Mass Tort Defense : Mass Tort Defense Lawyer & Attorney : Sean P. Wajert : Dechert Law Firm : Products Liability, Class Actions, Pharmaceutical Litigation

U.S. Senate negotiators apparently reached an agreement last week on food safety legislation in order to have it ready for the full Senate to consider when lawmakers return from the summer recess.

The group that negotiated the framework for the new Senate version of the Food Safety Modernization Act included Tom Harkin, D-Iowa; Mike Enzi, R-Wyo.; the bill's authors Dick Durbin, D-Ill., and Judd Gregg, R-N.H.; and lead co-sponsors Christopher Dodd, D-Conn., and Richard Burr, R-N.C.

The bill would require facilities that manufacture, process, pack, or hold food to have in place risk-based preventive control plans to address identified hazards and prevent adulteration.  It requires importers to verify the safety of foreign suppliers and imported food. It would give the FDA additional resources to hire new inspectors and requires FDA to inspect food facilities more frequently. The bill gives the FDA authority to order a mandatory recall of a food product if the food will cause serious adverse health consequences or death and a company has failed to voluntarily recall the product upon FDA’s request. It has provisions to enhance surveillance systems to detect food-borne illnesses.

Significantly, this version does not include language banning BPA, as originally demanded by Sen. Feinstein.  Her prior insistence, despite a lack of scientific evidence supporting such a ban, was one of the major logjams for the bill. She says she still plans to introduce an amendment to ban BPA from children’s products as soon as the bill arrives on the Senate floor.  Clearly, an abrupt and unnecessary ban on packaging containing BPA would affect consumer ability to find nutritious, valuable, and shelf-stable foods and beverages. The proposed ban runs counter to the fact that BPA has been used for over 30 years to improve the safety and quality of food and beverages, including by providing protective coating for cans. The overwhelming scientific evidence points to the conclusion that at current human exposure levels, BPA is not toxic. What is in fact occurring is that anti-chemical activists are simply manipulating consumers’ fears, and opportunistic politicians are jumping in.

 

 

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A federal court last week refused to dismiss most claims by a putative class challenging health claims in vitaminwater beverage labeling. Ackerman v. Coca-Cola Co., CV-09-0395 (E.D.N.Y., 7/21/10).

Here at MassTort Defense we have warned companies about the dangers of consumer fraud class actions and highlighted some of the many ridiculous, far-fetched, beyond belief claims that plaintiffs make about being misled about some product.  This one is near the top of the list. Plaintiffs allege that the name, "vitaminwater," along with a description of the vitamins in the water are somehow deceptive because they supposedly mislead people to believe that the beverages do not have sugar or calories in them. Plaintiffs are not alleging that vitaminwater doesn't have water or doesn't have vitamins or that the particular vitamins in vitaminwater fail to provide the benefit claimed. Rather, they claim that vitaminwater’s labeling and marketing are misleading because they "bombard" consumers with a message that supposedly draws consumer attention away from the significant amount of sugar in the product. About the sugar? The FDA-mandated label on each bottle bears the true facts about the amount of sugar per serving.

(The opinion also rejected defendant's argument that the claim was expressly and/or impliedly preempted by statutes and regulations preventing states from imposing labeling requirements that are different from those imposed by the FDA.)

The complaint alleged claims of unlawful business acts and practices in violation of California Business and Professions Code (“Cal. BPC”) § 17200 et seq. (“Unfair Competition Law” or “UCL”); Cal. BPC § 17500 et seq. (“False Advertising Law” or “FAL”); and California’s Consumers Legal Remedies Act, Cal. Civ. Code § 1750 et seq. (“CLRA”); (2) unfair business acts and practices in violation of California UCL; (3) fraudulent business acts and practices in violation of California UCL; (4) misleading and deceptive advertising in violation of California FAL; (5) untrue advertising in violation of California FAL; (6) unfair methods of competition or unfair or fraudulent acts or
practices in violation of § 1770(a)(7) of the CLRA; (7) deceptive acts or practices in violation of
New York General Business law (“GBL”) § 349; (8) false advertising in violation of New York
GBL § 350; (9) violation of New Jersey Consumer Fraud Act (“NJCFA”), N.J.S.A. 56:8-1 et
seq.; (10) breach of an express warranty; (11) breach of an implied warranty of merchantability;
(12) deceit and/or misrepresentation; and (13) unjust enrichment.

The claims were brought on behalf of three purported classes of plaintiffs: all California Residents who purchased vitaminwater at any time from January 15, 2005 to the present, (the “California Class”); all New York residents who purchased vitaminwater at any time from January 30, 2003 to the present, (the “New York Class”); and all New Jersey residents who purchased vitaminwater at any time from January 22, 2003 to the present (the “New Jersey Class”).

So what's misleading? The court found that plaintiffs had sufficiently pleaded that the collective effect of the marketing statements was to mislead a reasonable consumer into believing that vitaminwater is either composed solely of vitamins and water, or that it is a beneficial source of nutrients.   Despite the fact that the sugar content was plain as day to anyone who would look at the label. The court found that the fact that the actual sugar content of vitaminwater was accurately stated in an FDA-mandated label on the product does not eliminate the possibility that "reasonable" consumers may be misled. The court relied on Williams v. Gerber Products Co., 552 F.3d 934 (9th Cir. 2008), for the notion that the mere fact that an FDA-mandated nutritional panel provided
accurate nutritional information on a product did not bar claims that reasonable consumers could
be misled. Reasonable consumers should not, said the court, be expected to look beyond representations on the front of the box to discover the truth from the ingredient list in smaller print on the side of the box. But unlike the Gerber case, there were no allegations here that the packaging for vitaminwater contained any false statements or pictures. As noted, plaintiffs concede that vitaminwater actually contains the vitamins the marketing says it does. And it hardly seems like an unfair burden on a "reasonable" consumer to turn from the word "vitaminwater" on one part of the bottle to the label in close proximity on the very same bottle.

As a matter of law, plaintiffs should not be permitted to move forward with a claim about the presence of an ingredient that is clearly disclosed on the Nutrition Facts label, exactly where FDA tells the manufacturer to put that information.  And, of course, the problem with allowing the claim to proceed past the motion to dismiss claim is that the case will proceed through expensive discovery to reach a stage where common sense prevails and summary judgment is granted -- if a defendant is not blackmailed into settling.  And a common thread in many of these consumer fraud class actions is the fundamental notion by plaintiffs' attorneys --implicit in their theory-- that the public must be stupid, cannot read labels, and cannot make legitimate product choices for itself. In fact, the public speaks just fine with its wallets and pocketbooks. Fortified beverages are not new and are one of the fastest-growing market segments. Consumers are indeed able to read nutrition labels and ingredient listings and make smart choices, for themselves, without the help of the plaintiffs' bar.  Contrast this case with recent comon sense decisions.

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 A federal court has dismissed a proposed class action against PepsiCo Inc. alleging that consumers were somehow being misled to believe that the company's Cap'n Crunch's Crunch Berries breakfast cereal contain real fruit.  Roy Werbel v. PepsiCo Inc., No: C 09-04456 SBA (N.D. Cal. 7/1/2010).

Here at MassTortDefense we have railed against the trends in consumer fraud class actions, as plaintiff lawyers seek class status for alleged economic-only harm claims, when they find some word or image in advertising that they can quibble about or argue is somehow ambiguous to a client.  No one is really harmed; no one is misled; no one is defrauded.  The theories of the case make a mockery of common sense and personal responsibility. But, hey, fees may be available. This case is part of an appropriate response to such claims.

Cap'n Crunch debuted in 1963, and Crunch Berries came along in 1967. The Cap'n was drawn by the same guy that created Dudley Do-Right, George of the Jungle, and Moose and Squirrel (Rocky and Bullwinkle.)  Perhaps some of our readership will remember the original commercials featuring the canine Sea Dog, who sailed with the Cap’n on his ship, The Good Ship Guppy. The crew was tasked with keeping the cereal safe from the Cap’n’s nemesis, Jean LaFoote, the Barefoot Pirate.  Trivia question: what is the Cap'n's full name?  See below.

Plaintiff Roy Werbel brought the putative class action against defendant on behalf of consumers who allegedly were misled into believing that “Cap’n Crunch’s Crunch Berries” cereal derives some of its nutritional value from real berries or fruit.  On the package, immediately below the product name is a product description, which states: “SWEETENED CORN & OAT CEREAL.”  The display panel also depicts a ship’s captain in cartoon form standing behind a bowl of cereal, and holding a spoonful of multi-colored Crunch Berries. Plaintiff alleged that the colorful Crunchberries [sic] on the box conveyed only one message: that Cap’n Crunch "has some nutritional value derived from fruit.”  Although the product contains strawberry juice concentrate, that ingredient allegedly is for flavoring only.  According to plaintiff, the only reason that the front display panel on the Cap’n Crunch cereal box refers to “berries” is “to lead consumers to believe that the Product contains nutritional content derived from fruit.”

Plaintiff alleged statutory violations under California’s Unfair Competition Law (“UCL”), Cal. Bus. & Prof.Code § 17200, et seq., False Advertising Law (“FAL”), id. § 17500, et seq., and Consumer Legal Remedies Act (“CLRA”), Cal. Civ.Code § 1750, et seq., along with common law causes of action for intentional misrepresentation and breach of express and implied warranty. Claims made under these statutes are governed by the “reasonable consumer” test which focuses on whether “members of the public are likely to be deceived.” Williams v. Gerber Prods. Co., 552 F.3d 934, 938 (9th Cir. 2008) (citing Freeman v. Time, Inc., 68 F.3d 285, 289 (9th Cir. 1995)).

In response to the theory that members of the public were likely to be deceived into believing that Cap’n Crunch derives nutrition from actual fruit by virtue of the reference to Crunch Berries, the court gave a one word conclusion: "Nonsense."   It was obvious from the product packaging that no
reasonable consumer would believe that Cap’n Crunch derived any nutritional value from
berries. As an initial matter, the term “Berries” was not used alone, but always was preceded by the
word “Crunch,” to form the term, “Crunch Berries.”  Even the image of the Crunch Berries showed four cereal balls with a rough, textured surface in hues of deep purple, teal, chartreuse green and bright red. These cereal balls do not even remotely resemble any naturally occurring fruit of any kind we have ever seen; there are no pictures or images of any berries or any other fruit depicted on the Cap’n Crunch cereal box.  

Moreover, there were no representations that the Crunch Berries are derived from real fruit or are nutritious because of fruit content. To the contrary, the packaging clearly stated that product is a “SWEETENED CORN & OAT CEREAL.” In short, no reasonable consumer would be deceived into believing that Cap’n Crunch has some nutritional value derived from fruit. 

The warranty claim, that defendant allegedly warranted that Cap’n Crunch “contains berries” and “was a substantially fruit-based product deriving nutritional value from fruit,” was deemed "frivolous." No such claim was made expressly or impliedly anywhere on the Cap’n Crunch packaging or marketing material cited by plaintiff.

Case dismissed, with NO leave to amend to try to salvage some treasurer from nothing.  The Cap'n lives on.

Trivia answer: In May 2007 Cap'n Crunch's full name was revealed as Captain Horatio Magellan Crunch.

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We are generally hesitant to post about some of the ridiculous industry-bashing that many anti-science, anti-capitalism groups spout -- for fear of spreading their misguided word one inch farther.  But sometimes, when litigation is threatened, you just have to stop biting your tongue.

The self-proclaimed Center for Science in the Public Interest has apparently threatened to sue McDonald’s if the popular food company does not stop marketing toys with its Happy Meals.  The claim is that the toys included in the meals instill unhealthy eating habits in children.  CSPI sent a letter to McDonald's last week demanding that the company immediately pull toys from its Happy Meal children’s meals. By advertising that Happy Meals include toys, McDonald’s somehow supposedly unfairly and deceptively markets directly to children.   Advertising a small toy in a Happy Meal box is supposedly deceptive because children under the age of 8 are not advanced enough to understand the "intent" of the marketing.

Well, how wrong can one misguided group be?  Let's count the ways.  Last time we checked, in a democracy with a free market economy, product sellers were free to make their products attractive to consumers, free to advertise them, and free to market their wares with accurate and truthful statements.  A Happy Meal is advertised to contain a toy.  It does.  It has a meal, just like promised.  And as a dad, I can attest to the fact the box meal does make kids happy.  Where is the deception?  There is none. The group cites a variety of state consumer fraud acts in the letter, but not a single case supporting its preposterous legal theories -- because there aren't any. For example, the group cites the Massachusetts law (93A), but the recent case Rule v. Ford Dodge Animal Health Inc., 2010 WL 2179794 (1st Cir. 6/2/10), makes clear that there is no valid consumer claim when the customer does not suffer a traditional and real economic injury.

Next, last time we checked, very few small children were behind the wheel in the drive-through line.  Parents can decide what their kids eat.  And parents can still say "no" when little Johnny or Suzie wants burgers and fries too often. When did we cross the line from parents raising their kids to the best of their ability, to the government (regulators or the courts through a suit) determining how kids should be raised, down to what they can eat and whether they get a small toy to play with after dinner?  According to CSPI, many children will pester their parents to take them to McDonald’s.  So what?  Kids pester; that's what they do.  Parents say "no."  That's what they do.  Problem solved -- without a class action.

Next, the rabble rousers complain that the Happy Meals are slightly higher in calories than the group thinks is reasonable.  Thank goodness for the self-appointed calorie police who think that the best way to tackle the issue of weight in this country is to have the courts force all food companies to make food that looks and tastes like cardboard and is boring, anything but "happy."  How about we get kids to put down the remote control and exercise and play sports more?  Problem solved -- without the litigation.

But, cries the group, the toys build brand loyalty and send the customers back again in the future.  Since when was it an actionable wrong to actually provide your customers with a product they like so much they come back and buy it again in the future?  What kind of economy does this group want?

