We rely on drugs to improve our quality of life, but sometimes companies release unsafe products to the market that may cause terrible- sometimes irreversible side effects. It is vital to know which drugs are safe, and which ones are not. In 2016, there were several allegations made against the makers of faulty pharmaceutical products. Many are taking legal action against companies like Johnson & Johnson, Bayer, and Jenssen Pharmaceuticals, reporting their products resulted in physical harm- even death- in some instances, for those who used the defective drug.
What are the top drug lawsuits of 2016?
The U.S. Food and Drug Administration (FDA) is responsible for reviewing medical device and drug products before deeming them safe for commercial use. However, the FDA’s approval process does not guarantee a product’s safety. Ultimately, it is up to a drug or medical device manufacturer to ensure their product upholds certain standards, and will not cause harm or injury. They are the ones liable for a defective medical device or drug, and any damages that may arise from its use.
In 2016, a California state court allowed litigation against the birth control implant device, Essure, to move forward, after determining the manufacturer was accountable for injuries suffered by women who received the implant. Bayer, the maker of Essure, argued they were not liable because they had followed federal guidelines, and had gained product approval by the FDA. However, a judge ruled against this.There have been thousands of lawsuits filed by women who suffered complications as a result of the Essure medical device. This lawsuit is still active and involves two main courts, Alameda County Superior Court (California) and Eastern District of Pennsylvania. Currently, anyone who suffered serious injury or complications as a result of the Essure medical device implant may be eligible to join this lawsuit.
How does the Essure medical device work?
Essure is a permanent birth-control implant device inserted into the fallopian tubes. The medical device consists of two coils (one inserted into each fallopian tube) made of nickel, titanium, and other metal fibers. The body creates scar tissue around the coils, preventing pregnancy by blocking the tubes so sperm cannot enter and fertilize an egg.
Complications with the Essure device
Many women are horrified when complications arise after receiving the Essure medical device. They don’t know what to do. Some report shooting pains throughout their lower back, sides, and pelvic area. The Essure device is known to migrate from the fallopian tubes to other organs in the body; including the ovaries, uterus, and colon. It has also been known to cause painful menstrual cramping. The following negative side effects have also been reported with implantation of the Essure device, among others:
- Ovarian cysts
- Cervical cancer
- Sharp pelvic pain
In most cases, the faulty device must be surgically removed.
History of the Essure medical implant lawsuit
By 2004, a reported 850 adverse claims had been recorded by the FDA, citing the Essure device as unsafe. Essure has been sold since 2002, and was approved by the FDA in the same year. According to the FDA, “Through December 31, 2016, there have been 38 reports coded by the submitter as death. Eight of these were incorrectly coded, as there was no indication of death in the report.” In 2012, Essure’s safety label was amended to include a 5-year, follow-up visit for patient’s with the Essure device. On June 05, 2013, Bayer acquired Conceptus, the former maker of Essure. In 2016, after a surge in adverse reports, a physician and patient checklist was added to Essure’s boxed warning and brochure, advising of the risks of receiving the Essure medical device implant.
In 2016, four bellwether cases were established, advancing legal proceedings against the makers of the blood-thinning drug, Xarelto, after thousands of adverse bleeding events were reported. The first bellwether case was chosen in August of 2016. It is filed with the Eastern District Court of Louisiana. Mr. Joseph J. Boudreaux, Jr., alleges that he took Xarelto for one month in 2014, before experiencing life-threatening bleeding in his gastrointestinal tract. As a result, a lawsuit was filed against the makers of Xarelto, Johnson & Johnson and Bayer, both subsidiaries of Jenssen Pharmaceuticals. Mr. Boudreaux Jr. was hospitalized for several days and required multiple blood transfusions. The second bellwether lawsuit against the manufacturers of Xarelto is also filed within the Eastern District Court of Louisiana, and is slated to take place in 2017. Mr. Joseph C. Orr, Jr., will be filing on behalf of his wife, who passed away after taking Xarelto in February 2014. It is alleged that his wife, Sharyn Orr, experienced acute brain hemorrhaging after using the blood-thinner Xarelto. After becoming severely ill on April 24, 2015, she was rushed to a local hospital by ambulance, where her condition deteriorated. The makers of the drug Xarelto are being accused of inadequately warning patients of these adverse events, and not properly conveying pertinent information about the drug’s potentially dangerous effects to doctors dispersing the drug. Two other bellwether Xarelto lawsuit cases are scheduled to take place in courts in Mississippi and Texas.
How does Xarelto work?
Xarelto works by preventing blood clots. Its purpose is to prevent the formation of blood clots in veins or arteries by thinning the blood. Xarelto is typically taken by those with atrial fibrillation (AFib), deep vein thrombosis (DVT), those who have had surgical hip or knee replacements, and those with a pulmonary embolism (PE).
Side effects of Xarelto
Xarelto is reported to cause several severe side effects, including adverse bleeding events and blood clots centered around the spine. Currently, there is no way to stop excessive bleeding related to Xarelto use. Bleeding events are considered the most significant side effect of the blood-thinning drug Xarelto. However, Xarelto use has also been linked to wound-healing complications and sepsis.
History of the Xarelto Lawsuit
Initial reports of adverse bleeding events sparked the initial litigation process between the makers of Xarelto and members of the public. In 2014, a multi district litigation panel transferred cases to the Eastern District of Louisiana Court. In 2015, guidelines for eligibility into the Xarelto lawsuit were issued, also establishing the bellwether discovery pool selection process. In 2016, four Xarelto lawsuit bellwether cases were chosen, acting as precedents for forthcoming Xarelto lawsuits.
Zostavax is a vaccine used to prevent shingles in adults. In 2016, after receiving pressure from the FDA to change their labeling to include additional warnings, the makers of the shingles vaccine added ‘eye disorders’ to their product’s list of side effects. Zostavax is manufactured by Merck & Co. In 2017, a Nevada woman, Jorja Bentley, who received the Zostavax vaccine in 2014, filed a lawsuit against the company, alleging she experienced a number of negative side effects after receiving the vaccine. In fact, in 2014, the FDA ordered that Zostavax include shingles on its list of side effects. Ironically, this is the very ailment the vaccine aims to prevent.
How the Zostavax vaccine works
Like most vaccines, the Zostavax injection works by introducing the body’s immune system to a weakened form of the virus. According to sources, the Zostavax vaccine is not for everyone and receiving this injection should be discussed with a doctor.
Side effects of Zostavax
According to Jorja Bentley, she experienced side effects such as dizziness, weakness, and headaches within hours of receiving the Zostavax vaccine. Other adverse side effects of the Zostavax vaccine include:
- Eye complications/pressure behind eyes
- Blurry vision
- Skin rash
- Irritation at injection site
- Occurrence of shingles
Unfortunately, one side effect of Zostavax includes shingles. Although the Zostavax vaccine may be helpful for some, it is important to weigh the potential benefits and risks before receiving the Zostavax injection.
History of the Zostavax Lawsuit
The Zostavax vaccine was approved in 2006. In 2014, the first individual to file a lawsuit against Zostavax received the injection, experiencing significant adverse side effects. In the same year, the FDA ordered the makers of the Zostavax to include additional information regarding possible complications within their product’s label. Despite these attempts to make the Zostavax vaccine safe, an official Zostavax lawsuit was filed on February 22, 2017, in the Philadelphia (Pennsylvania) Court of Common Pleas.