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In re Budeprion XL Marketing & Sales Litigation

May 26, 2010

IN RE: BUDEPRION XL MARKETING & SALES LITIGATION
THIS DOCUMENT APPLIES TO: ALL ACTIONS



The opinion of the court was delivered by: Schiller, J.

MDL No. 2107

MEMORANDUM

In this putative nationwide class action brought under California state consumer protection laws, Plaintiffs claim that Defendants failed to warn them about differences between their generic anti-depressant medication and the name brand medication. Class members experienced adverse side effects after switching to the generic anti-depressants offered by Defendants. Plaintiffs suggest that they never would have purchased Defendants' products had they been made aware of the risks attached to the medication. Defendants believe that Plaintiffs' claims are preempted and have moved to dismiss the Complaint. The Court concludes that the Supreme Court's recent decision in Wyeth v. Levine, and subsequent cases interpreting that decision, have foreclosed Defendants' preemption argument. Their motion, therefore, is denied.

I. BACKGROUND

A. Factual and Procedural Background

Bupropion Hydrochloride ("Bupropion") is the active ingredient in the prescription antidepressant Wellbutrin and several generic antidepressants. (Admin. Class Compl. ¶¶ 11-12.) By 2007, Buproprion was the fourth-most prescribed anti-depressant in this country, with over 20 million retail prescriptions written annually. (Id. ¶ 13.) Its side effects include headaches, migraines, agitation, tremors, nervousness, dizziness, decreased memory, insomnia, abdominal pain, nausea, diarrhea, vomiting, chest pains, and seizures. (Id. ¶ 20.)

GlaxoSmithKline (Glaxo) first brought Bupropion to the market in the late 1980s under the name Wellbutrin. (Id. ¶ 21.) It was originally available only in an immediate-release form (Wellbutrin IR) that the patient was required to take three times per day. (Id. ¶ 22.) It used a matrix release mechanism and was metabolized in the upper gastrointestinal tract. (Id.) The concentration of Bupropion in the blood peaked two hours after taking Wellbutrin IR. (Id. ¶ 23.) The initial sale of Wellbutrin IR, however, was delayed due to the possibility of serious side effects. (Id. ¶ 24.)

In 1996, Glaxo introduced Wellbutrin SR, a sustained-release formulation of Wellbutrin, which also used a matrix release mechanism; concentrations of Buproprion in the blood peaked three hours after taking Wellbutrin SR. (Id. ¶¶25-26.) Wellbutrin SR users often took two 150 mg pills per day. (Id. ¶ 26.) This iteration of the drug was prone to "dose dumping," meaning the drug was absorbed quicker when the pill was taken with food. (Id. ¶ 28.) Glaxo, as well as the generic makers of Wellbutrin SR, disclosed the possibility of dose dumping on their labels though they considered it clinically insignificant. (Id. ¶¶ 28-29.) The Food & Drug Administration ("FDA") did not require a New Drug Application ("NDA") for this formulation; instead, Glaxo was permitted to rely on the data submitted along with the immediate-release formulation. (Id.¶ 25.)

In 2003, Glaxo released Wellbutrin XL, an extended-release formulation that only needed to be taken once per day. (Id. ¶ 30.) Wellbutrin XL employed a membrane-release technology, meaning that "the drug was not released through a dissolving pill, but seeped at a controlled rate through a membrane that actually passed through the entire GI tract intact." (Id. ¶ 31.) This release mechanism solved the dose dumping problem and Glaxo updated its label accordingly. (Id. ¶ 32.) Concentrations of Buproprion in the blood peaked five hours after taking Wellbutrin XL. (Id.) The membrane-release technology was patented and thus generic drug manufacturers had to devise an extended-release formulation that did not infringe upon the patent. (Id. ¶ 34.) Generic drug companies such as Watson Pharmaceuticals and Anchen Pharmaceuticals developed a similar membrane technology but Defendants did not. (Id. ¶¶ 35-36.)

