Drugs & Medical Devices

FDA Says Pelvic Mesh Products High Risk

January 8, 2016 | John Suthers

Thousands of lawsuits have been filed over the past six years against various manufacturers of surgical mesh products used to treat conditions such as pelvic organ prolapse and stress urinary incontinence in women. These lawsuits challenged the safety and effectiveness of these products, after years of reports of women experiencing pain, bleeding, infection and other complications caused by the mesh implants. Often, the complications resulted in women having to undergo multiple surgeries to repair or remove the mesh product. Now, the United States Food & Drug Administration (FDA) is finally getting on board with those of us who have been stating for years that these products are neither safe nor effective.

In July of 2011, the FDA concluded that women who were surgically implanted with vaginal mesh products had more complications than those who underwent traditional surgery involving stitches. At that time, the FDA issued an update on serious complications associated with the transvaginal placement of mesh for the condition known as pelvic organ prolapse (POP). This condition occurs when the tissue that holds the pelvic organs in place becomes weakened or stretched, resulting in the organs prolapse or bulge into the vaginal area, causing various and serious complications. In its 2011 update, the FDA informed doctors and patients that serious complications associated with the use of transvaginal mesh products for repair of pelvic organ prolapse were “not rare.”

This week, the FDA took a stronger stand against the use of surgical mesh products to repair POP in women, classifying transvaginal mesh products as “high-risk” medical products and subjecting them to additional regulatory scrutiny. Previously, these products were considered “moderate-risk” products. Now, the manufacturers of pelvic mesh products will have to submit new applications to the FDA, demonstrating both the safety and effectiveness of these mesh devices.

Zofran Linked to Serious Birth Defects

December 18, 2015 | Adam Harper

Suthers & Harper is actively investigating cases of birth defects caused by the drug Zofran. Recently, several medical studies have identified an association between Zofran (ondansetron) and birth defects. The manufacturer, GlaxoSmithKline (GSK), promoted the off-label use of the drug as a remedy for morning sickness in addition to its approved use as a drug for controlling nausea and vomiting after chemotherapy and surgery. However, Zofran was never approved for use during pregnancy, but GSK chose to market the drug to doctors treating pregnant women with morning sickness. Although it is not illegal for doctors to prescribe medications off-label, it is illegal for drug companies to market drugs for off-label uses. In 2012, GSK agreed to pay more than $1 billion to settle allegations that it illegally marketed medications – including Zofran – for off-label use

The results of studies done on Zofran’s risks to a developing fetus are very troubling. Because morning sickness most often occurs during the first trimester, the pregnant mother is taking Zofran at the infant’s most critical and fragile stage of development, when drugs can do the most damage. Birth defects that have been linked to Zofran include the following:

Cleft lip

Bard IVC Filter Lawsuits

August 19, 2015 | John Suthers

Medical device manufacturer, C.R. Bard, Inc., is back in the news and back in Federal Court. On August 18, 2015, the Judicial Panel on Multidistrict Litigation (JPMDL) announced that the lawsuits pending currently against C.R. Bard, Inc. and Bard Peripheral Vascular involving the IVC filter will be consolidated and transferred to the U.S. District Court for the District of Arizona. More than 200 pending cases will be transferred immediately, and it is believed that many more will follow.

An inferior vena cava (IVC) filter is a small medical device that is surgically implanted inside the body to capture blood clots before they migrate to other areas of the body, causing serious conditions such as a pulmonary embolism or stroke. However, a number of studies have shown that pieces can break away from the filter and migrate to other areas of the body, causing serious injuries and deaths. The New England Society for Vascular Surgery conducted a study, which concluded that the IVC filters fractured in 31% of the cases. These shards or splinters often migrated to the patients’ right ventricles of the heart. Another study found that in 25% of the patients studied, there were splinters that broke off, many of which migrated to the heart, lungs and the hepatic vein.

