A recent investigation by The Washington Post has revealed a chain of sloppy work and unsanitary conditions at three large-scale specialty pharmacies, which have resulted in deaths and illnesses over the past decade. The Post found that a deadly meningitis outbreak last year, stemming from safety lapses at a pharmacy in Massachusetts, was not an isolated event. Coumpounders, as the specialty pharmacies are sometimes referred to, supply 40% of all intravenous medications used in hospitals (a decade ago, this number was only 16%).
Serious safety violations long precluded the national attention trained on the New England Compounding Center, which produced contaminated steroid shots linked to 45 deaths and 651 illnesses. Little has been done by either state or federal authorities to inspect and fix problems at specialty pharmacies, which custom-make medications for patients, hospitals and clinics. The industry is barely regulated; pharmacies were rarely penalized, even when their errors resulted in patients dying. There are fifteen large-scale compounding pharmacies currently operating in the U.S. (all are multimillion-dollar companies); three were found to have serious problems (in addition to the New England Compounding Center). The Post gathered its information through interviews with government and industry officials, lawsuits, and Food and Drug Administration documents.
The three companies responsible for the tainted medications (which ship across state lines, frequently without individual patient prescriptions) have caused 39 reported cases of illness and at least six deaths. Some of the compounds were too potent, others were contaminated with bacteria. Central Admixture Pharmacy Services (CAPS), which is based in California, is currently under investigation by the FDA; information on the Illinois-based PharMEDium Services and Texas-based ApotheCure also revealed serious flaws.
John Armitage, a cardiologist who lost patients due to tainted medicine compounded by CAPS, commented on the FDA’s 2005 investigation of several CAPS: “The things they saw, they would chill your bones.” Although compounders make some of the riskiest drugs available—steroid injections linked to the meningitis outbreak, for instance—they don’t have to uphold the same safety regulations that commercial drugmakers (Pfizer, Merck, Novartis, etc) do. CAPS prepared cardioplegia (a drug used to stop the heart during open-heart surgery) for a two-year-old; the drug was made far too strong, and the girl’s brain bled. She suffered severe and lasting injuries. The family sued the hospital, which sued CAPS—the lawsuits were settled, but, two years later the company made the same medicine for two other patients undergoing open-heart surgery, and they both contracted horrible infections and died. Nine other cardiology patients were also infected and required lengthy stays in the ICU. And this is just one of the three specialty pharmacies that continues to operate despite repeated, documented failures.
If you or a loved one has been injured by a defective product, contact America’s Consumer Lawyer, at 312-224-4695 for a free consultation. We are a Chicago personal injury law firm representing individuals and families who have suffered an injury or loss due to an accident. America’s Consumer Lawyer, will handle your personal injury case quickly, will advise you every step of the way, and will not hesitate to go to trial for you. Lastly, America’s Consumer Lawyer, does not get paid attorney’s fees unless we win your case. Our no-fee promise is that simple. Therefore, you have nothing to risk when you hire us–just the opportunity to seek justice.
