Closing Argument Ed Wallace in Huskey v. Ethicon

Jane Akre

Your reporter, Jane Akre, was in the courtroom and listened to the closing arguments. They are usually a good summary of what transpired during the trial. Instead of trying to select bits and pieces, here is what was said as reasonably close to it as this reporter was able. The Plaintiff got to go first and last since they have the burden of proof based on the preponderance of the evidence.

Ed Wallace (Wexler Wallace) began, then Fidelma Fitzpatrick (Motley Rice) finished the one-and-a quarter hour allotted to each side.

This coverage is provided in conjunction with We Are Mesh Survivors, a coalition of synthetic vaginal mesh implant survivors united to demand justice for those who have suffered and to demand that existing products be pulled from the market until their safety can be demonstrated.

Ed Wallace, attorney for Jo Huskey

"I said at the beginning we said we’d show you evidence TVTO is defective. And that J&J failed to warn and that Jo Huskey’s injures are the cause of that. With all of the evidence you’ve seen we have to be very precise about what we are talking here. I’ve felt there have been a lot of times the defendants were trying an entirely different case than the one presented to you. We’ve talked laser cut, inside outside, levator injury. The other thing I really want you to be careful is the legal standards. It’s not substituting your standards but we will talk about law.

“This case is not about all polypropylene (PP) mid urethral slings. It’s not about all manufacturers obturator products. It’s not about all of Ethicon’s TVTO or laser products. It’s about Jo Huskey’s TVT-O laser cut mesh.

“You’ve been told about the long term data and you even hears about it today. Carl Gustaf Nilsson. You’ve heard his name you’ve heard 7 yr study and an 11 year paper. You heard about 17 yr of support on the stand. Without a doubt the evidence has shown the very inventor, all of the studies he’s done, he will not use laser cut mesh. So when you are considering the risk and benefit, look no further than the inventor of TVT products, who will not use the product that is in my client! Ladies and gentlemen invented the TVT and he will not use this mesh.

“Aaron Kirkemo- this is the only Ethicon witness you heard from. The only Ethicon employee! Remember what he said about TVT-O, he hated obturator slings and stuck to TVT classic. Do not make a leap that the medical director at Ethicon was not willing to make. He was employed at the time my client was implanted with her device.

“Think about whether or not you ever heard there was one study on the TVT-O laser cut mesh after all of these hours were spent.

“The levators. Dr. Siddique - he had to transect laterally to do this surgery. Remember laterally. We are making both a defective design and a negligence claim. With respect to defective design claim, there are two components. One is the device as designed is unreasonably dangerous, that the risks outweigh the benefits. The other component is the warnings. We also have a negligence claim against the company. Ethicon was negligent because they failed to be a reasonable person or a company. Ethicon has to follow the rules and be a reasonable person too.

“You will hear about proximate cause when it comes to her injuries. What does that mean? It need not be the only cause or the last or the nearest. Still proximate cause, even if it starts with something else, there still could be proximate cause. You also get to consider the warnings claim.

“Ethicon was not careful. They have to be a reasonable careful company. We submitted to you evidence they rushed to market. There is nothing wrong with competing and getting to the market quickly but put patient safety first. [2 jurors take notes} Ethicon cut corners. They launched first and worried about problems later. They were worried a soon as 2004 shortly after this went to market. There were no clinical trials before the TVTO went to market! They never considered an end game. They blew through the stop signs.

Dr. Rosenzweig

“Nine months was a new record. You heard about Project Mulberry from Dr. Bruce Rosenzweig. This was a choice by the board of directors to worry about problems after it got on the market. What were they told by Allison London Brown. One thing we need to consider is the clinical report for laser cut. What has the evidence shown – there was no clinical data.

“You heard evidence that laser cut and mechanical cut is the same. You heard from Dr. Rosenzweig it’s stiffer. Their own employees said we cannot claim equivalence to mechanically cut mesh. Even though Dr. Pramudji told you that even though she had no idea what rate they were being sold “Our inability to claim equivalence” is what Ethicon’s own employees said. Carl Gustaf Nilsson’s name comes up again.

Dr. Shelby Thames

“Dr. Thames was suddenly an expert on laser v mechanical cut mesh, suddenly he knew all about it until he was presented with a document, ie, Carl Gustaf Nilsson, who will not use laser cut mesh. Decisions were made by Ethicon and they ignored this. You also heard launching first and worrying about problems later. This is from a 2009 document, Professor Jean de Leval, the inventor of the TVT-O.

“They launched first and worried about problems later. Is that the actions of a reasonable person or company? Again, I have to live by the rules and so does Ethicon.

“Dr. Brigitte Hellhammer - what did you learn from her? This was old construction, heavy weight mesh. You heard about that from Dr. Rosenzweig and Hellhammer. They found the laser cut was three times stiffer.

I’d like to discuss why it was too much of the wrong material. Brigitte Hellhammer said it was heavyweight and designed for hernia repair in 1975. She said a heavyweight mesh of 102 grams, such as this, that was associated with excessive foreign body reactions and chronic inflammation. That doesn’t happen unless there is a problem. Transitory pain is one thing - Chronic inflammatory events are another thing. A lightweight mesh was developed by Ethicon to reduce the mess. Ethicon decided not to utilize its light weight large pore mesh in the TVT-O. It didn’t take the time because it decided to launch first and worry about problems later. Is that the action of a reasonably careful company?

What else did you learn? PP (polypropylene) is not inert. The body reacts, it reacts. Dr. Guelcher works inside the body and told you about reactive oxidative. Dr. Rosenzweig, who removes a lot of mesh, says it looks hard, stiff, brittle and fragmented when it is removed. Dr. Blavias said very much the same thing.

Dr. Scott Guelcher said PP is generally unstable. His area of study is making medical devices in the body. He works with companies to build better medical devices. He said it becomes brittle, hard, brittle and breaks. Dr. Guelcher talked about Ethicon’s documents that showed degradation and how the body reacted to PP and how PP reacted to it. The explanting surgeon Dr. Siddique, he is the most experienced doctor in central Illinois who removes mesh. He said chronic inflammation was there. That’s not a good thing. That’s why it had to be taken out. So when you hear it’s not the mesh, remember what he said, and remember what Brigitte Hellhammer said.

Ethicon chose not to bring in all the doctors who found degradation. They chose to bring in someone who did not deal with mesh. In 2014 Ethicon hires Dr. Shelby Thames to disagree with Ethicon’s own scientists who say this is happening. When confronted on the stand, you saw him, he said I’m just a chemist, I’m not a doctor. You saw how quickly he backed away from that. Where are the Ethicon employees who authored the documents?

Again I do appreciate your time I appreciate being here on behalf of Mrs. Huskey. #