Arguing Internet Availability to Establish Copyright Infringement Is Bananas

In an unpublished opinion, the US Court of Appeals for the Eleventh Circuit affirmed a district court’s decision finding that a pro se Californian artist failed to establish that an Italian artist had reasonable opportunity to access the copyrighted work simply because it was available to view on the internet. Morford v. Cattelan, Case No. 23-12263 (11th Cir. Aug. 16, 2024) (Jordan, Pryor, Branch, JJ.) (per curiam).A plaintiff alleging copyright infringement may show factual copying by either direct or indirect evidence showing “that the defendant had access to the copyrighted work and that there are probative similarities between the allegedly infringing work and the copyrighted work.” To do so, however, the copyright owner must establish a nexus between the work and the defendant’s alleged infringement. Mere access to a work disseminated in places or settings where the defendant may have come across it is not sufficient.

Joe Morford’s Banana and Orange and Maurizio Cattelan’s Comedian both “involve the application of duct tape to a banana against a flat surface” (see images below from the court decision’s appendix). Cattelan’s Comedian went viral and sold for more than $100,000 at Miami’s Art Basel. Morford claimed that Comedian was a copy. The district court found that Morford failed to show that Cattelan had reasonable opportunity to access Banana and Orange and thus could not establish a copyright claim. Morford appealed.

Orange and Banana, Comedian

On appeal, Morford argued that because he could show striking similarity between Banana and Orange and Comedian, he was not required to proffer evidence of access to show copyright infringement. In the alternative, he argued that he could show substantial similarity and that Cattelan had reasonable opportunity to access Banana and Orange as it was widely disseminated and readily discoverable online.

The Eleventh Circuit explained that in circuits adopting a widespread dissemination standard, that standard requires showing that the work enjoyed “considerable success or publicity.” Morford showed that Banana and Orange was available on his public Facebook page for almost 10 years and featured on his YouTube channel and in a blog post, with views in more than 25 countries. But Banana and Orange’s availability on the internet, without more, was “too speculative to find a nexus” between Cattelan and Morford to satisfy the factual copying prong of a copyright infringement claim, according to the Court.

The Eleventh Circuit also found that Morford failed to meet the high burden of demonstrating that the original work and accused infringement were so strikingly similar as to establish copying. Such similarity exists if the similarity in appearance between the two works “is so great that [it] precludes the possibility of coincidence, independent creation or common source,” but identical expression does not necessarily constitute infringement. In this analysis, a court addresses the “uniqueness or complexity of the protected work as it bears on the likelihood of copying.” Morford argued that he established striking similarity based on the “same two incongruous items being chosen, grouped, and presented in the same manner within both works.” Although the two incongruous items in both works were similar (i.e., a banana and duct tape), the Court decided that there were sufficient differences between Banana and Orange and Comedian to preclude a finding of striking similarity. Banana and Orange had both a banana and an orange held by duct tape, while Comedian only contained a banana.

Federal Circuit Weighs in on Exceptional Case Determinations in Realtime Adaptive Streaming v. Sling TV and Dish

A recent Federal Circuit decision provided some additional insight into exceptional case determinations in patent infringement disputes. In Realtime Adaptive Streaming v. Sling TV, the Federal Circuit reviewed an award of attorneys’ fees granted to DISH and related Sling entities (collectively, DISH) by the United States District Court for the District of Colorado. Realtime Adaptive Streaming LLC v. Sling TV, L.L.C. , Fed. Cir., 23-1035, vacated 8/23/24.

History of Events

On August 31, 2017, Realtime Adaptive Streaming LLC sued DISH and related Sling entities for alleged infringement of U.S. Patent Nos. 8,275,897; 8,867,610; and 8,934,535. Early in the case, the Defendants filed motions to dismiss and motions for judgment on the pleadings, asking the district court to find the asserted claims invalid under § 101. The district court denied these motions.

In October 2018, the Central District of California issued an order finding Claims 15-30 of the ‘535 patent ineligible under § 101 (Google decision). In December 2018, a magistrate judge in the District of Delaware found Claim 15 of the ‘535 patent ineligible (Netflix decision). Shortly after that, the district court stayed the infringement litigation pending IPR proceedings.

During the IPR proceedings claims 1-14 of the ‘535 patent were found to be unpatentable on obviousness grounds. Realtime then withdrew its claims under the ‘535 patent.

The district court lifted the stay on January 15, 2021. Shortly after stay was lifted the USPTO rejected claim 1 of the ‘610 patent as obvious as part of an ex parte reexamination.

In February 2021, DISH sent Realtime a letter conveying its belief the ‘610 patent was invalid and expressing its intention to seek attorneys’ fees.

On July 31, 2021, the district court granted DISH’s motion for summary judgment of invalidity, finding Claims 1, 2, 6, 8-14, 16, and 18 of the ‘610 patent directed to ineligible subject matter under § 101 and ultimately granted DISH’s Motion for Attorneys’ Fees, highlighting six “red flags” that Realtime’s case was fatally flawed.

On May 11, 2023, the Federal Circuit affirmed the district court’s order concluding that the asserted claims of the ‘610 patent are directed to ineligible subject matter under § 101. On August 23, 2024, it issued its opinion on the appeal of the attorneys’ fees award under 35 U.S.C. § 285, vacating the district court’s opinion and remanding for further consideration.

Federal Circuit’s Analysis of the District Court’s Red Flags

The Federal Circuit reviewed each of the six red flags identified by the district court:

a) Google and Netflix decisions: The Federal Circuit agreed that these decisions, which found claims of a related patent ineligible, were significant red flags.

b) Adaptive Streaming decision: The Federal Circuit found that the district court erred in treating this as a red flag, as it involved different technology and lacked sufficient analysis to show the patent infringement claim was exceptionally meritless.

c) Board’s invalidation of the ‘535 patent: The Federal Circuit found that the district court failed to adequately explain how these decisions supported a finding of exceptionality.

d) Reexamination of the ‘610 patent: The Federal Circuit found that the district court’s analysis was lacking and failed to adequately explain how these decisions supported a finding of exceptionality.

e) DISH’s notice letter: The Federal Circuit found that the letter alone was not sufficient to trigger § 285 and support an exceptionality finding.

f) Expert analysis evidence: The Federal Circuit found that the district court erred in its justification of Dr. Bovik’s opinions as a red flag.

