Medical Devices

What can I do?

If you feel you have a claim, our attorneys would like to talk to you. You may be entitled to compensation. Contact us today for a free, no-obligation legal consultation.

Power Morcellators

In April 2014, the U.S. Food and Drug Administration (FDA) urged doctors to stop using a medical device called a power morcellator, because studies showed the device may spread cancer. >An estimated 1 in 350 women develops uterine sarcoma — a type of uterine cancer — after undergoing a morcellator procedure. Morcellators are typically used to grind away uterine growths such as fibroid tumors, and in hysterectomies. They became popular as a less invasive surgical alternative. The FDA conducted a formal review of the devices in July 2014 and announced that its concerns with the morcellator were confirmed. During this time, Johnson & Johnson >announced it would stop selling the surgical tools.

Talcum Powder

As many as 2,200 cases of ovarian cancer diagnosed each year may have been caused by regular use of talcum powder. Talc is a mineral made of up various elements including magnesium, silicon and oxygen. Talc is ground to make talcum powder which is used to absorb moisture and is widely available in various products including baby powder and adult products including body and facial powder. Talc products used regularly in the genital area could increase the risk of ovarian cancer if the powder were to travel through the vagina, uterus and fallopian tubes to the ovaries. A jury recently found consumer health care products manufacturer Johnson & Johnson knew of the cancer risks associated with its talc products but failed to warn consumers.

According to a recent study published by the Cancer Prevention Research journal, the use of talcum powder-based products on a woman’s genitals increases the risk of developing ovarian cancer in a woman’s lifetime. This is because the particles that make up talcum powder are extremely fine. When directly applied to a woman’s genital area on a habitual basis, the particles may travel into the vagina, through the fallopian tubes and settle in the ovaries. The ovaries may then become hindered by the presence of talcum powder particles, resulting in an irritation that allows cancer cells to form, grow and spread.

Ovarian cancer is one of the most deadly forms of cancer. This is largely due to the fact that symptoms are often vague and diagnosis is missed until the cancer has progressed to an advanced stage and/or spread into other areas of the body such as the abdomen and pelvic region.

Ovarian cancer symptoms may include bloating, abdominal pain, changes in bladder and bowel movements and overall fatigue. Ovarian cancer may take several opinions before being correctly diagnosed.

An estimated 20,000 women are diagnosed each year with ovarian cancer, and more than 14,000 die. The disease strikes about one in 70 women, though studies show that women who use talc-containing products on their genitals have a one in 50 chance of developing the disease. An expert at trial testified at least 45,000 women have died as a result of

ovarian cancer that could be attributed to talcum powder use on the genitals, and estimated 1,500 women will die within the next year as a result of talc use.

Talcum Powder Lawsuits

Ristesund v Johnson & Johnson

On May 2, a jury in the City of St. Louis Circuit Court awarded Plaintiff Gloria Ristesund $55 million in her lawsuit against Johnson & Johnson alleging her ovarian cancer was caused by the company’s talcum powder products. Ms. Ristesund used Johnson’s Baby Powder for more than 40 years for feminine hygiene. The jury’s award included $5 million for actual damages and an additional $50 million in punitive damages. This was

the third trial in which Johnson & Johnson was found liable for ovarian cancer linked to its talc-containing products, and the second trial to award damages to the Plaintiff.

Fox v Johnson & Johnson

On Feb. 22, 2016, a jury in City of St. Louis, Mo., Circuit Court found Johnson &  Johnson liable for the development of Plaintiff Jacqueline Fox’s ovarian cancer and awarded her family a verdict of $72 million. Ms. Fox passed away from ovarian cancer in October 2015. She used talc-containing products for 35 years. The verdict includes $10 million in actual damages and $62 million in punitive damages.

Medtronic Insulin Pump

Beginning in April 2013, the Medtronic Paradigm® Insulin Pump has been the subject of a number of medical device safety alerts and recalls issued by its manufacturer and the U.S. Food and Drug Administration (FDA). The most serious of these notices include recalls of Medtronic MiniMed Paradigm Insulin Infusion Sets and Infusion Set Reservoirs.

The week of April 17, 2013, the FDA issued a Class II recall of the Medtronic MiniMed Paradigm Insulin Infusion Pump, intended for use to deliver insulin to people with diabetes. Medtronic recalled the pumps because the pump’s drive support cap may become detached from the pump case and protrude from the lower right side of the pump. When the pump is exposed to water, it may result in damage to the pump’s internal electronics, which can prevent the pump’s buttons from working properly or can cause the pump to alarm.

Model numbers affected by this recall include: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K, MMT-554, and MMT-754. The recall includes about 428,000 units distributed worldwide.

On June 7, 2013, the FDA issued a Class I Recall on Medtronic MiniMed Paradigm Infusion Sets. A Class I recall is the most serious type of recall and involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death. If insulin or other fluids come in contact with the inside of the tubing connector, it can temporarily block the vents that allow the pump to properly prime.

If the pump’s vents are blocked, this can potentially result in too much or too little insulin being delivered, which may cause hypoglycemia or hyperglycemia. In extreme cases, these conditions may cause loss of consciousness or death.

