January 2009

In yet another indicator of the confusion of who is in charge over what food – FDA or USDA – Local, State or Federal Regulators, "tip o’ the pen to" Bob Keefe for his story today – Troubled peanut firm’s chief also an industry quality adviser – in the Atlanta Journal-Constitution.  According to Mr. Keefe:

The president of the peanut company linked to a nationwide salmonella outbreak serves on an industry advisory board that helps the U.S. Department of Agriculture set quality standards for peanuts. Stewart Parnell, president of Peanut Corp. of America, based in Lynchburg, Va., was first appointed to the USDA’s Peanut Standards Board in July 2005 and was reappointed in October for a second term that runs until June 2011….

In a Press Release from 2002, the USDA announced that it was moving “to implement a new peanut quality program as outlined in the new Farm Bill.”  This included that “all peanuts marketed in the United States must be officially inspected and graded by federal inspectors or federally licensed state inspectors.  Imported peanuts will be subject to the same quality and handling standards as domestically produced peanuts.  The new Farm Bill … requires [the] USDA to appoint a new Peanut Standards Board comprised of members of the peanut industry. [The] USDA will consult with the board before establishing or changing quality and handling standards for domestically produced and imported peanuts."

I wonder what input Mr. Parnell had on “quality and handling standards?”

The White House is pledging stricter oversight of food safety in response to a Salmonella outbreak that has sickened more than 500 people in the United States and Canada and killed at least eight.  Press secretary Robert Gibbs said Friday that President Barack Obama plans to announce a new Food and Drug Administration commissioner and other oversight officials in the coming days.  Gibbs said they will put in place a "stricter regulatory structure" to prevent breakdowns in food-safety inspections.  Gibbs said recent revelations about poor oversight have been alarming.  He said he was referring to both the government’s own regulatory system and to the peanut company linked to the Salmonella outbreak.

President Obama, Mr. Gibbs, the "Batphone" number is 1-206-346-1890.

Peanut Product Recall Took Company Approval  The F.D.A. can seize a product that it suspects is contaminated, and it can ask a federal judge for authority to recall products if a maker refuses to do so. The agency can also announce that it suspects problems with a product before the company agrees to a recall. But it rarely does any of these.  Bill Marler, a food safety lawyer in Seattle, said the agency had neither the authority nor the courage it needed to keep the food supply safe.

Feds rarely file charges in tainted food cases   "There have been innumerable times they could have prosecuted but didn’t," said Bill Marler, a Seattle-based food safety lawyer who has filed two lawsuits against Peanut Corp. of America over the recent outbreak. "My sad speculation, frankly, is that prosecutors in the U.S. on the Justice Department side or state side don’t see poisoning people with food for profit as a crime."

Salmonella outbreak: What you need to know
  "Has most of it been consumed? Probably. Or is it in some broker’s warehouse? Some of these products have a [two-year] shelf life," said Seattle attorney Bill Marler, who specializes in food poisoning lawsuits and has become a food safety expert.

Punitive Claims Added to Peanut Butter Suit in Light of FDA Report  Bill Marler, a partner at Marler Clark in Seattle, who filed the suit, said the recent FDA report indicates willful intent. "Based on the fact that the plant was having pretty severe problems and was pretty clearly shipping product knowing it may likely be contaminated, it certainly, in my view, reaches to the level of a punitive claim," he said, especially if criminal charges are to be brought.

Federal officials want criminal investigation of peanut company
  "It’s an unusually high number of deaths for a salmonella outbreak," said Bill Marler, a Seattle lawyer and expert on food poisoning cases.

Lawsuits saddle peanut butter industry  "We do not allege punitive damages in most cases," attorney Bill Marler (of the firm Marler Clark) says in a press release. "Just the most egregious. In fifteen years of litigating food cases, this is one of the worst examples of corporate irresponsibility I have ever seen. Not only does the plant appear to have had atrocious practices, but the product that seems to have repeatedly tested positive for Salmonella but was shipped to hospitals, nursing homes and schools regardless."

