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Ethicon 11/10
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Ethicon Says Mesh Patients Abusing Discovery In MDL
Nov 9, 2015 | Law360
By Jody Godoy
Johnson & Johnson's Ethicon told a West Virginia federal court Friday that patients with injury claims over the company's pelvic mesh products are abusing the discovery process by seeking yet more testimony three years into the multidistrict litigation. -
Columbia Dismissed From Bard Pelvic Mesh Coverage Suit
Nov 9, 2015 | Law360
By Steven Trader
Starr Surplus Insurance Co. has nixed Columbia Casualty Co. from its lawsuit against policyholder C.R. Bard Inc. disputing coverage of class action litigation issues and potential settlements the company faces over allegedly defective pelvic mesh and heart filter products, according to a filing Monday in New York federal court. -
Texas Pelvic Mesh Ruling Could Make Plaintiffs Think Twice
Nov 9, 2015 | Law360
By Jess Davis
A Texas appellate court ruling overturning a $1.2 million judgment against Johnson & Johnson in a pelvic mesh case because the plaintiff failed to prove the device caused her injuries could turn the tide in a wave of similar suits, leading to fewer cases and less valuable settlements, lawyers say. -
Now there's no excuse for not doing those pelvic floor exercises
Nov 9, 2015 | Daily Mail
By Claire Coleman
Most women know the importance of regular exercise, but working out the pelvic floor muscles can get overlooked. These are the sling-shaped muscles which run from the pubic bone to the base of the spine and which support the pelvic organs - the bowel, bladder, uterus and vagina.
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Ethicon Says Mesh Patients Abusing Discovery In MDL
Nov 9, 2015 | Law360
By Jody Godoy
Johnson & Johnson's Ethicon told a West Virginia federal court Friday that patients with injury claims over the company's pelvic mesh products are abusing the discovery process by seeking yet more testimony three years into the multidistrict litigation.
The medical device maker urged the court to quash the patients' subpoenas seeking more company representatives to grill on the potential health effects caused by loose pieces of mesh in the products' packaging. The company claimed the patients have already asked more than two dozen Ethicon representatives about the issue and that a recently produced batch of documents doesn't entitle them to subpoena more testimony.
“Plaintiffs are attempting to use defendants’ agreement to produce these largely irrelevant materials — which they knowingly mischaracterize as a 'late' production of documents — as an excuse to depose still more corporate witnesses on a topic that has already been explored in depth,” Ethicon said. “The court should not permit this clear attempt to abuse the discovery process.”
The MDL includes more than 23,000 cases against Ethicon that allege its mishandling of transvaginal surgical mesh devices caused serious injuries to patients. The cases also claim Ethicon and related entities failed to provide appropriate warnings and instructions regarding the risks and dangers posed by the devices, which are used to treat pelvic organ prolapse and stress urinary incontinence.
The patients have argued that they need another chance to ask about manufacturing glitches — including the presence of loose mesh, metal bits and hair in the implants' packaging — because Ethicon has handed over more than a million pages of documents since February, when lawyers for the patients last got to interview an Ethicon representative.
Some of those documents lay out “a potential systemic manufacturing defect or defects with the TVT,” which the patients haven't yet gotten to ask Ethicon representatives about, they said. The patients say that problem seems to have resulted in thousands of mesh devices being discarded and that at least one case, which is set to go to trial early next year, implicates the TVT devices affected by the production issue.
Ethicon told the court Friday that the patients actually had many of the documents they now characterize as new for years and simply failed to wield them in previous depositions. The device maker told the judge it shouldn't have to field new representatives now “simply because plaintiffs hope to develop testimony they failed to secure the first few times around.”
To the extent the patients seek to ask about issues beyond the loose bits in the packages, their request is inappropriately broad, the company argued.
The patients also argued that the record is lacking because they haven't yet spoken to anyone who worked at Ethicon Sarl, Ethicon's Swiss manufacturing arm.
The company shot back on Friday that the patients had known where the devices were made but never asked to depose those employees and so shouldn't be allowed to do so now.
