Lawsuit Against Texas Neurology Clinic for Medical Malpractice After Critical Injury to Plaintiff
CAUSE NO. 15.3421014a93
MID CITIES NEUROLOGY
ASSOCIATES, P.A. of H/E/B d/bfa
KANE HALL BARRY NEUROLOGY and
Tarrant County, Texas
PLAINTIFFS’ REQUEST FOR DISCLOSURE TO THE HONORABLE JUDGE!
NOW COME Y 1= and 0=1= Mfrs. l’=” and “Mt and collectively, the “Plaintiffs”), in the above-numbered and styled cause, and file this their Original Petition complaining of Defendants Mid Cities Neurology Associates, P.A. of HIE/173 d/b/a Kane Hall Barry Neurology (“Kane Hall Barry”) and M.D. (“Dr. ” and collectively “Defendants”), and for their causes of action would respectfully show the Court as follows:
On Juno 26, 2013, Plaintiffs served Defendants with written notice of their claim by certified mail, return receipt requested. The Plaintiffs have otherwise in all respects complied with all applicable provisions of Chapter 74 of the Civil. PRACTICE AND REMEDIES CODE.
2. This is a medical malpractice action. Mrs. T suffered a single seizure for the first time in her life at the age of 41. She sought and relied upon the medical counsel, advice, and treatment from Di and her practice group, Kane Hall Barry. Seizure disorders are not rare occurrences. While determining the cause of a sudden onset of seizures is no simple task, generally speaking, the treatment of seizure disorders is a fairly routine process that requires the prescribing of an antiepileptic medication. There are many well-known, well-established, very effective antlepileptic drugs from which a physician can choose. Unfortunately for the Plaintiffs, Dr. failed to follow that standard of care and opted for a newly approved drug, Lamictal. However, this drug specifically has not been approved by the FDA for initial monotherapy for seizure disorder. To make matters much worse, Dr. failed to pass along the manufacturer’s warning of a serious, potentially fatal adverse reaction to this newly approved drug. Instead, Dr, handed Mrs. T a starter kit of the Lamictal and said nothing more than, “Call me if you get a rash.”
60% of Mrs. TM’s body surface was covered in second degree burns. She spent more than a month in Parkland Hospital’s burn unit — an ordeal she barely survived. Mrs. T suffered permanent and debilitating scarring both internally and on the surface of her skin. Mrs. T is permanently disabled; her life is ruined.
4. When she returned to Kane Hall Barry after being finally released from Parkland and explained to Dr. what had occurred, the doctor’s response was enlightening and at the same time, inexcusable as she admitted, “I’m so sorry, I had no idea something like this could happen.”
5. The Defendants breached the medical standard of care in three separate ways.
First, the drug was inappropriate for initial monotherapy needed by Mrs. T. Safer and proven effective alternatives existed and should have been tried first. Second, Dr. failed to provide Mrs. T with any warning regarding the risk of taking Lamictal versus other safer alternatives. Finally, at the very least, Dr. could have provided Mrs. T with the corresponding medical literature and FDA black box warning, which should have come as an insert in the Lamictal starter kit so they themselves could have read the warning for this product. Each of the Defendants negligence acts and omissions are the direct and
proximate cause of Mrs. T’s life threatening and permanent disabling injuries and the damages suffered by the Plaintiffs.
Finally, the Defendants in this case acted as the retail supplier of a manufactured product and failed to pass through the manufacturer’s warnings to the end user and consumer of the product and should also be held liable pursuant to the legal theory of products liability for the producing cause of Mrs. T’s injuries.
Plaintiffs intend to conduct discovery under Level 3 of the TEXAS RULES OP CIVIL PROCEDURE. The Plaintiffs request that discovery be conducted in accordance with a discovery control plan tailored to the particular circumstances of this suit. The Plaintiffs anticipate that the parties will submit an Agreed Scheduling Order for the Court’s consideration and approval.
Plaintiffs 1111 TM and DEM TM, individuals, are residents of Arlington, Tarrant County, Texas.
Defendant Mid Cities Neurology Associates, P.A. of H/E/B dfbla Kane Hall Barry Neurology, a Texas Professional Association, maintains a principal place of business in Bedford, Tarrant County, Texas, and may be served with process by serving its registered agent, Jerome M. Kane, at 1305 Airport Freeway, Suite 205, Bedford, Texas 76021. Defendant M.D., an individual, may be served with process at
her residence, Sonthlake, Texas 76092.