CSPI needs to worry more about junk science than junk food.  In fact, in my area, McDonald's heavily advertises the four-piece Chicken McNuggets Happy Meal, which includes Apple Dippers, low-fat caramel dip and 1 percent low-fat white milk.  Maybe the issue is that the parents of the CSPI members never told them "no."  Not to worry, they will soon hear it from the courts if they pursue this threatened litigation.
 

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A report issued last week by the Institute of Medicine (IOM) and the National Research Council (at the request of Congress) concludes that the FDA is not well equipped to handle potential problems with the food supply.  "Enhancing Food Safety: The Role of the Food and Drug Administration" notes that food-borne illnesses cause more than 300,000 hospitalizations and 5,000 deaths in the U.S each year. Food-borne diseases are caused by a variety of bacteria—such as Escherichia coli or Salmonella—viruses, parasites, or chemical residues.  

The severity of these diseases and the frequency with which they occur spurred this evaluation of how well the current food safety system protects the public’s health. While food safety is regulated by several agencies, the FDA oversees approximately 80 percent of the U.S. food supply, including all produce, seafood, and cheeses. Some food safety experts and some in the media have criticized the FDA’s food safety system and questioned whether it properly safeguards Americans from food-borne diseases. Congress asked the IOM to examine the possible gaps in the current food safety system under the purview of the FDA and to identify the tools needed to improve food safety.

Readers know that many of these food issues have led to litigation.

The IOM determined that the FDA lacks a comprehensive vision for food safety and should take a risk-based approach in order to properly protect the nation’s food. In addition, the FDA should provide standards for food inspection so that states and the federal government follow the same rigorous methods for inspections, surveillance, and outbreak investigations. Most notably, the IOM recommends that Congress take legislative action to provide the FDA with the authority it needs to fulfill its food safety mission. Americans will continue to suffer from food-borne illnesses unless the FDA reevaluates and reworks its approach to food safety management, claims the report.

The FDA, which sponsored the report, responded that through the President's Food Safety Working Group, which includes all agencies involved in food safety, it feels it is making significant progress to ensure government agencies are working seamlessly to protect the American public. But the IOM concludes that in order for the FDA to better ensure food safety, legislative and organizational changes may be necessary. Most notably, it says, Congress should consider taking legislative action to provide the FDA with the additional authority it needs to fulfill its food safety mission. Within the FDA, authority over field activities should shift from its Office of Regulatory Affairs to its Office of Foods. Such a change will ensure that responsibility lies with well-trained personnel with specialized expertise in food safety and risk-based principles of food safety management, says the IOM.

Recognizing that organizational reform will pose challenges, the report recommends that the federal government move toward the establishment of a single food safety agency to unify the efforts of all agencies and departments with major responsibility for safety of the U.S. food supply. The committee recommends establishing a centralized, risk-based analysis and data management center in order to improve efficiency and work toward a safer food supply. This center would include staff and support resources necessary to conduct rapid and sophisticated assessments of short- and long-term food safety risks and to ensure that the comprehensive data needs to support the risk-based system are met.

With regard to legislative changes, Senator Harkin (D-Iowa), head of the Health, Education, Labor and Pension Committee is trying to bring legislation overhauling the food safety system to the Senate floor later this month. He is pushing S. 510, the Food and Drug Administration
Food Modernization Act , which is co-sponsored by Sens. Dick Durbin (D-Ill.), and Judd Gregg (R-N.H.), among others.  The  bill would give the FDA new authority to track, detect, and halt contaminated food coming from either domestic or foreign suppliers. Food-handling facilities would be required to share additional information with the FDA. Inspections would be more frequent and industry would nee to construct risk-based preventive control plans. The FDA would also get new recall authority.

The House passed its own version of food safety legislation in July, 2009, as we noted.

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Sen. Dianne Feinstein (D-Calif.) announced last week that she would seek to ban the chemical bisphenol-A in food and drink containers as part of an amendment to the proposed Food Safety Modernization Act (S.510). That move has the double distinction of lacking in scientific merit and threatening to undermine the bipartisan support for the good parts of the pending bill.  The Grocery Manufacturers of America and the Chamber of Commerce had expressed support for the food safety bill, but may oppose it if the bill contains language banning the chemical. The food safety bill is expected to come up after Congress returns from its Memorial Day break.

The Senator's ill-supported approach by-passes the safety review that belongs with the FDA, and is ongoing, with a re-review assessment due in 2011. NIH has also launched a study on the safety of low level exposure to BPA.  World-wide regulatory agencies who have reviewed BPA have thus far concluded that BPA is safe for use in canned products.  The European Food Safety Authority has announced a delay in delivering its own latest BPA report, needing more time to review the body of research on the chemical.

Clearly, an abrupt and unnecessary ban on packaging containing BPA would affect consumer ability to find nutritious, valuable, and shelf stable foods and beverages.  The proposed ban runs counter to the fact that BPA has been used for over 30 years to improve the safety and quality of food and beverages, including by providing protective coating for cans. The overwhelming scientific evidence points to the conclusion that at current human exposure levels, BPA is not toxic.  What is in fact occurring is that anti-chemical activists are simply manipulating consumers’ fears, and opportunistic politicians are jumping in.

Even though there is no persuasive scientific evidence that BPA causes the type of harm the politicians speculate about, litigation is well underway in both the Western District of Missouri (MDL 1967) and the Western District of Kentucky (MDL 2137). The former involves class action suits against manufacturers of baby bottles and sippy cups. The claims include alleged violation of state consumer protection acts, fraud, breach of warranty, unjust enrichment, strict product liability, and negligence. MDL 2137, on the other hand, involves suits against an aluminum bottle manufacturer claiming that the manufacturer marketed its product as an alternative to BPA-containing plastic even though its metal bottles were allegedly lined with an epoxy resin containing BPA.  

 

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Last week, the House Subcommittee on Oversight and Investigations of the Energy and Commerce Committee, held a hearing to discuss the recent performance of FDA in ensuring food safety.

Witnesses included Michael R. Taylor, Deputy Commissioner for Foods, Food and Drug Administration; Steven M. Solomon, Assistant Commissioner for Compliance Policy, Office of Regulatory Affairs, Food and Drug Administration; Lisa Shames, Director, Agriculture and Food Safety, Government Accountability Office; Jodi Nudelman, Regional Inspector General for Evaluation and Inspections, Region II, Health and Human Services Office of Inspector General.

The hearing examined two reports relating to the Food and Drug Administration's management of international food imports and inspections of domestic food facilities. In September 2009, the Government Accountability Office (GAO) released a report on the safety of imported food, entitled Food Safety: Agencies Need to Address Gaps in Enforcement and Collaboration to Enhance Safety of Imported Food.  In the report, GAO examined FDA’s difficulties in coordinating information-sharing and enforcement efforts with Customs and Border Protection. CBP provides information on imported food shipments to FDA, but GAO found that the two agencies’ failure to assign unique identification numbers to import firms limited FDA’s ability to tackle problems with high-risk food shipments.  GAO also opined that FDA does not have sufficient authority to ensure importer compliance with existing requirements. After imported food enters the United States, it remains in the possession of the importing firm until the FDA approves its release. The importer posts a monetary bond with CBP that is intended to discourage the shipment’s unauthorized release prior to FDA approval. However, the report found that because the value of the bond penalty is low, GAO previously concluded that the system may not provide an effective deterrent.

FDA testimony last week acknowledged that GAO has raised some important issues in its report on imported food. The Agency apparently agrees with many of the GAO recommendations and will incorporate them, as appropriate, into both short-term and long-term initiatives to help ensure the safety of imported foods. FDA also admitted it has encountered certain problems with rolling out PREDICT (the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting system to improve import screening and targeting nationwide), due to difficulties with incorporating it into the Agency’s information technology infrastructure, which itself is in the process of undergoing major upgrades.

FDA officials also testified that enacting new food safety legislation is critical to strengthening FDA’s oversight of imported foods. H.R. 2749 would, among other things, provide valuable new tools, said the agency, for ensuring that importers reliably verify that the foods they import are produced in compliance with the same prevention-oriented standards that would be applicable to foods produced in the United States. For our food safety system to be effective, prevention must begin at the point of production, not at the port of entry, according the FDA.

The second report was from the Department of Health and Human Services Office of the Inspector General (OIG), and was entitled FDA Inspections of Domestic Food Facilities; it identified a number of challenges confronting FDA in safeguarding domestically produced food.  OIG found that, on average, FDA inspects only 24% of domestic food facilities annually; in addition, the number of inspections declined from 2004 to 2008.  The report also found that over the past five years, FDA has not inspected 56% of the food facilities subject to its authority.  OIG found that when violations were identified, FDA did not always take swift and effective action to ensure that these violations were remedied.  Additionally, OIG claimed that some facilities that had violations significant enough to warrant regulatory action refused to grant FDA inspectors access to their official records.

FDA claims the agency has already addressed many of the issues and recommendations noted in the report, and considerable progress is being made on others. FDA agrees with OIG’s assessment of the gaps in the Agency’s inspection authority. FDA is seeking more effective enforcement tools in accordance with OIG’s legislative recommendations. H.R. 2749 seeks to provide enhancements to FDA’s ability to trace the origin and distribution of tainted food. FDA would issue regulations that require food producers, manufacturers, processors, transporters, or holders to maintain a pedigree of the origin and previous distribution history of the food and to link that history with the subsequent distribution history of the food.  

 

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A federal court recently sent back to China various Chinese families' product liability cases stemming from alleged melamine contamination of infant formula. See Tang v. Synutra International Inc., 2010 WL 1375373 (D. Md.).

Plaintiffs, one hundred Chinese citizens residing in China, brought suit on their own behalf as parents and on behalf of fifty-three minor children who allegedly suffered adverse health
conditions, predominantly the development of kidney stones, as a result of ingesting contaminated milk products produced by Defendants’ Chinese subsidiaries.  The principal place of business of both defendants, Synutra International, Inc., and Synutra, Inc., is in Maryland. Plaintiffs sought compensatory damages of at least $5.5 million for each child and $1.5 million for each parent, as well as a collective punitive damages award of $500 million. Defendants filed their motion to
dismiss on, inter alia,  the grounds of forum non conveniens.

In September 2008, the Chinese Administration of Quality Supervision, Inspection and
Quarantine (“AQSIQ”) initiated an emergency testing program of the country’s dairy supplies. Later that month, AQSIQ announced that certain lots of infant formula were found to have contained melamine, a chemical commonly used as an industrial component in plastics, adhesives, countertops, etc.  Melamine is not a food additive. It is not approved for human consumption.

By December 2008, approximately 300,000 Chinese infants were found to have ingested dairy products contaminated with melamine. Allegedly as a result, at least six infants have died and scores of others have required medical treatment for maladies associated with kidney damage. AQSIQ found varying amounts of melamine in sixty-nine batches of infant milk powder produced by several companies, including defendants' subs. In response to this crisis, the Chinese government, in conjunction with the China Dairy Industry Association, established a compensation program, funded by the dairy companies, that produced the contaminated milk products and totals approximately $160 million. It offered a lump-sum payment to the families of affected children, according to the extent of injury. To date, the families of approximately ninety-five percent of the injured children have reportedly accepted the remedies provided by the plan. Of those who have not, some have opted instead to bring suits in Chinese or U.S. courts.

The adequacy of the Chinese courts to adjudicate these suits was a significant point of contention between the parties; indeed, it was the critical factor of the forum non conveniens analysis in this case.

At the outset of any forum non conveniens inquiry, the court must determine whether there exists an alternative forum. The defendant bears the burden of establishing that the alternative forum is
available to all parties and that an adequate remedy is available to the plaintiff.  Although some courts conflate these issues, the availability and adequacy of the supposed forum are better seen as raising independent issues that warrant separate consideration by the court.

Ordinarily, a defendant can satisfy the availability element by showing that it is “amenable to process” in the alternative forum. Where the remedy offered by the alternative forum is so clearly inadequate or unsatisfactory that it is no remedy at all, however, the court may conclude that dismissal would not be in the interests of justice. Many courts have presumed the adequacy of the alternative forum and placed at least the burden of production on the plaintiff to establish otherwise.

Although plaintiffs here challenged both the availability and adequacy of the alternative forum to adjudicate their claims, there was no question in the court's mind that the Chinese forum was
available, since the defendant showed that it is “amenable to process” in the alternative forum.

Whether China constitutes an adequate forum was the primary issue in dispute. The dispute as to the adequacy of the Chinese forum boiled down to the competing declarations of the parties' China law experts. Defendants’ declarant opined that Chinese courts are adequate to resolve plaintiffs’ dispute and described that Chinese law provides causes of action for personal injury and products liability, a right to present evidence and argument in court, the power to compel witness testimony, and a right to appeal. Plaintiffs would be entitled to recover compensatory damages for expenses such as loss of income, related travel expenses, food subsidies, living expenses for dependents, as well as compensation for emotional damages, but not punitive damages.

Plaintiffs' experts claimed that “several volunteer milk attorneys” were summoned to a meeting held at the Beijing Bureau of Justice, a government entity, where an official demanded all attorneys to withdraw from representation on tainted-milk cases. The experts also asserted that the Chinese courts have denied litigants access to the courts, as well as the right to appeal an adverse ruling, because none of the complaints filed by contaminated-milk victims has been “either accepted or formally denied,”  resulting in the cases remaining perpetually in limbo. They also asserted that families of “seriously sickened children” receive $4,400, and “those suffering from other kidney problems” receive $292 under the government compensation scheme, and this is not “a legal remedy,” but rather “a settlement offer" made by the dairy companies,  In essence, plaintiffs asserted that the Chinese courts were deviating from normal process with respect to melamine claims and pressuring lawyers to withdraw representation of these claimants, thereby forcing the
unfortunate victims into a Hobson’s choice between pursuing futile litigation or accepting the "meager remedy" provided by the compensation program.