Counsel for the parties did not immediately reply to requests for comment Monday.
The plaintiffs are represented by Thomas P. Cartmell of Wagstaff & Cartmell LLP and D. Renee Baggett of Aylstock Witkin Kreis & Overholtz PLC, among others.
Ethicon and J&J are represented by David B. Thomas of Thomas Combs & Spann PLLCand Christy D. Jones of Butler Snow PLLC.
The MDL is In re: Ethicon Inc. Pelvic Repair System Products Liability Litigation, case number 2:12-md-02327, in the U.S. District Court for the Southern District of West Virginia. -
Columbia Dismissed From Bard Pelvic Mesh Coverage Suit
Nov 9, 2015 | Law360
By Steven Trader
Starr Surplus Insurance Co. has nixed Columbia Casualty Co. from its lawsuit against policyholder C.R. Bard Inc. disputing coverage of class action litigation issues and potential settlements the company faces over allegedly defective pelvic mesh and heart filter products, according to a filing Monday in New York federal court.
According to a one-page joint stipulation of voluntary dismissal without prejudice, Columbia was removed from all claims filed by Starr Surplus in a September complaint, which accused Bard of failing to obtain written consent from its excess insurance carriers prior to entering into settlement agreements with consumers in multidistrict litigation alleging its line of transvaginal mesh implants can cause serious conditions, including scarring and bleeding.
Counsel for Starr Surplus declined to comment Monday and counsel for Columbia did not return a request for comment on the voluntary dismissal.
In its complaint, which was amended late in October, Starr is seeking a declaratory judgment, alleging that by failing to obtain its written consent, it is relieved of any obligation under the excess policies it issued to Bard between April 2011 and April 2012. Additionally, Starr says a pending litigation exclusion in a third-party “Evanston Policy,” which is incorporated by reference into its own policy, also eliminates its duty to cover any claims arising from the 2010 pelvic mesh MDL.
Starr issued an excess liability policy with a per-claim aggregate limit of $10 million to Bard in April 2011, in conjunction with a products-work hazard liability policy issued by Columbia at the same time, according to the complaint.
Bard began receiving claims of alleged defects related to its line of Avaulta pelvic mesh products in 2007, according to the complaint, and claims against other lines of similar mesh products began to mount until an MDL was commenced in July 2010.
In March 2012, in response to claims submitted to Bard, Columbia declared its intention to treat all the pelvic mesh product claims as one “related claim” under the terms of its liability policy, excluding those claims related to the line of allegedly defective Avaulta products, according to the complaint.
Starr responded by issuing a reservation of rights letter to disclaim coverage on a variety of grounds, including the right to contest Columbia’s decision to separate the claims of the two products, also noting that a number of exclusions in its policy related to pending litigation might apply, the complaint said.
The complaint alleged that Bard recently advised its excess insurance carriers that it is in the process of finalizing settlement agreements with two major groups of plaintiffs involved in the MDL, but contends that at no time did Bard seek or obtain consent from Starr or any other excess carriers prior to agreeing to those settlements.
In addition to claiming failure to obtain written consent, Starr’s complaint also accused Bard of breaching its contract, claiming that it has made repeated and regular requests to Bard relating to the pelvic mesh product claims, which the company has failed to provide.
Starr also sought declaratory judgment regarding its previous reservation of its rights to disclaim coverage of the set of pelvic mesh product “related claims” that Columbia grouped together as one in 2012, saying it had a right to contest that decision.
Aside from the pelvic mesh defect claims, Bard has also been contending with litigation related to allegedly defective inferior vena cava heart filter products, which began to mount for the company in 2005, according to Starr’s complaint.
Similar to the pelvic mesh MDL, in March 2012 Bard notified its excess insurance carriers of a decision to declare separate, “related” claims under its Columbia policy for claims asserted against Bard during the 2011 to 2012 policy period.
Again Starr issued Bard a reservation of rights letter asserting their right to contest Bard’s decision to relate all of the IVC filter product claims and warned of litigation exclusions in its policy which could allow them to disclaim coverage, according to the complaint.
