Commentary: One Hand Tied Behind Their Back
In an effort to streamline the proceedings Judge Joseph Goodwin had early on told the court that he would move these cases through his federal courtroom. He certainly did that with a directed verdict in favor of Ethicon on February 18, six days after the start of the Carolyn Lewis trial and on the eve of the defense’s case. What were the jurors thinking? We will never know because Judge Goodwin did not allow the proceedings to move on to that phase. As the only reporter sitting in the courtroom during the trial I thought a very good case had been made even with one hand tied behind their back. The following is an Opinion/Editorial of what I saw and what I knew going into the case. Apologies for the interpretation of a non-lawyer of the proceedings. Others are invited to submit their more learned interpretations.
What Jurors Never Saw- 50,000 Cases Filed
Defendants brought forward and Judge Goodwin granted several motions in limine on February 5. They included Ethicon’s motion to exclude evidence of other TVT lawsuits. Judge Goodwin agreed with attorneys for Ethicon that such “Evidence of other lawsuits is likely to confuse and mislead the jury from that task, and it is highly prejudicial to Ethicon. Accordingly, Ethicon’s motion on this issue is GRANTED.”
Never mind that it’s true.
There are currently 16,825 (as of March 3) cases filed against Ethicon, now more than any other mesh manufacturer with over 53,000 filed against six manufacturers.
This is just one federal court where cases have been amassed in multidistrict litigation (MDL), which groups cases together that have a similar cause of action. This does not count the hundreds if not thousands of other cases of mesh injuries that are filed in individual state courts around the country.
Of course jurors never heard that the Linda Gross case one year earlier in an Atlantic City courtroom had yielded an $11.1 million verdict in favor of the plaintiff including $7.76 million in punitive damages against Ethicon.
What Jurors Never Saw- Spoliation
On Thursday Feb 13th, the lawyers for Lewis tried again to put before the jurors the issue of the spoliation or destruction of evidence. Whether it was intentional on the part of Johnson & Johnson or just sloppy record keeping, jurors might want to know that thousands of pages of documents, computer hard drives and videos never made it into evidence. Sometimes those inner office notes yield the “smoking gun” everybody seeks.
In plaintiff’s Trial Brief in Support of her Request to put on evidence of Defendants’ Spoliation filed February 13, Doc #278 (here) is a trial brief to response to the Courts invitation that it would consider allowing plaintiff to submit evidence of Ethicon’s spoliation of documents to the jury. Plaintiffs want to play the deposition of James Mittenthal, Ethicon’s corporate representative on spoliation issues which was taken earlier in the week.
Attorney Adam Slater (attorney for Linda Gross, first Ethicon case in NJ, $11.1 million) had conducted a videotaped deposition of Mr. Mittenthal. The jury never saw it. Judge Goodwin did not allow the videotape to be shown.
“Plaintiff will be significantly prejudiced if the jury does not hear about the missing evidence, so that the jury may draw its own conclusions.” Plaintiffs say they would like access to the missing data so they could counter the claims by defendants in the opening that clinical trials have supported the safety and efficacy of the TVT product. Christy Jones praised the TVT as widely used by doctors around the world. “But because of the missing data from Medscand, none of the data from the clinical trials conducted by TVT inventor Ulf Ulmsten are unavailable to Plaintiff. [sic] they mean available]. The plaintiffs are disadvantaged if they cannot see the TVT studies that form the “cornerstone” of the campaign that sold TVT to doctors in the first place. There is no doubt that the “hard drive of the five-year worldwide president which was destroyed in 2010, would have had information about not only the TVT product, but about other products and about possible changes to the design.”
In addition the Plaintiffs say they lack important information about any financial payments to the authors of the study that support the use of TVT ie, Ulf Ulmsten and C G Nilsson.
It’s tough to prove what you don’t have.
Doc #278-1 here is the deposition of James P. Mittenthal, the designated corporate representative to testify on the subject. He was hired by the company and paid $400 an hour. It’s estimated his firm made hundreds of thousands of dollars to review the lost documents.
For its part, Ethicon objected to the deposition on the grounds of relevance and on February 7, 2014 motioned to exclude evidence and arguments related to the spoliation allegations. Ethicon objected to questioning custodians whose documents would not be relevant to design, safety and efficacy of the TVT, the basis of a defective product case. Ethicon objected on the grounds that it violates the court order prohibiting references to other pelvic mesh litigation.
The deposition was held in New York February 10 in the matter of Ethicon, Inc. Pelvic Repair Systems Products Liability Litigation, MDL Number 2327. The examination was conducted by attorney Adam Slater.
