Articles Posted in Drugs & Medical Devices

Hernia mesh is a medical device that is used to repair hernias, which occur when internal organs bulge out through a weak spot of muscle. The only way to permanently fix a hernia is with surgery. However, hernias often return and need another surgery. To reduce this risk, surgeons implant hernia mesh inside the body to reinforce weak tissue. Most of the mesh devices are made from synthetic materials like polypropylene, a kind of plastic.  Some type of hernia mesh product is used in more than half of all hernia surgeries in the United States.

Unfortunately, patients that have had a hernia repaired with mesh are experiencing a number of complications including:

  • Pain

All of us have been taught the importance of being personally responsible and accountable for our actions. This week, the U.S. House of Representatives will vote on Bills that will make it more difficult, if not impossible, for citizens harmed by the wrongdoing of others to seek justice in our nation’s courts. Congress is proposing legislation that will make lawsuits brought by injured patients, nursing home residents, and their families nearly impossible to pursue. This so-called “Protecting Access to Care Act of 2017” (Bill H.R. 1215) will rig the system against individuals and tip the scales in favor of doctors, hospitals, nursing homes and their insurance companies. These bills seek to prevent medical care providers who commit negligence from being held accountable for the injuries and damages they cause. Instead of protecting our most vulnerable citizens, such as nursing home residents, Congress is attempting to enact laws that will benefit only the corporations that run nursing homes and the companies that insure them.

Unfortunately, certain politicians, who are supported in large part by corporations and insurance companies, are proposing these laws that are designed to destroy your right to hold wrongdoers accountable for their negligent acts and omissions.  If passed, the Bills proposed will radically change existing laws and radically limit citizens’ access to courts.  The proposed Bills include the following:

  1. A law designed to protect doctors, hospitals, nursing homes, and medical device manufacturers by limiting compensation for injuries caused by their negligence to $250,000, regardless of how egregious their conduct was or how much the injury has devastated a victim’s life.

The Australian Therapeutic Goods Administration (TGA), similar to the United States Food and Drug Administration (FDA), issued a Hazard Alert on September 27, 2016 for Stryker LFIT Anatomic CoCr V40 femoral heads. The LFIT V40 is a femoral head that orthopedic surgeons utilized in hip replacement surgeries. The Stryker LFIT V40 can be used interchangeably with Stryker’s entire product line of modular total hip replacement devices and is designed to offer a large range of offsets based on a patients’ needs. According to the Australian TGA, some LFIT Anatomic CoCr V40 femoral heads have a “higher than expected incidence of taper lock failures.” The taper lock connects the femoral head and femoral neck of the hip prosthesis. If the taper lock fails, the patient can suffer severe complications including catastrophic disassociation and metallosis, resulting in the need for emergent revision surgery. These conditions can lead to the destruction of tissue in the area of the implant, causing all sorts of complications. Stryker has recently notified orthopedic surgeons who have implanted the LFIT V40 of the increased incidence of taper lock failure and ensuing complications.

The Defective Medical Product attorneys at Suthers Law Firm are investigating the Stryker LFIT CoCr V40 femoral head cases on behalf of patients who were implanted with these devices and have suffered complications. These attorneys previously prosecuted cases successfully against Stryker on behalf of  many patients who were surgically implanted with Stryker Rejuvenate hip replacement products, which products were recalled by the FDA because of similar complications.

After DePuy Orthopaedics, a subsidiary of Johnson & Johnson, recalled two models of its metal-on-metal hip replacement products in August of 2010, thousands of lawsuits were filed against the product manufacturer.  DePuy Orthopaedics recalled its ASR Acetabular System and the ASR Hip Resurfacing System after reports of high rates of failures by the products, leading to the patients needing revision (removal) surgery.  Similarly, Stryker Orthopaedics recalled in July of 2012 its Rejuvenate and ABG II hip implant products after multiple reports of produMetal-on-Metalct failures due to heavy metal fretting and corrosion.  Thousands of lawsuits were also filed against Stryker thereafter.

There were essentially two classes of victims involved in the litigation.  The majority of the lawsuits were filed on behalf of individuals who had suffered injuries, including loosening or instability in the hip joint, dislocations, difficulty walking and moving the hip properly, pain, inflammation or swelling in the area of the hip implant, tissue destruction or tissue necrosis, and elevated levels of cobalt and chromium in the bloodstream, a condition known as metallosis.  These individuals had to undergo revision surgery or surgeries during which the metal-on-metal hip implant was removed and replaced with a more traditional hip replacement product that utilized a metal femoral head with a plastic liner in the cup.  Many of the lawsuits that were filed on behalf of individuals who had already undergone revision surgery or surgeries have settled.  A substantial number of lawsuits remain pending on behalf of individuals who were surgically implanted with these defective hip products, but who have not yet undergone revision surgery.  These individuals have not yet had revision surgery because the injuries and problems resulting from metal-on-metal have not yet manifested themselves, or the patients have symptoms or problems, but their physicians have not yet recommended revision surgery.

One of many problems associated with metal-on-metal hip replacement products was the corrosion or fretting caused by the metal femoral head (ball) rubbing against the metal cup.  The constant rubbing of the two metal surfaces caused scratching or corrosion of the femoral head, acetabular liner, and/or the metal cup.  This resulted in metal debris or particles known as ions getting into the bloodstream and adjacent tissues, contributing to implant failure and tissue destruction.  The metal components of the hip replacement products contain cobalt and chromium.  When metal ions containing cobalt and/or chromium are released into the bloodstream or adjacent tissue, these particles are toxic to soft tissue, bone and muscle.  In essence, this poisons the hip joint.  The term “metallosis” has been used to describe excess levels of cobalt and/or chromium in a victim’s bloodstream.  Surgeons who have removed the defective hips have seen and documented the extensive tissue destruction and necrosis surrounding the hip implant area.

According to new research out this month, a popular group of medications used to treat heartburn, gastroesophageal reflux disease (GERD), stomach ulcers and irritation of the esophagus caused by acid reflux could increase the user’s risk of developing kidney disease and kidney failure.  The drugs are known as proton pump inhibitors (PPI), and are marketed and sold under well-known names such as Nexium, Prilosec and Prevacid.  Proton pump inhibitors work by blocking the production of stomach acid.

The new study published by the American Society of Nephrology linked these popular stomach acid medications to an increased risk developing chronic kidney disease.  The study utilized data from the United States Department of Veterans Affairs.  Researchers discovered that individuals who took PPIs had a 96% increased risk of developing kidney failure.  The study also concluded that such individuals had a 28% increased risk of developing chronic kidney disease compared to patients who took other medications, such as histamine H2 receptor blockers, instead to treat problems associated with stomach acid.  The study also concluded that individuals who took PPIs for a longer time period were more likely to develop kidney problems.

It is estimated that in America alone, 15 million people take prescription proton pump inhibitors.  However, that number is likely underestimated since a number of these medications are now available over-the-counter.

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
Suthers Law Firm 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

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 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 bottle
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.