Before introducing these filters on the medical market, Bard knew that IVC filters were associated with serious side effects. However, this information was not conveyed to doctors. Bard knew the filters were prone to fracture, which could lead to perforations of the vena cava, surrounding vessels and organs, necessitating serious and life-threatening open surgical procedures. On July 13, 2015, the U.S. Food and Drug Administration (FDA) cited Bard for failing to report adverse events associated with the IVC filters and for illegally selling a device that was designed to retrieve the filters. It is believed that Bard has sold more than 500,000 IVC filters. With failure rates approaching 40% after five years of implantation, there are far too many patients with IVC filters who are at risk.

Invokana Linked With Serious Injuries

July 2, 2015 | Adam Harper

Invokana is part of a new class of type 2 diabetes drugs known as sodium-glucose-cotransporter-2 (SGLT2) inhibitors. SGLT2 inhibitors are designed to control diabetes by blocking reabsorption of glucose by the kidneys, impacting normal kidney function and allowing more sugar to be passed from the body through urine. However, the FDA has recently issued a new warning for a number of SGLT2 inhibitors, including Invokana (canagliflozin). The agency has stated that these diabetes therapies can cause high levels of acid to build up in the blood, causing diabetic ketoacidosis, which can lead to diabetic coma or death.

In the FDA’s announcement, the agency warned patients using SGLT2 inhibitors that they should seek immediate medical attention if they experience any symptoms of ketoacidosis, including:

Unusual fatigue or sleepiness

Xarelto Litigation Update

May 13, 2015 | John Suthers

Xarelto (rivaroxaban) is a prescription blood thinner that was developed by pharmaceutical giant Bayer, and marketed by Janssen Pharmaceuticals, a division of another pharmaceutical giant, Johnson & Johnson. Xarelto is typically prescribed to reduce the risks of suffering a stroke or blood clot in patients who have a heart rhythm disorder known as atrial fibrillation or A-fib. For example, Xarelto is commonly given to patients with atrial fibrillation who have undergone hip replacement or knee replacement surgery to prevent blood clots from forming after the surgery. The drug’s manufacturer is attempting to expand the use of Xarelto for patients with another heart condition known as acute coronary syndrome.

There have been multiple reports of Xarelto causing excessive bleeding in patients. This can result in severe and permanent injuries, or death, if the bleeding is uncontrolled. As a result, multiple lawsuits have been filed across the U.S. against the manufacturer of Xarelto and the marketer of the drug, alleging these companies failed to warn both patients and physicians of the increased risks of fatal internal bleeding when using Xarelto. Because of the number of lawsuits filed in federal courts across the U.S., in December 2014, the United States Judicial Panel on Multidistrict Litigation (MDL) created a Xarelto MDL and consolidated all of the cases in the U.S. District Court for the Eastern District of Louisiana. The Xarelto litigation is in the beginning stages.

Interestingly, litigation against the manufacturer of a similar drug, Pradaxa, was settled in May 2014 for $650 million. The Institute for Safe Medication Practices issued a report in 2013, stating that more patients had suffered serious, disabling or fatal injuries from taking Xarelto than those who took Pradaxa. It should come as no surprise that Bayer and Janssen Pharmaceuticals are fighting the litigation, since annual sales of Xarelto in the U.S. were expected to exceed $1 billion for 2014. The companies believe that the drugs sales could eventually reach $3.5 billion a year.

Bellwether Metal-on-Metal Hip Replacement Trial Begins

September 4, 2014 | Adam Harper

The first MDL bellwether trial began this week against DePuy Orthopaedics in connection with their Pinnacle metal-on-metal hip replacement product. This trial is the first of more than 6,000 cases filed across the country that have been consolidated in U.S. District Court in Dallas, Texas.

The Plaintiff in the case, Kathleen Herlihy-Paoli, aged 58, had two Pinnacle hips implanted in 2009 and soon began to complain of pain from the devices. Blood tests before her 2011 revision surgeries found the implants had released dangerous levels of cobalt and chromium into her bloodstream. Doctors found Mrs. Paoli’s cobalt blood serum levels were 85 times higher than normal, and an MRI also showed the presence of a sizable pseudotumor growing around her left hip implant.