Congress to hold hearings on peanut product recall
  Meanwhile, a third lawsuit was filed on behalf of a victim against PCA yesterday. Seattle attorney Bill Marler, a 15-year veteran in litigating food-borne illness cases, filed in the U.S. District Court of California, Northern District, on behalf of the Trone family of Crescent City, Calif.‚Ä®‚Ä®The suit alleges that up to and including Christmas Day, Bryson Trone, 3, ate peanut butter cracker sandwiches made with PCA’s peanut butter product. He fell ill Dec. 26, and when symptoms worsened, was admitted to the hospital, where he remained for 5 days. While hospitalized, he tested positive for the strain of Salmonella Typhimurium associated with the PCA outbreak.

McGuire Says No Thanks to Peanut Corporation of America  Marler, who is filing another lawsuit today on behalf of the family of a boy who fell ill, says he’s now in contact with a new PCA attorney: Alan Maxwell, a partner of the Atlanta-based firm Weinberg Wheeler Hudgins Gunn & Dial. According to his bio, Maxwell has cornered the market on food-borne illness defense work, having represented, among others, spinach producers suspected in E. Coli outbreaks and other peanut butter producers sued over salmonella outbreaks.

Latest peanut scare may be linked to previous outbreak  One logical explanation could be the raw peanuts supplied to ConAgra before its salmonella contamination in late 2006-early 2007 came from the same farmer who supplied PCA during the current contamination, said Seattle attorney Bill Marler, who sued ConAgra on behalf of sickened people in 2007 and last month filed two suits on behalf of people sickened by PCA.

We all remember that on June 1, 2007, the CDC reported that a total of 628 persons had been infected with the outbreak strain of Salmonella serotype Tennessee in 47 states since August 1, 2006.  Rumor has it that that number was actually in excess of 700 – perhaps 714?  Those illnesses were eventually linked to ConAgra’s Sylvester Georgia Peter Pan and Great Value Peanut Butter Plant.  Multistate Outbreak of Salmonella Serotype Tennessee Infections Associated with Peanut Butter — United States, 2006—2007.

Now, As of January 29, 2009, the CDC reported that a total of 529 persons had been infected with the outbreak strain of Salmonella Typhimurium in 43 states since September 1, 2008.   The illnesses have been linked to Peanut Corporation of America’s (PCA) Blakely Georgia Peanut Butter Plant – 70 miles from Sylvester.  Multistate Outbreak of Salmonella Infections Associated with Peanut Butter and Peanut Butter–Containing Products — United States, 2008—2009.

A close reading on the recent CDC’s recent report notes an interesting connection between the 2007 outbreak and the recent one – "A possible association between the two outbreaks warrants further investigation…. The relationship of the S. Tennessee finding to the current outbreak is being investigated further."   The reason for the connection is that on January 22, Minnesota Department of Health found that a previously unopened container of King Nut peanut butter collected from the North Dakota distributor yielded Salmonella serotype Tennessee with a PFGE pattern that was indistinguishable from an outbreak strain in the multistate outbreak in 2006–2007 caused by contaminated peanut butter. ("tip o’ the pen to" Newday’s Delthia Ricks for asking the question at one of the FDA/CDC Press Conferences).

Interesting connection?   Did PCA or one of its suppliers provide peanuts or peanut products to ConAgra in 2006?  Perhaps environmental?   Perhaps somehow linked to raw peanuts grown in Georgia?   Perhaps linked to animal populations that enjoy the Southwest Georgia location?

More to come I imagine.

I received a lot of email and calls from folks today wanting to get some understanding of what might be facing The Peanut Corporation of America (PCA).  Here are my thoughts:

The Federal Food, Drug, and Cosmetic Act was passed by Congress in 1938 in reaction to the growing public safety demands.  The primary goal of the Act is to protect the health and safety of the public by preventing deleterious, adulterated or misbranded articles from entering interstate commerce.   Under section 402(a)(4) of the Act, a food product is deemed “adulterated” if, inter alia, the food was “prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.” A food product is also considered “adulterated” if it bears or contains any poisonous or deleterious substance which may render it injurious to health. If, however, the “poisonous or deleterious” substance is not an added substance, the food is not considered adulterated if the quantity of the substance in the particular food item does not ordinarily render the food injurious to health.

