industry must follow.
The F.D.A. is suggesting that the fresh-cut produce industry constantly monitor and control vulnerable places in the production cycle where the bacteria are likely to form.
The guidelines also call for record keeping for recalls and covers personal health and hygiene of workers and sanitation operations.
According to the agency, the number of illnesses stemming from produce stayed flat from 1998 to 2004 but more have been coming from the fresh-cut category, the fastest-growing segment of the produce industry, which has had $12 billion in annual sales.
March 02, 2007
Salmonella That Tainted Peanut Butter Traced to Georgia Production Plant
Article in the Washington Post -- FDA Tracks Salmonella to Georgia Peanut Butter Plant, by the Associated Press. Here's an excerpt:
Federal inspectors found the strain of salmonella that tainted peanut butter made at the ConAgra Foods plant in Sylvester, Ga., the Food and Drug Administration said yesterday.
Government and industry officials have said the contamination may have been caused by dirty jars or equipment.
ConAgra on Feb. 14 recalled all Peter Pan and Great Value peanut butter made at the Sylvester plant, after federal health officials linked the products to an outbreak that began in August and sickened 370 people. The recall now includes all such products made since December 2005, the FDA said.
February 28, 2007
Recall of Oscar Mayer/Louis Rich Chicken Breast for Listeria Risk
As noted in this article in the New York Times, there has been a product recall of
About 2.8 million pounds of fully cooked Oscar Mayer/Louis Rich chicken breast cuts and strips, manufactured by Carolina Culinary Foods, because it could be contaminated with Listeria monocytogenes, which can cause listeriosis. Listeriosis is an uncommon but potentially fatal disease that can cause serious or fatal infections in children, the elderly or those with weakened immune systems. Symptoms include high fever, severe headache and nausea. No illnesses have been reported.
February 19, 2007
Chicken Recall for Bacterial Contamination
Article in the Los Angeles Times -- Bacteria prompt chicken recall, by the Times Wire Reports:
Carolina Culinary Food is recalling packages of Oscar Mayer ready-to-eat chicken breast strips with rib meat because they may be contaminated, the U.S. Department of Agriculture's Food Safety and Inspection Service said.
Officials said Georgia Department of Agriculture food scientists found Listeria monocytogenes in a sample. That type of contamination can cause listeriosis, which is potentially fatal.
February 18, 2007
Salmonella Outbreak in Peanut Butter
Article in the Wall Street Journal -- Salmonella Outbreak Traced To Peter Pan Peanut Butter, by the Associated Press:
ConAgra Foods Inc. is recalling some jars of Peter Pan and Great Value peanut butter after the products were linked to a recent salmonella outbreak that has sickened nearly 300 people.
Consumers should throw away all Peter Pan and Great Value peanut butter jars that have a product code beginning with the number "2111" imprinted on the lid, ConAgra said. Officials at the Omaha, Neb., company haven't said how much peanut butter will be affected by the recall, but said consumers can return the product lids for a full refund.
Officials with the Centers for Disease Control and Prevention believe this to be the first salmonella outbreak associated with peanut butter in the U.S.
Since August, the outbreak has sickened 288 people in 39 states, federal health officials said Wednesday. About 20% of them have been hospitalized but none has died, said Mike Lynch, a CDC epidemiologist. About 85% of the infected people said they ate peanut butter, CDC officials said. The largest number of cases were reported in New York, Pennsylvania, Virginia, Tennessee and Missouri.