Consulting Services Provided
- Screening and Interpretation of Medical Records with
summation both oral and written - Access Standard of Care and Deviations
- Chronological Time Lines used to identify gaps, assess
for tampering and easily find what is missing - Authoritative Medical Research Expert
- Procurement of appropriate Expert Witness
- Demonstrative exhibit Preparation
- Attend Depositions
- Attend Independent Medical Exams and Defense
Medical Exams
Parks Medical-Legal Consulting is an Independent Medical-Legal
Consulting firm owned and operated by Mr. Paul Parks. A strong
Patient advocate, Mr. Parks educates in all areas of medicine taking
complex information and breaking it down in an easy to digest way
that both jurors and clients can easily understand. Mr. Parks has
had extensive training and clinical experience working in some of
the most prestigious teaching institutions in southern California
including: UC Irvine, Loma Linda University Medical Center, Balboa
Naval Hospital, UC San Diego, and numerous free standing surgical
centers practicing special procedures in such areas as: pain
management, urology, plastic surgery, gastroenterology, same day
surgery both as an OR circulator and sedation nurse.
Administration of sedative hypnotic agents for sleep induction both
in the hospital setting and as an independent practitioner. He is
fluent and up to date on all of the latest standards of care and
guidelines in all areas of nursing and medicine and is an excellent
source for a thorough understanding of medical care in a truly
objective manner.
Consulting firm owned and operated by Mr. Paul Parks. A strong
Patient advocate, Mr. Parks educates in all areas of medicine taking
complex information and breaking it down in an easy to digest way
that both jurors and clients can easily understand. Mr. Parks has
had extensive training and clinical experience working in some of
the most prestigious teaching institutions in southern California
including: UC Irvine, Loma Linda University Medical Center, Balboa
Naval Hospital, UC San Diego, and numerous free standing surgical
centers practicing special procedures in such areas as: pain
management, urology, plastic surgery, gastroenterology, same day
surgery both as an OR circulator and sedation nurse.
Administration of sedative hypnotic agents for sleep induction both
in the hospital setting and as an independent practitioner. He is
fluent and up to date on all of the latest standards of care and
guidelines in all areas of nursing and medicine and is an excellent
source for a thorough understanding of medical care in a truly
objective manner.
What is a Legal Nurse Consultant?
The Role of the LNC and Paralegal working together
The Pulse: A Monthly Newsletter
Vol. 1 Issue # 3
By Paul Parks RN, LNC
BELLEVUE SALON OWNER SENTENCED TO 13 MONTHS IN PRISON IN CONNECTION WITH
UNLICENSED COSMETIC TREATMENTS
Bellevue Cosmetologist Injected Women with Unknown Substance She Claimed was ‘Restylane’
XIN HE, aka FAITH HE, 46, of Issaquah, Washington, was sentenced today in U.S. District Court in Seattle to 13
months in prison and one year of supervised release for a felony count of Misbranding of a Drug While Held for Sale
and two misdemeanor counts of Receipt & Proffered Delivery of Adulterated Device. HE was convicted at a bench trial
October 30, 2009. She was ordered into immediate custody by U.S. District Judge Marsha J. Pechman. Today Judge
Pechman observed that HE persisted in “risky and dangerous behavior,” offering unlicensed treatments despite
warnings from employers, regulators, agents and others.
According to testimony at trial and records filed in the case, FAITH HE used counterfeit Botox© and Restylane© on
customers at her Bellevue beauty salon. FAITH HE was not a medical doctor licensed to use injectable treatments for
wrinkle removal such as Botox and Restylane. According to the indictment, as early as 2004, FAITH HE injected a
substance that she later represented was Restylane into the face of a Snohomish, Washington, woman. Court records
indicate the woman’s face became inflamed and she sought treatment from a dermatologist. The material injected into
the woman’s face was confirmed later not to be genuine Restylane. The Washington State Department of Health
investigated and issued a cease and desist order to FAITH HE in July 2006. The order was issued after HE offered to
inject an undercover agent with what she claimed was Botox at HE’s Issaquah home. Despite that order, in April 2008,
FAITH HE was once again injecting patients in a Bellevue salon. A Bothell woman had to be treated by a plastic surgeon
after the locations FAITH HE had injected became hard and swollen.
