Why a Pain Pump is not a Syringe.
I recently came across a post by Armand Rosetti which summarized some news articles relating to I-Flow Corporation and its Chief Executive, Donald Earhart. Especially interesting are some statements Mr. Earhart made in a November 5, 2008 conference call with investment analysts regarding the company’s third quarter earnings. Earhart was answering questions regarding the status of the shoulder chondrolysis lawsuits, and said:
I’ve said this argument before on the conference calls, is that a pain pump or a delivery device, whether it be a syringe or one of our pumps delivering a drug, how do you blame the device, because there’s no way the device can cause the disappearance of cartilage. It would have to be whatever is delivered into the site or would have to be the technique by the doctor or would have to be the sutures or it would have to be the staples or it would have to be something else used during the surgery, but it can’t be our pump, because our pump can’t cause cartilage to disappear…. It’s like using a syringe to deliver a narcotic. We can’t be held responsible for the side effects, if I’m the syringe manufacturer, of the drug.
This raises an important point. Clearly, it is the toxicity of the local anesthetic that causes the direct harm to the patient--whether the result be the destruction of shoulder or other joint cartilage, tissue necrosis around a surgical site, or other injury. How then can a plaintiff reasonably seek to blame the maker of the device and not the drug? Because a pain pump manufacturer retains a legal responsibility to patients to provide that their devices may be safely used with local anesthetics in a manner intended by the manufacturer of the local anesthetic. Continuous infusion through a pain pump is not a listed intended use of a local anesthetic; it is an off-label use. A statement such as I-Flow makes in its current Directions for Use for the On-Q pump, “medications or fluids must be administered per instructions provided by the drug manufacturer,” has little meaning when the use in question is not addressed by the manufacturer.
Mr. Earhart and I-Flow appear to take for granted that continuous infusion is no different than the uses approved by the local anesthetics manufacturers. I contend pain pumps represent a categorically different use both because of the larger volume of local anesthetic infused and the significantly greater duration of exposure of the affected tissues to the medication. For example, a single bolus dose of 100 mg (20 ml) of Marcaine to produce a nerve block may well create less risk of local tissue toxicity than continuously infusing smaller volumes—2ml/hr—but with a larger total volume 240 mg (100 ml) over a much longer time—2-5 days.
On the other hand, the uses to which a syringe is put--—local infiltration around a surgery site and injections to produce various types of nerve blocks—are approved uses by the drug manufacturer. Because there are a variety of known risks of patient injury with their devices, pain pump manufacturers have a duty to timely and adequately convey warnings of such risks to the physicians who use them.
