Episode 098: Left To Their Own Devices

Speaker 1: You are listening to Your Practice Made Perfect; support, protection and advice for practicing medical professionals, brought to you by SVMIC.

J. Baugh: Hello everyone and welcome to today's episode of Your Practice Made Perfect. My name is J. Baugh. I'll be your host today. I'm also one of the claims attorneys here at SVMIC, and we're going to talk about a closed claim and joining me today to talk about this particular claim is fellow claims attorney Katy Smith. Katy, welcome.

Katy Smith: Thanks J.

J. Baugh: Katy and I have a total of 32 years of experience.

Katy Smith: We've certainly seen a lot of claims.

J. Baugh: Yes, we have. We've reviewed many cases in our total of 32 years here at SVMIC, and today we're going to talk about a case involving the use of medical devices. Before we dive in, I would like to share just a little bit about the medical device market. The US is the largest medical device market in the world, generating over $180 billion in annual revenue. The role of medical device sales reps in patient care is a growing concern for some of the healthcare community, but it's often unknown to patients. There are concerns about ethical issues surrounding the presence of a rep in the operating room, or their influence in the device choice and a physician’s reliance on a medical device sales representative as a resource for treatment decisions during surgery.

Katy Smith: Yes, J, there are mixed feelings about this issue in the healthcare community. Proponents of the practice argue that attendance by the sales reps during the procedures allows them to provide their expertise to the surgeons about the use of a particular product device. They'd had significant hands on training about these specific devices as well as just their overall knowledge about the products. They support the development of a loyal relationship between the physician and the representative because they believe it fosters a comfort level among these providers to freely exchange information while keeping up with technological developments all to benefit the practice of medicine and to assist their patients.

J. Baugh: That's right. And as is often the case, there's two sides to every scenario. So it's important to point out that there needs to be a balance between reliance on a medical device sales rep and independent knowledge when determining the appropriate device and use for your patient. Relying solely on your interactions with a rep and knowledge obtained from him or her for a surgical procedure, can be a risky proposition for any physician. So let's take a look at a case. This case involves Dr. Strobel and a 60 year old male patient who was admitted to the hospital after a motor vehicle accident.

Katy Smith: This patient had an MRI upon arrival to the hospital which showed moderate stenosis at C3-C4, and severe stenosis at C4-C5 and also C6-C7. The patient was advised that he would need decompression surgery at some point.

J. Baugh: So, four months after the accident, the patient reaches out to Dr. Strobel with complaints of constant burning pain in both arms and loss of feeling in his hands. Dr. Strobel performs an anterior cervical discectomy at C3-C4, C4-C5, and C5 C6, with a partial corpectomy at C4, and a full corpectomy at C5 The medical device sales rep was in the operating room while Dr. Strobel placed an interbody spacer without plating. After initial assembly of the device, it fell apart and was put back together before being placed during surgery. So, it seems the procedure goes well and the patient moves into recovery. So Katy, how did the recovery go from here for the patient?

Katy Smith: Initially, the patient did very well the morning after surgery. He was able to walk about 100 feet in the ICU. However, later in the day after being moved from a bed to a chair, he suddenly lost motor function in his left upper extremity.

J. Baugh: So he's doing well for a little while and then suddenly things have a dramatic change. We know then that they did a CT of the cervical spine, which revealed that the strut between C4 and C5 had become dislodged, causing stenosis on the left side of the spinal canal. Dr. Strobel performed emergency surgery to retrieve and remove the C5 cage interbody spacer, and he placed a C5 titanium cage.

Katy Smith: And at this point in the surgery, Dr. Strobel found a retropulsed spacer that was causing spinal cord impingement and cervical stenosis. He also noted that the spacer had separated. Dr. Strobel performed a fusion surgery and later transferred the patient to a rehabilitation facility. At the time of discharge from the rehab facility, the patient could ambulate independently, but he still complained of chronic pain.

J. Baugh: So then after the patient recovers, he files a suit against Dr. Strobel and he alleged breach of the standard of care for using a prosthetic modular interbody spacer device in the cervical spine without plating. The allegations asserted against a device manufacturer consisted of a claim of negligent design and manufacturing of a device, asserting that defects in the design and construction rendered the product unreasonably dangerous. Damages included, but were not limited to, past pain and suffering, future pain and suffering, additional surgery, lost wages and medical expenses.

Katy Smith: So J, this was actually two claims in one. It was the traditional medical malpractice claim against the orthopedic surgeon, as well as a defective product claim against the company. Turns out that defensibility of the lawsuit was difficult. The medical sales device representative testified in his deposition that his device recommendation was based on the type of surgery Dr. Strobel advised that he was going to do that day. The rep gave assurances that off-label use of the product was appropriate, but when defending his actions, the representative and the manufacturer asserted that the product insert for the device clearly stated that it was not intended for the cervical spine, and should be used in conjunction with a plate for additional stability. The representative testified in his deposition, also, that Dr. Strobel discussed during the surgery that he would be unable to fit a plate. The representative admitted he acquiesced to Dr. Strobel, wanting to use the product without the plate, testifying that the physician made the decision to go forward after their discussion.

