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Through them all, there's a pattern: When a compounding pharmacy commits serious transgressions wrongs that endanger lives or involve large scale criminal conspiracies the regulatory sanctions often are minimal. Tougher punishments frequently come in the form of personal injury lawsuits, which can elicit court ordered penalties far more potent than, say, the suspension of a pharmacy's license.
In the same order that suspended the pharmacist, the board immediately issued a "stay" of that action. He was allowed to continue practicing pharmacy on a probationary basis, provided he pass a competency exam and refrain from compounding. "If that guy is able to go back and work in a pharmacy ? I think the regulatory system is not working, because the conditions in that plant were absolutely abysmal.
Warnings in an earlier outbreak
inadequate sanitary and quality control practices. When they tested unopened vials of the suspect medication, they also found the fungus.
When state and federal investigators inspected the facility where the drug was prepared, Urgent Care Pharmacy in neighboring South Carolina, they found faulty sterilization equipment and Converse Flats
Compounding pharmacies, which mix specialized and hard to get medications from raw ingredients, have been tied repeatedly to illness outbreaks the Food and Drug Administration has recorded about 200 "adverse events" linked to 71 compounded products since 1990. Some of those cases were eerily similar to the current meningitis episode, which has killed 28 so far.
At least three personal injury lawsuits have been filed against the Framingham, Mass. based New England Compounding Center, which state and federal investigators have identified as the chief suspect in the current meningitis outbreak. With more than 300 illnesses in at least 16 states, more claims are sure to follow.
But litigation can take years, and it doesn't always succeed.
The pharmacy was ordered to stop selling the contaminated drug immediately, state investigation records show. Warnings went to 11 states where hospitals and clinics had gotten drug shipments from the facility. Several victims were hospitalized; one woman died.
USA TODAY reviewed state and federal court records, investigative reports and regulatory actions on dozens of cases Converse Chucks High Tops
The lightly regulated businesses have been linked through the years in government investigations to high profile steroids scandals in sports and major tragedies involving veterinary drugs.
In some cases, there's almost no penalty for pharmacies that break the rules, and the people who run them simply continue with business as usual, sometimes with tragic results.
Even state license revocations are rare: Among cases reviewed by USA TODAY, the NECC closure was the only time a state revoked a compounding pharmacy's license permanently. "Whether they have the political will and the resources to pursue those cases is a question in my mind."
After the horses' death, the FDA also filed suit against Franck's, contending its operations should be halted because it was acting as a drug manufacturer, using bulk ingredients to produce drugs on a large scale. As a manufacturer, Franck's would need FDA approval and be subject to agency inspections for compliance with strict federal rules on safety and quality.
WASHINGTON The legal landscape is littered with charges of negligence and misconduct by compounding pharmacies such as the one implicated in the nation's ongoing meningitis outbreak, but they rarely result in tough punishments, an examination of legal records shows.
The South Carolina Board of Pharmacy directed Urgent Care to halt work until it corrected major deficiencies in its sterile practices and oversight of technicians.
"If there is conflict of interest at the state level, that may be a contributing factor in the lack of enforcement," Sellers says.
Joanne Doroshow, executive director of the Center for Justice Democracy at New York Law School. "Nothing else seems to be doing it ? because the entire regulatory system lacks teeth."
But that's the board's only bullet: Like many state pharmacy boards that regulate compounding operations, the Massachusetts panel has no power to issue fines for wrongdoing. Justice Department and the FDA are involved in the NECC probe. But such prosecutions are extremely rare, in part because the law makes it very difficult to hold pharmacists criminally liable for problems with the drugs they produce or dispense.
Civil lawsuits are a powerful tool "to make sure the most dangerous compounding pharmacies are forced out of business," says Converse Sale Uk Mens
In the fall of 2002, a spate of meningitis cases began cropping up in hospitals and clinics in North Carolina. In many respects, it was strikingly similar to today's outbreak: All the patients were sickened by a rare fungus after getting treated with an injectable steroid produced by an out of state compounding pharmacy. Even the drug was the same: methylprednisolone acetate.
Harsh punishments rare for drug compounding mistakes
The investigators have linked the outbreak to fungal contamination in injectable steroids that were produced by NECC and administered to an estimated 14,000 people for back pain. Last week, the Massachusetts Board of Registration in Pharmacy permanently revoked NECC's state operating license, as well as the licenses of its three chief pharmacists, after documenting multiple problems with sanitary conditions and quality control at NECC's facility.
Franck's acknowledged the dosing error even before federal investigators confirmed it, and owners of the horses filed a lawsuit seeking more than $4 million in damages from the pharmacy. But that case remains unresolved and is scheduled for a jury trial early next year.
"If these people aren't stopped through litigation," Horne adds, "they're not going to be stopped."
Sellers, who now runs Q Vigilance, a drug safety consulting firm, says she doesn't ever recall seeing another case in which a state shut down a compounding pharmacy permanently. She believes that might be due partly to the fact that state pharmacy boards often have members who operate or have interests in compounding pharmacies.
Dead horses and more lawsuits
in which compounding pharmacies produced contaminated or adulterated medication, mismeasured dosages, or manufactured and distributed drugs that were counterfeit or illegal. In many cases, it wasn't regulatory action that shut down those operations; it was damage awards they couldn't afford to pay.
Facing lawsuits from more than a half dozen people who claimed injuries from the contaminated injections, Urgent Care declared bankruptcy three months later. But the pharmacist who managed the operation moved on and now works at a different South Carolina pharmacy. Reached at that store, he Ladies Converse Dainty Navy declined to comment.
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