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KOMahonyLaw - Law Office of Kevin P. O'Mahony
Healthcare, Business
& Litigation Services

Medical & Professional Malpractice Investigations, Defense, Litigation & Alternative Dispute Resolution

At the Law Office of Kevin O’Mahony, we serve as outside counsel for hospitals, health systems and other healthcare entities, conducting investigations of unanticipated adverse patient outcomes and medical malpractice claims. We also represent and defend hospitals, physicians, physician assistants, nurse practitioners, nurses, and other healthcare entities and staff in medical malpractice lawsuits in both state and federal courts, arbitration, mediation and other alternative dispute resolution proceedings.

Internal Investigations & Outside Counsel’s Role

Every safety-critical industry devotes considerable time and resources to investigating and analyzing accidents, incidents and near misses. Systematic analysis of incidents has expanded understanding of both the causes and prevention of harm. These methods have been widely employed in healthcare for many years, and most healthcare organizations have their own internal systems and processes for reporting and responding to incidents.

However, it is also important – at least in some cases – to engage independent, outside counsel to investigate unexpected adverse outcomes. Such investigations are conducted in an effort to strengthen processes of care and improve the quality of care afforded patients, as well as minimize potential legal liability.

Expertise in conducting internal investigations cannot be found in case law or “how to” books. It comes through years of practice. We have many years’ experience working as outside counsel for both large and small healthcare organizations, conducting investigations of unanticipated adverse outcomes and incidents.

The following outlines some of the reasons for conducting internal investigations (even if no claim or suit is anticipated), why it is important to conduct an internal investigation as soon as possible after an unexpected adverse outcome or incident is discovered, and why it is wise to retain outside counsel to conduct investigations.

What is an internal investigation?

  • A factual review and legal analysis of potential problems or issues.
  • Often conducted by compliance officers, internal audit departments, outside counsel, or all of them.
  • Usually independent of a government investigation.

When may an internal investigation be warranted or necessary?

  • Patient’s or patient family member’s complaints.
  • Reasonable belief that a problem exists.
  • Discovery of potential error through a routine audit or by chance.
  • Receipt of actual notice of potential violation of law or regulation from employees or third parties.
  • Learning of departure from, violation or material breach of, standard of care, compliance program or organization policy.
  • Notification from a governmental agency (i.e., request for documents, subpoena or search warrant).
  • Learning that the government has begun an investigation.
  • Learning that your carrier or fiscal intermediary is conducting an audit.
  • Annual OIG Work Plan, OIG Audit Reports, new regulations or revisions to existing regulations identify risk areas.
  • Reports received from your Compliance Hotline.

Why do an internal investigation?

  • Provide insight into problematic practices within your organization.
  • Determine if there has been any wrongdoing.
  • Stop any wrongdoing and implement corrective action immediately.
  • Gather information for developing appropriate responses to the government or claimants.
  • Learn about the strengths and weaknesses of your current control processes.
  • Provide your attorney with the information necessary to counsel you about potential legal pitfalls, defenses and options on how to proceed with your case.
  • Minimize any potential civil or criminal liabilities.
  • Determine whether to make a voluntary disclosure or payment.

Who should conduct an internal investigation?

  • Compliance Officer, if he or she can effectively conduct objective, independent investigation.
  • Outside counsel (working collaboratively with Compliance Officer and/or in-house counsel) because they can more effectively assert the attorney-client privilege and work product exception to discovery, and maintain independence and credibility with outside parties, including the government.
  • Independent auditors and experts, but only if retained through, and directed by, an attorney so that their communications and work product can remain privileged.
  • The Compliance Officer or in-house counsel should work with outside counsel to determine when it is appropriate to conduct an investigation under attorney-client privilege.

Attorney vs. non-attorney directed investigations – what difference does it make?

