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My first blog this week offered some ideas for topics to consider when strategizing how to win your hip implant case involving Smith & Nephew’s unapproved metal on metal implants. I mentioned that surgeons and sales reps could face potential legal liability for their roles in surgeries involving hip implants that the Food and Drug Administration repeatedly declined to approve for use in this country. I promised to give examples of some evidence that can be used against the surgeons and sales reps.  That’s what I’ll do in this blog.

SURGEON AND SALES REP LIABILITY.

Most Plaintiff’s lawyers will probably agree that it is best to begin every case with a careful analysis of all the potential people or companies that can be sued in that particular lawsuit.  You hire a lawyer to obtain the fullest justice possible for you, and that includes consideration of who to sue if you are going to file a lawsuit. For example, I don’t think there are many lawyers in America who would deliberately sue just one of the drivers if you were involved in a four-car collision where everyone had a slightly different story about what happened. Most lawyers would at least consider suing all four drivers and let them fight about who is at fault. Similarly, if you fall on a slippery floor while the cleaning crew was talking to the building owner and general manager, then your lawyer will probably sue the cleaning crew and the building owner. Maybe even the general manager. Most lawyers would sue all potential parties and let them fight it out.

I think medical device cases are just like slip and fall cases and car wrecks in terms of the need to identify all potential parties. Why not carefully consider the potential liability of everyone involved in your surgery with unapproved metal parts? This blog is written for those who want to seek full justice from everyone responsible for a patient’s harm when their unapproved Smith & Nephew hip implants predictably fail.

The remainder of today’s blog will showcase some of the evidence that I think makes the sales rep and the implanting surgeon valid potential parties in all medical device cases involving implantation of unapproved Smith & Nephew parts. I’ll explain why below.

  1. SALES REP LIABILITY.

A Smith & Nephew “Sales Rep” is a person or company who represents Smith & Nephew in dealings with the company’s customers.  The federal judge overseeing all federal cases involving unapproved Smith & Nephew metal hips issued a Memorandum Opinion last week that expressly recognized the potential validity of including sales reps in some of these cases. The August 22, 2019 Memorandum Opinion in Fondren v. Smith & Nephew, et. al  is on the Legal Page of my website. The Fondren decision is a game changer for several reasons, but I am not focusing in detail on that opinion today. This opinion paves the way for finding liability against the commission-based sales reps who were involved in your surgery. It removes all doubt about the sales reps being potentially liable in the right case. I think the opinion in Fondren v. Smith & Nephew, et. al   is mandatory reading for anyone who is serious about obtaining full justice for people who were implanted with unapproved metal hip devices.

There is so much evidence of sales rep potential liability that it is hard to decide what to mention in this brief blog. I’ll start with the easiest examples. Most sales reps are “independent” from Smith & Nephew, and many of them have separate companies that are formed at Smith & Nephew’s suggestion. Every sales rep agreement[1] I have seen provides that the rep will not promote products for unapproved uses. That is the law, and the reps all understand that. Then how can anyone end up with an unapproved combination of metal parts in them? Good question. The sales rep was almost always present during the surgery. The sales rep always knows that the combination was not approved. The boxes[2] the parts came in say the same thing, and so do the papers inside the box. How did this happen? Did the surgeon know? Some surgeons actually say they were unaware the parts were not FDA approved. These are things you should try to learn before you get too far into your lawsuit or you may be surprised at a time when it is too late.

Another rich source for information about sales rep liability is the “Code of conduct and business principles”.  This document is on my website Legal Page under “Litigation Information.” This informs the sales reps that they could be “prosecuted” and “held responsible” if they violate the rules. Most of them signed a certification saying that they received the Code in early 2009. The Code of Conduct provides fertile ground for questioning the sales reps about their responsibilities and knowledge about their job.

The sales rep “training modules” are another source of information about sales rep liability.  The sales reps were required to know about their products before they could sell them to surgeons. They sometimes even had to understand the reasons for the rules they had to follow. They were taught that promoting unapproved uses was strictly forbidden, and they had to pass a test proving they knew that. There was even a “silent whistle” program for sales reps to anonymously report “off label promotion.” The sales reps even call themselves “consultants” to the surgeons.

However, I have had one sales rep say that he doesn’t really take the online training tests.  He just hits the answer buttons repeatedly until the light flashes telling him he randomly answered a question correctly. Then he goes to the next question and randomly hits those buttons again until he gets the right answer. This is a guy the company trusted to “consult” with surgeons about implantable medical devices. Smith & Nephew inexplicably misplaced many of the most important training records from one group of sales reps in one of my cases.

