Bayer ends U.S. sales of Essure permanent birth control implant

essure
Image: Bayer Healthcare Pharmaceuticals, Inc.

Pharmaceutical giant Bayer recently announced it would no longer sell its controversial Essure® contraceptive device in the United States. The decision follows years of concerning reports of dangerous complications and injuries. Continue reading “Bayer ends U.S. sales of Essure permanent birth control implant”

5 Things You Need to Know About Hernia Mesh

hernia meshPhysiomesh®, a surgical mesh commonly used in laparoscopic procedures to repair hernias, was recently withdrawn from the market. The products may be off the market, but anyone who underwent surgery prior to the withdrawal could still be at risk of suffering serious complications and injuries.

Here are five things you need to know about the hernia mesh withdrawal:

  1. Physiomesh was granted market entrance without clinic trials. The FDA prematurely approved the product based on its similarity to other mesh products already on the market.
  2. Ethicon, a subsidiary of Johnson & Johnson, voluntarily withdrew its Physiomesh products from the market in May following reports of severe complications and risks.
  3. Side effects and complications linked to the recalled hernia mesh products include organ damage, infection, chronic pain, migration or shrinkage of the mesh or a need for corrective surgery.
  4. Multiple types of flexible hernia mesh are putting patients at risk. Ten variations of the product in different shapes and sizes were used in procedures to prevent the reemergence of hernias.
    View the full list of affected Physiomesh products.
  5. If you suffered complications after a laparoscopic hernia surgery, you may be entitled to financial compensation. Elk & Elk is currently investigating hernia mesh claims related to surgeries that took place after March 2010.

If you know hernia mesh was used in your laparoscopic hernia procedure, but do not know the product code or type, we can help you find the answers to your questions.

Call 1-800-ELK-OHIO or fill out an online contact form for a free case evaluation.

Pelvic Organ Prolapse: What You Need to Know

What to know if you’ve suffered pelvic organ prolapse

Pelvic organ prolapse occurs when an organ, such as the bladder, Pelvic Organ Prolapsedrops from its normal position and pushes against the wall of other organs and tissue. Though it is an important medical issue to address, the device commonly used to treat this condition poses serious health risks to patients.

Why is transvaginal mesh dangerous?

When someone suffers pelvic organ prolapse, it is often treated using a transvaginal mesh implant. Also known as surgical mesh, this device can hold the bladder in place like a sling.

The mesh is causing major injuries, including infection, erosion of the uterus and perforation of other major organs. A plastic-like substance used in the mesh called polypropylene reportedly cuts through organ walls, causing severe bleeding, pain and infection.

One blogger claimed her physician told her the implanted mesh was covered with mucosa, a membrane naturally created within the body. The membrane on the woman’s device eroded away, leaving the exposed mesh touching the walls of other organs in her pelvis.

What can I do if I’m injured by surgical or transvaginal mesh?

You are not alone. More than 300,000 women underwent transvaginal mesh procedures. Many of the individuals who have pursued a lawsuit against the manufacturers of the mesh have obtained successful outcomes.

Victims of transvaginal mesh injuries could receive compensation to cover all medical bills, time missed from work and any other expenses resulting from their injuries. Let the attorneys at Elk & Elk represent your best interests.

It is important to remember that you will not be taking action against the doctor who implanted the mesh. The manufacturers of the mesh are the responsible parties, and have no relation to your physician in regard to the lawsuit.

For more information about the transvaginal mesh lawsuit, click here, contact us online or call 1-800-ELK-OHIO for a free, no obligation case consultation.

 

Hidden cancer risks for Hysterectomy and Fibroid Removal

womanpain-1

Uterine cancer is the fourth most common cancer in women in the United States and the most commonly diagnosed gynecologic cancer[1]. Prior to a hysterectomy or fibroid removal (myomectomy), the FDA estimates that approximately 1 in 350 women have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma.[2]

Stages of Endometrial (Uterine) Cancer

Undetected uterine cancer is frequently in Stage I, during which time, a woman could have no symptoms. However, shredding undetected tumors with a power morcellator can spread cancerous cells and upstage the disease. This “cancer seeding” can significantly worsen the patient’s long-term survival. After surgery, the cancer can progress from Stage I to Stage IV rapidly. Uterine cancer that has been upstaged by morcellation, such as leiomyosarcoma, is very aggressive. Some patients had the cancer spread to their spine or lungs. These tumors are difficult to treat, in large part because they are resistant to chemotherapy and radiation.

