Report Reveals Issues With Traceability Of Food Products

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

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.


Latest Federal Court Statistical Report Offers Snapshot of Mass Torts

An interesting snapshot of mass torts and product liability actions in the federal courts is found in the annual report, "Judicial Business of the United States Courts: 2008 Annual Report of the Director."  This report is produced by the Statistics Division, Office of Judges Programs, Administrative Office of the U.S. Courts The latest report shows that a surge in asbestos cases drove a significant rise in new federal personal injury and product liability litigation.

Overall, civil filings increased 4 percent in 2008 to 267,257, and the national pending civil caseload climbed 12 percent to 298,129, the report said.  The rise in diversity of citizenship filings resulted chiefly from personal injury cases related to asbestos, especially in the Eastern District of Pennsylvania, and diet drugs in the Eastern District of Arkansas. According to court officials, asbestos filings under MDL 875 and diet drug filings under MDL 1203 caused filings to swell by more than 19,500 cases. About 99,000 asbestos-related cases containing at least 3.3 million claims are pending in the MDL in the Eastern District of Pennsylvania. (In the Arkansas Prempro MDL, which consists of thousands of cases, the judge has ordered the plaintiffs to complete discovery involving defendants Pfizer Inc. and Wyeth Pharmaceuticals Inc. by Sept. 1 , 2009) .

In the 2007 reporting period, a total of 29,291 product liability cases were commenced in federal courts, and in the same period ending in 2008, that number jumped to 53,102, based largely on the surge in asbestos-related filings .

The United States Judicial Panel on Multidistrict Litigation acted upon 35,987 civil actions pursuant to 28 U.S.C. §1407 during the 12-month period ending September 30, 2008. The Panel transferred 8,156 cases originally filed in 92 district courts to 52 transferee districts for inclusion in coordinated or consolidated pretrial proceedings with 27,831 actions initiated in the transferee districts. Product liability cases involving the hormone therapy drug Prempro and the Kugel Mesh Hernia Patch were among the more significant of the Panel's transfer determinations during the report period. The Panel did not order transfer in 25 newly docketed litigations involving 150 actions.

Since the creation of the Panel in 1968, it has centralized 301,255 civil actions for pretrial proceedings. As of September 30, 2008, a total of 11,665 actions had been remanded for trial, 395 actions had been reassigned within the transferee district, and 186,747 actions had been terminated in the transferee court. At the end of this fiscal year, 102,448 actions were pending throughout 60 transferee district courts.

The federal judiciary calls the report the most comprehensive set of detailed statistical tables published on its work.


Latest Update on Digitek MDL

The Digitek MDL Judge, on March 5th,  entered PTO # 16, which details important case management and scheduling deadlines in this mass tort. 

For those interested in some of the nuts and bolts of managing an MDL: the Order  requires that within 45 days, each defendant named in the Master Complaint shall file a Master Answer or a Fed. R. Civ. P. 12 motion in response to the Master Complaint.

The Order sets deadline for plaintiffs to request and brief class certification of any wrongful death, personal injury or medical monitoring putative class in September, 2009.

Plaintiffs are required to fill out and sign Plaintiff Fact Sheets, providing basic fact discovery.  It sets up a process for handling deficiencies in the responses.

Plaintiffs are to provide signed undated authorizations for the gathering of medical records, and addresses for each health care provider, including hospitals, clinics and outpatient treatment centers, and any other custodian of records identified in a plaintiff’s Fact Sheet.

Plaintiffs are ordered to produce medical and pharmacy records in their  possession establishing that the plaintiff was prescribed Digitek and the date(s) on which each prescription issued.

The Order set up a procedure for governing the oft-debated ex parte contact by defendants of treating physicians.

Defendants are ordered to provide organizational chart information as well as QC/QA structures. Also specifications, instructions, test methods and standard operating procedures relating to the manufacture of  Digitek;  quality assurance/control and testing records for Digitek, and any of its component ingredients, including but not limited to records related to batch sampling, post-manufacturing testing and finished goods testing. 

