Product Liability

July 22, 2016

Risperdal lawsuits highlight gynecomastia side effects

Medical studies and recent lawsuits against the makers of Risperdal have helped highlight the links between the drug and gynecomastia, a condition that causes males to grow breasts.

A 2006 study conducted by Duke University showed that Risperdal was associated with gynecomastia and that it may cause lactation in girls, boys, and women not pregnant or nursing.

Despite this knowledge, the FDA approved Risperdal for the treatment of schizophrenia in children and bipolar disorder in both children and adults in 2007. The year after the FDA approval, the Wall Street Journal reported that Risperdal had been shown to increase prolactin levels (leading to breast development and lactation) and experts stated that up to 70 percent of gynecomastia childhood events were found to be caused by Risperdal use.

July 21, 2016

Power Morcellators linked to cancer trigger lawsuits

by Dr. Shezad Malik

nurse Links between laparoscopic power morcellators and cancer have trigger lawsuits throughout the United States just as the FDA issues a recall on three Johnson and Johnson devices.

The FDA and medical professionals express growing concern about the safety of surgical procedures that use power morcellators. These devices have been proven to be effective in some minimally invasive surgeries. But when they are used to break up uterine fibroid tumors or in some kidney and spleen surgeries, they tend to spread cells that lead to malignant tumors in men and women.

Metastic leiomyosarcoma, a type of uterine cancer, is a cancers that can develop in women as a result of the power morcellators.

July 20, 2016

Talcum Powder and ovarian cancer

by Dr. Shezad Malik

While some in the medical community continue to debate whether or not Talcum Powder, also known as Baby Powder, may cause ovarian cancer, two recent lawsuits suggest it does cause ovarian cancer.

The link between ovarian cancer and talcum powder was first discovered in 1971 in a study that revealed talc particles, the main ingredient used in Baby Powder, were found in the ovarian tissue of cancer patients.

This was the first instance in which medical professionals realized women were at risk when using the powder on their genitals, sanitary pads, diaphragms, and in condoms. Talc particles easily made their way into the vagina and were able to travel deeper into the reproductive organs. One sample study demonstrated the ability of carbon particles to travel through the vagina and into the fallopian tubes in as little as 30 minutes, leading researchers to believe the same was possible with talc particles.

July 19, 2016

IVC filter lawsuits on the rise July 19, 2016

by Dr. Shezad Malik

IVC Filter lawsuits Recent medical studies have linked inferior vena cava filters (IVC filters) to serious risks when the filter remains implanted in a person’s body for longer periods that what is recommended. Complications from prolong use of IVC filters have led to several lawsuits recently across the United States.

Surgeons implant retrievable inferior IVC filters in the veins of patients who are unable to take anticoagulants (blood thinners) in order to prevent blood clots from moving to the lungs. IVCs catch the clots in the blood stream and, over time, the clots dissipate. But the U.S. Food & Drug Administration (FDA) received hundreds of adverse reports about the retrievable filters. Reported complications included punctured organs, blood vessels and filter migration to different parts of the body.

In 2010, the FDA warned the retrievable filters posed risks of filter fracture, device migration and organ perforation and should be removed as soon as the patient’s risk for blood clots subsided. The FDA updated safety communication in 2014, stating most devices should be removed between the 29th and 54th day after implantation. But the warning signs came too late for some. Plaintiffs began filing lawsuits across the country claiming the filters caused harm and death.

July 18, 2016

Testosterone drug side effects trigger lawsuits

by Dr. Shezad Malik

Men who suffer stroke, cardiac arrest and other heart-related issues or other adverse side effects after using AndroGel and other testosterone drugs have filed lawsuits across the country alleging that they were not properly warned of the risks.

At the center of these lawsuits is a popular testosterone drug named AndroGel.

AndroGel is synthetic testosterone mixed into a gel with alcohol that is applied to the skin once daily. The testosterone is absorbed into the skin for continuous 24-hour delivery into the body. It is prescribe to men with low testosterone levels to increase their testosterone levels to a normal range.

July 15, 2016

Xarelto lawsuits on the rise across the country

by Dr. Shezad Malik

Uncontrolled bleeding caused by Xarelto has resulted in hundreds of people filing lawsuits against the company for failing to warn about the dangers associated with Xarelto.