The court granted the motion, finding China an adequate forum.  The guiding principles included that the prospect of delay presented by the alternative forum does not typically render the alternative forum inadequate. The complaints had not yet been rejected in China. The court was not wiling to make the value judgment, on the basis of what it called limited evidence presented, that corruption in the Chinese judiciary would systematically deny access to a legal remedy there.  Courts have traditionally been reluctant to cast such aspersions on foreign judicial systems absent a substantial showing of a lack of procedural safeguards.

Second, even if the Chinese courts were not open to plaintiffs, another remedy was indisputably available to them, namely, the compensation program. While the plaintiffs characterized the
program as a “government-sanctioned settlement plan” from the companies that produced the contaminated milk products, as opposed to a legal remedy , they cited no authority for the proposition that the available remedy need be purely “legal” in nature. Regardless of whether it was enacted by the Chinese legislature or sanctioned by the judiciary, it is undisputed that the compensation program developed in China in the wake of the melamine contamination crisis was organized and sanctioned by government entities working in conjunction with the dairy industry and administered through an insurance provider.

Third, although the remedy offered by the compensation program was far less lucrative than what plaintiffs sought in the U.S., the courts have made clear, that the test is not to compare the rights, remedies, and procedures available under the law that would be applied in each forum to determine whether the law applied by the alternative forum is as favorable. 

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From time to time, we have noted the significant litigation that may arise from food recalls.  For those readers interested in this area, we flag a recent article in the International Journal of Food Microbiology. Questeda, et al.,  "Trends in technology, trade and consumption likely to impact on microbial food safety," 10 I.J. Food Micro. 1016 (2010).

Experts from Unilever, the UK Food Standards Authority, and the US National Center for Food Safety and Technology outline what they think of as the key future threats to food safety, and strategies to tackle them. The article looks at current and potential future trends in technology, consumption, and trade of food that may impact on food-borne disease.  Among the most important factors driving an increase in the burden of food-borne disease in the next few decades were found to be the anticipated doubling of the global demand for food; the growing international trade in food; and a significantly increased consumption of certain high-value food commodities such as meat and poultry and fresh produce.

The article opines that the most important factor in reducing the burden of food-borne disease was an improved ability to first detect and investigate a food safety issue and then to develop effective control measures. Given the global scale of impact on food safety that current and potentially future trends have, it is observed that a key role may be played by intergovernmental organizations and by international standard setting bodies.

  

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Two Democratic legislators have introduced a bill that would create an FDA program to assess the potential health and safety effects of nano-technology ingredients in various consumer products.  Sens. Mark Pryor (D-Ark.) and Benjamin L. Cardin (D-Md.) introduced the "Nanotechnology Safety Act of 2010," S. 2942, last week. Their introductory remarks here.

The FDA established a Nanotechnology Task Force, which issued a report in July 2007. In the task force report, recommendations were made regarding FDA’s future direction for regulating nanomaterial-containing products. Guidance development was included as one the recommendations. The FDA’s Advisory Committee for Pharmaceutical Science and Clinical Pharmacology met In 2008. Among the agenda topics was a discussion of issues pertaining to the use of nanotechnology in drug manufacturing, drug delivery, or drug products.  Later, FDA held a public meeting to gather information that will assist the agency in further implementing the recommendations of the Nanotechnology Task Force Report relating to the development of agency guidance documents concerning nanotechnology.

The bill would create a program for the scientific investigation of nanoscale materials included or intended for inclusion in FDA-regulated products, to address the potential toxicology of such materials, the effects of such materials on biological systems, and interaction of such materials with biological systems.  Specifically, FDA would be charged to assess scientific literature and data on general nanoscale material interactions with biological systems and on specific nanoscale materials of concern to Food and Drug Administration, and collect, synthesize, interpret, and disseminate scientific information and data related to the interactions of nanoscale materials with biological systems.

Nanotechnology applications in drug development are likely to have a significant impact on the products that FDA regulates. Products containing nanomaterials are being investigated for potential applications as therapeutics, and some products containing nanoscale materials are already on the market. While some of these nanomaterials are nanoscale versions of larger materials used in approved products, other nanomaterials are novel and have never been used in drug products. In 2009, the FDA introduced the "Nanotechnology Initiative", a collaborative effort between FDA and the Alliance for NanoHealth.

The proposed law would also require a report from FDA by 2012 that includes a review of the coordination of activities under the program with other departments and agencies participating in the National Nanotechnology Initiative. The bill would send $25 million annual funding to the agency for the program. The bill was referred to the Committee on Health, Education, Labor, and Pensions,

Many readers of MassTortDefense know that nanotechnology refers to a new field of technology that seeks to manipulate and control products, really matter, on the atomic and molecular scale, typically 100 nanometers or smaller. To give some sense of scale, one nanometer is one billionth, or 10-9 of a meter. A nanometer compared to a meter is the roughly the same ratio as that of a baseball to the size of the Earth. Or another analogy, a nanometer is the length a man's whiskers grow in the time it takes him to lift his razor to his face to shave. We have posted on this topic here, here, and here.
 

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Yesterday, we posted about events in the MDL.  Today, the science, and it probably shouldn’t surprise readers of MassTortDefense that studies suggesting a product bears some risk get far more media attention than studies showing a product is safe, even when the latter are more rigorous. Similarly, studies funded by industry are dismissed by the media as hopelessly biased, as if product sellers have no interest in exploring their products, but studies from a pro-plaintiff, pro-litigation, anti-business, pro-regulation, big government biased interest group are deemed “neutral.”

Such continues to be the case with BPA. Consumer Union came out with a report of BPA levels detectable in 19 canned foods. They admitted that the study was limited and that the tests only “convey a snapshot of the marketplace and do not provide a general conclusion about the levels of BPA in any particular brand or type of product tested.”  Levels in the same product purchased at different types or places or in other brands of similar foods might differ from CU test results, they acknowledged. Published reports have noted that the group refuses to release the names of the external laboratories they used for testing; and the "study" would not have been published in a peer-reviewed scientific journal without a detailed description of the analytical methods used. The CU also apparently relies on animal studies in which the animals were injected with BPA, instead of ingesting it. Basic toxicology would indicate that the route of administration is important.

However, BPA has been confirmed as safe for use in food contact materials by the world’s major regulatory agencies. The food contact materials in your supermarket, including epoxy can linings, meet current regulatory standards, and as importantly, actually enhance food safety and extend product shelf life. Thus, BPA-based epoxy coatings in metal packaging provide important and measurable health benefits by reducing the potential for the serious and often deadly effects from food-borne illnesses. This packaging enables the high-temperature sterilization of food products when initially packaged and continuously protects against microbial contaminants. The head-long rush by a few zealots to ban BPA overlooks the need to balance this factor.

The levels CU says it detected are substantially below the advisory level of 600 parts per billion established by the European Union as a level of safe consumption for all ages, and below current U.S. guidelines that establish the daily upper limit of safe exposure as 50 micrograms per kilogram of body weight. They thus do not pose a health risk to consumers, of all ages.

The media gave far less attention to a study released that is a significant development in better understanding the safety of BPA. See Ryan, et al., In Utero and Lactational Exposure to Bisphenol A, in contrast to Ethinyl Estradiol, Does not Alter Sexually Dimorphic Behavior, Puberty, Fertility and Anatomy of Female LE Rats (Toxicological Sciences 2009). The study was sponsored by the Environmental Protection Agency. The study conclusion states: “The lack of effect of BPA on female and male rat offspring after oral exposure to low doses in our studies is consistent with the lack of adverse effects on growth, vaginal opening, fertility and fecundity of low doses of BPA in several other robust, well designed, properly analyzed multigenerational studies (Cagen, et al.,1999; Ema, et al., 2001; Tinwell, et al., 2002; Tyl, et al., 2002).”  This new rodent study thus finds that low-dose exposures to BPA showed no effects on the broad range of reproductive functions and behavioral activities measured. Well-conducted, peer-reviewed studies such as this should provide the basis for reasoned government assessments and regulatory decisions -- not the murky at best, results driven CU report.

 

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The U.S. Food and Drug Administration has launched two Internet-based initiatives that may be noteworthy for MassTortDefense readers involved in food safety issues.

First, the FDA has launched an Internet-based registry to track patterns in contaminated food.  The site, explained here, is a result of 2007 legislation requiring food facilities to report potentially dangerous products. Food industry officials are required to use the Reportable Food Registry to alert the FDA when they discover a risk that  their products might injure people or animals, the agency stated last week. By fostering real-time submission to the FDA of information on food safety hazards, the registry is supposed to enhance the agency’s ability to act quickly to prevent food-borne illness. The goal is to catch the problem before people get sick. 

Facilities that manufacture, process, or hold food for consumption in the U.S. must now tell the FDA within 24 hours if they find a “reasonable probability” that an article of food will cause severe health problems or death to a person or an animal. The reporting requirement, which applies to all foods and animal feed regulated by the FDA, does not reach infant formula and dietary supplements.

Any person who has to submit registration information to the FDA for a food facility that
manufactures, processes, packs, or holds food for human or animal consumption is deemed a “responsible party” and must follow the reporting requirement. A responsible party also must investigate the cause of the adulteration if the adulteration of food may have originated with the responsible party. 

The registry's proposal drew criticism from some industries, and they in fact had asked the FDA last month to extend the effective date for reporting. For example, national organizations representing the grain, feed, grain processing and pet food industries said that, at the very least, the FDA should exercise enforcement discretion in order to provide an appropriate phase-in period. FDA did not do so.

The launch of the FDA registry comes just as Congress is considering a new food safety bill that would give the FDA more funding and greater authority to order recalls of products. The House passed a food safety bill in the summer, and the Senate is expected to take up the issue later this fall.

At the same time, the administration is rolling out a new Web site designed to streamline food safety information for the public. Health and Human Services Secretary Sebelius announced the new Web site  last week. The site is a joint effort among HHS, the Department of Agriculture and the FDA.

The site will put food-related information from all federal agencies in one place.  It includes sections on how to "Keep Food Safe"; what to do in the case of suspected "Food Poisoning"; a section for industry relating to "Inspections & Compliance"; as well as food news, agency events (such as workshops, meetings, and conferences) for FDA, CDC, USDA; and educational materials on food safety.  Of particular interest to our readers may be the links to agency speeches and presentations, communications to Congress, and Congressional testimonies.

 

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The FDA is considering issuing guidelines on acrylamide content in food.  The agency has published a notice seeking comments from industry on the issue.

Acrylamide is a chemical formed primarily in baked and fried foods by a reaction between sugars and the amino acid asparagine. The reaction is partly responsible for the golden color and tasty flavor of baked, fried, and toasted foods. In 2002, some Swedish scientists reported unexpectedly high levels of acrylamide in carbohydrate-rich foods and also published a study associating the chemical to cancer in laboratory rats. Further research subsequently determined that acrylamide can form in some foods during certain types of high-temperature cooking.

FDA has not yet issued guidance for manufacturers on reducing acrylamide in food. However, it is anticipated by the agency that new information will soon be available about the toxicology of acrylamide, which may shed light on acrylamide's potential carcinogenicity in laboratory animals. Readers of MassTortDefense know how difficult it is to leap from animal studies to causation conclusions in human beings, because of the physiological and metabolism differences between species, the excessive dosages that are (and typically must be) given to experimental animals, and the varying biological defense mechanisms that species have to environmental insults.

International efforts to develop approaches to acrylamide mitigation are also beginning to prove successful. Moreover, FDA is aware that at least some manufacturers in the United States are seeking ways to reduce acrylamide in their products. In this context, FDA is considering issuing guidance for industry on reduction of acrylamide levels in food products.

Health Canada recently added acrylamide to that nation’s toxic substances list, as part of its ongoing review of over 200 chemical substances in commercial use. It stated that current consumption levels “may constitute a danger in Canada to human life or health,” but it also acknowledged that research into a possible carcinogenic link for humans has so far been inconclusive.

In fact, dietary intakes of acrylamide are not related to increased risks of brain cancer, according to a recently released study of 58,279 men and 62,573 women, published by Maastricht University in the Netherlands. J.G.F. Hogervorst, et al., “Dietary Acrylamide Intake and Brain Cancer Risk,” 18 Cancer Epidemiology, Biomarkers & Prevention (2009).  Researchers have also reported in the Journal of the National Cancer Institute that dietary acrylamide was not linked to lung cancer risk, and that the compounds may even reduce the risk in women. "Lung Cancer Risk in Relation to Dietary Acrylamide Intake," 101(9) JNCI 651-662 (2009).

 

 

In seeking comments, the FDA has asked food manufacturers to respond with details of any manufacturing changes they have made, the success and cost-effectiveness of those changes, methods for acrylamide reduction that could be appropriate for smaller manufacturers, and changes to on-pack instructions for consumers to mitigate acrylamide formation.

 

 

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The FDA's Science Board earlier this week heard  an update from the agency regarding the continued assessment of Bisphenol-A (BPA) in FDA-regulated products. (The Science Board to the Food and Drug Administration provides advice primarily to the Commissioner and other government officials on complex and technical issues as well as emerging issues within the scientific community.  The Board consists of a core of 21 members who are supposed to be authorities knowledgeable in the fields of food safety, nutrition, chemistry, pharmacology, toxicology, clinical research, and other scientific disciplines. Members represent academia and industry.)

At the meeting's update from the agency regarding the continued assessment of BPA,  the FDA Acting Deputy Commissioner briefed the agency's Science Board about agency plans to complete its evaluation of bisphenol A;  Dr. Goodman, who is also FDA's acting chief scientist, reportedly stated that the FDA will decide by Nov. 30 whether it will regulate bisphenol A in food packaging. FDA's National Center for Toxicological Research also described a variety of rodent and monkey studies that FDA is undertaking to further assess bisphenol A and potential health effects.