V. VENUE AND JURISDICTION
Venue is proper in Tarrant County, Texas, pursuant to TEx. Civ. PRAC. & REM. CODE § 15.002, because it is the county in which all or a substantial part of the events or omissions giving rise to the claim occurred. Venue is proper in Tarrant County against all Defendants pursuant to ‘Ilex. Civ. PRAC. & REM. CODE § 15.005 because venue is proper against at least one Defendant and all claims and causes of action in this case arise out of the same transaction, occurrence, or series of transactions or occurrences.
The Court has subject matter jurisdiction over this case as the amount in controversy exceeds the minimum jurisdictional limits of the Court.
11. ladies socials, and enjoyed being involved with her local church and singing in the choir. She maintained a successful, stable career as a lead services representative for a pharmaceutical company.
During the night of June 18, 2011 Mrs. T, then 41 years old, experienced for the first time in her life, a seizure, specifically; a generalized tonic-clonic seizure lasting approximately two minutes.
On June 21, 2011, Mrs. T consulted Dr., a neurologist at Kane Hall Barry, for a neurological examination, which included among other things, an electroencephalogram (“EEO”) to record the electrical activity of Mrs. T’s brain through the electrical impulses of her scalp.
On June 28, 2011, Mrs. TM, along with her step-daughter, returned to Kane Hall Barry for a follow-up consultation, During this visit, Dr. discussed with Mrs. T the results of the BEG, the diagnosis of a seizure disorder, and the need for treatment with an antiepileptic prescription drug.
During this visit, Dr. gave Mrs. T a Lamictal starter kit for her seizure disorder. First and foremost, Lamictal is not approved by the Food and Drug Administration for initial monotheraphy for generalized motor seizure like the one Mrs. T experienced. Had Dr. read the manufacturer’s packet insert herself she would have known this:
Safety and effectiveness of LAMICTAL have not been established (I) as initial monotharapy; (2) for conversion to monotherapy from AEDs other than carbamazepine,
Dr. should not have prescribed this drug for Mrs. T from the onset.
The Lamictal starter kit given to Mrs. T by Dr. did not include the instructional medication guide or “package insert” with the manufacturer’s warnings. Only the pills themselves were present. The packaging itself did not contain any type of warning. The The following medical literature references in paragraphs 19 and 21 are copied from an exemplar Lamictal starter package Insert provided by manufacturer GlaxoSmithKline. The actual Lamictal starter pack given to Mrs. T by Dr. did not include any package insert or any of the printed language copied herein.
A package insert that should have come with the Lamictal starter kit that warns the end users of the product to call a physician “immediately” upon the development of a rash, hives, skin blistering, fever, or sores in the mouth and throat:
WARNING: SERIOUS SKIN RASHES
See fix prescribing information for complete boxed warning.
Cases of life-threatening serious rashes, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and/or rash-related death, have been caused by LAMICTAL.
It is important to note that early manifestations of hypersensitivity and lymphadenopathy) may be present even though a rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. LAMICTAL should be discontinued if alternative etiology for the signs or symptoms cannot be established.
Prior to initiation of treatment LAMICTAL, patient should be instructed that a rash or other signs or symptoms of hypersensitivity (e.g., fever, lymphadenepothy) may herald a serious medical event and that the patient should report any such occurrence to a physician immediately.
Dr. merely told Mrs. T to call Kane Hall Barry if she noticed a rash. The patient’s chart indicates no reference whatsoever to any discussion of the risk of WS or TEN.
23. Compared to other available antiepileptic prescription medication, Lamictal has a significantly higher risk of serious, life-threatening reactions like SJS and TEN, and Mrs. T was deprived the opportunity to consider these risks or a safer alternative antiepileptic drug.
After the June 23, 2011 consultation at Kane Hall Barry, Mrs. T began taking an initial 25mg dose of Lamictal daily according to Dr. instructions. She took this dosage for two weeks and then began the next two-week series of a 50mg dose on July 12, 2011.
Only July 13, 2011, almost two weeks after starting the Lamictal sample package, Mrs. T presented to the Texas Health Arlington Memorial emergency room with a fever, a swollen neck, multiple ulcerations in her mouth, and generalized rash. Her attending physician diagnosed her with bronchitis and discharged her that day. Mrs. T had no reason to believe that she was experiencing an adverse drug reaction because she was not warned that these symptoms were indicative of a serious medical condition. She had been given no warning to heed. Had Mrs. T been warned by Dr. she would have realized that she was
displaying signs of hypersensitivity, the conditions precedent to a serious allergic drug reaction ahead. Accordingly, without sane appreciation of this risk, she accepted the emergency room physician’s diagnosis and went home.
