FDA Rebukes Teva Pharmaceutical for Lax Manufacturing Practices

By May 6, 2010July 17th, 2019Dangerous Drugs

The U.S. Food and Drug Administration has issued a warning to Teva Pharmaceutical Industries Ltd.’s Parenteral Medicines unit about manufacturing problems that contaminated an anesthetic. As a dangerous drugs attorney, I am dismayed to read that another drug manufacturer has been less than scrupulous with their manufacturing processes. Last month, I wrote about the legal and financial troubles at Ethex Corp., whose parent company is KV Pharmaceuticals here in St. Louis, arising from manufacturing problems that the company admitted that it tried to cover up. Parenteral Medicines would be wise to correct the problems that the FDA points out right away, for its own sake as well as the sake of patients.
Teva Pharmaceutical is an Israeli generic drug manufacturer with a manufacturing facility in Irvine, Calif. In December, the FDA had warned Teva that it needed to correct a problem with vials of propofol injectable emulsion, a general anesthesia drug that it produced. The drug was contaminated with bacterial endotoxin. Endotoxin contamination in pharmaceuticals can be extremely dangerous to patients, as it can lead to fever, lowered blood pressure, and septic shock, a serious medical condition with an approximately 50% mortality rate. Patients who undergo general anesthesia do so for medical procedures like surgery, which already exposes them to risks of complication and infection, so it is vital that they not be exposed to additional unnecessary risks from contaminated pharmaceuticals. In late April, the FDA rebuked Teva for allegedly releasing the contaminated lot of anesthesia and failing to correct the problem. The lot of contaminated propofol was recalled, but the FDA found more problems with Teva’s manufacturing practices. It said Teva hadn’t done microbiological testing of rugs or raw materials, and had insufficient cleaning and sanitizing practices.
I have seen enough cases in my work as a drug defect lawyer to believe that making money and saving time are often higher priorities for companies than making sure drugs are safe. The Ethex Corp. case that I wrote about in April was an extreme case, but other drug manufacturers have also faced FDA warnings — as well as lawsuits from patients who were harmed by defective drugs. Drug companies do not answer only to the FDA; they also are legally responsible to the people who use their drugs expecting that they will help them, not make them sicker or kill them. Patients who have been hurt by medications that manufacturers falsely represented as safe can make the drug manufacturers bear the costs of the harm they caused. Drug makers have a legal responsibility to warn the public and the FDA if their drugs carry risks, and if they do not do so, the law holds them accountable by allowing those harmed to sue.

The defective medication lawyers at the Lowe Law Firm focus on helping patients who have been harmed by medications that were supposed to help them. The law recognizes that you should not have to bear those costs on your own if they were imposed upon you through no fault of your own. Even when drug companies genuinely don’t know about a drug’s risk, they are legally responsible for ensuring that their products are safe. When evidence shows that drug manufacturers do know the risks, victims can also hold them responsible for knowingly putting patients at risk for the sake of profits. If a prescription or over-the-counter drug has seriously hurt you, our experienced attorneys can advise you about recovering compensation from the company that caused your injury for medical expenses, lost wages, permanent injuries and pain and suffering.
If you have been hurt by a defective drug or medical device, please call the Lowe Law Firm for a free consultation, toll-free, at 1-877-678-3400 or contact us through our website.