The Paradigm infusion sets are intended for use with the Paradigm insulin infusion pump. Infusion sets are used by patients with diabetes who require administered insulin to maintain acceptable blood glucose levels.

This recall affects the following model numbers: MMT-317, MMT-318, MMT-324, MMT-325, MMT-312S, MMT-312L, MMT-386, MMT-387, MMT-394, MMT-396, MMT-397, MMT-398, MMT-399, MMT-377, MMT-378, MMT-381, MMT-382, MMT-383, MMT-384, MMT-368, MMT-862, MMT-864, MMT-866, MMT-874, MMT-876, MMT-884, MMT-886, MMT-921, MMT-923, MMT-925, MMT-941, MMT-943, MMT-945, MMT-961, MMT-963, MMT-965, & MMT-975 Paradigm Infusion sets.

On July 3, 2013, Medtronic sent an urgent medical device recall notice to its customers
alerting them of problems with certain lots of MMT-326A and MMT-332A Reservoirs

used with Paradigm Insulin Pumps. According to the notice, the recall was issued because of the potential for the reservoirs to leak. A leak in the reservoir may result in delivery of less insulin than intended. Also, a leak may lead to an insulin blockage in the infusion set, and a failure of the device to sound an alarm to notify patients. Medtronic says the defect is caused by abnormal wear on a tool used to manufacture reservoir stoppers. They are recalling all lots of reservoirs that contain stoppers manufactured with this tool.

Medtronic advised patients who obtain reservoirs from mail order suppliers, distributors, pharmacies or their physician’s office, or any other source, to check lot numbers to determine if they may be affected. Medtronic will replace all reservoirs from affected lots at no cost to patients.

Lots affected by the Medtronic Reservoir recall are: 118416432, 118461538, 118489386,

H8512826, H8420977,
118492449,118517079,
H8463297,
118424676,
H8491921, H8515317,
118467888,118494645,
H8422490,
118521052,
H8464121,
118437486,
H8469703, H8496561, H8539013, H8441420, H8471745, H8500423, H8541843,
118442973, H8473106, H8500472, H8584244, H8451531, H8473271, H8503372,
H8603292, H8452933, H8476270, 118503728, H8604958, H8455959, H8478398,
H8509305, H8627745, H8457716, 118485398, 118510440, 118635301, 118459557,
H8486688, 118512566.

 

The lot numbers are located on the side panel of the reservoir box, as well as on the side of the individual reservoir packaging. The lot number starts with an “H” and is followed by a 7-digit number. Patients are advised not to use any of the recalled reservoirs and to dispose of them immediately, and to use a backup plan or device for insulin delivery.

Essure

Essure is a permanent birth control device manufactured by Bayer Health care. The device consists of two small nickel alloy coils, which are implanted through the vagina into the fallopian tubes. Scar tissue forms around the coils, preventing sperm from reaching the eggs. Since its approval in 2002, 750,000 Essure devices have been implanted. Adverse events reported with Essure include migration, leading to perforation of the fallopian tube or uterine wall or embedment in other organs, often requiring hysterectomy or surgical removal; allergic reactions; severe pain; and infection

Mirena

Mirena® is an intrauterine device (IUD) that was originally approved by the FDA as an intrauterine contraceptive. It was later approved as a treatment for heavy menstrual bleeding. It works by slowly releasing a low dose of levonorgestrel (a synthetic progestin hormone) directly into the uterus. Serious adverse side effects and potentially life-threatening complications have been reported following the implantation of the device. These complications include organ perforation, migration of the IUD to outside the uterus, expulsion of the IUD, and embedment in the uterus, among others

Transvaginal Mesh

What is transvaginal mesh?

Transvaginal mesh is a type of surgical mesh used for the repair of common pelvic floor disorders including pelvic organ prolapse. It is sometimes called a bladder sling. It is designed to shore up organs, such as the bladder and uterus that have dropped, or prolapsed, due to age, obesity or childbirth. These pelvic floor disorders are relatively common conditions and can cause symptoms such as urinary incontinence, and pain or discomfort.

What are the concerns about transvaginal mesh / bladder slings?

The FDA has issued a safety communication warning doctors, health care professionals and patients that the placement of surgical mesh through the vagina to treat pelvic organ prolapse may present greater risk for the patient than other options.

The agency reported that between 2008-2010, more than 1,500 reports of problems associated with the devices in the repair of pelvic organ prolapse had been recorded — five times more than what the agency received between 2005-2007.

According to the FDA, reported complications from the transvaginal placement of the mesh include erosion of the mesh into the vaginal tissue, organ perforation, pain, infection, painful intercourse, and urinary and fecal incontinence. Often women require surgery to remove the mesh. In some cases, this can require multiple procedures without successfully removing all the mesh.

Women who have received transvaginal mesh or bladder slings to repair pelvic floor disorders such as pelvic organ prolapse (POP) or urinary incontinence and are experiencing problems may not realize that they may be able to hold the manufacturer of the devices liable and receive compensation for their pain and suffering.

What can I do?

Currently, we are investigating cases involving mesh manufactured by Bard, Boston Scientific, Caldera, and Johnson & Johnson.

