Product Liability

May 2, 2016

Invokana risk of Diabetic Ketoacidosis (Ketosis) raises questions

Two years after the U.S. Food and Drug Administration (FDA) approved Johnson & Johnson’s Invokana, the FDA issued a drug safety communication that warned doctors and patients that Invokana may lead to diabetic ketoacidosis (DKA).

Invokana is a new class of Type 2 diabetes drug called sodium-glucose co-transporter 2 (SGLT2). This class of Type 2 diabetes drugs work by stopping glucose from being reabsorbed into the blood. The FDA approved Invokana in 2013. In May 2015 the FDA release a statement warning doctors and patients that SGLT2 drugs may lead to DKA. If DKA is left untreated, it can be fatal.

In December 2015, the FDA ordered manufacturers of SGLT2 inhibitors to add warnings regarding the risk of urinary tract infection and ketoacidosis to the drugs’ labels.

April 29, 2016

Taxotere permanent hair loss side effect raises questions

by Dr. Shezad Malik

Nearly 75 percent of women in the United States with breast cancer have been prescribed Taxotere as part of chemotherapy. Medical professionals are now taking a second look at the drug after reports suggests that it might lead to permanent hair loss.

Taxotere lawsuits on the rise According to a lawsuit filed by Ami Dodson, the drug caused her to suffer from permanent hair loss. Dodson’s lawsuit also alleges that the makers of Taxotere engaged in marketing schemes to drive up the sales of the drug while hiding the medication’s increased toxicity compared to other similar drugs.

“Defendants [preyed] on one of the most vulnerable group of individuals at the most difficult time in their lives,” Dodson alleges. “Defendants obtained billions of dollars in increased revenues at the expense of unwary cancer victims simply hoping to survive their condition and return to a normal life.”

April 28, 2016

IVC Filter Lawsuits On The Rise

by Dr. Shezad Malik

The number of lawsuits filed against the manufacturers of IVC filters are on the rise in the United States, with more than 400 pending cases. Currently, there are two Multi-District Litigation (MDL) in the U.S. concerning IVC Filters, with 343 lawsuits against Cook Medical that have been consolidated in the U.S. District Court in the Southern District of Indiana, and 382 lawsuits consolidated against C.R. Bard in the U.S. District Court in the District of Arizona.

IVC Filter lawsuits Five products produced by C.R. Bard and Cook Medical are at the center of these lawsuits. These products include:

Bard Recovery filter

April 27, 2016

Abilify gambling side effects trigger lawsuits

by Dr. Shezad Malik

Recent studies linking compulsive gambling to Abilify have triggered lawsuits across the country. A FDA report showed that from 2005 to 2013, at least 54 compulsive behaviors were reported by patients, including 30 reports of compulsive gambling.

Reports of compulsive gambling have since been on the rise – more than 29 reports were made to the FDA in 2014 alone.

In January 2016, Sean Brazil, a former Abilify user, filed a lawsuit against Bristol-Myers Squibb in New York federal court. Brazil says he developed a compulsive disorder problem after taking the antipsychotic drug Abilify and that U.S. users weren’t warned about the risk of compulsive gambling. Brazil began taking Abilify in 2004 and soon after that began compulsively gambling. The compulsive gambling continued until nearly a decade later when he was taken off Abilify.

April 27, 2016

Transvaginal Mesh Lawsuits Triggers Investigation

by Dr. Shezad Malik

Side effects from transvaginal mesh have triggered lawsuits across the United States.

Women in these lawsuits have claimed that after receiving the mesh implant, they have suffered injuries that include bleeding, infection, organ perforation, inability to engage in sexual intercourse, pelvic pain or severe vaginal pain, vaginal scarring, fistulas, erosion of mesh through the vagina, recurrent incontinence or prolapse, need for correctional surgery, urinary tract infections and neuromuscular problems. Spouses of some of the plaintiff have even included loss of consortium in their claims.

