Product Liability

August 11, 2016

Invokana lawsuits on the rise as safety concerns increase

The number of lawsuits filed by people who say they suffered serious side effects after taking Invokana (canagliflozin) continues to grow in Philadelphia amid rising safety concerns. Attorneys are also investigating other drugs in the Type 2 diabetes drug class known SGLT2 inhibitors.

While attorneys across the country are filing lawsuits on behalf of local plaintiffs, Pennsylvania is seeing a large number of cases. Dozens of cases made their way to Philadelphia. An attorney family with the cases told a reporter at the Legal Intelligencer that more than 150 suits are pending in Missouri and Illinois.

Attorneys say a judge may consolidate the cases if the volume continues to grow.

August 10, 2016

Increase in Zofran lawsuits over birth defects

by Dr. Shezad Malik

Many women who took Zofran during pregnancy had no idea that it was prescribed off-label, or in other words it wasn’t approved by the FDA to treat morning sickness.

The majority of women who take Zofran only take it in the first trimester and only for a few days to alleviate nausea during early pregnancy. But morning sickness can be dangerous for a small percentage of women so they continue using the drug throughout their pregnancy.

One woman, Marquita Smiley, took it a few times a week into her second trimester, according to a news article published on June 1, 2016 in the Brimmingham News. During her 5^th month of pregnancy an ultrasound showed her baby’s heart was underdeveloped. Just days after her son was born he had open-heart surgery and at two months of age he had a heart transplant. When Smiley say a an ad claiming that Zofran causes heart birth defects, she filed a lawsuit against the makers of Zofran. Smiley says if she had known of the risk of birth defects, “I would not have placed him at risk,” she told the newspaper.

August 9, 2016

Cordis TrapEase and OptEase IVC Filter Lawsuits

by Dr. Shezad Malik

IVC Filter lawsuits A device known as a vena cava filter (IVC filter) was implanted by doctors in hundreds of patients who are unable to take anticoagulants (blood thinners) in order to prevent blood clots from moving to the lungs. But recently two IVC filter devices named Cordis OptEase and Cordis TrapEase have came under scrutiny after lawsuits reveal potential design defects.

The Cordis Optease IVC filter is an egg-shaped wire device and Cordis TrapEase IVC filter is a star-shaped wire device. They are both implanted in a blood vessel called the inferior vena cava, which separates the heart and lungs. The filters are designed to catch blood clots before they enter the lungs and cause a pulmonary embolism.

The Cordis TrapEase IVC filter is supposed to be permanent, but studies have linked it to a 50% risk of fracture within four years. In another study, researchers warned about an “extremely high risk” of fracture within 2-3 years.

August 8, 2016

FDA issues warning on WEN hair products

by Dr. Shezad Malik

After hundreds of complaints from consumers, the U.S. Food and Drug Administration has issued a safety alert regarding the line of cleansing hair conditioners by Wen. These products are already part of an ongoing class-action lawsuit from 2014 over claims that it may cause hair loss.

127 incidents of adverse effects caused by the WEN products were reported to the FDA. Included in these reports were incidents of hair loss and breakage, balding, itching and rashes. The number of FDA complaints represents the largest number of reports ever associated with any cosmetic hair product. The FDA is also investigating an additional 21,000 complaints that were made directly to the WEN hair product manufacturer after the FDA discovered these complaints during an inspection.

The FDA has not yet determined a possible cause for the adverse events that have been reported, and today has called on the company to “provide any data that might help us to better understand the reports of hair loss associated with the use of WEN by Chaz Dean Cleansing Conditioner products.” The FDA also has reached out to physicians and other health care providers asking them to notify their patients of hair loss and other complaints associated with the use of these products and to report adverse events to the agency.

August 4, 2016

Nexium lawsuit filed in Tennessee

by Dr. Shezad Malik

Charles Bowers started using Nexium in July 2003. He used the drug routinely to treat symtpoms of heartburn until May 2008, when he was diagnosed with interstitial nephritis.