A representative of the Natural Resources Defense Council was among the public speakers who urged FDA to ban bisphenol A, despite the fact that the few studies of laboratory animals that have suggested an association with reproductive or developmental issues have used nonstandard test methods. Studies using standard protocols have not found any significant problems. The American Chemistry Council, BPA Joint Trade Association, and other industry groups argue that food and beverage containers made with BPA pose no undue risk of harm.  BPA is used in the lining of some food and beverage cans to prevent spoilage and is also used in a variety of other consumer products to enhance the structural integrity of plastic containers. Assessments conducted by Health Canada and California's Environmental Protection Agency suggest that dietary exposure would not pose risk to infants. Infant formula may be the most highly regulated food in the world.

Earlier this month, the Massachusetts Department of Public Health issued a health advisory   to parents and caretakers of children up to the age of two years suggesting they avoid the use of products that contain BPA for making or storing infant formula and breast milk. The state health agency further advised pregnant and breastfeeding women to avoid products that may contain BPA. The agency also noted that researchers caution that more research needs to be conducted.

Readers of MassTortDefense interested in BPA issue may want to look at "Science Suppressed: How America became obsessed with BPA,"  an in-depth examination by the STATS program at George Mason University of the science, risk assessment, and media coverage of the chemical, based on interviews with the lead authors of two major risk assessments, and focusing on the accuracy of the media's campaign to have the chemical banned. Some newspapers' coverage has had a knack, says the study, for avoiding research that showed BPA was safe, including risk assessments by the European Union, NSF International, Japan, and a lot more. Some of the media coverage has relied on a small circle of researchers whose work on BPA has been rejected by risk assessments across the world.

After the National Toxicology Program draft report was issued in early 2008, plaintiffs' attorneys nationwide began filing consumer class action complaints claiming violations of state consumer protection laws, fraud, breach of warranty, unjust enrichment, strict product liability, breach of contract and negligence. The lawsuits were consolidated as an MDL in the Western District of Missouri, last year (MDL-1967).  This multidistrict litigation consists of more than 25 cases that involve allegations concerning in baby bottles.

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Readers of MassTortDefense know how FDA actions can instigate and affect potential mass tort litigation involving drugs and devices. Last week, in a presentation to the Food and Drug Law Institute (FDLI), new FDA Commissioner Margaret A. Hamburg revealed that the FDA will implement procedural reforms designed to allow the agency to act more quickly and aggressively on the enforcement of food, drug, and medical device regulations. The FDA commissioner told FDLI that the federal watchdog will be a leaner and meaner organization under her leadership.

In her remarks, the Commissioner noted that while impressed by the commitment to compliance that many companies have made – both in terms of their corporate culture and their investment in compliance systems -- her goal is for all companies to make and implement such a commitment in order to prevent harm to the public. A key part of the strategy to support private sector compliance is more effective enforcement against violations of the law. She suggested that such enforcement helps industry too – by maintaining a level playing field for safe products. Making sure that offenders are held legally accountable prevents companies from having to choose between doing the right thing and staying competitive.

An effective enforcement strategy depends on several key elements she said:

• The FDA must be vigilant. Through regular inspections and follow-up on signals indicating problems, the FDA must work to identify and resolve problems early. Companies must have a realistic expectation that if they are crossing the line, they will be caught, and that if they fail to act, FDA will.
• The FDA must be strategic, she continued. The agency must place greater emphasis on significant risks and violations, and use meaningful penalties to send a strong message to discourage future offenses.
• The FDA must be quick. The agency must be able to respond rapidly to egregious violations or violations that jeopardize public health.

More specifically, she said the pathways for enforcement action can be too long and arduous. To address this, the FDA will set post-inspection deadlines. When the FDA finds that a firm is significantly out of compliance, it will expect a prompt response to the findings, generally no more than fifteen working days before the FDA moves ahead with a warning letter or enforcement action.

Second, the FDA will take steps to speed the issuance of warning letters. There will be a new policy to limit warning letter review to significant legal issues.

Third, the FDA will work more closely with regulatory partners to develop effective risk control and enforcement strategies. In many food safety cases, for example, local, state, and international officials have more authority to take action quickly than the FDA.

Fourth, the FDA will prioritize enforcement follow-up. After a warning letter is issued or a major product recall occurs, FDA will make it a priority to follow up promptly with appropriate action, such as an inspection or investigation to assess whether or not a company has made required changes in its practices.

Fifth, she said, the FDA will no longer issue multiple warning letters to non-compliant firms before taking enforcement action. And, in the case of significant health concerns or egregious violations, FDA will consider immediate action – even before issuing a formal warning letter.

Finally, the FDA is developing a formal warning letter “close-out” process. If the FDA can determine, usually based on a re-inspection, that a firm has fully corrected the violations raised in a warning letter, it will provide to the firm a “close-out” letter, indicating that the issues in the warning letter have been successfully addressed. One can imagine how the obtaining or failure to obtain a close-out letter may be anissue in litigation.
 

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FDA has announced a forthcoming meeting of the Risk Communication Advisory Committee.  This advisory committee provides advice and recommendations to the agency on a variety of regulatory issues. The meeting will be held on August 13, 2009, from 8 a.m. to 5 p.m. and August 14, 2009, from 8 a.m. to 2 p.m.

The Committee will discuss FDA’s external research on, and internal assessment of,  communications about food safety problems. This discussion will address research on consumer
knowledge of food recalls and plans for how to monitor communication effectiveness during the course of a recall. The goal of the discussion is to advise FDA on developing more effective communication strategies. The Committee will discuss FDA's external research on, and internal assessment of, communications about food safety problems. This discussion will address research on consumer knowledge of food recalls and plans for how to monitor communication effectiveness during the course of a recall. 

 

As background for this topic, the FDA directs the public to following sites:
• FDA Peanut Product website.

 

•2006 FDA/FSIS Food Safety Survey Top-line Report

•Rutgers University Food Recall Surveys – Consumer Responses to Food Recalls: 2008 National Survey Report
Public Response to the Salmonella Saintpaul Outbreak of 2008
Public Response to the Contaminated Spinach Recall of 2006

Readers of MassTortDefense are well aware of the signifcant food recall issues, and subsequent litigation, in recent years.
 

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The House Energy and Commerce Committee last week approved legislation that would give the FDA more funding and power to police food safety.  The unanimous voice vote for a version of the bill offered by committee Chairman Henry Waxman (D., Calif.) came after extensive negotiations between Democrats and Republicans. The "Food Safety Enhancement Act of 2009,"  H.R. 2749, will now go to the entire House.

The bill comes at least in part in response to recent outbreaks of illnesses traced to tainted spinach, peanuts, hot peppers and other foods. The legislation would give the FDA greater authority to order food recalls, impose new civil penalties, and require inspections of so-called high-risk food facilities at least once a year.  It also calls for companies to keep detailed records to help the FDA more quickly trace the distribution of tainted foods and track the source of the contamination.  Specifically, the FDA would be required to issue regulations that require food producers, manufacturers, processors, transporters or holders to maintain the full pedigree of the origin and previous distribution history of the food and to link that history with the subsequent distribution history of the food.
 

The Grocery Manufacturers Association, a food industry group, released a statement in support of the bill, after Democrats agreed to a number of changes. (For example, they added a cap so no company would be charged more than $175,000 in fees to pay for the new bill.)  Critics of the bill argue that it would impose a one-size-fits-all regulatory scheme on big and small farms and on national and local food producers; does not address the major underlying causes of food safety problems such as industrial agriculture practices and the consolidation of our food supply. Others assert that the bill, by apparently empowering the FDA to regulate how crops are raised and harvested, puts the federal government right on the farm, dictating to farmers "good farming practices" on organic farming, use of manure, GMO animal feed, animal drugs, and petrochemical fertilizers and pesticide issues.

At last report, the House hasn't scheduled a vote on the legislation. In the Senate, Illinois Democrat Dick Durbin has introduced similar food-safety legislation.

 

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The administration's Food Safety Working Group is collecting suggestions on its website for reforming federal food safety policy. Earlier this Spring, President Obama announced the creation of the Food Safety Working Group, chaired by the Secretaries of the Department of Health and Human Services and the Department of Agriculture. The President said in his address that the working group was designed to "bring together cabinet secretaries and senior officials to advise me on how we can upgrade our food safety laws for the 21st century; foster coordination throughout government; and ensure that we are not just designing laws that will keep the American people safe, but enforcing them."

The Working Group's charge is to ensure the country has safe food, to enhance food safety systems by fostering coordination throughout the government, and to enhance food safety laws for the 21st century. Apparently, the first work product from the Food Safety Working Group will be a set of principles and guidelines for improving food safety. The Working Group is receiving input from a broad range of stakeholders about their ideas for improving the food safety system. Others are invited to send their suggestions for reforming food safety policy, along with questions, comments, concerns. The Working Group can be reached through the White House comment form, or on twitter (hashtag #WHsafefood) or at their Facebook page.

Interested readers of MassTortDefense should think about reaching out to the Working Group with ideas for food safety that properly balance the importance of an adequate supply, the need for rapid transportation of foodstuffs, the public benefit of dietary choice and food options, the harmfulness of excessive governmental red tape; the need to avoid significant costs increases to the consumer in this challenging economic period, the inefficiency of government bureaucracy, the diversity and scope of the food service industry and its complex, multi-layered linkage with the supply chain, and other relevant concerns.

Most importantly to litigators, any thoughts would be welcome on safety steps that will not support or encourage additional litigation against the food industry. The CDC estimates that, each year, nearly 76 million people are affected by some type of food-borne illness, and approximately 325,000 Americans are hospitalized with a food-borne illness. Ultimately, this is because many pathogens continue to exist naturally in raw animal foods such as meat and poultry. Unfortunately, most food illness outbreak investigations fail to identify the real culprit, and some even identify the wrong source. In many cases, the claimants (who mistakenly think they got sick from the last thing they ate) sue the wrong party. Arguably, a significant part of the federal approach to food safety should focus on consumer and industry education, i.e., food safety educational programs that span the entire farm-to-table continuum, educating farmers, producers, distributors, food-handlers and consumers.

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A federal court has rejected class certification in the multidistrict litigation concerning McDonald's Corp.'s french fries. In Re McDonald’s French Fries Litigation, MDL No. 1784, Civ. No.06-C-4467 (N.D. Ill. May 6, 2009). Plaintiffs in all 50 states and Washington, D.C., brought claims against McDonald's for allegedly putting hydrolyzed wheat bran and hydrolyzed casein in a beef flavoring for oil used in production of french fries and hash browns. Plaintiffs included individuals with celiac disease; galactosemia; autism; and wheat or gluten allergies. Defendant was alleged to have falsely claimed the "Potato Products" were gluten, wheat, and dairy-free through its website and in literature available at the restaurants.

The plaintiffs did not claim that they were physically harmed by the presence of trace amounts of wheat gluten and casein — a milk protein — in the beef flavoring. Rather, they based their claims on theories of consumer fraud and alleged economic losses. Plaintiffs claim they purchased Potato Products based solely on defendant’s representations that those products were free of gluten, milk and/or wheat ingredients, that the Potato Products in fact contained these allergens, and that absent defendant’s misrepresentations, plaintiffs would not have purchased the Potato Products.

The court first addressed the class definition. Named plaintiffs had testified in their depositions that they were quite satisfied with the Potato Products they consumed. (This shows the importance of pre-certification discovery, and the common common disconnect between the theories of class counsel and the reality of the class). None of the named plaintiffs had any physical reaction to eating the Potato Products. It was clear, therefore, that many persons in the class as defined by plaintiffs had gone on eating defendant’s Potato Products even after defendant clarified its product disclosures. Expert testimony showed that many patients with food allergies conduct their own ‘trials’ to determine what foods with gluten they have previously enjoyed that they may eat in moderation without experiencing symptoms. People who continued to use the products suffered no injury, not even the economic one claimed in this lawsuit. So the class was both over-inclusive and too indefinite for certification.

Regarding a narrower possible class of persons who because of their diagnosis of celiac disease, galactosemia, autism or a wheat, gluten or dairy allergy would not have eaten McDonald’s french fries or  hash browns if they had known they contained, potentially, a small amount of hydrolyzed wheat bran and hydrolyzed casein in the beef flavor that makes up one percent of the oil in which the potato suppliers par-fry the potatoes before shipping them to McDonald’s, and who relied on a representation by defendant that its Potato Products were wheat or milk free in purchasing and eating the french fries or hash browns….the court found that individual issues and individualized proofs would destroy manageability of a class action. That class in essence asked the court or jury to, at a minimum, review and evaluate potentially millions of letters from doctors for each class member. In addition, each claimant would have to individually affirm that he or she had seen the representation, purchased Potato Products on the basis of the representation, and no longer did so following defendant’s expanded product disclosure in February, 2006. Such a necessary separate evidentiary inquiry into each class member’s claim precluded certification.

Finally, choice of law issues ensured that individual issues of law clearly predominated over
common issues, making a nationwide class unmanageable. In at least some jurisdictions, reliance is necessary to connect the representations with the economic harm claimed, and in others individual proof is necessary to show that any injury was proximately caused by the misrepresentation made by a defendant.
 

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Published reports cite data suggesting that the FDA is having difficulty meeting its audit goals for food-safety inspections done contractually by states on its behalf.  The FDA is ultimately responsible for the safety of about 80% of the U.S. food supply.  It tends to focus on high risk foods, and contracts with approximately 40 states for inspections of other foods. Nationally, about half of all inspections are performed by states, according to the GAO.

The FDA audits state inspections done on its behalf, with a goal of auditing 7% of the state efforts so as to ensure quality inspections. Recently released data suggests the agency did not meet this audit target in at least 17 states, with five states receiving no audits in the last reporting period. The quality of state inspections came under intense scrutiny this year during the salmonella outbreak allegedly traced to Peanut Corp. of America in Georgia. And, as readers of MassTortDefense realize, the end result can involve mass tort litigation.  Experts hypothesize that so many state and federal resources are devoted to major food-borne illness outbreaks, audits may get postponed.

