Ethicon Media Monitoring 07/27/16

Client Attorney Privileged/Attorney Work Product/At Request of Counsel

Online Sources

1. *Breaking News * Caldera Denied Settlement and Quick Exit to Pelvic Mesh Litigation

   Jul 26, 2016 | Mesh Medical Device News Desk

   Within the hour, the Judge overseeing a proposed settlement involving Caldera Medical denied the companies claim it is insolvent and only has pennies to settle with women injured by its pelvic mesh.
2. Labour steps up fight on surgical mesh

   Jul 27, 2016 | Newshub - News from New Zealand

   By Isobel Ewing
   
   
   Labour's stepping up the fight against surgical mesh, and says it's time people stopped being so squeamish about vaginas.
3. Ruling Highlights Importance of Attacking Punitive Damages When Seeking Summary Judgment

   Jul 26, 2016 | Lexology

   By Mitchell K. Morris and Davis M. Walsh
   
   
   Earlier this month, a federal judge denied two multidistrict litigation (MDL) defendants’ bid to dismiss punitive damages in a pelvic mesh suit because they did “not present any arguments” specific to punitive damages, stressing that “[t]he court will not make arguments for the defendants.
4. Questions to Ask Your Pelvic Mesh Removal Doctor

   Jul 26, 2016 | Mesh Medical Device News Desk

   She is a woman who was implanted with transvaginal mesh years ago. Today she is suffering theconsequences, including pelvic pain, chronic infections, as well as some autoimmune complications that mysteriously cropped up after she had the implant.

Client Attorney Privileged/Attorney Work Product/At Request of Counsel

Online Sources

1. *Breaking News * Caldera Denied Settlement and Quick Exit to Pelvic Mesh Litigation

   Jul 26, 2016 | Mesh Medical Device News Desk

   Within the hour, the Judge overseeing a proposed settlement involving Caldera Medical denied the companies claim it is insolvent and only has pennies to settle with women injured by its pelvic mesh.

   That means Caldera Medical must face thousands of defective product trials over its pelvic mesh or  declare bankruptcy.

   “The decision prevents a company still selling defective mesh from doing so and to get out of litigation for peanuts,” said attorney Lee Balefsky of Kline & Specter to MND. The law firm is one that had argued against the settlement  before Judge Wilson.

   California based- Caldera Medical  announced it was insolvent last February and had about $25 million in insurance coverage (Federal Insurance, a subsidiary of Chubb) remaining to settle defective mesh claims by 2,100 women.  There would be no opt out, according to the company.

   Caldera claimed the ongoing litigation had exhausted half of the $25 million and to continue would mean the claimants would receive nothing, according to the May 16th Joint Motion for Final Settlement and Approval of Class Certification.

   Last June, the company sought final approval of its proposed settlement before Judge Stephen v. Wilson U.S. District Judge for the Central District of California. Here is a background story. An estimated 46 women filed objections to the settlement including “Samantha” who filed a story with MND here.  

   Kline & Specter represented 36 of those women.

   In today’s decision in Federal Insurance Co V. Caldera Medical, Judge Wilson denied the motion for final settlement approval and class certification and denied a motion for attorneys’ fees as moot. There is no “definitely ascertained” limited fund he writes that has been placed into the settlement sum.

   Additionally, “Given that Caldera remains a solvent, operational business, without evidence regarding Caldera’s potential liquidated value, it is not clear that the Policies are the only available funds to contribute to the settlement. “

   At the time it announced its insolvency, Caldera Medical said it had signed an agreement withIVUmed
   to have its pelvic mesh implanted in women in third would countries and had committed $1 million to that effort.  See the background story here.  

   In June of last year, Caldera Medical Introduced the Vertessa Lite, a pelvic mesh abdominally placed and introduced through the Food and Drug Administration’s 510(k) approval process. See the MND story here. 

   Caldera makes the T-Sling®, Desara®, Ascend®, Hydrix®, and POPmesh®.

   The court will issue an order on the pending motion for summary judgment, which could have the case dismissed.

   
   

   http://www.meshmedicaldevicenewsdesk.com/breaking-news-caldera-denied-settlement-quick-exit-pelvic-mesh-litigation/
   

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2. Labour steps up fight on surgical mesh

   Jul 27, 2016 | Newshub - News from New Zealand

   By Isobel Ewing

   Labour's stepping up the fight against surgical mesh, and says it's time people stopped being so squeamish about vaginas.

   The party is calling on the Government to launch a full inquiry into surgical mesh and its use in surgery to repair vaginal prolapse.

   Health spokeswoman Annette King has supplied Newshub with information revealing inconsistencies in how mesh is used among district health boards. She says it demonstrates a need for Government regulator Medsafe to provide some direction on how mesh should be used, and to improve its regulation of medical devices coming into New Zealand.