Nephritis is a type of kidney inflammation that is usually caused by an allergic reaction to medications in the bloodstream. It can occur at any time in patients on Nexium, even if they have taken it safely before.

Many people who develop nephritis are left with long-term kidney problems. Bowers was diagnosed with chronic nephritis in May 2009. He, like most other people suffering from nephritis, now undergoes dialysis 3 times a week and needs a kidney transplant.

August 3, 2016

Sharp rise in Bair Hugger lawsuits

by Dr. Shezad Malik

Bair Hugger lawsuits are on the rise. The number of lawsuit filed against the makers of Bair Hugger warming blanket skyrocketed in June, according to a Reuters analysis of the data from the U.S. Judicial Panel on Multidistrict Litigation.

As of August 3, 2016 there are 457 pending lawsuits against 3M, the manufacturer of the Bair Hugger device. Most of these lawsuits are pending in federal or state court in Minnesota. Most plaintiffs had hip or knee replacement surgery or cardiovascular surgery and later developed surgical infections they claim was caused by the use of the Bair Hugger device.

In one lawsuit, filed by Edgar C. Woodyear Jr.’s window, alleges that he underwent a cardiac mitral valve replacement surgery and suffered a serious surgical site infection, which resulted in his death, according to the Louisiana Record. The plaintiffs claim 3M is responsible because they allegedly “designed, manufactured, promoted, marketed and distributed the defective device and concealed and continue to conceal their knowledge of the Bair Hugger’s unreasonably dangerous risks from consumers and the medical community”.

August 2, 2016

Hip replacement may lead to metallosis

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.

While all surgeries carry some risk, the type of implant used in hip replacement procedures may carry additional risks. For example, studies show metal-on-metal implants have greater risk of loosening or early failure because metal particles released from the device may weaken nearby bone and tissue. Popular brands of metal-on-metal implants include the DePuy ASR and Pinnacle, Smith & Nephew Emperion and Birmingham Hip and the Biomet M2a-Magnum.

Recently a growing number of lawsuits have been filed against the makers of metal-on-metal hip implants after patients developed metallosis.

August 1, 2016

Tranvaginal mesh lawsuit settlements and verdicts

by Dr. Shezad Malik

Transvaginal mesh injuries can change a women’s life and cause a lot of pain. They often require multiple medical procedures or surgeries. Even then, medical professionals make no guarantee. Recent jury verdicts and settlements against the device makers have sought to assist women in dealing with the high costs of a mesh injury.

In some cases, juries have awarded millions of dollars to women injured by Johnson and Johnson’s Ethicon mesh devices. But the company has been the the slowest transvaginal mesh device manufacturer to offer settlements. Perhaps one reason for the slow response from this manufacturer deals with the fact that they face the highest number of federal lawsuits. The company likely wants to dispose of unworthy claims before offering a settlement. Despite this, the company in 2015 settled 4 lawsuits for an undisclosed amount.

Jury awards range in size. For example, in September 2014, a jury decided against the company and awarded Jo Husky $3.2 million. The jury found that Ethicon’s Gynecare TVT mesh caused Husky permanent injuries and the company failed to warn her of the possible risks.

July 29, 2016

Taxotere lawsuit filed in California

by Dr. Shezad Malik

A lawsuit filed in California alleges that the makers of a popular chemotherapy drug misrepresented the drug’s benefits and hid side effects, including permanent hair loss.

Breast cancer survivor Ami Dodson filed a lawsuit against the makers of Taxotere (docetaxel) claiming the drug caused her to suffer permanent hair loss (alopecia). She also claims the drug maker engaged in marketing schemes to drive up the sales of the drug while hiding medication’s increased toxicity level compared to other similar drugs.

“Defendants [preyed] on one of the most vulnerable group of individuals at the most difficult time in their lives,” Ami Dodson said her lawsuit. “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.”

July 28, 2016

Lawsuits over Invokana side effects on the rise

by Dr. Shezad Malik

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). According to recent lawsuits, the makers of Invokana knew or should have known about diabetic ketoacidosis but failed to warn consumers.

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 patients and doctors 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.