President Obama's selection to head the FDA, Dr. Margaret Hamburg, has pledged to make protecting the country’s food supply a major priority. And the new proposed federal budget calls for a $260-million increase for the FDA's food safety program. Part of the new funding would go to rebuild the ranks of inspectors; the number of FDA food inspectors has dropped since 2003. Hamburg has noted that the globalization of food production (about 20% of our food supply comes from abroad), the emergence of new and complex food technologies, and the risk of adulteration or deliberate terror attacks on our food supplies all raise major concerns. She proposes a shift from chasing outbreaks after they have occurred to trying to prevent them in the first place.
 

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Readers may have heard the response by the person warned by a family member that what he or she was eating was bad for their heart. “Wait a month and there will be a different study showing it is good for me.”  What we know for sure about diet and the heart is actually a surprisingly short list.

This week comes the study, A Systematic Review of the Evidence Supporting a Causal Link Between Dietary Factors and Coronary Heart Disease, by Drs. Mente, de Koning, et al. , 2009 Arch Intern Med. 169(7):659-669. This review study did an analysis of nearly 200 studies involving millions of people.

The authors concluded that strong evidence supports valid associations of protective factors for vegetables, nuts, and "Mediterranean" diet patterns, but that associations of harmful factors included intake of trans–fatty acids and foods with a high glycemic index.

Significantly, insufficient evidence of association was present for intake of supplementary vitamin E and ascorbic acid (vitamin C); saturated and polyunsaturated fatty acids; total fat; meat; eggs; and milk. 

One of the interesting features is that the authors used the traditional Bradford Hill guidelines on drawing causation conclusions from evidence of association to derive a causation score, basing it on 4 criteria (strength, consistency, temporality, and coherence) for each dietary exposure in cohort studies; they also examined the results for consistency with the findings of randomized trials.

Epidemiology involves judgment; it is not an absolute science, and the presence of confounding factors and the difficulty in finding an adequate control/comparison group for many food issues are similar to the issues seen in toxic tort litigation. 

No surprise, then, that the authors conclude that future evaluation of dietary patterns, including their nutrient and food components, in cohort studies and randomized trials is recommended.
 

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The Food and Drug Administration’s Risk Communication Advisory Committee will be holding a public meeting on April 30, 2009, and May 1, 2009, at the Center for Drug Evaluation and Research Advisory Committee Conference Room, in Rockville, MD. On both days the Committee will discuss the Agency’s draft risk communication strategic plan and will be asked for comment and further advice on strategic priorities for research on effective risk communication.

That draft plan describes FDA’s strategy for improving how the agency communicates about regulated products. The strategy is intended to guide program development and research planning in a dynamic environment where rapidly evolving technologies enable patients and consumers to become increasingly involved in managing their own health and well-being. FDA has been looking to improve how it produces communications about the risks and benefits of regulated products, as well as how it oversees those communications produced by regulated entities. For example, as the Internet and emerging technologies have both enabled and fed the public’s demand for greater transparency and communication frequency, the traditional waiting periods for FDA guidance have given way to communication in real time. Designing a contemporary risk communication strategy is key to FDA’s efforts to reposition itself to realize its potential for effective protection and promotion of health, enabled by 21st century knowledge and technology.

Effective communication supports both optimal use of medical products and safe consumption of foods to maximize health. The IOM report on The Future of Drug Safety: Promoting and Protecting the Health of the Public (2006) focused on drug safety, but also highlighted communication more generally, referencing FDA’s mission of helping the public get the accurate, science-based information it needs. In response to an IOM recommendation, FDA launched its Risk Communication Advisory Committee in 2007 to give advice about FDA’s risk communication approaches for all FDA-regulated products.

The FDA has begun to identify research needs in this area, including on the broad topics of:

• When and what to communicate
• Reaching the audience (dissemination)
• Ensuring audience understanding
• Motivating audiences
• Evaluating effectiveness of communications
   

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A new report from the U.S. Centers for Disease Control and Prevention indicates that after "important declines" seen in previous years, the incidence of many food-borne illnesses in the United States has leveled off in the past few years.  U.S. health officials conclude that progress on food safety has plateaued, and that further measures are needed to prevent more food-borne illness.

The findings are from 2008 data reported by the Foodborne Diseases Active Surveillance Network (FoodNet), a collaborative project of CDC, the Department of Agriculture’s Food Safety and Inspection Service (FSIS), the FDA, and 10 state sites. Preliminary data from FoodNet indicate that diagnosed and reported illnesses from an array of bacteria, including campylobacter, cryptosporidium, cyclospora, listeria, shiga toxin-producing escherichia coli (STEC), shigella, vibrio and yersinia, have basically stayed the same since 2004.

In the case of salmonella, the bacteria recently found in peanuts and pistachios, infections may be trending upward. The report said that in 2008, 16 of every 100,000 people in the United States had laboratory-confirmed cases of salmonella infections. That translates into about 48,000 serious illnesses, since individual stool samples are generally sent to laboratories only when someone is suffering a severe bout. In 2005, the figure was 14 people per 100,000, or about 42,000 cases of laboratory-confirmed salmonella infections.

Part of the problem is that as food supply chains get longer, and global distribution networks more complex, there are simply more opportunities for things to go wrong, according to the CDC. If a manufacturer or distributor has wider reach, a single tainted ingredient can potentially infect large numbers of people. Often, therefore, outbreaks of food-borne disease can result in mass tort litigation.

Roughly 76 million people in the United States suffer food-borne illnesses each year, 300,000 are hospitalized, and 5,000 die, according to CDC estimates. Children younger than 4 are sickened by food more than those in any other age group, but adults over age 50 suffer more hospitalizations and death as a result of food-related infections.
 

The CDC report follows on the heels of a report released last week by the Inspector General of the U.S. Department of Health and Human Services finding that identifying the actual suppliers and distributors of tainted food products remains a serious issue. 

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Identifying the suppliers and distributors of food products remains a serious issue according to a report released last week by the Inspector General of the U.S. Department of Health and Human
Services.

Beginning in 2005, FDA required certain food facilities to maintain records identifying the sources, recipients, and transporters of food products. The purpose of these records is to allow FDA to trace an article of food through each stage of the food supply chain—from a retail shelf back to a farm—if FDA has a reasonable belief that a food product is adulterated and presents a serious health threat.

This new report was based on two primary data sources: (1) a traceability exercise of 40 selected food products and (2) structured interviews with the managers at the food facilities that handled the selected food products. Traceability is the ability to follow the movement of a food product
through the stages of production, processing, and distribution. Traceability includes both traceback and trace forward. Traceback is the ability to trace a food product from the retail shelf back to the farm. Conversely, trace forward is the ability to trace a food product from the farm forward to the retail shelf. Traceability is often needed to identify the sources of food contamination and the recipients of contaminated food in product recalls and seizures.

The issue of tracking the sources of food-borne disease outbreaks has gained attention since the massive recall of peanut-related products from Peanut Corp. of America earlier this year, which we have posted on.

For the traceability exercise, the agency purchased food products from different retail stores and attempted to trace them through each stage of the food supply chain back to the farm(s) or the border. The government asked the facilities that handled the food product for information about
their sources, recipients, and transporters, which was used in an effort to trace the product. The HHS inspector general's office and FDA representatives purchased 10 individual food products from retail stores in four metropolitan areas – New York, Chicago, San Francisco and Washington. The products included bottled water, manufactured ice, whole milk, eggs, plain yogurt, milled unbleached flour, plain oatmeal, fresh whole tomatoes, cut vegetables and fruit juice.

The department's inspector general's office found that retailers and distributors could trace the component ingredients of just five of 40 products purchased to the farm or country where the ingredients were produced. The inspectors were only able to locate facilities that likely handled the products for 31 of the products.

Several factors limited the ability to trace the specific food products through each stage of the food supply chain. These factors included: (1) processors, packers, and manufacturers not always maintaining lot-specific information, as required; (2) other types of facilities not maintaining lot-specific information because it is not required; (3) retailers receiving products not labeled with lot-specific information; and (4) the mixing of products from a large number of farms. These factors also affect the speed with which FDA can trace specific food products through the food supply
chain. In fact, more than half the 220 facilities contacted failed to meet federal requirements to maintain records about their sources, recipients and transporters of food. The report found that a quarter of the companies contacted did not even know about the requirements. 

In a food emergency, there could be serious health consequences if FDA cannot — at a
minimum — identify the facilities that potentially handled a contaminated food product.

The report recommends that:

• FDA  should seek statutory authority, if necessary, to require all processors, packers, and manufacturers to create and maintain lot-specific information for food products. FDA should also extend the requirements regarding lot-specific information to other types of facilities, such as distributors, storage facilities, and retailers, in order to further strengthen the traceability of food products.
• FDA should consider seeking additional statutory authority requiring food facilities to further strengthen the traceability of food products.
• FDA should work with the food industry to develop additional guidance on traceability.
• FDA should work with the food industry to develop standards for mixing raw food products from a large number of farms.
• FDA should seek statutory authority to request facilities’ records at any time, as opposed to its current authority to request records only when FDA has a reasonable belief that an article of food presents a serious health threat.
• FDA should develop education activities that focus on appropriate and reliable record-keeping systems.

 

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In the past few days, bills were introduced in both houses of Congress to ban bisphenol A in all food and beverage containers in the U.S.

The so-called Ban Poisonous Additives Act of 2009 is sponsored Rep. Edward Market, D-Mass. in the House, and by Sen. Dianne Feinstein, D-Calif. and Sen. Charles Schumer, D-N.Y. in the Senate. In the House it is H.R. 1523. In the Senate it is S.593

The proposed legislation would ban the sale of reusable beverage containers like baby bottles and thermoses that contain BPA and prohibit other food and beverage containers, including canned food and formula, containing the chemical from entering the market.

The bill, which would take effect 180 days after it is enacted, allows manufacturers who can show that a particular container cannot be made without BPA to obtain a renewable one year waiver to the ban. During that time, the company must label the product as containing BPA and submit a plan for removing the chemical in the future.

The bill also requires the secretary of HHS to conduct a periodic review of the list of substances that have been deemed safe for food and beverage containers, to determine whether new scientific research shows that the substances pose health risks. This review must take place “not less than once every 5 years,” under the bill.

MassTortDefense has posted about BPA issues before. With regard to BPA generally, based on all available evidence, the consensus of regulatory agencies in the United States, Canada, Europe, and Japan is that the current levels of exposure to BPA through food packaging do not pose an immediate health risk to the general population, including infants and young children.

Also in the press, six manufacturers — Avent, Disney First Years, Gerber, Dr. Brown, Playtex and Evenflo — announced that they would ban BPA in baby bottles they sell in the U.S. And Sunoco indicated that it had stopped selling BPA to anyone who would not promise to prohibit its use in products intended for children ages three and under.

Many of these companies are defendants in the ongoing BPA litigation, and their voluntary actions reflect the legal risks far more than the science. The companies noted this decision may address growing public concern and confusion regarding products made with polycarbonate plastic, but was not because these FDA-regulated products are not safe.

Any wide-spread ban of this product – or litigation accomplishing the same result -- may risk the public safety more than enhance it. Epoxy resins derived from bisphenol A are used to manufacture protective polymer coatings for the inner surface of metal food and beverage containers. This critical technology protects the contents of these containers from aggressive food products, thereby assuring a safe, wholesome, and nutritious food supply. Compared to other coating technologies, coatings derived from epoxy resins provide superior adhesion to the metal surface, greater durability, and higher resistance to the wide range of chemistry found in foods and beverages. These attributes are essential to protect the packed food from microbiological contamination, which is a significant food safety issue.

Canning might be the single most important innovation in the preservation of food in history. More than 1500 food items are regularly packed in cans, making out of season foods globally accessible year-round. More than 90% of food and beverage cans use epoxy-based coatings because of their strength, adhesion, formability and resistance to chemical reactions in the food and drinks -- without affecting the taste or smell of the product. They protect the food from the container and from bacterial contamination. They give canned foods their long shelf-life.

 

 

 

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Two years ago, there was a nationwide outbreak of E. coli linked to consumption of contaminated spinach from a California supplier. That was the 25th reported U.S. outbreak of E. coli infection that had been traced to contaminated leafy green vegetables since 1993. Each year, approximately 110,000 persons get this infection, and 50 of them die. This is despite greatly intensified efforts during the past decade on the part of federal food-safety agencies — the U.S. Department of Agriculture (USDA), the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC) — to prevent the spread of such infections.

In a 2008 outbreak, Salmonella was diagnosed in 1407 persons in 43 states. At least 282 patients were hospitalized, and 2 patients died. Although initial epidemiologic evidence suggested that contamination of tomatoes grown in the southwestern United States might be the cause, eventually the outbreak was isolated from jalapeño and serrano peppers that had been grown on a Mexican farm. In the mean time, tomato consumption plummeted, and the industry lost an estimated $200 million in sales.

This year, the disease was diagnosed in 600 persons in 44 states and Canada traced to contamination of one Georgia producer's peanut butter and the processed foods of other manufacturers that contained the company's peanut butter or paste. Beyond a recall of all peanut products produced by the company since January 1, 2008, more than 400 food products (including cookies, crackers, cereal, candy, ice cream, and pet foods) have been recalled.

Many of incidents like these have led to products liability and mass tort litigation. E.g., In Re ConAgra Peanut Butter Products Liability Litigation, MDL-1845, 2008 WL 2885951 (N.D. Ga., July 22, 2008). And this issue has caught Congress’ attention. Senator Durbin last week introduced S.510, the “FDA Food Safety Modernization Act,” a new bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the safety of the food supply. The bill calls for food manufacturers to conduct a Hazard Analysis and implement Risk-Based Preventive Controls; it calls for regulations to establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables that are raw agricultural commodities for which the agency has determined that such standards minimize the risk of serious adverse health consequences or death.