According to the Judicial Panel on Multidistrict Litigation (MDL), as of June 15, 2016, there were 5,853 lawsuits consolidated for pretrial proceedings in MDL 2592. Those lawsuits allege patients suffered uncontrolled bleeding events leading to serious injury as a result of using Xarelto. Inclusion in the MDL is not a comment on the lawsuits’ merits; rather it is an acknowledgment that the suits share similar issues.

Those issues involve uncontrolled bleeding linked to use of Xarelto. Because Xarelto is a blood thinner, uncontrolled bleeding is a risk for patients. However, patients allege they were not adequately warned about that risk, nor were they told that there was no antidote for Xarelto. Patients taking warfarin, also a blood thinner, have an antidote to counter act its effects. Warfarin can be counteracted by taking vitamin K. Xarelto on the other hand has no antidote and patients suffering from uncontrolled bleeding must wait for the drug to leave their system.

July 14, 2016

Hip and Knee infection after surgery trigger lawsuits

by Dr. Shezad Malik

Hip and knee infection on the rise. Some patients who develop an infection after undergoing hip or knee replacement surgery have filed lawsuits against the makers of a device named Bair Hugger. The device is used in a number of hip and knee replacement surgery and may be linked to some serious side effects.

The Bair Hugger device is usually used without the patients knowledge. The device is a warming blanket used to help maintain a patient’s body temperature during surgery. Doctors utilize this device to maintain a patient’s body temperature because studies have shown that maintaining proper body temperature can reduce bleeding, speed up recovery time, and provide other benefits.

Surgical warming blankets, such as Bair Hugger, work like a forced-air heater, pushing warm air through a hose into a blanket covering a patient. The device releases warm air over a patient’s body, but also releases air under the surgical table. The air released under the table has the potential to cause bacteria and germs to spread throughout the room, landing on a patient’s surgical site. This may cause an infection in the patient’s knee or hip, such as sepsis and Methicillin-resistant Staphylococcus aureus (MRSA). Unfortunately, these infections are very difficult to treat when they occur deep in a patient’s joint.

July 13, 2016

Metal-on-metal hip replacement lawsuits

by Dr. Shezad Malik

Metal-on-metal hip implants have led to some patients developing metallosis, a condition in which build-up of metal debris in the soft tissues of the body occur.

Hip replacement surgery (hip arthroplasty) has been described by many experts as one of the most significant medical device innovations of the last 40 years. It has helped millions of people overcome painful arthritis, recover from hip fractures and improve their quality of life. However, hip implants do not come without risk or complications. A growing number of implant recipients have experienced implant failure and other severe hip replacement complications.

There are three types of hip replacement surgery. With total hip replacement, the entire hip joint — ball and socket, as well as femoral stem — is replaced. Partial hip replacement requires only the ball (femoral head) to be replaced. In a hip resurfacing procedure, the cup is replaced, but the ball is not. Instead, the ball is reshaped and covered with a metal cap.

July 12, 2016

Women file transvaginal mesh lawsuits

by Dr. Shezad Malik

Problems with transvaginal mesh systems marketed by a number of different medical device manufacturers have caused women throughout the United States to suffer severe injuries.

Not only do these products pose a risk of serious complications, there is no evidence that transvaginal insertion of a bladder sling has any benefit for women when its primary use is treating pelvic organ prolapse.

Lawsuits are currently being investigated for women who have received any type of surgical mesh or bladder sling to repair pelvic organ prolapse, including:

July 11, 2016

Study links Xarelto’s side effects to serious injuries

by Dr. Shezad Malik

An independent study conducted by the Institute for Safe Medication Practices (ISMP) showed that side effects of Xarelto were linked to more serious injuries than any other drug studied by the institute. The study, which was submitted the U.S. Food and Drug Administration (FDA) last year, links more than 1,100 patient deaths to Xarelto.

In the group’s quarterly report issued last week, ISMP summarized adverse event reports submitted to the U.S. Food and Drug Administration last year, which are widely considered to be an important safety signal for prescription medications on the market.

The study found that “severe complications with Xarelto exceed those linked to all other drugs, mainly involving injuries associated with uncontrolled bleeding and failure to prevent a stroke or pulmonary embolism, which is what the drug is designed to do.”