Notice Letter Insufficient

The notice letter from DISH was not considered sufficient to trigger § 285 and support an exceptionality finding for several reasons:

  1. Limited analysis: The letter contained only two paragraphs dedicated to discussing the ineligibility of the asserted claims of the ‘610 patent. These paragraphs were described as “conspicuously short” and “riddled with conclusory statements” asserting similarities between the ‘610 patent claims and those of the ‘535 patent and the Adaptive Streaming patent.
  2. Lack of specific comparisons: The letter did not provide any further analysis or specific comparisons to support its assertions about the similarities between the patents.
  3. Insufficient notice: The court found that simply being on notice of adverse case law and the possibility that opposing counsel would pursue § 285 fees does not amount to clear notice that the ‘610 claims were invalid.
  4. Potential for abuse: The court noted that if such a notice letter were sufficient to trigger § 285, then every party would send such a letter setting forth its complaints at the early stages of litigation to ensure that—if it prevailed—it would be entitled to attorneys’ fees.
  5. Lack of follow-up: DISH did not follow up regarding its allegations after Realtime responded to the notice letter eleven days later.

The Federal Circuit concluded that without more substantive analysis or specific comparisons, the notice letter alone was not enough to put the patentee on notice that its arguments regarding ineligibility were so meritless as to amount to an exceptional case.

Conclusion

In conclusion, while the Federal Circuit agreed that some of the red flags identified by the district court were valid considerations, it found that others were not properly justified or explained. As a result, the court vacated the attorneys’ fees award and remanded the case for reconsideration consistent with its opinion.

The findings regarding the notice letter are not surprising. Patent cases may take a long time to develop and typically include an enormous amount of information. Both parties have a limited amount of information early in the case and so positions are staked out carefully. The court did not give an indication of what would be necessary to serve as adequate notice of the defects of a plaintiff’s patent assertion. It remains to be seen how the court treats the exceptional case analysis in light of the remand guidance from the Federal Circuit.

Deep in the Heart of Texas: Court Blocks FTC Non-Compete Rule

On August 20, 2024, the United States District Court for the Northern District of Texas invalidated the FTC’s rule banning most non-compete agreements.  Ryan LLC et al v. Federal Trade Commission, WL 3297524 (08/20/2024). In its highly anticipated opinion, the Court determined the FTC exceeded its authority in promulgating the rule and that the rule is arbitrary and capricious.  This decision was not limited to the parties before the Court and blocks the rule from becoming effective nationwide on September 4, 2024.  As a result, existing non-compete agreements may still be valid and enforceable when permitted under applicable law.

Ryan, LLC (“Ryan”) filed its lawsuit on April 23, 2024, arguing the FTC did not have rulemaking authority under the Federal Trade Commission Act, that the rule is the product of an unconstitutional exercise of power, and that the FTC’s acts and findings were arbitrary and capricious.  Several plaintiffs, including the U.S. Chamber of Commerce, intervened in the lawsuit to challenge the rule.

In July, the Court enjoined the FTC from implementing or enforcing the rule.  That ruling, however, was limited in scope and only applied to Ryan and the intervening plaintiffs.  Shortly thereafter, all parties filed motions for summary judgment.  Plaintiffs asked the Court to invalidate the FTC’s rule, and the FTC sought dismissal under the theory it has express rulemaking authority under the FTC Act.

The Court first examined the FTC’s statutory rulemaking authority and determined the rulemaking provisions under the FTC Act do not expressly grant the FTC authority to promulgate substantive rules.  The Court reasoned that although the Act provides some rulemaking authority, that authority is limited to “housekeeping” types of rules.  The Court concluded “the text and the structure of the FTC Act reveal the FTC lacks substantive rulemaking authority with respect to unfair methods of competition…”  As a result, the Court held the FTC exceeded its statutory authority in promulgating the rule.

Next, the Court considered whether the rule and the promulgation procedure was arbitrary and capricious.  The Court was unconvinced by the studies and other evidence relied on by the FTC in promulgating the rule and found that the FTC failed to demonstrate a rational basis for imposing the rule.  The Court also noted that the FTC was required to consider less disruptive alternatives to its near complete ban on non-compete agreements.  Although the FTC argued it had “compelling justifications” to ignore potential exceptions and alternatives, the Court concluded the rule was unreasonable and the FTC failed to adequately explain alternatives to the proposed rule.  Ultimately, the Court opined the rule was based on flawed evidence, that it failed to consider the positive benefits of non-compete clauses and improperly disregarded substantial evidence supporting non-compete clauses.

As a result of this ruling, the FTC’s rule will not become effective on September 4, 2024, short of any additional orders or rulings from a higher court reversing or staying the decision.  For the time being, the existing laws governing non-compete agreements will remain in place.  In Michigan, employers may enforce non-compete agreements that are reasonable in duration, geographical area and type of employment or line of business. In Illinois, they are regulated by the Illinois Freedom to Work Act, which imposes a stricter regulatory scheme. This should come as a relief for employers who can generally avoid—at least for now—analyzing complex issues regarding the impact that the FTC’s rule would have had on executive compensation arrangements tied to compliance with non-compete agreements, especially in the tax-exempt organization context.

by: D. Kyle BierleinBrian T. GallagherBarry P. KaltenbachBrian Schwartz of Miller Canfield

For more news on the Federal Court Ruling Against the FTC’s Non-compete Rule, visit the NLR Labor & Employment section.

Michigan Supreme Court Expands Employer Exposure to Public Policy Retaliation Claims

In Michigan, various state employment laws prohibit employers from retaliating against employees. But can an employee pursue a public policy retaliation claim against the employer in addition to a statutory retaliation claim?