The Order establishes a procedure for privilege logs. The parties were directed to reach an agreement concerning a document production protocol to include the production format of paper and electronic documents, objective coding and metadata, privilege logs and any other applicable issues. In the event the parties cannot agree, the issues will be presented to Magistrate Judge Stanley for resolution.

The PTO also sets deadlines for service of interrogatories, document requests, and company witness depositions. As to expert discovery: Plaintiffs shall serve their reports from liability experts no later than January 1, 2010. The parties shall complete their depositions of Plaintiffs’ liability  experts no later than March 12, 2010.  Defendants shall serve their reports from liability experts no later than March 31, 2010.  The parties shall complete their depositions of Defendants’ liability experts no later than June 11, 2010.

To efficiently manage discovery for all currently pending and future cases in the MDL, the cases will be divided into groups, with each group having a separate scheduling order. Following completion of the first wave of Plaintiffs’ Fact Sheets the Court shall schedule a hearing for purposes of  selecting the initial trial pool of cases (“Group 1”). No later than 5 days before the hearing, Plaintiffs shall select 15 cases and the Defendants shall select 15 cases, and each side shall exchange lists of such selections and submit them to the Court.  Within 10 days after the scheduled hearing, the Court shall select a total of no more than twenty of the proposed trial pool cases to constitute Group 1.

Case specific discovery is set up by Group, with staggered dates of initial discovery (DID),  corresponding discovery deadlines, and Daubert and dispositive motions deadlines 310 days after  DID.

Bills to Ban BPA Introduced in Congress

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.




China Melamine Suits to Proceed

When one thinks of global mass tort issues, questions of actions by European citizens in U.S. courts or the spate of class actions in Canada may come to mind. Perhaps we will need a broader perspective, as the courts in China have reportedly given the green light to suits arising out of the distribution of tainted dairy products. We have posted on this issue before, within the larger context of product issues arising from goods made in China.

The move signals an apparent change in the way Beijing is handling fallout from the melamine scandal, which was implicate din the death of at least six infants and sickening of nearly 300,000 others with kidney problems. A government-sanctioned compensation plan had been proposed to resolve the issues, but a large number of families have refused government compensation because it is too small, electing instead to try to sue. Under the payout plan organized by the dairies, families whose children died would have received 200,000 yuan ($29,000), while others received 30,000 yuan ($4,380) for serious cases of kidney stones and 2,000 yuan ($290) for less severe cases.

Plaintiffs needed government permission to bring suit, and it remains unclear how the government plans to handle the cases. Chinese courts often turn down class-action or group action suits, preferring to deal with cases one by one to avoid running afoul of Communist Party officials, who ultimately control the judiciary.

The crisis highlighted the need for major overhauls to China's food safety system, culminating in a law passed recently that proposes to consolidate hundreds of regulations covering the country's 500,000 food processing companies.

State Appellate Accutane Decision Reverses Verdict

The New Jersey Superior Court issued an interesting decision in the Accutane litigation last week.  See  McCarrell v. Hoffman-La Roche, Inc., And Roche Laboratories, Inc., 2009 WL 614484 (N.J.Super.A.D.) (March 12, 2009).

Plaintiff alleged that as a result of taking Accutane for an acne condition, he developed inflammatory bowel disease ("IBD"). The IBD allegedly led to the surgical removal of his colon and other serious medical complications. A jury returned a verdict in plaintiff's favor on his product liability claim against Roche, but not on his consumer fraud claim, and awarded him compensatory damages.

By order dated May 2, 2005, the state Supreme Court had designated all pending and future statewide actions involving Accutane as a mass tort.  Thus, all Accutane cases, including plaintiff's lawsuit, were transferred to Atlantic County to be heard on a coordinated basis. Discovery in the state cases proceeded in tandem with discovery in the federal Accutane multidistrict ("MDL") litigation.

