7/17/2019 12:22 PM

Velva L. Price
District Clerk
Travis County
D-1-GN-19-004106 D-1-GN-19-004106
CAUSE NO. _______________
Ruben Tamez

JOSSELYN STEVENS and § IN THE DISTRICT COURT

TREVOR STEVENS §
§
V. § TRAVIS COUNTY, TEXAS
§
STONEGATE PHARMACY, LP., §
RENE GARZA, PHARM.D. and § 200TH
ANDRES RUIZ, PHARM.D. § ____ JUDICIAL DISTRICT

PLAINTIFFS’ PETITION
CONTAINING REQUESTS FOR DISCLOSURE

TO THE HONORABLE JUDGE OF SAID COURT:

COME NOW, JOSSELYN STEVENS and TREVOR STEVENS, Plaintiffs, complaining

of STONEGATE PHARMACY, LP, RENE GARZA, PHARM.D. and ANDRES RUIZ,

PHARM. D., Defendants, and for cause of action would respectfully show the Court and jury the

following:

I.

DISCOVERY CONTROL PLAN

Plaintiffs request that this case be governed by a Level 3 Discovery Control Plan pursuant

to Texas Rules of Civil Procedure 190 and 190.4.

II.

PARTIES, JURISDICTION AND VENUE

Plaintiffs JOSSELYN STEVENS and TREVOR STEVENS are individuals residing in

Austin, Travis County, Texas.

Defendant, STONEGATE PHARMACY, LP, is a Texas limited partnership with a

principal place of business in Travis County, Austin, Texas and may be served with process by

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serving its registered agent for service of process: Rene Garza, 2501 W. William Cannon, Suite

203, Austin, Texas 78745.

Defendant RENE GARZA, PHARM.D., is an individual and was a Texas pharmacist at

the time of the events in question. He may be served at 2501 W. William Cannon, Suite 203,

Austin, Texas 78745.

Defendant ANDRES RUIZ, PHARM.D. is an individual and was a Texas pharmacist at

the time of the events in question. He may be served at 2501 W. William Cannon, Suite 203,

Austin, Texas 78745.

At times, Plaintiffs refer to Stonegate and Rene Garza and Andres Ruiz collectively as

Defendants or as Stonegate.

The District Courts of Travis County, Texas have jurisdiction over this case. The amount

in controversy exceeds the minimal jurisdictional limits of this Court, and the exercise of this

Court’s jurisdiction over the Defendants is proper.

Venue is appropriate in the District Courts of Travis County, Texas pursuant to Texas

Civil Practices & Remedies Code §§ 15.002(a)(1) and 15.001(a)(2) and (a)(3) in as much as a

substantial part of the events or omissions giving rise to the claim occurred in Travis County and

because Stonegate has a principal office in Travis County.

III.

Plaintiffs would show that Defendants have been or will be notified of Plaintiffs’ claim at

least sixty (60) days prior to the filing/prosecution of this lawsuit in accordance with the Texas

Medical Liability and Improvement Insurance Act, Tex. Civ. Prac. & Rem. Code § 74.051.

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 IV.

FACTS

Stonegate Pharmacy is playing pharmaceutical Russian Roulette with the lives of people

in Central Texas. This case is yet another against Stonegate that arises from its repeated

negligence. Multiple patients have suffered serious injuries due to the negligent errors of

Stonegate Pharmacy. Here, Stonegate compounded and ultimately delivered to Plaintiff Josselyn

Stevens a dose of vitamin B12 for injection that was so toxic it was more harsh than liquid

Drano, infusing her arm and body with a caustic chemical so rank and dangerous it literally

burned a hole in her arm. And Stonegate delivered it to other people as well, but to date has

refused to assure Plaintiffs it has taken steps to recall it or even warn potential consumers that

they may also be in serious danger. And Stonegate did this while on probation for previous

dispensing errors.

Unbelievably, this is not the first time in recent events that Stonegate has mis-

compounded medication, leading to dispensing errors that served up destruction and mayhem on

consumers in the form of a dangerous pill or chemical, and then done nothing to warn or protect

others that may be at risk from the Stonegate errors in that batch of pills or drugs.

Since 2014, Stonegate has been cited for at least seven different pharmacy code or rule

violations.

In December 2014, The Texas State Board of Pharmacy found Stonegate “failed to keep

and maintain complete and accurate records” for its hydrocodone supply.

In May 2014, the Board found Stonegate “inaccurately communicated” a testosterone

prescription to another pharmacy … which the patient was “fatigued” among other effects.

