Tuesday, September 30, 2014
Great Answer to the Open Records and Transparency Question of the Day
Yes--pharmacies should be subject to the same level of transparency to the public, and so should chemical repackagers, who proffer deals that result in pharmacies making larger profits than they would normally if they chose to dispense nationally authorized products. This alerts consumers and payers that there may be strong financial incentives influencing professional's specific therapeutic recommendations--a dose of "healthy skepticism" is warranted (see: http://www.healthyskepticism.org/global/).
But current lack of transparency is only one determinant clouding medical and pharmacy decision-making in the promotion-frenzied compounded drug marketplace that can lead to increased risk or unfair transfer and distribution of risk to patients and subsequently, payers. Where there are outright kick-backs for prescribing, compensation for pseudo-trials, or gradually elevating AWPs for ingredients, fraud and abuse must be identified and vigorously prosecuted.
But current lack of transparency is only one determinant clouding medical and pharmacy decision-making in the promotion-frenzied compounded drug marketplace that can lead to increased risk or unfair transfer and distribution of risk to patients and subsequently, payers. Where there are outright kick-backs for prescribing, compensation for pseudo-trials, or gradually elevating AWPs for ingredients, fraud and abuse must be identified and vigorously prosecuted.
Removal May Prove Difficult for Compounding Pharmacies
Like pharmaceutical and medical device manufacturers, it is not surprising that compounding pharmacies facing personal injury/products liability litigation prefer the typically more defense-friendly federal arena over the often more challenging (to put it mildly) state court system. But as today’s case demonstrates, that may not be the easiest path for compounders to follow.
The case is Cruz v. Preferred Homecare, 2014 U.S. Dist. LEXIS 132647 (D. Nev. Sep. 22, 2014) and it involves a horrific set of facts involving the death of a minor. The decedent was born with a condition known as gastroschisis which required she be treated with Total Parental Nutrition (“TPN”). Id. at *2. TPN is used for patients who cannot get sufficient nutrition through eating. It is a solution administered intravenously and contains a combination of sugar and carbohydrates, proteins, lipids, and electrolytes. In this case, decedent’s physician would prescribe TPN by designating both an overall volume and a specific percentage of each substance. Id. It was the job of the compounding pharmacist to calculate the percentages into grams. Id. The complaint alleges that in 2011 decedent received an overdose of dextrose causing her glucose levels to rise so high that she went into fatal cardiac arrest. Id. at *3.
continue to read Drug and Device Law Blog here
Reminder FDA Guidance Regarding Laboratory Developed Tests
October 2014
- Guidance for Industry and Staff: Food and Drug Administration Notification and Medical Device Reporting for Laboratory Developed Tests
FDA CDER System of Records including those for compounded and unapproved drugs
F]CDER System of Record (PDF - 103KB) 
www.fda.gov/.../UCM416566.pdf
Food and Drug Administration
BREAKING: Open Payments website launches By Jaimy Lee Posted: September 30, 2014 - 1:45 pm ET
The federal government today launched a highly anticipated website detailing at least $3.5 billion in financial ties in a five-month period between medical device and drug companies and physicians and teaching hospitals.
The Open Payments website is the first public repository of national data describing financial relationships between industry and healthcare providers. Critics of these payments say these payments can inappropriately influence clinical decisions.
The database was required by the Physician Payments Sunshine Act, a provision of the Patient Protection and Affordable Care Act that was spearheaded by Sen. Chuck Grassley (R-Iowa).
The Open Payments website is the first public repository of national data describing financial relationships between industry and healthcare providers. Critics of these payments say these payments can inappropriately influence clinical decisions.
The database was required by the Physician Payments Sunshine Act, a provision of the Patient Protection and Affordable Care Act that was spearheaded by Sen. Chuck Grassley (R-Iowa).
continue to read here
Morning Break: Pharma $$ to Docs Database Opens Published: Sep 30, 2014 By MedPage Today Staff
http://www.medpagetoday.com/PublicHealthPolicy/GeneralProfessionalIssues/47877?isalert=1&uun=g649657d2242R5784224u&utm_source=breaking-news&utm_medium=email&utm_campaign=breaking-news&xid=NL_breakingnews_2014-09-30
Ohio Board of Pharmacy Guidance Documents:Drugs compounded in a pharmacy must adhere to USP Chapters 795 & 797 January 1, 201
Ohio Pharmacists
.@OhioRxBoard Guidance Document: Drugs compounded in a pharmacy must adhere to USP Chapters 795 & 797 January 1, 2015 http://t.co/lGbST2JdZ0
Fourth Question of the Day September 30, 2014 The Physician Payments Sunshine Act requires that financial relationships between physicians and industry be made public on a government website known as Open Payments. Should there be a similar act requiring disclosure of pharmacists financial relationships, especially in light of all the overlapping ownership interest?
What Is Your Doctor Getting Paid?
The Physician Payments Sunshine Act requires that financial relationships between physicians and industry be made public on a government website known as Open Payments. Read More
UPDATE 2-Amag Pharma enters women health business with $675 mln deal--Makena, included
(Adds CEO and analyst comments, background, updates stock price)
By Vidya L Nathan
(Reuters) - Amag Pharmaceuticals Inc entered the women's healthcare business by acquiring privately held Lumara Health Inc for $675 million in its biggest deal ever, sending its shares up as much as 23 percent to a four-year high.
The cash and stock deal gives Amag access to Lumara's Makena, the only approved product designed to reduce the risk of preterm birth, and Amag CEO William Heiden said his company was on the hunt for more such deals.
"We'll target to acquire or license additional assets within the women's health segment," Heiden said in a conference call.
continue to read here
Executions on hold until legislators change law
DeWine: Executions on hold until legislators change law ...
www.dispatch.com/.../dewine-executions-on-hol...
The Columbus Dispatch
New laws that take effect October 1, 2014 | Ocala Post
New laws that take effect October 1, 2014 | Ocala Post
www.ocalapost.com/new-laws-that-take-effect-october-1-2014/59 mins ago - Compounding pharmacies that are located in other states, but sell in Florida, will now have a new set of standards and registration requirements. The law is ...
Cigna Announces New Rule Regarding Coverage for Compounded Medications Effective October 1, 2014
DF]Cigna Pharmacy Management 900 Cottage Grove Road ... 
www.cigna.com/pdf/compounded-drugs.pdf
Cigna
Tougher Compounding Rules Finally Law
Tougher Compounding Rules Finally Law | Health News ...
health.wusf.usf.edu/.../tougher-compounding...University of South Florida5 hours ago - Tougher regulations in the state's compounding pharmacy industry take effect Wednesday - two years after a national outbreak of fungal meningitis killed 64.
Third Question of the Day September 30, 2014 Are the GMPs really unworkable or is it that compounders and the groups that represent them are still dragging their hills because they want to be unregulated traditional compounders who are allowed to manufacturer and mass produce drugs without having to follow the rules manufacturers do?
Groups Say GMPs for Compounding Pharmacies are Unworkable
Groups Say GMPs for Compounding Pharmacies are Unworkable
Executive Summary
Pharmacy groups and pharmaceutical manufacturers are at odds over the applicability of GMPs to outsourced pharmacy compounding operations. In the meantime, FDA is going full steam ahead and taking an aggressive enforcement approach to compounding pharmacies that violate GMPs, issuing 16 warning letters so far this year.
AAN Warns Against Opioids in Chronic Noncancer Pain Published: Sep 29, 2014 | Updated: Sep 30, 2014Download Complimentary Source PDF By Kristina Fiore, Staff Writer, MedPage Today Reviewed by Zalman S. Agus, MD; Emeritus Professor, Perelman School of Medicine at the University of Pennsylvania and Dorothy Caputo, MA, BSN, RN, Nurse Planner
http://www.medpagetoday.com/PainManagement/PainManagement/47871?xid=nl_mpt_DHE_2014-09-30&utm_content=&utm_medium=email&utm_campaign=DailyHeadlines&utm_source=ST&eun=g649657d0r&userid=649657&email=stuckrichmond%40gmail.com&mu_id=5784224&utm_term=Daily
Manufacture of Active Pharmaceutical Ingredients (APIs) Who of Received Warning Letters from the FDA in 2014
Company/Individual
|
Product/Issue
|
Issue Date
|
|---|---|---|
manufacture of active pharmaceutical ingredients (APIs)
|
7/9/2014
| |
regulations for finished pharmaceuticals
|
7/8/2014
| |
manufacture of active pharmaceutical ingredients (APIs)
|
7/7/2014
| |
manufacture of active pharmaceutical ingredients (APIs)
|
6/16/2014
| |
manufacture of active pharmaceutical ingredients (APIs)
|
6/10/2014
| |
regulations for finished pharmaceuticals
|
5/7/2014
| |
regulations for finished pharmaceuticals
|
4/11/2014
| |
manufacture of active pharmaceutical ingredients (APIs)
|
3/18/2014
| |
manufacture of active pharmaceutical ingredients (APIs)
|
3/6/2014
| |
manufacture of active pharmaceutical ingredients (APIs)
|
2/27/2014
| |
regulations for finished pharmaceuticals
|
2/6/2014
| |
labeling/relabeling of active pharmaceutical ingredients (APIs)
|
1/31/2014
|
Second Question of the Day September 30, 2014 IACP Town Hall Recording Now Available for Members--What is interesting is that IACP Reports that only 160 of its members joined them for this town hall meeting. Is IACP losing or gaining members? Is this number typical for a town hall meeting? IACP touts over 150,000 Patients and Practitioners are involved in its partnership supporting compounding. So why are more practitioners involved in the town hall meetings?
IACP Member Town Hall Recording Available - International ...
www.iacprx.org/.../IACP-Member-Town-Hall-Recording-Available.htm
Question of the Day September 30, 2014 Who makes the decision regarding how much or what percentage of a drug a patient needs to take? In reading a recent post of a compounding discussion group the compounding pharmacist indicated she was having trouble getting the amount of the drug that needed to go into the compounded medication correct.