On appeal from the jury verdict, Roche specifically argued, inter alia, that the trial court erred in admitting the opinion testimony of plaintiff's causation expert Dr. Sachar because his methodology was unreliable and thus improper under  N.J.R.E. 702; and that the trial court denied Roche a fair trial in admitting the testimony about causality assessments based on Accutane ADEs, but in restricting the defense in presenting competing quantitative proofs to put the ADEs in context, including the actual number of Accutane users.

On the issue whether Dr. Sachar's causation testimony was sufficiently reliable in the field of scientific research to be admitted, the court noted that in New Jersey the standard of review of such
rulings under Rule 702 is a narrow one. "In reviewing a trial court's evidential ruling, an appellate court is limited to examining the decision for abuse of discretion."

On the merits, the defendant objected to the expert's heavy reliance on animal studies. The NJ  Supreme Court has previously recognized that animal studies can be an accepted scientific method to study the safety and efficacy of drugs.  Even though the dose administered in the animal studies was far different than the medicinal dose, "trained experts commonly extrapolate from existing data." Gen. Elec. v. Joiner, 522 U.S. 136, 146 (1997). In assessing the results of animal studies, which frequently involve high doses, experts should be careful to consider the dose-response differential between animals and humans. Magistrini v. One Hour Martinizing
Dry Cleaning
, 180 F. Supp. 2d 584, 593 (D.N.J. 2002), aff'd, 68 Fed. App'x. 356 (3d Cir. 2003). (Readers also know that the biological differences between commonly used animals such as rats and humans make the models inappropriate for many comparisons, regardless of dose.)

Defendants also challenged the use of anecdotal case reports as a basis for the causation opinion. The court recognized that "[c]ausal attribution based on case studies must be regarded with caution." Federal Judicial Center, Reference Manual on Sci. Evidence 497 (2d ed. 2000).
That is so because case reports typically reflect reported observations, and do not themselves contain scientific analyses. For instance, case reports may lack controls, may fail to screen out alternative causes, and may omit relevant facts about the patient's condition that can be pertinent to a causation assessment. Consequently, a number of courts have concluded that anecdotal case reports are not a scientifically reliable basis for an expert's opinion on causation.

Nevertheless, some other courts have allowed consideration of case reports as an acceptable basis for trying to show causation, particularly when accompanied by other reliable scientific evidence. New Jersey courts have previously upheld the admission of expert testimony that has relied, at least in part, upon case reports or comparable anecdotal evidence. The court also found significant that the case reports here included dechallenge and rechallenge reports. Dechallenge and rechallenge reports are a type of case report. Dunn v. Sandoz Pharms. Corp., 275 F. Supp. 2d 672, 682 (M.D.N.C. 2003). Such reports have limitations, but have been considered useful in some contexts in ascertaining causation because they measure a patient's reaction to a drug, said the appellate court.  (Readers will note that the dechallenge/rechallenge concept appears to make little sense when the effect of the drug is supposedly a permanent disease!)

The New Jersey court recognized it was issuing a causation decision contrary to the ruling in the Accutane MDL.  The state court declined to follow the federal court's decision because (1) the causation expert in the federal case was not Dr. Sachar, and that particular expert's methodology was not as "demonstrably sound" as that of Dr. Sachar; (2) the standards for expert admissibility under N.J.R.E. 702 are not identical to F.R.E. 702; and (3) the testimonial record in this case, having proceeded to trial, was more developed than it was in the Florida case on a pretrial motion, lending greater confidence to a conclusion to sustain the trial judge's decision to admit Dr. Sachar's testimony.

