ESSURE – Approved – 2002; Black Box – 2016; Off Market – 2019; Damaged Patients – Forever

“Essure is a permanent sterilization device intended for women who have decided against any, or any more, pregnancies. The aim of the permanent implant is to trigger tissue growth that blocks the fallopian tubes and prevents sperm from entering the ducts.” (https://www.medpagetoday.com/washington-watch/fdageneral/77134). “Conceptus Inc., a subsidiary of Bayer AG, developed Essure which is a Class III device for permanent surgical sterilization in women. Essure was approved by the Food and Drug Administration (FDA) on November 4, 2002. The device has two metal coils made from polyester fibers, nickel-titanium, stainless steel, and solder which are placed in fallopian tubes to induce fibrosis and block the fallopian tubes to prevent fertilization. Since 2002, it is estimated by Bayer that 750,000 women have received the Essure IUD.” (https://www.neuralit.com/mass-torts/devices/essure).

“In an official posting, FDA Commissioner Dr. Scott Gottlieb said the FDA is working with Bayer to “revise and strengthen” its post-market study of Essure, which was ordered by the federal watchdog in 2016. The trial will now follow patients who received the Essure device for five years rather than the initially requested three years, giving the agency “longer-term information on adverse risks of the device, including issues that may lead women to have the device removed,” Gottlieb wrote in the posting.” (https://www.massdevice.com/fda-updates-on-post-market-study-revisions-oversight-for-bayers-essure/). “On April 9, 2018, FDA restricted the sale of Essure device to only those doctors and healthcare facilities who use the FDA-approved “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement”. In July 2018, Bayer announced Essure would be wiped out of the market by December 31, 2018.” (https://www.neuralit.com/mass-torts/devices/essure).

“There are also currently over 16,0000 lawsuits alleging harm caused by Essure. There are serious concerns regarding the approval process of the device along with the post-approval studies, and a current study ordered by the FDA. Patient activist groups, such as the Essure Problems Facebook group, have created platforms for support and education. Before making your decision, you should consult your doctor and make sure to ask a lot of questions, such as… Why are you recommending this product after Bayer has announced pulling it from the market? How many of these procedures have you done? Do you have a copy of the current patient checklist we are mandated to review and the black box warning we can discuss? What is your failure rate in placing Essure correctly in one attempt? Do you use general anesthesia to place Essure, or will I be awake the entire time? Have you ever removed essure? If so, how?” (https://www.nwhn.org/bayer-has-recently-announced-they-will-remove-essure/).

If you, a family member, a loved one, a friend, or anyone you know is experiencing problems with an Essure device, it may be time for you or that other person to contact a lawyer. There are statutes of limitations (deadlines), so waiting too long can mean no case. Paul J. Molinaro, M.D., J.D. offers free consultations on Essure cases for patients who reside in California.

18,000 Essure Lawsuits

As of February 2019, Bayer was facing about 18,000.00 Essure plaintiffs. (https://www.jurist.org/commentary/2019/02/female-filings-a-look-into-the-current-essure-lawsuits/). “Plaintiffs claim that the manufacturer failed to inform patients and physicians of possible dangerous side effects. Some women have been forced to have additional operations in an attempt to correct complications that the device caused. Women’s organs have been perforated, devices have broken inside fallopian tubes, and many women have endured years of pain and suffering. Women are seeking several types of damages as a result of the pain and suffering from Essure, from compensatory damages for medical costs, to general damages for mental and emotional anguish. Consumers are also seeking punitive damages in order to punish Bayer for developing and selling a harmful product and to stop the company from making this negligent practice into a habit.” (https://www.jurist.org/commentary/2019/02/female-filings-a-look-into-the-current-essure-lawsuits/).

#essure #perforation #organperforation #brokendevice #fallopiantubes #painandsuffering #defectivemedicaldevice #bayer #conceptus #lawsuit #lawyer

Essure: No Longer Sold or distributed in U.S.

“Tens of thousands of women say they suffered painful and serious side-effects from Essure, a medical device meant as a permanent birth control option. The device is the subject of nearly 27,000 complaints to the FDA since its approval in 2002. Women reported excessive pain, severe allergic reactions and, in some cases, perforated organs.” (https://www.cbsnews.com/news/essure-birth-control-fda-women-report-pain-side-effects/). “Essure will no longer be sold or distributed in the U.S. after December 31, 2018, a decision that was made by the manufacturer, Bayer, for business reasons. Health care providers can implant Essure for up to one year from the date the device was purchased.” (https://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/essurepermanentbirthcontrol/ucm452250.htm). “The Essure system is a type of permanent birth control for women. It cannot be reversed. This type of female sterilization involves placing small metal and fiber coils in the fallopian tubes, which creates scar tissue that prevents sperm from reaching an egg. During the procedure, the doctor inserts a flexible tube with a small camera (hysteroscope) through the vagina and cervix and up to the uterus. From here, the doctor can see the opening to the fallopian tubes and place the Essure system coils into them. It takes about three months for the Essure system to prevent pregnancy. In some women, it may take up to six months. During this time, you must use another form of birth control to prevent pregnancy. Essure doesn’t protect you against sexually transmitted infections (STIs). The company that manufactures Essure plans to stop production of this contraceptive device at the end of 2018.” (https://www.mayoclinic.org/tests-procedures/essure/about/pac-20394017).

