Practice Areas & Industries: Wilson Elser Moskowitz Edelman & Dicker LLP

 




Pharmaceuticals & Medical Devices Return to Practice Areas & Industries

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Practice/Industry Group Overview

Pharmaceutical and medical device industries face increasingly complex challenges. Evolving case law, driven largely by Supreme Court decisions and sweeping new regulations, underscores the need for ongoing monitoring and analysis. With 30 years of related experience and a material presence in Washington, D.C., Wilson Elser understands this shifting landscape. We have helped countless pharmaceutical and medical device manufacturers with legal issues, whether simple and local or complex and multijurisdictional.

We have helped countless pharmaceutical and medical device manufacturers with legal issues, whether simple and local or complex and multijurisdictional.

The process of obtaining FDA clearance or approval of pharmaceutical and medical devices can be especially challenging. Even after a product is cleared or approved, companies frequently face complications related to compliance, labeling, marketing, recalls and litigation. Wilson Elser works in close collaboration with its drug and device clients to develop and implement strategies to successfully navigate this regulatory labyrinth.

Wilson Elser serves domestic and foreign manufacturers of drugs and medical devices in connection with regulatory compliance, claims and litigation. We act in various capacities, including national coordinating counsel, litigation and trial counsel, in defending suits against name-brand and generic drugs and approved or cleared medical devices. The firm’s national in-house infrastructure facilitates the handling and defense of large, cross-jurisdictional mass tort litigation with dockets numbering in the hundreds. The firm’s national network of 24 strategically located offices provides an essential forum for developing and coordinating uniform mass tort defense strategies.

Wilson Elser attorneys proactively identify innovative ways to resolve disputes at the earliest opportunity utilizing dialogue, arbitration, mediation or other forms of alternative dispute resolution. When early or alternative resolution solutions are not practical, our attorneys do not hesitate to try cases in court. Whether in local or district courts, Wilson Elser is proud of its reputation as one of the largest and most successful trial firms in the country. Our attorneys understand the limitations of a “one size fits all” litigation approach and devise intelligent closure strategies unique to our clients and their business realities. Many also enjoy practical medical experience from previous careers, further enhancing their ability to resolve the complex legal issues that have come to define this practice.
 


 
 
Articles Authored by Lawyers at this office:

Temporary Insurance Applications and Agreements: The Impact of Material Misrepresentations in Life Insurance Applications on Coverage
Michelle M. Arbitrio, November 19, 2013
Earlier this year, the Fourth Circuit upheld a decision of the U.S. District Court for the Eastern District of Virginia, Banner Life Ins. Co. v. Noel, No. 12-1329, 2013 WL 221650 (4th Cir. Jan. 22, 2013), holding that a material misrepresentation made in a life insurance application was a...

Maryland Court of Appeals Upholds the Frye-Reed “General Acceptance” Test for Admissibility of Expert Testimony
Peter W. Chin,Angela W. Russell, October 28, 2013
The Maryland Court of Appeals issued an opinion on September 24, 2013, in Josephine Chesson, et al. v. Montgomery Mutual Insurance Co., No. 97, 2013 WL 5311126, -- A.3d --- (Md. Sept. 24, 2013) (Chesson III), finding that, under Maryland’s Frye-Reed standard, where there exists continued...

As the “NY State of Health” Enters Its Third Week, a Look at the Role of Navigators
Frank J. Fanshawe,Sandy M. Smith, October 23, 2013
New York’s Health Insurance Marketplace, officially called the NY State of Health, has entered its third week of operation, and as of October 8, 2013, had enrolled 40,000 New York residents in health insurance plans offered through the Marketplace. These enrollments have taken place online,...

ACA Not Enough to Save Penn State’s Employee Wellness Program
Frank J. Fanshawe,Sandy M. McDermott, October 14, 2013
Recent negative media reports caused Pennsylvania State University to modify its employee wellness program, making clear that considering compliance with the Patient Protection and Affordable Care Act of 2010 (ACA) alone is not enough when employers launch such programs. Penn State followed the ACA...

Evaluating Employer Insurance Coverages to Defend against Claimed Violations of the Affordable Care Act
Frank J. Fanshawe,Sandy M. McDermott, October 09, 2013
Employers have long been subject to lawsuits brought by employees for employment actions such as wrongful termination, discrimination and harassment. With the opening this week of the Health Insurance Marketplaces and the deadline for employers to provide the Notice to Employees of Coverage Options...

HHS Issues Privacy Rule Guidance for Law Enforcement Agencies
Frank J. Fanshawe,Jason LaFlam, October 02, 2013
The Office for Civil Rights (OCR) of the Department of Health and Human Services recently announced the release of its guidance, “Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule: A Guide for Law Enforcement.” The guide is a resource OCR designed to assist law...

Administration Delays Launch of Federally Facilitated Small Business Health Insurance Exchanges
Frank J. Fanshawe,Sandy M. Smith, September 30, 2013
In 35 states where the federal government is taking a lead role in the development of the health insurance exchanges, small businesses will be required to wait until November to complete their online purchases of health coverage. The Obama Administration originally established October 1, 2013 as...

Business Associate Definition Expanded and HHS Empowered to Impose New Civil Fines
Frank J. Fanshawe,Jason LaFlam, September 25, 2013
Long-awaited omnibus regulations (Omnibus Rule) adopted earlier this year by the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) made significant modifications impacting “business associates” to the HIPAA Privacy, Security, Enforcement and Breach Notification...

Omnibus HIPAA/HITECH Rules Require Changes to Notice of Privacy Practices Prior to September 23, 2013
Frank J. Fanshawe,Jason LaFlam, September 04, 2013
Earlier this year, the Office for Civil Rights (OCR) in the Department of Health and Human Services (HHS) issued its long-awaited omnibus regulations that make significant modifications to the HIPAA Privacy, Security, Enforcement and Breach Notification Rules. These modifications are the result of...

U.S. Department of Health and Human Services Imposes $1.2 Million Penalty For Protected Health Information Breach Involving Leased Copiers
Frank J. Fanshawe,Jason LaFlam, August 24, 2013
Covered entities should examine their procedures to evaluate and safeguard protected health information (“PHI”) that may be stored on leased photocopiers and other office equipment. Under a settlement with the U.S. Department of Health and Human Services (“HHS”), Affinity...