We work with clients in the following areas:

Corporate/Transactional: mergers and acquisitions (M&A), licensing, strategic collaborations and other partnering agreements, venture capital financings and securities offerings, and SEC compliance and corporate governance

Intellectual Property: patent due diligence, prosecution, opinion, strategic counseling, and litigation

FDA Regulatory and Health Care Compliance: product approvals, advertising and promotion, reimbursement, and fraud and abuse compliance

Government Enforcement: investigations and litigation

Securities Enforcement: litigation and enforcement

Antitrust: investigations, litigation, and counseling 

Through a cross-disciplinary approach to advising medical device companies, we provide clients with straightforward advice tailored to their unique and specific legal and business needs. Our work on behalf of industry participants covers a range of therapeutic areas, including aesthetics, cardiovascular intervention, in vitro diagnostics (IVDs), oncology, ophthalmology, electrostimulation, drug delivery, orthopedics, among others.

With offices in London, Hong Kong, Shanghai and Tokyo, we have extensive experience advising clients on M&A, capital markets and IP matters in Asia, Europe and throughout the world.

Corporate/Transactional

Medical device companies turn to us for all their corporate needs, including M&A, private financings, public offerings, licensing and collaborations, and corporate governance. Our attorneys have significant experience representing investment banks and venture capital firms in all stages of funding. This depth and breadth of experience and industry knowledge enables us to identify key legal issues unique to the medical device industry and leverage, when appropriate, the vast experience of lawyers in all relevant disciplines. We understand all the perspectives and anticipate sticking points in negotiations while providing creative, cost-effective solutions.

Representative matters include:

• Assisted Covidien it its US$2.7 billion acquisition of ev3, its US$544 million acquisition of VNUS Medical, its US$210 million acquisition of Aspect Medical, and its US$60 million acquisition of Power Medical Innovations.
• Represented Becton Dickinson in its US$270 million sale of three distinct product groups: ophthalmic systems, surgical blades/scalpels, and critical care systems, to portfolio companies of RoundTable Healthcare Partners.
• Represented Salient Surgical Technologies in its US$525 million sale to Medtronic.
• Represented Stryker Corp. in the sale of its bone growth therapies product line (including OP-1 Implant, OP-1 Putty, Opgenra and Osigraft) as well as a manufacturing plant in New Hampshire, to Olympus Corp. for US$60 million.
• Represented Vivo Ventures, Sanderling Ventures and Clarus Lifesciences in a US$30 million Series D financing of NeoMend.

Intellectual Property

Our IP team is uniquely suited to meet the needs of both entrepreneurial start-ups and multinational corporations developing medical devices and related products. We have worked with leaders in the field of medical devices and consumer products to obtain patents, manage worldwide patent portfolios, negotiate licenses and aggressively defend patent portfolios in the United States and internationally. Many of our IP lawyers are qualified to practice in both the United States and abroad, including several who are dual-qualified to practice at the USPTO and the European Patent Office. We understand both the legal dimension of our clients’ intellectual property, and the scientific and substantive aspects of their innovations and products.

Representative matters include:

• In Therasense, Inc. (n/k/a Abbott Diabetes Care) & Abbott Labs. v. Becton, Dickinson and Co. & Nova Biomedical Corp. (N.D. Ca.), we defended Becton and Nova in an infringement case involving patents relating to blood glucose monitoring test strips. Between bench and jury trials, we defeated all four asserted patents. The case then went before the en banc Federal Circuit to determine the scope of the inequitable conduct doctrine and is on remand.
• Advised Smith & Nephew on patent claims and strategies to protect its orthopedics and wound care franchises in both the U.S. and European jurisdictions.
• Advised Medtronic in intellectual property due diligence of its US$1.35 billion acquisition of the spinal IP portfolio from Gary K. Michelson, M.D. and Karlin Technologies.
• Advised Johnson & Johnson Development Company in intellectual property due diligence for Series A-G investments of private medical device companies.

FDA Regulatory and Health Care Compliance

Medical technology is heavily regulated by the U.S. FDA and other domestic and foreign regulatory authorities. We assist medical device companies in formulating optimal regulatory strategies to get their products to market, obtain reimbursement, and ensure ongoing compliance with applicable laws and regulations to minimize the risks of product liability lawsuits, whistleblower actions, and government investigations. Our attorneys are adept at balancing the need for achieving compliance while remaining sensitive to business realities and ease of implementation.