The mesh is usually made of synthetic polyproplyne and is used to support the urethra in cases of stress urinary incontinence (SUI) and to support bulging organs in cases of pelvic organ prolapse (POP). Transvaginal mesh was approved by the FDA in 1996 for stress urinary incontinence procedures and in 2002 for pelvic organ prolapse.

April 25, 2016

Bair Hugger lawsuits

by Dr. Shezad Malik

The Bair Hugger Forced Air Warming system, a system used in operating rooms across the country, may increase patients’ risk of developing sepsis, MRSA, and other serious infections, particularly after hip and knee replacement surgeries.

Lawsuits filed across the country allege that the heat generated by the device can redirect air circulating during surgery. This redirection may cause bacteria and other contaminants on the floor to become airborne. The airborne contaminants may increase a patients’ risk of developing MRSA or other infections, according to the lawsuits.

Many of the lawsuits filed are by patients who underwent hip or knee replacement surgery and were left with serious deep joint infections. In some cases, these infections required additional surgeries and painful recoveries such as the removal and replacement of the artificial joint.

April 18, 2016

Risperdal Male Breast Growth Lawsuit

by Dr. Shezad Malik

Multiple lawsuits have been filed in the United States against the makers of Risperdal for failing to warn patients that it may cause male breast growth, a condition known as Gynecomastia.

Risperdal was approved for sale in the United States in 1993 by the Food and Drug Administration (FDA). It commonly used to treat irritability in people with autism, schizophrenia, and bipolar disorder.

The makers of Risperdal began marketing the drug to treat children as early as 2003, years before the FDA approved such action by the drug-maker. The makers of Risperdal also recently faced accusations that it was paying physicians to speak favorably of the drug, sponsor golf outings, and offering other incentives encouraging doctors to prescribe Risperdal to adolescents and children.

April 15, 2016

Zofran lawsuit reveals birth defect side effects

by Dr. Shezad Malik

Several lawsuits filed against the makers of Zofran, GalxoSmithKline, suggest that Zofran may cause birth defects.

In 1991 the Food & Drug Administration (FDA) approved the use of Zofran to treat extreme nausea arising from radiation therapy, chemotherapy, and for some post operative procedures. However, FDA never approved Zofran as a safe drug for pregnant women to use.

Nonetheless, Zofran manufacturers almost immediately began marketing the drug as a “safe” solution to nausea, vomiting, and morning sickness during pregnancy.

April 14, 2016

Taxotere permanent hair loss lawsuit

by Dr. Shezad Malik

Although hair loss is a common side effect of chemotherapy, permanent hair loss is not. However, as lawsuits against the makers of Taxotere are beginning to reveal, that is not always the situation.

The FDA approved Taxotere (docetaxel) in 1996 for treatment of breast cancer. Taxotere has since been used to treat several other types of cancers including non-small lung cancer, prostate cancer, gastric cancer, and head and neck cancer. While Taxotere is an effective cancer drug, lawsuits filed against the makers of Taxotere allege that the drug causes permanent hair loss.

Cancer patients who filed the lawsuit say that the makers of Taxotere failed to inform them or their doctors that a potential side effect of the drug could be permanent hair loss, also known as Taxotere alopecia. Although the Taxotere label has always mentioned hair loss as a possible side effect, there was no mention that the hair loss could be permanent.

April 12, 2016

Talcum Powder Lawsuits

by Dr. Shezad Malik

Hot on the heels of a record $72 Million Talcum Powder Ovarian Cancer verdict in February, the next talcum powder ovarian cancer injury trial has begun this week in St. Louis Circuit Court.

J&J Talcum Powder Ovarian Cancer lawsuits

Talcum Powder lawsuits increase across the U.S.

Gloria Ristesund filed her claim against Johnson & Johnson (J&J), after she was diagnosed with ovarian cancer in 2011. Ristesund used the J&J’s talcum-based baby powder products for more than 40 years for feminine dryness.