On July 22, 2024, the Michigan Supreme Court ruled that anti-retaliation provisions in two important workplace safety laws—the federal Occupational Safety and Health Act (“OSHA”) and Michigan’s Occupational Safety and Health Act (“MIOSHA”)—do not preclude a plaintiff from also asserting a violation of public policy in court. Stegall v. Resource Technology Corp (Case No. 165450, decided July 22, 2024).

Cleveland Stegall, an IT specialist working at FCA through the staffing agency Resource Technology, complained internally about asbestos insulation issues at the assembly plant and threatened to file complaints with the government. He was subsequently terminated. Stegall sued both entities for wrongful discharge under OSHA and MIOSHA’s anti-retaliation provisions, as well as termination in violation of public policy.

At-will employees generally may be terminated for any reason (or no reason at all). But one exception to this rule is that certain terminations violate public policy and therefore create an actionable legal claim. This includes firings for “failure or refusal to violate a law” or exercising a right conferred by the Michigan Legislature.

Both the trial court and the Court of Appeals dismissed Stegall’s public policy claim because they concluded that the OSHA and MIOSHA laws already forbid retaliation. The Michigan Supreme Court reversed. It reasoned that the remedies under OSHA and MIOSHA are insufficient, pointing to the truncated 30-day period to file a complaint with the relevant government agency, the discretion granted to the respective investigating agency, and the employee’s lack of control over what occurs after a complaint has been filed. See 29 U.S.C. §660(c)(2) and MCL 408.1065(2).

What does this case mean for employers? The Michigan Supreme Court’s decision provides another avenue for employees to pursue retaliation claims, particularly where the employee raises workplace safety concerns. It is unclear, however, whether courts will extend this ruling and allow employees to pursue public policy wrongful discharge claims if the employee is also seeking relief under another anti-retaliation statute.

The Economic Benefits of AI in Civil Defense Litigation

The integration of artificial intelligence (AI) into various industries has revolutionized the way we approach complex problems, and the field of civil defense litigation is no exception. As lawyers and legal professionals navigate the complex and often cumbersome landscape of civil defense, AI can offer a transformative assistance that not only enhances efficiency but also significantly reduces client costs. In this blog, we’ll explore the economic savings associated with employing AI in civil defense litigation.

Streamlining Document Review
One of the most labor-intensive and costly aspects of civil defense litigation is the review of vast amounts of discovery documents. Traditionally, lawyers and legal teams spend countless hours sifting through documents to identify and categorize relevant information, a process that is both time-consuming and costly. AI-powered tools, such as Large Language Models (LLM) can automate and expedite this process.

By using AI to assist in closed system document review, law firms can drastically cut down on the number of billable hours required for this task. AI assistance can quickly and accurately identify relevant documents, flagging pertinent information and reducing the risk of material oversight. This not only speeds up the review process and allows a legal team to concentrate on analysis rather than document digest and chronology, but significantly lowers the overall cost of litigation to the client.

By way of example – a case in which 50,000 medical treatment record and bills must be analyzed, put in chronology and reviewed for patient complaints, diagnosis, treatment, medial history and prescription medicine use, could literally take a legal team weeks to complete. With AI assistance the preliminary ground work such as document organization, chronologizing complaints and treatments and compiling prescription drug lists can be completed in a matter of minutes, allowing the lawyer to spend her time in verification, analysis and defense development and strategy, rather than information translation and time consuming data organization.

Enhanced Legal Research
Legal research is another growing area where AI can yield substantial economic benefits. Traditional legal research methods involve lawyers poring over case law, statutes, and legal precedents to find those cases that best fit the facts and legal issues at hand. This process can be incredibly time-intensive, driving up costs for clients. Closed AI-powered legal research platforms can rapidly analyze vast databases of verified legal precedent and information, providing attorneys with precise and relevant case law in a fraction of the time. Rather than conducting time consuming exhaustive searches for the right cases to analysis, a lawyer can now stream line the process with AI assistance by flagging on-point cases for verification, review, analysis and argument development.

The efficiency of AI-driven legal research can translate into significant cost savings for the client. Attorneys can now spend more time on argument development and drafting, rather than bogged down in manual research. For clients, this means lower legal fees and faster resolution of cases, both of which contribute to overall economic savings.

Predictive Analytics and Case Strategy
AI’s evolving ability to analyze legal historical data and identify patterns is particularly valuable in the realm of predictive analytics. In civil defense litigation, AI can be used to assist in predicting the likely outcomes of cases based on jurisdictionally specific verdicts and settlements, helping attorneys to formulate more effective strategies. By sharpening focus on probable outcomes, legal teams can make informed decisions about whether to settle a case or proceed to trial. Such predictive analytics allow clients to better manage their risk, thereby reducing the financial burden on defendants.

Automating Routine Tasks
Many routine tasks in civil defense litigation, such as preparation of document and pleading chronologies, scheduling, and case management, can now be automated using AI. Such automation reduces the need for manual intervention, allowing legal professionals to focus on more complex and value-added case tasks. By automating such routine tasks, law firms can operate more efficiently, reducing overhead costs and improving their bottom line. Clients benefit from quicker turnaround times and lower legal fees, resulting in overall economic savings.

Conclusion
The economic savings for clients associated with using AI in civil defense litigation can be substantial. From streamlining document review and enhancing legal research to automating routine tasks and reducing discovery costs, AI offers a powerful tool for improving efficiency and lowering case costs. As the legal industry continues to embrace technological advancements, the adoption of AI in civil defense litigation is poised to become a standard practice, benefiting both law firms and their clients economically. The future of civil defense litigation is undoubtedly intertwined with AI, promising a more cost-effective and efficient approach to resolving legal disputes.

