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Legal Woes Highlight Dangers of the Food Industry Supply Chain

chipotle

A spate of recent cases offers a clear warning for the food industry about the legal and reputational perils of not getting more serious about supply chain control.

On Monday, the U.S. Supreme Court declined to consider an appeal from Nestle, Archer Daniel Midlands Co. and Cargill Inc., allowing a slave and child labor lawsuit to proceed against the three food industry giants.

Three plaintiffs who claim they were trafficked from Mali as child slaves and forced to work harvesting and cultivating beans in Cote d’Ivoire, and allege that the companies aided, abetted or failed to prevent the torture, forced labor and arbitrary detention they suffered.

According to Reuters:

The plaintiffs, who were originally from Mali, contend the companies aided and abetted human rights violations through their active involvement in purchasing cocoa from Ivory Coast. While aware of the child slavery problem, the companies offered financial and technical assistance to local farmers in a bid to guarantee the cheapest source of cocoa, the plaintiffs said.

The defendants knew about the child slavery problems in the region and offered both financial and technical farming assistance to support the agriculture methods in place, the plaintiffs claim. What’s more, they say, the defendants could have used their leverage in the cocoa market to stop or limit the alleged child labor practices and failed to do so.

According to the Wall Street Journal:

Mark Theodore, a partner at Proskauer Rose, said that the ruling reinforces to companies that they need to be socially responsible employers. And while there is no way to ever completely prevent such risks, he said the ruling is a reminder to companies that they “should be monitoring and also maybe doing a little bit of introspective thinking about their own practices to avoid these things, or prevent them from happening, or to put themselves in legally defensible position if they can’t prevent them.”

In September, the Justice Department finalized a landmark conviction of the former head of the Peanut Corporation of America, who was sentenced to 28 years in prison for knowingly shipping salmonella-tainted products that sickened 714 people and killed nine. That may be the department’s first step in a new approach to taking food industry product safety more seriously, and more aggressively pursuing wrongdoing on a criminal level. The Justice Department has now opened formal investigations into the e. coli outbreak at Chipotle and the listeria outbreak at Blue Bell Creameries, both of which sickened hundreds of consumers.

The department has already signaled a broad intention to focus more efforts on individual law-breakers in corporate crimes. Now, the government appears to be showing the food industry that things are changing in terms of corporate responsibility and food safety, according to Andrew Lankler, partner at Baker Botts. Lankler told the Wall Street Journal that the Department of Justice is signaling that whatever standard the food industry thought it needed to meet for food safety, the bar is higher. “The department is going to step up enforcement in areas where they can prove they sold tainted product,” he said.

And the trouble at Chipotle shows little sign of abating. The CDC is still investigating multiple outbreaks, and the chain has now been served a subpoena as part of a criminal probe by the U.S. Attorney’s Office and the Food and Drug Administration’s Office of Criminal Investigations regarding an isolated norovirus incident in August.

A fourth lawsuit was recently filed by a customer who claims he was sickened by the same strain of e. coli linked to Chipotle, but this case dates back to July, meaning far more people may have been affected in the outbreaks. At least nine suits have been filed by customers, and Bill Marler, a food and safety litigator in Seattle, claims more are coming from the 75 Chipotle-related clients he represents.

At this week’s ICR conference this week, CEO Steve Ells said he is hopeful that the CDC will soon declare the restaurant’s e. coli outbreak over, adding, “we know that Chipotle is as safe as it’s ever been before.”

To that end, Chipotle announced today that it will close all of its stores on Feb. 8 to have a corporation-wide meeting with all staff regarding food safety.

But customers remain extremely wary. Indeed, while it may be an e. coli cliché, it would not at all be a stretch to say public opinion about the brand remains in the toilet, with YouGov’s BrandIndex score for the company seeing a drop equal to that of GM during its crisis.

yougov poll chipotle

To combat that, the company also announced plans to launch a sizable new marketing campaign to win back customers, using direct mail and traditional advertising to attempt to win back consumer confidence. As Fortune reported, executives said the campaign will attempt to provide a “detailed story of what happened” to explain to customers why they are now safe, and that it will not focus overtly on food safety, but will have “an undertone” of humility.

Chipotle’s stock dropped nearly 42% in the wake of the outbreaks, and according to an SEC filing, sales at stores open more than a year were down 30% last month. Ells and his team admitted they could not guess how much the fallout will impact 2016 financial results, but expect it will be a “messy” year. Costs are expected to go up from the marketing campaign and new food safety measures, including processing more food through centralized kitchens in an attempt to better control the conditions of ingredients.