First, as I have pointed out before, this is very troubling to me that a compounding pharmacist seems willing to take advice on such a question from a discussion group. This shows the huge problem of compounding pharmacists not being properly trained or educated in order to be able to compound prescriptions. It also started me thinking about how the process of prescribing drugs works and should work. When it is a manufactured drug that has been through the FDA-approval process, the doctor determines the dosage of that manufactured drug. The amount of the api has already been determined by going through the trials and studies. However, from reading the question posed in the discussion groups, it is appears that in a number of compounded drug cases it maybe the compounding pharmacist determining the dose and the percentage of api to give to the patient, which again points to the fact that these are new drugs that have not been through the FDA-approval process. This is different from taking out fillers and additives of a commercially available because it is medically necessary. This poses a number of issues. Should this be happening? Are doctors educated on compounded medications and knowledgeable enough to make these calls? Isn't this scary to the patient to think your compounded medication may be made from a recipe on the Internet? Should there be more training and education of doctors on compounded medications and their use? Do new ethical guidelines between doctors and pharmacists need to be adopted? These lines seem very blurring and ones where compounding pharmacists found a way to make profit, focused on that, and didn't really think through all the legal and ethical issues. Speaking of legal issues, if pharmacists are crossing over into a defined area of "practicing medicine without a license" --then this could be a criminal act that could be prosecute and of course there are also the possibility of civil liability. What is clear is that this area of law is still developing in the courts.
RACs recouped $3B for Medicare in 2013; Providers who appealed those audits won less than 1 in 5 tries
RACs recouped $3B for Medicare in 2013
Medicare's recovery auditors returned more than $3 billion into the program's coffers last year, a new government report shows. And providers that appealed those audits won less than 1 in 5 tries.(MODERN HEALTHCARE)
FULL STORY »
Medicare's recovery auditors returned more than $3 billion into the program's coffers last year, a new government report shows. And providers that appealed those audits won less than 1 in 5 tries.(MODERN HEALTHCARE)
FULL STORY »
Monday, September 29, 2014
Very Important Comment and Questions from Reader regarding compounded vs. counterfeit drugs
"Question of the Day September 29, 2014 When do compounded medications qualify under the law as counterfeit drugs? Should more legal action be taken in this area?"
1 Comment - Show Original Post
Anonymous said...- This is a really important question. While the public health outcomes of counterfeit, substandard or falsified medications are generally the same (patient exposure to potentially unsafe or ineffective drugs), the motives behind the business models and tolerance for introducing risk of harm to patients (and manufacturing personnel) may be very different. If the penalties are similar and severe across all fronts, patients/workers will have highest level of protection. If it is easier and as profitable to make a substandard or falsified drug and not risk harsh penalties, why bother making the drugs look original at all? Call them "customized" for that particular market space.
Also worrisome--what should define a counterfeit API, and how should they be (globally) authenticated for certain necessary uses, without risking growth of substandard/counterfeit/falsified marketplace?
Patents on the soles of your shoes...: Patents for Humanity 2013 – Identifying counterfei...
Patents on the soles of your shoes...: Patents for Humanity 2013 – Identifying counterfei...: Copyright © Françoise Herrmann It is controversial enough that patented and life-saving drugs are often unavailable for treatment in Third...
University of South Carolina Plans to move compounding facility offsite
FY2015 Strategic Plan
academicdepartments.musc.edu/pha...
Medical University of South Carolina
Jane Axelrad to Speak about Compounding at NABP Meeting on October 6, 2014
DF]Agenda - National Association of Boards of Pharmacy
www.nabp.net/.../districtage...
National Association of Boards of Pharmacy
Is Your Pharmacy Compliant with the FDA’s New Rules on Interstate Shipment of Compounded Drugs? September 29, 2014 Michael D. Tucker | Baker, Donelson, Bearman, Caldwell & Berkowitz, PC
https://www.pharmacompliancemonitor.com/pharmacy-compliant-fdas-new-rules-interstate-shipment-compounded-drugs/7587/
Sunday, September 28, 2014
What is Pharmacy Compounding? Roseann B. Termini Widener University - School of Law March 4, 2013 PBA Health Care Law Committee Newsletter, Vol. 3, No. 1, Winter 2013 Abstract: Pharmacy compounding usually involves a small quantity of custom-made prescriptions. However, this has changed over the years to what some term large-scale production. Number of Pages in PDF File: 2 Keywords: pharmacies, compounding, drugs, pharmaceutical industry, food and drug law, FDA JEL Classification: K32 Accepted Paper Series
Patient-Tailored Medicine, Part Two: Personalized Medicine and the Legal Landscape American Health Lawyers Association’s Advisory Council on Racial and Ethnic Diversity Patient Access to Unapproved Therapies: The Leading Edge of Medicine and Law Leah Voigt Romano and Peter D. Jacobson Enforcement Related to Off-Label Marketing and Use of Drugs and Devices: Where Have We Been and Where Are We Going? John N. Joseph, David Deaton, Houman Ehsan, and Mark A. Bonanno Protecting Yourself from Your Assertions: Navigating Multiple
http://digitalcommons.wcl.american.edu/cgi/viewcontent.cgi?article=1033&context=facsch_lawrev&sei-redir=1&referer=http%3A%2F%2Fwww.google.com%2Fcse%3Fcx%3D000933248691480580078%253A57y4iyinbqe%26q%3Dcompounded%2Bdrugs%26sa%3DSearch#search=%22compounded%20drugs%22
A Previous Law Review Asking Whether Pharmacists Would Survive the Fen-Phen Feeding Frenzy?
File Format: PDF/Adobe Acrobat
the diet drug combination popularly known as “Fen-Phen,” fenfluramine ..... prescription orders; the compounding, dispensing, labeling, administering, and.
SUBSTITUTION LAWS AND INNOVATION IN THE PHARMACEUTICAL INDUSTRY HENRY G. GRABOWSKI AND JOHN M. VERNON*
File Format: PDF/Adobe Acrobat
The Pure Food and Drugs Act was passed in 1906 primarily to deal with food abuses. See ...... (c) R0 is the dollar value of R&D investment compounded to time t.
The Enduring Paradox of Products Liability Law Relating to Prescription Pharmaceuticals M. Stuart Madden
April 2001
The Enduring Paradox of Products Liability Law
Relating to Prescription Pharmaceuticals
M. Stuart Madden
Follow this and additional works at: http://digitalcommons.pace.edu/plr
This Article is brought to you for free and open access by the School of Law at DigitalCommons@Pace. It has been accepted for inclusion in Pace Law
Review by an authorized administrator of DigitalCommons@Pace. For more information, please contact cpittson@law.pace.edu.
Recommended Citation
M. Stuart Madden, The Enduring Paradox of Products Liability Law Relating to Prescription
Pharmaceuticals, 21 Pace L. Rev. 313 (2001)
Available at: http://digitalcommons.pace.edu/plr/vol21/iss2/1
The Enduring Paradox of Products Liability Law
Relating to Prescription Pharmaceuticals
M. Stuart Madden
Follow this and additional works at: http://digitalcommons.pace.edu/plr
This Article is brought to you for free and open access by the School of Law at DigitalCommons@Pace. It has been accepted for inclusion in Pace Law
Review by an authorized administrator of DigitalCommons@Pace. For more information, please contact cpittson@law.pace.edu.
Recommended Citation
M. Stuart Madden, The Enduring Paradox of Products Liability Law Relating to Prescription
Pharmaceuticals, 21 Pace L. Rev. 313 (2001)
Available at: http://digitalcommons.pace.edu/plr/vol21/iss2/1
2013 Stemming the Global Trade in Falsified and Substandard Medicines
Lawrence O. Gostin
Georgetown University Law Center, gostin@law.georgetown.edu
Gillian J. Buckley
Institute of Medicine
Patrick W. Kelley
Institute of Medicine
Georgetown Public Law and Legal Theory Research Paper No. 13-033
This paper can be downloaded free of charge from:
http://scholarship.law.georgetown.edu/facpub/1209
http://ssrn.com/abstract=2259119
Second Question of the Day September 28, 2014 Isn't it true that compounders and sellers of chemicals are in a direct position to control risk of harm and share in liability--where use is direct result of targeted marketing? Should they then bear the lion's share? Read the 2012 case Barnes v. Bayside Orthopaedics, Inc.
.tiff)
Question of the Day September 28, 2014 How telling is it that these organizations--Alliance of Independent Pharmacists – Texas, International Academy of Independent Pharmacists, Unique Pharmaceuticals, Inc. and Professional Compounding Centers of America --joined together in their position in the Rondol Mills Pharmacy Case?
No. 13-1014
____________________________________________________
In the
SUPREME COURT OF TEXAS
____________________________________________________
RANDOL MILL PHARMACY, KVG ENTERPRISES, INC.,
GARY D. DALEY, JOHN WAYNE BAILEY,
JAMES ROBERT FORSYTHE, KEVIN LYNN HEIDE,
JULIE KNOWLTON LUBBERT, and CARA MORRELL,
Petitioners,
v.
STACEY MILLER and RANDY MILLER,
Respondents.
