Pennsylvania District Court Decision Signals a New Turn in the Generic Drug Preemption Debate; A Tough Pill to Swallow for the Generic Industry

June 2, 2010

 By Kurt R. Karst –   

Last week’s 29-page decision by the U.S. District Court for the Eastern District of Pennsylvania in In re Budeprion XL Marketing & Sales Litigation is yet more affirmation that lower courts are broadly reading and applying the U.S. Supreme Court’s 2009 decision in Wyeth v. Levine.  In Levine, the Court ruled, by a 6-3 vote, in the context of a  brand name drug, that FDA labeling approval does not preempt state laws.  Since that decision, myriad courts have taken up the issue of preemption doctrine as it applies to generic drugs (generally ruling against preemption), and the U.S. Supreme Court recently invited the Solicitor General to express the views of the United States on the topic (see our previous post here). 

In re Budeprion XL Marketing & Sales Litigation is a putative nationwide class action brought under California state consumer protection laws (i.e., California’s Unfair Competition Law and Consumer Legal Remedies Act) in which the plaintiffs allege that certain manufacturers of generic versions of the antidepressant WELLBUTRIN XL (bupropion HCl) Extended-Release Tablets failed to warn them about differences between their generic and the brand name drug, and that such differences caused undesirable effects.  According to the court, “[t]hese 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.”  As such, “[t]he generics subject to this litigation achieve peak concentrations in two hours, versus five hours for Wellbutrin XL . . . .  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.”  As we previously discussed, generic and brand name drugs can differ in release mechanism and still be therapeutic equivalents, provided the products are pharmaceutically equivalent and are demonstrated to be bioequivalent. 

In the bupropion class action, the plaintiffs contend that post-ANDA approval the generic manufacturers had a duty to disclose the differences between their products and the brand name drug by amending their labeling through FDA’s Changes Being Effected regulations.  The defendants argue in their Motion to Dismiss that “plaintiffs now directly challenge the exclusive role Congress assigned FDA to accomplish the Hatch-Waxman Act’s objectives,” and that the plaintiffs’ claims are preempted by the FDC Act and FDA’s determination that the generic WELLBUTRIN XL drug products are bioequivalent to the reference listed drug:

Recognizing the conflict between their claims and FDA’s equivalence determination, plaintiffs have tried to label their case as one about a “failure to warn.”  But this is not a personal injury case where a plaintiff seeks damages for injuries resulting from an undisclosed risk that FDA never considered or ruled on.  And none of the “failure to warn” cases concerns alleged differences between a brand and a generic product.  Here, plaintiffs’ fundamental complaint is with FDA’s decision to approve the Generic Products and allow them to remain on the market as equivalents of Wellbutrin XL.  If Plaintiffs’ allegations were right, and the Generic Products were not as safe and effective as the brand drug, then FDA could not allow the Generic Products to remain on the market as generic equivalents.  21 U.S.C. § 355(e).  Plaintiffs, however, seek to impose state-law obligations purportedly requiring defendants to disclose certain differences between the Generic Products and Wellbutrin XL, even though FDA has necessarily determined that all those differences are immaterial.  Requiring such representations would conflict directly with FDA’s determination that, as an equivalent generic, the Generic Products are “the same as a brand-name drug in: dosage, safety, strength, quality, the way it works, the way it is taken, and the way it should be used.”

And with respect to the applicability of the Levine decision, the generic drug manufacturers note that “[t]his is not a case where FDA has not ‘made an affirmative decision’ about the issue in dispute. . . .  Rather, FDA has addressed the exact issues raised by plaintiffs in finding the Generic Products to be bioequivalent to Wellbutrin XL and approving them for marketing.”  Moreover:

Were plaintiffs to prevail, FDA approval of a generic as bioequivalent would no longer be enough and generic drug manufacturers would have to engage in the very kind of safety and efficacy testing that the Hatch-Waxman Act expressly rejects for generic drug approval.  The result is undeniable: there would be fewer generic drugs developed for approval by FDA. . . .  The use of state law to second-guess FDA’s determination that the Generic Products are as safe and effective as Wellbutrin XL unquestionably would undermine Congress’s express delegation of exclusive authority to FDA to select the methods and standards for approving generic products as interchangeable with brand products, and discourage the marketing of approved products.  Such an application of state law is, thus, preempted.

The court (Judge Berle M. Schiller) was not persuaded and denied the defendants’ Motion to Dismiss.  “[T]he argument that Congress would permit state law to apply to the labeling of name brand drugs but would preempt state law actions against generic drug makers is a tough pill to swallow,” according to Judge Schiller, and “[t]he reasoning in Levine applies equally well to generic drugs.”  Central to Judge Schiller’s decision are fourt points:

  • First, a generic drug manufacturer is not absolved of liability because the FDA has approved its generic product.  The Hatch-Waxman Act allows generic drug makers to expeditiously get their products to market – it does not allow generic drug makers to wash their hands of any responsibility for monitoring the safety and efficacy of their drugs once sold.
  • Second, preemption is not to be lightly applied, particularly in this case because the field of law is one in which states have historically played a role.  Defendants have not pointed to any evidence of clear Congressional intent to preempt Plaintiffs’ claims, instead retracing arguments other courts have rejected. . . .   Furthermore, Plaintiffs would be left without a remedy if their state-law claim were preempted. Defendants need to posit more than the FDA’s bioequivalence determination to show that Congress meant to leave those injured by generic drug makers unable to seek redress for their injuries.
  • Third, Levine leaves it beyond doubt that ultimate responsibility for the labeling of drugs remains with the maker of the drug, not the FDA.
  • Fourth, although Defendants repeatedly assert that this is a case in which the FDA has already spoken and therefore a jury may not reassess the position taken by the FDA, that fact, even if correct, would not render Plaintiffs’ claims preempted. . . .  Federal laws and regulations do not leave generic drug makers impotent upon learning that their labels are inadequate or that their medication causes adverse side effects that must be reported. Generic drug makers may add or strengthen warning labels, even without prior FDA approval.

It is unclear whether the generic defendants in the case will appeal Judge Schiller’s decision.  Given the “Levine-creep” (the preemption version of “bio-creep”) that this decision represents, however, in which one has to ask what facts would, in fact, support Levine preemption, an appeal certainly seems like a possibility. 

Categories: Hatch-Waxman