The Law Offices of Brian D. Witzer Takes Historic Fight for Consumer Rights to Ninth Circuit Court of Appeals on Behalf of All Victims of Defective Drugs

Saturday, August 21st, 2010

On October 6, 2010, the Law Offices of Brian D. Witzer will fight for the right to sue generic drug manufacturers, on behalf of their clients and all people who suffer injuries due to defective generic drugs. On that day, in the Ninth Circuit, the Witzer Firm will argue their clients’ appeal of a lower court’s entry of summary judgment in favor Perrigo Pharmaceuticals (“Perrigo”) based upon federal preemption. The fundamental question raised by the appeal is one of first impression in the Ninth Circuit – whether state-law failure-to-warn claims against generic drug manufacturers are preempted by federal law – particularly in light of the Supreme Court’s landmark decision in Wyeth v. Levine, 129 S. Ct. 1187, 173 L. Ed. 2d 51 (2009). Based on Levine’s clear holding that drug manufacturers are responsible for injuries caused by their defective drugs, are not shielded by preemption, and can be held accountable under state law, the Witzer Firm is confident that the lower court’s decision must be reversed.

The plaintiffs in this case brought suit on behalf of their child against Perrigo – the manufacturers of the generic drug ibuprofen – after their child sustained acute liver injury and renal failure which required an emergency liver transplant. On June 3, 2004, the child underwent surgery to remove two benign moles. During the procedure, the anesthesiologist administered the anesthetic Halothane, a drug known to be “hepatotoxic” (i.e. toxic to the liver). At discharge, the surgeon prescribed ibuprofen and the plaintiffs purchased Perrigo’s over-the-counter 200 mg generic ibuprofen product and gave it to their child as directed.

By June 13, 2004, the child was seriously ill and was admitted to the pediatric intensive care unit of Children’s Hospital of Central California with septic shock, dehydration and acute liver failure. He was transferred from Children’s Hospital to Stanford University’s Lucille Packard Children’s Hospital on June 14, 2004, and by the next day, surgeons performed an emergency liver transplant in order to save his life. The child remained in the hospital until September 2, 2004. At Stanford, the child’s attending physician noted that his acute liver failure may be secondary to ibuprofen and his renal physician suspected ibuprofen as a possible cause of his hepatorenal syndrome. The child was placed on dialysis. Alternate causes of the liver failure were tested and ruled out.

The child developed other complications, including renal failure, respiratory compromise, status post liver transplant with choleastasis, infectious diseases, persistent hypotension requiring massive pressure support. He had blistering and sloughing of his ankles and necrosis of digits in his hands and feet. He underwent multiple operative procedures to debride necrotic tissue from his ankles and amputations of gangrenous digits in his hands and feet.

The link between mixed use of ibuprofen and hepatotoxic drugs and resulting liver injury has been well known for years – evidence put squarely before the district court at the summary judgment stage. Much of that evidence came directly from Perrigo’s own pharmacovigilence doctor. Before the court was clear evidence that there had been at least 592 adverse event reports (“AERs”) filed with the FDA involving acute liver disease in relation to ibuprofen use. There also have been at least a dozen important articles on the subject of hepatotoxicity. The literature reflects a significantly increased risk of liver injury if two hepatotoxic drugs are used concurrently. Furthermore, studies have shown a significant increased risk of liver injury with a concurrent use of ibuprofen and other hepatotoxic drugs. Despite the clear evidence of liver damage caused by mixed use of ibuprofen and hepatotoxic drugs, and although the FDA requires drug manufacturers to conduct literature reviews and collect adverse event reports, Perrigo never conducted a comprehensive survey and analysis of the reports of increased liver risk that were being published in the literature. Perrigo admits that its label did not warn doctors of the risk and that no “Dear Doctor” letters were ever sent to physicians warning of that risk. Because of that, the child’s doctors were unaware of the risks of administering ibuprofen along with hepatotoxic drugs and, as a result, the child suffered his devastating injuries.

To obtain relief for their child’s injuries, the plaintiffs brought six causes of action against Perrigo: (1) Defective Design; (2) Marketing Defect; (3) Breach of Express Warranty; (4) Breach of Implied Warranty; (5) Negligence and Gross Negligence; and (6) Deceit by Concealment pursuant to Cal. Civ. Code §§ 1709-1710. Specifically, the plaintiffs alleged that the generic manufacturers failed to warn prescribing physicians and consumers of the increased risk of acute liver injury and renal failure when ibuprofen is taken concomitantly with other drugs known to be hepatotoxic.

On December 15, 2008, the district court entered summary judgment in favor of Perrigo and the plaintiffs appealed that judgment to the Ninth Circuit. Since that time, Levine came down. Levine involved the question of whether state-law failure-to-warn claims are preempted by federal law. There, the subject drug had a brand name – Phenergan. Following Levine, the plaintiffs obtained a limited remand from the Ninth Circuit to the district court, where they moved to reconsider in light of Levine’s holding. The district court denied the motion on November 24, 2009, holding that because Levine dealt with a brand-name drug, and generic drugs manufacturers are subject to a different statutory scheme than brand-name drugs, Levine was not controlling.

