Tag Archives: liable

Product Liability in the Cannabis Industry: Insights From 2022 & Looking Forward

By Andrew Solow, David Kerschner, Alessandra Lopez
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In 2022, product liability lawsuits in the cannabis/cannabidiol (CBD) industry continued to focus on levels of THC and the psychoactive ingredient in cannabis, while federal agencies continued issuing warning letters for CBD products (including CBD-infused food and dietary supplements) that made misleading medical claims. Against this backdrop of ongoing litigation and regulatory enforcement, 2022 showed that at the Federal level, there is more recognition that marijuana is becoming increasingly normalized. For example, President Biden pardoned federal offenses of simple marijuana possession and requested a reassessment of marijuana’s classification as a Schedule I drug under federal law. Additionally, Congress passed its first standalone piece of cannabis reform with the Medical Marijuana and Cannabidiol Research Expansion Act (MMCREA) which, among other things, will ease restrictions on cannabis research and allow for more clinical trials. And even though the Food and Drug Administration (FDA) declined to act on CBD products, the agency announced that it will work with Congress to create a new regulatory framework for CBD products (2023 FDA Announcement).

These events of the past year provide a glimpse into what the future may hold for cannabis and CBD companies when it comes to product liability risks. This article looks at the types of product liability actions that the cannabis and CBD industry faced in 2022 and may encounter in the future, and provides some basic guidance on how to best mitigate, and if necessary, defend these potentially costly litigations.

Focus on Cannabis and CBD Risks

FDAlogoA central part of any product liability lawsuit—regardless of whether brought under a design defect and/or adequate warning theory—is that a product caused or was a substantial contributing factor to a Plaintiff’s injury or illness. Thus, any potential safety concerns over cannabis/CBD could end up as the subject of litigation in the future. In the 2023 FDA Announcement, the FDA recognized that “the use of CBD raises various safety concerns, especially with long-term use,” including potential harm to the liver and negative interactions with certain medications. The agency also noted that questions still exist on how much CBD can be consumed, and for how long, before causing harm. Furthermore, on December 2, 2022, President Biden signed the MMCREA into law, which is intended to advance research on the potential risks and medical benefits of cannabis and cannabis products.1 This additional funding will not only help researchers learn more about possible safety risks that may lead to future product liability claims, but will also allow for better exploration of the benefits of these products to possibly expand product indications and help reach new customers.

Given the FDA’s statements and the increased funding for new research, CBD and cannabis companies should ensure that they are properly monitoring both regulatory communications and new research regarding risks that may be associated with their products. As new information is released, companies should evaluate how their product labels and marketing messages should be altered. Announcements like this one by the FDA can be seen as providing industry participants with knowledge about certain risks, and how companies react could be analyzed, post hoc, in any litigation down the road.

2022 Product Liability Actions  

Over the last year, misbranding/mislabeling issues presented some of the most prevalent litigation risks for industry participants.

An example of a warning letter the FDA sent to a CBD products company making health claims

For example, at the Federal level in 2022, the FDA issued thirty-three warning letters to CBD companies, a nearly 400% increase from 2021. These letters generally focused on CBD products that made medical claims. Some of these warning letters addressed misbranding, where the product labels provided inadequate directions for consumer use. In one letter, the FDA noted that because the CBD products were “offered for conditions that are not amendable to self-diagnosis and treatment by individuals who are not medical practitioners,” ranging from cancer to diabetes, labeling compliance was only possible if the product was an FDA-approved prescription drug with FDA-approved labeling. Other companies received warning letters in March of 2022 for making misleading representations that their CBD products were safe and/or effective to prevent or treat COVID-19. Many of these representations were made via companies’ websites and social media platforms. The warning letters—often triggers for product liability actions, as well as consumer protection/fraud actions—serve as a reminder that companies cannot make medical claims on non-FDA approved drug products and must otherwise present accurate information to consumers not only on product packaging, but any form of marketing or advertising, including company websites and social media platforms.

Turning to state-level regulatory actions, Oregon’s Liquor and Cannabis Commission fined a cannabis company $130,000 and suspended the company’s license for 23 days over an alleged label mix-up between its CBD and THC products. According to the state’s investigative report, a company employee allegedly confused two product buckets with similar identification numbers, one that contained THC and the other CBD, and accidentally switched the labels of the two products. In addition to the fine and license-suspension, the state agency also issued a mandatory recall on the CBD drops based on the alleged undisclosed levels of THC.

This same incident also spurred a string of civil lawsuits, resulting in several settlements by the company in 2022.2 Numerous customers reported experiencing “paranoia,” “mind fog,” and feeling “extremely high,” with at least five people going to the emergency room with serious health issues due to use of the CBD drops. One lawsuit, which was publicly settled for $50,000 in January of 2022, alleged that the company failed to warn the plaintiff that the CBD drops contained THC or that the product may have been contaminated with foreign substances like THC, and that the company failed to exercise quality control standards that would have detected the THC.3 Nine other lawsuits made similar failure to warn allegations based on the same batch of CBD drops and were settled by January of 2022, although those settlements were not disclosed.4 In October of 2022, the company agreed to pay a settlement of $100,000 in a class action suit, which alleged that the company failed to disclose that the CBD product contained substantial amounts of THC.5 The class action focused on unlawful trade practices claims, including that the company falsely represented that the product had the characteristics, uses, and benefits of a CBD product that did not contain THC.6 Also in October 2022, the company settled a wrongful death lawsuit—alleging that the company failed to warn the plaintiff that the drops contained THC and had negligent quality control standards—stemming from the same CBD drops,7 where the plaintiff suffered stroke-like-symptoms, allegedly due to the tainted CBD product, and ultimately died.8

Other recent lawsuits have also focused on mislabeled cannabis products, alleging that companies failed to inform customers that products contained THC. For example, in Kentucky, a man who drove into a bus after using a CBD vape sued both the CBD manufacturer and retailer on December 14, 2022, claiming that he was not warned that the vape contained a substance that would make him intoxicated.9 According to the complaint, the store employees told the man that the vape was “all natural” but made no mention that the product contained THC.10 The man alleged that the vape actually contained Delta-8 THC and brought negligence, failure to warn, and state consumer protection law claims.11

As noted above, in addition to traditional product liability actions, companies are likely to face increased consumer fraud and false advertising actions in the absence of personal injuries. Two class actions brought in December of 2020 against a hemp tea maker alleged that the company’s website and the product’s packaging fraudulently stated that a tea contained zero THC.12 Plaintiffs claimed that they tested positive for THC after drinking the tea and that product testing similarly revealed that the tea contained some THC.13

Potency inflation marketing communications from a laboratory

Last year also saw a rise in cases focused on potency inflation, alleging that cannabis companies knowingly overstated the amount of THC in their products to charge higher prices.14 Again, while these actions focused on consumer fraud allegations rather than product liability claims, these cases underscore the importance of accurate labeling. Due to potency inflation concerns, states have started investigating licensed cannabis testing labs within their respective jurisdictions, resulting in product recalls and fines. Some states have also updated their regulations, requiring cannabis companies to test their products through two separate labs.

Finally, contamination and the existence of impurities and other byproducts has been a recent focus of several product liability lawsuits across the life sciences space, and this trend is something that cannabis and CBD companies should be aware of and take steps to mitigate.

