Mass Tort Litigation Blog

Bill Marler on Legal Issues for Food Safety

Bill Marler has posted his brief article, Legal Issues for Food Safety, on Marler Blog.

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Nestle Not Completely Cooperative with FDA Inspections Prior to E. Coli Outbreak

Article in the Wall Street Journal -- Nestlé Unit Denied FDA Requests, by Jane Zhang.  Here's an excerpt:

The Nestlé USA plant at the center of a federal probe into an E. coli outbreak involving cookie dough refused to give inspectors access to pest-control records, environmental-testing programs and other information, according to newly released inspection reports covering the past five years.

In a September 2006 visit, for example, managers at the Danville, Va., plant refused to allow a Food and Drug Administration inspector to review consumer complaints or inspect its program designed to prevent food contamination. The inspector found dirty equipment and "three live ant-like insects" on a ledge but nothing severe enough to give the plant a failing grade.

A year earlier, officials at the Nestlé plant presented another FDA inspector with a list of things it wouldn't do. "Among these are the refusal to review the firm's consumer complaint file, refusal to permit photography, refusal to sign affidavits or receipts and refusal to provide specific information on interstate commerce," the inspector wrote.

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Cargill Recalls More Than 1 Million Pounds of Beef Because of E.Coli Risk

Article in the Wall Street Journal -- Cargill Recalls Beef Over Fears Of More E.Coli, by the Associated Press.  The article notes that "Cargill Inc. said it was recalling more than one million pounds of ground beef that may be contaminated with E. coli bacteria, the second time in less than a month it has voluntarily recalled beef that may have been tainted."

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Blog Roundup

Drug and Device Law Blog has posts on Tort Reform Works in Texas; Notes from the Scientific Underground; Preemption Scorecards; The Vanishing Trial; and Riegel Survives.

Food Law Prof Blog has posts on Cargill meat recall based on e.coli; Bush signs FDA Amendments Act of 2007; More on the Recall Process; CRS Report on Recall Authority; Roberts on Role of Regulation in Minimizing; Thinking About Recalls; and  Yet another meat recall -- this one enough for one picnic.

Point of Law has posts on Refik Kozic v. Merck; Absurd RI lead abatement plan developed; 
"Defendants See a Case of Diagnosing for Dollars"; and Zyprexa protective order enforcement VI: Egilman settlement.

Torts Prof Blog has posts on Topps Meat Recall: Let the Filing Begin; 9/11 Opt-Outers Settle; Lead Everywhere; Stent Safety and Patents;  USSC Denies Cert In Engle (Tobacco) Case; FDA Warns Against Use of Cold Meds by Toddlers; and Sebok's Part II on NJ Supreme Court's Vioxx Ruling.

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Blog Roundup

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.

Torst Prof Blog has interesting posts on NEJM Clears (Mostly) Thimerosol; Goldberg & Zipursky on "Tort Law and Moral Luck"; and Sebok on NJ Supreme Court's Vioxx Ruling.

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United Food Group Expands Beef Recall Because of E.Coli Fears

Article in the New York Times -- Supplier Expands Beef Recall Over Concerns of E. Coli Contamination, by the Associated Press.  Here's an excerpt:

A meat supplier has expanded a ground beef recall to include about 5.7 million pounds of fresh and frozen meat because they may be contaminated with E. coli.

David Goldman, acting administrator of the federal Food Safety and Inspection Service, announced on Saturday that the recall would be expanded to include products with sell-by dates from April 6 to April 20. The beef was distributed by United Food Group LLC, based in California.

Mr. Goldman said that none of the latest batch of suspect beef was in stores now because the product would be well past its expiration date, but that consumers might still have some of the meat at home.

“It is important for consumers to look in their freezers,” he said.

The meat has been blamed for an E. coli outbreak in the Western states that resulted in 14 illnesses, spanning April 25 through May 18. All the patients have recovered.

