California Verdicts

Plaintiff(s):

Marion Liu , 

Augustine Liu , 

Estate of Augustine Liu, II (Male, 25 Years)

Plaintiff Attorney(s):

Simona A. Farrise;
Farrise Law Firm, P.C.;
Los Angeles,
CA,
for
Marion Liu, Augustine Liu, Estate of Augustine Liu, II ■ Daniel K. Balaban;
Balaban & Spielberger, LLP;
Los Angeles,
CA,
for
Marion Liu, Augustine Liu, Estate of Augustine Liu, II ■ Benjamin H. Adams;
Farrise Law Firm, P.C.;
Los Angeles,
CA,
for
Marion Liu, Augustine Liu, Estate of Augustine Liu, II

Plaintiff Expert(s):

Ernst von Schwarz; M.D.; Cardiology; Los Angeles,
CA called by:
Simona A. Farrise, Daniel K. Balaban, Benjamin H. Adams ■ Laura Plunkett; Ph.D.; Pharmacology; Houston,
TX called by:
Simona A. Farrise, Daniel K. Balaban, Benjamin H. Adams ■ Gerald Berry; M.D.; Pathology; Stanford,
CA called by:
Simona A. Farrise, Daniel K. Balaban, Benjamin H. Adams ■ Howard Pitchon; M.D.; Internal Medicine; Beverly Hills,
CA called by:
Simona A. Farrise, Daniel K. Balaban, Benjamin H. Adams ■ Jeffrey Goodman; M.D.; Cardiac Electrophysiology; Los Angeles,
CA called by:
Simona A. Farrise, Daniel K. Balaban, Benjamin H. Adams

Defendant(s):

Astra USA Inc., 

Kei-Cheun Lau, M.D., 

Robert Collen, M.D., 

College Hospital Inc., 

Madeline Valencerina, M.D., 

Janssen Pharmaceutical Inc., 

Coast Plaza Doctors Hospital, 

Astrazeneca Pharmaceuticals LP, 

Janssen Research & Development LLC, 

Clinical Pharmalogical Studies Inc., 

Johnson & Johnson Research & Development, 

Johnson & Johnson Pharmaceutical Research, 

Ortho-McNeil-Janssen Pharmaceuticals Inc.

Defense Attorney(s):

Alan J. Lazarus;
Drinker, Biddle & Reath, LLP;
San Francisco,
CA,
for
Janssen Pharmaceutical Inc., Janssen Research & Development LLC ■ None reported;

for
Astra USA Inc., Kei-Cheun Lau, M.D., Robert Collen, M.D., College Hospital Inc., Madeline Valencerina, M.D., Coast Plaza Doctors Hospital, Astrazeneca Pharmaceuticals LP, Clinical Pharmalogical Studies Inc., Johnson & Johnson Research & Development, Johnson & Johnson Pharmaceutical Research, Ortho-McNeil-Janssen Pharmaceuticals Inc. ■ John J. Powers;
Drinker, Biddle & Reath, LLP;
San Francisco,
CA,
for
Janssen Pharmaceutical Inc., Janssen Research & Development LLC

Defendant Expert(s):

Larry Ereshefsky;
Pharmacology;
San Antonio,
TX called by:
Alan J. Lazarus, John J. Powers ■ Laura Dunn;
Psychiatry;
San Francisco,
CA called by:
Alan J. Lazarus, John J. Powers ■ Robert Gish;
Hepatology;
San Diego,
CA called by:
Alan J. Lazarus, John J. Powers ■ Sarina van der Zee;
Cardiac Electrophysiology;
Santa Monica,
CA called by:
Alan J. Lazarus, John J. Powers ■ Michael Fowler;
Cardiology;
Stanford,
CA called by:
Alan J. Lazarus, John J. Powers ■ Michael Fishbein;
Pathology;
Los Angeles,
CA called by:
Alan J. Lazarus, John J. Powers