Defendant also challenged the expert's testimony about the company's alleged intent and motive and mind-set, a typical plaintiffs' tactic in mass torts.  Totally improper, highly prejudicial, and ignored by some courts because they seem overwhelmed by the plaintiff's characterization of the defendant's conduct.  Well-reasoned opinions exclude such testimony. See In re Baycol Prods. Litig., 532 F. Supp. 2d 1029, 1053 (D.Minn. 2007) (observing that "[p]ersonal views on corporate ethics and morality are not expert opinions"); In re Rezulin Prods. Liab. Litig., 309 F. Supp. 2d 531, 546 (S.D.N.Y. 2004) (holding that the objected-to opinions of expert witnesses on intent, motives, or state of mind of a corporation had no basis in any relevant body of knowledge or expertise).  Here, the court seemed not to understand the impact and purpose of this improper testimony, finding that although Dr. Sachar's testimony sharply criticized Roche, his criticisms did not rise to "such an inflammatory level" that would cause the appeals court to find an abuse of discretion by the trial court in not excluding it.  The issue is not only a Rule 403 prejudice issue; there is a fundamental relevance issue, and a serious issue about fit, foundation, and reliability.

Finally, there was what has been described as the "numbers" issue. The issue refers to the fact that the trial court allowed plaintiff's witnesses and counsel to refer, on repeated occasions, to the number of adverse incidents reported from Accutane users or from other sources while, at the same time, the court restricted Roche's attempt at trial to place those adverse numbers into any larger quantitative context. Specifically, the judge precluded Roche witnesses from more
fully informing the jury about the large number of persons who had taken Accutane before it was prescribed to plaintiff in 1995, and the comparative significance of those figures.

The court ultimately concludes that it was unfair to Roche for the trial court to have precluded such "numbers" counter-proof and that the court abused its discretion on this evidentiary issue. Had Roche been allowed to present the statistics showing five million Accutane users and other related counter-proofs, the jury would have had a fuller and more balanced picture of the data bearing upon the company's actions in changing its label. "Principles of completeness and fairness warranted the presentation of this contextual information to the fact-finder."



FDA Introduces Nanotechnology Initiative

Last week the FDA introduced the "Nanotechnology Initiative", a collaborative effort between FDA and the Alliance for NanoHealth (ANH) and its eight member institutions. The alliance's eight academic institutions are the Baylor College of Medicine, the University of Texas' M.D. Anderson Cancer Center, Rice University, the University of Houston, the University of Texas Health Science Center at Houston, Texas A & M Health Science Center, the University of Texas Medical Branch at Galveston and the Methodist Hospital Research Institute in Houston.

The initiative is designed to push for the development of safe and effective implementation of nanotechnology into medical products. Under a Memorandum of Understanding, the FDA/ANH Nanotechnology Initiative will work to expand knowledge of how nanoparticles behave and affect biologic systems, and to facilitate the development of tests and processes that might mitigate the risks associated with nanoengineered products. The nanotechnology initiative with the Alliance for NanoHealth is an effort to engage resources and technical expertise in this rapidly advancing field.

FDA recognizes that nanotechnology holds great promise for the advancement of novel medical products. All outcomes from this public-private partnership will be placed in the public domain.
Readers of MassTortDefense know that nanotechnology involves the creation and use of materials at the level of molecules and atoms; it presents opportunities but also challenges for the FDA's entire regulatory product jurisdiction, from food to medical devices to therapeutics. Products from the new technology may also present product liability issues for manufacturers.

Defendants Win Latest Battle in Agent Orange Mass Tort

While asbestos may be regarded as the grandfather of mass torts, Agent Orange is not far behind in longevity. In the latest chapter, the U.S. Supreme Court last week declined to review three court orders dismissing damages claims against manufacturers of Agent Orange; plaintiffs had alleged that exposure to defoliants during the Vietnam War caused cancer and other illnesses. See Isaacson v. Dow Chemical Co., U.S., No. 08-460, 3/2/09; Stephenson v. Dow Chemical Co., U.S., No. 08-461, 3/2/09; Vietnam Ass'n for Victims of Agent Orange v. Dow Chemical Co., U.S., No. 08-470, 3/2/09.