I have also seen a Sworn Declaration where a sales rep says his district manager “cautioned” him “not to have a written trail, in particular email” about the “entertainment to follow” with a hip implant surgeon and “Smith & Nephew’s president” later that evening. A sales rep got fired over the semi-nude “entertainment” that occurred that night.  He promptly filed a lawsuit and accused fellow sales reps of routinely engaging in “similar nights out” with senior executives.

Don’t let anyone tell you the sales reps are just box openers or delivery services. One surgeon I deposed has testified that he switched to Smith & Nephew unapproved hip devices based in part on what a sales rep told him. The federal judge overseeing these cases nationwide has written an opinion saying there can be valid causes of action against the sales reps in some cases. There are two Federal Court decisions in Dallas saying the exact same thing.

Some of the commission-based sales reps in cases I’m involved in caused a lot of local mischief, and they are viable parties in cases involving unapproved combinations of metal parts. An added benefit to suing the sales reps is that you frequently can stay in state court if you do that. There are many benefits to suing the sales reps and, to my knowledge, there is no downside to using that strategy.

  1. SURGEON LIABILITY.

The surgeon in your case also has potential legal liability in a case involving unapproved Smith & Nephew hip implants. The federal judge overseeing the federal cases involving Smith & Nephew unapproved metal hips issued a Memorandum Opinion last week that expressly recognized this. That August 22, 2019 Memorandum Opinion[3] is on the Legal Page of my website. The case involves a client of mine. It may pave the way to establishing liability against the surgeons involved in other cases. The Memorandum Opinion removes all doubt about the surgeon being potentially liable in the right case. Anyone who is serious about obtaining full justice for someone implanted with unapproved metal hip devices should carefully study the Kemp v. Pure Play Orthopaedics et. al. decision.

But you don’t have to take my word for it. Evidence of surgeon wrongdoing and potential legal liability for it is all over these cases. As I said above, the boxes the parts came in all mentioned their very limited approved uses. The box for the femoral head used in almost every Smith & Nephew THA says the parts were approved for “HEMIARTHROPLASTY USE ONLY.” That is half of a total hip replacement. The femoral head was only cleared for a procedure where it rubs against bone, not hard metal. Similarly, the boxes for the BHR cup and R3 Metal Liner say the part is only approved for resurfacing. How did you or your client end up with this unapproved combination of limited-use parts in a routine hip replacement? Who knew? There were two people involved in your surgery who should have known: the surgeon and the sales rep.

Internal Smith & Nephew documents show that the company agrees with me on surgeon and sales rep liability. For example, I have seen “Hip Task Force” meeting minutes that say, in so many words, “We do not have an FDA cleared MOM for total hips and therefore this poses a potential liability risk to the customer”. If the company believed that use of their unapproved products created potential liability for surgeons, then maybe it’s true. I certainly believe surgeon liability exists in some of these cases.

Another place to look for liability is the writings inside the boxes for the parts. The Surgical Technique for at least one of the resurfacing parts used in your unapproved THA surgery expressly said that the femoral head was not available for use in THAs in America. It is in plain English and no surgeon will admit he or she misunderstood what it says. How did this happen? You’ll need to ask your doctor.

Let me give one final example of why it is so important to at least consider suing your surgeon in addition to Smith & Nephew if your THA surgery goes bad. There is a September 28, 2011 email from a very high-level Smith & Nephew executive to a Dallas surgeon. The email notes that the surgeon is aware that “this combination has not been approved for MOM articulation by the FDA.” Two weeks later, the surgeon implanted someone with an unapproved THA. I think that case may be somewhat more difficult than others to win against the company. A similar email was sent to the entire surgeon design team for one of the R3 metal parts involved in many other cases.

In most instances, the surgeon knew the parts were not approved to go together. If they knew, then they should have told the patient. If they did not know, then what in the world were they thinking? How could they ignore all this evidence and all these writings? You will probably learn the answers to all these questions eventually.

CONCLUSION.

I think the Smith & Nephew unapproved hip implant facts make for a great case against the surgeon and sales rep in addition to Smith & Nephew, but those same facts could sometimes cause problems in a case where the surgeon and sales rep were never sued. Careful planning and early investigation will help unravel what happened in each individual case.

As always, feel free to send private or public questions about this week’s blogs. You or your lawyer can reach me via phone at (972) 294-7530 or through my online Contact Form or Hip Implant Questionnaire. I cannot talk with you about your case if you are represented, but I would gladly talk with your lawyer if he or she reaches out to me.

Good luck with your Smith & Nephew cases!

 

 

[1] An example of a Sales Rep Agreement is on my website under the “Litigation Information” button.

[2] A photo of a femoral head box is also on my website under the “Litigation Information” button.

[3] Kemp v. Pure Play Orthopaedics, et. al.

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