In February 2009, plaintiffs’ decedent Augustine Liu II, 25, a paranoid schizophrenic, was recruited into a human drug trial, paid for by Janssen Research and Development, for Risperdal, an anti-psychotic medication. The principal investigator on the drug trial was Dr. Madeleine Valencerina, Liu’s treating psychiatrist. As part of the protocol requirements mandated by Janssen, Valencerina was required to screen Liu for the study to determine if he qualified under the protocol’s criteria to participate in the study. Part of the screening included doing an electrocardiogram (EKG) and lab tests. In September 2008, four months before Liu entered the study, Valencerina had ordered lab tests, which included liver enzyme tests, on Liu at Kedren Community Mental Health, a local clinic where Liu was a patient since 2008. As part of the screening for the study, Liu’s blood was taken on Feb. 19, 2009, and the results provided to Valencerina showed that Liu’s liver enzyme results were not only higher than the normal range, they were three times higher than his baseline test results from four months earlier. Liu’s EKG, which was done the same day, had an initial "automatic" read provided by computer analysis and a follow-up read by a cardiologist. The automatic analysis allegedly evidenced sinus tachycardia (a cardiac arrhythmia that consists of an abnormally fast heart rhythm), old myocardial infarction (indicating a prior heart attack), and non-specific T wave abnormalities (indicative of cardiac stress, ischemia, myocarditis, or cardiomyopathy). An old myocardial infarct, especially in a 25-year-old male, is highly indicative of serious heart problems, such as ischemic heart disease, coronary artery disease, cardiomyopathy, or myocarditis. Additionally, Poor R-wave progression was noted and essentially meant that Liu was actually having a heart attack at the time. However, Liu’s parents claimed that although Valencerina ran multiple tests, all of which indicated that Liu had health complications, Janssen ignored the results and proceeded with the study. On Feb. 22, 2009, Liu took up residence at the Study Center for participation in the experiment. The next day, at 7:45 a.m., Liu received his first injection of 1-milligram of immediate release risperidone, pursuant to the study protocol. A blood draw was taken from Liu approximately one-half hour before the risperidone injection was administered, although the results were not reported until Feb. 24, 2009, and Liu underwent a second EKG at 9:45 a.m., after receiving the injection. The results of the EKG and liver enzyme tests on Feb. 23, 2009, were allegedly dramatically-worse and showed signs of serious heart and/or liver complications. Nursing notes also stated that Liu was allegedly demonstrating symptoms of cardiac and liver impairment, including being "slow to respond to questions," demonstrating poor judgment, depression, sadness, and fragmented and confused thought content with loose associations. He was also noted to be isolative, withdrawn, and feeling hopeless and helpless. These symptoms were allegedly all indications that Liu was feeling very sick. In addition, over the course of his participation, Liu gained 14 pounds in five days, and his sister reported observing that Liu’s face was shockingly swollen. Another blood draw was done on Feb. 25, 2009, at 9:45 a.m., but the results were not received until 6:15 a.m. the following day. The blood draw and the reporting liver enzyme tests were again both allegedly considered to be "high panic" values. Another blood draw was then taken at 12:05 p.m. on Feb. 25, 2009, and it was sent to Costa Mesa for "STAT" results. However, the results were not sent until 5:41 p.m., almost six hours later. The results again reported "high panic" liver enzymes. Liu was ultimately transferred to the Coast Plaza Doctors Hospital’s emergency room on Feb. 25, 2009. He died of a cardiac arrest at that hospital the next day. The decedent’s parents, Augustine Liu and Marion Liu, sued Janssen Pharmaceutical Inc., Janssen Research & Development LLC, Astra USA Inc., Astrazeneca Pharmaceuticals LP, Clinical Pharmalogical Studies Inc., Coast Plaza Doctors Hospital, College Hospital Inc. (which was doing business as College Hospital Cerritos), Johnson & Johnson Pharmaceutical Research, Johnson & Johnson Research & Development, Ortho-McNeil-Janssen Pharmaceuticals Inc., Dr. Robert Collen, Dr. Kei-Cheun Lau, and Dr. Madeline Valencerina. Several of the defendants were either dismissed or settled out of the case. Thus, the matter only continued against Janssen Pharmaceutical Inc. and Janssen Research & Development LLC. In addition, the decedent’s father, Augustine Liu, passed away prior to trial, so Marion Liu continued as the sole heir. Plaintiffs’ counsel argued that although Valencerina ran multiple tests that indicated that the decedent had health complications, Janssen ignored the test results and proceeded to administer the Risperdal. Counsel noted that Janssen’s protocol set out a list of exclusionary criteria, with the very first criteria stating that exclusion was required if the subject either had a history of, or currently had, any cardiac arrhythmias or other cardiac disease. Counsel argued that since the EKG that the decedent underwent on Feb. 19, 2009, evidenced both a cardiac arrhythmia (sinus tachycardia) and a prior heart attack, the decedent met the exclusionary criteria and was required to be excluded from the study. Plaintiffs’ counsel contended that Janssen had an independent duty to provide a study monitor to review the study proceedings at every stage, as required by the Institutional Review Board’s mandates for the study, as well as federal law and industry custom. However, counsel contended that despite the fact that the screening tests performed on the decedent mandated his exclusion from the study, and raised a red flag about his condition, Janssen’s monitor failed to act to preclude the decedent from the study and thereby breached Janssen’s independent duty to assure that the decedent was protected. Plaintiffs’ counsel also contended that Valencerina violated her ethical duties by recruiting the decedent into an experimental study in which she was the principal investigator. In addition, counsel contended that the decedent did not understand the consent form and that the decedent was not competent to sign it and, in fact, signed the admission papers for a different patient when Liu was admitted to the Study Center on Feb. 22, 2009. Thus, plaintiffs’ counsel argued that the procedures for the study called for the study coordinator to participate in obtaining informed consent, but that even though the study coordinator testified that he was in the general vicinity when Valencerina obtained the decedent’s signature on the informed consent forms, the study coordinator did not actually participate in obtaining the decedent’s informed consent, did not really pay attention, and did not know if the decedent actually understood the consent. After Liu was injected with the first dose of Risperdal on Feb. 23, 2009, tests showed more complications, plaintiffs’ counsel contended. They asserted that the results of the second EKG, which the decedent underwent at 9:45 a.m. on Feb. 26, 2009, confirmed that the decedent was not properly admitted to the study and should have been excluded initially, and certainly no later than Feb. 23, 2009. Counsel also asserted that the blood draw results indicated that, as of Feb. 23, 2009, the decedent’s liver enzymes test results were "HP," or "high panic" values, which meant that Valencerina and Janssen’s monitor should have ordered that the lab results be immediately repeated on a "STAT" basis because they were either indicative of a severe medical condition or they were erroneous. Counsel contended that even with a "STAT" order, it must always be assumed that there is a severe medical condition and, thus, the decedent should have been immediately transferred to an actual acute-care hospital for further assessment and tests, especially since this result was a 10-times increase over the prior liver enzyme test results and a 300-percent increase over baseline in less than three days, indicating a severe medical condition. Thus, plaintiffs’ counsel argued that, based upon the results of the Feb. 23, 2009 EKG and liver enzyme tests, and the protocol exclusion criteria, even if the decedent had been a proper candidate for inclusion in the first place, and he was not, the decedent certainly was no longer properly retained in the study because his dramatically-worse EKG and liver enzyme results showed signs of serious heart and/or liver complications. Counsel also argued that when the initial dramatically-worse EKG report was received by the study investigators, the decedent should have been immediately discharged from the study and immediately referred to an emergency room, cardiac specialist or other physician — with the pertinent medical records — for a complete work up. In addition, counsel argued that the immediate discharge of the decedent from the study and referral to appropriate medical care became even more urgent and imperative when the dramatically worse liver enzyme test results were received by the study defendants on Feb. 24, 2009, especially since the nursing notes confirmed that the decedent was demonstrating symptoms of cardiac and liver impairment, listing symptoms that were all indications that the decedent was feeling very sick. Additionally, counsel contended that when the decedent gained 14 pounds in five days and his sister reported observing that his face was shockingly swollen, the symptoms were signs of sudden edema, which is a clear sign and symptom of congestive heart failure. Plaintiffs’ counsel further contended that by Feb. 24, 2009, when the initial dramatically-worse EKG report was received by the study investigators, and the shockingly-worse liver enzyme test results were received, the decedent should have been immediately discharged from the study and immediately referred to an emergency room, cardiac specialist or other physician — with the pertinent medical records — for a complete work up. In addition, plaintiffs’ counsel contended another blood draw was done on Feb. 25, 2009, at 9:45 a.m., but the results were not received until 6:15 a.m. the next day and that second blood draw was taken at 12:05 p.m. on Feb. 25, 2009, which was supposed to be sent to Costa Mesa for "STAT" results, meaning that results should have reasonably have been returned within 15 minutes, but that the results were actually not sent until 5:41 p.m., almost six hours later. Counsel contended that both results reported "high panic" values, meaning that by Feb. 25, 2009, the decedent was very sick, with severe observable signs and symptoms of extreme illness, and that even a layperson could easily observe the need to immediately transfer the decedent for emergent medical care. However, plaintiffs’ counsel argued that since Janssen failed to take the decedent out of the study, the decedent subsequently died of cardiac arrest on Feb. 26, 2009, several days after his first dose of the drug. Counsel for Janssen Pharmaceutical and Janssen Research & Development argued that the decedent had no symptoms of any illness prior to Feb. 25, 2009, when he was finally transferred to Coast Plaza Doctors Hospital’s emergency room. Valencerina admitted that she was aware of the initial test results from Kedren Community Mental Health, but that she disregarded them. She testified that she believed she had the discretion, under the protocol, to ignore the cardiac exclusionary criteria based on her overall assessment of other factors, including the decedent’s family history and his physical examination.