  • Only attorneys can conduct privileged investigations and assert the attorney-client privilege and the work product immunity protection.
  • Experts retained by, and working at or by the attorney’s direction, normally fall under the attorney’s privilege umbrella and their reports will be (or at least have a better chance of being) shielded from discovery via the attorney-client privilege and work product exception to discovery.
  • Attorneys are better suited to analyze legal issues, examine legal consequences, and render legal advice regarding potential defenses, liabilities and corrective actions.
  • Potential for waiver (i.e., inadvertent disclosures) is greater when a non-attorney is leading an investigation.
  • In all instances, the complexity and materiality of the issue should be considered in determining who should conduct the investigation.

Internal Compliance Officer, In-House Counsel or Outside Counsel – what’s the difference?

Internal Compliance Officer or In-House Counsel – Advantages

  • Often more knowledgeable about the organization, its business operations and policies.
  • Has working knowledge of the organization’s compliance program.
  • May be more cost-efficient because investigation may proceed more quickly, and because he or she is already on the organization’s payroll.

Internal Compliance Officer or In-House Counsel – Disadvantages

  • Government and other outside parties’ potential perception of lack of objectivity and independence.
  • Internal conflicts of interest can arise if a wrongdoer is a high-level employee or official.

Outside Counsel – Advantages

  • Government and other outside parties often view outside counsel as independent of the organization.
  • Can more effectively maintain the attorney-client privilege and work product immunity protection.
  • Provides more objectivity in assessing legal issues and liabilities relating to the investigation.
  • Often has more experience in dealing with potential plaintiffs’ counsel and government agents in connection with governmental investigations.
  • May be able to avoid lawsuit or formal government action.
  • Usually is exposed to other areas of law and may have a broader knowledge of administrative, civil and criminal issues relating to fraud, etc.

Outside Counsel – Disadvantages

  • Scope and complexity of investigation may not warrant outside involvement.
  • Relative unfamiliarity with the client’s organizational structure, players and internal dynamics.
  • Cost.

What do the attorney-client privilege and work product discovery exception protect?

  • Attorney-client privilege covers the communications between an attorney and the client. It generally attaches to the complete communication, including legal advice and facts. But pre-existing documents, non-confidential matters of employment, or communications made in furtherance of a crime or fraud are usually not protected.
  • Work product immunity covers work relating to the preparation of the client’s case. It protects the materials prepared, the mental impressions developed, legal theories and conclusions made by an attorney, and communications made in anticipation of litigation or for trial.

How do we preserve privileges?

  • Identify who the attorney represents.
  • Obtain only legal advice from the attorney because business advice by itself is not privileged.
  • Clearly designate all covered written materials as being privileged.
  • Limit the number of persons who have access to privileged information and communications to those with genuine need “need to know.”
  • Avoid conflicts of interest.

What happens after we investigate?

  • Assess whether a written report outlining the investigative results is necessary and, if so, what it will cover.
  • Assess whether you should make a formal self-disclosure to the government, patient or patient’s representative, or an informal self-disclosure to your fiscal intermediary or insurance carrier.
  • If credible evidence of wrongdoing is uncovered, explore the advantages and disadvantages of self-reporting to the government or other parties.
  • Keep in mind that any information provided to the government via voluntary disclosure could result in a waiver of the attorney-client privilege and work product immunity, and could become discoverable by private third-party litigants.
  • Consider re-evaluating your compliance program to ensure its effectiveness and make any necessary and appropriate changes.

What are some of the advantages and disadvantages of self-reporting?

Advantages

  • Disclosure demonstrates that you have an effective compliance program that detected an incident of potential non-compliance.
  • Disclosure allows you to voluntarily enact measures to detect, reduce and eliminate future problems.
  • Disclosure may actually prevent a civil lawsuit and lead to a more favorable, less expensive resolution/outcome.
  • Disclosure helps prevent or reduce the number of potential whistleblower actions.
  • If potential criminal conduct is involved, entities or individuals who cover-up misconduct expose themselves to harsher criminal penalties and fines.
  • Federal Sentencing Guidelines for Organizations provides for leniency for those organizations that self-report, have no high level of involvement in the misconduct, and cooperate with the government’s prosecution.

Disadvantages

  • Voluntary disclosure could result in a potential waiver of privileges.
  • Adverse publicity may result from the disclosure.
  • Voluntary disclosure alerts the government and other parties of potential wrongdoing and may invite legal and punitive action.
  • The government and other litigants may use your voluntary disclosure against you if they decide to prosecute or sue.