According to the American Cancer Society, endometrial cancer is staged based on examination of tissue removed during an operation. This is known as surgical staging, and means that doctors often can’t tell for sure what stage the cancer is until after surgery is done.

Stage I

The cancer is only growing in the body of the uterus. It may also be growing into the glands of the cervix, but is not growing into the supporting connective tissue of the cervix. The cancer has not spread to lymph nodes or distant sites.

Stage II

The cancer has spread from the body of the uterus and is growing into the supporting connective tissue of the cervix (called the cervical stroma). The cancer has not spread outside of the uterus. The cancer has not spread to lymph nodes or distant sites.

Stage III

The cancer has spread outside of the uterus or into nearby tissues in the pelvic area.

Stage IV

The cancer has spread to the inner surface of the urinary bladder or the rectum (lower part of the large intestine), to lymph nodes in the groin, and/or to distant organs, such as the bones, lungs, or the omentum (a layer of fatty tissue that covers and supports the intestines and organs in the lower abdominal area).

Hysterectomy and Fibroid Removal Power Morcellator Cancer Symptoms

Some symptoms that could signal upstaged cancer after morcellation, include:

  • Vaginal bleeding or spotting, between periods or especially after menopause
  • Vaginal discharge
  • Pelvic or abdominal pain or a mass
  • Pelvic or abdominal swelling
  • Weight loss
  • Nausea or vomiting

If tumors affect other organs or bones such as the spine, symptoms could include back pain or nerve issues.

In 2014, the FDA issued a black box warning against the use of laparoscopic power morcellators. If you had a minimally invasive hysterectomy or myomectomy (fibroid removal) call us today at 1-800-ELK-OHIO. You may be entitled to compensation.


 

Resources:

[1] U.S. Cancer Statistics Working Group. United States Cancer Statistics: 1999–2011 Incidence and Mortality Web-based Report. Atlanta (GA): Department of Health and Human Services, Centers for Disease Control and Prevention, and National Cancer Institute; 2015.

[2] U.S Food and Drug Administration. (2014, November 24.) Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication. Retrieved from http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm.

 

J&J Pulls Hysterectomy Tool Due to Cancer Risk

Depression. young attractive woman with an awful migraineJohnson & Johnson has asked all hospitals to return a surgical device that can spread cancer in women being treated for uterine growths called fibroids. The company has instituted a voluntary “worldwide market withdrawal” of the surgical tool known as a laparoscopic power morcellator.

During laparoscopic hysterectomies and myomectomies, surgeons use a power morcellator to cut fibroids and uterine tissue into smaller pieces. The procedure has long been preferred over open abdominal surgery, which has an increased risk of infection, requires a longer hospital stay, as well as more time before the patient can return to normal activity.

However, in April 2014, the FDA announced that the device could spread undetected cancer cells throughout the abdominal cavity. Shortly thereafter, Johnson & Johnson suspended sales of new devices.

In a letter sent to healthcare providers on July 30, 2014, Johnson & Johnson’s Ethicon unit states:

We believe Ethicon Morcellation Devices perform as intended and there are patients who can benefit from procedures using laparoscopic power morcellators, but the risk-benefit assessment associated with the use of these devices in hysterectomy and myomectomy procedures for removing fibroids remains uncertain.

So, how risky is the procedure? A recent study published in the Journal of the American Medical Association (JAMA) estimates that one in 370 women who undergo a laparoscopic hysterectomy using a power morcellator has undiagnosed uterine cancer.

Colleen Daley, who lost her sister to rare and aggressive uterine cancer called leiomyosarcoma after a power morcellator procedure, asked the FDA advisory committee,

“Would you permit your wife or sister to undergo a procedure that has a one in 351 chance of spreading cancer throughout the body?”

Several manufacturers of power morcellators are now facing lawsuits from women who allege they were never warned the devices can spread cancer if they are used in a hysterectomy or fibroid surgery.

 

Source:

Johnson & Johnson Pulls Hysterectomy Device From Hospitals” by Jon Kamp and Jennier Levitz, The Wall Street Journal, July 30, 2014.

