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November 16, 2021

7 Due Diligence Issues to Avoid False Claims Act Lawsuits

Nelson Mullins partners Jennifer Malinovsky and Ed White join Alice Harris, an attorney with Nexsen Pruet, to go over the key compliance areas to look for in due diligence. 

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Michael J. Halaiko

Michael J. Halaiko

Partner

100 S. Charles Street
Suite 1600
Baltimore, MD 21201
101 Constitution Avenue, NW
Suite 900
Washington, D.C., 20001
mike.halaiko@nelsonmullins.com
+ Other Locations

Mike has over 20 years of experience providing pragmatic counsel and resolute advocacy to clients facing significant litigation exposure, managing risk, and making important business decisions. A significant part of Mike’s practice involves representing clients in high-dollar catastrophic personal injury and death cases. This portion of his practice consists of defending medical providers and hospitals in...

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Mike has over 20 years of experience providing pragmatic counsel and resolute advocacy to clients facing significant litigation exposure, managing risk, and making important business decisions. A significant part of Mike’s practice involves 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.

Another substantial part of Mike’s practice involves drafting and negotiating contracts, warnings, informed consents, and instructions. Mike’s litigation experience allows him the benefit of understanding how language is interpreted and applied when disputes arise. In this realm of his practice, Mike has worked with product manufacturers on creating and revising warnings and instructions; pharmaceutical and life science companies in developing and negotiating clinical trial agreements, master service agreements, letters of indemnification, and informed consent documents; and commercial contractors in developing, revising and negotiating agreements with general contractors, construction managers, subcontractors, and purchasers.

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.

Mike has tried cases to verdict and arbitrated cases in Maryland, Delaware, Pennsylvania, and West Virginia, and he has defended significant personal injury or death matters in jurisdictions all around the country. He also has appeared before appellate courts including arguments before the Indiana Court of Appeals and the West Virginia Supreme Court of Appeals.

Michael J. Halaiko

medical malpractice claims; defending product manufacturers against products liability actions; and defending commercial property owners against significant premises liability matters.

Another substantial part of Mike’s practice involves drafting and negotiating contracts, warnings, informed consents, and instructions. Mike’s litigation experience allows him the benefit of understanding how language is interpreted and applied when disputes arise. In this realm of his practice, Mike has worked with product manufacturers on creating and revising warnings and instructions; pharmaceutical and life science companies in developing and negotiating clinical trial agreements, master service agreements, letters of indemnification, and informed consent documents; and commercial contractors in developing, revising and negotiating agreements with general contractors, construction managers, subcontractors, and purchasers.

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.

Mike has tried cases to verdict and arbitrated cases in Maryland, Delaware, Pennsylvania, and West Virginia, and he has defended significant personal injury or death matters in jurisdictions all around the country. He also has appeared before appellate courts including arguments before the Indiana Court of Appeals and the West Virginia Supreme Court of Appeals.

Mike has over 20 years of experience providing pragmatic counsel and resolute advocacy to clients facing significant litigation exposure, managing risk, and making important business decisions. A significant part of Mike’s practice involves 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.

Another substantial part of Mike’s practice involves drafting and negotiating contracts, warnings, informed consents, and instructions. Mike’s litigation experience allows him the benefit of understanding how language is interpreted and applied when disputes arise. In this realm of his practice, Mike has worked with product manufacturers on creating and revising warnings and instructions; pharmaceutical and life science companies in developing and negotiating clinical trial agreements, master service agreements, letters of indemnification, and informed consent documents; and commercial contractors in developing, revising and negotiating agreements with general contractors, construction managers, subcontractors, and purchasers.

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.

Mike has tried cases to verdict and arbitrated cases in Maryland, Delaware, Pennsylvania, and West Virginia, and he has defended significant personal injury or death matters in jurisdictions all around the country. He also has appeared before appellate courts including arguments before the Indiana Court of Appeals and the West Virginia Supreme Court of Appeals.

Experience

Following is a selected sampling of matters and is provided for informational purposes only. Past success does not indicate the likelihood of success in any future matter.