He shows Mittenthal a document entitled Johnson & Johnson law department document preservation notice not to destroy specified documents. It said “Do not discard, destroy, or alter in any way any of the documents, electronic or paper, described below.” The notice was issued May 22, 2003 by the Johnson & Johnson law department to preserve papers and documents in connection with current or future litigation.
A companywide hold notice for mesh documents was issued April 30, 2007. Mr. Mittenthal said actually since 2003 there had been a defined policy. The employee is provided with a checklist and along with their manager they go through it to make sure “the departing employee’s obligations are complied with prior to his or her leaving the company, and that includes records retention or obligations.” The policy has now been revised to take into account technology he said. “
For my last question,” said Slater, “… you don’t expect people to actually tell you they did that in direct violation of a policy right?”
A: I ask at every interview if information was destroyed. I have spent several years now looking at this company and have understood the climate by which information is managed, the information, the systems in place, and the general attitude and demeanor of the employees. And I have no reason to believe that anyone has withheld information from me or been false with me.”
Q: “There’s no way for you to know,, for you to know what happened, right?”
A: “There’s no way for me to be absolutely certain. I would agree with you.”
In a motion filed by Ethicon February 12, 2014, (Doc #273 here) the company argued that documents from MedScand, the Swedish company that initially made the TVT should be barred from trial. Ethicon argues the only relevant MedScand materials concerning the inventor of TVT, Ulf Ulmsten and his research, were destroyed in a 2009 fire at a third-party storage facility over which Ethicon had no control.
In a ruling by Magistrate Judge Cheryl Eifert February 4, 2014, (PTO#100 here) plaintiffs should be allowed to put on spoliation evidence in every case. That never happened.
What the Jurors Never Saw- Failure to Warn
Part of a defective product case is defective in its manufacture, in its design and in its instructions for use (IFU). A manufacturer has no obligation to warn the patient. The end user is considered to be the doctor so any warnings would come in the form of the product label or Instructions for Use (IFU).
Plaintiffs had argued that the defendants were negligent in failing to use reasonable care to label their pelvic mesh products and a failure to do so led to an avoidable risk of harm to women. The burden falls on the plaintiff to show a proper warning would have changed the doctor’s decision to use the TVT.
Judge Goodwin ruled the plaintiffs failed to provide evidence that any inadequate warning caused the injuries to Lewis. (Doc #194 here). That’s because Dr. Boreham said she had not read the IFU since 2002 and did not rely on it in prescribing the TVT. Because of all of the above the plaintiffs Motion to Reconsider and Clarify Summary Judgment order and Daubert Order (Doc #205) was denied.
Of all of those elements, the plaintiffs were left with a defective design action alone.
What had Carolyn Lewis been told in advance of her surgery about the dangers? Did she have true informed consent? Dr. Muriel Boreham testified in her deposition (Doc #180-1 here) that she gave patients brochures which fail to include information about the potential for permanent pelvic damage and long-term chronic pain, nerve entrapment, dyspareunia, mesh erosion, infection, repeated attempted removal surgeries.
Jurors never heard Dr. Boreham received product updates from industry-sponsored symposiums, the American Urogynecologic Society peer reviewed journals and from sales reps and the brochures they dropped off. No one at Ethicon was monitoring whether older versions of the brochures were still being distributed or whether they had been replaced with newer versions, presumably with more information.
They never heard that Dr. Boreham has now switched to using the TVT Exact which has smaller trocar needles used in the blind passage into the pelvis to place the mesh.
They never heard that Dr. Boreham told patients a 92 percent cure rate was calculated on the return of stress urinary incontinence. If one had chronic pain or painful sexual relations she would still be considered cured.
Jurors never heard that ten percent of her surgeries are revision (removal) surgeries.
They never heard that toxicity studies on rats conducted by manufacturers of the resin used to make polypropylene mesh had shown sarcomas (cancer) developing at the site of mesh implantation, information Dr. Boreham agreed was important and something she would have liked to have known. (Her deposition page 109). The TVT IFU has never mentioned that the TVT has cytotoxic potential something the company studied back in 1979.
In (Doc #246 here) – Feb 3, 2014 – Judge Goodwin found that an inadequate warning in the product Instructions for Use is not relevant to the design defect claim in the Lewis case. The “user” of the product is the doctor not the patient and is considered the “learned intermediary” since she is a medical professional (they are in a better position to understand the risks involved), therefore the duty to warn only extends to her doctor not Lewis. Texas not yet adopted the learned intermediary rule and Lewis is from Texas so the case cited by the plaintiff has no or little relevance in this case ruled Goodwin.
The judge says Texas law only makes the warning relevant to defective design when they include instruction on how to make a device safer for the user. In the case of TVT the warning (IFU) there were no instruction that included the safer use of the product. Either the doctor used it or not and the IFU informed of some of the product’s risks (as we know from the Gross trial the IFU is inadequate in its warnings). Since the warning does not include a safe way to use the product, including evidence of an inadequate warning has the potential to confuse and mislead the jury into believing there is a failure to warn claim.