Be Careful What You Write: What a Heavily Redacted Antitrust Complaint Teaches Us About Creating Problematic Documents in Transactions

The Federal Trade Commission (FTC) recently filed a complaint in the U.S. District Court for the Southern District of Texas to stop Tempur Sealy’s proposed acquisition of Mattress Firm. See Federal Trade Comm’n v. Tempur Sealy Int’l, Inc. and Mattress Firm Group Inc., Case No. 4:24-cv-02508 (S.D. Tex. Jul. 2, 2024). On the same day, the FTC also commenced an administrative proceeding in its own court to block the transaction. See In re Tempur Sealy Int’l, Inc. and Mattress Firm Group Inc., Docket No. 9433 (FTC Jul. 2, 2024). According to the complaints, Tempur Sealy is the world’s largest mattress supplier and Mattress Firm is the largest mattress retailer in the United States. Vertical mergers between manufacturers and retailers can often produce procompetitive benefits, but this transaction struck the FTC as anticompetitive. The FTC’s principal concern appears to be that Tempur Sealy would shut off its rivals’ access to Mattress Firm.

Supporting the FTC’s decision to sue, Federal Trade Commissioner Melissa Holyoak said, “Despite the increased likelihood of procompetitive effects from vertical mergers, they may still result in harm in some circumstances. Consistent with these well-established economic principles, I vote in favor of filing this complaint based upon the substantial evidence generated by staff’s thorough investigation, especially the parties’ own ordinary-course documents. I have reason to believe that the effect of Tempur Sealy’s acquisition of Mattress Firm ‘may be to substantially lessen competition.’” (Emphasis added).

What exactly was in these ordinary course documents that caused Holyoak to believe this merger violates Section 7 of the Clayton Act and Section 5 of the FTC Act? The short answer is we don’t know. The complaints, which extensively quote some documents, are heavily redacted and the documents themselves, even in redacted form, are not attached to the complaints. Nor would we expect the documents to be attached, as they likely contain competitively sensitive information that ordinarily would not be on the public record. Rather than speculate about the documents themselves, let’s use the allegations in the FTC’s complaints as a tool to remind ourselves how documents are used in antitrust investigations and how lawyers and clients can work together to reduce the likelihood that potentially problematic documents are created.

  1. What’s an “ordinary course” document? As the name suggests, an ordinary course document is one that is created by the parties in the course of their ordinary business activities. It may be a routinely issued report, an email or text exchange by two employees, Slack messages, a slide deck, board minutes or any other form of written communication. Antitrust regulators routinely use these documents to gain insight into how the parties see themselves in relation to the competition, the rationale for a transaction, and how the parties view the likely competitive effects of a transaction. Often regulators will place more emphasis on communications from senior leadership in a corporation as those individuals may have greater knowledge of the transaction and have more authority to “speak” for an entity than lower-level employees. Regulators will use these documents not only to support their own theories and claims, but also to contradict the parties’ advocacy about the procompetitive aspects of a deal.
  2. How does the government obtain these ordinary course documents? In the case of the Tempur Sealy/Mattress Firm transaction and other high dollar value transactions, the parties were required to file Hart-Scott-Rodino (HSR) premerger notification forms. When an HSR filing is required, the parties must produce documents that discuss the transaction in relation to certain specific topics, such as competition, competitors, markets, and market shares. These documents are usually not ordinary course documents as they were created specifically for the deal but are nevertheless critical in the regulators’ review of potential competitive issues. Documents routinely produced in the HSR process, such as Confidential Information Memoranda (CIM) and Management Presentations, may contain statements that could create potential antitrust concerns. Clients should recognize that even the smallest of things in a CIM or Management Presentation have the potential to create big problems, as government regulators will read every page of what is submitted to them. For example, assume that an HSR filing contains a 100-page deck intended to serve as a Management Presentation, and one page of that deck contains a sentence that says: “We [seller] are the dominant player in our industry and we face minimal competition.” The rest of the deck might be completely innocuous, but depending on the circumstances, that one sentence has the potential to ignite regulators’ interest.Some transactions, such as Tempur Sealy/Mattress Firm, undergo a Second Request process after HSR is filed. A Second Request is an extensive subpoena requesting documents and data from the parties that goes far beyond the HSR process. The Second Request process is what likely turned up the “ordinary course” documents mentioned in Holyoak’s statement. This included text messages. See, e.g., Paragraph 108 of the federal complaint and Paragraph 99 of the administrative complaint. Judging from the amount of redacted material referenced in the complaints, the FTC appears to believe there are many documents that portray this transaction in an anticompetitive light.

    Clients should also be aware that the government’s authority to review and investigate transactions is not limited to only those transactions that require HSR filings; the government’s authority extends to any transaction that impacts competition in the United States. In addition to HSR filings, the government learns about deals through a variety of sources, such as press reports and third party complaints from customers or competitors. Accordingly, our views about document creation extend to all transactions, not just those requiring HSR premerger notification.

  3. Document creation in transactions is a team sport. That means lawyers and clients should work together as a team to minimize the creation of potentially harmful documents. The team should also include investment bankers and other advisors who are generating documents that analyze the transaction. In ideal circumstances, clients will involve experienced antitrust lawyers early on to understand: 1) whether the transaction potentially raises substantive antitrust concerns, such as when two direct competitors combine; 2) if the transaction will require HSR notification; and 3) whether or not HSR is required, what are the guardrails or best practices the client should observe. Recognizing that we don’t always operate in ideal circumstances and lawyers may only become involved after certain documents are created, lawyers should nevertheless remain vigilant about documents from the time they become involved in a deal. Coaching clients and their advisors about document creation best practices is always critically important.
  4. What are some best practices? Lawyers should proactively educate their clients on what to say (or not say) about the transaction and which words or phrases may be particularly susceptible to raising potential antitrust concerns. For example, words like “dominate” and “control” in relation to competition and competitors may create problems, as could market share statistics that overstate a seller’s prominence in a particular industry. Lawyers should also review drafts of documents such as CIMs, Management Presentations, and teasers to ensure that they are free of harmful verbiage.
  5. Expect statements to be misunderstood or taken out of context: Reading the Tempur Sealy/Mattress Firm complaints, two things are clear: 1) the government relied on portions of documents to support its allegations; and 2) the context of many of the quoted statements is unknown. It may be the case that some of the statements the FTC found important become less important when the entire document is reviewed and the context of the statement is made clear. Relatedly, there may be other documents not referenced in the complaints that indicate the transaction has procompetitive benefits. Allegations in a complaint are just that – allegations – and the evidence that emerges as the case progresses may or may not support those allegations. That being said, parties are wise to follow the best practices above. Similarly, they are also wise to avoid making exaggerated statements or statements intended to be humorous. These statements may be misunderstood by government regulators who do not know the specific industry or its players as well as clients do.
  6. Follow the general principle of “less is more” when it comes to document creation. Many transactions seem to move at lightning speed, but a moment of self-reflection can be very valuable. Ask yourself: do I need to write this, and if I do, what’s the best way to say it? Some organizations are more document-intensive than others, and there may be other reasons, unrelated to antitrust considerations, that require certain documentation. But in general, more documents are probably created than are truly necessary and more documents create the potential for more problems. Regardless, the key is to remember emails, texts, Slack messages, and slide decks may be read not only by their intended recipients but also by government antitrust regulators.

