The family of a man who was one of the more than 60 people nationwide to die as a result of a fungal meningitis outbreak, has reached a wrongful death settlement with the clinic that gave him tainted steroid injections.
David Wingate died after contracting fungal meningitis from an epidural steroid injection that was administered at the Insight Imaging clinic in Roanoke, Virginia. His family filed a wrongful death lawsuits against the clinic that sought $25 million, which has now been settled for an undisclosed amount, according to a report by the Roanoke Times.
The injection was one of thousands of contaminated shots distributed by the New England Compounding Center (NECC), which were distributed in the second half of 2012. An epidural steroid injection recall was issued by NECC after federal health officials determined that the products were contaminated.
More than 700 people throughout the United States developed fungal meningitis or other infections after receiving the injections, with at least 60 people killed.
The Wingate lawsuit is believed to be the first case to settle out of hundreds filed so far. Most of the litigation is currently pending against the defunct compounding center, which has filed for bankruptcy.
All federal cases are centralized in the U.S. District Court for the District of Massachusetts, where the lawsuits are consolidated as part of an MDL, or Multidistrict Litigation. However, many complaints are also pending in various state courts, including local hospitals and pain clinics that distributed the shots as defendants.
NECC has gone out of business and its owners have declared bankruptcy in the face of the growing litigation over the outbreak. The company and its attorneys are hammering out the details of a settlement agreement on behalf of the compounding pharmacy that would establish a $100 million victim’s fund. However, that settlement does not deal with claims against pain clinics and hospitals that distributed the shots from the compounding pharmacy.
FDA inspectors who followed up on the outbreak say that the injections sometimes had visible particles of fungus in them, and many hospitals and clinics purchased the shots in bulk despite the fact that compounding pharmacies are supposed to be structured to provide drugs unavailable anywhere else to local healthcare facilities on a per-prescription basis. In some cases, hospitals reportedly provided NECC with lists of patients so that the company could claim the mass marketing of its injections for back pain were prescription-based.
Stung by the allegations that it failed to do its job, the FDA has instituted a nationwide crackdown on compounding pharmacies over the past year, resulting in numerous recalls and a number of cases where the pharmacies contested the FDA’s right to regulate them.
The controversy eventually led to new laws that creates a hybrid tier of compounding manufacturer under FDA regulation, while isolating smaller compounding pharmacies from federal oversight.
Compounding Pharmacy Risks
A package of studies and commentaries published this week online in the medical journal JAMA Internal Medicine examine the risk of compounding pharmacies.
One study looked at an outbreak linked to intravenous fentanyl from an institutional compounding pharmacy. Researchers from Duke University examined the outbreak, which occurred at Duke University Hospital in late summer of 2012. They found that the compounding pharmacy failed to conduct routine sterility testing.
A letter to the journal looked at the costs of compound pharmacy drug outbreaks and found that one fungal contamination incident led a single hospital to recall 12,000 units of 44 different products from the same compounding pharmacy. That recall required the hospital to readmit 545 potentially contaminated patients, cost the hospital 15,000 hours of personnel time and added nearly $900,000 to the hospital’s expenses. The contamination was discovered by a nurse who saw “floaters” in an infusion bag of magnesium sulfate, raising questions about the compounding pharmacy’s sterility testing if contamination was visibly present.
A second letter addressing issues raised in the first letter called for increased oversight of the compounding pharmacy industry.