If we decide to self-report, what information should our report contain?

  • Circumstances that led to the investigation.
  • Investigative process and methodology.
  • Facts disclosed by your investigation.
  • Discussion of applicable laws or regulations.
  • Reason for violation.
  • Liability assessment, including arguments for and against healthcare organization’s position.
  • Recommended or actual corrective and remedial actions.

In-House Counsel and Outside Counsel’s Perspectives on Internal Investigations

  • Self-serving as it may sound coming from lawyers, we should be involved in the process as early as possible because we can be more objective and bring other advantages as well.
  • The provider needs to preserve privilege during this process; we can help.
  • We know the law and can best evaluate the provider’s civil and criminal liability exposure.
  • It’s better to know about potential problems than not know and pay a greater price later.

Defense of Medical Malpractice Claims & Lawsuits

Besides conducting investigations of adverse outcomes (which may or may not result in claims, demands for payment or lawsuits), we also assist in responding to settlement demands, and defend medical malpractice claims and lawsuits filed in state or federal court.

Medical professionals have much at stake in malpractice cases. Adverse patient outcomes – even unexpected ones — are not always caused by negligence or medical error. And difficult and complicated cases often result in less than ideal outcomes or results. But even in cases where negligence did not occur, a medical malpractice claim or lawsuit may ensue, which can have a drastic effect on a healthcare professional’s license, credentials, privileges and reputation.

While your financial exposure may be mitigated by malpractice insurance, you still may suffer professional licensing consequences and damage to your reputation based on the amount of a settlement or if you are found liable for malpractice. Medical facilities and entities also may have much at stake due to possible licensing implications, negative publicity and other issues.

We understand the strain a professional negligence investigation, claim or lawsuit can put on an individual professional and everyone else involved in the process. We therefore strive to make the process as painless as possible, by handling it professionally — from initiation of an investigation, to defense of a claim or suit, final decision or resolution, and dealing with the consequences afterward.

We have developed close working relationships with numerous medical experts in virtually every specialty. We also employ legal nurse consultants and have access to the most highly-respected and relevant medical resources, to assist in defending malpractice cases and achieving the best possible outcomes.  And we understand the importance of consistently advocating for our clients’ best interests, while at the same time complying with budgetary, billing and reporting guidelines.

We have defended a broad range of medical malpractice claims and lawsuits (including many alleging wrongful death), involving allegations such as:

  • Diagnostic errors or omissions
  • Failure to obtain informed consent
  • Failure to timely assess, diagnose or treat a condition, illness or complications
  • Failure to recognize and treat significant changes in a patient’s condition
  • Failure to communicate critical information to other healthcare professionals
  • Failure to properly monitor and supervise
  • Failure to report to regulatory agencies or boards
  • Improper charting or failure to document medical records appropriately
  • Improper testing
  • Improper wound care, pressure and decubitus ulcers prevention and treatment
  • Medication errors
  • Negligence, abuse, exploitation or improper relationships
  • Recommending or providing an improper form of treatment
  • Surgical and post-op errors
  • Violations of standard of care, statutes, regulations or policies

In addition to trials and appeals, we have achieved many favorable, cost-effective outcomes through motions to dismiss and for summary judgment, alternative dispute resolution proceedings, and pretrial settlements. We also work with clients to manage sensitive communications and negotiations with patients, their families and legal counsel, to properly handle staffing or administrative issues, and to address concerns related to the media or public.

Conclusion

At the Law Office of Kevin O’Mahony, we serve as outside counsel for healthcare clients investigating unanticipated adverse outcomes and incidents. We assist healthcare organizations in conducting root cause analyses, error reporting and disclosure, implementing corrective action plans, and managing and minimizing risks their patients and providers face.

We also represent and defend healthcare clients in medical malpractice pre-suit claims and lawsuits, mediations and arbitrations. And we handle, investigate and have successfully prosecuted and defended numerous medical device and pharmaceutical product liability claims. Please call or email us if you wish to schedule a consultation.

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