In late October, Bard responded that nothing in the terms and conditions of either the 2011 Columbia policy nor the 2011 Starr policy exclude coverage of bodily injury claims, which were asserted during the relevant policy period. Bard asserted a counterclaim against Starr seeking declaratory judgment and claiming breach of contract for refusing to indemnify it.
After Columbia determined that the pelvic mesh products related to stress urinary incontinence, pelvic organ prolapse and heart filter products would be declared under the Columbia policy as “related” claims, Bard says it placed Starr on notice for reimbursement for the ultimate net loss arising from claims on those products, which Starr has so far not done, according to the answer to the amended complaint.
Columbia is represented by James R. Greene of Colliau Carluccio Keener Morrow Peterson & Parsons.
Starr Surplus is represented by John F. Finnegan, Samantha B. Miller and Joy L. Langford of Chadbourne & Parke LLP.
Bard is represented by Barri Ann Frankfurter of Fox Rothschild LLP.
The case is Starr Surplus Lines Insurance Co. v. C.R. Bard Company et al., case number1:15-cv-07371, in the U.S. District Court for the Southern District of New York. -
Texas Pelvic Mesh Ruling Could Make Plaintiffs Think Twice
Nov 9, 2015 | Law360
By Jess Davis
A Texas appellate court ruling overturning a $1.2 million judgment against Johnson & Johnson in a pelvic mesh case because the plaintiff failed to prove the device caused her injuries could turn the tide in a wave of similar suits, leading to fewer cases and less valuable settlements, lawyers say.
The Fifth Court of Appeals in Dallas on Thursday reversed a judgment against Johnson & Johnson’s Ethicon Inc. unit, holding plaintiff Linda Batiste didn’t offer legally sufficient evidence that identified any alleged defect in J&J’s TVT-O pelvic mesh as the cause of her injuries, as compared with the device itself being the producing cause of her injuries. Batiste, who won the first trial holding Ethicon responsible for the bladder sling product used to treat stress urinary incontinence, had argued under Texas law that she needed only to prove the product caused her injuries.
In rejecting that argument, the appellate court applied what the Fourth Circuit has calledclear Texas precedent that requires plaintiffs to show both the defective condition of a product and a causal connection between that defect and a plaintiff’s injuries. That standard can be difficult for juries to parse, but sets a high bar that means even when a manufacturer loses in front of a jury, they have a good chance at knocking out an unfavorable verdict on appeal, Munsch Hardt Kopf & Harr PC’s Cliff Harrison said.
Harrison said for manufacturers, the Dallas appellate ruling has the potential to be a tipping point in pelvic mesh litigation, similar to what has happened with product liability litigation waves in years past for breast implants and hip implants.
“Once they start getting favorable appellate decisions, then that starts to change the landscape,” Harrison said. “Settlement values start going down. The plaintiffs’ side starts screening cases better because of causation.”
Batiste’s case was the first in the U.S. to hold Ethicon responsible for the bladder sling product used to treat stress urinary incontinence. After a 12-day trial in Dallas district court, a jury awarded her $1.2 million in compensatory damages, but declined to award punitive damages.
Batiste and plaintiffs in other pelvic mesh litigation have argued Texas case law was unclear about the requisite standard of proof on strict liability design defect claims and that plaintiffs need only have shown the defective product itself caused the injuries, without tying injuries to the specific defects.
The appeals court rejected that argument and said Batiste didn’t introduce evidence that the specific problems she alleged in the TVT-O device — that it used mechanically cut, heavyweight, small-pore mesh that was subject to degradation and particle loss — were what caused her pelvic and groin pain and other complications. The court said it’s undisputed that implantation of the TVT-O device can cause a number of complications and that Batiste suffered from those complications, but that the law of products liability doesn’t guarantee a product will be risk-free.
Harrison said the fact-intensive nature of the causation question means defendants in pelvic mesh suits aren’t going to start getting cases dismissed at the summary judgment stage, but that trial judges now have firmer ground to stand on when ruling against plaintiffs at the directed verdict or judgment as a matter of law stage of a trial.
