Product-Related Legal Issues

Product-Related Legal Issues

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Your products are subject to an increasing amount of international and national regulation to which the industry may have a hard time adjusting. To stay competitive, you have to stay ahead. Dentons can help you anticipate problems and provide solutions throughout a product’s life cycle: clinical trials, manufacture, quality control, marketing authorization, pricing, advertising, medical information channels, distribution and export. We track and anticipate regulations and incorporate them into your business practices so your business succeeds and grows.

Our manufacturing and quality control assistance includes drafting and negotiating contracts for manufacturing, imports and exports, advice on structuring manufacturing schemes including specific pharmaceutical tax optimization, recall and suspension of manufacturing licenses or products and disputes over Good Manufacturing Practices compliance. We work with you to manage legal risks associated with clinical trials. We can assist in negotiating trials-related contracts with institutions, investigators and patients, in structuring trials and administrative procedures. We can help you in your sales and marketing efforts, advise you on marketing authorization procedures patents data exclusivity and other intellectual property related issues, and on pricing and reimbursement of medicinal products.

We partner with you to map and manage your risks by preparing standard operating and compliance procedures concerning all areas of the product’s related activities. Our team is particularly experienced in identifying opportunities and risks associated with advertising operations, compliance audits and implementing marketing campaigns. Our distribution-related assistance includes modeling of product-related commercial activities, creation distributorship structures, drafting contracts with wholesalers, advising on trade marketing instruments in distribution channels and providing support in all aspects of public procurement for your products and antitrust assessments of your business activities

From product development to delivery, we look ahead.

Experience

Bioton S.A.: Representing a leading Polish life sciences company in an international patent dispute with a foreign competitor. We were litigating and simultaneously advising on formulating the relevant communication strategy for the market. Legal measures taken by the adversary created a threat to both distribution and sale of the client’s core product and were accompanied by a negative public relations campaign against it. By an immediate and top-quality reaction to the injunction granted by the court and consecutive 100% successful appeal, we have protected the company from irreparable damages in a very complex matter as it relates to patent infringement issues, misuse of rights, medical devices law and reimbursement issues.
Fastenetix, LLC: A developer of medical devices used in orthopaedic procedures, including spinal fusion and arthroplasty devices, in connection with a patent infringement and breach of contract litigation and successful nine figure settlement against one of the world’s largest medical device manufacturers, involving products representing annual sales in the multiple hundreds of millions of dollars.
Fougera Pharmaceuticals, Inc.: Defending an AWP case filed in the State of Louisiana against the client and dozens of other pharmaceutical companies in East Baton Rouge, Louisiana. Our team was able to obtain a favorable settlement.
K-V Pharmaceutical Company: Acting as national coordinating and lead trial counsel for a series of individual, multi-plaintiff, and class action product liability cases related to product recalls occurring in 2008 and 2009. Defending these cases at the trial and appellate level in the federal and state courts in at least 24 states, leanly staffing the matters with a core team from its Dallas office, and drawing also upon the expertise of lawyers in its own offices in Chicago, New York, New Jersey, Los Angeles, San Francisco, Washington, DC, St. Louis, Kansas City, and Phoenix, our team was able to use its broad experience in the pharmaceutical industry, product liability, class action defense, health care, and consumer protection to strategize across disciplines and jurisdictions and provide the client a coordinated defense and comprehensive service. The cases have been largely resolved to the company's satisfaction via dismissal or following early case assessment and resolution. Most recently, there were two major victories involving class actions. In Lefaivre/Polk v. KV Pharmaceutical Co., our team obtained a second dismissal of the case in which the alleged class of plaintiffs claimed economic injury based upon their purchase of a drug that was later recalled by the company. This case had previously been dismissed, the dismissal was reversed by the Eighth Circuit, and upon remand our team again obtained a dismissal. In Herndon v. KV Pharmaceutical Co., our team defeated class certification in a case in which the alleged class of plaintiffs claimed economic injury based upon their purchase of a number of drugs that were later recalled by the company. Class certification was denied after discovery, briefing and argument in March of 2012.
Medical suppliers: Counseling numerous medical equipment and other medical suppliers with respect to Medicare, Medicaid and other federal and state healthcare programs. We help the companies with supplier standards, licensure, contracting, coding, billing reimbursement and related issues. We also advise on how to structure arrangements with distributors, providers and group purchasing organizations; review product pricing and sample promotional programs and analyze advertising and marketing materials for compliance with federal and state fraud and abuse laws.

Insights

Decree 405/2023: Regulatory Framework for the Production, Research, and Commercialization of Cannabis

September 1, 2023

Argentina: On August 7, 2023, the Executive Branch issued a publication in the Official Gazette outlining the regulations specified in Law 27.669. This law establishes the framework for overseeing scientific research, industrial production, and the commercialization of the cannabis plant and its derivatives for medicinal and industrial purposes.

Uzbekistan replaces mandatory certification of local pharmaceuticals with post-marketing surveillance

April 18, 2022

Uzbekistan: Effective July 1, 2022, the mandatory certification of medicines, medical devices and medical equipment of local production will be replaced with post-marketing surveillance. The local pharmaceutical regulator, the Pharmaceutical Industry Development Agency of Uzbekistan, published for public consultation the draft procedure for post-marketing surveillance.

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