Ozempic Lawsuit Overview

Makers of Ozempic and other semaglutide drugs are facing hundreds of lawsuits throughout the United States. While intended for diabetes management and weight loss, research has linked the drug to increased risk of gastroparesis, stomach paralysis, pancreatitis and bowel obstruction.

Plaintiffs and their Ozempic lawsuit lawyers are seeking monetary compensation through products liability litigation. Victims are continuing to come forward. As of June 2024, cases are in preliminary stages, with new cases being added to multi-district litigation.

What Is the Ozempic Lawsuit About?

The Ozempic lawsuit is about whether the manufacturers of semaglutide drugs created and sold an unreasonably dangerous drug that hurt people. Plaintiffs say that the drugs created an unreasonable risk of gastrointestinal injury – a risk that the drug manufacturers knew about, and that they hid from the public.

What drugs are involved in the Ozempic weight loss lawsuit?

Ozempic might be the best known of the drugs involved in the weight loss lawsuits, but there are several drugs named in litigation. These drugs include:

● Ozempic
● Wegovy
● Rybelsus
● Trulicity
● Mounjaro

Ozempic, Wegovy and Rybelsus are manufactured by Danish pharmaceutical giant Novo Nordisk. Trulicity and Mounjaro are manufactured by Eli Lilly and Company.

Each individual case names the drug or drugs that the plaintiff took.

What are the issues in the Ozempic lawsuit?

There are three primary issues alleged in the Ozempic lawsuits:

1. Whether the drug companies knew or should have known that their semaglutide drugs could cause gastroparesis and other gastrointestinal issues.

2. Whether the drug companies adequately warned doctors and patients about the dangers of their products.

3. Whether the drug companies made false, misleading, or incomplete statements about safety as they marketed their products.

Overview of the Drug of Ozempic and How It Works

Danish pharmaceutical company Novo Nordisk developed the diabetes drug Ozempic. Its purpose is to treat type 2 diabetes.

How do Ozempic and related weight loss drugs work?

Ozempic is a glucagon-like peptide-1 (GLP-1) receptor agonist. The drug signals the body that it is not hungry and to stop eating. It is meant to act like the GLP-1 hormone.

When we eat, the body releases the GLP-1 hormone in the intestinal tract. The hormone signals the brain that it is full. When the hormone is present, a person may eat less or stop eating. In diabetes patients, the drugs trigger insulin production and reduce a hormone from the pancreas that increases blood sugar. The drug helps keep the person’s blood sugar level lower, managing their diabetes.

Over time, Novo Nordisk made and marketed three different semaglutide GLP-1 receptor agonist drugs:

● Ozempic – Injected with a pen, approved in 2017
● Rybelsus – Taken by pill, approved in 2019
● Wegovy – Targeted for weight loss patients, in a higher concentration than other forms of semaglutides, approved in 2021

With FDA approval, sales of these weight loss drugs soared. Medicare even began to cover the drug Wegovy in 2024, with some restrictions. There was such a demand for the products that there was a shortage in 2023.

Not a miracle drug after all

At first, manufacturers thought that they had created a miracle drug. The New England Journal of Medicine reported that people taking semaglutide drugs lost up to 15% of their body weight. Novo Nordisk aggressively marketed the drugs, including with consumer-direct marketing campaigns. Influencers on social media touted the benefits, and there were stories of celebrities who had found seemingly effortless success.

However, it soon became clear that there may be serious problems with the drugs. Doctors and researchers began learning that the drugs may cause higher rates of gastroparesis and other gastrointestinal issues. Victims say that when these drugs were marketed to them, they were unaware that they were placing themselves in serious danger.

What’s the problem with Ozempic?

Ozempic and other weight loss drugs may cause higher rates of gastroparesis. Gastroparesis is a medical condition of weakened stomach muscles and intestines. The condition can lead to other problems and complications because the person cannot move food through the body in a
timely manner.

What is gastroparesis?

Gastroparesis is delayed gastric emptying of the digestive tract, including the stomach, intestines and bowels. The person has weakened muscles in their stomach and intestines, so they’re not able to digest food at a reasonable pace. The condition can cause several problems
and complications, including:

● Stomach pain
● Vomiting, nausea, diarrhea
● Fatigue
● Vitamin, nutrition deficiencies
● Bloating
● Too many bacteria in the small intestine
● Obstructed intestine or bowel

Gastroparesis can cause discomfort. The condition can be dangerous and life-threatening. Diabetes can mask the symptoms of gastroparesis, making it harder to detect.

Ozempic Lawsuit Case Details

What type of case is the Ozempic lawsuit?

The Ozempic stomach paralysis lawsuit is a tort product liability case, which is not an Ozempic class action lawsuit. The claims have been consolidated into multidistrict litigation. People who were harmed by taking the drug are bringing civil claims, seeking compensation for their monetary damages, physical harm and suffering.

What is the Ozempic lawsuit case number?