____________________________________________________
On Petition for Review from the Second Court of Appeals, Fort Worth, Texas
____________________________________________________
Brief of Amicus Curiae Alliance of Independent Pharmacists – Texas,
International Academy of Independent Pharmacists,
Unique Pharmaceuticals, Inc. and
Professional Compounding Centers of America
____________________________________________________
E. Lee Parsley Jay B. Stewart
State Bar No. 15544900 State Bar No. 19211125
ATTORNEY AT LAW HANCE SCARBOROUGH , LLP
1621-B Enfield Road 400 W. 15 th Street, Suite 950
Austin, Texas 78703 Austin, Texas 78701
512.481.8800 – telephone 512.479.8888 – telephone
512.276.6592 – fax 512.482.6891 – fax
leeparsley@gmail.com jstewart@hslawmail.com
Attorneys for Amicus Curiae
FILED
13-1014
SUPREME COURT OF TEXAS
AUSTIN, TEXAS
2/12/2014 2:36:26 PM
BLAKE HAWTHORNE
CLERK
BRIEF OF AMICUS CURIAE Page ii
Table of Contents
Table of Authorities ................................................................................................. iii
Interest of Amicus Curiae .......................................................................................... v
Background ................................................................................................................ 2
Argument.................................................................................................................... 6
Conclusion ...............................................................................................................16
Certificate of Compliance ........................................................................................17
Certificate of Service ...............................................................................................18
BRIEF OF AMICUS CURIAE Page iii
Table of Authorities
Court Opinions
Cardwell v. McDonald, 356 S.W.3d 646 (Tex. App.—Austin 2011, no pet.) ........17
CHCA Bayshore, L.P. v. Ramos, 388 S.W.3d 741 (Tex. App.—
Houston [1 st Dist.] no pet.) ....................................................................................15
Diversicare General Partner, Inc. v. Rubio, 185 S.W.3d 842 (Tex. 2005) ..... 10, 14
Emeritus Corp. v. Highsmith, 211 S.W.3d 321 (Tex. App.—
San Antonio 2006, pet. denied).............................................................................17
Loaisiga v. Cerda, 379 S.W.3d 248, 256 (Tex. 2012) .................................... 7, 9, 10
Marks v. St. Luke’s Episcopal Hospital, 319 S.W.3d 658 (Tex. 2010) ...............9, 14
Medical Hospital of Buna Texas v. Wheatley, 287 S.W.3d 286
(Tex. App.—Beaumont 2009, pet. denied) ...........................................................10
Molinet v. Kimbrell, 356 S.W.3d 407 (Tex. 2011) .................................................... 7
Murphy v. Russell, 167 S.W.3d 835 (Tex. 2005) ....................................................11
Omaha Healthcare Center v. Johnson, 344 S.W.3d 392 (Tex. 2011).....................12
PM Management-Trinity NC, LLC v. Kumets, 368 S.W.3d 711
(Tex. App.—Austin 2012), reversed in part on other grounds,
404 S.W.3d 550 (Tex. 2013) .................................................................................16
Randol Mill Pharmacy v. Miller, 413 S.W.3d 844 (Tex. App.—
Fort Worth, pet. filed) .........................................................................................1, 6
Scoresby v. Santillan, 346 S.W.3d 546 (Tex. 2011) .................................................. 7
St. David’s Healthcare Partnership, L.P. v. Esparza, 348 S.W.3d 904
(Tex. 2011) ............................................................................................................12
Texas West Oaks Hospital v. Williams, 371 S.W.3d 171 (Tex. 2012) ....................11
Turtle Healthcare Group v. Linan, 337 S.W.3d 865 (Tex. 2011) ...........................13
Yamada v. Friend, 335 S.W.3d 192 (Tex. 2010) .............................................. 10, 13
BRIEF OF AMICUS CURIAE Page iv
Statutes and Rules
TEX . CIV . PRAC . & REM . CODE § 74.001(a)(12) ........................................................ 8
TEX . CIV . PRAC . & REM . CODE § 74.001(a)(13) ........................................................ 9
TEX . CIV . PRAC . & REM . CODE § 74.351(a) ............................................................... 5
TEX . CIV . PRAC . & REM . CODE § 74.001(a)(10) ........................................................ 8
TEX . CIV . PRAC . & REM . CODE § 74.001(a)(22) ........................................................ 6
Tex. H.B. 4, § 10.01, 78 th Leg., R.S. (2003) .............................................................. 7
BRIEF OF AMICUS CURIAE Page v
Interest of Amicus Curiae
The Alliance of Independent Pharmacists – Texas exists to ensure the
economic viability and security of independent pharmacy in Texas. The Alliance
provides a forum for those practicing in independent pharmacies to exchange
information, develop strategies, goals, and objectives that promote the practice of
independent pharmacy, and to ensure the highest standards of patient access. The
Alliance represents over three hundred Texas independent and compounding
pharmacies on legislative and regulatory issues regarding independent pharmacy
within Texas and the United States.
The International Academy of Compounding Pharmacists is an association
representing more than 3,600 pharmacists, technicians, students, and members of
the compounding community who focus upon the specialty practice of pharmacy
compounding. The Academy works on behalf of the compounding pharmacists
who work directly with prescribers, including physicians and nurse practitioners, to
create customized medication solutions for the many patients whose health care
needs cannot be met by manufactured medications.
Unique Pharmaceuticals, Inc., (UPI) is an industry-leading, FDA-registered
compounding pharmacy outsourcing facility providing safe, trusted, high-quality,
sterile compounded preparations. UPI provides preparations to hospitals, clinics,
surgery centers and physician offices across the nation. In addition to providing
emergency preparations needed during drug shortages, UPI provides compounded
BRIEF OF AMICUS CURIAE Page vi
preparations in pain management, obstetrics, anesthesia, general medicine,
emergency services, and health and wellness. Improving the quality of life for the
patients its customers serve and ensuring their safety is UPI’s top priority.
Headquartered in Houston, Texas, Professional Compounding Centers of
America (PCCA) is an independent compounding pharmacy’s resource for fine
chemicals, devices, equipment, training and support. PCCA helps compounding
pharmacies around the world deliver personalized, compounded medications.
PCCA provides products, services and support to almost 4,000 member pharmacist
throughout the United States, Canada, and Australia.
These organizations are the source of all fees paid for preparing this brief.
BRIEF OF AMICUS CURIAE Page 1
No. 13-1014
____________________________________________________
In the
SUPREME COURT OF TEXAS
____________________________________________________
RANDOL MILL PHARMACY, KVG ENTERPRISES, INC.,
GARY D. DALEY, JOHN WAYNE BAILEY,
JAMES ROBERT FORSYTHE, KEVIN LYNN HEIDE,
JULIE KNOWLTON LUBBERT, and CARA MORRELL,
Petitioners,
v.
STACEY MILLER and RANDY MILLER,
Respondents.
____________________________________________________
On Petition for Review from the Second Court of Appeals, Fort Worth, Texas
____________________________________________________
Brief of Amicus Curiae Alliance of Independent Pharmacists – Texas,
International Academy of Independent Pharmacists,
Unique Pharmaceuticals, Inc. and
Professional Compounding Centers of America
____________________________________________________
TO THE HONORABLE SUPREME COURT OF TEXAS :
On September 19, 2013, the Fort Worth Court of Appeals handed down its
opinion in this case, holding that the Texas Medical Liability Act does not apply to
pharmacist compounding. Randol Mill Pharmacy v. Miller, 413 S.W.3d 844 (Tex.
App.—Fort Worth, pet. filed). The Alliance of Independent Pharmacists – Texas,
BRIEF OF AMICUS CURIAE Page 2
the International Academy of Independent Pharmacists, Unique Pharmaceuticals,
Inc., and Professional Compounding Centers of America believe this decision is
contrary to both the language of the Texas Medical Liability Act (TMLA) and the
intent of the Legislature in enacting the TMLA. Therefore, the Alliance of
Independent Pharmacists – Texas, the International Academy of Independent
Pharmacists, and Unique Pharmaceuticals, Inc.—as amicus curiae—file this brief
in support of the petition for review filed by Randol Mill Pharmacy and the other
pharmacist petitioners, urging this Court to grant the petition for review and
reverse the erroneous judgment of the Fort Worth Court of Appeals.
Background
Pharmacy compounding is the customized preparation of a medicine that is
not otherwise commercially available. These medications are prescribed by a
physician or other prescribing practitioner, and compounded by a pharmacist
licensed under the Texas State Board of Pharmacy. Pharmacy compounding is a
centuries-old, well-regulated, common practice.
Millions of patients have unique health needs that off-the-shelf,
manufactured medications cannot meet. For these patients, personalized
medication solutions—prescribed by licensed practitioners and prepared by
trained, licensed pharmacists—are the only way to better health. Working with a
physician, a compounding pharmacist can meet a patient’s individual needs.
Whether it is an allergy to a dye or another ingredient, a need for a different
BRIEF OF AMICUS CURIAE Page 3
strength, or a preference for a different dosage form, compounding pharmacists
provide patients with solutions to their medication needs. Restricting doctors’
access to compounded medications—like the court of appeals holding in Randol
Mill Pharmacy would do—would be a serious mistake
Compounded medications are similar to the so-called “off-label” use of
FDA-approved drugs. When the FDA approves a specific drug as safe and
effective, this determination applies only to the specific strength, dosage form, and
disease or condition for which the drug was tested. But physicians often prescribe
medications for additional treatments for which the manufactured drug has not
been specifically approved. Medical professionals do this because, in their
judgment, the treatment is in the best interest of the individual patient. Similarly,
medical professionals often prescribe compounded medications because a patient
requires strength or dosage form that is not available from a manufacturer because
it was never submitted by the company for FDA review and approval. In such
instances, the best—and often only—medical options for prescribers to achieve the
desired therapeutic outcome is to have a medication compounded.
Additionally, some older medications are available only by compounding.
Because of the economics of pharmaceutical manufacturing, FDA-approved drugs
that serve a limited population often are discontinued by manufacturers, even
though they remain useful and valuable to prescribers and patients. In most of
these cases, the only option left for doctors and their patients is to have a
BRIEF OF AMICUS CURIAE Page 4
compounding pharmacist make the discontinued drug using pharmaceutical grade
ingredients.