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FDA Had Proposed Reform, But HHS Rejected It

Article in the Wall Street Journal -- FDA Stymied In Push to Boost Safety of Produce: Amid Rise in Outbreaks Of Illness, Agency Urged New Rules, Monitoring, by Jane Zhang.  Here's an excerpt:

The Food and Drug Administration, under fire for a string of illnesses caused by contaminated vegetables, earlier this year came up with an ambitious, industry-endorsed plan calling for tough new regulations on the handling of fresh produce.

But the plan went nowhere after it got a cold reception from FDA's parent agency, the Department of Health and Human Services. And even today, amid continuing concern about the safety of the nation's food supply, efforts to address the problem remain in limbo.

People close to the FDA say HHS officials led by acting Deputy Secretary Eric Hargan rejected the FDA plan, which was presented in February at HHS headquarters. At the meeting, the FDA warned that its current approach to protecting the safety of fruits and vegetables, which relies on the industry following voluntary guidelines, was failing to stop an increase in foodborne illnesses, according to people familiar with the matter. Those in attendance included Robert Brackett, director of the FDA's Center for Food Safety and Applied Nutrition.

Among other things, the FDA outlined a three-year effort that would pump $76 million into its coffers to monitor produce safety and impose stringent rules on growers and processors to prevent contamination. Such a campaign could cut produce-related outbreaks of illness in half, the FDA officials said.

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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.

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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.

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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.

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E.Coli Has Shaken Consumer Confidence in Leafy Green Vegetables

Article in the Chicago Tribune -- Consumers Still Worried About E. Coli, by Janet Frankston Lorin of the Associated Press:

September's national spinach recall has shaken consumer confidence in the safety of leafy green vegetables, according to a new national survey.

Consumers are still avoiding greens and questioning safety issues, months after spinach contaminated with E. coli bacteria killed three people and sickened nearly 200.

Plummeting spinach sales have also prompted the produce industry to seek federal oversight to assure buyers that fresh produce is safe.

"We need to be in front of this to maintain consumer confidence," said Tom Stenzel, president of the United Fresh Produce Association, a leading trade group. "Consumers need to eat fresh produce and feel safe in their choices," he said.

A new national survey to be released Monday by Rutgers University suggests that the broad recall could have lasting effects on spinach and other similar vegetables. As a result, consumers felt uncertain and threw away other bagged produce that was not affected by the recall.

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E.Coli Strain Linked to California

Article in the Washington Post -- Officials Track E. Coli Strain to Calif., by Andrew Bridges of the Associated Press:

Contaminated California-grown lettuce was the possible source of the E. coli outbreak that sickened more than 80 people late last year at Taco John's restaurants in two states, health officials said Friday.

State and federal investigators said they have matched the strain of the bacteria associated with the outbreak to two samples taken from dairy farms in California's Central Valley. The farms are located near lettuce fields, the Food and Drug Administration said.

Investigators continue to study whether bacteria-laden manure from the dairy farms could have contaminated the nearby lettuce-growing areas, the FDA said. The FDA said other sources of contamination were possible.

The outbreak sickened about 81 people who had eaten at Taco John's restaurants in Minnesota and Iowa in November and December. Among those sickened, 26 were hospitalized. There were no deaths.

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Lettuce Is Chief Taco Bell E.Coli Suspect

Article in the New York Times -- Shredded Lettuce Is Now Chief Suspect in E. Coli Outbreak, by Bruce Lambert:

Shredded lettuce was the “most likely” ingredient that spread E. coli bacteria in the recent outbreak among hundreds of customers of Taco Bell restaurants in the Northeast, federal health officials said last night.

The new conclusion was not based on testing of food samples, which so far have been negative for E coli. Instead, investigators surveyed what the stricken people ate and compared that with what their dining companions who remained healthy had eaten.

Those statistics narrowed the potential sources to lettuce, cheddar cheese and ground beef — all common to many Taco Bell items. Investigators then reviewed the record of those foods in past E. coli outbreaks and the way those foods are handled. The beef, for example, is cooked, and Taco Bell says the cheese is pasteurized.