On July 14, 2011, less than 24 hours later, Mrs. T returned to the Texas Health Arlington Memorial emergency room with a rash, extensive blistering, and sloughing of the skin across her trunk. Sacs of fluid had developed on her neck and feet. Her throat was so swollen that she could not eat or drink. The adverse symptoms had dramatically and rapidly worsened. Mrs. T’s attending physician diagnosed her with SJS, admitted her to the hospital, and immediately discontinued the Lamictal prescription. Over the course of a few days, Mrs. TM’s condition continued to deteriorate. Physicians and nurses diligently observed and dictated her illness:
Mrs. T’s chart from Texas Health Arlington Memorial Hospital dated July 18, 2011, Bates number 3028, from Texas Health Arlington memorial Hospital dated July 18, 2011, Bates number 3020.
She has blisters, some of them have broken on her eyelids and on her neck. She has diffuse ecchymotic rash all over her body, sparing her hands The buccal mucosa, tongue is coated. She has white exudative drainage. No blood. She could not open her mouth wide, it is sore. Eyes are injected and tearing. She has cervical adenopathy. She has a large blister on her neck anteriorly.
1. Stevene-Johnson syndrome, most likely from Lamictal.
2. Severe mucositis.
3. Leukopenia, maybe ceftriacone versus the medication itself.
4. Drug-induced hepatitis.
On July 18, 2011, Mrs. T transferred to the burn unit at Parkland Hospital for specialized treatment. The majority of her body, more than sixty-one percent, was bloody, blistered, oozing, peeling and shedding. Her skin of her eyes, scalp, face, mouth, neck, arms, back, chest, abdomen, buttocks, genitals, legs, and nails were all eroding, sloughing off in sheets. She was in excruciating pain.
Her diagnosis of SJS quickly progressed to TEN, a much more serious, often life threatening form of severe skin infection. She underwent aggressive wound care in the intensive care unit. Doctors intensely monitored her illness. Mrs. T did not solely suffer from problems with her skin: her entire body was failing, and she ultimately went into septic shock:
Mrs. T’s chart from Parkland Hospital dated July 24, 2011, Bates number 63. Mrs. T’s chart from Parkland Hospital dated My 24, 2011, Bates number 47. Mrs. T’s chart from Parkland Hospital dated July 24, 2011, Bates number 2532.
Ra Ophthalmology Flu
5: Pt reports she feels the same
0: Unable to fully open OS 212 paln/pl tightly closing eyes, attempted brief sweep but unable to reach famines. Ophthalmic Medication: tacrilube, artificial tears
Visual Acuity: Near, with -13.50 add
Right eye: 20/60
Left eye: 20/40
External: lid with sloughing skin
Pupils: 4—> 2 OU with no RAPD
Ocular motility: Gross orthotropla with full duotlons and versions bilaterally.
Visual Fields: Full to 3-state confrontation bilaterally.
PL Exam: Both eyes
Lids & lashes: Today pseudomembranes seen again OD, removed with cotton swab. Unable to assess OS.
Dx: TEN 81% TBSA involvement, 60% USA open no signs of infection.
Severe Septic Shock: Will continue vasopressors, will continue Broad Spectrum AIM Wens/Zoom, cultures pending. Otiguria -Will continue to monitor, I hope will improve with improved BP. Will recheck BMP to evaluate for acute kidney injury.
Leukooytosis due to response for septic event. Will continue to monitor.
Patient Active Problem List
- TEN (toxic epidermal necrolysis)
- Seizure disorder
- SIRS (systemic inflammatory response syndrome)
- Acute blood loss anemia
30. During this time, Mrs. T requested a chaplain and the completion of a living will, believing that her death was imminent. She almost lost her life due to all of the complications arising out of the Lamictal prescription. It is a miracle that she survived.
31. After weeks of incessant monitoring and diligent treatment, Mrs. T was filially stabilized and transferred out of the ICU and onto a hospital floor at Parkland on July 28, 2011. Over the course of weeks, Mrs. T continued to improve, her vital signs began to stabilize, and medical personnel successfully staved off infection of her wounds. After receiving physical and occupational therapy, she was ultimately discharged from Parkland Hospital on August 25, 2011.
However, it became obvious that Mrs. T was not going to make a full recovery. Her cognitive functions are significantly impaired. She sustained permanent complications as a result of the severe reaction to Lamictal, including digestive problems, vision impairment, extensive scarring, and brain burn. Her cognitive brain function is significantly impaired. Mrs. T now suffers from substance-induced persisting dementia, depression, anxiety, and insomnia:
Guarded. The onset of seizure in June 2011 followed by an adverse reaction to Lamictal. Patient has shown no improvement in her cognitive functioning which has had a precipitous decline. In her present condition, she is unable to work at any capacity or even to manage ordinary household responsibilities. Awareness of her impairment understandably contributes to her tendency to read depressively to her diminished capacity.
