Experience
Negotiation of Settlement in Misbranding Law Matter
We represented a physician who had been designated as a “target” of a federal grand jury investigation focusing on FDA allegations of misbranding. The client along with other oncologists potentially faced numerous felony charges. We successfully defended the physician, resulting in a plea agreement to a single misdemeanor, favorable resolution of all civil matters including false claims act violations and no debarment of physician.
Cyber Security Defense Verdict In FTC Administrative Action
Successfully defended LabMD at trial before the FTC Chief Administrative Law Judge. LabMD is the medical laboratory whose data security policies, practices and procedures allegedly violated section 5 of the FTC Act. After a lengthy trial the Administrative Law Judge dismissed the complaint. This is a landmark case because it is the first instance in which the FTC has prosecuted a HIPAA “Covered Entity” for violation of consumer privacy without being joined by HHS. It is also the first instance in which the FTC has been forced to take a case to trial involving data security and privacy. Thus this case established the adjudicatory framework for FTC cyber security administrative trials including the standard of proof and elements required to prove section 5 consumer harm in a cyber security case.
Medical Device Product Liability Litigation
Defending multiple product liability cases involving joint replacement products.
Successfully Defended a Pharmaceutical Company During a Patent Infringement Lawsuit
Kathryn defended her client, a pharmaceutical company, who was named in a patent infringement lawsuit under the Hatch-Waxman Act. She successfully defended her clients at trial and on appeal.
OxyContin Litigation
Defense of Purdue Pharma, LP in multiple state court cases involving product liability claims based on the marketing of the prescription pain relief medication Oxycontin. In the course of that defense, we successfully obtained one of the first judgments in favor of the company based upon the defense of misuse of the product. We also obtained the dismissal of a significant number of individual claims, and negotiated a resolution of one of the first actions instituted by a state attorney general against the company.
Allegations of Wrongful Termination by Ex-Employee of Medical Device Manufacturer
When a medical device manufacturer faced allegations of wrongful termination from an ex-employee, they turned to Dinsmore. The plaintiff was an engineer who was originally hired by the client to serve as a project manager. Upon hiring the plaintiff, the terms of his employment were laid out in an employment contract, which also contained deadlines for the completion of various projects. After nearly a year of employment, it was determined that the plaintiff had not met the required deadlines, and he was terminated. The plaintiff alleged he was wrongfully terminated and filed 10 claims against the client, including alleged violation of public policy, breach of contract and age discrimination. We filed a motion for summary judgment, which was granted on nine claims. For the remaining claim of violation of a public policy, we prepared the matter for trial, including managing discovery and taking depositions. On the first day of the trial, before proceedings officially began, we negotiated a settlement favorable to our client, enabling them to avoid litigation.
Lewis v. Synthes, et al.
Dinsmore & Shohl represented Synthes, a medical device manufacturer, in the Ohio cases involving alleged injuries from the use of pedicle screws. The cases were dismissed.
Consultant v. Intellectual Property Owner / Inventor
As part of our trial team, I served in 2012-2013 as counsel for the consultant on his claim for breach of a consulting agreement. Our client had assisted the defendant, an inventor of intellectual property, in successfully marketing his inventions to medical device companies, but the inventor then refused to pay our client the millions of dollars in contingent commissions which were owed. After we successfully obtained summary judgment on liability, the case became centered around complex proof of past and future damages which totaled many millions of dollars. I served as lead counsel for the client on several critical depositions, including depositions of defendant’s damages expert, defendant’s accountant, and the defendant-inventor himself. I also served as a liaison for some of our experts on damages-related infringement issues and on complex accounting issues. Using materials developed in discovery and at depositions, I served as lead counsel in responding to a critical motion in limine, whereby the Court approved central parts of our damages theory. This ruling helped lead to successful resolution of the matter shortly before trial.