Michael J. Halaiko, JD, CIPP/E

Michael J. Halaiko Healthcare Attorney
Organization Profile
Professional Biography

Mike is a partner in the firm’s Healthcare Team and leads its Clinical Trial Practice. He has over two decades of experience providing pragmatic counsel and resolute advocacy to clients negotiating complex agreements, managing risk, making important business decisions, and facing significant litigation exposure.

A substantial part of Mike’s practice involves working with life science companies, clinical 

research organizations, and academic institutions involved in clinical research and development. He is regularly involved in the drafting and negotiating agreements and advises clients involved in U.S.-based and global clinical trials on insurance, indemnity, intellectual property, and privacy, among other issues.  Mike’s background in litigation allows him the benefit of understanding how language is interpreted and applied when disputes arise.

Mike’s career started in litigation and he has more than two decades of experience representing clients in high-dollar catastrophic personal injury and death cases. This portion of his practice consists of defending medical providers and hospitals in medical malpractice claims; defending product manufacturers against products liability actions; and defending commercial property owners against significant premises liability matters. Mike has tried cases to verdict and arbitrated cases in Maryland, Delaware, Pennsylvania, and West Virginia. He also argued appeals before the Indiana Court of Appeals and the West Virginia Supreme Court of Appeals.

Mike is a Certified Information Privacy Professional (CIPP/E) and has particular experience advising client regarding the EU’s General Data Protection Regulation (GDPR) and the EU’s Clinical Trial Information System (CTIS).

Finally, Mike serves as outside general counsel for numerous companies advising these businesses on issues of risk management, insurance, employment, and litigation. Mike develops a deep knowledge of each client’s business needs, priorities, and practices, as well as an understanding of the risk tolerance of each client, which allows him to provide pragmatic advice and counsel.

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