Experience

  • Represented manufacturers in defense of complex product defect and fire-related claims involving catastrophic personal injuries
  • Defended healthcare institutions and professionals facing claims of professional negligence including cases involving catastrophic injuries or deaths
  • Drafted and negotiated complex contracts for construction companies and manufacturers and suppliers of consumer and industrial products and pharmaceuticals
  • Experienced in developing and examining expert witnesses, as well as in effectively communicating complex scientific and medical concepts
  • Represented builders, design professionals, contractors, suppliers, and real estate owners and operators in matters involving building defect disputes, mold and indoor air quality, and water intrusion claims
  • Served as an outside general counsel for several longtime clients, including manufacturers, distributors of products and home builders

Representative Matters

Litigation

  • Lead counsel in defense of German industrial product manufacturer against a lawsuit arising out of a construction jobsite traumatic brain injury. Successfully obtained summary judgment on behalf of manufacturer at trial court level. Argued and won appeal sustaining summary judgment before the Indiana Court of Appeals reported at Gleaves v. Messer Constr. Co., 77 N.E.3d 1244 (Ind. App. 2017).
  • Obtained defense jury verdict on the standard of care in Baltimore City Circuit Court in a medical malpractice case alleging negligence, lack of informed consent and loss of consortium. Plaintiff alleged that he suffered from toxicity from the improper dosing and management of an antibiotic. Plaintiff claimed he required, among other things, 12 hours a day of attendant nursing care. 
  • Lead counsel in defense of casino in widely publicized case involving the electrocution of four people, including two children, on the casino’s property. Retained experts and coordinated major investigation into the cause of the incident. Led legal defense and settlement negotiations of civil lawsuit filed against the casino.  
  • Obtained summary judgement on behalf of physicians and hospital system in case involving alleged wrongful birth. 
  • Tried wrongful birth case in Baltimore City involving a child born with microcephaly and severe neurocognitive impairment. Plaintiff alleged that multiple maternal fetal medicine providers failed to recognize and inform the Plaintiff that her child’s head measurements were below the mean. Plaintiff alleged that she would have terminated the pregnancy had she been informed of the severe abnormality. At the close of Plaintiff’s evidence, settled matter for less than Plaintiff’s final demand before trial.
  • Tried medical malpractice case in Baltimore City involving the death of a 28-year-old African American woman from severe acute pancreatitis. Reached “high/low” settlement during jury deliberation saving the client substantially on the jury verdict.
  • Represented Italian crane manufacturer in investigation by the Manhattan District Attorney’s Office arising out of a death of a construction worker when a crane fell off the fifth floor of a rising tower being constructed in New York City. Was successful in avoiding charges against the manufacturer by demonstrating the product’s use at the time of the incident was contrary to the published instructions and warnings for the product.

Contracting/Risk Management

  • Drafted master clinical trial agreement and developed negotiating matrix for cell therapy company for use in negotiating and enrolling clinical trial sites in a phase III clinical trial. The negotiating matrix provided various acceptable alternatives to most provisions of the master clinical trial agreement. The negotiating matrix allowed the client’s in-house contract manager and staff to negotiate with the clinical sites without escalation to legal on many routine contract negotiation issues.
  • Developed master service agreement for Irish clinical research organization (CRO) for use by CRO in servicing pharmaceutical clients engaging in clinical testing of products.
  • Drafted, revised, and negotiated numerous clinical site agreements and letters of indemnification with clinical sites and principal investigators engaged by pharmaceutical and life science companies in phase III clinical trials.
  • Drafted master form agreements of sale, construction contracts, terms and conditions, warranty disclaimers and subcontract agreements for product manufacturers, contractors and construction companies.
  • Reviewed and revised informed consent documents used in Phase III clinical testing of cell therapy on human subjects.
  • Revised warnings and instructions for use for foreign product manufacturers selling products within the United States to meet the heightened requirements of U.S. tort common law and U.S. regulations.
  • Advised manufacturer of first-to-market sporting goods product regarding risk management and the development of product warnings.

Education

  • The Ohio State University Moritz College of Law, JD (1999)
  • Capital University, BA, magna cum laude (1996)

Admissions

  • District of Columbia
  • Maryland
  • Pennsylvania
  • West Virginia
  • Supreme Court of the United States
  • U.S. Court of Appeals for the Fourth Circuit
  • U.S. District Court for the District of Columbia
  • U.S. District Court for the District of Maryland
  • U.S. District Court for the Eastern District of Pennsylvania
  • U.S. District Court for the Northern District of West Virginia
  • U.S. District Court for the Southern District of West Virginia

Practice Areas

Industries

The bar rules of some states require that the standards for an attorney's inclusion in certain public accolades or recognitions be provided. When such accolades or recognitions are listed, a hyperlink is provided that leads to a description of the respective selection methodology.

  • American Bar Association
  • Baltimore City Bar Association
  • Maryland Bar Association
  • Sports and Fitness Industry Association – Legal Task Force
  • KIND (Kids In Need of Defense) Pro Bono Attorney (2019–present)
  • Board member, Gorilla Doctors (2013–present)
  • Maryland Volunteer Legal Services Pro Bono Lawyer (2003–present)
  • Mountain Gorilla Veterinary Project Vice President (2017–present)
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