$100M NuvaRing Settlement

There may finally be a resolution for the thousands of NuvaRingiStock_000010165267Small® users who filed product-liability claims against Merck & Co., alleging the contraceptive device caused blood clots that caused heart attacks, or led to death in some cases. Last week, the pharmaceutical giant announced it would pay $100 million to resolve nearly 4,000 cases, with an estimated average payout of $58,000.

NuvaRing is a vaginal contraceptive ring, which releases the hormones estrogen and progestin. While all combined hormonal contraceptives carry risks, independent studies show that women using NuvaRing are twice as likely to develop venous thrombosis (blood clots in a vein) compared with women using oral birth control pills.

More than 3,800 lawsuits have been filed in state and federal courts in Missouri and New Jersey, claiming Merck put profits over safety and failed to provide proper warnings on the NuvaRing label.

Although the settlement does not include any admission of fault, plaintiff’s attorney Kristine Kraft said, “I believe this is an outstanding and favorable settlement for the women who have been harmed as a result of their use of NuvaRing.”

Merck’s offer is contingent upon at least 95 percent of the eligible claimants opting into the program. If more than 5 percent of plaintiffs refuse the settlement, Merck can rescind the offer, forcing the injured parties to wait even longer for an uncertain outcome.

While many victims of negligence want their day in court, mounting medical bills and other costs can make a quick settlement seem like an attractive offer. If you have been injured due to a dangerous drug or defective medical device, it is important to speak to an experienced attorney to discuss your individual circumstances.

 

Source:

Merck to Pay $100 Million NuvaRing Pact If Women Join” by Jef Feeley and David Voreacos, Bloomberg News, February 8, 2014.

Surgeon Performed Unnecessary Operations, Took Kickbacks

Nearly 30 patients in California have sued neurosurgeon Dr. Aria Sabit for medical malpractice; alleging he subjected them to needless spinal surgeries using implants supplied by a company from which he profited.

Dr. Sabit has already settled six of the cases out of court for undisclosed amounts. In the latest suit, an elderly patient named Vicenta Aguirre sued Sabit for medical malpractice, alleging fraud, deceit, concealment and negligence.

Physician kickbacks

Among her claims, Aguirre accuses the surgeon of performing excessive surgeries on the elderly, profiting from the hardware he implanted, and failing to meet the standard of care for sterile techniques, resulting in high infection rates, longer recovery times, and the need for additional surgical procedures. The lawsuit also states that Sabit owned an interest in Reliance Medical and Apex Medical Technologies, medical products distributors.

Conflict of interest

These cases bring to light a growing problem in the medical community: Physician-owned Distributors (PODs), also known as physician owned companies or intermediaries. A 2011 congressional report titled “Physician Owned Distributors (PODs): An Overview of Key Issues and Potential Areas for Congressional Oversight,” by the Senate Finance Committee reveals:

The basic arrangement involves medical device companies formed to give physicians a share in the profits generated by the sale of implants and other medical devices… In effect, these entities act as a middleman entity that exists to give its physician investors the opportunity to profit from the sale and utilization of the medical devices they provide to hospitals.

Proponents of PODs maintain that such arrangements decrease costs by eliminating the profits of traditional distributors. However, in March of 2013, the Office of the Inspector General (OIG) issued a Special Fraud Alert, which found that PODs have substantial fraud and abuse risk and pose dangers to patient safety.

This month, the Office of the Inspector General released a 27-page report entitled, “Spinal Devices Supplied By Physician-Owned Distributors: Overview of Prevalence and Use.” The OIG concluded:

  • In 2011, POD-supplied medical devices were used in nearly 20 percent of spinal fusion surgeries billed to Medicare.
  • Spinal fusion surgeries that used PODs devices used fewer devices but did not have lower device costs
  • When hospitals began purchasing devices from PODs, their rates of spinal surgery grew faster than average and they performed more spinal surgeries than those that did not.

These results appear to confirm the OIG’s concerns that PODs are associated with corruption of medical judgment, overutilization, increased costs to the Federal health care programs and beneficiaries, and unfair competition.

