Style of Case:

VIVIAN COLLINS, v. BAYER, A.G.; BAYOR CORPORATION A wholly owned subsidiary of BAYER, A.G.; SMITHKLINE BEECHAM CORPORATION, d/b/a GLAXOSMITHKLINE, and GLAXOSMITHKLINE, PLC.

Court and Case No.:

U.S. District Court of Minnesota
Case No.: MDL No. 1431

Trial Judge:

Honorable Michael J. Davis

Trial Date

Not set for trial

Plaintiff’s Attorney

David Sampedro, Esq., from the Law Firm of Panter & Panter, P.A. Charles S. Zimmerman, Esq., from the Law Firm of Zimmerman-Reed, PLLP Ronald S, Goldser, Esq., from the Law Firm of Zimmerman-Reed, PLLP Jennifer Sustacek, Esq., from the Law Firm of Zimmerman-Reed, PLLP

Defendant’s Attorney

Bradley D. Honnold from the Law Offices of Shook, Hardy & Bacon, LLP, in Kansas City, Missouri

Description of Liability Aspect of Case

Products Liability. Plaintiff was prescribed Baycol 0.8 mg on or about December 2000 Baycol is a statin which is intended to lower cholesterol. Prior to taking Baycol she had history of hyperlipidemia, hypertension and peripheral vascular disease. Ms. Collins took one 0.8mg Baycol tablet per day. At the time Ms. Collins began taking Baycol at 0.8 mg dosage she was also prescribed and was taking 600mg gemfibrozil.

As a result of taking Baycol, Ms. Collins began to experience symptoms of fatigue, pain and progressive weakening in hips and legs.

On January 9, 2001, Mrs. Collins was evaluated in the emergency room of Jackson Memorial Hospital for complaints of weakness, fatigue and an inability to move all of her extremities. She reported additional complaints of nausea and vomiting, with duration of 3 days. She was severely hypertensive at 179/101 and tachycardic at 113. While undergoing evaluation in the emergency room, Mrs. Collins’ condition became critical as she developed difficulty breathing and decreased urinary output. Her nausea and vomiting progressively worsened. Laboratory data revealed profound elevations of BUN at 790, creatine at 5.6 and CPK greater than 9600. Kidney ultrasound revealed echogenic kidneys, suggestive of acute renal failure. Ms. Collins was diagnosed with acute renal failure and rhabdomyolysis. She was immediately given intravenous fluids to compensate for the influx of extracellular fluid that occurs with rhabdomyolysis. She was also administered the diuretic Lasix reduce fluid volume to lower her blood pressure.

Ms. Collins was admitted to the intensive care unit with the admission diagnoses of acute renal failure and rhabdomyolysis. She was immediately given sodium bicarbonate to decrease her potassium, averting cardiac dysrhythmia. Ms. Collins underwent placement of a femoral catheter for hemodialysis access. Her blood pressure was managed with nicardipine.

On the 2nd day of admission, Ms. Collins aspirated some of the Loperamide she was given for treatment of persistent diarrhea. Almost immediately, she began experiencing difficulty breathing. Initially, she was administered 50 % oxygen via face mask. Despite the oxygen, her respirations decreased substantially. Arterial blood gases showed respiratory acidosis. She also became severely hypotensive. Before anesthesia could intubate her, she went into cardiac arrest. She was resuscitated and place on a ventilator. A norepinephrine drip was started to increase her cardiac output.

Ms. Collins’ hospitalization was further complicated by persistent fevers and critically elevated white blood cell counts, both indicators of sepsis. In addition to the aspiration pneumonia, Ms. Collins developed a second pneumonia. Blood cultures showed growth of a bacterial infection. Urine and stool cultured out Vancomycin resistant enterococcus, and Mrs. Collins had to be isolated. Another culture was positive for Candida. During her prolonged hospitalization, she was treated with a full course of broad spectrum antibiotics, as well as a very aggressive antibiotic therapy of Amphotericin.

Mrs. Collin’s acute renal failure and rhabdomyolysis were treated with hemodialysis every other day. Despite the treatments, the combination of severe myositis with renal failure continued, evidenced by a CPK that had reached an astounding 220,000. She produced very little urine output. On February 9, 2001, Mrs. Collins underwent a muscle biopsy because of the severity of the rhabdomyolysis and prolonged muscle pain. She required continuous ventilatory support, and a tracheostomy was performed to facilitate long term mechanical ventilation. She was continued on vasopressors to maintain cardiac output and was transfused with red blood cells.