   "I want an inquiry that looks at what has happened to women, what this product does in terms of its use, whether we should be using it, and how do we fix the problem of those where it has been used and has caused internal injury, pain, and disability."

   Surgical mesh is a medical device permanently implanted into the body's tissue. Different types of mesh have been used for more than 30 years in surgeries like breast reconstruction and hernia repair with few problems.

   However in some cases, particularly when it's used to strengthen the vaginal wall or to repair pelvic organ prolapse, it can erode or perforate organs - which can lead to chronic pain.

   Charlotte Korte is a sufferer of chronic pain caused by surgical mesh, and she says Labour's call is fantastic.

   "There needs to be more urgent action to help patients who are suffering already."

   She says what's needed is a multi-prong approach including Medsafe, ACC, the Health and Disability Commission and patients.

   "Unless we get those agencies together to discuss surgical mesh complications, we can't really move forward.

   "It's going to take a long time and cost a lot of money so the Government needs to start taking some accountability."

   Health select committee recommendations:Set up a surgical mesh registry , similar to the New Zealand Joint RegistryReview best practice around informed consent for mesh proceduresGreater transparency around patients with mesh complicationsMore education for surgeons on the use of mesh and mesh removalExpand Medsafe's role to assess the quality and safety of a medical device before it can be used in New Zealand.

   Health Minister Jonathan Coleman said in a statement today he was still seeking advice from officials on the issue following the select committee's recommendations.

   Ms King says the recommendations from the health select committee, which she sits on, were weak.

   "It is an issue that is serious, that affects many women, and there have been over 500 claims to ACC over the last decade on this particular product," Ms King says.

   "This is a bigger issue than a group of politicians. It needs the expertise outside of the political arena."

   She was alarmed by what she found when she requested information on how district health boards use mesh.

   "Some have never used it. Some have stopped using it based on reports, some continue to use it but using the guidelines of the College of Obstetricians and Gynaecologists.

   "And then when you look at the guidelines, this is what the guidelines say: 'Very little robust information is available on the efficacy and long term safety of polypropylene mesh kits marketed for their use in the management of pelvic organ prolapse.' That is from the college themselves."

   Ms King says part of the problem is an unwillingness to talk about "female problems".

   "It's flown under the radar. Perhaps because it's being used in vaginal prolapse, it's not something that people go out and talk about in public, get on television and say, 'This is what's happened to me.'"

   Newshub.

   http://www.newshub.co.nz/nznews/labour-to-health-minister-get-serious-about-vagina-problems-2016072620#ixzz4FaSnendo
   
   
   

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3. Ruling Highlights Importance of Attacking Punitive Damages When Seeking Summary Judgment

   Jul 26, 2016 | Lexology

   By Mitchell K. Morris and Davis M. Walsh

   Earlier this month, a federal judge denied two multidistrict litigation (MDL) defendants’ bid to dismiss punitive damages in a pelvic mesh suit because they did “not present any arguments” specific to punitive damages, stressing that “[t]he court will not make arguments for the defendants.” Fox v. Ethicon, Inc. (In re Ethicon, Inc., Pelvic Repair Sys. Prods. Liab. Litig.), No. 2:12-cv-0878 (S.D. W. Va. July 8, 2016). The court’s ruling highlights the importance of specifically attacking punitive damages when moving for summary judgment. The standard for recovering punitive damages is almost always higher than that for other claims, so dismissal of punitives may still be obtainable even when it is denied for other claims. 

   Fox is one of more than 75,000 cases in seven pelvic mesh MDLs pending in the Southern District of West Virginia. It was among three waves of 200 cases selected by the court for pretrial discovery and motions practice. The defendants moved for summary judgment, and the court determined that Texas law applied.

   After granting summary judgment as to certain of the plaintiffs’ underlying causes of action (i.e., failure to warn) and denying it as to others (i.e., design defect and negligence), the court turned to punitive damages. The court observed that “[t]he defendants assert that their Motion challenges all of the plaintiffs’ claims [including] punitive damages,” but the defendants did “not present any arguments regarding” punitives. The court, therefore, denied summary judgment on them. 

   The outcome in Fox illustrates an all-too-common occurrence in cases where punitive damages are sought. Punitive damages are recoverable only when there is a viable underlying cause of action such as negligence, failure to warn, or strict liability. Frequently, defendants move for summary judgment on all underlying causes of action, but do not make any substantive argument for the dismissal of punitive damages, asserting only that, with the underlying causes dismissed, punitives must fail, too.  Often, however, courts decline to grant summary judgment on all of the underlying causes of action, meaning that some potential basis for punitive damages remains. If the defendant has not separately addressed punitives, they will be left in the case, as they were in Fox. 