Disclosure requirements

Some hope that new reporting required by the Physician Payments Sunshine Act (also known as “Open Payments”) will increase disclosure of such relationships. Designed to decrease the potential for conflicts of interest in health care, the Sunshine Act requires drug, biological and medical device manufacturers and group purchasing organizations to annually disclose direct and indirect ownership and investment interests held by physicians and their immediate family members. However, as the OIG explains,

…disclosure in and of itself does not provide sufficient assurance against fraud and abuse…[because] disclosure of financial interest is often part of a testimonial, i.e., a reason why the patient should patronize that facility. Thus, often patients are not put on guard against the potential conflict of interest, i.e., the possible effect of financial considerations on the physician’s medical judgment.

Furthermore, not all PODs will be required to report under the Act. Although the rule is written to include most entities that purchase medical devices for resale to others, the language of the statute does not encompass all POD models.

When told an operation is necessary, many patients check the credentials of their surgeon. Websites allow the public to check a doctor’s board certification, hospital or ambulatory center accreditation, membership in prestigious fellowships or other organizations, and even online patient reviews. Now it seems we will also need to find out if our doctor is in the business of selling medical devices.

Bottom line: Always get a second opinion.

 

Sources:

“Alarming Allegations Against Spinal Surgeon” by Matt Reynolds, Courthouse News Service, November 1, 2013.

California Board Moves to Discipline Surgeon in Federal Probe” by John Carreyrou, The Wall Street Journal, September 17, 2013

“Final Sunshine Rule Requires Reporting of Physician Ownership in GPOs and Health Products Manufacturers” by Hall, Render, Killian, Heath & Lyman, P.C., Health Law News, March 13, 2013.

Medical Apps – Who’s Responsible?

FDA looking at mobile medical applications

photo_13870_20090831From programming your DVR to dealing with a car accident, these days there seems to be an “app” for everything. Now, according to the U.S. Food and Drug Administration, when a mobile device runs certain medical applications, it will be subject to FDA oversight.

The FDA has issued guidance to mobile app developers in an effort to protect patients from medical apps that could be harmful if they do not work properly. The guidance document states that the FDA will focus its oversight on medical mobile apps that meet the definition of a medical device in the Federal Food, Drug, and Cosmetic Act and are intended to:

  • transform a mobile device into a medical device regulated by FDA; or
  • be used as an accessory to a medical device regulated by the FDA

A mobile device is “transformed” into a medical device when it performs the same task as a medical device that is already regulated by the FDA, such as controlling the inflation and deflation of a blood pressure cuff. Accessories to medical devices would include apps that enable physicians to make diagnoses based on medical test results sent to their mobile device, such as x-rays or blood work.

Not all medical apps will be regulated

While many medical apps may fall into these two categories, the FDA stated they are focusing their oversight “on mobile apps that are devices for which safety and effectiveness are critical.” This means apps that recommend calorie or carbohydrate intake or track trends in a patient’s blood pressure or glucose levels would not be regulated.

As more medical apps are developed for the healthcare industry, the government must adapt its standards to protect patients and to set standards for liability in the event of an adverse effect. The FDA has made it clear that their policy only applies to the application software and not to the use of smartphones or tablets themselves. Providers of mobile medical apps, such as the iTunes store, would not be treated as a medical device manufacturer.

The FDA has already cleared around 100 mobile medical apps so far, and experts expect the market to grow exponentially in the future. If you are considering using a medical app on your mobile device, it is important to speak to your doctor. While many of these apps are helpful, they are not meant to be a substitute for care from a qualified professional.

 

Sources:

FDA to regulate some medical-related apps” by Michelle Castillo, CBS News, September 24, 2013.

“Keeping Up with Progress in Mobile Medical Apps” FDA Consumer Health Information, September 2013.

FDA to Track Medical Devices

The Food and Drug Administration (FDA) has issued a new rule requiring that most medical devices distributed in the United States carry a unique code. The code, also known as a unique device identifier (UDI), will include information about each specific device, including: model number, lot or batch number, serial number, the date the device was manufactured, and, if applicable, an expiration date.

These codes will be stored in a database accessible to the public, but it will not include personal information about patients. The Global Unique Device Identification Database (GUDID), will enable doctors, companies and regulators monitor safety concerns more efficiently.