On the 13th day of admission, Mrs. Collins began to show some improvement in oxygenation, though she was still in need of the ventilator. She was hemodynamically stable and no longer required vasopressors. Because of Mrs. Collins’ critical condition, she remained in the intensive care unit at Jackson Memorial Hospital for 26 days, she continued dialysis and was on a ventilator throughout this time. She was eventually transferred to the general medical floor on her 26th day.

While in the general medical unit she had difficulty breathing and remained on a ventilator. Due to the severity of her rhabdomyolysis and renal failure, Mrs. Collins’ remained hospitalized for several weeks. Throughout her hospitalization, Mrs. Collins demonstrated severe weakening of all four extremities. An EMG ordered to evaluate the affect of rhabdomyolysis on her muscles was cancelled due to her worsening condition. Just prior to discharge, she had slowly regained some strength in her upper extremities and had begun a course of physical therapy. During this time she had also started to recover most of her neurologic dysfunction that was caused by either an anoxic insult or myositis. It was not until March 8, 2001, that Mrs. Collins was transferred to the Rehabilitation Unit at Jackson Memorial Hospital.

Mrs. Collins remained in the Rehabilitation Unit for several days until March 23, 2001 when she as discharged after over two months of hospitalization. At the time of discharged, Mrs. Collins was using a wheelchair and required the assistance of a walker. She required assistance dressing and feeding herself, and with general hygiene. The severity of the rhabdomyolysis and renal failure which necessitated extensive treatment and a lengthy hospital stay significantly impacted Mrs. Collins social interaction which was evident at discharge. She attended a “community skills course” while at rehabilitation. She was discharged to her family and directed to continue physical and occupational therapy two times a week.

On May 8, 2001, Mrs. Collins underwent another operative procedure. Because of prolonged intubation secondary to the rhabdomyolysis, Mrs. Collins required a tracheotomy. Because of the prolonged intubation, Mrs. Collins speaks with a very raspy voice and is no longer requires dialysis, she still requires assistance with many daily activities and experiences severe pain in her legs on a daily basis.

However, Mrs. Collins is no longer the self-sufficient woman she was prior to Baycol. Because of the injuries she suffered as a result of Baycol, she is no longer able to drive. She is no longer able to enjoy time with her grandchildren, she is no longer able to drive her husband shopping, she is no longer able to take her grandchildren shopping or to the park, activities she regularly enjoyed before taking Baycol. Her legs are weak and she experiences severe pain when she walks. She cannot walk more than the length of her home before she must sit down because of severe pain. She must rely on a cane to walk. Her arms are also weak and her ability to perform normal household duties is substantially limited because of her injuries caused by Baycol. She is unable to hold or carry household items. Furthermore, as a result of the anoxia and myositis, Mrs. Collins suffers cognitive impairment and becomes frustrated and saddened by her inability to perform ordinary household tasks. Mrs. Collins also experiences significant vision problems which she did not experience prior to taking Baycol.

Mrs. Collins has been forced to limit her time with her family and friends because of physical pain and the emotional distress of not being able to enjoy activities she once enjoyed. Her social life has been dramatically limited and she relies on her pastor and her church for transportation to and from church. In addition to the physical injuries she suffered and continues to experience, Mrs. Collins has suffered substantial loss of enjoyment of life as a result of Baycol.

Medical bills relating to Mrs. Collins’ Baycol related injuries are not available at this writing but given the length of her hospitalization and subsequent care, they will be sizable.

Description of Plaintiff

The Plaintiff is Vivian Collins, a fifty-eight (58) year old woman who resides with her husband, in Miami, Florida.

Description of Injuries

As a result of taking Baycol, Ms. Collins began to experience symptoms of fatigue, pain and progressive weakening in hips and legs.

Treating Doctors

Jackson Memorial Hospital

Defense of this Claim

Defendants denied liability and claimed that the Baycol medication was not defectively designed or manufactured as required under section 402(A) of the reinstatement of torts and reiterated in West v. Caterpillar.

Lost Wages

Not applicable.

Expert Witnesses

None.

Settlement

The case was settled at mediation for $830,000.00.