Represented Global Pharmaceutical Manufacturer During Health Care Fraud Investigation
Defended a foreign-based global pharmaceutical manufacturer in a multi-jurisdiction (federal and state) government investigation of sales, marketing, and research activities. Client was dismissed from the False Claims Act (FCA) qui tam action, and intervention proceeded against their co-promote partner only.
Successfully Defended a Pharmaceutical Company in a False Claims Act Investigation
Defended a pharmaceutical company in a civil False Claims Act investigation by the U.S. Department of Justice related to alleged inappropriate product promotion and speaker program kickbacks. The DOJ closed the matter against the company after a two-year investigation period.
Internal Investigation Conducted on Behalf of Pharmaceutical Company
Conducted an internal investigation on behalf of a commercial pharmaceutical company arising from an employee whistleblower complaint. Allegations included inappropriate promotional activities, false claims, HIPAA violations, and kickbacks. The investigation included interviewing multiple employees, reviewing relevant documents, and preparing a findings memorandum with corrective action recommendations.
Internal Investigation Conducted on Behalf of Medical Device Company
Conducted an internal investigation on behalf of a medical device company arising from two employee whistleblower complaints alleging health regulatory and compliance violations. Allegations included pre-approval promotion, inappropriate promotional activities, and a detrimental lack of a corporate compliance program. The investigation included interviewing multiple employees, reviewing relevant documents, preparing a findings memorandum with corrective action recommendations, and assisting the company in implementing several corrective action recommendations.
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.
Representation of Richwood Pharmaceuticals, Inc.
Representation from inception of Richwood Pharmaceuticals, Inc., through sale to British based plc. Flagship product is Adderall, an attention deficit disorder drug.
1. Acquisition of Rexar Pharmacal, N.Y based manufacturer of products, including Obetrol, which after additional research and configuration became the Adderall® line of products approved by the FDA.
2. Acquisition of Manufacturing Chemists, Inc, Indianapolis based manufacturer of women's health product line. Assets included plant and facilities, product lines, and intellectual property.
3. Negotiation and implementation of multiple rounds of venture capital financing in support of development and marketing operations in the growth and development of Adderall prior to sale to Shire Group plc.
4. Negotiation and sale of Richwood Pharmaceuticals, Inc. to British based plc. Flagship product was Adderall® for attention deficit disorder.
Private Equity Acquisition of Medical Device Manufacturer
Dinsmore represented a closely-held international medical device manufacturer selling a controlling interest to a private-equity company. We advised the client through all aspects of the complex transaction including negotiating the purchase agreement, new governance structure, executive compensation, and non-compete agreements.
Provide Counsel and Patent Prosecution to Medical Device Manufacturer
We have been providing patent work for medical implant technology/devices, including hip, knee, shoulder, elbow and spine. The technologies mix different materials, which minimize the debris or fragmentation, last longer than previous devices and are more require a less traumatic surgery to surrounding bone and tissue.
Growing a business is challenging, even with the opportunities offered by today’s global marketplace. Expanding your product and service offerings to your customers requires a strategic vision and focused plan, as well as the resources to pull it all together.
Halma, p.l.c., is an international group of technology companies with its headquarters outside of London, England. Halma has worked with Dinsmore for nearly 25 years. In that time, Dinsmore has represented Halma through a multitude of acquisitions, both domestically and abroad, as Halma has grown to become a global leader in health and safety technology.
When the opportunity recently arose to acquire two companies to boost Halma’s Health and Analysis sector, the company again turned to Dinsmore for counsel. The acquisitions of California-based Sensorex, Inc. and Pennsylvania-based Accutome, Inc., offered myriad challenges. As the deals progressed, it appeared Halma would be able to announce the closings of both transactions to the Stock Exchange on the same day.
Our team worked to structure the asset purchase of Sensorex for $37.5 million and the stock purchase of Accutome for an initial payment of $20 million, handling everything from negotiating and drafting the documents to managing the legal due diligence for both transactions. We assisted Halma with the intellectual property, benefits and employment components of each deal and assisted with all details of closing.
On the Accutome deal, we were faced with the unique task of sequentially structuring the deal to comply with tax law related to the acquisition of Accutome’s Dutch subsidiary. Because of the tax implications of acquiring a subsidiary through one Halma affiliate, while acquiring the parent company through another affiliate, we were asked to ensure that the transaction involving the subsidiary was closed before the U.S. transaction was completed. This required that we coordinate compliance with Dutch requirements in real time, in order to complete the transaction prior to opening of the European markets.
Accutome is primarily known for designing diagnostic equipment used to identify eye conditions and for innovative surgical instruments. Sensorex, a manufacturer of electrochemical water sensors, will enable Halma to enhance its water analysis and water quality programs. Assisted by Dinsmore’s counsel, Halma continues to grow and expand its product offerings to clients and position itself as an industry leader.