Furthermore, although there are some pharmaceuticals that are dosed for
children, the majority of manufactured pharmaceuticals come in dosages that are
intended for adults. Children, of course, differ in size and individual needs. Some
have allergies and varying drug tolerances, requiring medications that are sugar-
free, gluten-free, casein-free, soy-free, or dye-free, for example. Drug dosing for
children is mostly done by weight, and it can be a challenge to find a commercially
available medication suitable for a child’s needs. A compounding pharmacist—
working closely with a pediatrician—can formulate a medication which meets the
child’s requirements.
Within pediatric hospitals, pharmacists rely on compounding a large number
of their medications. In many instances, the hospital is not equipped with staff or
expertise to handle all requirements for compounding and have to rely on
outsourcing pharmacies to effectively compound some of their medications. This
is essential for hospitals to deliver good patient care to their pediatric patients, yet
gravely at risk because of the Randol Mill Pharmacy holding.
* * *
The plaintiff in this case was diagnosed with Hepatitis C. Her physician
began administering weekly injections of the antioxidant supplement lipoic acid.
After nine weeks of treatment, the plaintiff had an episode of violent nausea and
BRIEF OF AMICUS CURIAE Page 5
vomiting when her physician administered an injection of lipoic acid. She alleges
that as a result of this administration of lipoic acid by her physician, she was
rendered blind in both eyes. She filed suit against the compounding pharmacists
from which her physician obtained the lipoic acid, alleging that the pharmacists
manufactured, distributed, and sold a defective product, and breached warranties
with regard to that product. The plaintiff did not file an expert report as required by
the Texas Medical Liability Act (TMLA) in health care liability cases. See CIV .
PRAC . & REM . CODE § 74.351(a). The pharmacists filed a motion to dismiss,
claiming the suit against them was a “health care liability claim” governed by the
TMLA, and that the plaintiffs were required to comply with procedural
requirements of the TMLA. The trial court overruled the motion to dismiss and the
defendants appealed.
The court of appeals described the case as follows: “The primary issue we
address in this appeal is whether a pharmacist’s act—of filling a bulk phone order
placed by a doctor for over twenty 30-milliliter vials of an injectable form of the
antioxidant supplement lipoic acid for use in the doctor’s office—constitutes
dispensing a prescription medicine as required for the pharmacist to qualify as a
health care provider under the Texas Medical Liability Act (TMLA).” Randol Mill
Pharmacy, 413 S.W.3d at 845. According to the court of appeals, the pharmacist
did not compound the injectable lipoic acid for delivery to an ultimate user (the
plaintiff) or any other specific person. Id. at 849. Consequently, as a matter of law
BRIEF OF AMICUS CURIAE Page 6
according to the court of appeals, the pharmacist was not “dispensing” a
prescription drug and did not meet the definition of a “pharmacist” under the
TMLA. Id.; see also TEX . CIV . PRAC . & REM . CODE § 74.001(a)(22) (defining
“pharmacist”).
The court of appeals decision constitutes a very narrow interpretation of the
TMLA to exclude what clearly is the provision of health care that is subject to the
TMLA’s substantive and procedural requirements. Since its passage in 2003,
Texas appellate courts have interpreted the TMLA broadly—in accordance with
the legislative intent—to impose the statutory scheme of reaching all activities that
constituting the provision of health care. The Randol Mill Pharmacy decision is
outside the mainstream, contrary to interpretive decisions, unduly restrictive, and
works to limit the provision of needed health care to thousands of Texans. It should
be reversed.
Argument
In 2003, the Texas Legislature amended Texas’s medical liability statutes
and codified them in chapter 74 of the Civil Practice and Remedies Code. See Tex.
H.B. 4, § 10.01, 78 th Leg., R.S. (2003). The Legislature’s goal was to make health
care more available and less expensive by reducing the cost of health care liability
claims. Scoresby v. Santillan, 346 S.W.3d 546, 552 (Tex. 2011). As this Court
recently noted, the “broad language used by the Legislature” in the TMLA
“evidences legislative intent for the statute to have expansive application.”
BRIEF OF AMICUS CURIAE Page 7
Loaisiga v. Cerda, 379 S.W.3d 248, 256 (Tex. 2012). The breadth of the statute’s
text creates a presumption that a claim is a health care liability claim if it is against
a physician or health care provider and is based on facts implicating the
defendant’s conduct during the course of a patient’s care, treatment, or
confinement. Id. It is this Court’s obligation to give effect to the Legislature’s
intent that the TMLA have expansive application. See Molinet v. Kimbrell, 356
S.W.3d 407, 411 (Tex. 2011) (courts must seek to give effect to Legislature’s
intent).
The Legislature’s intent that TMLA be widely applied to achieve its goals is
expressed in the TMLA’s definition of “health care,” which means “any act or
treatment performed or furnished ... by any health care provider for, to, or on
behalf of a patient during the patient’s medical care, treatment, or confinement.”
TEX . CIV . PRAC . & REM . CODE § 74.001(a)(10). It is plainly apparent that the event
in this case falls within the definition of “health care” because it was a treatment
performed by a health care provider (a physician) for, to, or on behalf of a patient
during the patient’s medical care, treatment, or confinement.
Additionally, the fact that a pharmacist is covered by the TMLA is
indisputable given that “health care provider” is defined as “any person,
partnership, professional association, corporation, facility, or institution duly
licensed, certified, registered, or chartered by the State of Texas to provide health
care, including ... a pharmacist.” Id § 74.001(a)(12). No one has challenged that the
BRIEF OF AMICUS CURIAE Page 8
defendants in this case are pharmacists “duly licensed, certified, registered, or
chartered by the State of Texas.” They are covered by the TMLA.
The TMLA defines a “health care liability claim” as “a cause of action
against a health care provider or physician for treatment, lack of treatment, or other
claimed departure from accepted standards of medical care, or health care, or
safety or professional or administrative services directly related to health care,
which proximately results in injury to or death of a claimant, whether the
claimant’s claim or cause of action sounds in tort or contract.” Id. § 74.001(a)(13).
Under this definition, a health care liability claim has three elements: (1) the
defendant is a health care provider or a physician; (2) the claimant’s cause of
action is for treatment or other claimed departure from accepted standards of
medical care, health care, or safety; and (3) the defendant’s alleged departure from
accepted standards proximately caused the claimant’s injury or death. Loaisiga,
379 S.W.3d at 255; Marks v. St. Luke’s Episcopal Hospital, 319 S.W.3d 658, 662
(Tex. 2010). This event falls within the definition.
The first element is met because a pharmacist is a health care provider. The
second element is met because the cause of action is related to a treatment
(administration of lipoic acid) and because the plaintiffs are effectively asserting
that the defendants departed from accepted safety standards by manufacturing a
defective product. The third element is met in that the plaintiffs are alleging that
the defendants’ departure from accepted standards caused the plaintiffs’ injury.
BRIEF OF AMICUS CURIAE Page 9
Under the plain words of the statute—even without giving the statute an expansive
application—this is a health care liability claim.
Here, despite the clearly applicable language of the statute, the plaintiffs are
attempting to avoid falling under the definition of “health care liability claim” by
artfully pleading that the pharmacists manufactured, distributed, and sold a
defective product, and breached warranties with regard to that product. Analysis of
the second element of the definition of “health care liability claim,” however,
focuses on the facts underlying the claim, not the form of, or artfully-phrased
language in, the plaintiff’s pleadings describing the facts or legal theories asserted.
Loaisiga, 379 S.W.3d at 255 (citing Yamada v. Friend, 335 S.W.3d 192, 196-97
(Tex. 2010) and Diversicare General Partner, Inc. v. Rubio, 185 S.W.3d 842, 847,
854 (Tex. 2005)). Claims premised on facts that could support claims against a
physician or health care provider for departures from accepted standards of
medical care, health care, or safety are health care liability claims, regardless of
whether the plaintiff alleges the defendant is liable for breach of any of those
standards. Id.; see also Medical Hospital of Buna Texas v. Wheatley, 287 S.W.3d
286, 291-92 (Tex. App.—Beaumont 2009, pet. denied) (a plaintiff cannot avoid the
requirements of the TMLA by attempting to recast a health care liability claim as a
different cause of action; and this is true even where a plaintiff attempts to
completely abandon its health care liability claims in favor of alternative claims).
These facts clearly could support a claim against a physician or health care
BRIEF OF AMICUS CURIAE Page 10
provider for departures from accepted standards of care. As such, they are health
care liability claims (especially if the legislative intent of an expansive application
of the statute is applied) despite the plaintiffs’ attempt to artfully plead them as
something else.
Furthermore, if expert medical or health care testimony is necessary to prove
or refute the merits of claim against a physician or health care provider, the claim
is a health care liability claim under the TMLA. 1 Texas West Oaks Hospital v.
Williams, 371 S.W.3d 171, 182 (Tex. 2012). Here, there is no way for the plaintiffs
to establish a causal connection between the lipoic acid and the alleged injury
without expert medical or health care testimony. Because that testimony is
essential, the plaintiffs cause of action is a health care liability claim.
Multiple decisions by this Court and various courts of appeals show that the
TMLA is applied expansively, in accordance with the Legislature’s intent. The
following opinions provide a sample of the breadth of the TMLA’s application.
Slip and Fall on Lubricating Gel. In St. David’s Healthcare
Partnership, L.P. v. Esparza, 348 S.W.3d 904, 905-06 (Tex. 2011),
the plaintiff filed a premises liability action against a hospital in
connection with injuries he suffered after slipping on a lubricating gel
that had fallen to the floor of his hospital room during or after a
1 Even if expert testimony is not necessary, the claim still may be a health care liability claim.
Murphy v. Russell, 167 S.W.3d 835, 838 (Tex. 2005) (“The fact that in the final analysis, expert
testimony may not be necessary to support a verdict does not mean the claim is not a health care
liability claim.”).
