Fenofibrate is a medication used to lower high cholesterol and triglyceride levels, and its most recognizable brand-name version was TriCor, originally manufactured by Abbott Laboratories. Throughout the 2000s, Abbott became embroiled in a series of lawsuits that, while not involving claims of dangerous side effects, brought scrutiny to its business practices in the pharmaceutical market. The core of these allegations revolved around the company's efforts to maintain its monopoly and prevent cheaper generic versions of fenofibrate from entering the market. This article will deconstruct the different facets of this complex litigation.
The “Product Hopping” Antitrust Lawsuits
At the center of the controversy was a strategy known as “product hopping.” As Abbott’s patent for an older formulation of TriCor was nearing its expiration, the company took measures to protect its market share. Instead of allowing generic manufacturers to compete, Abbott repeatedly launched slightly modified, new versions of the drug, while simultaneously pulling the older versions off the market.
For example, after launching the initial TriCor-1 formulation, Abbott introduced TriCor-2 and TriCor-3, both with minor changes to formulation or dosage. While these new versions were shown to be bioequivalent to the original, they were not demonstrably more effective, and the subtle differences prevented pharmacists from easily substituting a generic version. This strategy was alleged to be anticompetitive, forcing patients and healthcare systems to continue paying higher prices for the branded version of fenofibrate.
This tactic prompted two main types of antitrust lawsuits:
- Direct Purchaser Class Actions: Wholesalers, pharmacies, and other direct purchasers of TriCor filed lawsuits alleging that Abbott’s conduct had unlawfully inflated prices. This litigation eventually led to a settlement of $250 million, which was approved by the court in 2009.
- Multi-State Attorney General Lawsuits: A coalition of more than 20 states and the District of Columbia also filed suit against Abbott, alleging that its actions violated antitrust laws and caused financial harm to state governments and consumers. This was later resolved in a separate settlement for approximately $22.5 million.
Patent Infringement Claims and 30-Month Delays
In addition to product hopping, Abbott used patent litigation to its advantage to delay generic competition. Under the Hatch-Waxman Act, when a generic manufacturer files an abbreviated new drug application (ANDA) and challenges a brand-name patent, the brand-name manufacturer can file a patent infringement lawsuit. This action automatically triggers a 30-month stay, during which the FDA cannot approve the generic drug.
Abbott reportedly filed multiple such “sham” lawsuits against generic drugmakers like Teva and Impax, knowing that these actions would postpone the entry of lower-cost alternatives, regardless of the suits' eventual outcome. While the lawsuits were eventually dismissed, the strategic use of this legal mechanism was effective at extending Abbott’s market exclusivity. Teva eventually won a court ruling allowing its generic fenofibrate product to be approved and subsequently sought damages for lost profits in an antitrust lawsuit.
Kickbacks and Unlawful Marketing Allegations
A separate legal challenge emerged over allegations of improper marketing practices. In 2018, the U.S. Justice Department announced that Abbott and AbbVie (which spun off from Abbott) would pay $25 million to resolve claims that Abbott had engaged in a kickback scheme.
The False Claims Act lawsuit, originally filed by a whistleblower, alleged that from 2006 to 2008, Abbott provided kickbacks to physicians to induce them to prescribe TriCor. These kickbacks allegedly included improper payments disguised as consulting fees and speaking engagement payments, as well as gift baskets and gift cards. The settlement also resolved claims that Abbott promoted TriCor for off-label (unapproved) indications.
Comparing the Different Fenofibrate Lawsuits
| Lawsuit Type | Primary Allegation | Plaintiffs | Defendants | Outcome |
|---|---|---|---|---|
| Antitrust (Product Hopping) | Manufacturer introduced slightly modified formulations to delay generic competition | Direct Purchasers (wholesalers, pharmacies) and State Attorneys General | Abbott Laboratories, Fournier Industrie et Sante | Multiple settlements, including $250 million for direct purchasers and $22.5 million for states |
| Patent Infringement | Filing lawsuits against generic manufacturers to trigger 30-month FDA approval delays | Generic Drug Manufacturers (e.g., Teva, Impax, Novopharm) | Abbott Laboratories | Lawsuits dismissed, but tactics successfully delayed generic market entry |
| Kickbacks/False Claims Act | Paying physicians improper kickbacks to induce TriCor prescriptions; off-label marketing | U.S. Department of Justice (Whistleblower) | Abbott Laboratories, AbbVie Inc. | $25 million settlement |
No Major Side Effect Litigation Found
While consumers often associate drug lawsuits with adverse health effects, the major litigation involving fenofibrate did not center on product liability or personal injury claims. Though potential side effects like liver injury are known, these were not the subject of the large-scale class actions or multi-state suits. Instead, the legal focus was on corporate misconduct and market manipulation. The FDA also conducted a review of the drug's efficacy in preventing heart attacks and strokes, finding no significant benefit in a trial involving a combination therapy, and later withdrew approval for fenofibric acid with a statin, but this was a regulatory matter, not a personal injury lawsuit.
The Consequences and Wider Industry Impact
The resolutions of the fenofibrate lawsuits have had a significant impact on both the involved companies and the broader pharmaceutical industry. For Abbott and AbbVie, the settlements resulted in millions of dollars in penalties and a public record of their anticompetitive behavior. More importantly, the legal action brought attention to the problematic nature of product hopping and highlighted loopholes in the Hatch-Waxman Act, particularly the 30-month stay provision.
Academics and policymakers have since used the fenofibrate case as a prime example of the need for regulatory and legislative reform to prevent such tactics, protect generic competition, and ensure access to affordable medication. The case serves as a powerful reminder that corporate accountability extends beyond product safety to include fair market practices that ultimately benefit the healthcare consumer.
Conclusion
In summary, the lawsuits for fenofibrate, primarily against Abbott Laboratories and later AbbVie, were not about dangerous side effects but rather about the manufacturers' anticompetitive strategies. These included using “product hopping” to switch patients to newer, branded formulations and strategically employing patent litigation to delay generic entry. Furthermore, a separate settlement addressed allegations of illegal kickbacks paid to doctors to boost prescriptions. These cases underscore the complexities of pharmaceutical market regulation and the ongoing battle to balance drug innovation with affordability and fair competition, a topic that continues to draw legal and regulatory attention.
More information on the detailed product hopping tactics employed in the fenofibrate franchise can be found in this study published by the National Institutes of Health (NIH)(https://pmc.ncbi.nlm.nih.gov/articles/PMC3636774/).