In her Complaint, Ms. Herily-Paoli alleges that DePuy “knew, or should have known, of reports that metal-on-metal implants, such as the Pinnacle, generated unusually high amounts of metal debris over time due to unusual, premature or increased wear and tear,” and that the debris “can spread throughout the surrounding bone and tissue and cause serious complications and damage.” Further, the Plaintiff says DePuy officials misled patients and their doctors about the safety of the artificial hips, and sponsored a nationwide satellite telecast to orthopedic doctors to push the advantages of the Pinnacle device when they were already aware of the dangers of the product.

Testosterone Lawsuits Consolidated in Illinois Federal Court

July 16, 2014 | Adam Harper

AndroGel testosterone gel is a topical testosterone replacement therapy (TRT) manufactured by AbbVie, Inc. and formerly Unimed Pharmaceuticals of Abbott Laboratories, Inc. AndroGel is approved by the Food and Drug Administration (FDA) to treat men with low testosterone or “Low T,” associated with a diagnosed medical condition. AndroGel 1% and AndroGel 1.62%, are both applied topically to the skin. Patients apply it directly to their upper arm and shoulder and it is absorbed through the skin to deliver testosterone to the patient for approximately 24 hours. The drug has been heavily prescribed over the past several years as a safe way to treat men with low testosterone. However, numerous recent studies suggest that men taking AndroGel have a far greater risk of suffering a heart attack, stroke, congestive heart failure, or other adverse cardiovascular problem. The most recent study, known as the PLOS ONE study, performed on January 29, 2014, found that men 65 years and older who took testosterone injections or used the gel, had double the risk of a heart attack in the months after starting the treatment. On Jan. 31, 2014, after reviewing these studies, the FDA announced it would be investigating the risks of heart attack, stroke and death in men using prescription testosterone products.

On May 29, 2014, an order was issued that established a federal testosterone multidistrict litigation (MDL) before U.S. District Judge Matthew F. Kennelly in the Northern District of Illinois. The purpose of creating an MDL is to facilitate faster progression of a large number of lawsuits that have certain allegations of fact in common. An MDL is designed to eliminate inconsistent court rulings among these cases, as well as expensive and unnecessary duplication of discovery. All of the lawsuits that were transferred to the Northern District of Illinois allege that drugs such as AndroGel, AndroDerm, Axiron, Foresta, Testim and others caused serious, and sometimes fatal, cardiovascular problems in men. According to the June 6 Order, Plaintiffs predict the number of lawsuits associated with testosterone therapy side effects could eventually be in the thousands. (June 6, 2014 Order).

Suthers & Harper is currently investing claims on behalf of individuals who used AndroGel or other testosterone therapies and suffered heart attacks, strokes or other serious medical complications. Other testosterone therapies that have been associated with cardiovascular complications include Bio-T Gel, Delatestryl, Depo-Testosterone, Striant and Testopel.

Medtronic Pays $22 Million to Settle Spinal Fusion Lawsuits

May 14, 2014 | John Suthers

Medical product manufacturer, Medtronic, announced that it is paying $22 million to settle the claims of approximately 950 individuals involving Medtronic’s Infuse spinal surgery product. Moreover, Medtronic anticipates setting aside millions more to cover a larger number of claims that remain pending or will be filed in the future.

The Infuse product contained a drug known as BMP-2. BMP-2 is a genetically engineered bone morphogenetic protein-2. This product was approved by the United States Food and Drug Administration (“FDA”) in 2002. In conventional spinal fusion surgery, the surgeon normally harvests a small amount of bone from the patient’s hip and uses it in fusing the spine. Infuse and BMP-2 were considered to be an alternative to the traditional method of harvesting bone from the hip. The product turned out to be very popular with spine surgeons, leading to sales of approximately $800 million annually. To date, it is estimated that Infuse was implanted in more than 1 million people worldwide.