For example, a Canadian cannabis producer reached a $2.31 million settlement over a class action brought in March of 2017 regarding pesticide-contaminated medical marijuana. The marijuana was recalled due to the presence of myclobutanil and bifenazate pesticides, neither of which were authorized for use on cannabis plants in Canada. The lead plaintiff experienced nausea and vomiting, allegedly from consuming the medical cannabis, and brought numerous claims on behalf of the class, including negligent design, development, testing, manufacturing, distribution, marketing, and sales.15 In the United States, California’s Department of Cannabis Control issued a mandatory recall on January 26, 2022 for a batch of cannabis flower that was contaminated with mold. On March 25, 2022, the New Mexico Cannabis Control Division recalled cannabis products sold by a local medical cannabis company because the product contained impermissibly high levels of mold. New Mexico’s Cannabis Control Division also required the company to immediately cease and desist operations at its production and manufacturing site.

A Look at the Future and What Companies Can do to Mitigate Product Liability Risks  

The FDA’s 2023 announcement means that the industry will have to wait for Congressional action for the development of a regulatory scheme that can help standardize requirements and provide industry players additional defenses when facing product liability actions. Many of the proposed risk management tools in the FDA Announcement could help companies mitigate future litigation risks if implemented. These risk management tools may include “clear labels, prevention of contaminants, CBD content limits, and measures, such as minimum purchase age, to mitigate the risk of ingestion by children.” Although the FDA has had regulatory oversight over CBD and other hemp-derived products for nearly four years, the agency has not developed a regulatory framework for these products aside from issuing warning letters, leaving manufacturers and distributors without much guidance. The FDA has also left the states to fill the void, resulting in a patchwork of differing—and sometimes conflicting—state laws. Additional guidance and regulation on labeling at the federal level for cannabis and cannabis-derived products will make compliance a more straightforward proposition and may provide avenues for industry participants to explore preemption defenses in the face of future mislabeling claims.

Just some of the many CBD products on the market today

In addition to following the changing regulatory landscape and understanding how regulatory changes can impact litigation defenses, cannabis and CBD companies can continue to take various steps to help mitigate future litigation risks.

Quality Control: Adequate testing procedures and effective quality control procedures can help avoid contamination issues and situations where products are mixed up during the manufacturing process. For example, the company whose license was suspended in Oregon due to the alleged mix up between CBD and THC subsequently implemented new ingredient tracking protocols, adopted a policy to retain samples from each batch of product, and now sends additional samples to an independent lab to ensure product compliance before anything is sold.

Proper documentation of testing and quality control procedures, as well as maintaining records of compliance checks, can also help companies put together a defense to state regulatory actions or lawsuits relating to contamination or manufacturing defects. Indeed, in February of 2022, an Arizona marijuana testing lab was fined $500,000 for various incomplete records and documentation as well as improperly calibrated machines for contamination testing, with an inspector also noting that one of the employees was trained to use a technique that produced inflated potency results.

Ongoing Safety & Regulatory Review: Keeping up to date with regulations and science will play a key role in making sure labels are accurate and defendable. Working directly with regulators and seeking guidance from regulators on labeling can help potential defendants present a clear and compelling labeling defense. Moreover, the 2023 FDA Announcement made clear that the agency will not pursue rulemaking on CBD’s potential use in foods and dietary substances. Thus, industry players should monitor agency announcements and engage with the FDA’s Cannabis Product Committee (CPC) and Congress to better understand the potential structure of this new regulatory pathway.

Stay on Top of the Science: A boost in cannabis research is on the horizon, as the Medical Marijuana and Cannabidiol Research Expansion Act (MMCREA) will advance research on the potential risks and benefits of cannabis products and promote the development of FDA-approved drugs derived from marijuana and CBD. On the litigation front, causation is an essential element in most causes of action, and plaintiffs will have to prove that the cannabis caused their injury. Thus, industry players should be aware of the current science, including potential side effects.

Litigation Monitoring: Finally, companies will also be well served by following court decisions involving CBD and cannabis products. For example, courts in 2022 were split over the legality of Delta-8 THC, a substance typically manufactured from hemp-derived CBD. The Ninth Circuit held in AK Futures v. Boyd Street Distro that Delta-8 THC found in e-cigarettes and vape products is legal under the 2018 Farm Act, at least in the intellectual property context.16 But in Kansas, a federal judge ruled that the 2018 Farm Act does not make selling hemp-derived products such as Delta-8 THC legal.17 In Texas, litigation initiated in 2021 is ongoing over the legality of Delta-8 THC.18 There, a hemp company sued the Texas Department of State Health Services for its classification of Delta-8 THC as a Schedule I drug, making the sale of this substance a felony offense. A temporary injunction was granted on November 8, 2021—temporarily lifting the ban on sales of Delta-8 THC products—but the plaintiff’s request for a permanent injunction remains pending.19 As these lawsuits show, the legality of different products may vary by jurisdiction, whether by regulation or a judicial decision.

References

  1. Medical Marijuana and Cannabidiol Research Expansion Act, Pub. L. 117–215, 136 Stat. 2257 (2022).
  2. Agbonkhese v. Curaleaf Inc., No. 3:21-cv-01675, (D. Or. Jan. 5, 2022).
  3. Agbonkhese v. Curaleaf Inc., No. 3:21-cv-01675, ECF 1, 6 (D. Or.).
  4. See Crawforth v. Curaleaf, Inc., No. 3:21-cv-1432 (D. Or. Sept. 29, 2021); Lopez v. Curaleaf, Inc., No. 3:21-cv-1465 (D. Or. Oct. 6, 2021);
  5. Williamson v. Curaleaf, Inc., No. 3:22-cv-782, ECF 1, 8 (D. Or.).
  6. Williamson v. Curaleaf, Inc., No. 3:22-cv-782 (D. Or. May 30, 2022).
  7. Estate of Earl Jacobe v. Curaleaf, Inc., No. 3:22-cv-00001, 19 (D. Or. Oct. 18, 2022).
  8. Estate of Earl Jacobe v. Curaleaf, Inc., No. 3:22-cv-00001 1 (D. Or. Jan. 1, 2022).
  9. Howard v. GCHNC3 LLC et al., No. 5:22-cv-00326 (E.D. Ky. Dec. 14, 2022).
  10. Complaint at ¶ 11, Howard v. GCHNC3 LLC et al., No. 5:22-cv-00326 (E.D. Ky. Dec. 14, 2022).
  11. Complaint at ¶¶ 15-33, Howard v. GCHNC3 LLC et al., No. 5:22-cv-00326 (E.D. Ky. Dec. 14, 2022).
  12. Williams v. Total Life Changes, LLC, No. 0:20-cv-02463 (D. Minn. Dec. 3, 2020); Santiago v. Total Life Changes LLC, No. 2:20-cv-18581 (D.N.J. Dec. 9, 2020).
  13. Complaint at ¶¶ 54-59, Williams v. Total Life Changes, LLC, No. 0:20-cv-02463 (D. Minn. Dec. 3, 2020); Complaint at ¶¶ 21-25, Santiago v. Total Life Changes LLC, No. 2:20-cv-18581 (D.N.J. Dec. 9, 2020).
  14. See Centeno v. Dreamfields Brands Inc., No. 22STCV33980 (Cal. Superior Ct. L.A. Cnty. Oct. 20, 2022); Shanti Gallard v. Ironworks Collective Inc., No. 22STCV38021 (Cal. Superior Ct. L.A. Cnty. Dec. 6, 2022).
  15. Downton v. Organigram Holdings Inc., Hfx No. 460984 (Sup. Ct. Nova Scotia Mar. 3, 2017).
  16. AK Futures LLC v. Boyd St. Distro, LLC, 35 F.4th 682 (9th Cir. 2022).
  17. Dines v. Kelly, No. 2:22-cv-02248, 2022 WL 16762903 (D. Kan. Nov. 8, 2022).
  18. Hometown Hero v. Tex. Dep’t of State Health Services, No. D-1-GN-21-006174 (Travis Cnty., Tex. Oct. 20, 2021).
  19. Hometown Hero v. Tex. Dep’t of State Health Services, No. D-1-GN-21-006174 (Travis Cnty., Tex. Nov. 8, 2021).

