Everyone is nervous before going under for a medical procedure. Thankfully most times, when in the hands of good doctors, everything turns out according to plan. But what happens when a drug company manufactures drugs in a huge vial, about three times the amount needed for one procedure, yet clearly labels it single use? Then, negligent doctors decide instead of wasting and throwing away the leftover amount, to use it on another patient. Negligence, product liability and outbreaks of Hepatitis C, is the answer.
Arguing that oversized vials of a drug were “weapons of mass infection” that led to an outbreak of Hepatitis C at outpatient surgical centers, a small law firm convinced a jury that the manufacturer and its distributor, TEVA Pharmacueticals, should be punished with $500 million in punitive damages.
In 2000 Teva requested and got FDA approval for producing smaller 10 ml and 20 ml vials. The company stated that the smaller-dose vials were closer to the amount needed for shorter procedures and would reduce the risk of reusing the vials and spreading infection. However the company was motivated by greed and soon found that it made more money by selling the larger vials. A pharmacist with Teva admitted on the stand that the risk of infection was foreseeable.
The large vials created a risk that doctors would reuse them in shorter surgeries requiring smaller doses, thus spreading infections between patients.
The source of the lawsuit was an outbreak of Hepatitis C at several colonoscopy clinics in Las Vegas. Two subsequent outbreaks in Miami and Washington D.C. also occurred, according to Eglet.
Plaintiff Henry Chanin, 62, the principal of The Meadows prep school in Las Vegas, underwent a routine colonoscopy in 2006 during which he was given propofol from a 50 ml vial that had been reused from another patient. Several weeks later he developed acute symptoms of Hepatitis C.
Hepatitis C is a liver disease caused by the Hepatitis C virus. It can result in liver cirrhosis and cancer. It is mainly transmitted through contact with the blood of an infected person, primarily through sharing contaminated needles to inject drugs. Symptoms can include decreased appetite, fatigue, abdominal pain, jaundice, itching, and flu-like symptoms.
The danger wasn’t just to Mr. Chanin. The company had constructive knowledge of 148 reported cases of infections associated with propofol at endoscopy centers, and under the “Kessler rule” of statistics, every reported case could represent 100 unreported cases.
While $500 million in punitive damages seems like a large amount, it really isn’t when put into perspective. An individual who was punished would expect to give up a few weeks of his or her paycheck. The companies here had an income of $14 billion last year between the two of them. The jury’s $500 million award was essentially only two weeks of earnings.
Drug makers have a duty to warn patients and prescribers fully about the side effects of medications. When companies fail to meet this duty, people injured or killed by the drugs have an undeniable right to compensation for their suffering and medical expenses.