The company darkened its outlook for Q4 results, and As Wells Fargo Securities wrote in a recent research note, “We expect CMG to point to a hard-fought and long-tailed [same-store sales] recovery across 2016, and to stress that there is still much work to be done in assessing the sizeable costs associated with the company’s supply chain overhaul.”

For more about food safety crises and product recall, check out the following articles from Risk Management:

Feeding an Appetite for Trust, A Q&A with Center for Food Integrity CEO Charlie Arnot

Food Safety Updates Stalled by Funding

Maximizing Coverage for a Product Recall

Rules Needed for Office Lottery Pools

Powerball

With the current Powerball Jackpot estimated at $1.4 billion, the highest amount ever, people everywhere are lined up to buy tickets—and making plans for their winnings. The odds of winning Powerball, however, are one in 292,201,338. Meanwhile the odds of being struck by lightning in any given year are one in 700,000.

To maximize their odds of winning, many form pools to purchase more tickets. Often this takes place at work, but if a company is located in a state where the lottery or gambling is illegal, an office pool may not be a good idea.

Powerball tickets are sold in 44 states, as well as Washington, D.C., the U.S. Virgin Islands and Puerto Rico. They are not allowed to be sold in Alabama, Alaska, Hawaii, Mississippi, Nevada and Utah.

“Even if you pool your money and then buy a ticket from another jurisdiction, the criminal statute may still apply. You were arguably participating in and promoting a lottery within the state,” Stephanie Rabiner wrote.

Employees of the U.S. government should also be aware that they are prohibited from taking part in any gambling activity on government-owned or government-leased property, or when they are on duty for the government.

But with so much money at stake, what could go wrong? Plenty, and with the jackpot so high, the likelihood for complications is also increased.

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Midge Seltzer, president of Engage PEO, lists a few of the potential problems and steps that can be taken to circumvent them.

Potential issues:

  • Employee claims he or she bought the winning ticket and was not part of the pool.
  • Employee only verbally said, “I’m in,” or “Yes, and I’ll give you the money tomorrow.

  • Participants aren’t actually known, because the pool is so loosely handled.
  • An employee had participated previously, but was absent to contribute to this pool.

Guidance:

  • Ensure that all participants pay prior to purchase of lottery tickets.
  • Choose a leader—the employee who will be responsible to purchase the tickets and put them in a safe place.
  • Make copies of the tickets.
  • Have all participants write and sign their names and have the lead confirm that he/she paid for the tickets.
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  • Agree beforehand how employees will choose the numbers (at random or set numbers).
  • Agree beforehand whether employees will take a lump sum or payout.

What are the most popular states for Powerball?

Residents of Rhode Island have bought the most Powerball tickets, with an average of 3.44 tickets per person since the last jackpot was won on Nov. 4, according to consumer finance website ValuePenguin.

The top 20 states for per-capita participation in Powerball:

Top-20 States for ticket sales

U.S. Sues VW

VW logo

The U.S. Justice Department on Monday sued Volkswagen in federal court in Michigan for illegally installing faulty emission control devices in about 600,000 vehicles. The lawsuit, filed on behalf of the U.S. Environmental Protection Agency (EPA), accuses VW of four counts of violating the U.S. Clean Air Act, including tampering with the emissions control system and failing to report violations.

According to a Reuters review of the U.S. complaint, VW could face fines of up to $37,500 per vehicle for each of two violations of the law, up to $3,750 per “defeat device,” and another $37,500 for each day of violation.

Risk Management magazine reported in December 2015 that the affected EA 189 diesel engines were installed in more than 11 million Volkswagen and Audi vehicles manufactured between 2009 and 2014. The company announced on Oct. 22 that it was also looking into whether the software might be in earlier versions of its latest EA 288 diesel engine, potentially adding millions more to the total.

Regulators across the globe, including in India, South Korea and Germany, are conducting their own investigations, as are attorneys general in all 50 U.S. states. The Justice Department has been seen as the only agency that might hold executives personally accountable, according to The New York Times.

The government is seeking a number of penalties against the company, including fines and further actions to mitigate the emission of harmful pollutants. A federal court will determine what actions the company must take to reduce emissions and a dollar figure for the penalty.

VW (VOWG_p.DE) shares fell as much as 6% to a six-week low on Jan. 5, the biggest drop yet on Germany’s blue-chip DAX index, Reuters said.

Balancing Risk and Compassion: Life Sciences Companies Face New Risks from Expanded Access

Pharmaceutical companies operate with a singular objective: bring drugs to market. This is how they profit, how they ensure that their products help the most people, and how they maintain the resources to continue innovating.