The Infuse litigation uncovered a conflict of interest between certain spine surgeons and the manufacturer. After the product was approved by the FDA, some prominent surgeons began authoring papers in medical journals, touting the benefits of the product, but failing to mention several potential, serious complications associated with the product. These complications included cancer, growth of unwanted bone, and sterility in men. When another group of doctors became concerned about the fact that these complications had been ignored by the authors of the articles, they began their own study and published the results in 2011 in the medical publication, Spine Journal. According to the study results, the risk of adverse events associated with BMP-2 is 10 to 50 times the original estimates that were reported in the industry-sponsored articles.

NuvaRing Contraceptive Product Lawsuit Update

January 22, 2014 | John Suthers

At present, more than 1,700 women have sued the manufacturers of NuvaRing, a prescription contraceptive device. NuvaRing was manufactured originally by Organon USA, Inc., a company which was subsequently acquired by Merck & Co., and was approved by the U.S. Food and Drug Administration (FDA) in October of 2001. The product consists of a vaginal ring that contains the hormones estrogen and progestin. NuvaRing was designed to be used monthly. It was marketed as being more convenient than daily birth control pills, but equally effective. A study that was commissioned by the FDA and published in 2011 reported a 56% increase in blood clot risks for NuvaRing users, including an increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), when compared to birth control pill users. In 2012, studies published in The New England Journal of Medicine and The British Medical Journal stated that the side effects of NuvaRing included an increased risk of blood clots, strokes and heart attacks.

One case that is pending against the manufacturers involves a then 20 year old college student, who began using NuvaRing in 2008. After using NuvaRing for more than a year, she suddenly became ill and began spitting up blood. She was rushed to the hospital, where she spent 10 days receiving anticoagulants in an effort to thin her blood. Her doctors had a hard time believing she had a blood clot in her lung because she was only 22 years old at the time, she did not smoke, and she had no family history of blood clots. Her doctors eventually concluded that she had developed a blood clot in her lung, a condition known as pulmonary embolus, which can be fatal. Because she was a healthy 22 year old at the time and did not have other risk factors for blood clots, her doctors concluded that NuvaRing caused the blood clot.

A 24 year old woman who had used NuvaRing was not so fortunate. She suffered what was described as a massive pulmonary embolism that, in turn, triggered four heart attacks, resulting in her untimely death. Her doctors also believed that NuvaRing was the cause of her pulmonary embolism. In 2011, her parents filed a lawsuit against the product manufacturers.

Stryker Spine Plate Recall Lawsuit

September 16, 2013 | Adam Harper

A Class I recall was recently issued for Stryker Spine’s OASYS Midline Occiput Plate warning patients and physicians that the device is at risk for fracture. According to the FDA, the recall affects products that were distributed from April 23, 2010 through February 12, 2013. The OASYS Midline Occiput Plate is part of the OASYS Occipito-Cervico-Thoracic System and was used in fusions of the cervical spine and occipito-cervico-thoracic junction (Occiput – T3). The OASYS Midline Occiput Plate was originally designed to provide stabilization at the junction between the occipital bone and the vertebrae in the cervical spine.

Over the last several months Stryker has received numerous reports indicating post-operative fracture of the pin that connects the tulip head to the plate body. In May of this year the company first issued a recall, warning of serious health consequences including blood loss and nerve damage. Then, in June, Stryker notified spinal implant surgeons that it is recommending routine clinical and radiographic post-operative evaluation for patients with an implanted OASYS Midline Plates, and that those experiencing pain, weakness, or numbness may require revision surgery to replace the fractured implant.

It is important to remember that a Class I Recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these recalled products will cause serious adverse health consequences or death. If you or a loved one has been implanted with and injured by the Stryker OASYS Midline Occiput Plate it is important you contact your physician as soon as possible. Additionally, you should take action to secure the compensation you need and ensure that the responsible parties are held accountable for any harm done to you or a loved one. The lawyers at Suthers & Harper have years of experience litigating defective medical device cases. Suthers & Harper is currently investigating cases on behalf of individuals who were injured after being surgically implanted with Stryker’s Spine OASYS Midline Occiput Plate. To discuss a potential lawsuit for yourself, a family member or friend, call 1-800-320-2384 or go to www.sutherslaw.com for a free Stryker lawsuit consultation.