Legal Reviews

Large Blog ImageLawrence F Muscarella, PhD, is an internationally recognized expert, with almost 25 years of experience in identifying the causes and prevention of medical errors, with a focus on healthcare-associated infections (“HAIs”).

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Determining the cause and circumstances of an HAI require an investigation and understanding of several factors, including:

— the type of infection;

— the organism that caused the infection;

— the contaminated surgical instruments that might have caused the infection;

— whether the infection was preventable.

Dr. Muscarella can help. He specializes in reviewing cases and providing expert legal opinions and confidential conclusions to legal counsel about the causes of infections, especially those linked to contaminated reusable medical equipment, such as:

  • HEATER-COOLER DEVICES colonized with mycobacteria and other types of bacteria (these devices are used to control the patient’s temperature during open-heart surgery).
  • GASTROINTESTINAL ENDOSCOPES, particularly duodenoscopes contaminated with multidrug-resistant bacteria, including carbapenem-resistant Enterobacteriaceae (“CRE”);

Brochure:  Download and read Dr. Muscarella’s brochure explaining the expert case review services he offers legal counsel.

  • AUTOMATED ENDOSCOPE REPROCESSORS, or “AERs,” which are used in healthcare facilities to clean and disinfect many types of flexible endoscopes, including duodenoscopes and other types of  gastrointestinal endoscopes; and
  • BIOPSY FORCEPS (REUSABLE, CERVICAL), which are used in healthcare facilities to sample tissue from a woman’s cervix.


Other expertise

Dr. Muscarella also:

  • provides comprehensive reviews and summaries of a medical device’s filed adverse events listed the past several years in the FDA’s MAUDE database;
  • performs root cause analyses of infections and outbreaks;
  • provides a timeline of events leading up to and following a healthcare facility’s identification and investigation of an outbreak;
  • performs “gap analyses,” identifying gaps in clinical practice and providing recommendations and “corrective actions” to enhance patient safety; and
  • performs simulated and clinical in-use tests to validate a medical device’s safety and effectiveness, as may be required to better understand the precise cause of a medical facility’s infection or bacterial outbreak.


Dr. Muscarella services are designed to:

  • provide comprehensive, confidential reviews
  • reduce costs
  • mitigate risk
  • improve quality and safety
  • prevent patient infections
  • ensure confidentiality and trust


Click here to read more about Dr. Muscarella. A copy of Dr. Muscarella’s curriculum vitae is available on LinkedIn.


Email Dr. Muscarella directly with your questions:

Note: Dr. Muscarella’s confidentiality and privacy policies are strict. No confidential correspondence of any type, at any time, is disclosed directly or indirectly in this blog — click here for more details.

Question and Answers

1.  Dr. Muscarella’s expertise focuses on what specific medical procedures?

Dr. Muscarella provides risk assessments and expert case reviews about the causes of infections and both bacterial and viral outbreaks following many different types of medical procedures.

He specializes in ‘superbug’ outbreaks during gastrointestinal endoscopic procedures, but he is also an expert in the transmission of diseases during:

  • rigid endoscopy (e.g., arthroscopy, laparoscopy) – a sample;
  • flexible endoscopy (e.g., GI endoscopy, bronchoscopy, “ENT,” and cystoscopy) – sample #1 and sample #2 and sample #3; and
  • general surgery, robotic surgery, cardiac surgery, and neurosurgery, among others – a sample.

Questions? Email Dr. Muscarella:

2A.  Dr. Muscarella provides expert case reviews of what general healthcare topics?

Dr. Muscarella provides expert reviews on:

  • healthcare-associated infections, or “HAIs” (including bacterial, viral and fungal outbreaks);
  • the design and federal regulation of duodenoscopes and other types of reusable medical devices;
  • superbugs, including “CRE”;
  • other related types of medical errors and patient harms;
  • surgical errors;
  • disinfection and sterilization;
  • contaminated reusable medical equipment (e.g., IV syringes, flexible endoscopes);
  • surgical instrument and endoscope reprocessing (i.e., cleaning and sterilization); and
  • operating room (aseptic) technique.

2B. Continued: Any other healthcare topics in which Dr. Muscarella is an expert?

Yes. Dr. Muscarella also provides expert advice on:

  • opening and completing corrective and preventive actions, or CAPAs;
  • performing root cause analyses (RCAs);
  • the design, use, and labeling of reusable medical devices and equipment;
  • the risk of infection associated with specific infection control breaches (with a focus on endoscope- and instrument-reprocessing lapses);
  • the reuse of single-use, disposable medical devices and equipment; and
  • the FDA’s regulation of medical devices, including flexible endoscopes and automated endoscope reprocessors, or AERs, both of which have been recently linked to multiple “superbug” outbreaks.

3A. What are the primary objectives of Dr. Muscarella’s expert reports and case reviews?

The objectives of Dr. Muscarella’s expert reports and case reviews include:

  • to review the findings of a hospital’s outbreak investigation for accuracy and completeness;
  • to identify the true cause of an HAI;
  • to assess the merit of a medical claim involving an infection-control breach, HAI, outbreak, or a related type of medical error;
  • to strengthen and enhance the validity of such a medical claim or defense;
  • to provide advice and an objective perspective;
  • to perform a root cause analysis (RCA) of an HAI or a related type of medical error; and
  • to perform a risk assessment of an infection-control breach or related medical error.

Questions? Email Dr. Muscarella:

4A. Why are Dr. Muscarella’s expert case reviews important?

Dr. Muscarella’s expertise and independence are invaluable.

Moreover, performing a scientifically sound assessment of all of the possible causes  of an infection or bacterial outbreak — including identifying the infectious agent’s source and mode of transmission — is important to:

  • improve patient safety;
  • enhance healthcare quality;
  • save money; and
  • reduce the risk of HAIs.