The bill also calls for inspection of food makers’ facilities, according to their risk profile, based on the facility's history of food recalls, outbreaks, and violations of food safety standards, and the rigor of the facility's hazard analysis and risk-based preventive controls. Some facilities would be designated as high-risk facilities and subject to annual inspections. the proposed legislation would also upgrade the nation’s food-borne illness surveillance systems to improve the collection, analysis, reporting, and usefulness of data on food-borne illnesses by coordinating Federal, State and local food-borne illness surveillance systems, including complaint systems, and increasing participation in national networks of public health and food regulatory agencies and laboratories.

Regarding imports, the bill would require each United States importer to perform risk-based foreign supplier verification activities, and the FDA would be required to establish by 2010 an office in not less than 5 new foreign countries to provide assistance to the appropriate governmental entities of such countries with respect to measures to provide for the safety of articles of food and other products regulated by the FDA and exported by such country to the United States.
 

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China will set soon up a central food safety commission, according to state-owned media last week. The new commission will be organized under the State Council, and is to help enforce new food-safety legislation meant to tighten supervision of manufacturers and impose tougher penalties on those who manufacturer defective items. The new law, approved by the standing committee of the National People's Congress, has been in the making for two years. It also sets up a system to recall problem products and authorizes the enforcement of uniform nationwide standards on nutritional labeling.

Reportedly, the commission's task will be "to strengthen the country's food monitoring system, whose low efficiency has long been blamed for repeated food scandals," as China seeks to restore public confidence after a number of problems with tainted food. Presumably, that refers in part to the melamine scandal in which at least six infants died last year and nearly 300,000 were sickened by baby formula tainted by an industrial chemical that had been added to milk supplies to give the appearance of higher protein.

How effectively China maintains the safety of its food supply is increasingly important to consumers in other countries as well, as Chinese ingredients end up in foodstuffs sold around the world. Between 2004 and 2007, Chinese food exports climbed about 63%. Several tainted Chinese products led to mass tort litigation in the U.S.

The national food-safety commission is supposed to coordinate work by other government agencies, and reduce the number of agencies involved. United Nations public health experts last year called for an overhaul of China's food-safety system, criticizing the country's use of a patchwork of various local and national government agencies to police the food supply.
 

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A federal district court recently denied defendant’s motion to dismiss in a putative class action under California's Unfair Competition Law alleging that defendant engaged in misleading conduct by advertising its “Healthy Choice” pasta sauce as “all natural” even though it includes some “high fructose corn syrup.” Lockwood v. Conagra Foods, Inc., 2009 WL 250459 (N.D.Cal. Feb. 3, 2009).

Defendant moved to dismiss on several grounds: arguing plaintiffs' claims were expressly preempted by the Nutrition Labeling and Education Act; were impliedly preempted by comprehensive FDA regulations under the Federal Food and Drug Cosmetic Act; that the court should defer to the FDA under the “primary jurisdiction” doctrine. Finally, defendants asserted that the court should strike the class allegations because plaintiffs cannot prove reliance on a class-wide basis.

Regarding the field preemption argument, the court noted that the purpose of the NLEA was to clarify and to strengthen FDA's authority to require nutrition labeling on foods, and to establish the circumstances under which claims may be made about the nutrients in foods. Under the Act, states may impose labeling requirements for artificial favors, colors or preservatives only if such requirements are identical to those imposed by the FDCA; any differences are preempted. But, the court held, this provision does not apply to plaintiffs' complaint as currently pled. Plaintiffs did not allege that defendant's pasta sauce contains artificial flavoring, coloring or a chemical preservative; rather, they allege that the “high fructose corn syrup” is not produced by a natural process and therefore the pasta sauce is not “all natural.”  One wonders why the claims of not all "natural" due to the use of an "artificial" flavor isn't squarely in that ballpark.

Turing to implied field preemption, the court noted that NLEA's provisions suggest Congress did not intend to occupy the field of food and beverage labeling. The FDA's policy as to the word “natural” similarly suggested an intent not to occupy the field of food labeling. Under the policy, the agency has considered natural to mean merely that nothing artificial or synthetic (including colors regardless of source) is included in, or has been added to, the product that would not normally be there. Although the FDA acknowledges that some consumers may be misled by the use of the term “natural,” it has declined to adopt any regulations governing this term. This inaction is consistent with an intent not to occupy the field. This is especially so given that at the time the FDA declined to formally define “natural” it was aware of and had reviewed state regulation of the use of the term, yet it made no mention of the need for uniformity or a preemptive federal regulation.

On conflict preemption, the court found that the defendant had not proved as a matter of law that plaintiffs' claims, if successful, make compliance with federal law a physical impossibility. A manufacturer could comply, that is, not violate, the FDA's policy as to use of the term “natural” and still comply with state law as articulated by plaintiffs in this case, thought the court. Nor does California law stand as an obstacle to the accomplishment and execution of the objectives of the FDCA. Again, it seems questionable that this type of claim wouldn't risk imposing labeling requirements for "artificial" favors, directly in contrast to federal regulations.

Regarding primary jurisdiction, the court found application of the doctrine was not appropriate here. At a minimum, various parties have repeatedly asked the FDA to adopt formal rulemaking to define the word natural and the FDA has declined to do so because it is not a priority and the FDA has limited resources. Moreover, the court did not feel this was a technical area in which the FDA has greater technical expertise than the courts. Finally, plaintiffs' claims were based on state law and, thus, federal law would not dispose of plaintiffs' state law claims.

Finally, the court declined to strike the class allegations at this juncture, finding that if a misrepresentation is material an inference of class-wide reliance may be inferred under the California law. MassTortDefense has posted about the growing trend of plaintiffs to use consumer fraud act claims in place of traditional product theories. Plaintiffs continue to believe that claims based on unfair and deceptive trade practices acts are somehow easier to certify as class actions because of differing notions of reliance and causation.
 

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The Government Accountability Office issued a report last week that listed the FDA as a "high-risk" area of the federal government. The GAO said the U.S. Food and Drug Administration was being hampered by globalization, more complex products, and laws that have made it more difficult for the FDA to ensure the safety of pharmaceuticals, biologic drugs, and medical devices. GAO says its work examining a variety of issues at FDA echoes the conclusions reached by others (think IOM) that the agency is facing significant challenges that compromise its ability to protect Americans from unsafe and ineffective products. FDA needs to, among other things, improve the data it uses to manage the foreign drug inspection program, conduct more inspections of foreign establishments, systematically prioritize and track promotional materials for review, and adopt management tools to ensure that drug sponsors comply with regulations on the presentation of clinical trial results.
 

The perception of the FDA and its ability to do an effective job is a crucial underlying feature in product liability litigation involving regulated drugs, devices, and food products. Jurors’ perceptions of the agency can affect a myriad of issues and themes the defense may wish to present.

Meanwhile, the Pharmaceutical Research and Manufacturers of America (PhRMA) asserts that the issue is a need for more resources for the FDA, to keep drugs safe. The agency “is being asked to do more than it can do” with current resources, the trade group says. Specifically, FDA needs more resources to conduct foreign inspections so the drug supply can be kept safe. PhRMA also said that FDA needs more resources to modernize because, for example, the agency still looks at clinical trial information on paper.
 

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The FDA has reported on its investigation into the source of the recent Salmonella Typhimurium outbreak. At this time, the FDA and the Centers for Disease Control and Prevention (CDC) say they have traced sources of Salmonella Typhimurium contamination to a plant owned by Peanut Corporation of America (PCA), which manufactures peanut butter and peanut paste—a concentrated product consisting of ground, roasted peanuts—that are both distributed to food manufacturers to be used as an ingredient in many commercially produced products including cakes, cookies, crackers, candies, cereal and ice cream. In addition, PCA peanut butter is reportedly distributed to and institutionally served in such settings as long-term care facilities and cafeterias.

The FDA has notified PCA that product samples originating from its Blakely, Georgia processing plant have been tested and found positive for Salmonella by laboratories in the states of Minnesota and Connecticut. Connecticut and Minnesota have reported to FDA that samples of King Nut peanut butter tested in those states are a genetic match to the strain of Salmonella associated with the nationwide outbreak of Salmonella Typhimurium. The results from the Connecticut Department of Health Laboratory are from an unopened container of King Nut peanut butter.
 

On January 18, PCA expanded its previous voluntary recall to include more products and lot numbers relating to peanut butter and peanut paste products manufactured on or after July 1, 2008, at its plant because of potential Salmonella contamination. The peanut butter products being recalled are sold by PCA in bulk containers ranging in size from five (5) to 1700 pounds. The peanut paste is sold in sizes ranging from 35-pound containers to product sold by the tanker container. These products are not sold directly to consumers. PCA has stopped all production at its Blakely, Ga. plant as the FDA continues its investigation.

At least 85 companies bought peanut butter and peanut paste produced in the Georgia plant. More than 125 products including cookies, crackers, ice cream and even some pet food have been recalled in connection with the outbreak. Six deaths may be associated with the outbreak, the U.S. Centers for Disease Control and Prevention has said. The CDC said at least 486 people from 43 states and one person in Canada have been reported ill from the outbreak of the Salmonella typhimurium strain, with 107 of them being hospitalized. Salmonella can cause abdominal cramping, diarrhea and fever. 

Litigation has ensued, with at least one products liability suit in the Middle District of Georgia.

 

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The issue of mercury levels in fish has spawned litigation, including some controversial decisions about the preemptive effect of FDA policies on the regulation of labels of tuna. Now, the FDA is urging amendment of the 2004 advisory that women and children should limit how much fish they eat, saying that the benefits of seafood outweigh the health risks. Bottom line, people should eat more fish, even if it contains mercury.

Currently, the government suggests that women of childbearing years, pregnant women, nursing mothers, infants and children, can be harmed by the mercury in fish and should limit their consumption. In a draft report, FDA proposes to update the existing health advisory. The report argues that nutrients in fish, including omega-3 fatty acids, selenium and other minerals could boost a child's IQ. The greatest benefits, the FDA report said, would come from eating more than 12 ounces of fish a week, which is the current limit advised for pregnant women, women of childbearing age, nursing mothers and young children.

The FDA and the EPA both play a role in protecting the public from mercury contamination. The EPA investigates and regulates mercury and other contaminants in recreationally caught fish, while the FDA regulates mercury in seafood sold in markets and restaurants. States rely on the federal agencies in issuing their own advisories.

Not surprisingly, the Environmental Working Group attacked the draft report. But the National Fisheries Institute applauded the FDA's science-based approach, pointing out the amount of research since the advisory was last updated in 2004 suggesting the real risk to women and children is not eating enough seafood. A Harvard University study released in September of 2008 highlighted the benefits of a seafood rich diet. New research published in the Lancet in 2007 found that mothers who ate the most seafood during pregnancy had children with the highest developmental outcomes. A 2006 Institute Of Medicine report encouraged women to include seafood in their diets. The Harvard Center for Risk Analysis in 2005 wrote that curtailing fish consumption could lead to an increase risk of adverse health outcomes. 

 

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Many readers of MassTortDefense know that nanotechnology refers to a new field of technology that seeks to manipulate and control products, really matter, on the atomic and molecular scale, typically 100 nanometers or smaller. To give some sense of scale, one nanometer is one billionth, or 10-9 of a meter. A nanometer compared to a meter is the roughly the same ratio as that of a baseball to the size of the Earth. Or another analogy, a nanometer is the length a man's whiskers grow in the time it takes him to lift his razor to his face to shave.

First, the European Food Safety Authority (EFSA) recently called for public comments on its draft scientific opinion document assessing the potential risks of engineered nanomaterials used in food and feed. EFSA opinions provide guidance for the European Commission and European Union member state food safety organizations.

EFSA has noted that complete information about engineered nanomaterials in food is lacking, leading to uncertainties in risk assessment. In particular, the agency said knowledge is limited about how engineered nanomaterials in food should be characterized, detected, and measured. It also said more information is needed on the toxicological and environmental impacts of using such nanomaterials.

The comment period on the draft opinion is open until Dec. 1, after which the scientific opinion will be revised and finalized, taking the comments into account.

Second, back in the US, the activist group Consumers Union released new product tests this week, claiming to show that some sunscreens claiming not to contain nanoparticles appeared to contain them.
 
The group is concerned because nano-size particles are known in some applications to have different properties than the conventional versions of these chemicals. Sunscreen manufacturers use nano-size particles of these ingredients for several reason, including because they help make the products clear rather than opaque, something consumers prefer. The European Union has required manufacturers to submit data on sunscreens containing nanoparticles.

Third, the EPA has issued an announcement intended to give notice of the potential application of the Toxic Substances Control Act (TSCA) requirements to carbon nanotubes (CNTs). Carbon nanotubes are generally made from sheets of graphite no thicker than an atom—about a nanometer, or one billionth of a meter wide—and formed into cylinders, with the diameter varying from a few nanometers up to tens of nanometers. They are excellent conductors of electricity. Carbon nanotubes can also be used to reinforce polymers to create very strong plastics. Carbon nanotubes show promise as building blocks for computer chips that are smaller and faster than those made of silicon. Economists predict that the market for carbon nanotubes will grow to more than $1 billion by 2014.

EPA generally considers CNTs to be chemical substances distinct from graphite or other allotropes of carbon already listed on the TSCA Inventory. Many CNTs may therefore be new chemicals under TSCA. If a particular CNT is not on the TSCA Inventory, anyone who intends to manufacture or import that CNT is required to submit a premanufacture notice (PMN) at least 90 days before commencing manufacture. MassTortDefense has posted about carbon nanotubes before.

Apparently, inquiries to the Agency and questions in public forums indicated a lack of clarity on this issue. Some of the misunderstanding may be the result of an EPA communication to a chemical manufacturer a number of years ago pertaining to a substance the Agency now considers to be a carbon nanotube material. EPA understands that the earlier communication may have been misunderstood by some companies as a possible indication that all CNTs may be equivalent to other allotropes of carbon already on the TSCA Inventory. Hence the clarification.
 

