Life Sciences

Medical device manufacturers and technology companies face a rapidly evolving regulatory and business environment, underscored by new mergers and partnerships between medical device and medical technology companies, increased regulatory scrutiny, rapid technological advancement, and growing cybersecurity threats.

Antitrust

As with any growing industry, we expect the medical device and technology fields to experience a surge in competition-related claims and antitrust concerns. NERA has provided assistance to clients involved in antitrust claims for half a century. Our experts combine institutional knowledge of the medical device market and a rigorous economic approach with a deep understanding of antitrust and competition law. The following are select examples of NERA services provided to our medical device clients:

• Competition analysis, including market definition, market power, relevant market, barriers to entry, injury to competition, and antitrust damages, in the medical equipment, device, and supply markets
• Evaluation of competitive impact of proposed transactions or mergers

Intellectual Property

NERA’s intellectual property economists apply thorough analysis in IP disputes to determine damages in connection with infringement and breach-of-contract claims involving patents and trade secrets for clients in the medical device industry. We also work with clients to address such issues as irreparable harm and the impact of alleged false or misleading advertising. Beyond this, our consultants work with medical device clients to value IP in connection with selling or licensing negotiations, preparing required transfer pricing documentation, obtaining advanced approval from a tax authority for the price of a particular trade flow or resolving a tax controversy. We help our clients identify portions of their IP portfolios that have value, develop strategies to manage risk, and use their IP for strategic advantage in the marketplace. The following are recent examples of our work:

• Designed and conducted surveys to address trade dress issues
• Conducted statistical analysis for a medical device manufacturer preparing for arbitration in a National Advertising Division challenge
• Calculated reasonable royalties, lost profits, and price erosion in patent and trademark infringement cases involving  innovation in medical technology and equipment
• Quantified damages for medical research and development patent infringement cases

Product Liability and Mass Torts

NERA economists work with medical device companies on projects related to product recalls, damages claims, insurance disputes, mergers and acquisitions and consumer class actions.  Examples of recent matters include:

• Estimated the liability related to the implantation of artificial hips, including projecting likely failure rates and expected claiming rates
• Estimated the liquidated value of all present and future product liability claims, including settlements and opt-outs, in a bankruptcy case involving medical devices
• Provided a valuation of liabilities and analysis of insurance allocation for a medical equipment company resulting from a mass silica exposure lawsuit 

Securities

NERA’s securities and finance economists work with clients in the medical device and medical equipment industries to address allegations of product liability and securities fraud, to assist in resolving commercial disputes, and to manage financial, legal, and securities risks. Examples of recent matters include:

• Valued the assets of a medical device company in a bankruptcy proceeding involving claims of fraudulent transfers
• Provided analysis and expert testimony in a securities class action involving a medical equipment company

Transfer Pricing

Based throughout Europe and the US, NERA’s transfer pricing economists provide clients in the medical device and medical technology industries with expert analysis, valuation support, and advice on domestic and cross-border tax and valuation matters, and serve as expert witnesses in tax litigation and arbitration matters. Examples of recent work include:

• Provided expert testimony in tax controversy proceedings involving a multinational medical device company
• Provided a policy and documentation review in light of changing medical device and accessory regulations
• Conducted a transfer pricing analysis for a medical technology, wholesale, and retail company for its operations in the EU and Russia
• Performed a detailed analysis and consulted on the transfer pricing structure between the EU and US for a medical device company