The denial of cert leaves intact three decisions last year by the Second Circuit in favor of Dow Chemical, Monsanto Co., and other defendant companies . See Isaacson v. Dow Chemical Co., 517 F.3d 129 (2d Cir. 2008); Stephenson v. Dow Chemical Co., 2008 U.S. App. LEXIS 6201 (2d Cir. 2008); Vietnam Ass'n for Victims of Agent Orange v. Dow Chemical Co., 517 F.3d 104 (2d Cir. 2008). The Second Circuit rulings largely relied on the government contractor defense to protect the government and wartime contractors from being sued civilly for their federal executive function activities. The government contractor defense in essence prevents plaintiffs from doing an end run around a statute that prohibits them from suing federal officials directly. The government contractor defense shields companies from liability if they rely on government specifications, accurately follow those specifications, and inform the government about any problems with the product the government doesn’t know about. Here, the government continued to order Agent Orange and declared its toxicity levels acceptable, the Second Circuit found.

A major settlement was reached in the Agent Orange cases filed decades ago, but another later round of suits was filed by people who alleged they became ill after 1994 as the result of Agent Orange exposure. Defendants, no doubt, are hopeful that this will be the end of the Agent Orange litigation.

In the third case, the claims brought by Vietnamese nationals under the Alien Tort Statute alleged that the spraying of herbicides in South Vietnam between 1962 and 1970 was a violation of international law. The Second Circuit dismissed the appeal by the Vietnamese nationals, finding that because the toxin was used to protect U.S. troops against ambush, and not as a weapon of war against human populations, the plaintiffs had failed to adequately plead a violation of international law. In addition, the court concluded that any domestic tort law claims by Vietnamese citizens were barred by the government contractor defense.

New Voluntary Guidelines For Device DTC Ads

The Advanced Medical Technology Association has just released a set of “Guiding Principles for Direct to Consumer Device Advertising. “ The principles are intended to help assure that patients have accurate and meaningful information about health care treatment options and encourage them to speak with their physician. Direct-to-consumer (DTC) advertising can be an important tool for educating patients about advanced medical technologies, which are making life better for patients through faster recovery and better outcomes and in many cases, reducing health care costs.

The Advanced Medical Technology Association (AdvaMed) is the world’s largest
association representing manufacturers of medical devices, diagnostic products, and
medical information systems. AdvaMed members and subsidiaries manufacture nearly
90 percent of the health care technology products purchased annually in the United
States and more than 50 percent of the health care technologies purchased annually
around the world.

The voluntary guidelines contain 13 principles that support compliance with the Food and Drug Administration’s and Federal Trade Commission’s existing direct-to-consumer regulations. They also include additional principles, which include revising or withdrawing ads when new safety-risk information comes to light; excluding any content designed to minimize risk information; educating healthcare professionals about new products or new-use indications before the launch of an ad campaign; and submitting TV ads for restricted devices to the FDA at the time of an ad’s release.

The principles were not an effort to ward off regulation from Congress and the new Administration, but to respond to concerns that have been raised in the media in recent months about some DTC ads. 

Readers of MassTortDefense know that plaintiffs try to make an issue of DTC advertising in failure to warn claims, and have succeeded in some contexts in having DTC advertising undermine the traditional learned intermediary rule.

New Food Safety Bill Introduced in Congress

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.

Supreme Court Decides Levine v. Wyeth

The Supreme Court has issued its decision in the much-anticipated Levine preemption case.

Readers of MassTortDefense will recall that Wyeth manufactures the anti-nausea drug Phenergan. After a clinician injected plaintiff Levine with Phenergan by the “IV push” method, whereby a drug is injected directly into a patient’s vein, the drug entered Levine’s artery, she developed gangrene, and doctors amputated her forearm. Levine brought a state law damages action, alleging, inter alia, that Wyeth had failed to provide an adequate warning about the significant risks of administering Phenergan by the IV-push method. The jury determined that Levine’s injury would not have occurred if Phenergan’s label included an adequate warning, and it awarded damages for her pain and suffering, substantial medical expenses, and loss of her livelihood as a musician. The trial court rejected Wyeth’s argument that Levine’s failure-to-warn claims were pre-empted by federal law because Phenergan’s labeling had been approved by FDA. The Vermont Supreme Court affirmed.