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 The Board found that Stonegate “did not possess a [proper] license” but still compounded

and dispensed medications for four months in 2014.

In 2018, Stonegate got hit with a $16,200 total fine with fees and penalties, a five-year

probation and an order to develop an internal “continuous quality improvement program.” Yet

the violations keep coming.

The FDA has gotten involved. Although the FDA does not regulate or verify the safety

of a compounded drug, the FDA can inspect a facility. The FDA has inspected Stonegate.

The FDA records show two inspection reports, including violations, for Stonegate

Pharmacy – one in 2016 and one in 2018.

And it is not just the bad compounding and improper dosage that is so harmful and

disturbing – it is also Stonegate’s pattern and practice of failing to warn others once a problem

with contamination or a dispensing error is discovered. Recently, at least three patients of

Stonegate were overdosed with a thyroid medication due to Stonegate’s preparation errors. In

one such event, Stonegate and its Director of Pharmacy compounded a 1,000 fold overdose of

Levothyroxine and the patient took it for three days before Stonegate discovered the error and

contacted that patient to instruct her to stop taking the medication. That patient was hospitalized

and suffered damage. In another incident, Stonegate dispensed a compounded prescription of T4

T3 to a patient. After taking two doses of the prescription, the Patient sought immediate medical

treatment after having being notified of a possible error by Stonegate and was hospitalized for

approximately two days and experienced adverse effects over several weeks, including fever,

rapid heartrate and anxiety. Yet despite knowing of its thyroid medication errors in early March

of 2016, Stonegate never made any attempt to contact a third victim it knew or should have

known about to check on her prescription of Levothyroxine or whether it had likewise been

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improperly compounded. Callously, Stonegate did nothing and said nothing. In fact, Stonegate

concealed the other incidents from that third patient and said nothing about them even later when

she contacted Stonegate to explain what had happened to her and have the dosage investigated.

Several weeks after being approached by her, Stonegate confirmed through an independent lab

report that Stonegate had made a huge, life changing error and admitted that to her. But, even

then, Stonegate still said nothing to her about other patients being overdosed and suffering the

same fate.

The case here is another chapter in Stonegate’s pattern and practice of pharmaceutical

Russian Roulette; where it is simply a matter of time before another wrongly mixed Stonegate

prescription goes off and hurts someone. Here, the victim is Plaintiff Josselyn Stevens, a mother

of three, a wife, a professional working woman and a cancer survivor.

Plaintiff Josselyn Stevens has taken Vitamin B12 shots for years relating to a medical

condition. Plaintiff Josselyn Stevens continued to receive the B12 shots even after her cancer

diagnosis, her double mastectomy and her ongoing chemotherapy. Plaintiff has never had an

issue with any B12 shots until receiving the contaminated shot delivered recently by Stonegate.

On Monday, June 13, 2019 at approximately 10:30 a.m., Plaintiff was administered a B12

injection in her right upper arm. The B12 was compounded by Stonegate Pharmacy. Stonegate

distributed the solution to her doctor’s office (Neuronutrition Associates) (NNA) for office use.

Immediately upon receiving the injection, the Stonegate solution that was injected caused an

excoriating burning pain at the injection site and then had immediate shooting pain in Josselyn’s

her right arm followed by limited mobility in her right arm. As the day went on, Josselyn

experienced dizziness, a severe headache, slurred speech and disorientation. On June 13, 2019,

Josselyn spoke with her provider from NNA about the symptoms and the provider shared she

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would be contacting Stonegate because another patient who had received the same Stonegate

B12 solution had similar complaints (burning and shooting pains in arm) the week prior. The

same afternoon, Plaintiff removed the band aid placed on the injection site and a layer of her skin

came off with the band aid and the skin was dark brown. This was alarming as her skin is

normally a fair ivory color. Seeing that layer of skin come off concerned Plaintiff so she

immediately went to the mirror in a bathroom and discovered a large brown area and blue

widespread bruising. The brown area looked similar in color to the B12 injection. After

discovering the area, Plaintiff immediately contacted her provider from NNA, Jana Roso to

notify her of the reaction. Ms. Roso shared she was very concerned with the reaction and that

she would be contacting Stonegate again for more information. Ms. Roso advised Plaintiff to

call her oncologist and PCP to be seen ASAP and Plaintiff did so immediately.

On June 14, 2019 at approximately 8:45 a.m., Plaintiff saw her primary care provider and

was told she had a 3rd degree chemical burn at the injection site that gone completely necrotic as

a result of the contents of the B12 injection.