The lifecycle of drug development can be complex and onerous, despite improvements to the regulatory approval process over the past several years. Now, a trend sweeping the industry is forcing many pharmaceutical companies to decide under which circumstances they’re willing to divert resources from their mission of helping the masses.

Expanded Access, or “Compassionate Use,” refers to the use of an experimental drug not yet approved by the FDA to treat a critically ill patient outside of a clinical trial. The FDA received more than 1,800 requests for access to experimental drugs last year and, over the last five years, it has approved 99% of these requests.

But ultimately, once requests are approved by the FDA, it’s up to manufacturers to provide the drug to these patients, many of whom are children, and many of whom have just months left to live.

Companies are then faced with a choice: to provide an unapproved drug to individual patients, which can delay the process of making the drug widely available, or to deny the request and risk backlash from the public, who see only a dying patient and the pharmaceutical company that could save them. In several cases, the latter has fueled social media campaigns demonizing companies for withholding potentially life-saving medicines.

How a company handles expanded access requests can affect its reputation and financial stability. Pharmaceutical executives often operate under a microscope, where patient outcomes are the key to keeping investors on board. As expanded access patients often do not qualify for clinical trials, they may be higher-risk candidates, so reporting their results to the FDA could potentially prolong approvals and market availability. On the other hand, a company that denies an expanded access request can face significant reputational damage and even legal action if investors believe that management decisions hindered the company’s progress.

Small and mid-size life science firms in particular may fear that they don’t have the resources to navigate expanded access cases. But requests for experimental drugs are on the rise: the FDA saw a 92% year-over-year increase in requests in 2014. Companies need to prepare their approach and policies before they find themselves in the throes of a difficult decision with pressures mounting from both sides. Here are four ways they can set themselves up to make informed decisions about balancing risk with compassion:

Monitor the Regulatory Environment

Over the last year, the FDA has been working to simplify the process for physicians requesting access to experimental drugs on behalf of patients. In February 2015, the agency streamlined the application form, which now requires physicians to submit just eight types of information, as compared with 26 types in the previous form.

The FDA has also been working with life sciences companies to find alternative solutions to expanded access when needed, such as designing expedited open-label trials for these patients.

Additionally, as of August 2015, 24 states have introduced right-to-try bills, which allow physicians to request experimental drugs without going through the FDA’s application process.

With both federal and state governing bodies paving the way for easier access to experimental drugs, the decision to provide these drugs falls squarely on the shoulders of corporate leadership at pharmaceutical companies. These firms also ought to keep in mind the need to prioritize building and maintaining relationships with the FDA, which can be key in developing a creative solution.

Update Your Crisis Management Plan

Crisis management plans are sometimes written in broad strokes. In preparing for expanded access cases, risk managers need to bring together leadership from various departments—senior management, investor relations, finance, human resources, etc.—to weigh in on the specific risks associated with experimental drugs. Many firms will seek outside counsel to guide the process.

At a basic level, a crisis plan should map out vulnerabilities across all risk areas. For example, companies need to consider the process for securing their facilities, fielding press inquiries, addressing social media backlash, managing investor concerns and navigating potential lawsuits.

Most importantly, companies need to develop the principles that will guide decisions in crisis situations. Rather than scrambling for direction in the heat of public scrutiny, companies should establish a clearly-stated policy and set of guidelines for participation in expanded access programs. This will serve as the foundation of a response if an issue arises. Management must then be prepared to defend that position to all stakeholders, including employees, investors, patients, physicians and potentially press.

Evaluate and Re-evaluate Your Insurance Policies

Organizations need to consider which financial risks they can transfer to their insurance policies. Not everything will be insurable, but a strong policy can provide protection if an expanded access case threatens a company’s financial stability.

This starts with a comprehensive review of a company’s insurance portfolio with the issue of expanded access in mind. Oftentimes, risk managers revisit their policy language through the lens of a specific issue and realize that their expectations for coverage don’t accommodate current events. This can be the case with expanded access.

When reviewing their policies, companies need to understand the intent of the language relevant to expanded access and work with their broker to make sure the coverages are as granular as possible.

Lead the Way

This year, Johnson & Johnson created a Compassionate-Use Advisory Committee composed of doctors, bioethicists and consumer advocates to evaluate expanded access requests and make recommendations to the company’s clinicians. While many have hailed this as a creative solution for maintaining ethical standards, smaller companies with fewer resources cannot as easily take such an approach. These firms have an opportunity to set the standard for managing expanded access cases by developing thoughtful policies, collaborating with regulators and academics and, of course, addressing risks to business from the onset.