There’s one good thing coming out of the horrific and rising death toll from possibly-contaminated drugs produced by a small drug compounding firm. There’s nothing like a few deaths to concentrate the attention of policy makers.
If that sounds heartless and cruel, it is nonetheless quite true.
Much more attention will now be paid to the practice of compounding, bringing much-needed focus on the very real dangers inherent in the practice. To date, a dozen people have died as a result of the tainted drug, but the count may well increase: thirteen thousand people received the injections. Experts believe about 650 individuals will end up infected, up from 121 today.
Roberto Ceniceros reported that many of the facilities using the tainted drug treat workers comp patients.
The reality is compounding is not tightly regulated; the FDA is responsible for ingredients but individual states handle manufacturing and oversight. That’s not for a lack of trying; the FDA has repeatedly tried to increase its oversight of compounders, only to see those efforts blocked by compounders’ lobbyists. (side note – think of this when you listen to politicians ranting about regulatory burdens).
The meningitis outbreak is only the latest in a string of what the FDA reports is 200 “adverse events” associated with 71 compounded drugs, one of which blinded two veterans at a VA facility. Back in 2009, Dan Reynolds of Risk and Insurance wrote an extensive article on the problems with compounding, citing experts from PBM HealtheSystems.
Implications for workers’ comp
1. The drug in question was typically injected into the back to relieve back pain. The procedure, known as an epidural steroid injection, is all too common in workers’ comp. It is highly likely that some of the victims were comp claimants. Here’s hoping the insurers for the victim(s) vigorously pursue legal action against the compounder.
2. As CWCI, WCRI, and others have reported, compounding is growing in workers comp. There’s been a significant increase in California since the Golden State slapped controls on over-charging for repackaged drugs, one theory is the profiteers looked for another place to suck money out of the system. Hopefully regulators and legislators will now have the impetus they need to blow thru compounders’ lobbyists and put stronger controls on the practice.
Too bad they won’t look at the indications for the injections to realize that at least 50%, if not more, are not indicated. Epidural steroids are indicated for radicular pain secondary to compression, not back pain
Work Comp carriers can anticipate additional costs related to the complications caused by the tainted injections. As you say, hopefully they will at least attempt to subrogate for those expenses.
Wait just a minute here. If anyone needs to be subrogating here it is the consumer against the WC carrier for being forced to endure a treatment that (1) is forced out as a matter of due course; (2) violates the consumer’s right to safe and efficacious treatment; and (3) utilizes unregulated, unsafe materials that are neither approved by FDA or inspected under GMPs. A number of these pain clinics and physicians are in financial arrangements that are not disclosed to patients and breach conflicts of interest in care provision. Yes, WC is very involved in this outbreak – up to the eyeballs. Don’t even get me started on the carriers who refused consumers medical diagnostic supports once it became clear they were sickened.
Terri – thanks for the comment.
I don’t follow how the consumer (claimant) would subrogate against the WC carrier. The physician orders the treatment, the pharmacy compounds it, all the WC carrier does is pay for it. In the vast majority of states the WC carrier has no control over the treatment plan. However if the claimant is injured as a result of defective medicine, the WC carrier has to pay for all treatment to address that secondary injury.