And for plaintiffs' lawyers, the lesson to take away is that they need to screen cases carefully, particularly in cases where the client alleging injuries from a pelvic mesh implant has a history of other medical conditions that could explain her symptoms, Harrison said. In those circumstances, plaintiffs need to be prepared to explain away, with expert testimony, why those other conditions aren’t the cause of the injuries.
“The days of taking a case because a woman comes in and says she has pain and also had an implant, that’s not good enough,” he said.
Product liability defense lawyer Doug Fletcher of Fletcher Farley Shipman & Salinas LLPsaid the opinion isn’t new law, but an application of a longstanding precedent in product liability cases.
“It’s like if you have a car and you’re in a car wreck and the car had defective airbags, but those airbags didn’t cause the accident or the injuries — that’s not going to be enough,” Fletcher said. “They have to show that the product was used, that the product was defective and that the defect caused the injury.”
The Dallas court is one of the first to apply Texas precedent to a pelvic mesh case, but the Fourth Circuit held in a March decision affirming a win for Johnson & Johnson that although the Texas statute codifying the specific causation requirement in design defect cases does not, by its own terms, apply to medical device cases, the statute doesn’t trump common law.
The federal appeals court said the Supreme Court of Texas has been clear that Texas common law requires a plaintiff in a strict liability design defect case to show both the defective condition of a product and a causal connection between that defect and a plaintiff’s injuries.
“If the perception is that it’s going to be more difficult because there’s now an added element of causation, it could have a dampening effect on plaintiffs who want to bring these kinds of claims,” Brett Myers of Fox Rothschild LLP said.
Myers said plaintiffs’ lawyers could be more selective in the cases they bring “because they know they’re going to be facing a causation fight in every case.”
That’s true to some extent, said Jim Perdue of Perdue & Kidd, who represents plaintiffs in several pelvic mesh suits and won a $27.6 million verdict against Boston Scientific Corp. in 2014.
“There are certainly some women out there who have brought claims that would have problems under this standard,” Perdue said. “But for defendants, this lone opinion doesn’t suddenly give them a broad brush to say all plaintiffs’ claims face causation challenges.”
Perdue said the case is a lesson for plaintiffs, who didn’t know the court would “wholeheartedly adopt the defendant’s view of causation.” What the court adopted is not an impossible standard to overcome, he said.
“That said, you just build a more robust evidentiary bridge from what they recognize as defects in the product to injuries a specific woman has,” Perdue said.
Perdue said the opinion’s evaluation of the specific evidence and testimony in Batiste’s case means one can’t extrapolate the ruling broadly to predict future pelvic mesh judgments would also be reversed.
Lawyers for Batiste have said they plan to appeal the decision to the Texas Supreme Court.
But defense lawyers said Monday that they don’t think the high court will bite, because the standard is so well-established in Texas law.
“I don’t imagine the Supreme Court would take it up just based on the Dallas decision,” Myers said. “That doesn’t seem likely to me. It won’t be until there’s a split in the appellate courts that the Supreme Court would step in.”
Johnson & Johnson was represented by Stephen Brody and Charles Lifland of O’Melveny & Myers LLP and Scott Stolley of Cherry Petersen Landry Albert LLP.
Batiste was represented by Peter de la Cerda of Edwards & de la Cerda PLLC, Richard A. Capshaw of Capshaw & Associates, Tim Goss and Sara Turman-Vedral of Freese & Goss PLLC and David P. Matthews of Matthews and Associates.
The case is Johnson & Johnson et al. v. Batiste, case number 05-14-00864-CV, in the Texas Court of Appeals for the Fifth District. -
Now there's no excuse for not doing those pelvic floor exercises
Nov 9, 2015 | Daily Mail
By Claire Coleman
Most women know the importance of regular exercise, but working out the pelvic floor muscles can get overlooked. These are the sling-shaped muscles which run from the pubic bone to the base of the spine and which support the pelvic organs - the bowel, bladder, uterus and vagina.