What Jurors Never Heard – The FDA
Mesh used to treat hernias, incontinence and pelvic organ prolapse does not undergo any clinical trials for safety and efficacy. It simply is not required under the FDA’s 510(k) approval process so unlike drugs that must undergo a premarket approval (PMA), the most stringent required by the agency, the majority of medical devices get on the market after the manufacturers notifies the FDA it plans to market the device and assures the agency it is the “substantial equivalent” of a device already being sold. It’s really that simple, costs a few thousand dollars and can be accomplished in a matter of weeks.
The jurors never heard that Ethicon never completed a controlled study on live women before marketing the TVT device beginning in the EU in 1997 and in the U.S. in 1998.
The FDA began to get wind of the dangers of transvaginal mesh and in 2008 issued its first Safety Alert that adverse events were being reported. Since the FDA receives only an estimated 1 to 10% of actual adverse events, it is hardly a reliable barometer of what is happening in the real world.
In 2011, another FDA Safety Alert (here) was issued after the FDA noticed a five-fold increase in complications from transvaginal mesh. This one was much more strongly worded and said that complications are “not rare” and that the risks of mesh for prolapse repair might outweigh the benefits. That doctors should evaluate their patients carefully and that even multiple surgeries to repair complications may not resolve the issues.
Jurors never heard about the FDA’s 510(k) approval process or the predicate for the TVT mesh cited by many other meshes as a “predicate” was the Boston Scientific ProteGen, recalled by the company for being “misbranded” and “adulterated” and “does not appear to function as intended.” In fact, for the Carolyn Lewis trial Ethicon filed Motion in Limine No. 14 Motion to Exclude Evidence of Recall of the ProteGen Sling. Ethicon argued that the recall of the ProteGen does not speak to the safety of efficacy of the TVT and therefore is irrelevant.
Isn’t the failure of the 510(k) to assure safety, no matter what medical device, exactly on point? Judge Goodwin granted Ethicon’s motion in limine.
What Jurors Never Heard- Science
Jurors never heard the Ethicon marketing materials stated that TVT mesh had ‘large pores” in direct contradiction to what scientists on the stand said about the Prolene mesh.
On December 12, 2013, the defense had filed a motion (Doc #132 here) to limit the opinions and testimony of Dr. Uwe Klinge. Dr. Klinge, a scientist from Germany who has studied Prolene mesh used for hernia repair in patients, who at one time was a consultant to Ethicon offered opinions that were “unreliable, will not assist the jury and far exceed his qualification and the bounds of permissible expert testimony.”
The defense asked the court to enter an order precluding Dr. Klinge from testifying about Ethicon’s corporate ethics and about its documents; that TVT is susceptible to case an increase risk of infection; that TVT degrades and undergoes particle loss; do not mention pore deformation of mesh as its in the body; and not to mention that PVDF mesh was a feasible alternative to polypropylene mesh; and not to offer any opinion or testimony about the pelvic mesh explants.
His expert report (Doc #132-1 here) states that implantation of TVT mesh, a heavy weight “over-engineered” mesh deforms, collapses and leads to fibrotic bridging, scar plate formation, mesh shrinkage leading to chronic pain erosion, dyspareunia and a need for reoperation making it unsafe for its intended purpose. He testified in his expert report that Ethicon’s Medical Director Piet Hinoul deferred to Dr. Klinge and Dr. Klosterhalfen and their expertise.
Among the 485 pelvic floor mesh explants they collected in Germany at the Institute for Pathology, Duren, they found severe fibrosis in 60% of the TVT Prolene meshes explanted, about 50 percent of Prolift and 30 percent of Prolift +M (Ultrapro mesh) along with considerable shrinkage in the TVT of 40 percent.
Both medical directors Dr. Hinoul and his colleague Charlotte Owens testified they knew prior to the launch of pelvic meshes in the U.S. that some women would suffer severe, chronic, life-altering inflammatory response to its pelvic meshes.
“Ethicon has performed no appropriate studies in order to determine in which women, serious, life-altering complications may occur due to implantation of TVT slings.” Ethicon has failed to act as a “reasonable manufacturer” in this regard, Dr. Klinge concludes.
Dr. Klinge did appear on the stand Thursday, February 13 but jurors did not hear that the largest maker of polypropylene in the country is in Kenovah, They also did not hear from Dr. Klinge’s Expert Report (Doc #132) that the compounding resin hasn’t changed much since hernia mesh was first made.
