McDonald Hopkins LLC

Our firm has attorneys dedicated to the representation of medical device companies, funds and financing sources that invest in or finance medical device businesses, and research centers and universities that develop and commercialize medical devices.

Our services to clients in the medical device industry include:

• Benefits consulting
• Business restructuring and bankruptcy
• Data privacy and cybersecurity
• Employment and labor law
• Environmental matters
• Executive compensation, equity and incentive programs
• Federal, state and local tax matters, including multi-state tax planning
• General corporate including, but not limited to, choice of entity, organizational structure and governance consulting
• Government incentive programs
• Government affairs
• Intellectual property matters
• Licensure and accreditation
• Litigation
• Merger and acquisition
• Real estate and construction transactions
• Regulatory compliance, FDA due diligence and investigations and agency approval processes
• Reimbursement consulting and payor contracting, investigations, disputes, and actions
• Securities matters
• Trade secret and non-compete protection
• Venture structuring

Representative Matters

• Represented privately-held manufacturers of medical devices in sale of minority interest (with option to purchase rest of company) by strategic buyer.
• Represented medical products/services company in capital infusion transaction with venture capital investor.
• Represented multiple medical device companies in M&A transactions.
• Represented a spine implant company on corporate, and fraud and abuse matters.
• Negotiated a merger and amendments to operating and consulting agreements for an implant manufacturer.
• Represented large pharmaceutical companies in employment litigation.
• Represented a biosurgery and pharmaceutical products company in the asset sales of medical device patents and products through a bankruptcy section 363 process.
• Represented a biosurgery and pharmaceutical products company during an FDA investigation impacting punitive damages coverage.
• Represented two major medical device manufacturers on their real estate transactions.
• Represented several medical device companies in the design and implementation of employment agreements and equity and incentive programs.
• Real estate transactions for one of the fastest growing distributors of medical and surgical supplies.
• Represented a medical device start-up company.
• Represented a Fortune 500 medical device manufacturer in both U.S. and international real estate and commercial transactions.
• Represented a start-up closely-held spine implant manufacturer whose investors include orthopedic surgeons in all corporate and commercial matters.
• Performed fraud and abuse counseling for an implant manufacturer including anti-kickback advice and the development of a compliance plan.
• Responded to a government investigation on behalf of an implant manufacturer.
• Prepared and reviewed distribution agreements for an implant manufacturer.
• Represented a medical device manufacturer in regard to the licensing of spine fixation devices and consulting agreements.
• Represented a medical device manufacturer involved in pedicle screw and spinal implant technology.
• Counseled medical device manufacturers on organizing entities, negotiating consulting agreements, setting up medical advisory boards, negotiating manufacturing contracts, and license distribution agreements.
• Represented a large pharmaceutical company in a multi district litigation matter.
• Represented insurer of medical device and pharmaceutical manufacturers in product liability cases.
• Counseled a large medical distributor/manufacturer on finance and real estate matters.
• Counseled medical device companies on equipment leasing.
• Defended a medical device manufacturer in multi-district products liability litigation.
• Performed document discovery and document review for a medical device manufacturer.
• Provided new product analysis and product clearance for a medical device manufacturer.
• Identified potential patentable subject matter in new products for a medical device manufacturer.
• Prepared, filed, and procured both patents and trademarks for a medical device manufacturer.
• Protected patents and trademarks in foreign countries for a medical device manufacturer.
• Counseled medical device clients regarding license agreements with third parties.
• Counseled multiple medical device companies on non-compete and trade secret protection strategies.
• Assisted medical device companies in identifying government incentive program opportunities and in successfully obtaining government funds through such programs.
• Advised multiple medical device manufacturers on federal, state and local tax matters, including multi-state tax planning.
• Represented foreign and U.S. based medical device companies in divestiture of domestic and foreign subsidiaries and product lines.