If you or a loved one has received transvaginal mesh / bladder sling for the treatment of POP or urinary incontinence, and have experienced complications, you may have a claim

Actos

“Actos (pioglitazone)” manufactured by. Takeda Pharmaceuticals and distributed by Eli Lilly and Company, has been under FDA review since September 2010. In June 2011, the FDA issued a warning for Actos, while at the same time drug regulators in France and Germany suspended use of the drug, after it was linked to an increased risk for the development of bladder cancer.

Following its review, the U.S. Food and Drug Administration (FDA) approved updated warning labels for Actos, a prescription medication used to treat Type 2 diabetes. The updated label states that Actos usage for more than one year may cause bladder cancer.

The FDA reported in its data summary that “the risk of bladder cancer increased with increasing dose and duration of Actos use, reaching statistical significance after 24 months of exposure.”

Actos quickly became one of the top-selling drugs in the United States after it received FDA approval in July 1999. However, in June 2011, the FDA warned that patients taking Actos for one year or longer were exposed to a risk of bladder cancer 40 percent higher than those who hadn’t taken the drug and ordered Takeda to include a warning about the increased risk of bladder cancer on the drug’s labeling.

Most recently, a Canadian study led by Montreal epidemiologist Dr. Laurent Azoulay and published online in the British Medical Journal found that patients who take Actos two years or longer are twice as likely to develop bladder cancer as those who have never used the drug

Hip Replacements

Traditional hip implants are made with ceramic or plastic parts, but metal-on-metal implants were designed with all metal parts intended to be more durable and hold up better over time. However, that proved not to be the case. All-metal hip implants were failing at a higher than expected rate.

Hip implants should last as long as 20 years or more. Many of the metal-on-metal hip implants being investigated in this litigation have been found to fail within as little as five years. Many patients have had to undergo revision surgery to remove and replace their defective metal hip implant. These surgeries are typically more invasive and require longer recovery than initial hip replacement surgery.

Patients who reported problems in the first five years and had revision surgery reported a variety of symptoms, including pain, swelling and problems walking. These symptoms are normal for patients following a hip replacement, but can be a sign that something is wrong if they Continue or come back frequently. These symptoms may indicate serious problems, including:

  • Loosening — when the implant does not stay attached to the bone in the correct position
  • Fracture — where the bone around the implant may have broken
  • Dislocation — where the two parts of the implant that move against each other are no longer aligned

It was discovered that as the metal parts of the device rubbed together, bits of metal would fall into the joint space, inflaming and damaging tissue causing the device to fail.

The metal bits were also leeching into the bloodstream causing a type of blood poisoning known as metallosis. Short-term symptoms of metallosis range from fatigue to headaches. No one is sure of the long-term effects though some studies show that metallosis can damage DNA, which can lead to serious health complications including cancer.

Physicians advise people who have undergone hip replacement surgery who have, or think they have, a metal-on-metal implant to contact their orthopedic surgeon even if the joint appears to be functioning well to rule out metallosis.

These defective hip devices are manufactured by various companies, such as Johnson & Johnson and DePuy Orthopedics, among others. Lawsuits have been filed against the manufacturers of these defective hip implants by people who have been injured by the device.

PAIN PUMPS AND PAGCL

A recent study published by The American Journal of Sports Medicine (Postarthroscopic  Glenohumeral Chondrolysis , July 2007) identified intra-articular pain pumps as the likely cause of a condition known as Postarthroscopic Glenohumeral Chondrolysis (PAGCL). This is a devastating condition that can cause severe pain and stiffness in the affected shoulder, along with limitations on range of motion, reduced strength and the need for constant pain management. It is not uncommon for patients afflicted with PAGCL to require repeat surgical procedures, and the condition may ultimately require shoulder joint replacement surgery.

Furthermore, a paper presented at a 2006 meeting of the American Academy of Orthopedic surgeons showed that of 152 patients who underwent arthroscopic surgery, 12 developed PAGCL. All 12 patients who developed PAGCL after the surgery also had a pain pump during their surgeries. In fact, use of the pain pump was the only factor that all patients had in common.

WHAT IS PAGCL?

Postarthroscopic Glenohumeral Chondrolysis actually means a breakdown of the cartilage in the glenohumeral joint (the shoulder joint) following arthroscopic surgery. Essentially, the cartilage in the patient’s shoulder deteriorates, causing pain and stiffness. In some cases, the patient completely loses the ability to use the shoulder.

Symptoms of PAGCL include:

  • Pain when the shoulder is in motion and/or at rest
  • Clicking, popping and/or grinding,
  • Weakness or stiffness in the shoulder, and
  • Decreased range of motion.

WHAT IS THE PROGNOSIS FOR INDIVIDUALS DIAGNOSED WITH PAGCL?

Most patients who develop PAGCL will require surgery. Although some patients feel better with the use of anti-inflammatory medications, those who have lost all their cartilage require shoulder replacement surgery. Replacement surgery (arthroplasty) involves replacing the shoulder joint with plastic and metal parts. The surgery generally takes two to three hours to perform and patients may be required to stay in the hospital for up to three nights. Patients usually require physical therapy following the surgery