A Game of Chicken

on January 30, 2015 ·

Posted in Food and Beverage

The United States Department of Agriculture’s (“USDA”) Food Safety and Inspection Service (“FSIS”) recently announced new safety measures that will expand food inspection standards for poultry production establishments in response to concerns about foodborne illnesses. (See press release). Under the proposed rule, FSIS will test raw chicken and turkey parts, including chicken breasts, legs and wings for bacteria Salmonella and Campylobacter. The proposed guidelines are part of FSIS’ Salmonella Action Plan, launched in December 2013. (See action plan).

Beginning in March 2015, FSIS will replace its existing Salmonella sampling set-approach with a moving-window sampling approach for all FSIS –regulated products subject to Salmonella and Campylobacter verification testing. Previously, once a sample set began, a production establishment was on notice that it would be sampled on consecutive days that the product was produced for the set time period. FSIS identified that this knowledge “might create a bias because establishments may, intentionally or not, adhere more conscientiously to proper sanitary procedures during this time.” (See guidance at 35). Furthermore, FSIS identified that its set-approach disproportionately based sampling schedules on past performance (e.g. those establishments that continuously achieved pathogen reduction performance standard goals were not sampled routinely).

By contrast, FSIS now intends to adhere to a moving-window approach to assess the number of positive samples taken within a 52-week period. On week 53, the moving window shifts forward to exclude the week 1 sample and include the week 53 sample; this moving window approach preserves a 52-week sampling period to allow FSIS to continuously assess the process control of an establishment. If an establishment exceeds the maximum acceptable samples for the 52-week period, FSIS will automatically conduct follow-up samples independent of the moving window approach to asses if the establishment has ameliorated its food safety system.

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We have often covered issues relating to jurisdiction over foreign defendants in suits filed in the United States, but the landscape can be even more complex when that foreign defendant is a sovereign nation that asserts immunity.  Indeed, the Foreign Sovereign Immunities Act, 28 U.S.C. §§ 1602 et seq. (“FSIA”), governs where a United States court may assert subject matter jurisdiction over claims against a sovereign nation, its political subdivisions, agencies or instrumentalities. The FSIA presumes immunity for foreign sovereigns and lays out several specific exceptions under which plaintiffs may bring claims against them in U.S. courts.

There could be an entire blog devoted to these issues, which tend to be particularly sensitive since they touch on issues of foreign relations and international comity, but the Supreme Court recently agreed to hear an appeal that is particularly worth watching.  The case, OBB Personenverkehr AG v. Sachs, No. 13-1067, is an opportunity for the Supreme Court to clarify the requirements of the FSIA’s commercial activity exception.  The commercial activity exception provides that a foreign state and its instrumentalities are not immune from suit in the United States when the action is based upon: (i) a commercial activity carried on in the United States by the foreign state, (ii) an act performed in the United States in connection with a commercial activity of the foreign state elsewhere, or (iii) an act outside the territory of the United States in connection with a commercial activity of the foreign state elsewhere and that act causes a direct effect in the United States.  28 U.S.C. § 1605(a)(2).

In Sachs, a California resident brought a suit against OBB Personenverkehr AG, Austria’s national railway and a foreign sovereign instrumentality under the FSIA, in California federal court. The plaintiff had been seriously injured while attempting to board a train in Austria and asserted negligence, design defect, failure to warn, and breach of implied warranty claims.  She invoked the FSIA’s commercial activity exception to overcome the railway’s sovereign immunity, specifically the clause regarding commercial activity carried on in the United States by the foreign state.  The complaint claimed that the railway, by selling Eurail train tickets in the United States through a Massachusetts-based internet seller, was carrying on commercial activity in the United States.  In an en banc opinion, the Ninth Circuit reversed the appellate panel and the district court to hold that the internet ticket seller was an agent of the Austrian national railway and therefore the railway conducted enough commercial activity in the U.S. so as to deprive it of its sovereign immunity for purposes of the plaintiff’s claims.  The Ninth Circuit found no immunity even though there was no contractual relationship between the railway and the ticket seller, the ticket was for travel exclusively outside of the U.S., and the alleged tortious acts and injuries all took place in Austria.  The decision was accompanied by two dissenting opinions, one by Judge O’Scannlain, joined by Chief Judge Kozinzki and Judge Rawlison, and a separate one by Chief Judge Kozinzki. [click to continue…]