Risk Management Considerations for Cannabis Retailers in New Jersey

By Eric Schneider
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Despite the US making cannabis regulations challenging to navigate, the industry is snowballing toward profitability. New Jersey legalized adult use cannabis on April 21 this year. One month earlier, The Garden State began accepting applications for Class 5: Retailers, Dispensing and Delivery.

Although New Jersey isn’t shy about its licensing requirements and standards, many people want to know how retailers can stay in the game for the long run. So, let’s talk about risk management considerations New Jersey retailers need to know.

Top Risks Cannabis Retailers Face in New Jersey

Regardless of what kind of retailer you operate —medical or adult use — it’s critical to know what you’re up against. The following are the most common risks we’ve watched cannabis retailers face daily in New Jersey, making a customized risk management strategy necessary.

Theft

Like other retailers, New Jersey cannabis retailers are vulnerable to theft. Unfortunately, theft can come from various angles, such as in-store, in-transit and insider crime. Besides cannabis retailers typically having a well-stocked inventory, it’s not uncommon for them to have more cash on hand than most other businesses.

Although the SAFE Banking Act could positively impact the cannabis industry, it’s in a notorious stall yet again. Briefly, the SAFE Banking Act would no longer allow financial institutions, such as banks and credit card companies, to refuse to do business with cannabis companies. However, cannabis retailers must operate in a cash-only environment, for now, forcing them to make bank runs multiple times a day. We probably don’t have to explain how enticing a significant inventory and fat bank bags look to criminals.

Cybersecurity

Since the onset of the global health crisis, the cyber liability landscape has nearly spun into a death spiral. In other words, cybercriminals sat on the edge of their seats during the pandemic, waiting to pounce on anything that looked slightly vulnerable. Remote workers, small businesses, and emerging industries were hard-hit.

It’s no surprise that New Jersey cannabis retailers face many cybersecurity risks through their point of sale (POS) systems. Additionally, retailers often gather and store personal information, such as email addresses, credit card numbers, shipping addresses, etc. Hackers and cybercriminals gravitate to this vital data rapidly.

Property Damage

In addition to the risk of theft, as mentioned above, cannabis retailers must protect their property from losses. Without adequate protection, damage to equipment or buildings could add up to high out-of-pocket costs. Consider the damage a weekend office fire or late-night vandalism would cause. If property damage occurs, retailers must figure out how to sustain business operations while recovering from the loss simultaneously. As a result, New Jersey retailers must protect their property and maintain business continuity.

How to Customize a Risk Management Strategy

Watch or listen to any news reports and there’s a decent chance that you’ll feel some slight sense of doom and gloom. And sure, a lot is going wrong in our world; however, that doesn’t need to impact how you perceive your businesses. Instead of casting a massive net over every possible risk that you can imagine, we recommend trying the following 5-step approach. Here’s the gist:

  1. Identify: Pinpoint high-level risks that are specific to the cannabis industry. Then, let the process trickle down to focus on company-specific exposures.
  2. Analyze: Determine how badly a particular risk could harm your retail company. How much will this hurt should the “what-ifs” play out?
  3. Evaluate: Categorize risks according to how risk tolerant your company is. Will you avoid, transfer, mitigate or accept the risk?
  4. Track: Use your history or the stats from a similar retailer to map out how you’ve handled the risk over time. Older retailers have an advantage over younger retailers, of course, but you can still get a feel for your risk management style.
  5. Treat: Make good on your evaluation promises by avoiding, transferring, mitigating, or accepting the various risks you identified.

Recommended Insurance for New Jersey Retailers

Sales totals in the first month of New Jersey’s adult use market

The New Jersey Cannabis Regulatory Commission issued detailed requirements for new cannabis businesses. That said, part of the application requirements considered is the plan for companies to obtain liability insurance. Many new retailers opted for a “letter of commitment” as opposed to a certificate of insurance (COI), stating their plans for obtaining the following coverages:

  • Commercial general liability: Protects cannabis companies against basic business risks.
  • Product liability: Protects against claims alleging your product or service caused injury or damage.
  • Property: Reimburses cannabis companies for direct property losses.
  • Workers’ compensation: Covers employees if they are injured on the job and can no longer work.

In addition to the required insurance coverages, we recommend New Jersey retailers customize their risk management package with these policies:

  • Crime: Protects your cannabis company against specific money theft crimes.
  • Cyber: Protects your cannabis company against damages from specific electronic activities.
  • Directors & officers: Protects corporate directors’ and officers’ personal assets if they are sued.
  • Employment practices liability: Protects cannabis companies against employment-related lawsuits.
  • Professional liability: Protects cannabis companies against lawsuits of inferior work or service.

With more states in the US entering the marketplace soon, New Jersey is doing its fair share of the heavy lifting by spearheading the onboarding process. Remember, doing your due diligence at the start pays off in the long run — New Jersey retailers are proving that. Consider teaming with a commercial insurance broker calibrated to the cannabis industry, so you get the most out of your broker, marketplace and the cannabis industry as a whole.

New Insurance Risks as Cannabis Lounges Open Across the US

By Jason Scheurle
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In a growing number of communities around the U.S., new cannabis lounges are offering a social setting where guests can openly use cannabis products. Colorado and New Mexico both saw their first cannabis lounges open in April, Michigan’s first cannabis lounge is set to open this summer, and officials in Nevada are currently discussing how the recently approved class of businesses should be regulated. In West Hollywood, California, where the state’s first cannabis lounge opened in 2019, multiple new lounges are now in the works after two years of slowdown due to the pandemic.

The bar-like establishments add a new dimension of potential revenue — and risk — to an industry that is expected to add almost $100 billion to the U.S. economy this year. This new and emerging segment within cannabis isn’t happening in every legal state, but more are starting to enact regulations to provide for some type of on-site consumption.

These new ventures need insurance policies tailored to address the risks of serving cannabis products, which could be looked at similarly to liquor liability for bars and restaurants.

Whether it’s alcohol or cannabis, these products impair people’s judgment, meaning everyone reacts differently to them. But how do you know when to cut someone off?

Cannabis lounges could be held liable & run risk of being sued for overserving

If a cannabis lounge faced a lawsuit alleging that it overserved a patron, leading to a third-party bodily injury, the business’ Commercial General Liability (CGL) Insurance and Products Liability Insurance could potentially cover costs such as legal defense, medical expenses and settlement amounts. Until such a case occurs, it is not yet known how exactly these lawsuits would be covered by insurance.

Because of the short history of cannabis lounges in the U.S., something like this is largely untested, making it hard to speak to exactly how a scenario would play out. Many of the existing cannabis insurance policies are highly exclusionary, meaning it could exclude a loss that is deemed to have arisen out of the use of cannabis.

Recent liquor liability lawsuits have shown the potential for a significant loss is clear. In early April 2022, a $20 million lawsuit was filed against a nightclub in Houston, Texas, alleging it overserved customers and allowed underage drinking, contributing to a drunk driving crash that killed a teenager.

In December 2021, a jury in Texas awarded the family of two drunk driving victims over $301 billion after a lawsuit alleged the driver was overserved at a bar before the accident; though largely symbolic, the settlement marked the largest personal injury award in U.S. history.