In court today Assistant United States Attorney Kathryn Warma urged the court to reject the defense request for a
probationary sentence saying, “This defendant cannot be trusted. She is a liar and manipulator. (By injecting unknown
substances), she was exposing every person she treated to risk of death.” Ms. Warma noted that until the court ordered
HE into custody, “No one, nothing, had stopped her before.”
Each year in the United States, including the State of Washington, consumers are injured by individuals who are
neither licensed or trained to perform medical procedures. Oftentimes, the people performing these cosmetic treatments
use drugs and devices not approved by the FDA for use in the United States. The injuries range from severe burns,
infection and permanent scaring. The FDA has investigated cases where some consumers have died after receiving
such treatments from individuals not licensed to perform such procedures.
This was a joint investigation between the FDA Office of Criminal Investigations and U.S. Immigration and Customs
Enforcement (ICE). Both the Washington State Department of Health and the Washington State Department of
Licensing assisted with the investigation.
The case is being prosecuted by Assistant United States Attorneys Kathryn Warma and Kathryn Kim Frierson.
For additional information please contact Emily Langlie, Public Affairs Officer for the United States Attorney’s Office, at
(206) 553-4110 or Emily.Langlie@USDOJ.Gov.
-
-
For Medical-Legal News visit my blog- The Legal RN: A multimedia learning tool for
Medical and Legal Professionals.
Click on the DNA logo to take you higher learning.
Keeping the FDA and Medical Device Companies Accountable
CHANTIX and Suicide a Very Real Problem Being Overlooked
Since Chantix was approved by the FDA in May 2006, there have been hundreds of reports of suicides and serious
suicidal thoughts linked to the drug. Pfizer, the manufacturer, has failed to adequately warn users and the medical
community about Chantix suicide side effects. There actions have prevented people from recognizing the problems
which may be caused by the drug before it resulted in serious physical injury or death.
In February 2008, the FDA issued an alert highlighting important changes made to the Chantix warning label about
potential psychiatric side effects, including severe changes in mood and behavior, as well as information about suicides
and suicide attempts. The FDA indicated that their review of data indicates it is "increasingly likely that there may be an
association between Chantix and serious neuropsychiatric symptoms."
Between May 2006 and December 2007, the FDA received the following serious adverse event reports associated with
the use of Chantix:
* 227 reports of suicidal acts, thoughts or behavior
* 397 cases of possible psychosis
* 525 reports of hostility or aggression
Hospira Issues Nationwide Voluntary Recall of Certain Lots of Liposyn™ and Propofol Products That May Contain
Particulate Matter
Contacts:
Media Financial Community
Dan Rosenberg
(224) 212-3366 Karen King
(224) 212-2711
FOR IMMEDIATE RELEASE - Nov. 6, 2009 - Lake Forest, Ill. - Hospira, Inc. (NYSE: HSP), a global specialty
pharmaceutical and medication delivery company, is voluntarily recalling 85 lots of Liposyn™ II 10%, Liposyn II 20%,
Liposyn III 10%, Liposyn III 20%, Liposyn III 30% and 73 lots of Propofol Injectable Emulsion 1% products that begin
with the lot numbers 79 and 80 because some of the containers may contain particulate matter. The source of the
particulate matter has been identified as stainless steel equipment used in the manufacturing process. The affected lots
were distributed between July 2009 and October 2009, and no other lots are affected by this recall.
Hospira is undertaking this recall in consideration of the potential for safety issues if the products are administered to
patients. Since these particulate contaminants do not dissolve in blood they could potentially act as emboli and impede
blood flow. Particulates may also cause mechanical damage to the body and may escalate damage through the
Systemic Inflammatory Response Syndrome (SIRS). Restriction in blood supply to tissues could lead to stroke,
respiratory failure, kidney failure, liver failure, heart attack and/or death.
Hospira has not received any reports of adverse events related to this issue. Hospira has identified the root cause and
corrective actions have been implemented. Hospira has made the U.S. Food and Drug Administration (FDA) aware of
the situation.
