Injuries Caused by Drugs or Medical Devices

Portner & Shure Law Firm Serving Maryland, Virginia & Washington D.C.

Drug Injuries

Benicar

Why are there lawsuits?

Over 1,700 claims have been filed against the manufacturer of Benicar, Daiichi Sankyo, for severe gastrointestinal problems. Benicar was introduced in 2012 to treat high blood pressure. However, in 2013, the FDA issued a Warning that the drug can cause spruce-like enteropathy (intestinal problems). Lawsuits quickly ensued following this Warning.

What is the purpose of the drug?

Benicar was prescribed to treat high blood pressure. In fact, it was the most widely prescribed blood pressure medication in the country. The medication works by blocking receptors that cause blood vessels to constrict, thereby allowing blood vessels to become dilated.

What are the injuries and side effects?

The popular blood pressure medication can cause serious gastrointestinal issues, including diarrhea and villous atrophy (disorder that causes the intestinal lining to lose texture and makes nutrient absorption difficult). Without proper nutrient absorption, affected persons become malnourished, nauseous, and lose weight. The difficulty with properly diagnosing these side effects is that oftentimes these symptoms reveal themselves as celiac disease, which proves to be incorrect. If this condition goes untreated, a person can starve to death because their body cannot absorb any nutrients from food.

Invokana

Why are there lawsuits?

Lawsuits have been filed against Johnson & Johnson, the manufacturer of Invokana, arguing that they withheld risks of kidney failure, diabetic ketoacidosis, and heart attacks from users of the drug. After being introduced in 2013, Invokana became a very popular prescribed diabetes drug, especially as the number of people diagnosed with diabetes rose. In 2015, the FDA required Johnson & Johnson to include Warnings about these serious side effects.

What is the purpose of the drug?

Invokana is a drug prescribed to people with Type 2 Diabetes that helps lower blood sugar and improve glycemic control. The drug is designed to lower blood glucose levels by inhibiting some kidney functions.

Invokana is the only Type 2 Diabetes drug that uses the kidneys and allows a high level of glucose to enter the kidneys. It works by causing blood sugar to leave the body through urine.

What are the injuries and side effects?

Invokana Side EffectsUse of Invokana can cause kidney failure, heart attacks, stroke, and ketoacidosis. Since it has been on the market, numerous reports of complications and serious side effects have occurred, the most common problem being an accumulation of high levels of acid.

You may be entitled to compensation if you suffered kidney failure within 45 days of last use of the drug, diabetic ketoacidosis within 15 days of last use, or heart attack within 15 days of last use.

 

 

Taxotere

 

Why are there lawsuits?

Women who have taken the chemotherapy drug Taxotere have suffered permanent alopecia (hair loss). Drug manufacturer Sanofi-Aventis Failed to Warn of the risk of permanent hair loss for those taking the drug.

What is the purpose of the drug?

Taxotere is a common chemotherapy drug used to treat various forms of cancer, including breast cancer, stomach cancer, head and neck cancer, and prostate cancer. Taxotere is the most prescribed drug in its class and is most commonly prescribed for women seeking treatment for breast cancer.

What are the injuries and side effects?

A common side effect of chemotherapy is hair loss. But that hair loss is just temporary. Users of Taxotere for chemotherapy treatment were left with permanent hair loss. While hair loss may only be a cosmetic injury, for cancer survivors it is an emotional and physical loss that they suffer. It is a constant reminder of their struggle and pain in fighting the horrific disease.

Xarelto

Why are there lawsuits?

Users of Xarelto can suffer uncontrollable internal bleeding that can be fatal. As with other defective drugs, the claims against Xarelto allege a Failure to Warn of serious side effects. For those suffering from severe bleeding as a result of taking Xarelto, there is nothing that can treat it, whereas other anticoagulant medications that may cause internal bleeding can be treated.

What is the purpose of the drug?

Xarelto is a blood thinner drug that came onto market in 2011 and is prescribed to prevent blood clots. It is commonly prescribed for people suffering from an irregular heartbeat, deep vein thrombosis, pulmonary embolism, and stroke.

What are the injuries and side effects?

The most serious side effect is uncontrollable bleeding that CANNOT be treated and often results in death. The scary fact is that currently there is no treatment that can reverse the type of internal bleeding caused by Xarelto. Other common anticoagulant medications that result in internal bleeding CAN be treated.

Nexium/Prilosec

Why are there lawsuits?

Nexium and Prilosec are used by more than 15 million people to treat acid reflux and heartburn. There are serious hidden risks with taking these drugs over time, including kidney damage, renal failure, and dementia. AstraZeneca, the drug, manufacturer, Failed to Warn users of these more serious side effects of the drug. In 2014, the FDA required AstraZeneca to include new warnings about long-term use because it was never approved for long-term use.

What is the purpose of the drug?

Medications such as Nexium or Prilosec are proton-pump inhibitors that are used for treatment of various gastrointestinal problems. Nexium was developed in 2001 and Prilosec (currently over-the-counter) was developed in 1989 as drugs to reduce the amount of acid in one’s stomach.

What are the injuries and side effects?