The Barbary Coast lounge in San Francisco

With these cannabis lounge establishments more or less encouraging intoxication of patrons on their premises, it’s very similar to a liquor liability type situation. If someone overindulges at a lounge, leaves and causes a crash resulting in injury or death, that could come back to the establishment.

While it remains to be seen how cannabis overserving lawsuits could play out in American courts, it’s worth noting Canada forbids on-site consumption of cannabis products and any loss or damage will not be covered by their insurance policies – despite it being legal country-wide.

Lawsuits possible over product issues, budtender advice

Even cannabis operations that do not allow on-site consumption can face liability related to the products they sell, making Products Liability Insurance and Product Recall Insurance necessary for growers and retailers. They should also consider Employment Practices Liability (EPL) Insurance to cover staffing-related allegations such as discrimination and ask their insurance broker whether budtender liability is included in their CGL Insurance policy.

Budtenders must walk a fine line between giving advice versus general information on products.

Budtenders, or individuals who work at cannabis retailers, are not allowed to offer medical advice to consumers. They must walk a fine line between giving advice versus general information on products. Although we are not aware of lawsuits that have been filed over a budtender’s advice, it would ultimately be up to the courts and lawyers as to how those proceedings would play out.

Budtender liability is not very different from professional liability insurance, and it’s more like an incidental coverage based off the budtender’s informal advice. There are, indeed, insurance carrier partners today that offer that service.

CGL Insurance can also cover in-store slip-and-falls and other third-party injuries and property damage. Because most cannabis retail stores are fairly small, these incidents have been rare, but GCL cannot be overlooked. Businesses must be prepared for anything to happen – and need to know that no risk is too small.

Theft, vandalism among top threats to cannabis businesses

Whether or not a cannabis business includes a lounge for cannabis use, any business in this industry may be more vulnerable to certain risks, including theft and vandalism.

In the U.S., where many cannabis companies operate on a cash-only basis because of banking difficulties tied to recreational products being federally illegal, a recent surge in cannabis shop robberies has led to calls for a new banking bill. Some of these incidents have even turned deadly, including an April 30 dispensary robbery in Los Angeles, California, during which one man was reportedly shot and killed.

Many insurance carriers require retailers to install alarm systems, video monitoring equipment or safes

Large amounts of cash are on-hand daily at these premises, and workers might have to make multiple bank runs throughout the day, leaving a heightened exposure and risk for robberies.

From robberies and vandalism to fires and flooding, Commercial Property Insurance is a key protection for cannabis retailers. Equipment Breakdown Insurance may also be needed, particularly when the stores contain expensive refrigeration equipment. The potential loss is large in this industry, especially at growing facilities, and there’s a lot at stake with such high-value equipment.

Security systems, employee training can help reduce risks

Many insurance carriers require business owners to install alarm systems, video monitoring equipment or safes to help reduce potential property losses, and employees should be trained to use the alarm systems consistently. Policyholders and business owners should also know there is a lot they can do to curb some of the risks, such as businesses doing background checks on every hire and taking steps to ensure they are hiring individuals they can trust.

Installing bars on glass windows and doors is another loss prevention measure that is strongly encouraged because it adds an additional layer of security to get through – it won’t be an easy or quick process to break-in and will trigger the alarm system.

The importance of working with an insurance broker

Working with an insurance broker who is specialized in the cannabis industry can help business owners better explore available coverage options. With cannabis or any type of risk, you should always work with someone who has knowledge and expertise in that area. When you work with someone who knows the ins-and-outs of the regulations, you can have more peace of mind.

You might have a risk warranty that always requires two drivers in that vehicle, or GPS monitoring on the vehicle.

Understanding your policy in its entirety is also essential, as these policies have any number of different limitations and exclusionary forms that could preclude you from collecting if you had not understood and followed the language of the policy.

In a transportation situation, for example, you might have a risk warranty that always requires two drivers in that vehicle, or GPS monitoring on the vehicle. In the event of a claim, if the investigation determines the business did not have those items present at the time of loss, that claim will not be covered.

In a rapidly growing and changing industry, business owners should not underestimate the value of working with a team of insurance experts who keep a close pulse on the quickly evolving industry. Brokers are aware of the different legal environments in each state or even each city or county. Cities and counties can add different levels of compliance matters, so as a buyer, you can be confident that you have the most recent information and are in compliance with state law and any insurance requirements that may be present. Being able to explain the differences between the markets and the coverage options is beneficial to any business owner in this ever-changing industry.

Cannabis Businesses Need D&O Coverage; What Does The Insurance Landscape Look Like?

By Benjamin Sibthorpe
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Cannabis continues to be a hot sector across the United States; buoyed by its ‘Essential Business’ status during the pandemic, a surge of plant touching and ancillary service providers have set up shop in the past 12 months to capture a share of this burgeoning growth. The cannabis industry is currently the leading job creator in the country, employing almost 430,000 workers according to a recent report from Leafly. Estimates on the overall size of the industry vary depending on the source, but projections of over $100bn in value by 2030 are not uncommon, while M&A activity continues to gather pace after a downturn in 2019. Clearly, investors and the public are bullish on the industry as a segment, with further state legislation to expand the number of adult use and medical markets to come. So why is the directors & officers (D&O) and management liability insurance market not embracing this growth industry?

At its core, a good D&O policy will protect the individual directors, officers and executive teams of companies, including their personal assets, in the event of suits and allegations filed based on their running and oversight of their business. For private companies, this also extends to balance sheet protection and coverage for the entity; for public companies, coverage for securities suits and claims.

The cannabis industry, despite the macro factors propelling its growth, faces numerous challenges when trying to procure D&O insurance. Very few D&O and management liability carriers are willing to entertain cannabis and related risks; even fewer are specialty underwriters willing to provide meaningful, expert coverage which truly addresses the exposures faced by executives and operators in the cannabis industry.

Cannabis D&O premiums can cause sticker shock, typically priced 4 to 10 times higher than non-cannabis businesses. Some operators have an air of invincibility and forego the purchase, believing it is not worth the cost. Meanwhile, the ability to attract and retain talented executives and directors away from other industries typically depends on having this coverage purchased and in place. Yet the outlay can be a burden in an industry which already faces fierce competition for market share, and a disparate tax treatment at a state and federal level.“The value of a D&O policy cannot be overstated.”

Even those carriers and underwriters who do entertain cannabis risks are constantly evaluating the nuances of the space: an ever changing complex state regulatory environment; the relative immaturity of the industry and the hyper-focus on growth; the lack of standardized valuation and accounting; the lack of access to institutional financing; the continued uncertainty of insolvency or restructuring in lieu of federal bankruptcy protections for plant touching companies; the operating inefficiencies for MSOs across state lines and the lack of interstate commerce; in short, the cannabis industry certainly poses its own unique and evolving risks for D&O insurers.

Ultimately the market will continue to evolve for cannabis insureds, as the data matures and the regulatory landscape become clearer. The value of a D&O policy cannot be overstated. Most public companies purchase D&O as a matter of course, but even for private cannabis companies, the right coverage is invaluable. Not having the protection afforded by a D&O policy can be ruinous for a cannabis operator, particularly in a niche area where defending claims and circumstances is complex, time consuming and ultimately expensive – typically much more so than the upfront cost of the D&O policy.

Partnering with the right broker who specializes in both management liability and cannabis is step one to getting the best value coverage. Step two is securing a policy from a dedicated market with underwriters who truly understand the cannabis space and tailor coverage to protect the executives, boards and companies that are driving this exciting growth industry.