BRIEF OF AMICUS CURIAE Page 11
bladder scan. This Court held that these were health care liability
claims under the TMLA. The nurse’s alleged negligence in permitting
the gel to fall and remain on the floor was inseparable from the
procedures for the disposition of gloves in a hospital, according to the
Court, and therefore covered by the TMLA.
Spider Bites. In Omaha Healthcare Center v. Johnson, 344 S.W.3d
392, 394-95 (Tex. 2011), this Court held that claims brought against a
nursing home by the estate of a deceased resident who died as the
result of a spider bite were health care liability claims under the
TMLA.
Failure to Provide a Battery. In Turtle Healthcare Group v. Linan,
337 S.W.3d 865, 868-69 (Tex. 2011), the plaintiff alleged that a
pharmacy was negligent in failing to provide properly charged
batteries for a patient’s prescribed ventilator. This Court held that
these were health care liability claims under the TMLA because the
claims were based on an allegation that patient’s death had been
caused by the ventilator supplier’s negligence in the operation or
maintenance of the ventilator or its components and accessories.
Death at a Water Park. In Yamada v. Friend, 335 S.W.3d 192, 196-
98 (Tex. 2010), the plaintiffs sued a doctor after their daughter
collapsed at a water park and died from a heart condition. The
BRIEF OF AMICUS CURIAE Page 12
plaintiffs’ claims were based on the doctor’s failure to properly
provide advice and recommendations to the owner of the water park
about its safety practices, including the placement and maintenance of
automatic external defibrillators. This Court held that all of the
plaintiffs’ claims were governed by the TMLA. According to this
Court, permitting a claimant to maintain both health care liability
claims and different types of claims based on the same underlying
factual scenario “‘would open the door to splicing health care liability
claims into a multitude of other causes of action with standards of
care, damages, and procedures contrary to the Legislature’s explicit
requirements. It is well settled that such artful pleading and recasting
of claims is not permitted.’”
Slip and Fall off Hospital Bed’s Footboard. In Marks v. St. Luke’s
Episcopal Hospital, 319 S.W.3d 658, 661-62 (Tex. 2010), this Court
held that in a case in which the plaintiff sustained an injury when he
fell from a bed while attempting to use a footboard to push himself
into standing position, the plaintiff’s claims against the hospital for
alleged failure to properly train and supervise its agents, employees,
servants and staff, failure to provide the patient with the assistance he
required for daily living activities, and failure to provide the patient
with a safe environment in which to receive treatment and recover,
BRIEF OF AMICUS CURIAE Page 13
were “health care liability” claims within meaning of Medical
Liability and Insurance Improvement Act.
Sexual Assault. In Diversicare General Partner, Inc. v. Rubio, 185
S.W.3d 842, 849-53 (Tex. 2005), the plaintiff was the victim of a
sexual assault at a nursing home. She filed suit against the nursing
home based in part on claims that the nursing home failed to hire and
train appropriate personnel, failed to provide twenty-four-hour
nursing services from a sufficient number of qualified nursing
personnel to meet her nursing needs, hired incompetent staff who
were unqualified to care for her, and failed to establish and implement
appropriate safety policies to protect its residents. This Court held that
these claims were health care liability claims under the medical
liability act because they amounted to causes of action for departures
from accepted standards of professional health care.
Identification, Handling, and Disposal of Specimens. In CHCA
Bayshore, L.P. v. Ramos, 388 S.W.3d 741, 744-47 (Tex. App.—
Houston [1 st Dist.] no pet.) a patient who suffered a miscarriage sued a
hospital alleging negligence and negligent infliction of emotional
distress as a result of the hospital giving her the amputated toe of
another individual instead of the fetal remains for burial. The court of
appeals held that these were “health care liability claims” under the
BRIEF OF AMICUS CURIAE Page 14
TMLA because the identification, handling, and disposal of
specimens were “professional or administrative services” as
contemplated by TMLA; and training and supervision of employees,
as well as maintenance of adequate policies, were inseparable parts of
fulfilling a hospital’s responsibilities for proper handling of
specimens.
Nursing Home Billing Fraud. In PM Management-Trinity NC, LLC
v. Kumets, 368 S.W.3d 711, 722-23 (Tex. App.—Austin 2012),
reversed in part on other grounds, 404 S.W.3d 550 (Tex. 2013), the
court of appeals held that allegations of billing fraud against nursing
home asserted by the family of a patient were health care liability
claims subject to the requirements of the TMLA because it was
reasonable to conclude that the billing was fraudulent both with
regard to whether the services the patient received while in the facility
were carried out in an appropriate manner by qualified personnel, as it
was represented they would be, and whether all the billed services
were provided.
No Physician-Patient Relationship; Marriage Counseling. In
Cardwell v. McDonald, 356 S.W.3d 646, 652-59 (Tex. App.—Austin
2011, no pet.), the wife of a psychiatrist’s patient sued the psychiatrist
based on an alleged misdiagnosis of a psychiatric condition and an
BRIEF OF AMICUS CURIAE Page 15
alleged communication of that misdiagnosis to the patient following
purported “marriage counseling” with the patient and his wife. The
court of appeals held that this constituted a “health care liability
claim” even though the psychiatrist did not have a physician-patient
relationship with the wife because the plaintiff asserted facts that
came within statutory definitions of “health care,” “medical care,” and
“practicing medicine,” and the plaintiff would have to present expert
testimony to support her cause of action.
Fights at Assisted Living Facility. In Emeritus Corp. v. Highsmith,
211 S.W.3d 321, 327-28 (Tex. App.—San Antonio 2006, pet. denied),
an assisted living facility resident brought claims against the facility
arising out of resident-on-resident altercations. The court of appeals
held that these claims were health care liability claims under the
TMLA.
These opinions show the wide range of fact situations that fall with the
purview of the TMLA. It applies to causes of action based on slips and falls, fights
at assisted living facilities, spider bites, sexual assaults, and nursing home billing
fraud, among other things. It applies even when the plaintiff does not have a
physician-patient relationship with the physician she is suing. It applies
exceptionally broadly because the Legislature compelled an expansive application
of the Act.
BRIEF OF AMICUS CURIAE Page 16
Here, the alleged injury clearly resulted from the provision of medical care
to a patient. It did not result from billing fraud, a spider bite, or a fight. The
plaintiff was being treated by a physician for hepatitis, and was being
administering weekly injections of lipoic acid by the physician. The plaintiff
alleges she reacted adversely to the lipoic acid after the ninth treatment, and that
the treatment rendered her blind. These are health care liability claims under the
TMLA. The character of the plaintiffs’ cause of action is not changed by the fact
that she has omitted suing her physician or by the fact that she recast her causes of
action to try to avoid the Act. If the Legislature intended to capture slip and falls,
sexual assaults, billing fraud, fights and spider bites with the TMLA expansive
provisions, surely the Legislature also intended to also catch the unambiguous
provision of health care to a patient.
Conclusion
The court of appeals erred in holding that the plaintiffs’ claims in this case
are not governed by the TMLA. Its holding will limit the ability of Texans to
obtain necessary health care. The court of appeals decision is outside the
mainstream and ignores this Court’s admonition that the act is to be applied
broadly to achieve its purposes. Your amicus curiae respectfully urge this Court to
grant the Petitioners’ petition for review and reverse the court of appeals erroneous
judgment.
BRIEF OF AMICUS CURIAE Page 17
February 12, 2014 Respectfully submitted,
/s/ E. Lee Parsley
E. Lee Parsley
State Bar No. 15544900
ATTORNEY AT LAW
1621-B Enfield Road
Austin, Texas 78703
512.481.8800 – telephone
512.276.6592 – fax
leeparsley@gmail.com
Jay B. Stewart
State Bar No. 19211125
HANCE SCARBOROUGH , LLP
400 W. 15 th Street, Suite 950
Austin, Texas 78701
512.479.8888 – telephone
512.482.6891 – fax
jstewart@hslawmail.com
Attorneys for Amicus Curiae
Certificate of Compliance
I hereby certify that this brief includes 3578 words in 14-point Times New
Roman font, thus complying with Texas Rule of Appellate Procedure 9.4.
/s/ E. Lee Parsley
BRIEF OF AMICUS CURIAE Page 18
Certificate of Service
I certify hereby that on February 12, 2014, I electronically submitted the
foregoing document with the clerk of court using the electronic case files system of
the court, which will send a Notice of Electronic Filing to all counsel of record, as
shown below.
Erin E. Lunceford
Michele Quattlebaum
SPROTT , RIGBY , NEWSOM , ROBBINS & LUNCEFORD , P.C.
2211 Norfolk, Suite 1150
Houston, Texas 77098
Attorneys for Petitioners
Michael W. Minton
LAW OFFICES OF MICHAEL W. MINTON , P.L.L.C.
6100 Western Place, Suite W0541
Fort Worth, Texas 76107
and
Greg Fitzgerald
LAW OFFICE OF GREG FITZGERALD
413 Harwood Road
Bedford, Texas 76021
Attorneys for Respondents
Miguel S. Rodriguez
Taylor Dunham, LLP
301 Congress Avenue, Suite 1050
Austin, Texas 78701
Attorneys for Southwest Pharmacy Solutions, Inc. d/b/a American
Pharmacies
/s/ E. Lee Parsley
____________________________________________________
In the
SUPREME COURT OF TEXAS
____________________________________________________
RANDOL MILL PHARMACY, KVG ENTERPRISES, INC.,
GARY D. DALEY, JOHN WAYNE BAILEY,
JAMES ROBERT FORSYTHE, KEVIN LYNN HEIDE,
JULIE KNOWLTON LUBBERT, and CARA MORRELL,
Petitioners,
v.
STACEY MILLER and RANDY MILLER,
Respondents.
