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Smith & Nephew Hip Cases Offer State Court Options

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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Smith & Nephew Hip Cases: Time to Bring Your Cases Home

There are currently almost seven hundred metal on metal hip implant cases filed against Smith & Nephew, Inc. in this country, with more getting filed every week. As of a filing from August 26, 2019[1], there were 204 involving metal on metal total hip arthroplasties (“THAs”)[2]. The so-called THA cases involve products that were not FDA cleared for use in total hip replacements. In fact, the FDA repeatedly declined to clear the Smith & Nephew devices that were used in thousands of Smith & Nephew THA surgeries across America. That means that surgeons who implanted these devices in THAs did so in an “off label”, unapproved manner, exposing him or her to potential legal liability. The commission-based sales reps who encouraged such use also could have personal liability if he or she knew it was happening.

Internal Smith & Nephew documents show that the company agrees with me. I have seen emails and business documents that show the Smith & Nephew executives believed the unapproved nature of this combination of parts created potential liability for the surgeons, and sales reps were told they could lose their job or even get “prosecuted” for promoting unapproved usage of the parts.

I think the above facts implicate the surgeons and sales reps in some products liability cases involving these unapproved products. These facts also present the opportunity for creative ways to seek justice on behalf of people who have suffered injuries from these dubious devices.

The Smith & Nephew THA cases on file in American courts today have a lot in common. Roughly 99% of them are filed in Federal Court. One hundred percent of the cases allege that the company’s metal hip products caused harm to people, and they also all allege that the company concealed important medical information from surgeons and from the public. More than 99% of the Federal cases are currently consolidated in front of one Federal judge in Baltimore, Maryland.

Three other important things that more than 99% of the Smith & Nephew THA cases nationwide have in common include the following:

  1. No surgeons are sued.
  2. No Smith & Nephew sales reps are sued.
  3. Smith & Nephew will blame the surgeon or sales reps for the use of unapproved combinations of Smith & Nephew metal parts.

I predict there will be an emerging nationwide concern among Smith & Nephew THA implant victims when people realize that their cases usually do not include all responsible necessary parties, such as surgeons and sales reps. The concern will increase when people start realizing how good Smith & Nephew’s lawyers are at blaming those absent but partly responsible surgeons and sales reps. I saw this for myself last week at a deposition of a surgeon expert in a case where the implanting surgeon performed almost 200 surgeries using unapproved Smith & Nephew parts. That deposition convinced me I need to rethink my strategy. Fortunately, a court decision last week showed me the path to doing just that.

This blog is written today to emphasize the importance of understanding what the surgeon and sales reps knew about the Smith & Nephew hip implants when they were implanted in you or your client. It is necessary to know this when deciding if the surgeon and/or sales reps should possibly be added as Defendants to the THA lawsuit. I like to find these things out early on, because I have seen situations where the surgeon was blind to information all around him and the sales rep happily let him remain ignorant while earning large commissions.

I am sharing the information below because it would help my clients obtain justice in their cases if more people employed some of the creative legal tactics I describe below. This analysis shares things I learned just last week about this exact topic.

  1. The “Blame the Surgeon or Sales Rep Defense.”

I believe that anyone suing Smith & Nephew for bad THA hip implants needs to carefully analyze the medical and scientific evidence that was available to the surgeon at the time he or she implanted the device. Equally important is the need to consider what the commission-based Smith & Nephew sales rep knew when the unapproved combination of parts was implanted. What did they know and when did they know it? What did they do about it? The company already knows all these answers, and some of their lawyers have been diligently working on how to use this information to defend the THA cases for well over a decade. You need to learn this information if you want to have the best chance of proving your THA case against whoever you have decided to sue.

I know this information about Smith & Nephew’s defense of THA cases because I have seen their tactics over the past five years, and the company’s defense strategy was made crystal clear last week when one of my experts gave his deposition in a Smith & Nephew case that is set for trial soon. I have attended almost thirty depositions in Smith & Nephew cases over the past five years, but last week was the first time for one of my experts to give testimony. It was a real eye-opener for me despite all this recent experience fighting this company.