“Ethicon’s use of polypropylene as a suture material dates to the late 1960’s when it began purchasing polypropylene resin for its Prolene sutures from the Montecatini Company at their Novamant Plant in Kenovah, West Virginia. The mixing and compounding of the resin has not changed since that time – same composition; same molecular weight; and same molecular weight distribution. The individual component additives to the resin are Santonox (antioxidant); calcium stearate (lubricant); dilauralthiodipropionate (antioxidant); Procol LA-10 (lubricant); and CPC pigment (colorant to enhance visibility). After the extruded resin material leaves. the compounder in pellets for shipping to Ethicon.”
The West Virginia-based Braskem America’s Neal Plant was purchased from Sunoco in 2010 and makes 70 different types of PP. 1.4 million lb/day in this 24 hour operation. Background story is here:
In Doc #250 Opinion and Order (here) February 5, 2014 – Judge Goodwin was asked to reconsider excluding some opinion of Dr. Klinge regarding secondary infection. They tend to appear when mesh remains in the body he said (Doc #195). The plaintiffs argued since Ms Lewis has some mesh remaining, Judge Goodwin says secondary infections were not a fact in issue for Ms Lewis so Klinge’s opinion was excluded. Judge Goodwin determine Dr. Klinge’s analysis of 485 mesh explants from the Institute for Pathology in Duren were unreliable because Dr. Klinge did not explain how he selected those explants, and whether or not they constitute the entirely of his collection of pelvic floor explants. Judge Goodwin says he has no information on the “Potential rate of error” (Doc #246 here).
Plaintiffs’ motion to reconsider and Clarify summary Judgment Order (Doc #205) is denied because information about Dr. Klinge’s methodology is left unanswered and Judge Goodwin denies the motion to reconsider.
What the Jurors Never Heard- Material Safety Data Sheets
Recall in the C. R. Bard cases, lawyers showed the MSDS issued by the companies making the raw polypropylene. In the case of Bard it was Chevron Phillips MSDS for Marlex Polypropylene mesh which clearly said the materials were not to be used for implantable medical devices. This is as close as one can come to a “smoking gun” in making a case, especially when the evidence then showed internal company discussion to intentionally distance themselves from the supplier by creating a middleman company, Red Oak, to purchase the materials.
Motion in Limine (Doc #250) No. 15 by Ethicon tries to avert a similar revelation for Ethicon. The supplier of the polypropylene for the company was Sunoco and Braskem. Both companies issue a MSDS for the C4001 polypropylene homopolymer. The warning not to use for any implantable device does NOT appear on the MSDA by those companies but the suppliers to warn of carcinogenicity or whether polypropylene causes cancer. Ethicon says the risks discussed in the Sunoco and Braskem MSDSs are irrelevant “as they relate to injuries that Ms. Lewis did not suffer,” that being the development of cancer.
Judge Goodwin agreed to grant the motion excluding all MSDSs that are not an Ethicon supplier.
What Jurors Never Heard – Ethicon’s Own Admissions
Doc # 180-24 (here) is a report The (clinical) argument of lightweight mesh in abdominal surgery by Boris Batke, Ethicon Research & Development
Ethicon’s own literature extolling the virtues of lightweight mesh- a smoking gun, heavyweight contracts up to 40 percent, lightweight 10-20 percent. Heavyweight creates bridging fibrosis and a scar place that causes shrinking. Ethicon then launched a new line of lighter weight hernia meshes. The TVT relied on the old standby, heavyweight, small pore Prolene mesh that had been used for hernias.
Motion in Limine No. 13 in Doc #250 states that a DVD featuring Dr. Todd Heniford entitled “The Benefits of Lightweight meshes in Ventral hernia Repair” should be excluded. According to Ethicon the video features the Kugel Composix Hernia Mesh made by C.R. Bard (Doc #208) in which Dr. Heniford, then working as a consultant for Ethicon, discusses heavyweight hernia mesh and the development by the company and advantages of using a lighter-weight mesh for use in the abdomen. Heniford says the lightweight polypropylene mesh allows for better tissue ingrowth and improved vascularization of the mesh.
Dr. Heniford was withdrawn as a testifying expert in the matter December 11, 2013 because the company thought plaintiffs might try to impeach his current positive views regarding Ethicon’s product. Goodwin granted Ethicon’s Motion provided Heniford did not testify at trial.
What Jurors Never Heard- Crude References
Emails from within the company (Doc #207) showed that the company was considering a registry of Prolift and provide that information to physicians on a CD-Rom. In an email chain between Medical Director Dr. Piet Hinoul and Aaron Kirkemo, Hinoul said that if physicians were not provided a CD-Rom “then they could not use it as a pessary when the mesh fails.”
A pessary is removable device used to hold back prolapsing organs. #