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According to some media outlets, food allergies in American children are on the rise, now affecting about 3 million kids. The media is citing a recent report by the CDC, a comprehensive federal study of the problem. Branum and Lukacs, NCHS Data Brief No. 10, “Food Allergy Among U.S. Children: Trends in Prevalence and Hospitalizations,” (October 2008). The study reports that about 1 in 26 children had food allergies last year, up from 1 in 30 kids in 1997.

Food allergy is a potentially serious immune response to eating specific foods or food additives. Eight types of food account for over 90% of allergic reactions in affected individuals: milk, eggs, peanuts, tree nuts, fish, shellfish, soy, and wheat. About 1 in 50 are allergic to shellfish and nearly 1 in 100 react to peanuts. Other research suggests that about 1 in 40 Americans will have a milk allergy at some point in their lives, and 1 in 50 percent will be allergic to eggs. Reactions to these foods by an allergic person can range from a tingling sensation around the mouth and lips to hives to death, depending on the severity of the allergy.

The report:
• In 2007, approximately 3 million children under age 18 years (3.9%) were reported to have a food or digestive allergy in the previous 12 months.
• From 1997 to 2007, the prevalence of reported food allergy increased 18% among children under age 18 years.
• Children with food allergy are two to four times more likely to have other related conditions such as asthma and other allergies, compared with children without food allergies.
• From 2004 to 2006, there were approximately 9,500 hospital discharges per year with a diagnosis related to food allergy among children under age 18 years.

While some are quick to blame product manufacturers, nobody knows for sure what's driving the increase. The mechanisms by which a person develops an allergy to specific foods are largely unknown. Food allergy is more prevalent in children than adults, and a majority of affected children will "outgrow” food allergies with age.

A likely big part of the explanation of the new data is a from of reporting bias, as parents are more aware and quicker to have their kids checked out by a doctor these days. Parents and doctors are both more likely to consider food as the trigger for generic symptoms like vomiting, skin rashes and breathing problems. Parents today are quicker to take their kids to specialists to check out the possibility of food allergies. Thus, the findings could be related to increased awareness, reporting, and use of specific medical diagnostic codes for food allergy rather than a real increase in the number children who are experiencing food-allergic reactions.

The fact that a small number of the population is so constituted that they may suffer severe reactions to products which may be harmless or generally beneficial to others poses a dilemma to the legal scholars and courts. Generally speaking, the allergic or unusually susceptible plaintiff has found the road to financial recovery a difficult one, irrespective of the theory of recovery, the manufacturer of a reasonably safe product generally having been held not liable for damages where the basis of the injury was an allergy, hypersensitivity, or unusual susceptibility on the part of the user. See 63 Am. Jur. 2d, Products Liability § 1453. Plaintiffs’ main theory in allergy cases is that the supplier should be liable for damages arising from an allergenic, idiosyncratic reaction to its product where it has failed to give adequate and timely warning. E.g., Livingston v. Marie Callender's, Inc., 85 Cal. Rptr. 2d 528, 533 (Cal. App. 1999) (warning for allergy to MSG); Brown v. McDonald's Corp., 655 N.E.2d 440, 444 (Ohio App. 1995) (warning for allergy to seaweed); Advance Chem. Co. v. Harter, 478 So.2d 444, 448 (Fla. App. 1985) (warning for allergy to ammonia); Gober v. Revlon, Inc., 317 F.2d 47, 50 (4th Cir. 1963) (warning for allergy to nail polish). At times, plaintiffs will also try to add a manufacturing defect claim in the nature of an alleged failure to reduce or minimize the amount of the allergen in the product by washing, for example. This was seen in the latex glove mass tort.
 

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A group of scientists and physicians have petitioned the Food and Drug Administration asking for more regulation of popular energy drinks, because their caffeine content. The group contends the ingredient puts drinkers at possible risk for caffeine intoxication and other ailments. The letter was written by Dr. Roland Griffiths, of the Johns Hopkins School of Medicine.

The United States is the world's largest consumer by volume of energy drinks, roughly 290 million gallons in 2007. That works out to about 3.8 quarts per person per year. The U.S. market for the drinks is estimated at $5.4 billion. Pretty much any successful product these days is likely to become a target of plaintiffs’ attorneys or Big Brother regulations designed to prevent people from making voluntary choices and excusing them from taking responsibility for their choices.
Caffeine is found in coffee beans, tea leaves, cocoa beans and other plants. Caffeine is an ingredient that consumers have enjoyed in many drinks for more than 100 years. The beverage industry offers both caffeine-free and caffeinated drinks. And customers are free to choose their drink of choice, whether caffeinated or non-caffeinated.

Caffeine is one of the most comprehensively studied ingredients in the food supply, with centuries of safe consumption in foods and beverages. In 1959, the FDA designated caffeine in cola drinks as "Generally Recognized As Safe" (GRAS). The FDA considers caffeine safe for all consumers, including children. In 1987, following extensive review, the FDA "found no evidence to show that the use of caffeine in carbonated beverages would render these products injurious to health." More than 140 countries have specifically considered the safety of caffeine and allow its use in beverages at various levels.

Red Bull, the best-selling energy drink in the USA, contains 80 milligrams of caffeine per 8.3-ounce can, about the equivalent of a cup of coffee. The "pick me up" quality long associated with many drinks reflects a complex mix of ingredients, including caffeine. The bitter taste of caffeine also adds to the complex overall flavor profile of soft drinks.
 

Consumers can easily find out how much caffeine is in a beverage by calling a company's 1-800 number or visiting its website for those drinks that don't list content on their labels. As with all foods and beverages, parents should use common sense in deciding whether to give their children caffeinated foods and beverages, and how much. That’s a parent’s job, not the government’s.
In the most recent version of the Diagnostic and Statistical Manual of Mental Disorders, caffeine is specifically excluded from the category of substances classified as causing "substance dependence." Unlike drugs of abuse, people who choose to consume foods and beverages that contain caffeine can control or moderate their caffeine intake. Scientific studies confirm that although many people enjoy caffeinated products, those who choose to stop consuming or reduce caffeine in their diets can do so without difficulty.
 

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The FDA has issued the results of its interim safety and risk assessment of melamine and melamine-related compounds in food, including infant formula. The purpose of the FDA interim safety/risk assessment, which was conducted by scientists in the Center for Food Safety and Applied Nutrition, was to identify the level of melamine and melamine-related compounds in food which would not raise public health concerns.

For infant formula, the safety/risk assessment concludes that at this time FDA is unable to establish any level of melamine and melamine-related compounds in infant formula that does not raise public health concerns. Melamine in baby formula has sickened more than 54,000 infants in China. The government there ordered the recall of more than 10,000 tons of formula. Last week, 12 more Chinese dairy companies were named as violators after tests found 31 batches of milk powder contaminated with melamine.Chinese officials believe that the contamination was intentional and  occurred at milk collecting stations, rather than on dairy farms. MassTortDefense has posted on this before.

In food products other than infant formula, the safety/risk assessment concludes that levels of melamine and melamine-related compounds below 2.5 ppm do not raise public health concerns. This conclusion assumes a worst case exposure scenario in which 50% of the diet is contaminated at this level, and applies a 10-fold safety factor to the Tolerable Daily Intake (TDI) to account for uncertainties.

According to the CDC, melamine is a synthetic chemical with a variety of industrial uses including the production of resins and foams, cleaning products, fertilizers and pesticides. It does not occur naturally in food. Animal studies have demonstrated that exposure to low levels of melamine produced no observable toxic effects. Exposures to high levels of melamine, or exposures to lower doses of melamine together with certain other chemicals, have caused urinary tract problems in animals. These have included urinary tract and kidney crystal and stone formation, and kidney failure. Exposures of animals to high doses of melamine over long time periods (years) have been associated with cancer of the bladder.

Because melamine is a component in plastics, there may be melamine in dinnerware, cups, and even Formica counter tops. But the amount of melamine that actually transfers from those products into food is very, very small, according to FDA.

Several melamine-contaminated foods found in recent weeks in the United States had far more than that amount of the chemical. White Rabbit candies from China were recalled after authorities in at least two states found melamine. And a New Jersey company announced that it was recalling Blue Cat Flavor Drink, after FDA testing found melamine. The chemical has also turned up in dairy products sold across Asia and, to a lesser extent, Europe.

The FDA guidelines were issued to help federal and state investigators checking for contaminated Chinese products as they enter the country and in grocery stores. To date, there have been no reports of illness from contaminated Chinese milk products in the United States. There are no approved uses for melamine to be added to food in the United States.

Melamine contamination was at the center of the tainted pet food scandal that resulted in more than 80 class actions and the creation of MDL 1850.  The federal judge overseeing the multidistrict pet food litigation has just issued final approval of a $24 million settlement that seeks to resolve claims over a massive recall of more than 90 contaminated dog and cat foods last year.

 

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Quality control investigators in China have announced they had found a dangerous protein substitute in dairy products produced by 20% of the Chinese companies that make infant formula. Reports are that more than 12,000 children had been hospitalized, most with kidney ailments, and 40,000 with less severe symptoms have been treated without admission. At least three have been killed.

Melamine, a protein imitator that is toxic, was used as a cheaper fill, and was found in the test samples. Melamine is the same protein replacement used in the Chinese-made pet food that killed thousands of cats and dogs last year.

What is the impact for readers of MassTortDefense? Several major Chinese dairy companies involved have international investors. But none of the formula products were exported to North America. The FDA said there is no known threat of contamination in infant formula manufactured by companies that have met requirements to sell the formula in the United States. However, FDA is investigating whether infant formula manufactured in China is being sold in markets here that serve the Asian community. And the FDA is alerting consumers that seven "Mr. Brown" instant coffee and milk tea products are being recalled by a Taiwanese company, due to possible contamination with melamine.

The developing food safety scandal has called into question, yet again, the effectiveness of China’s quality control system in general, and the country's new food safety regime in particular. Last year’s spate of product recalls, including drugs, toys, pet food and tires, placed the spotlight on China's quality control problems. MassTortDefense has posted on this here and here. Now comes the news that the newly enacted food safety recall system was not activated for at least two weeks after the problem became known to local officials, and the prime minister of New Zealand (an importer) charged the matter was covered up for several weeks while the Beijing Olympics were underway. Thus, thoughts naturally turn to efforts importers may mitigate the risks. A recent article in Risk Management Magazine offers a broad perspective on this. (Kent Kedl, Risk Strategies for the Chinese Market , published by the Risk and Insurance Management Society, which targets corporate risk managers.) At bottom, it is risk management to avoid a potential mass tort.

First, plan Strategy before Structure. In recent years, the Chinese government has changed its investment regulations to allow --and even encourage-- a variety of business arrangements, from strategic partnerships to wholly foreign-owned enterprises, to full acquisitions. RM suggests that companies coming to China must first ignore the "how" of structure and first focus on the "why" of their strategic intent for China: What products will have the most play? What segments of the market should they target? What distribution channels should they use? Who will be the major competition and how can they structure a defensible and sustainable value proposition?

Second, they advise companies to Get Close to the Market. Clearly, there are Chinese factories that have had quality issues, but the fact remains that there are millions of products coming out of China every month, most of which have no problems whatsoever. Maybe, then, the question should be how best to manage product quality, because someone is doing it right. Kedl and RM suggest that foreign companies need to manage their vendors on an ongoing basis. Meet with suppliers; validate the supply chain; don’t worry about price and on-time delivery to the exclusion of all else. Companies sourcing from China should consider putting their own people on the ground to manage their supply chain, establish and monitor their own quality systems, and maintain ongoing relationships with the vendors. This approach may raise a company's fixed costs but, in the long run, may greatly lower the risk associated with having products made in an emerging market.

Third, recognize that Relationships Matter. Early successful foreign entrants to China worked hard to build a relationship network for themselves. As China has developed a more credible legal framework and a more predictable market environment, however, foreign companies too often have believed they no longer need that social network and that, instead, they can do it on their own. RM suggests that may be a mistake.

Ongoing events put a premium on efforts by both China and the U.S. in implementing the 2007 Memorandum of Agreement (MOA) on food and feed safety. The MOA established a bilateral mechanism to provide greater information and other assurances to enhance the safety of food and feed products traded between the two countries. The countries have improved the exchange of information on food safety and on the relevant regulatory systems. The U.S. has agreed to conduct training for Chinese officials on U.S. regulatory standards. Each has designated new emergency contacts and notification thresholds for import safety issues. The two countries have also been working towards an electronic certification system between the FDA and China's General Administration of Quality Supervision, Inspection and Quarantine to ensure that Chinese exports meet FDA standards for safety and manufacturing quality. The countries also agreed to increase their focus on inspection, supervision and laboratory testing of Chinese imports. Finally, the report described the establishment of a cooperative mechanism to notify each other of significant risks to public health related to product safety or the gross deception of consumers, and to share information to facilitate each other’s investigation.
 

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The U.S. Food and Drug Administration has released a draft report finding that the chemical bisphenol A does not pose a serious health risk. BPA is used in several products, including some plastic baby bottles, food containers, and water bottles. The chemical is added to make polycarbonate plastic bottles clear and shatterproof.

As MassTortDefense has noted before, and here, BPA has been much in the news. In May, 2008, FDA officials told a congressional panel that the agency had no reason to recommend that consumers stop using products containing BPA.  FDA has been examining the data on BPA in anticipation of a September meeting on the issues surrounding the potential toxicity of the chemical. The new draft document will be reviewed by the Bisphenol A Subcommittee of the FDA Science Board on Sept. 16th. Details on the science panel's meeting can be found here.

The new assessment was particularly focused on the concerns for developmental toxicity identified in recent assessments of BPA, including those of the National Toxicology Program and their expert panel, based on animal data. FDA concluded that this data was insufficient to merit a change in the exposure levels the agency currently allows for BPA. FDA concluded that an adequate margin of safety exists for BPA at current levels of exposure from food contact uses, for infants and adults. This assessment represents a full examination of data considered pivotal to the relevant exposure levels associated with food contact substances, the FDA said.