33. Since her recovery, Mrs. T has lost her job and can no longer work. She cannot drive, cook, or maintain her home. She can do very simple, non-strenuous tasks and is easily weakened and tired from doing basic tasks, such as climbing stairs. Her memory is fleeting. Mrs. T now considers herself a recluse, she is ashamed of her appearance due to the extensive scarring and uneven skin pigmentation, perpetuating her anxiety and depression. Her self-esteem has plummeted. She is a mere shell of the former vibrant individual who she used to be.
Mrs.T’s chart from Richard D. Schmitt, PhD dated November 26, 2011, Bates number 2973. Mrs. T’s chart from Sunil Matthews, M.D. dated Febtuary 2, 2012, Bates number 2993.
VII. CAUSES OF ACTION
COUNT 1: MEDICAL NEGLIGENCE
34. Plaintiffs incorporate by reference and re-allege all preceding sections of this Petition and would further show that the Defendants are liable for medical negligence pursuant to Chapter 74 of the TEX. Civ. PRAC. & REM. CODE. Plaintiffs will show the Court that the damages suffered by Plaintiffs were a direct and proximate cause of the negligence and wanton disregard of Defendants. Defendants failed and refused to afford Mrs. T the minimal degree of medical attention and care she so rightly deserved. Defendants are liable to Plaintiffs for numerous negligent acts, including but not limited to, the following:
- In failing to do that which a healthcare provider of ordinary prudence would have done under the same or similar circumstances or doing that which a healthcare provider of ordinary prudence would not have done under the same or similar circumstances;
- In failing to provide adequate medical care and treatment as would a healthcare provider of ordinary prudence;
- In failing to implement and/or follow reasonably prudent procedures to assess, remedy and/or prevent injury to Mrs. T;
- In falling to assess or evaluate the appropriate prescription regimen for Mrs. T given her medical history;
- In failing to prescribe a safer alternative antiepileptic drug with a lower incidence of Stevens-Johnson Syndrome;
- In failing to prescribe a FDA approved antiepileptic drug for initial monotheraphy;
Plaintiffs incorporate by reference and re-allege alt preceding sections of this Petition and would further show that the Defendants are liable for failure to disclose to the patient the risks and hazards involved in her kind of care pursuant to Chapter 74 of the TEL CIV. PRAC. & REM. CODE. Defendants are liable to Plaintiffs for the following acts:
- In failing to be aware of the manufacturer’s product information, propensities, and dangers that were material and relevant to the performance of the Lamictal prescription that they knew or should have known;
- In failing to warn Mrs. T required product information that was material and relevant to the performance of the Lamictal prescription and was causally related to her injury;
- In failing to explain to Mrs T the foreseeable risk of harm posed by Lamictal, which harm could have been avoided had reasonable instructions or warnings been given;
- In failing to warn Mrs T. specifically of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis as potential life-threatening risks of taking Lamictal;
- In failing to provide Mrs. T with a medication guide or insert in conjunction with the Lamictal starter kit; and
- In failing to warn Mrs. T of symptoms of Stevens-Johnson syndrome, including congestion, sore throat, neck and throat swelling, ear and eye pain, and fever.
Each of these acts and omissions, whether taken singularly or in combination, constituted negligence by Defendants which is the proximate cause of the incident made the basis of this suit and the injuries and damages sustained by Plaintiffs.
COUNT 3: PRODUCT LIABILITY — MARKETING DEFECT
Plaintiffs incorporate by reference and re allege all preceding sections of this Petition and would further show that the Defendants are liable for marketing Lamictal without adequately warning Mrs. T of the potential risk of substantial harm of which Defendants knew or should have known but Mrs. T did not.
Defendants are liable to Plaintiffs for the following reasons:
- There is an inherent risk of harm in the use of Lamictal;
- At the time Defendants prescribed Lamictal to Mrs.T they knew or could
reasonably foresee the risk of harm;
- The Lamictal starter kit given to Mrs. T by Dr.did not include the
instructional medication guide or “package insert” with the manufacturer’s warnings;
The absence of the manufacturer’s warnings rendered the medication unreasonably dangerous; and
- Defendants’ failure to warn Mrs. T was a producing cause of the Plaintiffs’ damages.
39. Each of these acts and omissions, taken in combination, constituted a marketing defect by Defendants which is a producing cause of the incident made the basis of this suit and the injuries and damages sustained by Plaintiffs.