Anyone with an existing inventory should quarantine the product immediately and call Stericycle at 1-866-654-0725 to
arrange for the return of these products. For medical inquiries, please contact Hospira Medical Communications at 1-
800-615-0187 between 8 a.m. and 5 p.m. CST, Monday through Friday.
Any adverse reactions experienced with the use of these products and/or quality problems may also be reported to the
FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600
Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
Hospira is currently manufacturing both products and has begun to ship replacement product. Please contact Hospira
Customer Care at 1-877-946-7747 for further details.
About Hospira
Hospira, Inc. is a global specialty pharmaceutical and medication delivery company dedicated to Advancing Wellness™.
As the world leader in specialty generic injectable pharmaceuticals, Hospira offers one of the broadest portfolios of
generic acute-care and oncology injectables, as well as integrated infusion therapy and medication management
solutions. Through its products, Hospira helps improve the safety, cost and productivity of patient care. The company is
headquartered in Lake Forest, Ill., and has approximately 14,000 employees. Learn more at www.hospira.com.
###
The Role of the LNC and Paralegal working together
The Pulse: A Monthly Newsletter
Vol. 1 Issue # 3
By Paul Parks RN, LNC
BELLEVUE SALON OWNER SENTENCED TO 13 MONTHS IN PRISON IN CONNECTION WITH
UNLICENSED COSMETIC TREATMENTS
Bellevue Cosmetologist Injected Women with Unknown Substance She Claimed was ‘Restylane’
XIN HE, aka FAITH HE, 46, of Issaquah, Washington, was sentenced today in U.S. District Court in Seattle to 13
months in prison and one year of supervised release for a felony count of Misbranding of a Drug While Held for Sale
and two misdemeanor counts of Receipt & Proffered Delivery of Adulterated Device. HE was convicted at a bench trial
October 30, 2009. She was ordered into immediate custody by U.S. District Judge Marsha J. Pechman. Today Judge
Pechman observed that HE persisted in “risky and dangerous behavior,” offering unlicensed treatments despite
warnings from employers, regulators, agents and others.
According to testimony at trial and records filed in the case, FAITH HE used counterfeit Botox© and Restylane© on
customers at her Bellevue beauty salon. FAITH HE was not a medical doctor licensed to use injectable treatments for
wrinkle removal such as Botox and Restylane. According to the indictment, as early as 2004, FAITH HE injected a
substance that she later represented was Restylane into the face of a Snohomish, Washington, woman. Court records
indicate the woman’s face became inflamed and she sought treatment from a dermatologist. The material injected into
the woman’s face was confirmed later not to be genuine Restylane. The Washington State Department of Health
investigated and issued a cease and desist order to FAITH HE in July 2006. The order was issued after HE offered to
inject an undercover agent with what she claimed was Botox at HE’s Issaquah home. Despite that order, in April 2008,
FAITH HE was once again injecting patients in a Bellevue salon. A Bothell woman had to be treated by a plastic surgeon
after the locations FAITH HE had injected became hard and swollen.
In court today Assistant United States Attorney Kathryn Warma urged the court to reject the defense request for a
probationary sentence saying, “This defendant cannot be trusted. She is a liar and manipulator. (By injecting unknown
substances), she was exposing every person she treated to risk of death.” Ms. Warma noted that until the court ordered
HE into custody, “No one, nothing, had stopped her before.”
Each year in the United States, including the State of Washington, consumers are injured by individuals who are
neither licensed or trained to perform medical procedures. Oftentimes, the people performing these cosmetic treatments
use drugs and devices not approved by the FDA for use in the United States. The injuries range from severe burns,
infection and permanent scaring. The FDA has investigated cases where some consumers have died after receiving
such treatments from individuals not licensed to perform such procedures.
This was a joint investigation between the FDA Office of Criminal Investigations and U.S. Immigration and Customs
Enforcement (ICE). Both the Washington State Department of Health and the Washington State Department of
Licensing assisted with the investigation.
The case is being prosecuted by Assistant United States Attorneys Kathryn Warma and Kathryn Kim Frierson.