To avoid underestimating risk, FDA said it made the conservative assumption that an infant drank only formula from cans lined with a bisphenol A-based enamel coating and that the parents heated that formula in polycarbonate baby bottles. Based on such assumptions, FDA estimated that an infant might consume up to 2.42 micrograms bisphenol A per kilogram body weight. Based on animal studies, FDA estimated that the no observed adverse effect level (NOAEL) for bisphenol A would be 5 milligrams per kilogram body weight. That means the margin of exposure, or the difference between infants' exposure and the NOAEL, is about 2,000x. That is, FDA said, "an adequate margin of safety...."

FDA's draft conclusion is consistent with the European Food Safety Authority's July 23 statement that it considers current uses of bisphenol A to be safe. FDA's draft assessment called for more research, and said data from nonhuman primates would be helpful, along with measurements of bisphenol A in the U.S. population. 
 

In other BPA news, the California Assembly rejected a bill (S.B. 1713) that would have banned bisphenol A in children's products, specifically BPA at levels above 0.1 part per billion in baby bottles, cups, food containers, or any other container designed for children under the age of 3 years. By Jan. 1, 2012, S.B. 1713 would have barred the sale of any liquid, food, or beverage in any can or jar containing 0.5 ppb or more of bisphenol A. The American Chemistry Council and numerous experts have contended the products the bill would ban are safe.
 

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A Washington, DC think tank last week released a new report with suggestions on how the next administration should approach regulation of nano-technology in products.  The Project on Emerging Technologies is based at the Woodrow Wilson Center in Washington. The Project was established in 2005 as a partnership between the Woodrow Wilson International Center for Scholars and the Pew Charitable Trusts. The Project is dedicated to helping ensure that as nanotechnologies advance, possible risks are minimized, public and consumer engagement remains strong, and the potential benefits of these new technologies are realized.

Nanotechnologies are hailed by many as the next industrial revolution. They promise to change everything from the cars we drive to the clothes we wear, from the medical treatments our doctors can offer to our energy sources and workplaces. Although focused on very small particles, nanotechnologies offer large potential benefits. From new cancer therapies to pollution-eating compounds, from more durable consumer products to detectors for bio-hazards like anthrax, from novel foods to more efficient solar cells, nanotechnologies are changing the way people think about the future.

The Project on Emerging Nanotechnologies collaborates with researchers, government, industry, NGOs, policymakers, and others to look long term, to identify gaps in knowledge and regulatory processes, and to develop strategies for closing them. The Project's stated mission is to try to provide independent knowledge and analysis that can inform critical decisions affecting the development and commercialization of nanotechnologies.

A source of uncertainty for nanotechnology is regulation. The Project released a 28-page regulatory agenda for the next administration, noting that whichever candidate wins is going to have to deal with this issue, probably sooner rather than later. The next president has the opportunity to ensure that nanotechnology’s benefits will be maximized and its risks identified and mitigated, says the group. 

The report, Nanotechnology Oversight: An Agenda for the Next Administration, calls for the White House and federal agency policymakers to maximize the use of existing laws to improve nanotechnology oversight. Such measures include defining nanomaterials as “new” substances under federal toxics and food laws, thereby enabling the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) to consider the novel qualities and effects of nanomaterials. The group addresses whether the Federal Food, Drug and Cosmetic Act, the Toxic Substances Control Act and the Consumer Product Safety Act need to be amended to cover nanotechnology.

The Project notes that more nanotech products are hitting the market. From March, 2006 to February, 2007, the number of manufactured goods using nanotech tripled to 600.  For fiscal 2009, the federal government has devoted $1.5 billion to nanotech, a sum split up between various agencies. Under the Bush administration, EPA has a Nanoscale Materials Stewardship Program, which is endorsed by the Synthetic Organic Chemical Manufacturers Association, the American Chemistry Council and the NanoBusiness Alliance. Some state governments, however, are pushing forward with their own rules on nanotech.

Coincidentally, consumer advocates said this week that food produced by using nanotechnology is quietly coming onto the market, and they want U.S. authorities to force manufacturers to identify them. New consumer products created through nanotechnology are coming on the market at the rate of 3 to 4 per week, according to The Project on Emerging Nanotechnologies.

MassTortDefense has posted on nanotechnology here and here.

 

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A federal court last week refused to certify two different classes of plaintiffs in multidistrict litigation that accuses ConAgra Foods Inc. of selling salmonella-contaminated peanut butter. In Re ConAgra Peanut Butter Products Liability Litigation, MDL-1845, 2008 WL 2885951 (N.D.Ga., July 22, 2008). 

The MDL transferee court ruled that the plaintiffs' economic claims (unjust enrichment) and personal injury claims were not suitable for class certification on predominance, manageability (choice of law), and superiority grounds (alternative means for resolution).

The litigation arises from the illness of several hundred people in numerous states; plaintiff class action lawyers allege the clients became ill from salmonella poisoning after eating ConAgra's peanut butter manufactured at its Sylvester, Ga., plant.

The plaintiffs had asked the court to certify two classes: a class of purchasers of the peanut butter, which was allegedly rendered “unusable and valueless” when the product was recalled; and a class of plaintiffs who consumed the peanut butter and claimed personal injury.

The court first rejected the plaintiffs' argument that it should apply Georgia's choice of law rules in the case. In multidistrict litigation, under 28 U.S.C. § 1407, the transferee court applies the state law that the transferor court would have applied. Murphy v. F.D.I.C., 208 F.3d 959, 965 (11th Cir. 2000). When this action was consolidated, separate actions had been filed in 10 different states. Thus, the MDL court needed to apply choice of law rules from each of the transferor courts, the court said. The obvious inference from that situation alone is that the class would be unmanageable.  Even if a class is not ipso facto unmanageable due to the application of different choice of law rules, there is substantial conflict between Georgia substantive law and other jurisdictions on the issues raised. On unjust enrichment, some states have a common law claim; others have a preemptive statute.  Privity is required in some; some but not all states require a direct benefit conferred by the plaintiff upon the defendant as a prerequisite; some but not all states have a state of mind requirement for recovery, etc. The court also found that proving damages under the unjust enrichment claim would require individualized determinations.

The un-manageability arsing from the choice of law issue also impacted the absence of superiority, what the court called the “inferiority of classwide resolution due to discerning the many differing legal standards.” Moreover, the defendant's refund program provided an alternate way of addressing the claim.

The court also declined to certify the class pursuing a personal injury claim, even a  limited "issues" class. The court found that such an issues class would not promote judicial economy or materially advance the litigation. “Although the defendant has not formally admitted liability, it is highly unlikely that it will deny that salmonella-contaminated peanut butter is a defective product and makes people sick who eat it,” the court said.

The importance of this reasoning to readers of MassTortDefense is that it points out that in balancing predominance, and assessing superiority and manageability, the court needs to take a realistic view of what issues will actually be litigated. The trial plan proposed by the parties has to reflect the real issues to be litigated.  The allegedly predominant common issue of defect or defendant negligence is immaterial if that is not an issue on which the parties will spend considerable time and effort.

Moreover, although the court focused on the predominance issue in denying the personal injury class, it made an important observation about the constitutional implications of an issue class or a bifurcated class proceeding. Denying the common issues personal injury class here also avoided "potential constitutional problems." Rule 23(c)(4) issues classes can violate the parties' Seventh Amendment jury trial rights, especially in personal injury cases. Many jurisdictions differ on the details of even a negligence claim.  Such nuances "can be important, and its significant is suggested by a comparison of differing state pattern instructions on negligence and differing judicial formulations of the meaning of negligence and the subordinate concepts.” In re Rhone-Poulenc Rorer, Inc ., 51 F.3d 1293, 1300 (7th Cir.1995).  And there is the very real risk that a second jury (even if just on damages) would have to reconsider some of the liability issues decided by the first jury: too substantial a risk to certify the issues class. The Court thus heeded the "binding authority" which cautions that separate trials of liability and damages must be approached "with trepidation” to avoid offending the Seventh Amendment. State of Alabama v. Blue Bird Body Co., Inc., 573 F.2d 309, 318 (5th Cir.1978).

Yet another important observation by the court was that the plaintiffs' case for class certification collapses when it confronts the fact that certification of a common issues class will not dispose of a single case or eliminate the need for a single trial. Any saving in judicial resources is speculative at best. See Castano v. American Tobacco Co., 84 F.3d 734, 749 (5th Cir.1996). Under the plaintiffs' trial plan, at least 6,000 individual trials on exposure, injury, causation, damages and other individual issues would have to be prosecuted whether or not a class is certified, presumably by the lawyers already retained by the personal injury claimants. The lesson here is the court was willing to "look down the road" to how the case would go.

Finally, another gem on the issue of superiority: While it would be possible, said the court, to have a common issues trial on the issue of, “Can eating peanut butter that is contaminated with the bacteria listed above cause illness?” (i.e. the general causation issue), "why bother having a trial on issues of such abstract generality?"  And a class trial of issues such as what the defendant allegedly knew or should have known and the adequacy of its general plant sanitation practices in relation to the onset of illness for thousands of people -- plaintiffs' quintessential "common" issues -- would require special interrogatories and a verdict form "of unimaginable complexity. I cannot imagine how to fashion a verdict form that would provide meaningful answers...."  

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Quick follow-up to our recent post on salmonella in which we noted a current focus on peppers rather than tomatoes: Federal officials announced yesterday that they have found the bacteria in a jalapeño pepper from a small distribution facility in McAllen, Tex. Accordingly, they warned consumers to avoid eating raw jalapeños or products that contain them.

The company has stopped distributing jalapeño peppers and is recalling jalapeños sold since June 30 to customers in Georgia and Texas. Investigators don't know where the contamination occurred. CDC officials are hoping that another round of interviews with people who got sick since early June in Arizona and New Mexico will shed more light on the source of the outbreak.

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Federal officials announced last week that all tomatoes currently on the U.S. market are safe to eat. But they admit they still don't know what's causing a salmonella outbreak that has affected thousands over the past three months. Jalapeno and other peppers remain under investigation. Tomatoes had been identified in early June as the likely source of one of the largest food-borne illness outbreaks in the past decade. There were more than 1200 confirmed illnesses linked to the outbreak. While new cases are still being found, the rate has slowed, according to the CDC.

The FDA says it's possible tomatoes caused some illnesses and that it's impossible to prove that they didn't cause any. But not a single contaminated tomato has been found. FDA tested 1,700 samples without finding traces of the outbreak. Apparently, this is not unusual: In half of all produce disease outbreaks, health investigators have never determined what made the people sick. The short shelf life of most fresh fruits and vegetables means it's less likely the items will still be in people's refrigerators when investigators arrive. And the complexity of the produce distribution system can be a large impediment.

Industry leaders are not so sure. They worry it was not a failure of traceability, but a lack of imagination. When the trace-back did not support the tomato hypothesis, investigators should have more quickly tried alternative hypotheses, they say.

In any event, a broad coalition of growers, distributors, restaurants, and retailers have been working on a national tracking system. The current proposal would utilize a global trade item number (GTIN). Every part of the distribution chain would be required to use a bar code encoded with the GTIN and the grower or shipper who produced it, the production lot it was part of, and the date it was packed or harvested. If the GTIN system were to be adopted, investigators could quickly determine where a box of fruit or vegetables came from, and thus whether it needs to be isolated or recalled.

This ability to better link up the product may impact product liability litigation: cause in fact is a basic element requiring plaintiffs to show that the product of the defendant caused his or her injury.  But industry recognizes that it is in everyone's interest to be able to trace back the source as quickly as possible and thus to take immediate action that will limit the number of people possibly affected.  And the inability to quickly trace back may have significant financial impact: The tomato warning, issued for varieties of fresh tomatoes, likely cost the industry millions of dollars, according to trade associations.

The L.A. Times recently reported on an AP poll that finds that nearly half of consumers have changed their eating and buying habits in the past six months because they're afraid they could get sick by eating contaminated food. Also, 86% of those polled said produce should be labeled so it can be tracked through layers of processors, packers and shippers, all the way back to the farm. The poll found that 80 percent of Americans said they would support new federal standards for fresh produce.

The Professors at the Mass Tort Litigation Blog have posted on this as well.

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The United States and China issued a joint progress statement last week that described the measures both have recently taken to improve the safety of international food and feed imports.
The safety of a variety of products and substances imported from China have been in the news, ranging from pet food, to toothpaste, to toys, to pharmaceutical ingredients. MassTortDefense has posted on this here and here.

According to the statement, both countries have improved the exchange of information on food safety and on the relevant regulatory systems. The U.S. has agreed to conduct training for Chinese officials on U.S. regulatory standards. Each has designated new emergency contacts and notification thresholds for import safety issues. The two countries have also been working towards an electronic certification system between the FDA and China's General Administration of Quality Supervision, Inspection and Quarantine to ensure that Chinese exports meet FDA standards for safety and manufacturing quality. The countries also agreed to increase their focus on inspection, supervision and laboratory testing of Chinese imports.

The document outlines steps taken by both nations in implementing the 2007 Memorandum of Agreement (MOA) on food and feed safety. The MOA established a bilateral mechanism to provide greater information and other assurances to enhance the safety of food and feed products traded between the two countries.

Finally, the report described the establishment of a cooperative mechanism to notify each other of significant risks to public health related to product safety or the gross deception of consumers, and to share information to facilitate each other’s investigation.

The report comes as Senator Sherrod Brown (D.-Ohio), in a letter to the FDA's Center for Drug Evaluation & Research, called on the agency to investigate outsourcing of drug ingredients, and just as China has granted diplomatic approval for the FDA to open three inspections offices in China that also will help increase China's ability to ensure delivery of safe foods, drugs and other products. The FDA reportedly hopes to open the offices in Beijing, Shanghai and Guangzhou before the end of this year, with a total staff of around 12 people.

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