The Ozempic gastrointestinal lawsuits are currently joined in Multi-District Litigation In Re: Glucagon-Like Peptide – 1 Receptor Agonists (GLP-1 RAS) Products Liability Litigation, MDL-3094. The cases are joined in the United States District Court for the Eastern District of Pennsylvania. Each individual case that is part of the multi-district litigation proceeds retains its
own individual case number.

Note: Ozempic is also the subject of unrelated multi-district litigation regarding patents (MDL-3038). The cases have been consolidated in a Delaware court. The issues are unrelated to the issues in the defective drug products liability cases.

Who is the judge of the Ozempic multi-district litigation?

District Judge Gene E.K. Pratter was assigned to preside over the Ozempic multidistrict litigation. However, she passed away in May 2024. A new judge will be assigned to the case.

How many cases are a part of the Ozempic lawsuit?

As of June 2024, there are 101 cases pending in the Ozempic lawsuit multi-district litigation. New cases are being added periodically as victims come forward.

Multi-District Litigation – Cases Joined Together for Preliminary Proceedings

The Ozempic lawsuit started as separate lawsuits filed throughout the United States. At first, 18 cases were filed in 11 judicial districts. There were another 37 related cases in 15 districts.

Nine of the original plaintiffs believed that it would make more sense to build their cases together. They thought their cases were similar enough that they should work together for preliminary proceedings. They wanted to work together in discovery, preliminary motions, depositions and evidentiary rulings. On December 1, 2023, they filed a motion to transfer the cases from their respective courts.

On February 5, 2024, the courts agreed and ordered the cases combined for preliminary proceedings in multi-district litigation.

Not everyone wanted the transfer. Some plaintiffs thought that only claims against Novo Nordisk should be combined. The parties opposing MDL didn’t want multiple defendants combined.

However, the court transferred all claims involving similar allegations about GLP-1 RA drugs and whether they cause gastrointestinal issues. The court said that even though the two companies sold drugs with different molecular structures, complete overlap of issues is not required.

Current Status of the Ozempic Weight Loss Litigation

The Ozempic weight loss litigation is in the early stages. As of June 9, 2024, the court has issued four case management orders. These orders direct the parties to do certain things in preliminary proceedings.

Case management order no. 1 – February 15, 2024

● A statement that cases transferred to the court, and cases subsequently transferred to the court, will be subject to the court’s orders.
● Attorneys are directed to review the court’s policies and procedures.
● The court set the date, time and place for the first in-court case conference. The court set aside two hours of court time for the conference.
● Topics to be discussed included selecting plaintiff’s lead counsel, the responsibilities of lead counsel and allocation of tasks. The court said that pleadings, timing, future status conferences and other issues could be discussed.

Case management order no. 2 – February 16, 2024

● Waiving pro hac vice fees in the case.
● Requiring parties to submit the court’s pro hac vice form, if applicable.

Case management order no. 3 – April 23, 2024

● Appointing Liaison Counsel for Plaintiffs, and a mentor.
● Identifying and appointing counsel to the Plaintiff’s Committee.
● Authorizing Committee members to select additional counsel for the Committee, up to 25 total members.
● Allowing the Committee to create subcommittees.
● Ordering the Committee to propose conference dates.

Case management order no. 4 – April 24, 2024

● Requiring the parties to preserve potentially relevant evidence.
● Parties must keep documents, data and tangible things in their presence that are relevant to the claims and defenses in the case.
● Each party must take reasonable steps to avoid loss of the evidence. Auto-delete features must be disabled.
● Certain sources don’t need to be preserved, searched or produced from.
● Keeping evidence or information is not an agreement or concession that the material is relevant to litigation.

There have been other filings in the case. These filings are procedural, like asking the court for additional time to respond to the motion to transfer the cases to multi-district litigation and required proof of service documents.

The court held a status conference on March 14, 2024. Preliminary proceedings will continue, after which the court may schedule bellwether trials. These early trials inform the parties as to how cases may be decided if they go to trial.

Basis of a Claim

The decisions that people make about their medical care may impact the rest of their lives. The choices that people make about their healthcare should be informed.

A critical basis for the Ozempic lawsuit is the claim that the drug manufacturer failed to warn consumers about the risks of the drugs. Some claims allege that the warning label was too generic, listing minor symptoms but saying too little about gastrointestinal issues, and not
emphasizing the dangers enough.

Many patients saw the direct-to-consumer marketing campaigns, including $180.2 million spent to market the drug in 2022. Marketing efforts for Rybelsus were similarly robust in 2022, at $167.2 million spent. Much of the marketing budget was spent on national television ads.

The marketing worked, and sales climbed high that year. Novo Nordisk credited the marketing effort for its 36% revenue growth in North America in 2022.

Consumers say that with marketing efforts this strong, they had the right to complete information before taking Ozempic or another semaglutide drug.

U.S. products liability law and the Ozempic case

In the United States, drug manufacturers have a legal liability to make products that are reasonably safe. Product liability is the type of case that a victim may bring if they are harmed by a dangerous drug. One of the ways that a drug can be dangerous is if the public doesn’t have the information that they need about the risks and potential harm.

A claim may also be based on misleading statements in advertising. The lawsuits say that the drug manufacturer proclaimed the benefits of the drugs without emphasizing the potential risks. Plaintiffs say that the advertising campaigns were deficient enough that the drug companies
should be liable for damages.

Damages for Ozempic Lawsuit

The purpose of the Ozempic lawsuit is to compensate victims. A person who develops gastroparesis likely has significant losses due to medical expenses. They may have physical suffering.

Damages claimed may include economic and non-economic losses. Valuing damages is an important part of any case.

Proving an Ozempic Legal Claim

While you can file an Ozempic lawsuit, to succeed in an Ozempic lawsuit, a person must prove:

● They took Ozempic or a related drug.
● The drug was defective under legal standards.
● Because of taking the drug, the victim developed medical problems. There is causation between using the drug and the harm that occurred.
● Damages resulted to the victim including medical bills, other financial losses, physical pain, suffering and other damages.

Novo Nordisk is aggressively fighting claims. They have responded to the allegations and will be fighting the claims in the months to come. The parties will continue to discuss medical evidence and pursue their respective positions.