____________________________________________________
On Petition for Review from the Second Court of Appeals, Fort Worth, Texas
____________________________________________________
Brief of Amicus Curiae Alliance of Independent Pharmacists – Texas,
International Academy of Independent Pharmacists,
Unique Pharmaceuticals, Inc. and
Professional Compounding Centers of America
____________________________________________________
E. Lee Parsley Jay B. Stewart
State Bar No. 15544900 State Bar No. 19211125
ATTORNEY AT LAW HANCE SCARBOROUGH , LLP
1621-B Enfield Road 400 W. 15 th Street, Suite 950
Austin, Texas 78703 Austin, Texas 78701
512.481.8800 – telephone 512.479.8888 – telephone
512.276.6592 – fax 512.482.6891 – fax
leeparsley@gmail.com jstewart@hslawmail.com
Attorneys for Amicus Curiae
FILED
13-1014
SUPREME COURT OF TEXAS
AUSTIN, TEXAS
2/12/2014 2:36:26 PM
BLAKE HAWTHORNE
CLERK
BRIEF OF AMICUS CURIAE Page ii
Table of Contents
Table of Authorities ................................................................................................. iii
Interest of Amicus Curiae .......................................................................................... v
Background ................................................................................................................ 2
Argument.................................................................................................................... 6
Conclusion ...............................................................................................................16
Certificate of Compliance ........................................................................................17
Certificate of Service ...............................................................................................18
BRIEF OF AMICUS CURIAE Page iii
Table of Authorities
Court Opinions
Cardwell v. McDonald, 356 S.W.3d 646 (Tex. App.—Austin 2011, no pet.) ........17
CHCA Bayshore, L.P. v. Ramos, 388 S.W.3d 741 (Tex. App.—
Houston [1 st Dist.] no pet.) ....................................................................................15
Diversicare General Partner, Inc. v. Rubio, 185 S.W.3d 842 (Tex. 2005) ..... 10, 14
Emeritus Corp. v. Highsmith, 211 S.W.3d 321 (Tex. App.—
San Antonio 2006, pet. denied).............................................................................17
Loaisiga v. Cerda, 379 S.W.3d 248, 256 (Tex. 2012) .................................... 7, 9, 10
Marks v. St. Luke’s Episcopal Hospital, 319 S.W.3d 658 (Tex. 2010) ...............9, 14
Medical Hospital of Buna Texas v. Wheatley, 287 S.W.3d 286
(Tex. App.—Beaumont 2009, pet. denied) ...........................................................10
Molinet v. Kimbrell, 356 S.W.3d 407 (Tex. 2011) .................................................... 7
Murphy v. Russell, 167 S.W.3d 835 (Tex. 2005) ....................................................11
Omaha Healthcare Center v. Johnson, 344 S.W.3d 392 (Tex. 2011).....................12
PM Management-Trinity NC, LLC v. Kumets, 368 S.W.3d 711
(Tex. App.—Austin 2012), reversed in part on other grounds,
404 S.W.3d 550 (Tex. 2013) .................................................................................16
Randol Mill Pharmacy v. Miller, 413 S.W.3d 844 (Tex. App.—
Fort Worth, pet. filed) .........................................................................................1, 6
Scoresby v. Santillan, 346 S.W.3d 546 (Tex. 2011) .................................................. 7
St. David’s Healthcare Partnership, L.P. v. Esparza, 348 S.W.3d 904
(Tex. 2011) ............................................................................................................12
Texas West Oaks Hospital v. Williams, 371 S.W.3d 171 (Tex. 2012) ....................11
Turtle Healthcare Group v. Linan, 337 S.W.3d 865 (Tex. 2011) ...........................13
Yamada v. Friend, 335 S.W.3d 192 (Tex. 2010) .............................................. 10, 13
BRIEF OF AMICUS CURIAE Page iv
Statutes and Rules
TEX . CIV . PRAC . & REM . CODE § 74.001(a)(12) ........................................................ 8
TEX . CIV . PRAC . & REM . CODE § 74.001(a)(13) ........................................................ 9
TEX . CIV . PRAC . & REM . CODE § 74.351(a) ............................................................... 5
TEX . CIV . PRAC . & REM . CODE § 74.001(a)(10) ........................................................ 8
TEX . CIV . PRAC . & REM . CODE § 74.001(a)(22) ........................................................ 6
Tex. H.B. 4, § 10.01, 78 th Leg., R.S. (2003) .............................................................. 7
BRIEF OF AMICUS CURIAE Page v
Interest of Amicus Curiae
The Alliance of Independent Pharmacists – Texas exists to ensure the
economic viability and security of independent pharmacy in Texas. The Alliance
provides a forum for those practicing in independent pharmacies to exchange
information, develop strategies, goals, and objectives that promote the practice of
independent pharmacy, and to ensure the highest standards of patient access. The
Alliance represents over three hundred Texas independent and compounding
pharmacies on legislative and regulatory issues regarding independent pharmacy
within Texas and the United States.
The International Academy of Compounding Pharmacists is an association
representing more than 3,600 pharmacists, technicians, students, and members of
the compounding community who focus upon the specialty practice of pharmacy
compounding. The Academy works on behalf of the compounding pharmacists
who work directly with prescribers, including physicians and nurse practitioners, to
create customized medication solutions for the many patients whose health care
needs cannot be met by manufactured medications.
Unique Pharmaceuticals, Inc., (UPI) is an industry-leading, FDA-registered
compounding pharmacy outsourcing facility providing safe, trusted, high-quality,
sterile compounded preparations. UPI provides preparations to hospitals, clinics,
surgery centers and physician offices across the nation. In addition to providing
emergency preparations needed during drug shortages, UPI provides compounded
BRIEF OF AMICUS CURIAE Page vi
preparations in pain management, obstetrics, anesthesia, general medicine,
emergency services, and health and wellness. Improving the quality of life for the
patients its customers serve and ensuring their safety is UPI’s top priority.
Headquartered in Houston, Texas, Professional Compounding Centers of
America (PCCA) is an independent compounding pharmacy’s resource for fine
chemicals, devices, equipment, training and support. PCCA helps compounding
pharmacies around the world deliver personalized, compounded medications.
PCCA provides products, services and support to almost 4,000 member pharmacist
throughout the United States, Canada, and Australia.
These organizations are the source of all fees paid for preparing this brief.
BRIEF OF AMICUS CURIAE Page 1
No. 13-1014
____________________________________________________
In the
SUPREME COURT OF TEXAS
____________________________________________________
RANDOL MILL PHARMACY, KVG ENTERPRISES, INC.,
GARY D. DALEY, JOHN WAYNE BAILEY,
JAMES ROBERT FORSYTHE, KEVIN LYNN HEIDE,
JULIE KNOWLTON LUBBERT, and CARA MORRELL,
Petitioners,
v.
STACEY MILLER and RANDY MILLER,
Respondents.
____________________________________________________
On Petition for Review from the Second Court of Appeals, Fort Worth, Texas
____________________________________________________
Brief of Amicus Curiae Alliance of Independent Pharmacists – Texas,
International Academy of Independent Pharmacists,
Unique Pharmaceuticals, Inc. and
Professional Compounding Centers of America
____________________________________________________
TO THE HONORABLE SUPREME COURT OF TEXAS :
On September 19, 2013, the Fort Worth Court of Appeals handed down its
opinion in this case, holding that the Texas Medical Liability Act does not apply to
pharmacist compounding. Randol Mill Pharmacy v. Miller, 413 S.W.3d 844 (Tex.
App.—Fort Worth, pet. filed). The Alliance of Independent Pharmacists – Texas,
BRIEF OF AMICUS CURIAE Page 2
the International Academy of Independent Pharmacists, Unique Pharmaceuticals,
Inc., and Professional Compounding Centers of America believe this decision is
contrary to both the language of the Texas Medical Liability Act (TMLA) and the
intent of the Legislature in enacting the TMLA. Therefore, the Alliance of
Independent Pharmacists – Texas, the International Academy of Independent
Pharmacists, and Unique Pharmaceuticals, Inc.—as amicus curiae—file this brief
in support of the petition for review filed by Randol Mill Pharmacy and the other
pharmacist petitioners, urging this Court to grant the petition for review and
reverse the erroneous judgment of the Fort Worth Court of Appeals.
Background
Pharmacy compounding is the customized preparation of a medicine that is
not otherwise commercially available. These medications are prescribed by a
physician or other prescribing practitioner, and compounded by a pharmacist
licensed under the Texas State Board of Pharmacy. Pharmacy compounding is a
centuries-old, well-regulated, common practice.
Millions of patients have unique health needs that off-the-shelf,
manufactured medications cannot meet. For these patients, personalized
medication solutions—prescribed by licensed practitioners and prepared by
trained, licensed pharmacists—are the only way to better health. Working with a
physician, a compounding pharmacist can meet a patient’s individual needs.
Whether it is an allergy to a dye or another ingredient, a need for a different
BRIEF OF AMICUS CURIAE Page 3
strength, or a preference for a different dosage form, compounding pharmacists
provide patients with solutions to their medication needs. Restricting doctors’
access to compounded medications—like the court of appeals holding in Randol
Mill Pharmacy would do—would be a serious mistake
Compounded medications are similar to the so-called “off-label” use of
FDA-approved drugs. When the FDA approves a specific drug as safe and
effective, this determination applies only to the specific strength, dosage form, and
disease or condition for which the drug was tested. But physicians often prescribe
medications for additional treatments for which the manufactured drug has not
been specifically approved. Medical professionals do this because, in their
judgment, the treatment is in the best interest of the individual patient. Similarly,
medical professionals often prescribe compounded medications because a patient
requires strength or dosage form that is not available from a manufacturer because
it was never submitted by the company for FDA review and approval. In such
instances, the best—and often only—medical options for prescribers to achieve the
desired therapeutic outcome is to have a medication compounded.
