In Re Avandia Marketing, Sales Practices & Product Liability Litigation

804 F.3d 633, 2015 U.S. App. LEXIS 18633, 2015 WL 6445640
CourtCourt of Appeals for the Third Circuit
DecidedOctober 26, 2015
Docket14-1948
StatusPublished
Cited by50 cases

This text of 804 F.3d 633 (In Re Avandia Marketing, Sales Practices & Product Liability Litigation) is published on Counsel Stack Legal Research, covering Court of Appeals for the Third Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
In Re Avandia Marketing, Sales Practices & Product Liability Litigation, 804 F.3d 633, 2015 U.S. App. LEXIS 18633, 2015 WL 6445640 (3d Cir. 2015).

Opinion

OPINION

ROTH, Circuit Judge:

This interlocutory appeal involves claims brought against GlaxoSmithKline LLC (GSK) by third-party payors (TPPs), based on GSK’s alleged misrepresentation and concealment of the significant safety risks associated with use of Avandia, Avandam-et, and Avandaryl (collectively, Avandia), Type II diabetes drugs. GSK argues that the District Court erred in finding that the TPPs adequately alleged the elements of standing under the Racketeer Influenced and Corrupt Organizations Act (RICO). 1 We agree with the District Court’s analysis, finding standing, and therefore we will affirm.

I.

A. 2

Plaintiffs, Allied Services Division Welfare Fund, UFCW Local 1776 and Participating Employers Health and Welfare Fund, and United Benefit Fund, are TPPs. They are union health and welfare funds and are suing GSK on behalf of themselves and other similarly situated TPPs. TPPs typically provide medical coverage, including prescription drug coverage, to their members and members’ dependents.

Whether a TPP will cover the cost of a member’s prescription, in whole or in part, depends on whether that drug is listed in the TPP’s “formulary.” Pharmacy Benefit Managers (PBMs) prepare TPPs’ formu-laries of drugs approved for use by the TPPs’ members. The formularies are prepared by analyzing research regarding a drug’s cost effectiveness, safety and effica *635 cy. When a PBM determines that a drug offers advantages over a competing drug, it will give that drug preferred status on the formulary. A TPP will typically cover more of the cost of a particular drug when that drug has a higher preference status on the formulary. The greater coverage of cost by the TPP allows the member to pay a lower co-payment when prescribed that drug.

Type II diabetes is the most common form of diabetes and results from the body’s failure to produce enough insulin or its inability to properly use insulin. Type II diabetes was first treated with oral medications, primarily metformin and sul-fonylureas, or with injected insulin. In the 1990s, pharmaceutical companies began to develop a new form of Type II diabetes treatment known as thiazolidinediones (TZDs). On May 25, 1999, the Food and Drug Administration (FDA) approved Avandia, a TZD, for sale in the United States. GSK marketed Avandia as a more effective and safer alternative to the cheaper, existing Type II oral medications. In turn, TPPs included Avandia in their formularies and covered Avandia prescriptions at a favorable rate.

Soon after the FDA approved Avandia, concerns regarding its heart-related side effects began to surface. For example, in 2001, the FDA requested that GSK add a warning to the prescription label regarding the increased risk of fluid retention resulting from Avandia use. Shortly thereafter, GSK’s sales representatives denied the existence of this risk. As a result, the FDA instructed GSK to stop minimizing the risk of heart attacks and heart-related diseases in its marketing. In 2006, the FDÁ required GSK to update the warning to include new data about the potential increased occurrence of heart attack and heart-related chest pain in some Avandia patients.

In May 2007, Steven E. Nissen and Kathy Wolski published a paper in The New England Journal of Medicine, documenting the results of forty-two clinical trials of Avandia. The Nissen study concluded that, compared with the use of competing diabetes drugs, Avandia use was associated with a significant increase in the risk of myocardial infarction and a borderline-significant increase in the risk of death from heart-related diseases. According to the TPPs, GSK responded to the Nissen study with a marketing campaign designed to sway doctors and consumer confidence. This campaign included publishing full-page advertisements in more than a dozen newspapers and the release of promotional materials to prescribing physicians. Specifically, GSK ' challenged the Nissen study’s methodology and conclusions and described the results of its own favorable study.

On May 23, 2007, the FDA recommended that GSK add a “black box” warning to Avandia’s label to warn of the risk of congestive heart failure in connection with the use of Avandia. On August 14, 2007, GSK added the warning, which stated that TZDs “cause or exacerbate congestive heart failure in some patients.... Avandia is not recommended in patients with symptomatic heart failure.” Three months later, the FDA added a second black box warning, describing the Nissen study’s results as showing “Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction.”

In February 2010, the U.S. Senate Finance Committee released a report on Avandia. The Committee concluded that the “totality of the evidence suggests that GSK was aware of the possible cardiac risks associated with Avandia years before such evidence became public” and that GSK failed to notify the FDA and the *636 public of these risks despite its duty to do so. The report also noted that GSK attempted to minimize or misrepresent those risks in order to contradict the Nissen study and to intimidate independent physicians.

Ultimately, on September 23, 2010, the FDA restricted access to Avandia in response to increasing evidence of its cardiovascular risks. Specifically, the FDA limited access to existing users and to new patients whose blood sugar could not be controlled with other medications and who had decided with their doctor not to take Actos, a competing TZD drug. Doctors were required to advise existing Avandia users of Avandia’s cardiovascular risks before continuing to prescribe it.

Since its release, Avandia has been used on a regular basis by at least one million individuals in the United States and has generated billions of dollars in revenue for GSK. A one-month supply of Avandia has sold for $90 to $220, with the TPP covering between $135 and $140 per prescription and the patient paying the balance. This was a dramatic increase in the cost of Type II diabetes treatment. Previously, the most prevalent oral drug therapy, met-formin, cost approximately $45 to $55 for a one-month supply, with the TPP covering $40 to $50 of that amount. Although plaintiffs identify Actos as another alternative to Avandia, they do not provide the price which. TPPs typically covered for Ac-tos prescriptions.

B.

Plaintiffs bring this class action on behalf of themselves and other similarly situated TPPs that covered the cost of Avan-dia after May 25, 1999. They assert that GSK’s failure to disclose Avandia’s significant heart-related risks violated RICO based on predicate acts of mail fraud, 3 wire fraud, 4 tampering with witnesses, 5 and use of interstate facilities to conduct unlawful activity. 6 They also assert claims for unjust enrichment and violations of the Pennsylvania Unfair Trade Practices and Consumer Protection Law 7 and other states’ consumer protection laws.

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804 F.3d 633, 2015 U.S. App. LEXIS 18633, 2015 WL 6445640, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-avandia-marketing-sales-practices-product-liability-litigation-ca3-2015.