Justice for Ozempic Victims

Ozempic lawsuits are still in the early stages. New plaintiffs are continuing to join, and the cases are moving through preliminary proceedings. The court will schedule future dates as the parties develop their cases, pursue settlement and prepare for trial.

China’s Supreme People’s Court Releases Two Recent Patent-Related Typical Anti-Monopoly Cases

On June 24, 2024, China’s Supreme People’s Court (SPC) released five recent typical anti-monopoly cases, two of which relate to patents. The SPC stated that the cases were released so that Courts can “correctly apply the revised Anti-Monopoly Law and accurately understand the new judicial interpretation of anti-monopoly civil litigation issued today, fairly and efficiently hear monopoly cases, ensure the correct implementation of the Anti-Monopoly Law, and maintain fair competition in the market.”

Explanations from the SPC regarding the two cases follows:

Case No.:【案号】(2020)最高法知民终1140号

[Basic facts of the case] Yang XX Pharmaceutical Group Co., Ltd. and its subsidiaries (collectively referred to as Yang) are the manufacturers of the anti-allergic drug desloratadine citrate tablets with the trade name “Beixue.” Hefei Yi XX Pharmaceutical Co., Ltd. owns the relevant patents for desloratadine citrate. The company and its subsidiaries and affiliated companies (collectively referred to as Yi) are the only suppliers of the desloratadine citrate API required for the production of “Beixue”. In addition to producing desloratadine citrate API, Yi also produces desloratadine citrate hard capsules. Yi and Yang are both the supply and demand parties of the desloratadine citrate API involved in the case, and are also competitors in desloratadine citrate preparations. Yang believed that Yi used its dominant position in the market of desloratadine citrate API to restrict Yang to only purchase the API involved in the case from it, significantly raised the price of the API involved in the case, and threatened to stop supplying the API involved in the case to force Yang to accept other commercial arrangements unrelated to the API transaction involved, causing huge losses to Yang and therefore constituting an abuse of market dominance. Yang requested that Yi stop abusing its market dominance and compensate Yang for losses and reasonable expenses of 100 million RMB. The court of first instance found that Yi had abused its market dominance by restricting transactions, setting unfair high prices, and attaching unreasonable transaction conditions, and ordered it to immediately stop the above-mentioned behaviors and compensate Yang more than 68 million RMB. Both parties were dissatisfied and appealed to the Supreme People’s Court.

The Supreme People’s Court held in the second instance that Yi has a dominant market position in the desloratadine citrate API market in China, but its dominant market position has been weakened to a certain extent due to the strong indirect competition constraints from the downstream second-generation antihistamine preparation market. Based on the existing evidence, it is difficult to determine that it has abused its dominant market position. First, desloratadine citrate falls within the scope of protection of Yi’s patent rights. The time and scope of Yi’s restriction that Yang can only purchase the patented API involved in the case from it do not exceed the scope of the legitimate exercise of patent rights, and the resulting market blocking effect does not exceed the statutory exclusive scope of patent rights, so it does not constitute a restricted transaction behavior that abuses the dominant market position. Second, considering the internal rate of return after the price increase and the matching degree of price and economic value, it is more likely that the initial price of the patented API involved in the case is a promotional price, and the subsequent large price increase is likely to be a reasonable adjustment from the promotional price to the normal price. The fact that the price increase is significantly higher than the cost increase is not enough to determine that there is an unfair high-price behavior that abuses the dominant market position. Third, the existing evidence is insufficient to prove that Yi has explicitly or implicitly bundled the sales of the patented API involved in the case with unrelated products, so it is difficult to determine that there is an act of attaching unreasonable transaction conditions. Therefore, the judgment was revoked and the first-instance judgment was changed to dismiss Yang’s lawsuit request.

[Typical Significance] This case is the first monopoly civil lawsuit in China involving raw material pharmaceuticals. The judgment clarified the consideration of indirect competition constraints from the downstream market when judging the market dominance of intermediate input operators, the relationship between the market blocking effect of limited trading behavior and the statutory exclusive scope of patent rights, and the basic ideas and specific methods for judging unfair high prices. It has positive significance for promoting the accurate application of the Anti-Monopoly Law and effectively maintaining fair competition in the pharmaceutical market.

【案号】(2021)最高法知民终1482号

[Basic facts of the case] Ningbo XX Magnetics Co., Ltd. is an enterprise engaged in the production of sintered NdFeB materials in Ningbo, Zhejiang Province. A Japanese metal company has more than 600 sintered NdFeB patents in the field of rare earth materials worldwide. After licensing eight companies in China to implement its patented technology, it decided not to add new licensees. From March 2014 to March 2015, Ningbo XX Magnetics Co., Ltd. repeatedly requested a license from the Japanese metal company but was rejected. Therefore, it filed a lawsuit in December 2014, requesting that the Japanese metal company stop the abuse of market dominance such as refusal to trade and compensate Ningbo XX Magnetics Co., Ltd. for economic losses of 7 million RMB. The court of first instance determined that the Japanese metal company had a dominant position in the patent licensing market for essential patents for sintered NdFeB and that its refusal to trade had no legitimate reason. Therefore, it ordered the Japanese metal company to stop abusing its market dominance by refusing to trade and compensate Ningbo XX Magnetics Co., Ltd. for economic losses of 4.9 million RMB. The Japanese metal company was dissatisfied with the decision and filed an appeal.

The Supreme People’s Court held in the second instance that the evidence in this case was insufficient to prove that the sintered NdFeB patent of a Japanese metal company was irreplaceable, nor was it sufficient to prove that there was an independent licensing market for patents necessary for the production of sintered NdFeB. Therefore, it was difficult to determine that the relevant market in this case was the patent licensing market for patents necessary for the production of sintered NdFeB owned by the Japanese metal company. In this case, based on the demand substitution of sintered NdFeB material production technology, the relevant market in this case should be defined as the global sintered NdFeB material production technology market, including patented technologies and non-patented technologies with close substitution. Given that sintered NdFeB material production technology is used to produce sintered NdFeB materials, and the market share of sintered NdFeB materials (products) and other conditions can more accurately and conveniently reflect the market conditions of sintered NdFeB production technology, the market power of the technology owner in the relevant market involved in the case can be evaluated through the market share of the sintered NdFeB material market. Taking into account the evidence in the case, the Japanese metal company does not have a dominant position in the global sintered NdFeB material production technology market. Therefore, the court ruled to revoke the first-instance judgment and dismiss the lawsuit filed by the Ningbo magnetic company.

