By now it’s common knowledge that a compounding pharmacy in Massachusetts delivered tainted preservative free methyl-prednisolone to a number of hospitals / clinics. The taint was a fungus. And morbidity and mortality have climbed.
Why did doctors/ facilities even order from a compounding pharmacy? Two reasons: First, the typical preservatives used to suppress fungus can wreak havoc if the injection accidentally strays into the spinal sac (CSF). So, preservative-free is, in principle, a good idea as it is impossible to know with certainty the injection is in the epidural space. There are ways to be quite sure – but not completely sure.
Next, preservative-free methyl-prednisolone was in short supply. Major manufacturers had exited the space.
Lawsuits have been initiated against New England Compounding Center alleging product liability, pharmacy malpractice, general negligence, breach of warranties, and more.
Most recently, two New Jersey lawsuits have targeted an orthopaedic clinic and two doctors – alleging negligence and violation of product liability laws. For attorneys prosecuting these cases, they assume that there will not be enough assets or insurance to cover claims for affected patients. New England Compounding Center will likely have to file for bankruptcy if its assets cannot cover the load. And, whether the Compounding Center has adequate insurance to defend and cover claims, who knows? Doubtful. So, attorneys will likely broaden their pool of defendants.
Typically, it’s difficult to prevail against a physician in a product liability claim if the doctor didn’t manufacture the defective product. The questions that will be probed: Did the doctor still use the product after the recall? Did the doctor timely notify patients at risk once aware of the problem? Would a reasonably reasonable practitioner use such a pharmacy for the specific prescription?
“The flood gates are going to open,” D’Amore (a medical malpractice lawyer at the Cochran Firm in Washington, D.C.) predicted. “You’re going to get people suing everyone.”
State laws and the courts have traditionally protected health care providers from product-liability claims, he said. A medical malpractice suit would also have to show that providers acted both negligently and outside the norms of professional standards, D’Amore added.
That might be cold comfort to doctors who are sued, yet prevail over time.
I am a pain physician. I am board-certified By the American Board of anesthesiology with a subspecialty in pain medicine. I have performed over 32,000 steroid injections!!
We have never used compounding agents in our Practice. Interestingly in all, in 2004 the FDA, Recommended that we use Celestone or betamethasone for steroid injections in the spine that is epidural steroid injections. The FDA contacted Schering-Plough the manufacturer of Celestone to increase production for pain physicians. Originally Celestone was only approved for neonatal lung maturity. We stopped using methylprednisolone or triamcinolone in 2004 because of the FDA. We continued use methylprednisolone in joints that is the sacroiliac joint knee and hip joints Until last year when we changed everything over to Celestone. Basically we did this because it was getting too confusing ordering different types steroids. The reason for Celestone over methylprednisolone in the epidural space has to do with the particulate size of the Celestone. Celestone is a lot smaller hence if there is an asked this an accidental injection into an artery there’s less chance of clotting the artery. I believe the real reason for using compounded steroids in the epidural space is cost.
Another irresponsible post. First, plaintiff’s are under a burden to sue all possible tortfeasors because if they don’t, in most jurisdictions, the percentage of liability (or an amount), eventually attributed to a non-party, who could have been sued, will be deducted from any verdict in a plaintiff’s favor. I don’t know who “D’Amore” is, but if in fact he/she said, what you say he or she said, then he is also irresponsible. The reason physicians are usually insulated from product liability actions is not because what the say-nothing D’Amore stated, but as you already stated in the post, they cannot be held liable if they utitlized the steroid in the prescribed manner for epidural injections and did not use it after the recall and timely notified their patients after the recall. As for ordering the steroid from a compounding pharmacy, there are a number of drugs which cannot be obtained from regular pharmacies and presuming any number of physicians utilized this particular pharmacy, I cannot see any liability.
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Kathy, call me old school, but, I am not a fan of the shoot first, aim later club. Let’s be clear, the statute of limitations, if that is of concern, will not come into play for a while. So, thoughtful attorneys can investigate first, then get a better idea of who the likely (not just possible) tortfeasors are. Then the likely tortfeasors can be sued.
I think we have just coined a new phrase here. “Defensive lawyering”. With defensive medicine, the doctor feels compelled to order every conceivable test under the sun (no matter how unlikely a test will yield an answer) to feel comfortable he/she will be immune from litigation. With defensive lawyering, an attorney must sue every possible tortfeasor, no matter how unlikely that defendant violated a standard of care causing damages. Defensive medicine and defensive lawyering impose negative externalities.