Today, the Supreme Court affirmed, 6-3, J. Stevens writing for the majority, holding that federal law does not pre-empt Levine’s claim that Phenergan’s label did not contain an adequate warning about the IV-push method of administration. The argument that Levine’s state law claims are pre-empted because it is impossible for Wyeth to comply with both the state law duties underlying those claims and its federal labeling duties was rejected. Although a manufacturer generally may change a drug label only after the FDA approves a supplemental application, the agency’s “changes being effected” (CBE) regulation permits certain preapproval labeling changes that add or strengthen a warning to improve drug safety. Pursuant to the CBE regulation, Wyeth could have unilaterally added a stronger warning about IV-push administration, said the Court, as there was no good evidence that the FDA would ultimately have rejected such a labeling change. Wyeth’s reading of the CBE regulation and its assertion that unilaterally changing the Phenergan label would have violated federal law governing unauthorized distribution and misbranding of drugs are based on the “fundamental misunderstanding” that the FDA, rather than the manufacturer, bears primary responsibility for drug labeling.

The Court also rejected Wyeth’s argument that requiring it to comply with a state law duty to provide a stronger warning would interfere with Congress’ purpose of entrusting an expert agency with drug labeling decisions, because it relies on an overbroad view of an agency’s power to preempt state law. The history of the FDCA shows that Congress did not intend to pre-empt state law failure to warn actions, said the majority. The preamble to the 2006 FDA regulation declaring that state law failure to warn claims threaten the FDA’s statutorily prescribed is merely an agency’s assertion that state law is an obstacle to achieving its statutory objectives. The weight the Court accords the agency’s explanation of state law’s impact on the federal scheme depends on its thoroughness, consistency, and persuasiveness. Skidmore v. Swift & Co., 323 U. S. 134. Under this standard, the FDA’s 2006 preamble did not merit much deference, said the Court. It was limited in light of the FDA’s failure to offer interested parties notice or opportunity for comment on the preemption question; it is at odds with the available evidence of Congress’ purposes; and it reverses the FDA’s own longstanding position that state law is a complementary form of drug regulation.

Quick reactions: The Court was able to get around some facts that made the case appear strong for Wyeth, noting the findings below that that a stronger warning would have made a factual difference (getting around the issues of possible medical malpractice), and that this was indeed a failure to warn and not a duty to contraindicate case. Second, it seems that congressional intent is the touchstone of not only express preemption, but also implied preemption. Third, the presumption against preemption, which some argued really applies only in express cases, also applies to implied preemption cases. Fourth, the Court recognized that some state-law claims might well frustrate the achievement of congressional objectives, but “this is not the case." Defendants will have to carefully explore that opening, develop a robust regulatory record, and see where that may take them.

Seventh Circuit Affirms Defense Verdict, Exclusion of Subsequent Remedial Measures

The Seventh Circuit has affirmed a defense jury verdict in a suit by a woman whose husband killed himself two days after starting the drug Effexor to treat major depression. Giles v. Wyeth, 2009 WL 331290 (7th Cir. Feb. 12, 2009).

Before the trial in this case, Wyeth filed a motion in limine asking the district court to exclude: (1) all suicide-related warnings that accompanied Effexor after Mr. Giles's death in 2002, and (2) scientific data related to suicidality in pediatric patients taking anti-depressants. The district court granted the motion in part, ruling that evidence of post-2002 suicide-related warnings was not admissible. It also denied the motion in part and allowed the use of scientific evidence relating to pediatric patients, including such evidence from after Mr. Giles's death. After a three-week trial, the jury returned a verdict in Wyeth's favor. Mrs. Giles appealed the judgment.