4B. Continued: Why else are Dr. Muscarella’s expert legal reports important?

Dr. Muscarella’s case reviews and reports are also important to:

  • optimize clinical practice;
  • ensure re-accreditation;
  • stop an infection or outbreak through the implementation of one or more effective corrective actions and preventive (CAPAs); and
  • prevent an infection’s or outbreak’s recurrence.

5.  Has Dr. Muscarella’s expertise been a focus of the media?

Yes. Dr. Muscarella’s research has been discussed in many newspapers and TV news shows including:

CNN | NBC’s Today Show | NBC Nightly News | CBS Evening News | ABC World News Tonight | CBS News 3 (Philadelphia, PA) | WFMZ 69News (Allentown, PA) | Huffington Post Live | Wall Street Journal Live | CBS News (Los Angeles, CA) | WSOC-TV (NC) | Al Jazeera America

New York Times | USA TODAY | Los Angeles Times | Philadelphia Inquirer | Philadelphia Inquirer | Philadelphia Inquirer | WSOC-TV Eyewitness News | Bloomberg News | Scientific American | MassLive! | The Seattle Times | Newsweek | NPR Radio (Los Angeles) | Highlands Today | The Palm Beach Post | Reuters | KNX-1070 NewsRadio | The Associated Press | The San Francisco Chronicle | The Iowa City Gazette | Wall Street Journal | Investors Business Daily | The San Juan Weekly | Al Jazeera America | WSPA-TV | CBS News Radio | The Washington Post

6.  In which medical journals has Dr. Muscarella’s research been published?

Some of Dr. Muscarella’s peer-reviewed articles have been published in the following renowned medical journals:

  • The Journal of Hospital Infection, American Journal of Infection Control, Infection Control and Hospital Epidemiology, Gastrointestinal Endoscopy, Chest, The World Journal of Gastrointestinal Endoscopy, among many journals.

The following article by Muscarella is the most complete article published, to date, on the topic of: “Risk of transmission of carbapenem-resistant Enterobacteriaceae (CRE) and related ‘superbugs’ during gastrointestinal endoscopy” — click here.

Questions? Email Dr. Muscarella:

7.  Where did Dr. Muscarella receive his doctorate?

Dr. Muscarella received his Ph.D. from the University of Pennsylvania’s School of Engineering and Applied Sciences (Philadelphia, PA) in 1990.

Since then, he has worked in the fields of infection control, prevention of medical errors, disinfection and sterilization, risk and legal management, and instrument reprocessing

8.  What are some samples of Dr. Muscarella’s research, writings, and investigations?

Samples of Dr. Muscarella’s research and writings include:

A — Dr. Muscarella’s review, critique and assessment of the Centers for Disease Control and Prevention’s (CDC) investigation of:

  • an outbreak of Pseudomonas aeruginosa in 2009 linked to contaminated arthroscopic instrumentation (Texas); Click here; and
  • an outbreak of antibiotic-resistant Enterobacteriaceae in 2013 linked to contaminated gastrointestinal endoscopes (Illinois); Click here.

B — Dr. Muscarella’s root cause analysis of this bacterial outbreak in Texas: Click heresee: Table 4;

C — Dr. Muscarella’s review of the soundness of assessments of the effectiveness of interventions for the prevention of central line-associated bloodstream infections: Click here.

D — Dr. Muscarella’s review, critique and assessment of the FDA’s regulation of a specific type of medical technology: Click here.

Questions? Email Dr. Muscarella:

9 What are some other examples of Dr. Muscarella’s root cause analyses, reassessments of the causes of a hospital outbreak, and evaluations of the risk of infection associated with a specific type of medical procedure?

Some other examples of some of Dr. Muscarella’s recently published, peer-reviewed scientific papers that study the causes of HAIs and other types of patient harms include:

  • Bacterial infections following arthroscopy: Click here to read Dr. Muscarella’s “Other possible causes of a well-publicized outbreak of Pseudomonas aeruginosa following arthroscopy in Texas.
  • Central line-Associated Infections:  Click here to read Dr. Muscarella’s article: “Assessment of the reported effectiveness of five different quality-improvement initiatives for the prevention of central line-associated bloodstream infections in intensive care units.
  • Carbapenem-resistant Enterobacteriaceae: Click here to read Dr. Muscarella’s article: “Risk of transmission of carbapenem-resistant Enterobacteriaceae and related ‘superbugs’ during gastrointestinal endoscopy.”
  • Medical Errors:   Click here to read Dr. Muscarella’s article: “Medical errors, infection-control breaches and the use of adulterated and misbranded medical devices.
  • Current issues in gastrointestinal endoscopy:  Click here to read Dr. Muscarella’s co-authored article: “Current issues in endoscope reprocessing and infection control during gastrointestinal endoscopy.”

Connect with Dr. Muscarella on LinkedIn or click here to review a copy of his curriculum vitae.

10.  What are some of Dr. Muscarella’s other activities, services?

Dr. Muscarella also performs both risk analyses and root cause analyses of medical errors and bacterial outbreaks.

For more information, download his brochure (click here) or visit this website’s “Audits,” “Risk Assessments” and “Root Cause Analyses” pages.

11.  Click here to email Dr. Muscarella with your confidential question(s) or comment(s).

Lawrence F Muscarella, PhD, President | LFM Healthcare Solutions, LLC | P.O. Box 684, Montgomeryville PA 18936 (Page updated: 8/27/2015, Rev A.)

One thought on “Legal Reviews

  • would like some legal advice since I had to of caught the infection either by doctor error or operating room conditions, thank you for your time.

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