The Act authorizes factory inspections and added injunctions to the enforcement tools at the Food and Drug Administration’s (FDA) disposal.   Following hearings in the early 1950s, a series of laws addressing pesticide residues (1954), food additives (1958), and color additives (1960) gave the FDA much tighter control over the growing list of chemicals entering the food supply, putting the onus on manufacturers to establish their safety.   The Act stands today as one of the primary means by which the federal government enforces food and pharmaceutical safety standards.

Chapter III of the Act addresses prohibited acts, subjecting violators to both civil and criminal liability.   Provisions for criminal sanctions state that:

  • Felony violations include adulterating or misbranding a food, drug, or device, and putting an adulterated or misbranded food, drug, or device into interstate commerce.  Any person who commits a prohibited act violates the FDCA.  A person committing a prohibited act "with the intent to defraud or mislead" is guilty of a felony punishable by three years imprisonment.
  • A misdemeanor conviction under the FDCA, unlike a felony conviction, does not require proof of fraudulent intent, or even of knowing or willful conduct.  Rather, a person may be convicted if he or she held a position of responsibility or authority in a firm such that the person could have prevented the violation.   Convictions under the misdemeanor provisions are punishable by up to one year imprisonment or a $1000 fine.

The Act also includes provisions for individual liability, specifically.  Individuals who are responsible for criminal behavior are normally named as defendants along with corporate entities through which crimes are committed.  A corporate defendant’s willingness to enter a plea of guilty is accordingly not a basis for dismissal of charges against an individual.  Individual defendants are generally the highest ranking officials in a firm who made decisions that violated the law, along with others who actively participated in fraudulent activity.  Thus, presidents of corporations and managers of facilities where violations take place are often appropriate defendants.

One thing to remember, before we try and convict PCA, is that in 15 years of involvement in every major foodborne illness case, there have been only a handful of prosecutions and fewer convictions.  This has been true in cases involving acts as egregious or more so than those of PCA.  Not to say they should not be prosecuted, just remember to keep in in context.

References

  Carol Benjamin and Betsy J. Floman, Federal Food and Drug Act Violations, 31 Am. Crim. L. Rev. 629 (1994).
  21 U.S.C. §331.
  21 U.S.C. §333(a)(2).
  See United States v. Park, 421 U.S. 658, 674-77 (1975); United States v. Dotterweich, 320 U.S. 277, 280-81 (1943).
  See United States v. Marcus, 82 F.3d 606 (4th Cir. 1996) (President/CEO of generic drug manufacturing firm prosecuted for altering heart medication formula without adequate testing or FDA approval); United States v. James V. Mays, 77 F.3d 906 (6th Cir. 1996); United States v. Samuel and Patsy Mays, 69 F.3d 116 (6th Cir. 1995), cert. denied, 116 S. Ct. 2504 (1996) (President, Secretary/Treasurer, and Operations Manager of juice concentrate company prosecuted for secretly adding 20,000,000 pounds of sugar to product sold as pure 100% orange concentrate).

CDC reported today that 529 persons infected with the outbreak strain of Salmonella Typhimurium have been reported from 43 states. The number of ill persons identified in each state is as follows: Alabama (2), Arizona (11), Arkansas (5), California (68), Colorado (13), Connecticut (9), Georgia (6), Hawaii (3), Idaho (13), Illinois (6), Indiana (6), Iowa (3), Kansas (2), Kentucky (3), Maine (4), Maryland (8), Massachusetts (43), Michigan (26), Minnesota (36), Missouri (9), Mississippi (3), Nebraska (1), New Hampshire (11), New Jersey (23), New York (20), Nevada (5), North Carolina (6), North Dakota (12), Ohio (72), Oklahoma (2), Oregon (11), Pennsylvania (14), Rhode Island (4), South Dakota (4), Tennessee (9), Texas (6), Utah (5), Vermont (4), Virginia (21), Washington (13), West Virginia (2), Wisconsin (3), and Wyoming (2). Additionally, one ill person was reported from Canada.

Among the persons with confirmed, reported dates available, illnesses began between September 1, 2008 and January 16, 2009. Patients range in age from <1 to 98 years. The median age of patients is 16 years which means that half of ill persons are younger than 16 years. 21% are age <5 years, 15% are >59 years. 48% of patients are female. Among persons with available information, 22% reported being hospitalized. Infection may have contributed to eight deaths: Idaho (1), Minnesota (3), North Carolina (1), Ohio (1), and Virginia (2).