I would be concerned right now if the surgeon and sales reps were not named as Defendants in my Smith & Nephew THA cases. The liability facts against the surgeon and sales rep in some of these cases are that strong.

There will be slight variations of the “blame the surgeon or sales rep defense” in each THA case, but I think that defense will potentially be there in every one of them. You may have to look for it sometimes because the company lawyers don’t broadcast that they are using these defense tactics, but they probably are going to try to blame the surgeon and/or sales rep to some extent in every THA case. You can be sure they are considering that defense in every case. They can’t help it. The defenses are too obvious and the evidence too strong for them not to make use of the facts.

  1. The Defense is Easy.

One of the scariest things about the “blame the surgeon or sales rep defense” is that it is so easy to employ. Defense lawyers like easy defenses. All they have to do is determine the date of implantation surgery and then go to the company’s massive library of sales and surgeon data and see what the surgeon and sales reps knew and what they were doing at the time. The company has all this information readily available in electronic, searchable form. They have been preparing for this day ever since the FDA started rejecting the company’s applications for permission to sell these unapproved parts in America way back in 2006.

Did the sales rep know the combination of parts used was not FDA approved? I guarantee he or she knew unless they were completely oblivious to their surroundings, in which case I think you MUST sue any sales rep that is that clueless. Did the surgeon know? Maybe not, but he or she certainly should have known. It was in writing on and in the boxes these parts came in. The surgeon in last week’s case has sworn he was ignorant of the fact the parts were not FDA approved. This despite written warnings and instructions both on the boxes the parts came in and throughout the paperwork inside the boxes. He claims he was ignorant even though he used this unapproved combination of parts in almost one hundred people before he unknowingly implanted the unapproved parts in my client.

How could a good defense lawyer for Smith & Nephew ignore the facts that the surgeon ignored? They cannot do it and they won’t even try. They will focus on the written warnings and instructions on and in the product boxes, and they will easily establish that anyone bothering to read this information must have known the combination of parts was not FDA approved. It’s then up to the surgeon and sales rep to justify what they did.

I think these facts make for a great case against the surgeon and sales rep in addition to Smith & Nephew, but they could spell trouble in a case where the surgeon and sales rep were never sued.

CONCLUSION. Surgeries involving implantation of unapproved medical devices make for very interesting products liability cases. I think there is always the need to explore the possibility of suing the surgeon who implanted the unapproved parts and/or the sales rep who facilitated and frequently encouraged the surgery. I have seen for myself how easily the company can blame the surgeon and sales reps when things go wrong after such surgeries.

Later this week, I will post a blog that will provide some examples of evidence that can easily be used against the surgeon and sales reps. It is evidence showing what they knew and when they knew it. It is evidence that will be used against YOU if you don’t figure out how to use it against them. After that, I will write about last week’s Federal Court opinion that paves the way for a new strategy that includes the surgeons and sales reps in some of the THA cases. Last week’s decision recognizes the general validity of the Smith & Nephew THA cases against surgeons. I know of two other Federal Court cases in Dallas that recognize the general validity of THA cases against local Smith & Nephew sales reps. These decisions will all be used against you if you don’t figure out how to use them against all of the responsible parties in your 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.

Good luck with your Smith & Nephew cases!

 

[1] Every Monday, Smith & Nephew files a report in Baltimore Federal Court on the number of each cases filed against it. The August 26, 2019 Report is on the Legal Page of my website.

[2] The differences between these cases has been explained in my past blogs and in various legal articles on my website. See, for example, “Smith & Nephew Hip Implant Plaintiffs Need to Look Before They Leap Into a Federal Court Slowdown” from May 14, 2019, and “Chicago “Bet the Company” MDL Seminar + What’s So Special About Smith & Nephew Metal Hip Implant Cases?”, from May 30, 2018.