The statute of limitations varies and I know of no lawyer who would take a chance that they would be caught in that situation. The fact is we very well may not know the actual involvement of an individual physician until after depositions so your shoot first, aim later analogy does not work since it would put the attorney at risk for malpractice for missing a statute. In actuality, thoughtful attorneys will not sue a physician in consultation with their client who signs off in an informed consent letter acknowledging their understanding that if that physician is found a percentage liable, then they they will lose that percentage or some part of the award. The idea that somehow or another the statute of limitations provide a buffer is erroneous for many reasons: 1. you assume that the client comes with the entire time period; 2. you fail to understand just how long it takes to get all of the pertinent records; 3. check the records for completion; 4. obtain those portions not provided (the path report which is exactly what you need, the second operative report, the list is endless), 4. Analyze the records, do medical research and a memo of usually no less than 5-8 single spaced pages, 5. Locate appropriate experts for both liability and causation if necessary. These things take a lot of time and I know because I’ve been doing it this way for many years and successfully. In wrongful death cases you have to have an administrator of executor appointed and this may well be complex depending on how many children are involved, tax implications, and any complexities with a preexisting estate. And, just like a doctor, we have more than one client at a time.
Lastly, your analogy to defensive medicine is also faulty. First, the physician is in control of the medical information and has a relationship with the patient. The attorney representing a plaintiff has only the information from the client who is not medically sophisticated, has to rely on the medical records which may be difficult to read, sparse EHR, and the attorney does not have access to investigations performed after the fact or the impressions of other pertinent medical witnesses. You see Medical Justice the actual odds are stacked in your favor. Please don’t hesitate to ask any questions you may have, since I actually have a plaintiff’s medical malpractice practice, I understand how it works in the real world. You’ve been talking to too many defense attorneys.
Adding to the list of defendants will surely add to the costs of litigation geometrically, not linearly. Plaintiffs generally see about 25% of the award, and this will decrease with the only clear winners being the attorneys. Oddly, it is the defense bar that most reliably is paid, regardless of the merits of the case.
It remains a puzzle to me why our system, unlike that of nearly every other civilized nation, will not adopt a “loser pays” mode of dispute settlement. Specious claims will not be brought, understanding that if you lose, you will have to pay to play. We simply can’t afford the system as it is.
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Interesting Post and comments. i would like to know more about what defines proper use of compounded medications. Does there have be a advantage? Does it have to be the only way to get the medication?
Tom…Great question. My understanding is there were good reasons to use single dose preservative-free methyl-prednisolone. Single dose versus multi-dose vials prevents the issues that nearly bankrupted a professional liability carrier in Nevada. In a surgicenter, allegations were made that multi-dose propofol vials were used for sedation in colonoscopy. Several patients developed hepatitis and the question was whether the vials were a vector from an infected patient. This suit was settled with Teva Pharmaceuticals and Baxter for several hundred million dollars. Then, Teva exited the propofol market. Next, preservatives can cause severe arachnoiditis if injected into the thecal sac. Why would a medication intended for the epidural space ever get into the thecal sac? Because even with fluoroscopic guidance, it happens. And if it happens despite the best of technique and an abundance of caution, the patient can be injured.
So, strong argument can be made for single dose, preservative free steroid vials.
What I do not know is whether these compounds could be purchased from big Pharma. For all types of steroid medications, there have been episodic shortages. So, even if available, having more than one source would make sense.
Medical justice…. Methylprednisolone can be purchased preservative free single-dose vials. In fact this is what we used until 2004. Once again the FDA recommended use of betamethasone or Celestone for interlaminar epidural steroid injections. Celestone is with a preservative and is in a multidose vial. I did not believe anybody still used methylprednisolone for interlaminar epidural steroid injections. I believe the answer is preservative free Celestone for interlaminar epidural steroid injections. This would have to come directly from the manufacturer Schering-Plough. The transforaminal epidural steroid injection is a whole different ballgame!!
This article discusses the legal exposure for physicians who used an unexpectedly adulterated product over which the only control they had was to use or not use it. An interesting way to look at this is through plaintiff’s attorneys’ eyes, who deliberately selects the widest range of defendants they can in order to avoid charges of errors and omissions on their part. Medical Justice correctly compared this to a shotgun approach often used by physicians (tests and procedures) to avoid the same complaints.
In this case, Government dropped the ball. There was no or completely inadequate supervision of the compounders. Physicians pay taxes (like everyone else) for regulation. The same complaint was used regarding the financial industry, during the great crash of 2008. The model used by Government to fix the financial crisis was to lend/give money to miscreants to increase liquidity in the emergency.
Maybe Government should face up to their responsibility: Provide physicians with a pre-paid Government issued insurance policy relating only to this incident.
In the case of the Great financial collapse, erstwhile regulators who utterly failed their duty stepped neatly through revolving doors to 7 figure incomes from private investment firms after the fact without answering a single question. Congress, in their infinite wisdom (Rep. Pete Stark) has chosen instead to block physicians from the same financial structures that private industry and legal providers have used and continue to use for years.
Michael M. Rosenblatt, DPM
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Dr. Pain – Since no manufacturer makes celestone preservative free and particulate free then it would have to be purchased from a compounding pharmacy right? It seems that if the compounding pharmacies that provide sterile injectables (not commercially available) were required to test each lot for bacteria, endotoxins, and fungus using a 3rd party lab and not allowed to ship until the microbiology results were on record it would be much safer. Some pharmacies do this already and some do not so the cost of production may go up a little but it would be safer and eliminate issues like the one being discussed.
This is really good action taken by the government. This is looking like that the government is more conscious about medical malpractice issues.