Ethicon Media Monitoring 3/8/2017

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

Online Sources

1. J&J’s legal costs surge in wave of product lawsuits

   Mar 7, 2017 | Financial Times

   By David Crow
   
   
   ... More than 54,000 women are suing J&J over claims that its vaginal mesh inserts were unsafe, while about 3,000 have brought lawsuits alleging the company’s Johnson’s baby powder caused their ovarian cancer.
2. Court clears Caldera’s $12.3m transvaginal mesh settlement

   Mar 7, 2017 | Mass Device

   By Fink Densford
   
   
   A California federal judge last week approved a $12.3 million deal to settle a number of insurance claims over injuries allegedly caused by Caldera Medical’s transvaginal mesh.
3. FDA: Lapdog Enforcement on Reporting Adverse Events

   Mar 7, 2017 | Mesh Medical Device Newsdesk

   n mild mannered newly-issued language, The U.S. Food and Drug Administration (FDA) recommends that medical device manufacturers report adverse events to the agency, but it’s not legally enforceable.
4. What’s Added to Plastic Mesh?

   Mar 7, 2017 | Mesh Medical Device Newsdesk

   By now readers may understand that most mesh, whether for hernia repair or to treat prolapse and/or incontinence, is made of the plastic polypropylene (PP). But you may not know about the chemical smorgasbord that accompanies the PP.

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

Online Sources

1. J&J’s legal costs surge in wave of product lawsuits

   Mar 7, 2017 | Financial Times

   By David Crow

   Johnson & Johnson’s legal costs jumped last year after a surge in the number of people suing the world’s largest healthcare company.

   The company is facing lawsuits from more than 100,000 patients, including 18,500 men who say they grew “female” breasts after taking its antipsychotic medicine Risperdal.
   
   The number of lawsuits disclosed by J&J jumped by 28,300 during 2016 to hit 104,700 by the start of 2017, according to a recent securities filing. Litigation expenses increased 480 per cent year-on-year to $817m.

   Men prescribed Risperdal as children allege the drugmaker knowingly played down the risk the medicine could cause gynecomastia, or breast swelling, if taken by boys

   Only a minority of the Risperdal cases have been settled or gone to trial with some juries awarding substantial damages.
   
   Last year, a jury in Philadelphia awarded $70m to the family of a boy who developed gynecomastia at the age of five after taking the medicine. The judgment was about 30 times larger than the $2.5m awarded to an Alabama man in 2015 who sued J&J after developing size 46DD breasts.

   
   Lawyers for the plaintiffs have argued that J&J intentionally concealed evidence showing the drug could lead to elevated levels of a hormone known as prolactin, which can cause gynecomastia, if prescribed to boys.

   
   J&J said: “Contrary to the impression the plaintiff’s attorneys have attempted to create over the course of this litigation, Risperdal is an important FDA-approved medicine. We will continue to defend this litigation and will try cases where appropriate.”

   The company is appealing the verdicts it has lost including the $70m award, and points out it has also won several Risperdal court cases or had them dismissed.

   In 2013, J&J paid more than $2.2bn to resolve civil and criminal investigations by the US Department of Justice into its marketing of Risperdal and several other drugs.

   
   
   Prosecutors said that between 1999 and 2005 J&J marketed Risperdal for uses not approved by the US Food and Drug Administration, not least for children with autism and attention deficit hyperactivity disorder.

   J&J is facing allegations that several products besides Risperdal also caused harm to patients.
   
   Almost 17,000 people are suing the company over Xarelto, its blood thinner, claiming the drug causes uncontrollable bleeding, and the first of the cases is due to be heard in a court in Louisiana next month.
   
   More than 54,000 women are suing J&J over claims that its vaginal mesh inserts were unsafe, while about 3,000 have brought lawsuits alleging the company’s Johnson’s baby powder caused their ovarian cancer.

   J&J was last week cleared by jurors over claims the baby powder caused a 55-year-old woman to develop ovarian cancer, although it has lost several other court cases brought over the cosmetic talc.

   
   “The jury’s decision is consistent with the science, research, clinical evidence and decades of studies by medical experts around the world that continue to support the safety of cosmetic talc,” said J&J.

   Regarding the Xarelto and vaginal mesh lawsuits, J&J said: “We remain committed to defending the litigation concerning the use of these two products.”
   