Additionally, some older medications are available only by compounding.
Because of the economics of pharmaceutical manufacturing, FDA-approved drugs
that serve a limited population often are discontinued by manufacturers, even
though they remain useful and valuable to prescribers and patients. In most of
these cases, the only option left for doctors and their patients is to have a
BRIEF OF AMICUS CURIAE Page 4
compounding pharmacist make the discontinued drug using pharmaceutical grade
ingredients.
Furthermore, although there are some pharmaceuticals that are dosed for
children, the majority of manufactured pharmaceuticals come in dosages that are
intended for adults. Children, of course, differ in size and individual needs. Some
have allergies and varying drug tolerances, requiring medications that are sugar-
free, gluten-free, casein-free, soy-free, or dye-free, for example. Drug dosing for
children is mostly done by weight, and it can be a challenge to find a commercially
available medication suitable for a child’s needs. A compounding pharmacist—
working closely with a pediatrician—can formulate a medication which meets the
child’s requirements.
Within pediatric hospitals, pharmacists rely on compounding a large number
of their medications. In many instances, the hospital is not equipped with staff or
expertise to handle all requirements for compounding and have to rely on
outsourcing pharmacies to effectively compound some of their medications. This
is essential for hospitals to deliver good patient care to their pediatric patients, yet
gravely at risk because of the Randol Mill Pharmacy holding.
* * *
The plaintiff in this case was diagnosed with Hepatitis C. Her physician
began administering weekly injections of the antioxidant supplement lipoic acid.
After nine weeks of treatment, the plaintiff had an episode of violent nausea and
BRIEF OF AMICUS CURIAE Page 5
vomiting when her physician administered an injection of lipoic acid. She alleges
that as a result of this administration of lipoic acid by her physician, she was
rendered blind in both eyes. She filed suit against the compounding pharmacists
from which her physician obtained the lipoic acid, alleging that the pharmacists
manufactured, distributed, and sold a defective product, and breached warranties
with regard to that product. The plaintiff did not file an expert report as required by
the Texas Medical Liability Act (TMLA) in health care liability cases. See CIV .
PRAC . & REM . CODE § 74.351(a). The pharmacists filed a motion to dismiss,
claiming the suit against them was a “health care liability claim” governed by the
TMLA, and that the plaintiffs were required to comply with procedural
requirements of the TMLA. The trial court overruled the motion to dismiss and the
defendants appealed.
The court of appeals described the case as follows: “The primary issue we
address in this appeal is whether a pharmacist’s act—of filling a bulk phone order
placed by a doctor for over twenty 30-milliliter vials of an injectable form of the
antioxidant supplement lipoic acid for use in the doctor’s office—constitutes
dispensing a prescription medicine as required for the pharmacist to qualify as a
health care provider under the Texas Medical Liability Act (TMLA).” Randol Mill
Pharmacy, 413 S.W.3d at 845. According to the court of appeals, the pharmacist
did not compound the injectable lipoic acid for delivery to an ultimate user (the
plaintiff) or any other specific person. Id. at 849. Consequently, as a matter of law
BRIEF OF AMICUS CURIAE Page 6
according to the court of appeals, the pharmacist was not “dispensing” a
prescription drug and did not meet the definition of a “pharmacist” under the
TMLA. Id.; see also TEX . CIV . PRAC . & REM . CODE § 74.001(a)(22) (defining
“pharmacist”).
The court of appeals decision constitutes a very narrow interpretation of the
TMLA to exclude what clearly is the provision of health care that is subject to the
TMLA’s substantive and procedural requirements. Since its passage in 2003,
Texas appellate courts have interpreted the TMLA broadly—in accordance with
the legislative intent—to impose the statutory scheme of reaching all activities that
constituting the provision of health care. The Randol Mill Pharmacy decision is
outside the mainstream, contrary to interpretive decisions, unduly restrictive, and
works to limit the provision of needed health care to thousands of Texans. It should
be reversed.
Argument
In 2003, the Texas Legislature amended Texas’s medical liability statutes
and codified them in chapter 74 of the Civil Practice and Remedies Code. See Tex.
H.B. 4, § 10.01, 78 th Leg., R.S. (2003). The Legislature’s goal was to make health
care more available and less expensive by reducing the cost of health care liability
claims. Scoresby v. Santillan, 346 S.W.3d 546, 552 (Tex. 2011). As this Court
recently noted, the “broad language used by the Legislature” in the TMLA
“evidences legislative intent for the statute to have expansive application.”
BRIEF OF AMICUS CURIAE Page 7
Loaisiga v. Cerda, 379 S.W.3d 248, 256 (Tex. 2012). The breadth of the statute’s
text creates a presumption that a claim is a health care liability claim if it is against
a physician or health care provider and is based on facts implicating the
defendant’s conduct during the course of a patient’s care, treatment, or
confinement. Id. It is this Court’s obligation to give effect to the Legislature’s
intent that the TMLA have expansive application. See Molinet v. Kimbrell, 356
S.W.3d 407, 411 (Tex. 2011) (courts must seek to give effect to Legislature’s
intent).
The Legislature’s intent that TMLA be widely applied to achieve its goals is
expressed in the TMLA’s definition of “health care,” which means “any act or
treatment performed or furnished ... by any health care provider for, to, or on
behalf of a patient during the patient’s medical care, treatment, or confinement.”
TEX . CIV . PRAC . & REM . CODE § 74.001(a)(10). It is plainly apparent that the event
in this case falls within the definition of “health care” because it was a treatment
performed by a health care provider (a physician) for, to, or on behalf of a patient
during the patient’s medical care, treatment, or confinement.
Additionally, the fact that a pharmacist is covered by the TMLA is
indisputable given that “health care provider” is defined as “any person,
partnership, professional association, corporation, facility, or institution duly
licensed, certified, registered, or chartered by the State of Texas to provide health
care, including ... a pharmacist.” Id § 74.001(a)(12). No one has challenged that the
BRIEF OF AMICUS CURIAE Page 8
defendants in this case are pharmacists “duly licensed, certified, registered, or
chartered by the State of Texas.” They are covered by the TMLA.
The TMLA defines a “health care liability claim” as “a cause of action
against a health care provider or physician for treatment, lack of treatment, or other
claimed departure from accepted standards of medical care, or health care, or
safety or professional or administrative services directly related to health care,
which proximately results in injury to or death of a claimant, whether the
claimant’s claim or cause of action sounds in tort or contract.” Id. § 74.001(a)(13).
Under this definition, a health care liability claim has three elements: (1) the
defendant is a health care provider or a physician; (2) the claimant’s cause of
action is for treatment or other claimed departure from accepted standards of
medical care, health care, or safety; and (3) the defendant’s alleged departure from
accepted standards proximately caused the claimant’s injury or death. Loaisiga,
379 S.W.3d at 255; Marks v. St. Luke’s Episcopal Hospital, 319 S.W.3d 658, 662
(Tex. 2010). This event falls within the definition.
The first element is met because a pharmacist is a health care provider. The
second element is met because the cause of action is related to a treatment
(administration of lipoic acid) and because the plaintiffs are effectively asserting
that the defendants departed from accepted safety standards by manufacturing a
defective product. The third element is met in that the plaintiffs are alleging that
the defendants’ departure from accepted standards caused the plaintiffs’ injury.
BRIEF OF AMICUS CURIAE Page 9
Under the plain words of the statute—even without giving the statute an expansive
application—this is a health care liability claim.
Here, despite the clearly applicable language of the statute, the plaintiffs are
attempting to avoid falling under the definition of “health care liability claim” by
artfully pleading that the pharmacists manufactured, distributed, and sold a
defective product, and breached warranties with regard to that product. Analysis of
the second element of the definition of “health care liability claim,” however,
focuses on the facts underlying the claim, not the form of, or artfully-phrased
language in, the plaintiff’s pleadings describing the facts or legal theories asserted.
Loaisiga, 379 S.W.3d at 255 (citing Yamada v. Friend, 335 S.W.3d 192, 196-97
(Tex. 2010) and Diversicare General Partner, Inc. v. Rubio, 185 S.W.3d 842, 847,
854 (Tex. 2005)). Claims premised on facts that could support claims against a
physician or health care provider for departures from accepted standards of
medical care, health care, or safety are health care liability claims, regardless of
whether the plaintiff alleges the defendant is liable for breach of any of those
standards. Id.; see also Medical Hospital of Buna Texas v. Wheatley, 287 S.W.3d
286, 291-92 (Tex. App.—Beaumont 2009, pet. denied) (a plaintiff cannot avoid the
requirements of the TMLA by attempting to recast a health care liability claim as a
different cause of action; and this is true even where a plaintiff attempts to
completely abandon its health care liability claims in favor of alternative claims).
These facts clearly could support a claim against a physician or health care
BRIEF OF AMICUS CURIAE Page 10
provider for departures from accepted standards of care. As such, they are health
care liability claims (especially if the legislative intent of an expansive application
of the statute is applied) despite the plaintiffs’ attempt to artfully plead them as
something else.
Furthermore, if expert medical or health care testimony is necessary to prove
or refute the merits of claim against a physician or health care provider, the claim
is a health care liability claim under the TMLA. 1 Texas West Oaks Hospital v.
Williams, 371 S.W.3d 171, 182 (Tex. 2012). Here, there is no way for the plaintiffs
to establish a causal connection between the lipoic acid and the alleged injury
without expert medical or health care testimony. Because that testimony is
essential, the plaintiffs cause of action is a health care liability claim.
Multiple decisions by this Court and various courts of appeals show that the
TMLA is applied expansively, in accordance with the Legislature’s intent. The
following opinions provide a sample of the breadth of the TMLA’s application.