For additional information please contact Emily Langlie, Public Affairs Officer for the United States Attorney’s Office, at
(206) 553-4110 or Emily.Langlie@USDOJ.Gov.
-
-
For Medical-Legal News visit my blog- The Legal RN: A multimedia learning tool for
Medical and Legal Professionals.
Click on the DNA logo to take you higher learning.
Keeping the FDA and Medical Device Companies Accountable
CHANTIX and Suicide a Very Real Problem Being Overlooked
Since Chantix was approved by the FDA in May 2006, there have been hundreds of reports of suicides and serious
suicidal thoughts linked to the drug. Pfizer, the manufacturer, has failed to adequately warn users and the medical
community about Chantix suicide side effects. There actions have prevented people from recognizing the problems
which may be caused by the drug before it resulted in serious physical injury or death.
In February 2008, the FDA issued an alert highlighting important changes made to the Chantix warning label about
potential psychiatric side effects, including severe changes in mood and behavior, as well as information about suicides
and suicide attempts. The FDA indicated that their review of data indicates it is "increasingly likely that there may be an
association between Chantix and serious neuropsychiatric symptoms."
Between May 2006 and December 2007, the FDA received the following serious adverse event reports associated with
the use of Chantix:
* 227 reports of suicidal acts, thoughts or behavior
* 397 cases of possible psychosis
* 525 reports of hostility or aggression
Hospira Issues Nationwide Voluntary Recall of Certain Lots of Liposyn™ and Propofol Products That May Contain
Particulate Matter
Contacts:
Media Financial Community
Dan Rosenberg
(224) 212-3366 Karen King
(224) 212-2711
FOR IMMEDIATE RELEASE - Nov. 6, 2009 - Lake Forest, Ill. - Hospira, Inc. (NYSE: HSP), a global specialty
pharmaceutical and medication delivery company, is voluntarily recalling 85 lots of Liposyn™ II 10%, Liposyn II 20%,
Liposyn III 10%, Liposyn III 20%, Liposyn III 30% and 73 lots of Propofol Injectable Emulsion 1% products that begin
with the lot numbers 79 and 80 because some of the containers may contain particulate matter. The source of the
particulate matter has been identified as stainless steel equipment used in the manufacturing process. The affected lots
were distributed between July 2009 and October 2009, and no other lots are affected by this recall.
Hospira is undertaking this recall in consideration of the potential for safety issues if the products are administered to
patients. Since these particulate contaminants do not dissolve in blood they could potentially act as emboli and impede
blood flow. Particulates may also cause mechanical damage to the body and may escalate damage through the
Systemic Inflammatory Response Syndrome (SIRS). Restriction in blood supply to tissues could lead to stroke,
respiratory failure, kidney failure, liver failure, heart attack and/or death.
Hospira has not received any reports of adverse events related to this issue. Hospira has identified the root cause and
corrective actions have been implemented. Hospira has made the U.S. Food and Drug Administration (FDA) aware of
the situation.
Anyone with an existing inventory should quarantine the product immediately and call Stericycle at 1-866-654-0725 to
arrange for the return of these products. For medical inquiries, please contact Hospira Medical Communications at 1-
800-615-0187 between 8 a.m. and 5 p.m. CST, Monday through Friday.
Any adverse reactions experienced with the use of these products and/or quality problems may also be reported to the
FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600
Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
Hospira is currently manufacturing both products and has begun to ship replacement product. Please contact Hospira
Customer Care at 1-877-946-7747 for further details.
About Hospira
Hospira, Inc. is a global specialty pharmaceutical and medication delivery company dedicated to Advancing Wellness™.
As the world leader in specialty generic injectable pharmaceuticals, Hospira offers one of the broadest portfolios of
generic acute-care and oncology injectables, as well as integrated infusion therapy and medication management
solutions. Through its products, Hospira helps improve the safety, cost and productivity of patient care. The company is
headquartered in Lake Forest, Ill., and has approximately 14,000 employees. Learn more at www.hospira.com.
###
 | American Nurses Association | |
| American Association of Legal Nurse Consultants | |
| Member of National Patient Advocate Foundation | |
| Listed in Martindale-Hubbell | |
| Desert Bar Association | |
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