Top Five Insurances Cannabis Businesses Need in 2022

By Eric Rahn
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Cannabis remains one of the fastest growing industries with no signs of slowing down. According to a recent article in Forbes Magazine, the legal cannabis market is poised to grow 20-30% per year to the tune of $50 billion by 2026.[1]With great opportunity comes numerous risks. Claims and lawsuits against cannabis businesses are increasing in frequency and magnitude. As an insurance broker who specializes in the cannabis industry and works with a wide variety of cannabis, hemp and CBD businesses in every state where cannabis laws are established, our recent analysis has unveiled the top five insurances your cannabis business needs in 2022.

  1. General Liability

General liability is the most essential coverage your business needs to protect you from a variety of claims including personal injury, bodily harm, property damage and other situations that may arise including slander, libel, copyright infringement and more.

Since general liability is not always required to obtain a cannabis license, many businesses are tempted to forgo the expense. This is one of the biggest mistakes you can make as one single lawsuit has the potential to cripple your business. With a comprehensive, cannabis-specific general liability insurance policy in place, your insurance company, not you, will pay medical expenses and property damage claims from third parties, in addition to hefty legal fees and fines.

  1. Property & Casualty Insurance
P&C insurance is an important part of your security and protection plan.

If you own a dispensary, grow operation, warehouse, testing facility or any other type of cannabis business with inventory, you need to protect your assets from potential loss or damage. Property & casualty (P&C) insurance safeguards your business against common and costly perils such as a fire, lightning, explosion/implosion, and even less common – but still possible – risks like riots, strikes and terrorism.

P&C insurance not only pays for damages to your business property resulting from a covered loss but it also covers the contents within your place of business, including office furniture, computers, inventory and other assets essential to your business operations. There are policies that will also provide the funds required to keep your business afloat until the damages from the loss are repaired. Any cannabis business with a physical property and location(s) should have a comprehensive property and casualty P&C policy in place.

  1. Product Liability/Product Recall

Recently, we’ve seen a dramatic influx of product liability claims, and in particular, product recalls. Lawsuits have ranged from a single plaintiff seeking damages for personal injuries to class action lawsuits where a defective product is tied to an entire group of claimants.

control the room environment
Preventing contamination can save a business from extremely costly recalls. Having the right insurance can prevent a recall from becoming costly in the first place.

As a cannabis business owner, you can be sued for any damage resulting from products that cause harm to others, this includes false advertising, mislabeled or defective products. No matter where you are in the supply chain, your business could be held liable. The process of defending litigation or reaching a settlement agreement can completely drain a company’s resources. You’ll have to deal with regulatory compliance, producing and distributing product warnings, recalling products, claim investigation, product testing and additional risk assessment.

Product liability insurance is often overlooked, especially by small to mid-size businesses. However, your cannabis business needs this type of coverage if you sell any goods or products that end up in the hands of the public. In fact, your business may be contractually obligated to have product liability insurance. One such lawsuit is enough to fold a business due to costly legal fees and fines, as well reputation damage beyond repair.

Product liability insurance is designed to protect your cannabis company from claims that can happen anywhere along the supply chain, including product contamination, mislabeled products, false advertising or defective products. With proper coverage, your insurance company will pay for damages and legal expenses if you are sued, up to your policy limits. Your product liability policy will also cover any medical expenses for those who are harmed by your business. Making sure your insurance policy includes product liability insurance should be a top priority in 2022.

  1. Cyber Defense/Data Breach Insurance

Cyber fraud and data breaches are two of the greatest risks facing cannabis companies in 2022. With so much cash pouring into the space, cannabis businesses of all sizes are bulls-eye targets for cybercriminals. Even the smallest of cannabis businesses are at risk of data breaches because they are part of a larger interconnected network of seed to sale vendors. These types of crimes can have detrimental effects on your business in numerous ways. In the case of a data breach resulting in the disclosure of a third party’s private information, the third party could sue your business. The SEC could also find your company negligent in cyber fraud cases and impose significant fines.

By forgoing cyber defense & data breach insurance, your business will be solely responsible for expensive legal bills, significant revenue losses and hefty fines and penalties from regulators. Cyber defense & data breach insurance is a must-have coverage in 2022, and beyond, to protect your business from cybercrimes.

  1. Directors & Officers Insurance

If you are looking to secure venture capital or funding from investors in 2022, and/or attract and retain qualified leadership, you need directors & officers (D&O) Insurance. D&O protects corporate directors and officers, as well as their spouses and estates, from being personally liable in the event your company is sued by investors, employees, vendors, competitors, customers, or other parties, for actual or alleged wrongful acts in managing the company. In the event of litigation, your D&O insurance will cover legal fees, fines, settlements and other expensive costs.

D&O is often the most overlooked coverage because many cannabis businesses are independently run, and no one foresees the potential for operational failures and mismanagement. However, businesses with any sort of vision for growth should make D&O a top priority. It not only protects your current executives and board members but is critical in attracting leading talent in the space, as well as drawing in new investors to scale up your business. In fact, we’re seeing more prospective investors and board members requiring D&O insurance prior to engaging with a company to ensure they are fully protected in the event of litigation.

When it comes to mitigating risk in this business, the stakes are sky high. Cannabis companies that have not incorporated risk management into their business/operational plans will need to in 2022. It all boils down to the THREE P’s: being “Proactive, Prepared and Protected.”

FAQs: How Cannabis Businesses Can Avoid TCPA Liability

By Artin Betpera
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As the cannabis industry continues to experience growth in markets across the country, cannabis businesses are becoming an ever-increasing target of plaintiff’s lawyers in Telephone Consumer Protection Act (TCPA) lawsuits. Text messaging provides a potent channel of customer engagement, but at the same time is subject to strict regulations under the TCPA, with violators subject to steep statutory penalties of $500-$1,500 per message. While one-off cases won’t typically break the bank, that’s far from the case when many thousands of texts are bundled together in a class action. And this potential for big paydays means plaintiff’s lawyers have a financial incentive to file cases as class actions whenever they can.

Some well-known names in cannabis have been the target of TCPA class action. Cannabis delivery service Eaze has battled some fairly well-publicized TCPA class actions in the past couple of years. There has also been an assortment of dispensaries across several western states that have been the targets of similar lawsuits. Notably, these lawsuits share a common thread: they are based on marketing or promotional text messages sent to consumers.

In this landscape, firing off texts without the proper compliance safeguards is a game of roulette. At some point in time, one or more messages will invariably land in the wrong hands, sparking an expensive, high-stakes class action. In this competitive space, there are far more productive things any cannabis business can be doing than spending the time and resources on this type of lawsuit.

So how can your business avoid being caught in a TCPA trap? The following Q&A will walk you through some of the questions you should be asking if you are currently texting, or planning to text your customer base for marketing purposes. One quick note before starting: the TCPA has different rules for different types of messages (such as informational versus marketing messages). This Q&A will cover the distinction between these types of messages, but focuses on the rules around marketing messages since these are rules cannabis businesses get tripped up in most frequently when sued for TCPA violations.

Question: How do I know if the TCPA applies to me?

Answer: Are you texting your customers? If so, are you using some kind of platform that lets you send multiple texts at once? If you answered yes to both, then the TCPA most likely applies to you.

In short, the TCPA prohibits calling or sending texts to cell phones using an Automatic Telephone Dialing System (ATDS). Without getting into the many nuances of how courts have interpreted the legal definition of that term (and risk boring you to death), you can assume that unless you’re hitting send on each and every single text that goes to your customers, that you’re using an ATDS, and your texts are subject to the TCPA.

Q: So it looks like the TCPA applies to me. What now?

A: If you don’t have a compliance plan in place, now’s the time to implement one. To start, take stock of (a) how you’re sending texts; (b) who you’re texting; (c) where you obtained their phone number; and (d) whether you have their prior express written consent. That last part is key: under the TCPA, if you’re sending any text messages to your customers for “telemarketing” purposes, you’ll need what the TCPA calls “prior express written consent”.