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 The provider noted that there must have been a pH imbalance in the shot. The PCP said

it was likely that Plaintiff would need surgery urgently and sent Plaintiff to a dermatologist that

same day. The dermatologist shared she also believed it was a 3rd degree chemical burn from

the shot, that the wound was completely necrotic and said Plaintiff would need a surgical

procedure urgently (and likely several more throughout the healing of the wound). The

dermatologist then sent Plaintiff to North Austin Medical Center. At North Austin Medical

Center the ER doctor called in a general surgeon who confirmed Plaintiff would need a surgical

procedure.

Also, on June 14th, 2019 the provider, Ms. Roso received contact from a female

pharmacist from Stonegate Pharmacy that committed and confirmed the lot number provided

from the B12 vial was a part of “bad batch due to unbalanced pH”. The admission from the

Stonegate pharmacist confirmed that Stonegate knew the B12 it had mixed was part of a bad

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batch but had inexplicably done nothing to warn or recall the poison. Upon information and

belief at least five other people have been harmed from the contaminated B12 batch.

On Monday, June 17, 2019, Plaintiff was forced to undergo her first surgical debridement

and culture of the wound. All cultures came back normal with no infection or bacteria. A

debridement is when a surgeon cuts out dead and diseased objects in a wound. This is intensely

painful. Shortly after the debridement, Plaintiff spoke with Mr. Andres Ruiz from Stonegate

Pharmacy as she had called him to understand how this could have happened and to get

Stonegate’s protocol information and quality assurance procedures, if any. Mr. Ruiz skirted

around all of her questions and would not answer them. Mr. Ruiz stated he had no doubt it was

the B12 that had hurt her but said he didn’t understand why as he claimed the pH was 6.5 when

leaving the pharmacy.

Because of the chemical burn to Plaintiff, the Stonegate B12 solution was tested to see

what the pH level was and whether it was acidic or basic. pH stands for 'potential of Hydrogen',

a measure of the acidity or alkalinity of water soluble substances. The test on the Stonegate B12

showed that Plaintiff was injected with a substance that had a pH of over 13.2. It was supposed

to be between 6.5 and 7. Another test indicates it may be as high as 14.0.

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 The following chart shows the range of pH levels from 1-14

The difference between each pH unit is a tenfold value. That is, a pH 9 is ten times higher

in hydroxyl ions (more alkaline) than at a pH 8. By extension, a pH of 13 is 100,000 times more

alkaline than pH 8. With a pH of 13 or higher, the Stonegate solution was well over 100,000

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times more alkaline that it should have been. The solution dispensed by Stonegate as vitamin

B12 was instead essentially like injecting Josselyn with oven cleaner or liquid drain cleaner.

On Friday, June 21, 2019 Josselyn was seen at Wound Care of Cedar Park and the wound

was again confirmed to be a 3rd degree burn caused by the contents of the B12 due to the high

pH. The wound care doctor confirmed it was a 3rd degree alkaline burn and she would have to

do a bedside surgical debridement again and another on Friday, June 27, 2019 (that was done on

June 21, 2019 at approximately 4:30pm and again on June 27, 2019 at approximately 3:30pm).

Plaintiff had another surgical debridement for July 8, 2019 at 8:45pm. In all, Plaintiff will likely

require 13-15 debridements. The damage has also substantially interfered with her cancer

treatment and put her life at risk. Plaintiff has irreversible damage to her arm as a result of the

injury and her physical therapy had to be discontinued until she is further along in her healing.

Plaintiff has constant pain in her arm and limited mobility. Plaintiff is also required to change

the dressings 2x per day or as instructed by wound care (sometimes after treatment the dressing

frequency changes).

Plaintiff’s treatment and struggles with the damage caused by Defendants’ negligence

and gross negligence continues to date and will into the future. It has greatly affected her, her

husband and her children. And Plaintiffs are greatly concerned there may be more victims to

come unless the toxic solution is recalled. Plaintiff continues to suffer great damages as a result

of Defendants’ negligence and gross negligence and the Plaintiffs now bring this action for fair

and full compensation for the damages they have suffered and will continue to suffer.

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 V.