Representative matters include:

• Assisted Stryker in conducting a regulatory assessment across various aspects of its business, helping the company draft internal policies and guidance, and working with the company to enhance certain regulatory controls.
• Advised Nova Biomedical on 510(k) clearance requirements for in vitro diagnostic devices.
• One of our partners served on secondment as acting general counsel of the Spine and Biologics division of Medtronic, and advised on a broad array of legal and regulatory issues.

Government Enforcement

Guiding and counseling medical device companies and their executives through investigations brought by domestic and foreign enforcement bodies alleging violations of laws such as the False Claims Act (FCA), the Federal Anti-kickback Statute, and the Foreign Corrupt Practices Act (FCPA) is one of the many areas where our Government Enforcement team excels. We also provide comprehensive advice to clients conducting internal investigations prompted by government inquiries, responding to criminal and regulatory enforcement inquiries, and developing risk assessment and prevention programs.

Representative matters include:

• Defending a prominent medical device manufacturer in responding to a federal criminal investigation into off -label promotion and a related civil FCA litigation. We won dismissal of the FCA allegations that the company submitted fraudulent submissions to FDA and promoted its products off -label to physicians.
• Represented a multinational medical device company in connection with two qui tam actions and a related investigation by a U.S. Attorney’s Office focusing on the company’s promotion and sale of one of its products. We won dismissal of all claims on behalf of the government in one of the actions and dismissal of the remaining retaliation claim in that action on motion for judgment on the pleadings. We continue to defend the claims in the second relator’s action and to represent the company in the related investigation.
• Leading an internal investigation stemming from a high profile Department of Justice (DOJ) and SEC industry-wide FCPA sweep in the medical device industry for an international medical device company. The sweep involved investigations in 12 countries on four continents. We are also representing the company in connection with any future monitorship that the DOJ and SEC may require.

Securities Litigation and Enforcement

We regularly advise medical device clients on important and highly complex SEC disclosure decisions, and defend them in traditional securities litigation involving mergers and acquisitions and stock price drops. Our attorneys have substantial experience conducting internal investigations and representing clients in both civil and criminal investigations and enforcement proceedings before the SEC, DOJ, and other regulatory agencies, as well as follow-on private litigation related to the disclosure of accounting issues, potential insider trading, and compliance with the FCPA.

Representative matters include:

• Representing BioForm Medical and former members of the Board of Directors in a class action shareholder litigation alleging breaches of various fiduciary duties in connection with the board’s approval of a proposed tender offer by Merz Aesthetics and in connection with disclosure regarding the transaction. Successfully opposed plaintiff’s application for a temporary restraining order to enjoin the tender offer by Merz to the BioForm shareholders. The matter is ongoing and a class representative has not yet been certified.
• Represented Covidien and its merger subsidiary in multiple state class action litigations involving inadequate disclosure and failure to obtain adequate price claims filed in connection with Covidien’s US$2.7 billion tender offer acquisition of ev3. We ultimately obtained a favorable settlement, with no admission of wrongdoing and no monetary payment, by which the plaintiff's in both jurisdictions dropped all of their claims.

Antitrust

Our Antitrust team regularly represents leading medical companies on matters, including pricing, exclusive contracts, bundling, product design, competitor collaborations, and mergers, before enforcement agencies such as the Federal Trade Commission (FTC) and DOJ. We also advise these companies in connection with nonpublic government investigations involving group purchasing organizations (GPO) contracting. In addition, we represent both plaintiff's and defendants in litigating cutting-edge issues that medical device companies confront, including product design, bundled discounts, technological tying, and exclusive dealing.

Representative matters include:

• Represented Becton Dickinson before the FTC in obtaining clearance of its US$205 million acquisition of Accuri Cytometers without a Second Request.
• Represented Covidien before the FTC in obtaining clearance of its US$2.7 billion acquisition of eV3 without a Second Request.
• Represented Salient Surgical Technologies before the FTC in obtaining clearance of its US$525 million sale to Medtronic without a Second Request. Medtronic simultaneously acquired PEAK Surgical.

For more information, please contact:

Greg Levine

Marc Rubenstein 

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