Q: But I’m a cannabis business, not a telemarketer. Why should I worry about the TCPA again?

A: The TCPA’s rules requiring prior express written consent apply when the text is sent for “telemarketing” purposes, defined as “the initiation of a telephone call or message for the purpose of encouraging the purchase or rental of, or investment in, property, goods, or services, which is transmitted to any person.” Put simply, if you are sending texts to market or promote something you sell, then it’s likely the message will be considered “telemarketing” under the law. In contrast, if you’re sending a text for purely information purposes, such as sending a receipt for a transaction, or advising on the status of a delivery, then those message are still regulated by the TCPA, but subject to a more relaxed consent standard (a topic for another article).

Q: What do I need to do to get prior express written consent from my customers?

A: It’s important to know that prior express written consent is a technical, legally defined term that requires the caller be provided a written disclosure containing certain information and disclosures, which they “sign.” There are three key components to prior express written consent:

First, the consent agreement has to be in a signed writing. The law affords some flexibility here, allowing callers to obtain consent digitally through a number of mediums including web-based and electronic forms. If structured properly, consent may even be obtained through a text message flow.

Second, the consent agreement has to say certain things. It must authorize the caller to deliver advertisements or marketing messages using an ATDS, it must specify the phone number to which messages are being authorized, and it must say that the consumer doesn’t have to provide their consent as a condition to receiving goods or services.

Third, the disclosures must be “clear and conspicuous”. There’s no real rocket science here, but this is a very important part of the rule. It’s challenging to enforce an agreement that’s hard for a consumer to find or see, meaning the consent disclosures can’t be hidden away, in imperceptible font, or baked into another legal document (such as terms and conditions).

Q: I have a great customer contact database, but I don’t think I check all the boxes for prior express written consent. Can I still text them with specials and promotions?

A: No. At least not with your usual automated or mass-texting platform. But with some legwork, you can leverage your existing database and obtain consent. It’s not ideal, but it’s better than taking the risk of texting in this situation.

Let’s start with the fact that people like to get deals and specials on cannabis products, so there will likely be interest across your customer base for signing up. And with the flexibility afforded by the E-SIGN Act, businesses can try multiple avenues in obtaining prior express written consent from existing customers. This could include a call-to-action campaign, where consumers can initiate a text message consent flow by texting a keyword to a short code. The TCPA does not regulate e-mails, so businesses can consider an e-mail campaign that encourages their customers to follow a link that takes them to a web-based consent form. For businesses with storefronts, customers can be encouraged to sign up for texts on-site by filling out and submitting a form on a tablet device. Bottom line, there’s room for some creativity in designing campaigns to enrich your existing customer database with the necessary consent to send marketing texts.

Q: What happens when a consumer opts out of receiving texts?

A: You should stop all texts to their phone number unless and until they opt back in to receiving texts. Under the TCPA, a consumer has the right to revoke their consent, and any text message sent after an opt-out will violate the TCPA. This means it’s important to have clear opt-out instructions in every message you send (i.e. text stop to stop), and to ensure you have the proper systems in place to automatically suppress any further texts to the consumer’s phone number following an opt out.

Q: If I don’t follow these rules, what are the odds of getting sued for a violation?

A: Pretty high in my opinion. As mentioned, the TCPA is a very lucrative statute for Plaintiff’s lawyers. There are several thousand TCPA cases filed in federal courts each year, and lately cannabis businesses are becoming an increasing share of the defendants named in those suits. Additionally, the TCPA has a four-year statute of limitations, meaning exposure for non-compliant practices has a really long tail. It’s far easier to develop and execute a compliance plan up front, than to take on the risk that comes without one.

Q: Is there anything else I can be doing to protect my business?

Absolutely. Your TCPA compliance policy should be one layer of a holistic approach to legal compliance. Businesses have other tools at their disposal, such as arbitration provisions and class action waivers, that they can build into their consent-gathering process to further protect themselves in the event of a legal dispute.

Q: Any other tips to help keep my business out of the TCPA fracas?

A: Yes. Lots. More than I could fit into just this one article. But my goal here was to get you to think in the right direction when it comes to the TCPA, if you aren’t already. While I tried to make the basics of this as straightforward as possible, there are plenty of grey areas and nuance when it comes to compliance (especially when you inject the real world into the situation). This is where having lawyer experienced in this arena can come in really handy to vet your disclosures, review your compliance processes, and help you implement other risk mitigation strategies.

TCPA claims have become the cost of doing business when contacting consumers on their cell phones. But by being proactive, businesses have ample opportunity to mitigate their risk, and protect themselves in the event the legality of their text message campaigns is challenged.

Gaps in Standard Property Insurance Can be an Unknown Hazard for Cannabis Businesses

By Susan Preston, T.J. Frost
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Basic business liability coverage is not enough for those cultivating, selling and distributing cannabis. General liability, property and even commercial renter’s insurance policies all exclude aspects of cannabis operations, leading to significant gaps in coverage.

Unfortunately, many cannabis operations purchase traditional property policies, assuming they’re insured. Then, when a claim comes to light, they find out they’re not covered.Consider the following common exclusions that could lead to a costly business interruption – or worse

Although the production, sales and distribution of cannabis is legal in many U.S. states, it is still illegal federally. This disparity can cause confusion when it comes to insurance compliance. Cannabis companies will want to secure industry specific coverage for risks associated with property, business interruption, and auto as well as general liability.

Consider the following common exclusions that could lead to a costly business interruption – or worse – a shutdown of operations when not properly insured:

  • Property coverage does not cover crops. Cannabis crops require specific coverage for different growth stages, including seedling, living plant and fully harvested. The insurance industry has designed policies specifically for indoor crop coverage for cannabis operations. There is some market availability for normal insured perils such as fire and theft, to name a few. Work with your broker to review your property policy and any potential exclusions related to cannabis operations. There is currently not much availability for insurance for outdoor crop.
  • Auto policies exclude cannabis transport. Some states require separate permits for transportation. Review coverage options with a knowledgeable broker before moving forward with driver hiring. Implement driver training sessions on a regular basis, conduct background checks and review MVRs prior to hiring company drivers. Teach drivers how to handle accidents on the scene, including informing law enforcement of the cannabis cargo. Remember that transporting cannabis across state lines (even when legal in both states) is still illegal due to federal law.
  • Equipment damage and/or breakdown coverage may be excluded from property policies. Consider the expenses and potential loss of revenue due to mechanical or electrical breakdown of any type of equipment due to power surges, burnout, malfunctions and user error. Having the right equipment breakdown insurance will help you quickly get back into full operation, with minimal costs. Conduct an onsite risk assessment of your equipment to get a comprehensive picture of your risk exposure, and review current insurance policies to identify key exclusions. 

Organizations looking for cannabis business insurance are best off working with a qualified broker who is knowledgeable in the cannabis space.As the cannabis industry continues to expand, more and more insurance options have become available. And yet as with any fast-paced industry, not every option that appears legitimate is a good risk for your cannabis business.

Be a contentious insurance consumer. Review the policy closely for exclusions and coverage features so you understand the premium rates and limits of the policy.  Discuss with your broker the history of the carrier as to paying claims in a timely fashion.

Organizations looking for cannabis business insurance are best off working with a qualified broker who is knowledgeable in the cannabis space.