Slip and Fall on Lubricating Gel. In St. David’s Healthcare
Partnership, L.P. v. Esparza, 348 S.W.3d 904, 905-06 (Tex. 2011),
the plaintiff filed a premises liability action against a hospital in
connection with injuries he suffered after slipping on a lubricating gel
that had fallen to the floor of his hospital room during or after a
1 Even if expert testimony is not necessary, the claim still may be a health care liability claim.
Murphy v. Russell, 167 S.W.3d 835, 838 (Tex. 2005) (“The fact that in the final analysis, expert
testimony may not be necessary to support a verdict does not mean the claim is not a health care
liability claim.”).
BRIEF OF AMICUS CURIAE Page 11
bladder scan. This Court held that these were health care liability
claims under the TMLA. The nurse’s alleged negligence in permitting
the gel to fall and remain on the floor was inseparable from the
procedures for the disposition of gloves in a hospital, according to the
Court, and therefore covered by the TMLA.
Spider Bites. In Omaha Healthcare Center v. Johnson, 344 S.W.3d
392, 394-95 (Tex. 2011), this Court held that claims brought against a
nursing home by the estate of a deceased resident who died as the
result of a spider bite were health care liability claims under the
TMLA.
Failure to Provide a Battery. In Turtle Healthcare Group v. Linan,
337 S.W.3d 865, 868-69 (Tex. 2011), the plaintiff alleged that a
pharmacy was negligent in failing to provide properly charged
batteries for a patient’s prescribed ventilator. This Court held that
these were health care liability claims under the TMLA because the
claims were based on an allegation that patient’s death had been
caused by the ventilator supplier’s negligence in the operation or
maintenance of the ventilator or its components and accessories.
Death at a Water Park. In Yamada v. Friend, 335 S.W.3d 192, 196-
98 (Tex. 2010), the plaintiffs sued a doctor after their daughter
collapsed at a water park and died from a heart condition. The
BRIEF OF AMICUS CURIAE Page 12
plaintiffs’ claims were based on the doctor’s failure to properly
provide advice and recommendations to the owner of the water park
about its safety practices, including the placement and maintenance of
automatic external defibrillators. This Court held that all of the
plaintiffs’ claims were governed by the TMLA. According to this
Court, permitting a claimant to maintain both health care liability
claims and different types of claims based on the same underlying
factual scenario “‘would open the door to splicing health care liability
claims into a multitude of other causes of action with standards of
care, damages, and procedures contrary to the Legislature’s explicit
requirements. It is well settled that such artful pleading and recasting
of claims is not permitted.’”
Slip and Fall off Hospital Bed’s Footboard. In Marks v. St. Luke’s
Episcopal Hospital, 319 S.W.3d 658, 661-62 (Tex. 2010), this Court
held that in a case in which the plaintiff sustained an injury when he
fell from a bed while attempting to use a footboard to push himself
into standing position, the plaintiff’s claims against the hospital for
alleged failure to properly train and supervise its agents, employees,
servants and staff, failure to provide the patient with the assistance he
required for daily living activities, and failure to provide the patient
with a safe environment in which to receive treatment and recover,
BRIEF OF AMICUS CURIAE Page 13
were “health care liability” claims within meaning of Medical
Liability and Insurance Improvement Act.
Sexual Assault. In Diversicare General Partner, Inc. v. Rubio, 185
S.W.3d 842, 849-53 (Tex. 2005), the plaintiff was the victim of a
sexual assault at a nursing home. She filed suit against the nursing
home based in part on claims that the nursing home failed to hire and
train appropriate personnel, failed to provide twenty-four-hour
nursing services from a sufficient number of qualified nursing
personnel to meet her nursing needs, hired incompetent staff who
were unqualified to care for her, and failed to establish and implement
appropriate safety policies to protect its residents. This Court held that
these claims were health care liability claims under the medical
liability act because they amounted to causes of action for departures
from accepted standards of professional health care.
Identification, Handling, and Disposal of Specimens. In CHCA
Bayshore, L.P. v. Ramos, 388 S.W.3d 741, 744-47 (Tex. App.—
Houston [1 st Dist.] no pet.) a patient who suffered a miscarriage sued a
hospital alleging negligence and negligent infliction of emotional
distress as a result of the hospital giving her the amputated toe of
another individual instead of the fetal remains for burial. The court of
appeals held that these were “health care liability claims” under the
BRIEF OF AMICUS CURIAE Page 14
TMLA because the identification, handling, and disposal of
specimens were “professional or administrative services” as
contemplated by TMLA; and training and supervision of employees,
as well as maintenance of adequate policies, were inseparable parts of
fulfilling a hospital’s responsibilities for proper handling of
specimens.
Nursing Home Billing Fraud. In PM Management-Trinity NC, LLC
v. Kumets, 368 S.W.3d 711, 722-23 (Tex. App.—Austin 2012),
reversed in part on other grounds, 404 S.W.3d 550 (Tex. 2013), the
court of appeals held that allegations of billing fraud against nursing
home asserted by the family of a patient were health care liability
claims subject to the requirements of the TMLA because it was
reasonable to conclude that the billing was fraudulent both with
regard to whether the services the patient received while in the facility
were carried out in an appropriate manner by qualified personnel, as it
was represented they would be, and whether all the billed services
were provided.
No Physician-Patient Relationship; Marriage Counseling. In
Cardwell v. McDonald, 356 S.W.3d 646, 652-59 (Tex. App.—Austin
2011, no pet.), the wife of a psychiatrist’s patient sued the psychiatrist
based on an alleged misdiagnosis of a psychiatric condition and an
BRIEF OF AMICUS CURIAE Page 15
alleged communication of that misdiagnosis to the patient following
purported “marriage counseling” with the patient and his wife. The
court of appeals held that this constituted a “health care liability
claim” even though the psychiatrist did not have a physician-patient
relationship with the wife because the plaintiff asserted facts that
came within statutory definitions of “health care,” “medical care,” and
“practicing medicine,” and the plaintiff would have to present expert
testimony to support her cause of action.
Fights at Assisted Living Facility. In Emeritus Corp. v. Highsmith,
211 S.W.3d 321, 327-28 (Tex. App.—San Antonio 2006, pet. denied),
an assisted living facility resident brought claims against the facility
arising out of resident-on-resident altercations. The court of appeals
held that these claims were health care liability claims under the
TMLA.
These opinions show the wide range of fact situations that fall with the
purview of the TMLA. It applies to causes of action based on slips and falls, fights
at assisted living facilities, spider bites, sexual assaults, and nursing home billing
fraud, among other things. It applies even when the plaintiff does not have a
physician-patient relationship with the physician she is suing. It applies
exceptionally broadly because the Legislature compelled an expansive application
of the Act.
BRIEF OF AMICUS CURIAE Page 16
Here, the alleged injury clearly resulted from the provision of medical care
to a patient. It did not result from billing fraud, a spider bite, or a fight. The
plaintiff was being treated by a physician for hepatitis, and was being
administering weekly injections of lipoic acid by the physician. The plaintiff
alleges she reacted adversely to the lipoic acid after the ninth treatment, and that
the treatment rendered her blind. These are health care liability claims under the
TMLA. The character of the plaintiffs’ cause of action is not changed by the fact
that she has omitted suing her physician or by the fact that she recast her causes of
action to try to avoid the Act. If the Legislature intended to capture slip and falls,
sexual assaults, billing fraud, fights and spider bites with the TMLA expansive
provisions, surely the Legislature also intended to also catch the unambiguous
provision of health care to a patient.
Conclusion
The court of appeals erred in holding that the plaintiffs’ claims in this case
are not governed by the TMLA. Its holding will limit the ability of Texans to
obtain necessary health care. The court of appeals decision is outside the
mainstream and ignores this Court’s admonition that the act is to be applied
broadly to achieve its purposes. Your amicus curiae respectfully urge this Court to
grant the Petitioners’ petition for review and reverse the court of appeals erroneous
judgment.
BRIEF OF AMICUS CURIAE Page 17
February 12, 2014 Respectfully submitted,
/s/ E. Lee Parsley
E. Lee Parsley
State Bar No. 15544900
ATTORNEY AT LAW
1621-B Enfield Road
Austin, Texas 78703
512.481.8800 – telephone
512.276.6592 – fax
leeparsley@gmail.com
Jay B. Stewart
State Bar No. 19211125
HANCE SCARBOROUGH , LLP
400 W. 15 th Street, Suite 950
Austin, Texas 78701
512.479.8888 – telephone
512.482.6891 – fax
jstewart@hslawmail.com
Attorneys for Amicus Curiae
Certificate of Compliance
I hereby certify that this brief includes 3578 words in 14-point Times New
Roman font, thus complying with Texas Rule of Appellate Procedure 9.4.
/s/ E. Lee Parsley
BRIEF OF AMICUS CURIAE Page 18
Certificate of Service
I certify hereby that on February 12, 2014, I electronically submitted the
foregoing document with the clerk of court using the electronic case files system of
the court, which will send a Notice of Electronic Filing to all counsel of record, as
shown below.
Erin E. Lunceford
Michele Quattlebaum
SPROTT , RIGBY , NEWSOM , ROBBINS & LUNCEFORD , P.C.
2211 Norfolk, Suite 1150
Houston, Texas 77098
Attorneys for Petitioners
Michael W. Minton
LAW OFFICES OF MICHAEL W. MINTON , P.L.L.C.
6100 Western Place, Suite W0541
Fort Worth, Texas 76107
and
Greg Fitzgerald
LAW OFFICE OF GREG FITZGERALD
413 Harwood Road
Bedford, Texas 76021
Attorneys for Respondents
Miguel S. Rodriguez
Taylor Dunham, LLP
301 Congress Avenue, Suite 1050
Austin, Texas 78701
Attorneys for Southwest Pharmacy Solutions, Inc. d/b/a American
Pharmacies
/s/ E. Lee Parsley
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