We have all seen the commercial, “One pill a day, 24 hours, zero heartburn!” These medications are advertised as safe and effective, but there are serious life-threatening side effects that drug manufacturers have failed to warn about for long-term use. Long-term use of proton-pump inhibitors can result in kidney disease, dialysis, renal/kidney failure, bone fractures, and increased risk of heart attack.

Medical Devices

Essure

Why are there lawsuits?

Numerous lawsuits have been filed by women suffering injuries caused by Essure birth control devices. Essure is advertised as the only surgery-free and hormone-free method for birth control. However, serious risks and complications, such as perforation of the uterus and fallopian tubes, chronic pain, bleeding, and ectopic pregnancies were not communicated to users of the device.

What is the purpose of the device?

Essure, which was introduced in 2002, is a medical device that is used as a method for permanent birth control for women who do not want any more children. Essure does not require surgery or any incisions. Placement of the device takes about ten minutes. After being placed in the fallopian tubes for about three months, tissue grows around the device to form a blockage, which prevents contraception.

What are the injuries and side effects?

Since its introduction, thousands of Essure users have reported complications, the most serious being perforation and migration. In addition, there have been nearly 300 fetal deaths related to Essure. In 2016, the FDA required Essure manufacturer Bayer AG to undertake new safety studies on its device because several women have suffered complications from using the device.

IVC Filters

Why are there lawsuits?

Patients with IVC Filters placed inside them have suffered serious injuries as a result of the device failing inside them. In many cases, the filter breaks and metal fragments then move through the blood and damage an organ. Manufacturers of the device Failed to Warn about these complications, and there are even allegations that they had research that showed these dangers of the filter and they hid these results in order to gain FDA approval.

What is the purpose of the device?

IVC, or Inferior Vena Cava, is a large vein in the body that carries deoxygenated blood to the heart. IVC filters are devices that are implanted in the Inferior Vena Cava of patients at risk for a blockage in their lungs. These devices are designed to prevent blood clots from travelling to the lungs.

What are the injuries and side effects?

Several different complications have been reported as a result of IVC Filters, including perforation, migration, fractures, heart or lung injury, and wrongful death. In many cases, the filter has fallen out of place or broken apart. The device is metal, so when it breaks apart or falls out of place, there are metal pieces that can travel in the blood stream and hit a vital organ.

Bair Hugger

Why are there lawsuits?

Nearly 80% of all hospitals use Bair Hugger temperature management systems during surgery. However, numerous patients have developed infections after surgery as a result of using these devices.

Surgeries involving implants have a higher risk of infections, and use of Bair Hugger devices greatly increases that risk. In fact, there are studies that indicate that devices, like Bair Hugger, could increase the risk of infection during surgery. Bair Hugger manufacturer 3M tried to discredit these studies and Failed to Warn of any infection risk associated with its device.

What is the purpose of the device?

The Bair Hugger device is a warming blanket that helps keep a patient’s body warm during surgery. The Bair Hugger device uses a forced-air heater to push warm air through a hose in the blanket. Warm air is then released under the surgical table. These warming blankets are used to help reduce bleeding and speed up recovery time after surgery.

What are the injuries and side effects?

When bacteria are being spread throughout the operating room during a surgery, infections can easily develop inside a patient’s body. The most serious risk caused by using a Bair Hugger blanket is deep joint infections. Use of the blanket is common during joint replacement surgeries, like hips and knees, thereby making it very easy for infections to develop deep in the joints. Amputation is required in the most severe cases.

Hernia Mesh

Why are there lawsuits?

Since 2010, composite hernia mesh complications have risen dramatically, specifically among two main products: Atrium C-QUR and Ethicon Physiomesh. Numerous patients who have had a composite hernia mesh implanted inside them have required a subsequent surgical intervention to correct complications. In May 2016, Ethicon voluntarily recalled their product after clinical trials were terminated due to concerns of increased adverse events. Numerous lawsuits have been filed against Atrium as well.

Both products were first placed on the market despite several concerns, not to mention that they received approval through the FDA’s 510(k) process. This approval process does not require testing by the FDA, instead only requiring the manufacturer to show that their product is “substantially equivalent” to a previously approved product.

What is the purpose of the device?

More than 1 million hernia repair surgeries are performed each year in the United States. A significant portion of these procedures involve a composite hernia mesh to repair the tear. Since 2005 Atrium C-QUR patches have been used and since 2010 Ethicon Physiomesh has been used in these surgeries.

Composite mesh is made of poly propylene, as many hernia meshes are, but composite mesh also has a coating around the barrier of the mesh. This coating is what causes complications because it does not properly integrate with the body once the mesh is in place. The body’s healing process begins immediately after the mesh is implanted, however, the coating can take several months to fully degrade, which then interrupts the healing process.

What are the injuries and side effects?

The most serious complication of using a composite mesh to repair a hernia is the need for an additional surgical procedure to either remove the mesh and/or correct recurrence. Other common side effects include pain, bowel obstruction, adhesions, infections, mesh migration, seromas, and fistulas. Sometimes the surgical correction is not so simple and is quite extensive in order to repair the damage caused by the composite mesh.