CBD Health Claims Spur FDA Warning & Product Seizure Threats

By Greg Boulos
3 Comments

The 2018 Farm Bill gave cannabis businesses around the country a legal path to market and sell hemp and hemp-derived products. Despite the groundbreaking law, several regulatory uncertainties remain. The FDA has been a source of many of those uncertainties, but recent action suggests that the agency plans to impose heavy burdens on companies selling CBD products that claim to provide health benefits. Recently, the FDA held a public hearing during which it signaled that health claims associated with cannabis-related products was a primary concern. Congress subsequently pressured the FDA to develop a regulatory framework for the cannabis industry and the agency announced that it was expediting its efforts to do so, promising an update on its progress by this fall.

FDAThen, on July 22, the agency issued a warning letter to Curaleaf regarding its claims that several of its products provide specific health benefits. The agency included a threat to seize Curaleaf’s products if the issues raised in the letter are not resolved. How the FDA ultimately regulates cannabis products going forward will have a significant impact on the industry as a whole. Indeed, the agency has significant powers over product manufacturers, including the ability to seize products through the U.S. Marshalls. This article will delve into the specifics on the FDA’s warning letter and address how manufacturers can limit the risks associated with making health-related claims.  

The FDA’s Warning: Beware of “Unsubstantiated” Health Claims

The FDA’s letter explained that it determined several of Curaleaf’s CBD products “are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FDCA).” The letter goes on to say that one of Curaleaf’s pet CBD products “are unapproved new animal drugs that are unsafe.” Curaleaf has 15 days to respond to the agency’s letter. The agency cited the following health claims as problematic, among others.

  • “CBD has been demonstrated to have properties that counteract the growth of [and/or] spread of cancer.”
  • “CBD was effective in killing human breast cancer cells.”
  • “CBD has also been shown to be effective in treating Parkinson’s disease.”
  • “CBD has been linked to the effective treatment of Alzheimer’s disease ….”
  • “CBD is being adopted more and more as a natural alternative to pharmaceutical-grade treatments for depression and anxiety.”
  • “CBD can also be used in conjunction with opioid medications, and a number of studies have demonstrated that CBD can in fact reduce the severity of opioid-related withdrawal and lessen the buildup of tolerance.”
  • “CBD oil is becoming a popular, all-natural source of relief used to address the symptoms of many common conditions, such as chronic pain, anxiety … ADHD.”
  • “What are the benefits of CBD oil? …. Some of the most researched and well-supported hemp oil uses include …. Anxiety, depression, post-traumatic stress disorders, and even schizophrenia …. Chronic pain from fibromyalgia, slipped spinal discs . . . Eating disorders and addiction . . ..”
  • “[V]ets will prescribe puppy Xanax to pet owners which can help in certain instances but is not necessarily a desirable medication to give your dog continually. Whereas CBD oil is natural and offers similar results without the use of chemicals.”
  • “For dogs experiencing pain, spasms, anxiety, nausea or inflammation often associated with cancer treatments, CBD (aka cannabidiol) may be a source of much-needed relief.”

The letter explicitly warned, “Failure to correct the violations promptly may result in legal action, including product seizure and injunction.” The FDA has a history of seizing products it deems non-compliant with its regulations. Recently, the U.S. Marshals, at the direction of the FDA, seized 300,000 units of a cosmetic company’s product. The impact of such a seizure on a business’ profits and operations is staggering. FDA action also has a direct impact on publicly traded cannabis companies’ stock price. When news of the FDA’s Curaleaf letter circulated, Curaleaf shares plunged 8%.

Balancing Regulatory Risk and Business Objectives

While the FDA’s letter appears to create a new risk for the cannabis industry, the stock market’s reaction is arguably overblown. The fact that the FDA would question a product’s ability to kill cancer cells is not surprising. I am not familiar with Curaleaf’s research efforts and it is not my goal to pass judgment on their claims. Rather, my point is that manufacturers need to make sure legitimate scientific studies underpin all of their health claims, regardless of the industry. Manufacturers will never be able to avoid regulatory scrutiny or even litigation regarding their health claims entirely. Instead, cannabis companies should take steps to ensure that they can credibly respond to regulatory scrutiny or present strong defenses in potential litigation. Establishing a robust research department is a start. But manufacturers must develop institutional knowledge of the most cutting-edge research regarding their products.Developing in-depth institutional knowledge regarding the state-of-the-art scientific research on your product is a must. 

Manufacturers that market products primarily for their health benefits should consider working with clinical researchers to study their products. There should be written policies and guidelines, as well as employee training, for conducting these studies and dealing with researchers in order to protect the quality of the study. For purposes of mitigating regulatory and litigation risks, the perceived quality of these studies can be just as important as their actual quality. Regulators and plaintiff’s attorneys can easily misinterpret (sometimes intentionally) written communications between a manufacturer and researcher in ways that suggests a particular study was outcome-driven and not a legitimate scientific undertaking. Manufacturers should consult with attorneys experienced in defending product liability and mass tort litigation so that their labeling and research practices are based on historical examples of successful (and sometimes, unsuccessful) product manufacturers.

Key Takeaways

Manufacturing consumer products comes with substantial litigation and regulatory risks. There are several historical and current examples of product labels, health claims, and warnings leading to thousands of lawsuits filed simultaneously across the country against a single manufacturer. Fees associated with defending against even meritless claims can force a manufacturer into bankruptcy. The regulatory risks can also have devastating effects on the day-to-day business operations of any manufacturer. Eliminating these risks is impossible, but addressing them upfront before a product launch, regulatory crackdown, or lawsuit is considerably less expensive than dealing with costly litigation or government seizure of entire inventories. Developing in-depth institutional knowledge regarding the state-of-the-art scientific research on your product is a must. Also, consider working with a clinical researcher to support any claimed health benefits or even discover new health benefits associated with your product. Finally, consult a lawyer with experience in product liability and mass tort litigation to strengthen your policies and procedures regarding research, develop credible health claims, and craft strong warnings.

The 2018 Farm Bill Legalized Industrial Hemp. Now What? Get Your Answers Here.

By Josh Smart
2 Comments

The Agriculture Improvement Act of 2018 legalized the growth, sales and transportation of industrial hemp across state lines. Although it looks identical to other types of cannabis, this cannabis plant contains less than 0.3 percent THC, and can be used to make building insulation, beauty products, car dashboards and more. Most significantly for farmers, it can serve as an ideal rotational crop because of its ability to reduce soil toxicity.

Until this update to the Farm Bill, hemp was considered a controlled substance and few U.S. farmers were granted rights to plant and harvest it. Now, the agricultural commodity is expected to raise the crop’s already growing GDP to that of liquor and beer sales and some estimate it should reach $20 billion in as little as five years.

Agribusinessesand farmers alike will now be looking to secure processors and other commodity buyers ahead of planting industrial hemp and purchasing the necessary equipment for its harvest. Because hemp can be grown in any climate, it may be especially attractive to tobacco growers and dairy farmers who have been less profitable as of late. 

Now that it’s been legalized, what’s the risk?

As more agribusinesses and farmers look to confirm viability of industrial hemp growth, potential liabilities will surface. The 2018 Farm Bill left many questions unanswered. Here are a just a few FAQs:

Question: Can I just add hemp to my crop rotation, or is additional insurance required?

Answer: The standard multi-peril crop insurance policy DOES NOT provide coverage for planting hemp, or endorsements for its storage and transportation- yet. Instead, industrial hemp must be insured on separate private policies for: harvest, extreme weather and crop storage and transportation. There’s a strong push to get industrial hemp into the federal crop insurance program as early as crop year 2020. As hemp planting, harvesting, storage and transportation become more understood and predictable, new policy options will likely become available. Inquire about new coverage options at your next annual renewal.

