Product Liability

June 16, 2016

FDA issues Invokana warnings

texas_dangeous_drug_attorney The Food and Drug Administration (FDA) issued a drug safety communication stating that it has revised the warning labels of SGLT2 inhibitors, including Invokana, to include information about acute kidney injury.

According to a press release from the FDA, between March 2013 and October 2015, the agency received reports of 101 confirmed cases of acute kidney injury, some of which required dialysis and hospitalization, related to Invokana/Invokamet (canagliflozin, Janssen Pharmaceuticals) and Farxiga/Xigduo XR (dapagliflozin, Bristol-Myers Squibb/AstraZeneca).

The communication advised health care professionals to “consider factors that may predispose patients to acute kidney injury prior to starting them on canagliflozin or dapagliflozin.” These include lower blood volume; chronic kidney insufficiency; congestive heart failure; and taking medications such as diuretics, ACE inhibitors, angiotensin receptor blockers and nonsteroidal anti-inflammatory drugs.

June 14, 2016

Xarelto side effects trigger lawsuits

by Dr. Shezad Malik

Approved in 2011, Xarelto (rivaroxaban) is one of the newest blood thinners on the market and is manufactured by Bayer and marketed in the U.S. by Johnson & Johnson’s subsidiary, Janssen Pharmaceuticals. So far, Xarelto brought in about $2 billion for Bayer and J&J in 2015 alone. In the first quarter of 2016, J&J reported the drug already made $567 million.

But people injured by the drug say its makers put profit before safety. The most dangerous side effect for people who take Xarelto is uncontrollable bleeding. The drug does not have an antidote, and former Xarelto users filed lawsuits saying they were not warned sufficiently about the medication’s risk.

Lawsuits against Bayer and Johnson & Johnson’s Janssen Pharmaceuticals are alleging:

June 10, 2016

Prilosec Side Effects Trigger Lawsuits

by Dr. Shezad Malik

A recent medical study has shown that people who have taken Proton Pump Inhibitors (PPI), such as Prilosec, may be at an increased risk for chronic kidney disease.

A 2016 study published in the Journal of the American Medical Association (JAMA) shows that people who were taking the anti-ulcer medication Prilosec may be 20 to 50 percent more likely to experience chronic kidney disease than those not taking the medication. The study indicated that taking the medication more than once daily or for longer periods of time, increased the risk.

Concerns about Prilosec and other Proton Pump Inhibitor medications reach back to 2006 or before but the new results indicate that the risk of kidney failure is higher than previously thought. Researchers indicate that many patients taking the medications could have been discontinued without any adverse effects and that many prescriptions may have been given without a clear, medical diagnosis.

June 9, 2016

Risperdal Lawsuit Settles for $15.5 Million

by Dr. Shezad Malik

Risperdal is an effective drug for treatment of various degrees of psychosis and schizophrenia, ADHD and bipolar disorder. However, like other pharmaceuticals, there are Risperdal side effects, some of which can be particularly harmful to the elderly and children.

Last year the makers of Risperdal settled for $15.5 million a lawsuit filed by the Attorney General for the State of Kentucky. The lawsuit accused the makers of Risperdal of not disclosing risks associated with the drug to consumers, and marketing Risperdal for uses other than originally intended or approved for by the U.S. Food and Drug Administration (FDA). This has caused excessive and unnecessary costs to Medicaid and Medicare in the state, according to the lawsuit.

Among the allegations brought by the state of Kentucky was that the makers of Risperdal marketed the drug as an appropriate treatment for dementia in non-schizophrenic elderly patients. It was alleged that a study undertaken by the drug company had suggested death rates among the elderly in association with Risperdal use doubled the risk of death. And yet, not only did the makers of Risperdal market and promote the drug for use among the elderly for a use not approved by the FDA, they created an elder care sales force to further target the elderly market, according to the lawsuit.

June 8, 2016

WEN hair loss lawsuit

by Dr. Shezad Malik

A class action lawsuit launched against WEN Cleansing Conditioner alleges that the popular hair product causes hair loss.

WEN Cleansing Conditioner is designed to be an all-in-one hair cleaner that replaces detanglers, conditioners and shampoo. It was developed by celebrity hair stylist Chaz Dean and sold and marketed by Guthy-Renker in the United States.

The first lawsuit was filed by Amy Friedman in California. Friedman had previously used organic shampoos and conditioners without any hair loss issues. However, within two weeks of using WEN Cleansing Conditioner she began losing substantial and abnormal amounts of hair. She stopped using the product but her hair loss continued for three more weeks. Ultimately, Friedman lost nearly a third of her hair.

