Medical Devices

Overview

Our practice advises medical device companies of all sizes. It is the largest practice devoted solely to FDA counseling in the Southeast, with offices in Washington, D.C., and Atlanta, is known for its pragmatic, creative, and cost-efficient approach to solving problems. Its clients include medical device companies of all sizes, start-up to multinational businesses, many traded on NYSE, NASDAQ, and other foreign-trading exchanges. We work with medical device companies to identify potential regulatory and business challenges and help overcome obstacles. We partner with clients to provide value in a cost-efficient manner, balancing regulatory objectives with real-world business considerations. We help clients understand and successfully navigate the FDA regulatory process from initial clinical trial development, to product approval, product promotion, post-approval requirements and life-cycle management in addition to advising company compliance and enforcement issues.

We assist in preparing Investigational Device Exemption (IDE) applications, Premarket Notification (510(k)) submissions, and Premarket Approval (PMA) applications and related human clinical trial investigation. We also counsel on combination products and on related issues that affect the industry such as privacy, fraud and abuse, state gift reporting, import and export matters, licensing, patents, trademarks, and copyright laws.

Our lawyers are committed to the medical device industry and currently serve as founding members of Giorgia Bio (Georgia’s Life Science trade association), as teachers of food and drug law at Emory University School of Law and lecturers at programs sponsored by the Food and Drug Law Institute, Southeastern Medical Device Association and the Regulatory Affairs Professionals Society, as members of the Editorial Boards of at least three national FDA regulatory and law periodicals, and on the Board of the National Health Museum.

Experience

  • Successfully defended a medical device manufacturer in federal court bench trial against claims for breach of a license agreement and assertion of over $10 million in damages. Unlike a typical breach of contract claim, the issues in this case required proving patent non-infringement and tendering expert testimony in a highly niche area of x-ray technology.

  • Represented Georgia-based biological medical device company in complex contract-based litigation concerning global distribution agreement.  Successfully resolved case favorably to client prior to trial.

  • Advised U.S. medical device company on drafting of contract manufacturing agreements with suppliers in the U.S., European Union, and South Korea, and provided guidance on own brand labeling requirements related to supply arrangements

  • Assisted practice physician practice group with an investigation related to the reuse of single-use devices.

  • Successfully represented biomedical company in connection with a contentious, multi-million dispute arising from an exclusive distribution agreement, which included claims for breach of contract, breach of the implied duty of good faith and fair dealing, fraud, RICO, misappropriation of trade secrets, libel, tortious interference with business relations, and the Georgia deceptive trade practices act.

  • Successfully represented leading medical device company in federal court litigation involving claims for breach of an international distribution agreement, fraud, tortious interference, libel, and violations of the Lanham Act, Georgia’s Uniform Deceptive Trade Practices Act, Georgia Trade Secrets Act, and Georgia’s RICO Act. Managed numerous complex electronic discovery issues, including: collection of over 2.3 terabytes of electronic data from approximately 150 custodians; review and categorization of responsive documents by over thirty contract attorneys; and related obligations imposed by court-appointed Discovery Special Master. Secured multi-million dollar settlement for client.

  • Represented CryoLife, Inc. in federal litigation in Georgia regarding alleged breaches of an international distribution agreement for a medical device.

  • Represented the lead investor in a $30 million Series B round investment in an early stage medical products company.

  • Assisted manufacturer of medical devices that aid in early detection of disease to prepare 510(k) submission to FDA for the device and related software.

  • Assisted clients with preparation of regulatory opinion for IPO filings.

  • Counseling a New York-based pharmaceutical company on FDA regulation in the social media area, product promotion and clinical area, trial recruitment.

  • Serves on multiple client promotional review boards for pharmaceutical and medical device companies as the legal representative to ensure  regulatory compliance of FDA’s labeling and promotional requirements.

  • Counseling a Montreal-based pharmaceutical company on FDA regulation in the social media area, product promotion and clinical area, trial recruitment.

  • Serving on client review board for a North Carolina-based pharmaceutical company as the legal representative on the company’s internal committee that reviews advertising and promotional materials.

  • Serving on client review board for a Montreal-based pharmaceutical company as the legal representative on the company’s internal committee that reviews advertising and promotional materials.

  • Counseling a Georgia-based medical services manufacturer on FDA regulation in the social media area, product promotion and clinical area, trial recruitment.

  • Successfully defended medical device manufacturer in federal court bench trial against a claim for more than $10 million based on an alleged breach of license. Unlike a typical breach of contract claim, the issues in this case required proving patent non-infringement and tendering expert testimony in a niche area of x-ray technology. Anuj also handled and successfully defeated an appeal of the judgment before the Eleventh Circuit and Florida Supreme Court.

  • Counseling an Alabama-based manufacturing company on FDA regulation in the social media area, product promotion and clinical area, trial recruitment.

  • Represented the lead investor in both a $10 million Series B round and $10 million Series C round investment in an early stage medical products company.

  • Successfully represented CryoLife, Inc. (CRY:NYSE), a leading medical device and tissue processing company focused on cardiac and vascular surgery, in its tender offer to acquire Cardiogenesis Corporation, a leader in the treatment of severe angina, for approximately $22 million.

  • Successfully obtained a sanctions award and order rejecting a private company’s efforts to curtail shareholder rights by refusing shareholder inspection requests.

  • Represented distributor of specialized medical device computer cables in sale to private equity fund.

  • Successfully defended an international retailer against charges of misappropriation of trade secrets and alleged Lanham Act violations on Motion for Summary Judgment in the United States District Court for the Northern District of Georgia; Affirmed in the 11th Circuit Court of Appeals.

  • Represented a private investor in connection with an investment in and the subsequent $236 million sale of a medical products company to a public company. Even though our client did not control management of the company, it did have a veto over a sale. As a result of this veto, and our client’s experience in negotiating transactions, our firm played a major role in negotiating and documenting the sale.

  • Served as lead counsel for CryoLife Inc., a medical devices company, in an $18.2 million sale of preferred stock in a registered direct offering.

  • Served as lead counsel in a $21.5 million sale of common stock in a “PIPE” transaction for a leading medical devices company.

  • Coordinated the nationwide defense for a major medical device manufacturer, in a series of product liability lawsuits.

  • Represented CryoLife Inc., a leading medical devices company, by underwriting multiple public offerings of common stock.

  • Advised numerous medical device manufacturers concerning product recalls and market withdrawals to minimize business disruption, cost and damage to brand.

  • Represented CEO of publicly-traded medical devices company against lawsuit seeking to prevent him from completing purchase of shares in the opposing party. Secured settlement, with CEO completing purchase and acquisition of all shares.

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