Q: How will the FDA regulate industrialized hemp?

A: The FDA will develop rules and regulations on industrial hemp throughout 2019, and will be ready for rollout during the 2020 crop year. Because it’s impossible to distinguish a cannabis plant with THC from an industrial hemp plant in the field, crop lifecycle testing and documentation will likely be required. The question remains if this testing and documentation will be incumbent on the farm/agribusiness, or FDA agents. Some states are further along in this process and have already hired testing and compliance officers.

Q: How can farmers ensure that the THC content of their plants does not exceed .3%?   

A: Farmers must have a contingency plan for monitoring their hemp’s THC content which should include employing a seasoned agronomist who can institute controls, keep plants properly hydrated and create a plan to maintain optimal THC levels. In the heat of the summer, THC levels typically remain low, but rise with cold and rain. Should there be a local cold spell, high rainfall, or if the hemp plant was seeded late in the season and the harvest runs into the fall, THC levels could rise quickly. When this happens, farmers will have to chop down the plant to control the level and harvest the plant’s flower before its next THC test.As with any emerging market, there is still a lot of doubt surrounding the growth and sales of industrial hemp, as many risks are unknown. 

Q: Can I transport hemp across state lines to a processor in another state?

A: On paper, industrial hemp is legal across all 50 states, and therefore can be transported across state lines and sold as any other commodity. In reality, though, hemp is undistinguishable from cannabis to the naked eye, and therefore, shipping an entire biomass directly from the field across state lines has a good chance of being confiscated.

When hemp is confiscated on the side of the road – even if it is eventually returned – there could be significant lag in delivery, storage is uncertain and quality control can’t be maintained. Alternatively, farmers are now shipping their hemp in smaller, unmarked loads, which is forcing them to hold onto product for longer than usual.

As with any emerging market, there is still a lot of doubt surrounding the growth and sales of industrial hemp, as many risks are unknown. On the flip side, industrial hemp offers small farmers and agribusinesses alike an unprecedented opportunity to get in at the ground floor of a new crop. If you do, make sure to work with your insurance broker to secure proper coverage immediately.

How Half-Baked Labels Can Destroy a Cannabis Business

By Greg Boulos
2 Comments

Cannabis manufacturers and consumers are currently in a honeymoon phase. Consumers love their CBD gummies and believe wholeheartedly in the benefits of cannabis-related products. But it is only a matter of time before industrious plaintiffs’ lawyers take a close look at ways to attack manufacturers. We know from other industries that product labels tend to be the entry point for plaintiff lawyers eyeing manufacturers and looking for easy targets. Any company in the business of manufacturing cannabis-related products needs to devote significant time and resources to developing labels that minimize the risk of bet-the-company litigation down the road. Most notably, manufacturers need to think through whether there are any adverse effects associated with their products of which consumers should be aware. Also, manufacturers must scrutinize any “all natural” or “organic” claims on their labels to ensure that they are not misleading consumers.

Failure to Warn of Potential Detrimental Effects

Most manufacturers are well aware of state mandated labels for cannabis products. And, based on the recent FDA public hearing on cannabis, the industry will likely see FDA labeling requirements in the near future. However, simply complying with these requirements does not insulate a manufacturer from litigation, particularly failure to warn claims. One example, dating back to the 1970s, relates to OSHA’s regulation of asbestos-containing products as it became more and more clear that certain types of asbestos could cause a rare form of cancer, mesothelioma. Among other things, OSHA required manufacturers of asbestos-containing products to add a warning to all packaging. The mandated warning included very specific language. Manufacturers largely complied and added the OSHA-mandated label to their product packaging.

FDAFast-forward 40 years and today, several of those manufacturers are now bankrupt due to litigation based on their alleged failure to warn consumers that asbestos can cause cancer. Plaintiffs have been successful in bringing these claims because the OSHA label only warned that asbestos could cause harm, but it did not mention the word cancer. Some juries have found that the language in the warning was not sufficient to caution end users of the increased risk of developing cancer. While there have also been numerous defense verdicts in asbestos litigation and many asbestos-related cases lack merit – especially against certain defendants – the plaintiffs’ verdicts and legal fees to defend these cases are staggering. Recent plaintiffs’ verdicts have ranged from $20 to $70 million.

Of course, asbestos is an extreme example since CBD has not been associated with an increased risk of developing cancer. But there are other health concerns that manufacturers should consider. For instance, one group of doctors claim to have linked consuming cannabis before the age of twenty-five to development delays. Another study purports to link cannabis consumption to increased risk of premature birth. If there are legitimate studies underpinning these concerns, manufacturers can become the target of potential lawsuits. Beware that when plaintiff law firms find a manufacturer to target, they often file thousands of cases around the country – not just one. Even if the claims are entirely bogus, the legal fees to merely defend these cases are crippling and can lead to a swift bankruptcy.

While there are risks involved with failing to warn consumers of possible adverse effects of a product, manufacturers should not try to mention every alleged adverse effect on its labels. Rather, manufacturers must do their due diligence and investigate whether claimed adverse effects are legitimate, then warn of those that appear to be based on valid scientific studies. Each manufacturer’s research department should assess the credibility of any study linking cannabis use to an adverse health effect and have a candid discussion with their attorneys on whether a warning is warranted. Do not fear lawsuits, they are unavoidable. Rather, work toward ensuring that the company and product(s) have a strong, defensible warning in the event litigation arises.

Questionable “All Natural” and “Organic” Claims

It seems like every CBD product on the market has an “all natural” or “organic” claim on the label. If the product is truly organic, fantastic. Flaunt that organic label. But several food companies have landed in hot water with these labels when there is a hidden ingredient that is not natural. What’s more, manufacturers have been sued when their product contain genetically modified organisms, or GMOs. These lawsuits come in the form of class actions at the state and federal level. Class action litigation is very expensive to defend. And they typically result in settlements for beaucoup bucks – typically multi-million-dollar settlements. Plaintiffs lawyers love these claims because their fees typically also end up in the millions. One example of this kind of class action is a case involving the well-known Kashi brand. Kashi was accused of misleading consumers by including the words “All Natural” on some of its products. Plaintiffs asserted that the products contained bio-engineered, artificial and synthetic ingredients. The class action was settled for $3.9 million.

Just some of the many CBD products on the market today.

How can all natural or organic claims lead to millions of dollars in damages? Here is an example of how these cases usually work: A group of consumers determine that an “all natural” product is not “all natural.”  Let’s call this Product A and assume it sells for $5 per unit. The consumers then find a similar product that is not labeled “all natural.” That product is $2 per unit. The consumers argue that they overpaid for Product A by $3 per unit because they thought the product was all natural. Three dollars may not sound too bad, but if the class consists of two-million consumers, each entitled to $3, that’s a $6 million damages claim against a company. That does not count the hundreds of thousands of dollars that will be spent on legal fees defending the class action.

Cannabis manufacturers should not use all natural labels loosely and should consult with an attorney experienced in product labeling class actions to determine whether they should forgo these labels. The same is true for any labels that claim a product provides unique health benefits. 

Key Takeaway

When manufacturers are excited about introducing a product to the market, trying to compete with other manufacturers and already dealing with miles of regulatory red tape, it may be tempting to avoid self-imposed labeling requirements. But to ensure their businesses are sustainable over the long-term, manufacturers need to take necessary steps now that will limit future litigation risk.  The cost of taking preventative measures to develop a meaningful label is considerably less than the types of product labeling verdicts and settlements affecting other industries. Focus on warnings and the use of all natural labels as a starting point. Then speak with an attorney about the unique aspects of your product, potential adverse effects and the adequacy of your warning. We are here to help.