On February 19, 2013, the first of over 3,000 Actos lawsuits went to trial in the Superior Court of California. The plaintiff in the case alleged that Takeda Pharmaceuticals, Asia’s largest drugmaker and Actos manufacturer, was negligent in presenting the risks associated with their diabetes medication. Some news outlets suggest that Takeda concealed the dangers of the drug from physicians for fear they would affect the profitability of the drug.[1] With this knowledge, thousands of individuals afflicted by the drug have brought suit. From a litigation standpoint, identifying the harms indicative of a breach and finding the right experts are critical to successfully litigating the claim.
The Elements of Litigation
Actos is an oral medication used to treat diabetes. Also known as pioglitazone, it is an anti-diabetic drug (thiazolidinedione-type, also called “glitazones”) used to control high blood sugar in patients with type 2 diabetes (non-insulin-dependent diabetes). It works by helping to restore the body’s proper response to insulin, thereby lowering one’s blood sugar. The drug originally received FDA approval in 2009.[2] In June 2011, however, the FDA released a warning stating that patients who had been taking Actos for longer than a year were at an increased risk for bladder cancer.[3] The report suggested that the risk of bladder cancer to those who had the longest exposure to Actos could be as high as 40%. The report also warned that patients who had been taking Actos may experience the following symptoms of bladder cancer:
– Painful urination
– Blood in the urine
– Pain in the back and the abdomen
– Frequent urination.
– Heart attacks
– Congestive heart failure
– Liver damage
– Blindness
– Bone fractures
– Kidney damage[4]
Actos Lawsuits
As cases start to get underway, the specific issues litigated will set the standards for plaintiff and defense counsels going forward. It will be critical to see how juries react to the warnings, or lack thereof, on Actos, allegedly due to Takeda’s fears of how it would affect the profitability of the drug, the different pieces of evidence that courts will allow, and what defenses Takeda will assert. Additionally, as with many cases involving pharmaceuticals and medical devices, many of the plaintiffs have pre-existing conditions or circumstances that also may contribute to the eventual harm (in these cases, bladder cancer). It is critical that the plaintiff show that their bladder cancer was directly caused by Actos in order to link the alleged breach to the subsequent harm. Conversely, defense counsel’s ability to attribute most of the harm to other circumstances is one of the better defenses that Takeda can use. This contrast of approaches was highlighted in the recent case of Jack Cooper v. Takeda Pharmaceuticals America Inc., et al.
The Cooper Case
On May 1, 2013, the judge threw out a $6.5 million jury verdict in Jack Cooper v. Takeda Pharmaceuticals America Inc., et al because the plaintiff’s lawyers failed to produce sufficient evidence that showed his cancer was caused by the use of Actos.[5] The two-month trial featured a former cable splicer, Jack Cooper, who brought suit against Takeda alleging that the pharmaceutical company did not properly warn consumers about the risk of bladder cancer associated with their product.
Cooper focused on evidence that Takeda was aware of the dangers associated with Actos, but feared that a cancer warning would hinder sales. Takeda, however, alleged that Cooper was an elderly male with diabetes and a history of smoking. With these risk factors, he was already at a high risk for bladder cancer. The jury returned a verdict in favor Cooper, and awarded him $6.5 million.
Takeda, however, convinced the judge to throw out the $6.5 million verdict. He ruled that Cooper’s lawyers could not show the bladder cancer was caused by the drug because testimony from their expert witness proved to be “inherently unreliable.”[6] Cooper’s lawyers stated that they believed the judge misinterpreted the law and planned to appeal.
There are cases awaiting trial in Illinois and more than 1,200 suits have been before a federal judge in Louisiana for pretrial and information exchanges. Other states where numerous claims have been filed include Florida, New York, and Ohio.[7]
Actos Expert Witnesses
One important lesson from Cooper is the importance of finding the right expert. Actos expert witnesses need to be knowledgeable on the application of the drug, the possible side effects, and the appropriate warnings that should have been on the drug. Generally, the experts, especially medical experts, should have experience prescribing Actos or treating individuals who were taking Actos.
Urology
Urologists, also known as genitourinary surgeons, focus on diagnosing and treating disorders of the urinary tracts of males and females, and on the reproductive system of males. These specialists manage non-surgical problems such as urinary tract infections and benign prostatic hyperplasia, as well as surgical problems such as the surgical management of cancers (ex. bladder cancer), the correction of congenital abnormalities, and correcting stress incontinence.
Pharmaceutical Labeling
Pharmaceutical labeling experts are generally used to discuss the adequacy of the labeling, and the proper procedures for determining what warnings should have been provided to both patients and treating physicians. Also, they can speak to the testing and regulations factors that go into determining what warnings should be provided
Hematology and Oncology
Hematology is a subspecialty of internal medicine that requires additional fellowship training. Hematologists specialize in diseases of the blood, spleen and lymph nodes. This specialist treats conditions such as anemia, clotting disorders, sickle cell disease, hemophilia, leukemia, and lymphoma. Oncology is also a subspecialty of internal medicine that requires additional fellowship training. Medical oncologists specialize in the diagnosis and treatment of all types of cancer and other benign and malignant tumors. This specialist decides on and administers therapy for these malignancies, as well as consulting with surgeons and radiotherapists on other treatments for cancer.
Endocrinology
Endocrinology is a subspecialty of internal medicine that requires additional fellowship training. Endocrinologists concentrate on disorders of the internal (endocrine) glands such as the thyroid and adrenal glands. This specialist deals with disorders such as diabetes, metabolic and nutritional disorders, obesity, and pituitary diseases, along with menstrual and sexual development problems.
Pathology
Pathologists deal with the causes and nature of disease through knowledge gained by the laboratory application of the biologic, chemical and physical sciences. This specialist uses information gathered from the microscopic examination of tissue specimens, cells and body fluids, and from clinical laboratory tests on body fluids and secretions for the diagnosis, exclusion, and monitoring of disease.
Toxicology
Medical Toxicologists are physicians who specialize in the prevention, evaluation, treatment and monitoring of injury and illness from exposures to drugs, chemicals, and biological and radiological agents. These specialists care for people in clinical, academic, governmental and public health settings, and provide poison control center leadership. Important areas of medical toxicology include acute drug poisoning, adverse drug events, drug abuse, addiction and withdrawal, chemicals and hazardous materials, terrorism preparedness, venomous bites and stings, and environmental and workplace exposures.
Economic Damage
Economists who speak on damage calculations are brought in to discuss the economic impact that the harm may have had on the plaintiff. This can include measures of lost wages, increased expenses due to ailments, and other factors that go into the monetary impact on the patient’s life.
[1] http://www.bloomberg.com/news/2013-03-05/takeda-put-actos-sales-ahead-of-user-safety-witness-says.html
[2] http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails
[3] http://www.fda.gov/Drugs/DrugSafety/ucm259150.htm
[4] http://www.drugwatch.com/actos/lawsuit.php
[5] http://www.bloomberg.com/news/2013-05-01/takeda-gets-6-5-million-diabetes-drug-verdict-thrown-out.html
[6] Id.