The district court excluded the later warning evidence based upon its determination that FDA-mandated warnings were “subsequent remedial measures” within the scope of Federal Rule of Evidence 407, and also under Federal Rule of Evidence 403, which allows a district court to exclude relevant evidence when its “probative value is substantially outweighed by the danger of unfair prejudice, confusion of the issues, or misleading the jury, or by considerations of undue delay, waste of time, or needless presentation of cumulative evidence."

The 7th Circuit focused on Rule 403, as the standard of review here was abuse of discretion,  The warnings that accompanied Effexor after Mr. Giles's death had little, if any, probative value. First, and most significantly, the excluded warnings did not help establish that Wyeth knew or should have known about an increased risk of suicidality in adults of Mr. Giles's age. Mr. Giles was forty-six years old when he took Effexor. The excluded post-2002 warnings, however, focused on children and adults younger than twenty-five years old. In fact, instead of suggesting an increased risk of suicidality, the Effexor warnings after 2002 actually more directly disclaimed any increased risk of suicidality in adults of Mr. Giles's age.

Plaintiff identified no evidence that the excluded post-2002 warnings were based on information Wyeth knew or reasonably could have known at the time of Mr. Giles's death. The later warning was based on conclusions the FDA drew after the death, based mostly on data gathered after the death.  Moreover, it drew these conclusions from an analysis of adult clinical trial data from all antidepressant manufacturers, not just from Wyeth. There was no proof Wyeth could have known about other company's data.

The tendency of the later warnings to prove that Wyeth knew of an increased risk of suicidality in persons of Mr. Giles's age "was essentially nil in this case." The later warnings, which focused on children, adolescents, and persons who were much younger than Mr. Giles, could have confused the jury. That is, the jury might have thought that the warnings that antidepressants had increased suicidal thinking and behavior in certain adolescents and young adults also had application to Mr. Giles, when there was no evidence to support that.

As a result, the court of appeals did not find an abuse of discretion in the district court's determination that the probative value of the post-2002 warnings was substantially outweighed by the danger of confusing the jury.


China To Set Up Food Safety Commission

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.

Digitek MDL Court Issues Federal-State Coordination Order

An important aspect of mass tort case management involves the level of coordination between cases in a federal MDL and those cases in state courts involving the same product. The MDL judge in the Digitek products liability multidistrict litigation, In Re: Digitek Products Liability Litigation, MDL No. 1968, No. 08-md-1968( S.D. W.Va.), issued an order coordinating activities between the federal litigation and the mass tort litigation recently coordinated before the state court in West Virginia's Circuit Court. In Re: Digitek Litigation, No. 08-C-5555, (W.Va. Cir., Kanahwa Co.).

Readers of MassTortDefense will recall the nationwide recall of Digitek products, involving tablets with higher dosage than called for which may have been released to the public. Approximately 60 cases arising from the recall were transferred last August to a multidistrict litigation assigned to Chief U.S. Judge Joseph R. Goodwin of the Southern District of West Virginia. Later in the Fall, multiple Digitek stats court cases were coordinated in the Kanawha County Circuit Court.

Pretrial Order (PTO) No. 11 concerns state and federal coordination. The court found that the state and federal litigation share common issues and will involve common discovery.  The court said proper coordination will avoid unnecessary conflicts and expense, conserve judicial resources, and expedite the disposition of all the cases. 

He ordered lead and liaison counsel for the plaintiffs and defense to endeavor to coordinate activities between the federal and state litigation. He also ordered the creation of a joint document depository for use by parties in the federal-state litigation. The Order provides a mechanism for cross-noticing depositions.  Also, counsel in the West Virginia state litigation who obtain confidential documents are subject to the confidentiality/protective order issued in the MDL.

Chief Judge Goodwin also said he is prepared to conduct "consolidated hearings and status conferences with the presiding state judicial officers, and to enter joint rulings, except to the extent that differences may be mandated by different laws or rules governing this court or justified by particular circumstances of the cases before this court."