In many product liability cases we try, plaintiffs argue that certain government statements (e.g., on causation or adequacy of the labeling), are inadmissible on hearsay grounds.  In a recent case having very little to do with product liability law, a Michigan state appellate court issued a favorable ruling regarding the admissibility of FDA, CDC, and other government-authored documents.  In Kagen v. Kagen, 2014 WL 7217819 (Mich. App. Dec. 18, 2014), a divorced couple disputed whether to continue vaccinations for their children (pursuant to the divorce judgment, neither party was permitted to make major medical decisions relating to the children without consulting the other).  The mother claimed that she maintained religious objections to employing vaccinations and refused to authorize them. Over the mother’s objections, the father took the daughter to the doctor for four vaccinations, and the mother filed a motion in the circuit court to prevent any further unilateral action.

The circuit court agreed with the mother; the critical finding was that the court agreed that the parties had previously agreed not to vaccinate the children and that the father failed to present sufficient evidence that a change in their prior agreement was in the children’s best interests.  But, in order to reach that conclusion, the court had excluded statements and summaries of scientific studies regarding the safety, benefits, and risks of childhood inoculations, issued by the CDC, NIH, and FDA.  The court held that those statements were inadmissible hearsay that did not fall within the “catch-all” exception, as argued by the father.  The court ruled that the “catch-all” exception only applies where the hearsay is the “best evidence” and it is in the interest of justice to admit it.   The court contended that the best evidence about the safety and necessity of childhood vaccinations would have come from the children’s pediatrician which would be nonhearsay derived from firsthand knowledge.  [Note: it is not clear why the father did not argue the “public record and report” exception applied].

On appeal, the Michigan appellate court reversed.  “The circuit court abused its discretion in excluding [the] proffered evidence based on the “best evidence” requirement . . . .  The four reports proffered by [the father] were prepared by experts in the field of child immunizations and were based on scientific study. The fact that the reports were otherwise hearsay does not render them less worthy of belief. And, as noted by [the father], it would impose an unreasonable burden to expect him to present the testimony of the government agents who compiled or prepared the reports.”

In addition, the appellate court recognized the obvious – if the question at hand is whether the vaccinations are the appropriate medical treatment (or, in cases we often litigate, whether a medicine causes a particular condition or the label is adequate) – the FDA, the CDC, and the NIH’s conclusions on the topic are often the most relevant and reliable evidence in the case.  If the goal is to get to the truth, a judge or jury ought to consider (and frankly, give great weight to), such evidence.  The appellate court agreed, stating:  “The focus of the hearing was the parties’ disagreement on childhood vaccinations. Mr. Kagen believed such vaccinations to be safe, necessary and in the children’s best interests while Mrs. Kagen thought they are poisonous, unnecessary and contrary to the children’s best interests. The opinions of these particular government agencies would certainly assist the fact finder in resolving whether the best interests of the children would be served by vaccination against disease.”  In addition, while (as noted above), the father did not argue for the applicability of the public record exception, the appellate court cited to it as further support for its conclusions.  “All four reports are official (formal) statements by government agencies. The presentation of this information in a public forum and as part of the authors’ official duties suggests ‘that the declarant would have been likely to consider the accuracy of the statement when making it’ . . . ‘The principal basis for the presumption of trustworthiness of public records is the assumption that public officials will properly perform their duties with accuracy and fidelity. Officials have the duty to make accurate statements, and this special duty will usually suffice as a motive to incite the officer to its fulfillment.’” (internal citation omitted).

Kudos to this court for applying common sense when analyzing the admissibility of hearsay evidence.

New Year, New You, New FDA Guidance

January 23, 2015

If you’re reading this, you may be one of the hundreds of millions of consumers who downloaded a mobile health app this year to help you keep your New Years’ resolution. You may also be one of the estimated 92% of people who, by the third week of January, have already given up on that […]

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SCOTUS Passes On Opportunity to Resolve Daubert Circuit Split

January 20, 2015

Following up on my colleague Melody Akhavan’s excellent post on a recent “Daubert Do-Over,” I wanted to revisit the certiorari petition filed by SQM North America Corporation (SQMNA) seeking to reverse the Ninth Circuit’s decision in SQM N. Am. Corp. v. City of Pomona, 750 F.3d 1036 (9th Cir. 2014).  The petition struck me as notable because it highlighted the existing circuit split over the interpretation […]

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