Members of our group are widely regarded as among the top lawyers in reimbursement and regulation of pharmaceuticals, biotech products and medical devices. We work extensively with all of the relevant federal agencies.
We counsel manufacturers and their customers on historic and prospective pricing and price reporting issues; developing reimbursement strategies for new services, drugs and technologies; obtaining new or modified reimbursement codes; and negotiating product sales and vendor service contracts. Our lawyers are deeply familiar with the complexities of Medicare Parts B and D, as well as Medicaid, and provide assistance to pharmaceutical, biotech and device clients on the regulatory, strategic pricing and business issues associated with them.
We regularly counsel clients on the federal and state regulatory and fraud and abuse implications of various sales and marketing practices. Areas of particular focus include product distribution, discounting and rebating, GPO and PBM administrative fees and rebates, free goods, samples, educational and research grants, “advisory committees” and similar personal services relationships, gifts and business courtesies, joint ventures of various types and tracking of state law marketing expenditures.
We also represent drug, biologics, and device manufacturers in criminal, civil, and administrative enforcement matters and a wide range of civil litigation.
Pharmaceutical Product Liability Litigation
Members of our group have exceptional depth and breadth in all phases of complex pharmaceutical product liability litigation, including multiparty and multijurisdictional cases, class actions, MDL proceedings and state coordinated proceedings. We currently serve lead roles, for example, in the Baycol, Bextra and Celebrex, and Seroquel MDL proceedings. We have served as national and regional counsel in the defense of pharmaceutical products including blood products, anti-cholesterol agents, asthma medications, atypical antipsychotics, diabetes medications, anesthetic agents, birth control drugs, anti-coagulants and weight loss medications.
We have defeated class certification in pharmaceutical litigation throughout the country. A recent example is Zehel-Miller v. AstraZeneca Pharmaceuticals LP, 223 F.R.D. 659 (M.D. Fla. 2004), in which a federal judge rejected plaintiffs’ efforts to certify a nationwide class of individuals who allegedly suffered injury arising from their use of an antipsychotic medicine. The United States Court of Appeals for the Eleventh Circuit refused to accept an appeal of this order, and the case, following discovery and the filing of a motion for summary judgment, was then voluntarily dismissed with prejudice.
There has been a growing trend for foreign litigants to file pharmaceutical claims in U.S. courts. In this regard, our lawyers have successfully obtained dismissals of the claims of foreign litigants through the forum non conveniens doctrine. Of note, Sidley lawyers achieved a significant victory for pharmaceutical manufacturers of blood products. A federal judge in Chicago granted the defendants' motion to dismiss, on forum non conveniens grounds, the United Kingdom plaintiffs in Gullone et al. v. Bayer Corp. et al., a case in the multidistrict litigation involving foreign hemophiliacs who allege that they contracted HIV and/or Hepatitis C from blood derivatives processed by U.S. defendants. The defendants sought dismissal of claims of eight representative plaintiffs of the more than 200 British and Welsh MDL plaintiffs. The ruling emphasized public interest factors that favored a trial in the UK, particularly the burden the litigation would cause U.S. jurors and courts, and lays the groundwork for future forum non conveniens motions in the MDL, which involves more than 2,500 plaintiffs from 31 countries.
Increasingly, plaintiffs’ counsel are focusing their efforts on claims of consumer fraud or purchase actions brought by third-party payors and consumers regarding pharmaceutical medications. Sidley has extensive experience in this area. For instance, Sidley represented a manufacturer of an anti-cholesterol medication in national and statewide litigation brought by third-party payors. Sidley was able to negotiate settlement of those claims on behalf of the manufacturer.
Sidley lawyers have successfully defended pharmaceutical claims on theories such as the learned intermediary doctrine. For instance, recently Sidley obtained a major victory involving an anti-cholesterol medication. Senior Judge Herman J. Weber of the Southern District of Ohio granted in full AstraZeneca's motion for summary judgment. The court held, in part, that the learned intermediary doctrine precluded a finding of proximate causation because AstraZeneca had warned physicians of risks associated with the medication "in no uncertain terms." The Court concluded that based on the evidence presented a "reasonable jury" could not find that the manufacturer violated "a duty to warn of the risk that caused plaintiff's injury."
We take great pride in our experience in developing and implementing strategies for series of cases involving the same product where rapid response, strategic insight and litigation know-how are critical to containment of exposure. For example, in MDL litigation involving an anti-cholesterol medication, we have taken several creative approaches that have resulted in thousands of cases being dismissed, and have demonstrated to the court that the vast majority of cases have no merit and that most plaintiffs will abandon their cases rather than prepare them for trial.
Over the years we have tried many cases and have developed a wealth of resources to successfully defend pharmaceutical claims at trial. We have also negotiated and implemented creative and cost-saving individual and global settlements.
We counsel pharmaceutical manufacturers on a wide range of strategic issues that arise outside of the litigation context, including interactions with federal regulatory agencies. Our lawyers have experience in all phases of interactions with regulatory authorities.