Representation of U.S. Subsidiary of British Based plc
Representation of U. S. subsidiary of British based plc in selected transactions as follows:
1. Acquisition of Atlantic Pharmaceutical Services of Columbia, Maryland via stock purchase transaction. Handled all aspects of transaction inclusive of due diligence, real estate, bond financing modifications, intellectual property issues and other matters related to fully effecting transaction.
2. Sale of over the counter product line, inclusive of products Colace and peri-Colace, to Purdue Pharma L.P. Negotiated asset transaction and all aspects related thereto for sale of product line inclusive of distribution and other arrangements.
3. Reorganization of investment in Qualia Computing, Inc., a medical equipment company in Dayton, Ohio that produced breast imaging machines. Reorganization effected via recapitalization of Qualia. Participated in all aspects of negotiation and documentation of the transaction.
Medical Device Product Liability Litigation
Defending multiple product liability cases involving joint replacement products.
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.
Patent Preparation and Prosecution
Our firm works with a large company in the medical device industry in the preparation and prosecution of patent applications related to numerous technologies in its IP portfolio.
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.
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.
Venture Capital Financing
Represented group venture funds in $15,000,000 "A" round preferred stock financing of North Carolina biotech firm.
Represented Biotech Client During a Stock and Real Property Sale to a Strategic Buyer
We assisted our client with a sale of stock and a piece of real property to a strategic buyer. We assisted in all phases of the transaction, including negotiation, documentation and closing the deal. This enabled our client to retire at the right time and maximize the sale price of the business.
Acquisition of venture-funded imaging software company by cash merger.
Advise hospital on data access arrangement that allows safe patient information sharing
We worked with a hospital to build a data access arrangement that enabled them to share data between coding staff and off-site providers. We worked with the client to help structure the agreements to ensure protected and sensitive health care records and information are properly protected, as well as to build policies to ensure controls are in place.
Acquisition of Two Affiliated Swiss Companies
Representation of Pharmaceutical Companies
Representation of many pharmaceutical companies with licensing of products, acquisition and divestitures of assets.
Mr. Jernigan has served as principle West Virginia counsel for Purdue Pharma, LP in the defense of claims based upon the marketing of its prescription pain relief medication, OxyContin. In the course of that defense, Mr. Jernigan was successful in obtaining one of the first judgments in favor of the company based upon the defense of misuse of the product. Mr. Jernigan was also able to obtain the dismissal of a significant number of individual claims and negotiate a resolution of one of the first actions instituted by a state attorney general against the company.
In re Bendectin Product Liability Litigation
Defense of Merrell Dow in several thousand suits alleging that birth defects were caused by the prescription anti-nausea medication, Bendectin. Numerous summary judgments and jury verdicts obtained in favor of Merrell Dow.
Counseled a Pharmaceutical Company on Compliance Program Development and Implementation
Advised a clinical-stage pharmaceutical company regarding its transition to commercial stage, including the development and implementation of a corporate compliance program. This included training company executives on compliance and regulatory matters, drafting and reviewing compliance policies and procedures, reviewing promotional materials, advising on implementation of a transparency tracking/reporting program consistent with federal and state laws, and advising on compliance and regulatory matters.
Conducted a Compliance Review and Assessment of a Biotechnology Company’s Corporate Compliance Program
Assessed the implementation and effectiveness of a biotechnology company’s corporate compliance program, including review of company policies, procedures, guidelines, training materials, risk assessment processes, internal investigation reporting mechanisms and follow-up, and auditing and monitoring activities. Also made recommendations for enhancing the program and assisted with implementation of such recommendations.
Defense of Pharmaceutical Company in False Claims Act (FCA) Lawsuit
Defended a global pharmaceutical company in a False Claims Act investigation involving five qui tam complaints related to the sales, marketing, and promotional activities for several drugs in the company’s product portfolio. Criminal and civil investigators from multiple federal agencies were involved in the investigation, including the U.S. Attorney’s Office for the District of Massachusetts, U.S. Food and Drug Administration (FDA), Veterans Administration (VA), and Federal Bureau of Investigation (FBI). The matter included document collection from more than 1,800 employees, witness interviews, and presentations to investigators. I negotiated a civil settlement agreement with the Department of Justice, settlement agreement and release with the lead qui tam relator, civil settlement agreements with the National Medicaid Fraud Control Unit team and individual states, and a corporate integrity agreement (CIA) with the U.S. Department of Health and Human Services Office of Inspector General (OIG).
Defense of Clinical Laboratory in False Claims Act (FCA) Investigation
Defended a clinical laboratory in civil and criminal investigations by the Department of Justice, U.S. Attorney’s Office for the Northern District of California, Office of Inspector General, Federal Bureau of Investigation, and the California Department of Insurance related to inappropriate sales and marketing activities, phlebotomy payments, and other kickbacks. Civil and criminal investigators declined to intervene in the matter against the company.
Diet Drug Litigation
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