NEGLIGENCE/NEGLIGENCE PER SE/GROSS NEGLIGENCE OF

DEFENDANT STONEGATE PHARMACY, LP and RENE GARZA AND ANDRES RUIZ

Through the substandard care and treatment of Josselyn Stevens, Defendants Stonegate,

Rene Garza and Andres Ruiz and/or their agents, representatives and/or employees fell below the

applicable standard of care due to her. Those negligent failures included one or more of the

following negligent acts or omissions, acting singularly or in combination:

1. Failure to properly fill and/or compound a prescription/solution;

2. Failure to conform to the standard of care a reasonably prudent healthcare

provider would have done under the same or similar circumstances;

3. Failure to discover the preparation/compounding error during a check of the

prescription solution, if any;

4. Failure to properly hire, train, oversee, supervise, retain and/or review employees,
agents or servants.

5. Failure to investigate and alert Plaintiffs and others when Stonegate became
aware it had committed egregious and dangerous errors compounding the B12
solution at or near the same time as it provided one to Plaintiff or others.

6. Failure to not reasonably and responsibly to recall the dangerous solution;

7. Violating pharmacy laws, codes and statues intended to protect people such as
Plaintiff.

The acts and/or omissions of Defendants constitute negligence and negligence per se.

Such conduct was a proximate cause of the injuries and damages of the Plaintiffs. Conduct

attributable to the Defendants also constitutes gross negligence and was a proximate cause of

damages to Plaintiffs.

Upon information and belief, at all relevant times, the involved agents, employees,

servants and/or pharmacist(s) at Stonegate were agents or employees or servants of Stonegate

Pharmacy, LP. The pharmacist(s) improper preparation/compounding of the medication for

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Plaintiff Josselyn Stevens was performed within the course and scope of duties with Stonegate

Pharmacy, LP. Therefore, Stonegate Pharmacy, LP is also vicariously liable for the negligence

of Defendants Rene Garza and Andres Ruiz and any/all others the involved agents, employees,

servants, pharmacist(s) through the doctrine of respondeat superior, agency and all other

applicable direct and vicarious liability doctrines at law and equity.

VI.

DAMAGES

The conduct and/or negligence of Defendants, jointly and severally, proximately caused

damages to Plaintiffs. Plaintiff Josselyn Stevens has suffered bodily injuries and damages and

Plaintiff Josselyn Stevens has incurred expenses for medical care and attention. These expenses

incurred were necessary for the care and treatment of the injuries sustained by Plaintiff Josselyn

Stevens and the charges made and to be made were the usual and customary charges for such

services in Travis County, Texas. Plaintiff will require further medical care and attention and

will incur reasonable expenses in the future for such medical needs.

Further, Plaintiff Josselyn Stevens would show that reasonable compensation should be

awarded for her pain, disability, disfigurement, loss of earnings, loss of earning capacity,

physical impairment, medical care and expenses and mental anguish, in the past and future.

Plaintiff Trevor Stevens, her husband, has also suffered damages, including loss of

household services and loss of consortium.

The parties seek full and fair compensation from a jury and monetary relief over the

amount of $1,000,000.00.

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 VII.

EXEMPLARY DAMAGES

Defendants also are liable for exemplary damages caused by their gross neglect and/or

gross negligence, which were a proximate cause of the injuries and the resulting damages to

Plaintiffs.

VIII.

INTEREST

Plaintiffs would show that they are entitled to recover interest for all elements of damages

recovered for which the law provides for pre-judgment interest, beginning (1) on either the 180th

day after the Defendants received written notice of claim from the Plaintiffs, or (2) the day that

the lawsuit was filed, whichever is earlier, and ending on the day preceding the date judgment is

rendered, at the pre-judgment interest rate governed by the laws of the State of Texas. Plaintiffs

are also entitled to post-judgment interest at the lawful and legal rate.

All conditions precedent have been performed or have occurred.

IX.

JURY DEMAND

Plaintiffs hereby respectfully demand a trial by jury.

X.

REQUEST FOR DISCLOSURE

Plaintiffs request the defendant provide information responsive to Texas Rules of Civil

Procedure 194.2 (a)-(l) within fifty days of service of this petition.

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 XI.

PRAYER

WHEREFORE, PREMISES CONSIDERED, Plaintiffs pray that upon final trial hereof,

they recover Judgment against Defendants for all damages, for costs and interest, both

prejudgment and postjudgment, and all other such relief at law and in equity, both general and

special, to which they may show themselves justly entitled and for which they now pray.

Respectfully submitted,

HOWRY BREEN & HERMAN, L.L.P.

__________________________________
Sean E. Breen
State Bar No. 00783715
1900 Pearl Street
Austin, Texas 78705-5408
E-mail: sbreen@howrybreen.com
Phone: (512) 474-7300
Fax: (512) 474-8557

ATTORNEYS FOR PLAINTIFFS

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