   For this reason, defendants seeking summary judgment should always seriously consider specifically attacking punitive damages, especially because the standard for recovering them is almost always higher than that for underlying torts like negligence and strict liability. Whereas negligence is the failure to exercise ordinary care, punitives typically require that the defendant was at least consciously or recklessly indifferent. The burden of proof for punitive damages also may be higher (i.e., clear and convincing, as opposed to preponderance). These heightened standards mean that even when summary judgment is denied as to negligence, there may still be grounds for dismissing punitive damages due to insufficient evidence of the requisite culpability. Just last year, for instance, the same court presiding over Fox denied a product liability defendant’s bid for summary judgment on the plaintiffs’ “liability claims,” but nevertheless held that “Plaintiffs fail to articulate a basis for punitive damages.” Nease v. Ford Motor Co., No. 3:13-29840 (S.D. W. Va. Mar. 13, 2015). 

   As one court recently observed, “a punitive damages claim can be a ‘game changer’ in litigation.” TRG Desert Inn Venture, Ltd. v. Berezovsky, No. 3D15-424 (Fla. 3d DCA June 15, 2016).  Accordingly, defendants should avail themselves of every opportunity to obtain dismissal of punitive damages, including by specifically attacking them at the summary judgment stage. Even if summary judgment on liability is denied, there may nevertheless be grounds for dismissal of punitive damages, which, in turn, can dramatically reduce a defendant’s potential exposure.

   http://www.lexology.com/library/detail.aspx?g=bec23b6d-9c9d-429d-be83-bd9c1524e526
   

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4. Questions to Ask Your Pelvic Mesh Removal Doctor

   Jul 26, 2016 | Mesh Medical Device News Desk

   She is a woman who was implanted with transvaginal mesh years ago. Today she is suffering theconsequences, including pelvic pain, chronic infections, as well as some autoimmune complications that mysteriously cropped up after she had the implant.

   Kathleen has talked to countless doctors about her mesh removal and feels that her experience has helped her become well-versed in the questions that any woman should ask before considering the removal of her pelvic mesh.

   First, are you having complications?  Unlike what Kathleen is currently going through, many women do not experience complications of pain, chronic infection and mesh erosion, at least not initially.   Experienced mesh removal doctors say complications may take years to emerge. According to Dr. Shlomo Raz of UCLA, a leading mesh removal doctor, he is seeing complications up to a decade after an implant.

   Some percentage of women have complications initially, but that number is unknown because no one is tracking the big picture. Because the pelvic region is rich with blood vessels, nerves, ligaments and because a mesh implant is a permanent, blind procedure, it is fraught with potential problems.

   A surgical nick to the bladder is not uncommon and will eventually heal, but an injury to the colon during the placement of a mesh in the posterior pelvis may not heal.   Sepsis is a very real possibility and a serious problem. Sepsis is a very severe and fast moving bacterial infection of the blood that originates from fecal matter. There are also the nerves, which may become impinged by a mesh placement or become encapsulated by scar tissue.

   So what should you ask your physician to get the most complete removal in one surgery?

   First, make sure he or she is one of the few experts at removing mesh.

   Kathleen suggests you sharpen your interview skills and she suggests you bring along a friend. She did. The friend was a woman who had already undergone a removal and a reconstruction of her pelvic floor.

   These are suggested questions. Find the words that work best for you but it truly is NOT a time to be shy.Do you remove the mesh completely?
   Understand that partial removals are the norm by most doctors who snip away a small piece of mesh that has eroded into the vagina, for example. A full removal in one surgery is preferred for the reasons above.How can you be sure you’ve removed the mesh in its entirety?
   Did the doctor measure the explant to see how many centimeters it contains?  By doing the math can he or she determine how much remains behind?Do you remove the arms and anchors?
   This is an important question because many doctors will not enter into ligaments to further remove the plastic anchors that are dug deeply into the pelvis. In many cases, it may be too dangerous to do so. Ask your doctor what technique is used to remove anchors without causing more harm.What diagnostic equipment do you have? 
   Some doctors like to “see” the pelvic mesh before they go to retrieve it. The transvaginal ultrasound is the only imaging device that will show the mesh, unless it is hidden behind a bone. Make sure a trained technician is operating the equipment to read it accurately.Can you do repairs and reconstruction using my own fascia tissue graft within 6 months of removal if needed?
   Many doctors do not have the skill to retrieve or harvest fascia from your own body to create a sling that is biocompatible. Make sure your doctor can perform that surgery to treat incontinence or prolapse if it returns.How many have you removed, completely?
   Make sure the person answers the question you asked and does not include partial removals in his tally.Can you predict what reconstructive surgery I will need?
   After surgery you may need to follow up to repair any damage done during the removal. How often does this doctor do these surgeries and what will be needed to ensure the best results for you with the least amount of further injury. ##

   http://www.meshmedicaldevicenewsdesk.com/questions-ask-pelvic-mesh-removal-doctor/
   

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