   In a recent securities filing, J&J said the legal proceedings were unlikely to have an impact on the company’s financial health but warned the amount spent on resolving lawsuits could have a “material adverse effect” on its earnings in some quarters.

   https://www.ft.com/content/ab12bce8-02b6-11e7-ace0-1ce02ef0def9
   

   Return to headline | Return to top

2. Court clears Caldera’s $12.3m transvaginal mesh settlement

   Mar 7, 2017 | Mass Device

   By Fink Densford

   A California federal judge last week approved a $12.3 million deal to settle a number of insurance claims over injuries allegedly caused by Caldera Medical’s transvaginal mesh.

   Caldera’s insurer, Federal Insurance Co., will distribute $10.6 million to over 2,700 class members, as well as a $670,020 payment for attorney’s fees and costs in the case.

   The ruling came despite the efforts of 36 objectors who sought an independent audit last June, saying they wanted evidence as to whether or not the payment would be larger if the Agoura Hills, Calif.-based company liquidated.

   The company won FDA 510(k) clearance for its next-gen Vertessa Lite polypropylene mesh for treating pelvic organ prolapse in June 2015.

   Caldera claimed that the new version of the mesh was lighter, 31% stronger than other market-leading meshes and has a 32% increased suture pull out strength.

   http://www.massdevice.com/court-clears-calderas-12-3m-transvaginal-mesh-settlement/
   

   Return to headline | Return to top

3. FDA: Lapdog Enforcement on Reporting Adverse Events

   Mar 7, 2017 | Mesh Medical Device Newsdesk

   Mesh Medical Device News Desk, March 7, 2017 ~ In mild mannered newly-issued language, The U.S. Food and Drug Administration (FDA) recommends that medical device manufacturers report adverse events to the agency, but it’s not legally enforceable.   

   This new regulation issued November 2016, updates 20-year-old regulations for medical device reporting (MDR).

   Guidance for Industry and Food and Drug Administration Staff (here) 

   Medical Device Reporting (MDR), is not a legally enforceable responsibility, says the guidance on page 1.

   “Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.”

   While industry, in an apparent conflict of interest, is charged with monitoring itself, the FDA says “The use of the word ‘should’ in guidance documents means that something is suggested or recommended, but not required.”

   “This guidance represents the current thinking of the Food and Drug Administration on this topic. It does not establish any rights for any person and is not binding on FDA or the public.   You can use an alternative approach if it satisfied the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff or Office responsible for this guidance as listed on the title page.”

   MDR Policy Branch 301-796-6670.  MDRPolicy@fda.hhs.gov. An automated voice answers, “Sorry, is not available. record your message at the tone.”     

   The goal is to detect and correct problems in a timely manner and is directed at manufacturers, hospitals, ambulatory surgical facilities, nursing homes, outpatient diagnostic facilities,  outpatient treatment facilities, importers of medical devices and medical device distributors.

   Enforcement can include seizure, injunction, civil money penalties and criminal prosecution.

   What’s reportable? Events that “manufacturers become aware of that reasonably suggest that one of their marketed devices may have caused or contributed to a death or serious injury, or has malfunctioned and the malfunction of the device or a similar device that they market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.” See page 2.

   Under statute 803.12, Manufacturers must conduct an investigation into an event, even if it involves death or serious injury and then are required to submit reports to the FDA of a reportable death, serious injury or device malfunction.

   They must be submitted within 30-calendar days after the day the manufacturer becomes aware of the event, and are referred to as “30-day reports.”  There are also 5-day reports if something requires remedial action to “prevent an unreasonable risk of substantial harm to the public or health.”

   Here are those cited regulations.

   Manufacturers may take note of the exemption to reporting a MDR on page 13.

   “You are not required to submit an MDR report  if you have information made by a person who is qualified to reasonably conclude that your device did not cause or contribute to a death or serious injury, or that a malfunction would not be likely to cause or contribute to a death or serious injury if it were to recur.”

   In other words, self-monitoring.

   If the user intervenes before the malfunctioning device can cause harm, it should still be reported.

   Back in 1997, the assumption was if a medical device malfunctioned and caused death or serious injury, a presumption of malfunction is established.  So leave the device on the market for another two years and see how it performs, recommends the FDA:

   “This presumption will continue until either the malfunction has caused or contributed to no further deaths or serious injuries for two years, or the manufacturer can show through valid data that the likelihood of another death or serious injury as a result of the malfunction is remote.”  Page 13. 

   At that time, the manufacturer may want to submit information it has to assure the FDA the malfunction will not occur again.

    

   HOW DO YOU REPORT AN ADVERSE EVENT 

   So how do you report your own adverse event?  Here is a story from August 2014.

   You can report directly to MedWatch, the FDA Safety Information and Adverse Event Reporting program online:By phone- 1-800-FDA-1088By FAX – obtain a fillable form online and print it out and fax it to 1-800-FDA-0178By mail – or mail it to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787

   MedWatch Online Voluntary Reporting Form (3500) is here.