Defendant Impax Laboratories, Inc. currently makes a 150 mg generic product called "bupropion hydrochloride XL," which is distributed by Global Pharmaceuticals, an Impax subsidiary. (Id. ¶ 50.) Impax also makes a 300 mg generic drug, Budeprion XL, which is distributed by Defendant Teva Pharmaceuticals. (Id. ¶ 49.) The generic versions of Wellbutrin XL involved in this litigation entered the market in late 2006/early 2007. (Id. ¶ 41.) These generics use a matrix technology rather than a membrane-release technology and rely on the size of the pill to control the release of the medication. (Id.) The generics subject to this litigation achieve peak concentrations in two hours, versus five hours for Wellbutrin XL and generic versions produced by Anchen and Watson. (Id. ¶ 43.) The matrix technology caused Defendants' pills to break apart quicker than the name brand drugs and metabolize in the upper GI tract. (Id. ¶ 44.) Thus, the amount and rate of the active chemical released into the body from Defendants' drugs depended upon factors like food and alcohol consumption, other medications, and other GI issues. (Id. ¶ 44.) Wellbutrin XL users, on the other hand, attain the benefits of their medication without focusing on these issues. (Id.)

Plaintiffs do not dispute the FDA's finding of bioequivalence, which was necessary to approve the generic drugs before they could be marketed. Instead, Plaintiffs claim that post-approval, Defendants became aware that the differences between Wellbutrin and their products were material, and thus they had a duty to disclose this information. (Id. ¶ 48.) Specifically, Plaintiffs say the more rapid release of Defendants' drugs renders them less effective in treating depression and more dangerous than those products using a membrane-release technology. (Id. ¶ 52.) After Defendants' products arrived on the market, complaints poured in from patients who claimed that the generic drugs they were taking was not as effective as Wellbutrin XL and they were experiencing adverse side effects. (Id. ¶ 54-56.) Those patients who switched back to Wellbutrin XL or a nonImpax generic drug immediately improved. (Id. ¶ 57.) Although Defendants were made aware of the problems with their drugs, they failed to disclose this information or warn patients and doctors about the differences between the medications. (Id. ¶ 59.) In fact, to protect their market share, Defendants continued to misrepresent that the release profile of their products was identical to those of the name brand product. (Id. ¶¶ 60-62.) Furthermore, during patent litigation involving the delivery method of Defendants' drugs, Defendants touted the differences between their method of delivery and that used in Wellbutrin XL. (Id. ¶ 63.) This litigation was sealed from the public. (Id.) Additionally, studies showed that Budeprion XL released 34% of its Bupropion within the first hour, compared to only 8% for Wellbutrin XL (300 mg). (Id. ¶ 64.) And within two hours of ingestion, Budeprion XL released between 25% and 50% of its Bupropion, compared with less than 20% for Wellbutrin XL. (Id. ¶ 66.) In April of 2008, under pressure from consumers, non-profit watchdogs, and the medical community, the FDA issued a report explaining some of the differences between Wellbutrin XL and Defendants' generic product; however, the FDA made no determination as to whether Defendants' warnings were adequate. (Id. ¶ 69.)

According to the Complaint, Defendants have made the following omissions and misrepresentations, among others: (1) failure to disclose that the Bupropion contained in Budeprion XL reaches its peak concentration in the bloodstream in just two hours and instead insisting that maximum levels are only reached after five hours; (2) failure to disclose that taking Defendants' products with food increases the amount of the drug eventually released into the body thereby causing adverse events; (3) failure to disclose that the 300 mg generic drug was never tested for bioequivalence with Wellbutrin XL; (4) failure to disclose the existence of tests indicating that the dissolution of Defendants' products varied significantly from Wellbutrin XL; (5) failure to disclose numerous complaints of adverse side effects and decreased efficacy suffered by persons who switched from Wellbutrin XL to Defendants' products; (6) failure to disclose that their products had a different physiological and therapeutic effect than Wellbutrin XL; (7) failure to disclose that Defendants' products employed an inferior release technology; and (8) misrepresenting that their product worked the same as Wellbutrin XL. (Id. ¶ 71.) Defendants also failed to inform those taking their drugs that they needed to be closely monitored. (Id. ¶¶ 72-75.) Defendants kept all of this information secret in an effort to protect their market share. (Id. ¶ 76.) Indeed, after word of the patient complaints became public, Budeprion XL lost significant market share. (Id. ¶ 79.) According to the Complaint, if Plaintiffs knew the truth about Defendants' generic products, they would not have purchased those products. (Id. ¶ 142.) As a result, they suffered injury and lost money because they paid for an unsatisfactory product. (Id. ¶ 153.)

