A jury in Los Angeles has awarded a total of $8.3 million in damages to a Montana man who received a DePuy ASR metal-on-metal hip implant in 2007. The jurors said manufacturer Johnson & Johnson was negligent but didn’t owe punitive damages to Loren “Bill” Kransky, a retired prison guard.
Johnson & Johnson recalled 93,000 DePuy implants in 2010, after finding that 12 percent of the devices failed within five years. Analysts say the lawsuits could cost J&J billions of dollars to resolve.
Kransky’s lawyers alleged that Johnson & Johnson failed to properly test the device, downplayed complaints of failures and considered a redesign of the device before halting the effort in 2008.
“More patients will soon be told they received potentially contaminated drugs from the New England Compounding Center, whose products already are associated with 297 illnesses and 23 deaths. On Monday, the Food and Drug Administration posted on its website a list of more than 1,200 hospitals and clinics that had purchased steroids and other drugs from NECC that if contaminated would be especially dangerous for patients.” Read the full article.
During the campaign for President this election season, candidates have debated the merits of a government-sponsored health care coverage system for Americans. Although there has been a lot of discussion about pre-existing conditions and affordability of care, there has been little to no discussion about drug safety. The recent outbreak of fungal meningitis illustrates how important an issue drug safety is to American health.
The outbreak first gained attention at the beginning of October, when a Tennessee man developed fungal meningitis and investigators traced the fungus back to a compounding pharmacy that manufactures injectable medications such as back steroid medications. The initial investigation revealed a fungus contamination at New England Compounding Center’s facilities. NECC recalled the back steroids that had been linked to the outbreak on October 6; 13,000 people had already potentially been infected. Two weeks later, over 200 people have developed fungal meningitis and 19 of those people–almost 10 percent–have died. The ongoing investigation is looking into whether any of NECC’s other drugs were contaminated, how the contamination occurred and whether state regulators did an adequate job of overseeing NECC’s activities. At least two patients who received other injectable drugs from NECC are under observation for potential fungal meningitis.
NECC may face criminal charges if the investigation shows that it broke state or federal drug safety laws. The compounding pharmacy has already lost its license to practice in Massachusetts and Michigan, and at least one civil lawsuit has been filed by a patient who developed fungal meningitis. For many Americans, criminal and civil consequences may be enough to make them feel that justice has been served.
The problem is that the meningitis outbreak is far from an isolated incident. Although most outbreaks aren’t as severe or dramatic in nature as this story, they are still fairly common. Patient advocates have been calling for better regulation of these pharmacies for over a decade, but it hasn’t happened yet. This case demonstrates many of the problems that cause Americans to risk their safety when taking prescription medications. For example, the FDA had safety concerns about NECC in 2006, yet the pharmacy continued to operate for another six years before the meningitis outbreak finally forced a shutdown. There are also questions about whether NECC followed standard safety procedures and whether state regulators inspected this plant appropriately.
This outbreak potentially affected 13,000 people in 23 different states. The next outbreak could affect even more Americans. So it’s important that the questions of how this happened and who was responsible be answered. It’s also important that regulators see this as a warning of what might come in the future and allow the FDA to oversee compounding pharmacies.
Compounding pharmacies are a fast growing industry. These pharmacies make customized medications for patients and are used for everything from cough syrup to chemotherapy treatments. Thus, it’s vital to the health of Americans that they be regulated appropriately. Drug safety is as much a health crisis as adequate access to health care providers; the federal government needs to address it.
The recent outbreak of fungal meningitis, which has been linked with contaminated steroid injections, is the most serious such outbreak in US history. This problem has led to 14,000 exposures and almost 200 deaths. Unfortunately, this is not the first such outbreak America has seen as a result of using compounding pharmacies, and it is not likely to be the last.
Compounding pharmacies create customized medications for people who can’t take standard medications. They are used for a wide range of medications. Many cancer medications come from compounding pharmacies, as do flavored cold medications for young children. These pharmacies are popular with doctors and clinics because they don’t charge as much as traditional pharmacies do to provide medications.
Compounding pharmacies also are not as regulated as traditional pharmacies. They are more or less free to manufacture the drugs however they want as long as they follow state and federal laws. The FDA does not oversee how these pharmacies are run, although it steps in if there is a problem or if unsanitary conditions are reported. Thus, drugs made in these pharmacies may not be manufactured safely.
In the recent case, it’s not yet clear how the steroid injections became contaminated or whether NECC, the company that manufactured the drugs, followed all necessary safety precautions. Federal oversight may have helped correct any unsanitary practices before contamination occurred.
There have been other such incidents in the past; as recently as this past March, consumers expressed concern about compounding pharmacies after some patients were exposed to a fungus that caused eye infections. In 2011, nine people in Alabama died after receiving contaminated nutritional supplements. Incidents like this go all the way back to 2001, when consumer watchdogs first urged the FDA to tighten regulations and directly oversee compounding pharmacies. Since compounding pharmacies are responsible for a large number of drugs, failure to tighten regulations now may lead to an even worse outbreak of disease in the future.
This latest outbreak demonstrates the severity of the problem. Currently, 50 out of 17,000 potentially contaminated vials have tested positive for fungal meningitis; many more may turn out to be contaminated after testing is complete.
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