Augustine Liu II was transferred out of the study facilities to Coast Plaza Doctors Hospital, in Norwalk, to investigate abnormal liver test results. However, he ultimately died of cardiac arrest on Feb. 26, 2009, several days after his first dose of Risperdal. An autopsy revealed his cause of death was dilated cardiomyopathy, a heart injury that can be aggravated by the use of Risperdal, but could also have been treated. The decedent was 25 years old at the time of his death. The decedent’s mother, Marion Liu, sought recovery of wrongful death damages for the loss of her son.

The jury found that Janssen was negligent in failing to adequately monitor the study and protect the study subject. It also found Janssen’s negligence was a substantial factor in causing the decedent’s death. The jury also found that Valencerina was negligent and that her negligence was substantial factor in causing the decedent’s death. It subsequently apportioned 30 percent fault to Valencerina and 70 percent fault to Janssen. The jury also determined that Marion Liu’s damages totaled $8 million for the wrongful death of her son. Since Valencerina was already out of the case, she would recover the $5.6 million amount owed by Janssen.

Actual Award:

$5,600,000

Judge:

Richard L. Fruin

This report includes information that was gleaned from court documents and an interview of plaintiff’s counsel. Counsel for Janssen Research & Development LLC and Janssen Pharmaceutical Inc. did not respond to the reporter’s phone calls. Counsel for the remaining defendants were not asked to contribute.