In addition, I just got a few more documents from the Gerogia State Department of Health:

And people say investigative journalism is a lost art. Hat tip to Sharon Theimer and Ricardo Alonso-Zaldivar of AP for uncovering that “weeks before the earliest signs of a national Salmonella outbreak that now has been traced to peanuts from a Georgia processing plant, peanuts exported by [Peanut Corporation of America] were found to be contaminated and were returned to the United States.” The reason for the Oasis notation on the FDA website was, “the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance, or is otherwise unfit for food in that it appears to contain foreign objects.” The AP article provides further details:

The rejected shipment – coming over the U.S. border across a bridge between New York and Canada – was logged by the Food and Drug Administration but never was tested by federal inspectors, according to the government’s own records. The chopped peanuts from Peanut Corp. of America in Blakely, Ga., were prevented by the FDA from being allowed back into the United States in mid-September because the peanuts contained an unspecified "filthy, putrid or decomposed substance, or is otherwise unfit for food," according to an FDA report of the incident. It was not immediately clear whether the date on the government’s record, Sept. 15, was when the unspecified importer rejected the shipment or when the FDA refused it. It also was not known whether the peanut shipment ultimately was destroyed or sent somewhere else.

Here are the details from the FDA Oasis Site:

Manufacturer FEI: 3006771904
Manufacturer Name: Peanut Corp Of America
Manufacturer address line 1: Hwy 62 East
Manufacturer City: Blakely
Manufacturer Province/state: GA
Manufacturer Country: United States
Product code: 23NFH01
Importers product description: US GOODS RETURNED – CHOPPED PEANUTS
Refusal date: 15-SEP-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: 112-2270017-4/1/1/
Bill of Lading: LOGF0002758
FDA sample analysis: No
FDA record of private lab sample analysis: Yes
Charge(s): FOREIGN OB
Reason: FOREIGN OB
Section: 402(a)(3), 801(a)(3); ADULTERATION
Charge: The article appears to consist in whole or in part of a filthy, putrid, or decomposed substance, or is otherwise unfit for food in that it appears to contain foreign objects.

The New York Times story in the morning profiles Christopher Meunier, age 7, who is my client in the most recent Salmonella Peanut Butter Outbreak. He suffered a high fever, bloody diarrhea, vomiting and was hospitalized for six days because he ate peanut butter.

Somewhere, the intrepid reporters of the New York Times found this quote from now President Obama:

“Far too often, tainted food is not recalled until too late,” Mr. Obama said last year. “When I am president, it will not be business as usual when it comes to food safety. I will provide additional resources to hire more federal food inspectors.”

Perhaps that means that the administration is paying attention.

According to AP reports, Rep. Henry Waxman, D-Calif., chairman of the House Energy and Commerce Committee, will conduct hearings the week of February 11, 2009 into the cause of the Peanut Butter Outbreak that has sickened over 500 and killed eight.  It is anticipated that Mr. Waxman will ask Salmonella victims to tell their stories, as well as put under oath the owners (the Parnell’s) of the Peanut Corporation of America (PCA).  In addition, two private labs now under scrutiny in the outbreak (J. Leek Associates Inc., and Deibel Labs Inc.) will also be called to testify.  It is unclear if other manufacturers (King Nut and Kellogg) will be called to testify too.

Well, I missed the Inauguration, but will not miss these fireworks.  I have testified before this Committee on two occasions – 2007 ad 2008.  Hopefully we can make a bit more progress.  My advise to PCA – "Things to do before Mr. Waxman puts you under oath:

1.  PCA should not destroy any documents;

2.  PCA should let all interested parties into the Blakely plant;

3.  PCA should pay the medical bills and all related expenses of the innocent victims and their families;

4. PCA should offer to pay the cost of all related Health Department, CDC and FDA investigations;

5.  PCA must provide all bacterial and viral testing of all PCA peanut butter products – before and after recall;

6.  PCA must release all inspection reports on the PCA plant by any governmental entity or third-party auditor;

7.  PCA must release all bacterial or viral safety precautions taken – especially after the 2007 Salmonella peanut butter outbreak.

Seven good ideas before you book your flight to Washington DC.