USING THE LEGAL TEAM APPROACH TO ATTACK BILLION DOLLAR OPIOID MANUFACTURERS AND DISTRIBUTORS

Aggressively, efficiently, and successfully litigating complex cases against companies worth hundreds of billions of dollars requires a legal team of experienced law firms with seasoned trial attorneys who also have the financial ability to advance the millions of dollars that will be needed. Fransen & Molinaro, LLP is working with a team of law firms that meet these criteria. One member of the team is the law firm of Levin Papantonio Thomas Mitchell Rafferty Proctor P.A. This firm has been handling mass tort, medical device, and pharmaceutical cases for decades. In 2004, Mike Papantonio helped launch a nationwide organization called Mass Torts Made Perfect. This organization holds annual conferences for the top personal injury attorneys and teaches them successful litigation strategies to use against multi-national corporations.

The team approach is well-suited to handle the representation of cities, counties, and states in litigation against billion-dollar international companies like Purdue Pharma, McKesson, Teva Pharmaceuticals, Cardinal Health, AmerisourceBergen, Mallinckrodt, Janssen, Endo Health Solutions, Cephalon, Watson, Allergen, Johnson & Johnson, and others. The team will pool resources, work more efficiently, and replicate successful strategies. They know how to bring lawsuits designed to hold billion-dollar international companies responsible for the damages their opioids cause.

If you are a governmental official in California, Fransen & Molinaro, LLP wants to work with your city or county, or with the State of California to sue the corporations that have ruined countless lives and financially drained local governments. These corporations need to be held accountable.

CIVIL LAWSUITS AGAINST OPIOID MANUFACTURERS AND DISTRIBUTORS CAN PROVIDE BETTER RECOVERY FOR LOCAL GOVERNMENTS

There is no fee if there is no recovery.” “There is no reimbursement of litigation expenses if there is no recovery.” These two sentences are written, in boldface type, in every retainer agreement a governmental client will sign when it decides bring a lawsuit against the opioid manufacturers and distributors through Fransen & Molinaro, LLP and their associate attorneys. These contractually binding statements mean that there are zero upfront costs to the client.

This important fact should not be overlooked, because it means that the enormous litigation costs will be completely advanced by the attorneys and not come from your budget. This fact also means that there is no risk of financial loss to your department. Even if a suit is unsuccessful, no reimbursement will be sought by your attorneys. The retainer agreement will also state that, upon recovery, the lawyers will be paid thirty percent of the gross recovery plus reimbursement for litigation expenses. Considering that many personal injury attorneys charge forty percent of the gross recovery for simple automobile accident cases, the thirty percent contingent recovery rate is quite reasonable.

Another advantage to hiring Fransen & Molinaro, LLP and its associate attorneys is less obvious. By representing multiple governmental clients against the same manufacturers and distributors, many of the pleadings, discovery efforts, and litigation actions will be used in other cases. This means that the costs, for which each individual client is responsible will be less than if only one lawsuit was filed. Handling many similar lawsuits against the same defendants, allows private practice attorneys to not only decrease litigation expenses, but duplicate the tactics. Fransen & Molinaro, LLP and its associate attorneys are not new to litigation against billion-dollar corporations. Their experience and track make them the right choice.

THE OPIOID EPIDEMIC DRAINED STATE AND LOCAL BUDGETS… CAN WE GET THAT MONEY BACK?

The United States is suffering from a prescription opioid epidemic, the likes of which has never been seen before. In the late 1980s, when I was in medical school, I was correctly taught that opioids were addictive and dangerous pain relieving medications which should be used in very limited situations. I was taught that opiate pain relievers were only to be used for short-term treatment of severe acute pain like that experienced immediately following surgery or for long-term palliative (end-of-life) care in cancer patients. My respected medical school professors and fellow students did not question these ethical and wise standards.

Many people wrongly believe that those who suffer from opiate abuse and die from opiate overdoses are heroin addicts and abusers of other illegal street drugs. However, the truth is that the majority of opiate abusers are abusing prescription opiates. The prescription opiates causing the physical, economic, and social devastation are made by large scale pharmaceutical manufacturers, distributed by billion-dollar wholesalers, prescribed by licensed healthcare providers, and sold by pharmacies. The only true link to heroin and the current opiate epidemic is that most of today’s heroin users abused prescription opiates before turning to heroin.

Fransen & Molinaro, LLP will represent California counties and cities against opiate manufacturers and distributors and sue them to recover the money spent by these governmental entities fighting the opioid epidemic with its hundreds of millions of dollars in associated medical, criminal, and societal costs.

Medical Malpractice:EMRs Can Be Your Friend or Foe in a Lawsuit

The electronic medical record (EMR) is touted as one of the best new additions to medical record keeping due to its time-saving abilities, its ease of transferring records and its tailor-made templates, which should make it all but impossible to fail to document an important step in patient care. And, yes, recording the detailed care of the patient can be your best friend in the event of a malpractice case. However, some of the very features that make the EMR so quick and easy to use make it potentially dangerous with a couple of pitfalls.

Read the Full Article

– Paul

WHAT IS MEDICAL MALPRACTICE?

“Medical malpractice” refers to actions for personal injury against a healthcare provider based on professional negligence. The term is most often used to apply to law suits brought by patients against physicians as a result of getting “bad care.” However, “healthcare provider” also includes nurse practitioners, physician assistants, dentists, chiropractors, and anyone else holding a healthcare license.  Continue reading

MEDICAL MALPRACTICE – SHOULD YOU GET SECOND OPINIONS?

With regard to potential case evaluation, law is as much about opinion as it is about facts. The good medical malpractice case will have substantial injury as a result of medical services done below the standard of care. Both damages and poor practice are needed. Opinions differ greatly as to what constitutes substantial damages and poor practice.  Continue reading