   Or you can report to MAUDE.

   Manufacturer and User Facility Device Experience (MAUDE) data

   As it stands now, the injured have to find the FDA’s MAUDE database (Manufacturer and User Facility Device Experience Database) and understand the criteria to enter to pull up injuries resulting from your mesh. It can be intimidating, and if they are involved in litigation are generally advised not to enter information.

   For example, in the case of one mesh patient,  (Suffering in Silence- Part 1) finding data on Ethicon’s Gynecare Tension Free family of mesh products involves knowing the criteria: 

   1.) Product Class: Mesh, Surgical, Polymeric (You will have to scroll through the M’s to find this phrase.)

    

   2.) Brand Name: Tension Free

    

   3.) Date Report Received by the FDA: (Date Range) 05/12/1999 to Current Date.

    

   4.) Records Per Report Page: Change to 500 and click Search.

   http://www.meshmedicaldevicenewsdesk.com/fda-lapdog-enforcement-reporting-adverse-events/
   

   Return to headline | Return to top

4. What’s Added to Plastic Mesh?

   Mar 7, 2017 | Mesh Medical Device Newsdesk

   Mesh Medical Device News Desk, March 7, 2017~ By now readers  may understand that most mesh, whether for hernia repair or to treat prolapse and/or incontinence, is made of the plastic polypropylene (PP).  But you may not know about the chemical smorgasbord that accompanies the PP.

   There is no other way to say it – polypropylene (PP) is a cheap plastic mesh material and a dominant polymer used by the medical device industry.

   Besides pelvic and hernia mesh, uses include catheters, tubing, syringes, and contact lenses. And PP use for medical devices is predicted to grow, despite the indications it might not be biocompatible.

   Any chemical handled by workers as part of industrialized production is accompanied by a Materials Safety Data Sheet or MSDS. It is required by OSHA, the Occupational Health and Safety Administration.

   The MSDS for polypropylene (PP) resin states clearly it is not to be made into implantable medical devices.

   What does industry know that patients do not?

   In 2011, Dr. Donald Ostergard, past president of the American Urogynecologic Society (AUGS), told its members that “mesh is not inert.”

   Mesh is able to incite an inflammatory response or foreign body reaction in the body. In other words, there is a continuing process of change and degradation.  Electronic microscopy showed the deep cracks in the PP as it degrades in the body. It can shrink up to 50 percent.

   Without chemical additives to slow the process, PP was seen to degrade in live animal tests (Liebert, 1976) and that degradation process occurred as soon as a few days after implantation.

   An added antioxidant retarded the degradation process.

   That insight, opened the door to a chemical smorgasbord of additives to PP mesh, the effects of which are unknown.

   CHEMICAL ADDITIVES TO MESH

   Court documents in pelvic mesh litigation show us that the proprietary formulation of Ethicon/ Johnson & Johnson’s Prolene (PP) show the addition of Procol LA-10, a lubricant to help reduce tissue drag and promote tissue passage.

   Santonox is an added antioxidant. Its role is to protect the resin from thermal oxidation during the extrusion process during the making of sutures or threads.

   Also added is the lubricant, Calcium Stearate.

   DL TDP, also known as dilauralthiodipropionate, is an antioxidant that improves the long-term storage of the resin, reducing any impact of oxygen or ultraviolet light.

   A copper-based pigment is added to make the mesh more visible in the body.

   The U.S. Food and Drug Administration (FDA) clears PP mesh for market and we know from inside those clearance documents that PP mesh implants are exposed to ethylene oxide (EtO) gas, a low-temperature sterilization agent.

   EtO is considered toxic by the Environmental Protection Agency and a carcinogen. Exposure is regulated by the EPA in the workplace under the rules of OSHA.

   Europe is light years ahead of the U.S in these concerns.

   In May 2016, the European Parliament and EU Council of Ministers agreed to limit the use of devices that contain carcinogenic, toxic, mutagenic or hormone-disrupting properties.

   That would include plastics.

   The effort there comes after a disaster in France when a manufacturer used industrial grade silicone to fill breast implants.

   The EU data will list all implantable devices that are on the market.

   The U.S. has yet to establish a national database for medical devices that go wrong, though the MAUDE database is a start. Reporting can be voluntary, the database is difficult to decipher and adverse event reports often go first to the manufacturer, which can under FDA guidance decide if the complication is related to its medical device or not.     ###

   http://www.meshmedicaldevicenewsdesk.com/whats-added-plastic-mesh/
   

   Return to headline | Return to top