Lipitor Lawsuits Climbing but Pfizer Digging In

New York, NYAs the number of cases in the Lipitor Diabetes Lawsuits MDL continue to spike, Lipitor manufacturer Pfizer Inc. continues to position itself following the expiration of its patent in November 2011. One of those moves, as evidenced by a Bloomberg report earlier this year, is a hoped-for introduction of an over-the-counter (OTC) version of Lipitor (atorvastatin) at some point in the near future.

Never mind that a growing chorus of women have alleged atorvastatin Type 2 diabetes from taking Lipitor - without, or so it is alleged, any other predispositions to the disease. Also never mind allegations that Lipitor fosters memory problems akin to Alzheimer’s disease in some patients.

Pfizer, mindful of the billions and billions of dollars its hallmark drug has earned since it was introduced in 1997, is bent on protecting and preserving its brand. With various cheaper generic versions of atorvastatin now competing against actual, branded Lipitor for a piece of the cholesterol-lowering prescription pie, Pfizer is looking to the OTC frontier to breathe new life into its hallmark brand.

Will Pfizer succeed? And if successful, will “Lipitor 2.0” exacerbate the pool of grievous side effects now being alleged from the original, prescription version?

Lipitor was originally developed by Warner-Lambert and approved by the US Food and Drug Administration (FDA) for introduction to the market in 1997. Pfizer, at the time, agreed to partner with Warner-Lambert and bring its considerable marketing prowess to the table in exchange for a portion of the annual sales revenue, according to a Bloomberg TV report in November 2011. Internal sales estimates by Warner-Lambert had Lipitor peaking at $500 million in annual sales.

However, it’s now apparent that Pfizer, in becoming involved at the time, saw something much bigger - and they were right on the money. According to Bloomberg TV, sales of Lipitor eclipsed Warner-Lambert’s own peak forecasts, hitting the $865 million plateau in its first year. The next year, Lipitor brought in $2.2 billion and in 1999 sales climbed even higher. The unbridled success of Lipitor would prompt Pfizer to become involved, according to Bloomberg TV (11/1/11), in a bidding war to acquire Warner-Lambert. Pfizer won out, and in 2000 was successful in acquiring control of Warner-Lambert at a price tag of $115 billion.

But the price tag to have complete control over Lipitor appeared worth it, as sales continued to climb: $6.6 billion by 2001, $10.98 billion by 2004 and $12.7 billion in global sales in 2007. By 2010 - the year prior to losing the patent - sales fell off a bit, but remained respectable at $10.7 billion, and at one time, Lipitor was the largest-selling prescription drug on the planet.

The expiration of its patent, even with the number of lawsuits in the Lipitor mdl steadily climbing, appears to be more worrisome for Pfizer - hence the push to develop an OTC version. Bloomberg (3/3/14) reported earlier this year that testing on an OTC version has begun, amidst a view that health insurers are becoming more price conscious and often insist that a cheaper generic is prescribed unless it is medically necessary to stick with the higher-priced heritage brand (Lipitor). By going OTC, Pfizer can capitalize on brand loyalty amongst consumers who might be willing to pay a bit more for branded Lipitor on pharmacy shelves.

Pundits suggest this could be the start of a growing trend. But what of Lipitor side effects? Will they be similar to those manifesting from the prescription version of atorvastatin? Will results stemming from the Women’s Health Initiative (WHI) statin study be mirrored in Lipitor OTC if, and when, it is approved and becomes available?

Will the prospect of more plaintiffs like Margaret Clark, without any predisposition to Type 2 diabetes, wind up with diabetes trouble with the OTC version of Lipitor? Not to mention the potential for memory loss.

Plaintiffs in Lipitor Diabetes Lawsuits MDL hold that women face a higher risk than men of developing diabetes from Lipitor, while enjoying fewer benefits. Such an allegation flies in the face of a long-held FDA mantra that suggests a drug is only considered safe and effective if the benefits for the intended patient community outweigh the risks.

The first bellwether atorvastatin Type 2 diabetes lawsuit is scheduled for July 2015. Legal pundits suggest a consolidated case load could climb to as high as 10,000 cases or more…