The problem with the district court’s holding is that it ignores the strong presumption against preemption of state law failure-to-warn claims against drug manufacturers. It ignores the long history of co-existence between the FDCA and state tort law. It ignores Congress’ purpose of allowing persons injured by unsafe drug products to seek compensation under state law, as recently re-affirmed in Levine. There are no legal bases supporting the district court’s finding of preemption.

The fact is, generic drugs – just like their brand-name equivalents – must have adequate label warnings to protect their users, and generic companies like Perrigo must revise their labels “to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug.” 21 C.F.R. § 201.57(e) (2005). Perrigo could have strengthened the warnings without prior FDA approval, pursuant to 21 C.F.R. § 314.97. In addition, Perrigo could have sought FDA approval for a labeling change under the so-called “Prior Approval” supplement procedure, or Perrigo could have sought to notify health care professionals, such as treating doctors, through “Dear Doctor” letters. Despite the available scientific literature and adverse event reports, Perrigo did not seek to use any of these three procedures to change its label, or otherwise notify the FDA of any need to do so.

The district court incorrectly applied and interpreted federal law which, by its plain language, imposes the same duties and obligations on generic drug manufacturers as those imposed on their brand-name counterparts, to make sure that their drugs remain safe and effective after the FDA approves them for marketing to the consumer.

This is a case of first impression in this Circuit, in a rapidly developing area of law. Although Levine involved a brand name drug manufacturer, Levine’s “mode of analysis” is controlling in this case. Two circuit courts have already applied Levine to state-law failure-to-warn claims against generic drug manufacturers and held that such claims are not preempted by federal law. The majority of lower courts as well as the California Court of Appeal, agree. And since this appeal began, even more courts have issued opinions on preemption, including that of the Seventh Circuit, and several more district courts and state appellate courts. All of the courts, except for one district court case currently on appeal, have found that state law failure to warn claims are not preempted. The reason that all courts have found no preemption in light of Levine is because a plain reading of the text of the statutes and regulations show that all drug manufacturers have a continuing obligation to change and strengthen their labels after their drug application has been approved by the FDA. Thus, cases for prescription/brand-name, prescription/generic, and OTC/brand-name drugs, have all held that state law failure to warn claims for injuries caused by drugs are not preempted by federal law.

Appellants’ failure-to-warn claims against the generic drug manufacturer are consistent with existing federal requirements that a manufacturer must maintain adequate warnings on its drug. They are consistent with the purposes and objectives of the FDCA, including the Hatch-Waxman Amendments to the Act.

Finally, public policy strongly militates against preemption in this case.

First, affirming preemption would unfairly favor generic manufacturers over brand-name manufacturers who market the same drug. Since Levine has already held that manufacturers of brand-name drugs cannot avoid liability from state-law failure-to-warn claims, a contrary ruling in cases where the defendant is a generic manufacturer of the same, bioequivalent drug and marketed with the same label produces an inequitable result – not only for the injured plaintiff but also for the defendant brand-name manufacturer.

Second, preemption would create arbitrary and irrational distinctions between classes of patients-consumers where the injured consumer’s ability to recover would be based on their available financial resources and other accidental circumstances. As such, an injured consumer’s access to legal remedy would depend on how much money they had in their pocket that day, whether the store that the consumer visited happened to stock only generic versions of the drug, whether the pharmacist unilaterally decides to fill a prescription with a generic version of the drug instead of the brand-name. There is no basis to find that Congress intended to trade off the lower cost of generic drugs for the right of consumers injured by such products to sue under state tort law. The argument that “consumers who opt for generic drugs over name-brand equivalents may have effectively lost their right to recompense … is not only distasteful but also contrary to the fundamental principles of tort law.” Bartlett v. Mutual Pharm. Co.,No. 08-cv-358-JL, 2009 WL 3126305, *25, fn 40 (D.N.H. Sept. 30, 2009).

Third, a rule that immunizes generic manufacturers from tort action creates a perverse incentive for generic manufacturers not to strengthen their label warnings while continuing to market and reap profits from a drug they know is unsafe. This is precisely the reason why the FDA imposed the same obligations on generic manufacturers to monitor the safety of their drugs on the market and to propose label changes to the FDA, whether by CBE, prior approval or by a “Dear Doctor” letter.

Fourth, and most importantly, preemption would leave injured patients without any remedy. The Levine Court examined the legislative history of the FDCA, which necessarily also includes the Hatch-Waxman Amendments of 1984. The Court took note of the absence of a federal remedy for persons injured by unsafe drugs, precisely because Congress always intended to maintain the FDCA’s 70-year coexistence with the available of remedies provided by state law. The Levine Court recognized that the lack of a federal remedy under the FDCA was due to Congress’ intent to preserve the states’ ability to protect the health and safety of its citizens, through its tort laws. Without a clear expression of congressional intent, courts should not find preemption.

For all of these reasons, the Witzer Firm is proud to take this fight to the Ninth Circuit and settle these questions once and for all. The Witzer Firm has been at the forefront of pharmaceutical litigation for many years, and this battle is its next chapter in the ongoing struggle to fight for all consumers and victims of ibuprofen and defective products in general.

For more information about this article or about your legal rights, please don’t hesitate to call us today at 1-888-948-9376 begin_of_the_skype_highlighting 1-888-948-9376 end_of_the_skype_highlighting begin_of_the_skype_highlighting 1-888-948-9376 end_of_the_skype_highlighting, or email us at Witzer@witzerlaw.com.