According to the FDA website, the UDI system will have many benefits when the system is fully implemented – in 7 years. The Associated Press reports:

The FDA will begin phasing in the new system in the coming year, starting with high-risk devices like heart stents and defibrillators. The requirement will then be expanded to moderate-risk devices such as X-ray systems, surgical needles and power wheelchairs. Makers of those devices will have three years to implement the tracking codes. Many low-risk devices, such as bandages, will be exempt from the requirements.

Given the number of patients harmed by  recalled medical devices, doctors and patient advocate groups are pleased with the new regulations. Patients have recently reported adverse reactions to a wide range of devices, including hip replacement systems, knee replacements, surgical mesh, and the Mirena Intrauterine Device.

“The rule that came out today is a victory for patients, hospitals and clinicians,” said Josh Rising, director of Pew Charitable Trusts’ medical device initiative. “Up until now medical devices were among the only products on the market that could not be uniquely identified. This is going to be a tremendous victory for all of those interested in improving the performance of devices.”

If you have been injured by a defective product, it is very important to report the incident. Call the experienced medical device attorneys of Elk & Elk for more information at 1-800-ELK-OHIO or contact us online.


Sources:

FDA requires tracking codes on medical implants” by Matthew Perrone, Associated Press/USA Today, September 20, 2013.

The final rule was published in the Federal Register today (9/24/13) and is available online at http://federalregister.gov/a/2013-23059.

Johnson & Johnson Considers $3 Billion Settlement

Healthcare giant Johnson & Johnson is reportedly contemplating a massive settlement agreement with patients injured by their DuPuy unit’s ASR Hip Implant. Bloomberg News reports that “five people familiar with the matter” revealed that J&J may be willing to pay more than $300,000 per case, pushing the total settlement amount over $3 billion if most plaintiffs accept the offer.

In August 2010, DePuy Orthopaedics, a division of Johnson & Johnson, issued a voluntary recall of its ASR™ XL Acetabular Hip System and DePuy ASR™ Hip Resurfacing System. According to the U.S. Food & Drug Administration (FDA), the recall was due to the high failure rates associated with the metal-on-metal hip replacement devices.

More than 11,500 lawsuits have been filed against J&J in the U.S., with plaintiffs alleging the metal-on-metal implants caused a number of serious complications, including pain, swelling, and metallosis (a build-up of metal debris in the soft tissue of the body) which sometimes resulted in revision surgery to replace the failing hip.

Too Early to Guess

Two individual trials involving DePuy ASR recall claims have already concluded in other states with split results. In March of this year, a plaintiff was awarded more than $8 million after a California jury found that the ASR implant was defectively designed. However, just a few weeks later, a jury in Chicago found in favor of Johnson & Johnson in a second trial.

No official word has come from Johnson & Johnson regarding a settlement ahead of litigation. DuPuy representative Laurie Gawreluk issued an email stating, “Reports about a possible resolution of the litigation are premature and speculative, including any estimates of resolution amounts.”

Several consolidated federal cases will soon be heard around the country. The Court has scheduled McCracken v. DePuy Orthopaedics, Inc., et al., Case No 1:11 dp 20485, to be the first bellwether trial. The case will be heard on September 9, 2013 at the U.S. District Court, Northern District of Ohio (Cleveland).

Stryker Hip Implant Recall

In July of 2012, two other types of hip systems were also recalled.  The Rejuvenate Modular Primary Hip System and Rejuvenate Total Hip System, both manufactured by the Stryker Corporation, were recalled due to possible side effects similar to those seen in metal-on-metal hip implants.

Design issues are a key factor in these devices, but so is the choice of materials. Using the combination of titanium and cobalt chromium in a modular implant can result in corrosion. In addition, it exposes patients to potential multi-organ injuries from the release of heavy metals into the body. A study of the U.S. Food and Drug Administration’s Adverse Event database reveals Stryker Rejuvenate Modular Hip System has been linked to a number of problems and has caused injuries to patients, as well as requiring painful additional surgical operations to remove the devices.

If you have experienced pain and discomfort as a result of a Stryker hip implant, please call our medical device attorneys today. We can be reached 24 hours a day, 7 days a week, 365 days a year at 1-800-ELK-OHIO or just fill out our easy no-obligation online contact form.

 

Source:

J&J Said to Weigh $3 Billion Settlement of Its Hip Implant Cases” by Jef Feeley & David Voreacos, Bloomberg News, August 21, 2013.