June 7, 2016

Taxotere lawsuits on the rise over permanent hair loss

by Dr. Shezad Malik

Cancer patients receiving chemotherapy understand there is a risk of hair loss involved. In fact, along with nausea, hair loss is the most common and well known side effect of cancer drugs. Cancer paitents tolerate hair loss as a side effect because of the hope that the drug will save their lives and the knowledge that their hair will grow back after cancer treatment.

But a growing number of lawsuits filed against the makers of Taxotere allege that the company failed to warn patients that Taxotere may cause permanent hair loss. The lawsuits also claim that the drug manufacturer actively encouraged doctors to use Taxotere despite its risks and despite the availability of other, safer cancer treatments.

Taxotere was first approved by the FDA in 1996. It was a more powerful version of another chemotherapy drug that had already been approved for use. Taxotere has been approved for the treatment of metastatic prostate cancer, non-small cell lung cancer, neck and head cancer, advance stomach cancer and breast cancer. It is also being investigated as a possible treatment for other cancers, including small cell lung cancer and pancreatic cancer.

June 6, 2016

Xarelto uncontrolled bleeding lawsuit

by Dr. Shezad Malik

Xarelto is a new type of blood thinner approved in 2011 by the Food and Drug Administration and marketed in the U.S. by Johnson & Johnson’s subsidiary company, Janssen Pharmaceuticals.

When a person is taking blood thinners they must have routine blood tests and make adjustments to their dosage. They also must watch the foods they eat. This is part of Xarelto’s main selling point: it is a one-size-fits-all medication. Unfortunately, this characteristic is what also makes Xarelto dangerous.

Xarelto consumers have filed lawsuits alleging that the drug manufacturer failed to properly warn about some of the risks.

June 3, 2016

Talcum powder and ovarian cancer links

by Dr. Shezad Malik

Baby Powder lawsuits Recent lawsuits against Johnson and Johnson’s Baby Powder product has brought to light evidence linking Talc, the main ingredient in Baby Powder, and ovarian cancer.

Johnson and Johnson began selling Baby Powder more than 100 years ago. Unlike pharmaceuticals, Baby Powder and other Talc products are not regulated by the Food and Drug Administration (FDA). This makes it more difficult for the government to require Johnson and Johnson to place warning labels on their Talc products. But recent lawsuits against Johnson and Johnson could result in the company adding new warning labels to Baby Powder.

These lawsuits have been fueled by mounting evidence linking Baby Powder to ovarian cancer. In 1971, British researchers were the first to discover the possibility that Talcum Powder (Baby Powder), may pose risks. They analyzed 13 ovarian tumors and found talc particles “deeply embedded” in 10 of the tumors. In 1982 Dr. Daniel Cramer, an epidemiologists at Brigham & Women’s Hospital, published a study in the journal Cancershowing a statistical link between genital talc use and ovarian cancer. Since Dr. Cramer study, an additional 20 epidemiological studies have found that long term perineal talc use increases the risk of ovarian cancer by about 33 percent. The links between talc and ovarian cancer are so strong that the World Health Organization in 2006 issues a statement warning that talc may cause cancer.

June 2, 2016

Cook IVC Filter Lawsuit

by Dr. Shezad Malik

IVC Filter lawsuits Cook Medical, the makers of Gunther Tulip and other IVC filters, continue to face lawsuits from consumers who have accused the manufacturer of “selling dangerous medical devices and failing to warn about the risks” consumers face.

Parker Thompson, a man from Texas who was implanted with the IVC filter in 2005, is the latest person to file a lawsuit against Cook Medical over their Gunther Tulip device. Thompson joins approximately 400 other people who are suing the Gunther Tulip IVC filter manufacturer in the U.S. District for the Southern District of Indiana.

The lawsuits allege that some of Cook’s blood-clot filters have broken apart, moved or poked through the blood vessel where they are implanted.

June 2, 2016

Takata air bag recall lawsuit

by Dr. Shezad Malik

Air bag injury lawyer More than a decade after the first injury linked to Takata’s defective air bags occurred, the largest recall in U.S. automobile history is underway. An estimated 100 million vehicles across the world are being recalled altogether.

The air bag design flaw has led to 13 deaths, including 10 in the U.S., and more than 100 injures. The air bag was designed by Takata, a Japanese company founded in the 1930s.

The recall in the U.S. covers more than 60 million air bags in vehicles from Toyota, Telsa, Honda, Ford, BMW, and 12 other car companies. In other words, on in every five cars on the road in the U.S. are part of the recall.