“We think that shredded lettuce consumed at Taco Bell restaurants was the most likely cause of the outbreak,” Dr. Christopher Braden, an epidemiologist for the federal Centers for Disease Control and Prevention, said in a telephone news conference. “We’re fairly confident” that lettuce is to blame, he said, but added, “we’re not done with the investigation.”

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Still Searching for E.Coli Source at Taco Bell

Article in the New York Times -- With Onions No Longer the Top Suspect, the Search for E. Coli Resumes, by Andrew Martin.  The article notes that there are at least 466 confirmed or suspected cases of E.coli related to Taco Bell.  Here's an excerpt:

Nearly two weeks ago, on Nov. 30, Taco Bell officials learned that several customers had become sick with a virulent strain of E. coli after eating at one of the chain’s restaurants in New Jersey.

By the following Monday, Dec. 4, it became clear that the outbreak was spreading beyond that restaurant, in South Plainfield in central New Jersey, and Taco Bell issued its first public statement, saying it had closed nine restaurants in New Jersey and New York.

Two days later, Taco Bell appeared to have a major break: Preliminary tests by a private laboratory showed that green onions were the probable culprit, and it ordered them out of all 5,800 restaurants nationwide. Now, almost a week after saying they had zeroed in on a possible cause of the outbreak, investigators say that those early indications appear to be wrong and that they may never learn the cause with certainty.

More sophisticated testing of the green onion samples — the required next step — actually found no traces of E. coli O157:H7. Although additional testing continues, the authorities now say the source of the E. coli outbreak could be any number of ingredients used by Taco Bell, but probably not onions.

An article in the Washington Post -- Lettuce Suspected in Taco Bell E. Coli, by Andrew Bridges of the Associated Press -- notes that interviews with the ill indicated that lettuce may be the source of the E.coli.

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Source of E.Coli in Taco Bell Still Unclear

Article in the Washington Post -- Source of Taco Bell E. Coli Remains Unknown, by Steven Reinberg:

Investigators are no closer to determining the source of an outbreak of E. colithan they were when the first of 64 people in the Northeast became ill in early November, federal health officials said Monday.

Tests on green onions, believed to have been a possible cause, were negative, they said.

But the outbreak, linked to Taco Bell restaurants, may be winding down. No new cases have been added to those reported in five states since late last week, the U.S. Centers for Disease Control and Prevention reported.

Dr. Christopher Braden, an epidemiologist with the U.S. Centers for Disease Control and Prevention, told a news teleconference there may yet still be unconfirmed cases of people sickened by E. coli.

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A Single Federal Food-Regulation Agency?

Op-ed in the New York Times -- Has Politics Contaminated the Food Supply?, by Eric Schlosser.  Apart from noting breakdowns in regulation and the resulting illnesses, the op-ed piece also endorses recent proposed legislation to create a single federal food-regulation agency:

Last year, Representative Rosa DeLauro of Connecticut and Senator Richard Durbin of Illinois, both Democrats, introduced an important piece of food-safety legislation that tackles these problems. Their Safe Food Act would create a single food-safety agency with the authority to test widely for dangerous pathogens, demand recalls and penalize companies that knowingly sell contaminated food.

It would eliminate petty bureaucratic rivalries and make a single administrator accountable for the safety of America’s food. And it would facilitate a swift, effective response not only to the sort of inadvertent outbreaks that have occurred this fall, but also to any deliberate bioterrorism aimed at our food supply.

The Safe Food Act deserves strong bipartisan backing. Aside from industry lobbyists and their Congressional allies, there is little public support for the right to sell contaminated food. Whether you’re a Republican or a Democrat, you still have to eat.

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Stronger FDA Regulation Likely After E. Coli Outbreaks

Article in the New York Times -- Stronger Rules on Produce Likely After Outbreaks of E.Coli, by Andrew Martin:

With processed fresh produce like bagged salads and baby carrots growing in popularity in the past decade, the Food and Drug Administration realized as long ago as 2000 that recommendations for safe handling of the products were needed.

The agency went so far as to draft guidelines and kept the issue high on its priority list, but pressed by budget cuts and competing F.D.A. demands, the proposal languished.