[Typical Significance] This case is a typical case in which intellectual property rights and antitrust are intertwined, and has received widespread attention. The second-instance judgment properly handled the relationship between the exercise of patent rights and antitrust, and through scientific and reasonable definition of the relevant market, revised the judgment in accordance with the law to determine that the foreign right holder’s refusal to license the patent involved did not constitute monopoly behavior. The judgment in this case demonstrates the judicial concept of Chinese courts to equally protect the legitimate rights and interests of Chinese and foreign parties and the trial ideas of antitrust cases involving intellectual property abuse in accordance with the law, and actively responded to the concerns of the industry at home and abroad.

The original text including three additional cases is available here (Chinese only).

Supreme Court Upholds Refusal to Register Trademark Containing the Name of Living Individual – Donald Trump

In a recent unanimous decision in the case Vidal v. Elster (602 U.S. ___ (2024)), the U.S. Supreme Court upheld the refusal to register a federal trademark for the phrase “Trump Too Small” based on the fact that the Lanham Act prohibits the registration of the name of a living individual without their consent. The plaintiff in this case, Mr. Elster, filed a federal trademark application in 2018 for the mark “TRUMP TOO SMALL” for use on clothing as shown below, without the prior consent of former President Trump, arguing that the phrase was intended to be a criticism of Donald Trump and his policies and that the refusal was a violation of Mr. Elster’s First Amendment right of free speech. Mr. Elster claimed he wanted to register the mark to convey a political message about the former president.

The Supreme Court reviewed the matter based on the initial refusal to register issued by the United States Patent & Trademark Office, which was then appealed to the U.S. Court of Appeals for the Federal Circuit, who overturned the refusal holding that barring registration of “Trump Too Small” under a provision of federal trademark law unconstitutionally restricted free speech. The Court’s ruling upholds the “living-individual rule” established under the Lanham Act which requires the consent of the living individual prior to registration. Specifically, “No trademark … shall be refused registration … on account of its nature unless it…[c]onsists of or comprises a name, portrait, or signature identifying a particular living individual except by his written consent….” 15 U.S.C. §1052(c). Proponents of the law, including the International Trademark Association, argue that this provision of trademark law is consistent with the concepts of the right of publicity and privacy, and assists in preventing the unauthorized use of individuals’ names in commercial contexts. In explaining the rationale for the decision, Justice Thomas wrote: “This Court has long recognized that a trademark protects the markholder’s reputation, and the connection is even stronger when the mark contains a person’s name,” and further stated, This history and tradition is sufficient to conclude that the names clause — a content-based, but viewpoint-neutral, trademark restriction — is compatible with the First Amendment.”

It is worth noting the Court’s decision does not affect the ability of Mr. Elster to offer goods or services under any particular name or brand – in fact, Mr. Elster’s T-shirts bearing the phrase “Trump Too Small” are still available online for $24.99, even though his trademark application was refused. But the ruling does uphold the prohibition of seeking and obtaining federal trademark protection where the mark contains the name of a living individual without their consent. This ruling from the Supreme Court joins a string of other First Amendment challenges to provisions of the Lanham Act, the main statute governing trademarks. The high court in 2017 struck down a section of the law that barred registration of disparaging marks and did the same for a provision prohibiting immoral or scandalous marks in 2019.

The key takeaway from this narrowly tailored decision is that, prior to seeking federal trademark protection for a mark containing the name of a living individual, consent from that individual must be obtained. In the context of protecting a name or brand focused on a living individual, or in the continuation of such use post-merger or other transaction, it is important to ensure that the consent of the living individual is secured in some manner.

No Arbitration for Lead Buyer: Consent Form Naming Buyer Does Not Give Buyer Right to Enforce Arbitration in Tcpa Class Action

A subsidiary of Move, Inc. bought a data lead from Nations Info, Corp. off of its HudHomesUsa.org website. The subsidiary made an outbound prerecorded call resulting in a TCPA lawsuit against Move. (Fun.)

Move, Inc. moved to compel arbitration arguing that since its subsidiary was named in the consent form–it argued the arbitration clause necessarily covered it because the whole purpose of the clause was to permit parties buying leads from the website to compel TCPA cases to arbitration.

Good argument, but the court disagreed.

In Faucett v. Move, Inc. 2024 WL 2106727 (C.D. Cal. April 22, 2024) the Court refused to enforce the arbitration clause finding that Move, Inc. was not a signatory to the agreement and could not enforce it under any theory.

Most interestingly, Move argued that a motivating purpose behind the publisher’s arbitration clause was to benefit Move because Nations Info listed Opcity —Move’s subsidiary—in the Consent Form as a company that could send marketing messages to Hud’s users. (Mot. 1–2.)

But the Court found the Terms and Consent Form were two different documents, and accepting the one did not change the scope of the other.

The Court also found equitable estoppel did not apply because Plaintiff was not moving to enforce the terms of the agreement. Quite the contrary, Plaintiff denied any arbitration (or consent) agreement existed.

So Move is stuck.

Pretty clear lesson here: lead buyers should make sure the arbitration provisions on any website they are buying leads from includes third-parties (like the buyer) as a party to the clause. Failing to do so may leave the lead buyer stuck without the ability to enforce the provision–and that can lead to a massive class action with potential exposure in the hundreds of millions or billions of dollars.

Lead buyers are already forcing sellers to revise their flows in light of the FCC’s new one to one consent rules. So now would be a GREAT time to revisit requirements around arbitration provisions as well.

Something to think about.