We represent pharmaceutical manufacturing clients in some of the most challenging litigation in the country, and our clients have enjoyed broad and widely-recognized success. Our lawyers are among the most experienced in the nation; they write articles, they give speeches, they teach — but mostly, they try cases. We are the Firm to which our clients turn when the stakes are highest.
We have handled some of the leading published federal trial-level and appellate-level cases on issues, such as those involving the admissibility of expert testimony, critical to the pharmaceutical industry. Additionally,The National Law Journal has recognized three of the Firm's cases as Top Defense Wins: Crowson v. Davol, Inc., the first jury trial in the country involving allegations that hernia-repair mesh can cause infertility; Glastetter v. Novartis Pharm. Corp., one of our Daubert summary judgment victories, recognized as a top win without trial (and subsequently affirmed by the Eighth Circuit, it stands as one of the industry’s most important Daubert rulings to date); and finally our defense verdict in a jury trial in southern Mississippi, Warren v. Sandoz Pharm. Corp.
Pharmaceutical Products Litigation
Among its most significant pharmaceutical representations, the Firm is national trial counsel to one of the world's largest manufacturers in product liability claims involving an obstetrical drug, Parlodel®. These claims have provoked intense media coverage and present complex issues of medical causation, liability, and FDA regulation. We have successfully tried cases — in diverse, difficult forums from coast to coast, including Minnesota, Alabama, eastern Texas and southern Mississippi — and we have upheld our defense verdicts on appeal. See, e.g., Rider/Siharath v. Sandoz Pharm. Corp., 295 F.3d 1194 (11th Cir. 2002), aff'g, 131 F. Supp. 2d 1347 (N.D. Ga. 2001); Hollander v. Sandoz Pharm. Corp., 289 F.3d 1193 (10th Cir. 2002),aff'g, 95 F. Supp. 2d 1230 (W.D. Okla. 2000); Warren v. Sandoz Pharm. Corp., 783 So. 2d 735 (Miss. Ct. App. 2000). We have won multiple major cases by summary judgment and successfully defended those judgments on appeal as well. See, e.g., Glastetter v. Novartis Pharm. Corp., 252 F.3d 986 (8th Cir. 2001), aff'g, 107 F. Supp. 2d 1015 (E.D. Mo. 2000). We also have successfully litigated in the context of extensive Rule 706 proceedings. See Soldo v. Sandoz Pharm. Corp., 244 F. Supp. 2d 434 (W.D. Pa. 2003). The medical claims in these cases generally involve severe neurological or cardiovascular injuries, including stroke, seizure, and myocardial infarction. We also have intensely litigated non-medical issues in these cases, such as Buckman federal preemption, off-label use, and essential corporate document confidentiality.
The Parlodel® appellate trilogy illustrates a number of the issues with which we routinely deal in the national litigation: rapidly evolving medical literature; scientific and medical fields of epidemiology, toxicology, neurology, cardiovascular disease, and obstetrics; chemical structure analyses; biochemical mechanisms of action; anecdotal evidence; putative corporate admissions; broad regulatory oversight; international and domestic adverse drug reaction reporting; and the company's withdrawal of the indicated use in the United States. (Summaries of key holdings in Glastetter and other of our significant pharmaceutical products cases may be found by following the Case Finder link in the main navigation above.)
Our pharmaceutical products liability work also involves such products as anti-fungals, anti-cholesterols, migraine treatments, anti-depressants and anti-coagulants. These representations include both national trial counsel service in serial litigation and the defense of single-plaintiff cases. Our clients are manufacturers and distributors of prescription drugs, and we also work closely with and represent many amici curiae whose interests parallel those of our pharmaceutical clients.
We coordinate and control massive discovery efforts of international scope through the use of our in-house, lawyer-managed technology and related staff. We track world literature through Washington's preeminent resources at the National Institutes of Health and the National Library of Medicine. We assemble teams of world-class experts. And we have developed an outstanding network of regional and local counsel with whom we work in jurisdictions all over the country.
The Firm hosts an Annual Seminar on Complex Litigation Defense, now in its 33rd year. Leading defense practitioners share cutting-edge legal theories and strategies developed through years of experience successfully defending high-stakes cases involving pharmaceutical, medical device, and chemical products, and environmental torts.
Regulatory Counseling
The Firm's attorneys also counsel clients regarding food, drug and medical device law with an emphasis on U.S. Food and Drug Administration regulation of pharmaceuticals, medical devices, biologics, and food chemical additives. We represent manufacturers, distributors and suppliers of finished and bulk products regarding FDA regulation, inspections and enforcement actions.
Our attorneys prepare compliance programs, conduct internal corporate investigations and due diligence reviews, and have represented clients in connection with FDA hearings, advisory committee proceedings, citizen petitions, clinical trial investigations and reviews, FDA civil and criminal investigations, and congressional investigations. We counsel clients on FDA regulation of prescription and over-the-counter drugs, biologics (including blood plasma derivatives), medical devices, dietary supplements, and food additives, and on pioneer and generic drug marketing exclusivity claims under the Drug Price Competition and Patent Term Restoration Act. This work involves product approval applications, clinical trials, domestic and international pharmacovigilance, good manufacturing practice, and product labeling, packaging and promotion, as well as establishment inspections, warning letters, product recalls, seizures and injunctions, suspension and debarment, and fraud and abuse investigations.