Now, with the recent outbreaks of E.coli related to processed vegetables, the F.D.A.’s oversight of produce is likely to be treated with new urgency.

“I think it’s fairly clear that something needs to change,” said Dr. David Acheson, the chief medical officer for the F.D.A.’s Center for Food Safety and Applied Nutrition. Regulations for produce could be part of the changes, he said.

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Over 60 Sickened from Taco Bell E. Coli

Article in the New York Times -- Taco Bell E. Coli Tests Clear Most Foods, by the Associated Press:

Taco Bell announced Saturday tests have ruled out all its ingredients except one -- scallions -- as a possible source of a harsh strain of E. coli that has sickened more than 60 people in the Northeast.

The green onions had been pulled from the company's 5,800 restaurants nationwide on Wednesday after it said preliminary tests showed scallion samples contained the E. coli strain, and it no longer plans to sell them, said Rob Poetsch, a spokesman for the Irvine, Calif.-based company.

Poetsch said samples from the company's entire menu were collected from multiple restaurants in several states for the independent testing done by Certified Laboratories in Plainview, N.Y.

Another interesting article in yesterday's New York Times -- E. Coli Fears Inspire a Call for Oversight, by Marian Burros -- which details moves by the produce industry asking for greater government regulation:

Facing a loss of consumer confidence in fresh fruits and vegetables because of repeated outbreaks of food-borne illness, three major produce industry groups have for the first time called for government regulation in an industry that until now has had none.

One of the groups, Western Growers, says it has gone further, meeting over the past six weeks with state officials in California to draw up an agreement that would call for a formal system of farm inspections, regulations of water and soil quality and sanitation and even cease-and-desist orders for violations.

The agreement may be ready by spring, said Tim Chelling, vice president of communications for the group, which represents growers in California and Arizona who account for half the nation’s produce. “Anyone who ignores this,” Mr. Chelling said, “will be out of business.”

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E.Coli, Produce, and the FDA

Article in the New York Times -- Green Onions Identified as Source of E. Coli Cases, by Andrew Martin and Bruce Lambert.  Given the E.coli infections earlier this year related to spinach, we might expect growing calls for reforming FDA oversight of produce.  The New York Times article notes:

“I think we are really at a tipping point for consumer confidence with fresh fruits and vegetables,” said Caroline Smith DeWaal, the group’s director of food safety. She noted that the F.D.A.’s guidelines for safe farming practices were voluntary and that the number of inspectors had been pared by budget cuts.

The F.D.A. regulates the produce and seafood industries, while the Department of Agriculture oversees poultry and meat production.

“We are doing a number of things to address food-borne outbreaks and recognize that the system is not perfect,” said an F.D.A. spokeswoman, Julie Zawisza. “But fresh produce does carry risks, and we are committed to finding effective ways to prevent and reduce incidents and have made good progress using available resources in a more targeted and strategic way.”

For additional coverage, see the L.A. Times article, Outbreak triggers calls for tougher produce guidelines, by Jerry Hirsch and Ellen Barry.

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Taco Bell Green Onions & E. Coli

Article in the Wall Street Journal -- Taco Bell Removes Green Onions After They Are Tied to E. Coli, by the Associated Press:

Taco Bell ordered scallions removed from its 5,800 U.S. restaurants yesterday after tests suggested they may be responsible for the E. coli outbreak that has sickened at least three dozen people in three states.

The fast-food chain said preliminary testing by an independent lab found three samples of green onions appeared to have a dangerous strain of the bacteria.

"In an abundance of caution, we've decided to pull all green onions from our restaurants until we know conclusively whether they are the cause of the E. coli outbreak," said Greg Creed, president of Irvine, Calif.-based Taco Bell, a subsidiary of Yum Brands Inc.

The company wouldn't immediately identify the supplier of the scallions, so it was unclear whether contaminated green onions reached other restaurants or supermarkets.

For additional coverage, see the New York Times article -- Thousands of Taco Bells Discard Green Onions, by Andrew Martin and John Holusha.

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