One in three women is thought to experience some form of pelvic floor dysfunction, leading to incontinence, constipation, prolapse and sexual problems. But research shows that keeping these muscles in shape can help to keep such issues at bay. Knowing how to perform the exercises correctly and persevering with them, however, can be a struggle.
Tania Boler, 39, from London, knows this first-hand, and her experience spurred her to design a device to address these issues.
'After my son was born three years ago, I started doing pelvic floor exercises but soon got bored,' says Tania, a women's health expert turned entrepreneur. 'When I looked into it further, I found that despite strong evidence for the effectiveness of exercise, most women do not stick with the programme. Part of the reason is the lack of feedback - imagine running but never knowing how far or how fast.'
So she began working on a gadget to encourage women to strengthen their pelvic floor muscles. The result was Elvie, a device worn internally that connects wirelessly with a mobile phone app, which guides the wearer through a series of exercises and monitors how well they are doing them. The device, which is shaped like a flattened egg, is worn only during a pelvic floor workout (the manufacturers recommend three five-minute sessions a week).
It is inserted like a tampon and has sensors that detect when the pelvic floor muscles are activated; this is shown on the mobile phone screen in the form of a moving gemstone. When the muscles are contracted, the gemstone moves higher up the screen; when relaxed, the gemstone drops.
The idea is that you can see when you are contracting your muscles and learn to exercise them properly. Afterwards, you are given a score indicating the strength of the contractions.
This translation of a muscle movement into a visual representation is a form of 'biofeedback', where electronic monitoring of a body function is used to teach better control of it.
It is not the first device to help women exercise their pelvic floor, however. Vaginal weights - sets of small, tampon-shaped weights, each one heavier than the last - have been available for some time, but they do not give biofeedback. In clinics, physiotherapists use probes to measure a muscle's electrical output, or the air displaced by a contraction, to give biofeedback.
Katie Mann, a chartered physiotherapist based in Liverpool, who specialises in pelvic obstetric and gynaecological physiotherapy, says these can be unreliable, are not widely available for home use, and without a physiotherapist checking technique, the results can be misinterpreted.
Experts say one issue with pelvic floor exercises is that women may get them wrong. A 1991 study, in the American Journal of Obstetrics and Gynaecology, suggested only half of women contracted muscles correctly after verbal instructions.
'A quarter were doing nothing at all and a quarter were bearing down, promoting a downward force on their pelvic floor, increasing the chance of leaking,' says Katie Mann.
That is where the Elvie is said to differ from other gadgets. As well as sensors to measure muscle movement, it contains an 'accelerometer' (which measures the acceleration and direction of a moving object), to identify whether the device is moving upwards during muscle contractions or incorrectly moving downwards.
'If, after several attempts, you are still not getting it right, the app will suggest you may benefit from visiting a physiotherapist,' says Tania Boler.
Tania's background includes a PHD on teenage pregnancy and HIV in South Africa, plus a role at women's health charity Marie Stopes International. She helped to design the Elvie with guidance from Rufus Cartwright, a urogynaecology specialist at Imperial College London, and Professor Linda McLean, who researches pelvic floor dysfunction at the University of Ottawa. Professor McLean is planning a series of clinical studies on the product.
Katie Mann is not aware of any other home use pelvic training device that gives this feedback but, at £149, Elvie is not cheap. However, it is similarly priced to other fitness tracking devices, such as some FitBit models (worn on the wrist), but at least five times more expensive than a set of vaginal weights.
'Although the technology seems sound, this is not a medical device and I would want robust clinical trials proving its efficacy before I could recommend Elvie,' says Katie Mann. 'However, I can see it having a useful role.'
She applauds anything that encourages women to do pelvic floor exercises: 'Every woman should do them for life. NICE guidelines recommend at least eight contractions performed three times per day but if you have a problem, such as incontinence, a physiotherapist can give a more tailored programme.'
However, she says internal devices should not be used during pregnancy, and that women who already have pelvic dysfunction should not see such gadgets as an alternative to medical help. 'Incontinence can be the first symptom of a more serious problem, such as multiple sclerosis,' she adds. 'No gadget can diagnose that.'
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