Lipitor Antitrust Litigation has been dubbed as one of the must-watch competition cases by Law360, a New York-based legal news service. This case against pharmaceutical giant Pfizer and its predecessors and affiliates has been dragging on for over a decade.
The plaintiffs mainly alleged that Pfizer worked with India-based Ranbaxy Laboratories to delay the release of affordable and generic versions of Lipitor through an overarching anticompetitive scheme. This broke various state laws, including defrauding the United States Patent and Trademark Office.
What’s Lipitor?
Lipitor (generic name: Atorvastatin) is a blockbuster drug developed by Pfizer. Not only is it produced by one of the world’s top biopharmaceutical companies, but it has also become the best-selling prescription drug in the world, with annual sales of over $12 billion.
It belongs to the drug class statins (cholesterol-lowering drugs). It can lower low-density lipoprotein (LDL) or “bad” cholesterol, total cholesterol, triglycerides, and the risk of cardiovascular problems, such as heart complications, heart attack, and stroke.
Lipitor is often compared to Zocor (generic name: Simvastatin), another statin typically compared to it and developed by the Merck Pharmaceutical Company. Here’s a quick Lipitor vs. Zocor Comparison:
- Recent research has shown that Lipitor is more potent than Zocor. This means it’s more effective at lowering bad cholesterol. If Zocor is taken at higher doses to increase its potency, it’s thought that it’s more likely to cause muscle pain.
- However, another study showed that Zocor is better at increasing high-density lipoprotein (HDL) “good” cholesterol levels and has fewer gastrointestinal (GI) side effects than Lipitor.
Lipitor Lawsuits
In 1996, the Food and Drug Administration (FDA) approved Pfizer’s Lipitor as a medicine to prevent cardiovascular diseases by lowering cholesterol. As stated, it became one of the best-selling prescription medicines worldwide, with $94.67 billion in U.S. sales from 1992 to 2017.
However, in 2012, several US women claimed to suffer serious side effects caused by Lipitor consumption. These include an increased risk of developing type-2 diabetes and even memory loss.
Pfizer and Ranbaxy were then initially sued not only for Lipitor’s diabetes-causing allegations but also for being involved in an “antitrust scheme.” According to a legal filing, Pfizer used patents related to Lipitor to delay the entry of generic cholesterol medication into the market.
Specifically, the plaintiffs alleged that this scheme:
- Defrauded the US Patent and Trademark Office
- Filed a baseless FDA petition
- Conspired with Ranbaxy to keep products off and not enter the market until the agreed-upon date in 2011
Plaintiffs alleged this caused consumers to be deprived of a cheaper generic version of Lipitor. Hence, this resulted in overcharges reaching almost a billion dollars. Hence, both Pfizer and Ranbaxy were sued for violating federal antitrust laws.
Moreover, in 2013, 56 lawsuits about Lipitor causing users’ diabetes were filed in federal court. The next year, this number shot up to almost 1,000 Lipitor diabetes claims, which made the U.S. Judicial Panel on Multidistrict Litigation centralize them in one court in the Southern District of South Carolina.
Pfizer strongly denied liability and chose to face lawsuits. After all, their cases are far different from those against other drug companies. First, many consumed the drug, which suggests that there are many potential plaintiffs.
Second, despite risk warnings, the FDA still emphasized the benefits of statins. In fact, Amy Egan, one of its officials, even stated that statins’ heart benefits outweigh the small increased risk for diabetes.
From 2015 to 2016, while they faced many trials, Pfizer won a summary judgment ruling for two multidistrict litigation (MDL) bellwether cases, which resulted in a federal judge dismissing their MDL cases. However, plaintiffs appealed to remand the cases back to state courts.
In 2018, the Fourth Circuit of the U.S. Court of Appeals dismissed suits in the Lipitor diabetes MDL. Still, the Supreme Court denied Pfizer’s re-consolidation request of the cases in federal courts in 2019.
In 2021, Pfizer won a summary judgment in other remaining Lipitor diabetes cases. Judge Carolyn Kuhl terminated many coordinated cases in California courts in September 2022, while the others remained active in California superior courts.
Pfizer’s $93 million settlement
In February 2024, Pfizer agreed to pay $93 million to settle wholesale drug distributors’ antitrust claims. At the same time, plaintiffs also sought a whopping $31 million in legal fees in the settlement fund.
Many lawyers explained that if cleared, this settlement would give plaintiffs immediate economic relief. However, other plaintiffs’ lawyers argued that such a settlement only helped Pfizer and Ranbaxy evade “continued litigation, potential appeals, and no recovery.” Pfizer, in contrast, said the settlement was “fair, reasonable and the best way to resolve this litigation.”
In addition to the settlement, Pfizer also gave Ranbaxy access to all the patents needed to produce the generic and six-month-long market exclusivity. Ian Read, former Pfizer’s chief, then commented that this is a “win-win-win” deal: “pro-patient, pro-competition and pro-intellectual property.”
Final Thoughts
Now, the Lipitor Antitrust Case only needs a judge’s approval to close. However, note that there could be other unpredictable events that may occur, so stay tuned on the latest news for more accurate updates.