J. Baugh: And so, matters got even more complicated when conflicting testimony developed, where Dr. Strobel testified that the manufacturer's representative encouraged him to use the product and assembled the device. However, the rep testified that the product came apart and then Dr. Strobel handed it to the nurses to reassemble. Despite knowing that the literature said that the product was not to be used if this occurred, the medical device sales rep said nothing. He testified that he believed it was the surgeon's responsibility to know this information, as he was the one placing it in the patient's body. And so the rep also testified that he didn't think the placement was correct, but he didn't say anything because he was not the surgeon.

Katy Smith: So you have a few things going on here. You've got the finger-pointing between defendants, each defendant presenting different versions of what happened in that operating room. And that's never helpful when you have finger-pointing between two defendants.

J. Baugh: That's right. I think if you talk to any of the claims attorneys here at SVMIC, they're going to tell you about cases they've had where finger-pointing caused the case to become so much more difficult to defend. And sometimes it's very natural to want to say, "Well, I didn't do this. It was this other person who did this." But, the problem with that kind of a defense is, that other person is then going to point the finger back at you, and then if that happens, the jury doesn't know what to do. And so oftentimes the jury just says, "Well, somebody must have done something wrong." And then the plaintiff ends up winning the case simply because defendants are pointing fingers at each other.

Katy Smith: Right? So you've got defendants blaming each other and defendants presenting two different versions of the story. They can't both be right.

J. Baugh: That's right.

Katy Smith: They're very different. So, you're forcing the jury to either pick between the two, or decide with the plaintiff, which is really often you see that happen.

J. Baugh: Yeah. That's what usually happens in that situation.

Katy Smith: You’re also seeing in this fact pattern what's called in the law, the learned intermediary doctrine. Which is a theory that says if you've got this special knowledge like a physician, then even if you're given a product or a pharmaceutical or something like that that has instructions with it, you are charged as the learned intermediary with learning about the device, learning about the product and being able to use your independent judgment as to whether or not it's appropriate for your patient, appropriate in the circumstances. So one of the lessons here, is that the medical representatives testimony hurt Dr. Strobel, because he made it clear that Dr. Strobel relied on the representative to do the things that he probably should have known to do, like put it together, moving forward without the plating, using the device off-label.

And it became clear as the case developed, that he really had a little personal knowledge of the product. So that goes back to what you mentioned J, in the beginning of our discussion, that there should be a balance between the reliance on a medical device sales representative, and your own independent knowledge as the treating physician, when you're determining the appropriate device and whether or not to use it for your patient.

J. Baugh: Yeah, that's right. While everyone has this joint goal for having quality patient care, if you're the physician, you can't rely solely on your medical sales rep regarding a medical device. Of course, you can look to them to provide pertinent information about the device, but it's also necessary to have a working knowledge of such devices, and the risk associated with its use and contraindications and going back to the learned intermediary doctrine. When you get in a situation like this, the physician should know that the pharmaceutical rep or the sales rep or the medical device rep is going to say, "I wasn't the physician. I'm the one providing the pharmaceutical. I'm providing the device." And they're going to defer to the physician to make the best choices for the patient. So, as a physician, you can use information that you get from a rep in helping you make decisions, but ultimately it is your decision to make and you're going to be held responsible for that.

Katy Smith: A jury is going to expect the treating physician to do more than just blindly rely on what a manufacturer's representative tells you.

J. Baugh: Absolutely, yes.

Katy Smith: Exactly. Unfortunately in this case, Dr. Strobel admitted that he didn't spend any time familiarizing himself with a device or reading about it, and that I am sure made this case very difficult to defend. A jury expects the physician to do a little homework.

J. Baugh: That's right. So, the attorney for the manufacturer and the representative defended the case with arguments that are typical in these circumstances, such as the device was placed by the physician who should have had a working knowledge of the device, its components and the possible damage caused by the device, since the physician is in the best position to know.

Katy Smith: And that learned intermediary doctrine gives the manufacturer a defense.

J. Baugh: Ultimately the physician is going to be the one who's responsible for what happens to the patient, and trying to point a finger back at the rep is not going to be helpful.

Katy Smith: And it wasn't here. Ultimately, it was determined that the case should be settled, and it was settled on behalf of the surgeon. The manufacturer also had a separate settlement with the patient.

J. Baugh: So, as we draw this episode to a conclusion, let's talk about some of the key takeaways and maybe some helpful pieces of advice that might be valuable to our listeners. The first thing I would say is that a medical device sales rep can be a useful resource in determining the appropriate device to use for your patient, but it's necessary for the physician to have their own knowledge base when working with any device.

Katy Smith: And J, it's also important to realize that while a medical sales manufacturer can certainly face liability on a product's claim for a defective product, it won't prevent an action against the treating physician for improper use of the device, leaving the physician to defend a lawsuit regardless.

J. Baugh: Ultimately it will rest on the physician, because he or she is the one who has the most medical knowledge about using the device or the pharmaceutical product.

Katy Smith: Yes.

J. Baugh: Well, Katy, thank you for being here today and helping us work our way through this closed claim. I think we got some good points for our listeners to take with them to use in their practice.

Katy Smith: Thanks very much J, it was a pleasure.

Speaker 1: Thank you for listening to this episode of Your Practice Made Perfect, with your host J. Baugh. Listen to more episodes, subscribe to the podcast and find show notes at SVMIC.com/podcast. 

The contents of this podcast are intended for informational purposes only and do not constitute legal advice. Policyholders are urged to consult with their personal attorney for legal advice as specific legal requirements may vary from state to state and change over time. All names in the case have been changed to protect privacy.