According to Plaintiffs, Defendants' actions have disrupted the generic market for antidepressants. The problems relate only to Defendants' generic antidepressants; doctors, however, cannot direct pharmacists to fill a prescription with a particular version of a generic drug. (Id. ¶ 84.) Instead, doctors have been insisting that pharmacists use the brand name drug rather than a generic. (Id. ¶ 85.) Thus, Wellbutrin XL has managed to recapture a chunk of the Bupropion market despite the existence of comparable generic drugs and has actually increased in price. (Id. ¶¶ 86, 89.)

The named Plaintiffs in this putative class action are Andrew Richards and Micki Sackler. Richards is an adult citizen of California who suffers from depression and used Defendants' product to treat his depression from January to March 2008. (Id. ¶ 114.) Prior to using Defendants' product, he used Wellbutrin XL (300 mg), which treated his depression with little or no side effects. (Id.) He believed that Defendants' generic was identical to Wellbutrin XL but while on the generic, his depressive symptoms returned and/or increased and he also suffered a seizure. (Id.) Sackler is also an adult citizen of California who, in or around 2008, used Defendants' product to treat her depression. (Id. ¶ 115.) She had been taking Wellbutrin XL (150 mg) and when she switched to Defendants' generic drug, she noticed an immediate return of her depression and also had trouble sleeping. (Id.) As stated in the Administrative Class Action Complaint, "[t]his lawsuit seeks to apply California's statutory business standards to a California drug manufacturer (Impax) and its distribution partner (Teva) for uniform national conduct emanating from California. Defendants engage in nationwide market activity, providing the same label with every Impax Product that omits material information. A national solution makes sense." (Id. ¶¶ 99-100.) Plaintiffs have sued under California law, specifically, the California Business and Professions Code and the California Consumer Legal Remedies Act. (Id. ¶¶ 104-10.) Plaintiffs are not seeking recovery for any personal injuries that any Class member may have suffered but rather want an injunction and restitution for money they have spent to purchase the deceptive products. (Id. ¶ 121.)

The Class asserts jurisdiction under the Class Action Fairness Act, 28 U.S.C. § 1332(d)(2), and claims that this litigation may be maintained as a class action under either Rule 23(b)(2) or 23(b)(3) of the Federal Rules of Civil Procedure. (Id. ¶¶ 111-12, 122-28.) The Class consists of:

All persons or entities in the United State who purchased, paid-for (in whole or in part), Bupropion Hydrochloride XL (150 mg) and/or Budeprion XL (300 mg) manufactured by Impax.

Excluded from the Classes are Defendants, any parents, subsidiary or affiliate of Defendants, and their officers, directors, and employees, who are or have been employed by Defendants, and any judicial officer who may preside over this action. (Id. ¶ 119.)

Count I is a claim under California's Unfair Competition Law based on the omissions and misrepresentations surrounding Defendants' products. (Id. ¶¶ 129-45.) Plaintiffs allege that Defendants engaged in a pattern of unfair business practices that has harmed consumers, physicians, pharmacies, and insurance companies. (Id. ¶ 132.) Furthermore, Defendants' actions have also harmed competitors in that they have unfairly seized market share. (Id. ¶¶ 134, 136, 138.) Count II is a claim under the California Consumer Legal Remedies Act and is brought on behalf of Richards and Sackler as well as a subclass of the putative class, comprised of those members who bought Defendants' products within three years of the commencement of the action. (Id. ¶ 147.)

This litigation developed from the numerous complaints filed in both federal and state courts throughout this country. In all of the cases, the plaintiffs sought to represent themselves and a class of individuals who had taken Defendants' generic version of Wellbutrin and whose conditions had worsened after switching to the drug. Both Plaintiffs and Defendants agreed that the cases should go to the United States Judicial Panel on Multidistrict Litigation and be consolidated for pretrial purposes, although the parties disputed to which district the cases should be transferred. On December 2, 2009, the MDL panel issued its decision and, pursuant to 28 U.S.C. ยง 1407, transferred the cases to this District. Following ...


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