by Spencer Aronfeld | Nov 9, 2015 | Defective Drugs, Defective Products, Low Testosterone
The multi-district litigation brought by men from around the country who have been injured taking low T drugs is now in front of Judge Matthew Kennely, who is a Clinton appointee. He has been on the Federal Bench in the Northern District of Illinois since 1999. This will be Judge Kennely’s first major pharmaceutical case, and he has already ordered limits on the number of depositions that can be taken. On March 1, 2016, the judge will pick six trials. The bellwether cases are set to start sometime next year, selected randomly from 100 cases. Each sider will be able to pick 16 cases and can object to each other’s selection. The first trial will start October 31, 2016 for a thrombotic-event case and then another in February 2017 for cardiovascular-event cases. The primary defendant in this matter is low testosterone drug maker AbbVie. The drug is made in both France and Thailand. Depositions have already started, with AbbVie’s Director of Trade Pablo Hernandez, and many more are scheduled for the next couple of months. The other defendants include Auxilium and Lilly, Actavis, Endo, Testopel, and Pfizer. ANDA representatives have filed motions claiming that their generic low testosterone drugs are preempted by Federal law. The latest developments in the low testosterone cases against the drug makers of low T therapies across the country rely on a number of medical studies, including the Vigen 2013 JAMA study and Finkle study (PLOS One), that showed an increased risk from the use of gels, injections, and patches, doubling the risks of heart attacks in all men over the age of 65, and in...
by Spencer Aronfeld | Oct 28, 2015 | Defective Drugs, Defective Products
The widely prescribed medications Benicar, Benicar HCT, Azor, and Tribenzor have been linked to serious gastrointestinal symptoms. All four drugs are used to treat high blood pressure and are actually made by the same company, Daiichi Sankyo, co-promoted by Forest Pharmaceuticals. Some of the common symptoms we have found reported include severe chronic diarrhea, dehydration, malnutrition, and weight loss. Once people stop taking the drug, they get better. When the drug first came on the market in 2002, it contained no warning of these side effects. This is not the first time Daiichi Sankyo has been in serious legal hot water. In January 2015, Daiichi Sankyo had to pay a $39 million dollar settlement to the Department of Justice in a Qui Tam/ Whistleblower case, as well as nearly $6 million dollars to the individual whistleblower. Daiichi Sankyo was accused of illegally bribing doctors to prescribe these same drugs–as well as over-promoting their drugs for uses that were not specifically approved by the FDA, and for violating the Anti-Kickback Statute. The Anti-Kickback Statute was enacted to encourage doctors to make prescription decisions and referrals based solely upon the best medical interests of the patient, rather than for receiving improper payments and gifts from drug makers. The Anti-Kickback Statute strictly prohibits anyone from paying to induce another to provide referrals for items or services covered by federal healthcare programs like Medicare and Medicaid. Following the announcement of the DOJ settlement in April 2015, a class action lawsuit was filed on behalf of thousands of people from around the country who had been injured by taking Benicar. The cases were consolidated...
by Spencer Aronfeld | Oct 21, 2015 | Defective Drugs, Defective Products
Johnson and Johnson’s medication known as Invokana (canagliflozin) is currently being investigated by class-action lawyers from around the country in light of recently released reports indicating that people who are taking this drug are at increased risk for developing serious medical conditions, such as kidney failure, heart attacks, and strokes. Blood sugar is supposed to be metabolized in the kidneys and provides the body with fuel. Invokana, marketed to people with Type 2 Diabetes, is purportedly designed to inhibit glucose excretion through urine by preventing the body from metabolizing sugar, while actually delivering unmetabolized, unfiltered sugar directly to the kidneys. Invokana is the only Type 2 Diabetes drug that does this. As a result, the medication has been found to actually increase glucose while simultaneously decreasing ketones. As of today, these drugs have not been approved for use by Type 1 Diabetics. Diabetics are required to check their blood-sugar levels frequently. One of the problems with this medication is that it can affect blood-sugar data. Type 1 Diabetics commonly experience ketoacidosis. An increase in occurrences in ketoacidosis among Type 2 Diabetics who rarely have had a problem with increased acid levels in their systems is now being reported FDA WARNS OF INVOKANA RISKS In May 2015, the FDA released an advisory opinion warning that these Type 2 Diabetes medicines– known as sodium-glucose cotransporter-2 (SGLT2) inhibitors, like Invokana–can cause a variety of serious medical conditions, such as diabetic ketoacidosis. Ketoacidosis is a chemical imbalance in the body, which can result in major organ failure, diabetic comas, and death. In September 2015, the FDA reported an increased risk of fractures associated...
by Spencer Aronfeld | Mar 18, 2014 | Defective Drugs, Defective Products, Medical Malpractice
When it comes to potentially dangerous drugs–like testosterone replacement therapies—or cars, or even a light bulb, manufacturers always know more about the product’s risks than its consumer does. The law in our country that protects us from makers of those products–who put their profit ahead of the safety of people–is commonly referred to as strict liability. STRICT LIABILITY LAW The law of strict liability dates back hundreds of years, when people were found to be legally responsible for the damages they caused by conducting certain “inherently dangerous activities,” like transporting dynamite or keeping a tiger in their apartment. In those situations, to win their cases the plaintiffs or injured parties do not have to prove that the defendant was careless, but merely the extent of their injuries. That is a significantly easier case for a plaintiff. As the law has evolved, it has become one of the few remaining protections of the injured when a dangerous or defective product is sold that hurts or kills people. GM RECALLS 1.6 MILLION CARS The most compelling and recent example of how the strict liability law can be used to protect the injured is the delayed recall by General Motors of nearly 2 million vehicles that have faulty ignition systems and have been linked to a dozen deaths. The defect that prompted the recall is a faulty ignition switch that can suddenly turn off a car, leaving it difficult to steer and disabling its air bags. The cause has been traced to not having enough resistance in the ignition switch to counter the weight of heavy keys and key chains. This is also an important...
by Spencer Aronfeld | Mar 11, 2014 | Defective Drugs, Low Testosterone
As an Androgel injury lawyer in Miami, I am concerned about the recent reports that men who take Androgel, Axiron, Testim, Foresta, and other low testosterone replacement drugs are at a higher risk for heart attacks and strokes. Our lawyers in Miami for people who want to sue a drug company believe the FDA should now require low T drugs to come with a “Black Box” warning. Black Box warnings issued by the FDA are reserved for drugs that can cause problems leading to death or serious injury. Drugs with the Black box, or “box warning,” carry warnings on the sides of their boxes, and those drugs are not permitted to use reminder ads. The drug warning labels are designed by the pharmaceutical company that actually makes the drug and must be approved by the FDA. BLACK BOX WARNING NEEDED ON LOW T DRUGS We believe there should be a Black Box warning on testosterone boosters after our review of recent reports of patients who have taken low T drugs and then suffered heart attacks and strokes. This should be a serious health concern for the over five million men in America who last year received prescriptions for testosterone products made by Androgel, Axiron, Testim, and Fortesta. Currently almost 13,000 prescriptions are filled for testosterone replacement drugs each day. Some recently published reports and studies show an increased risk of heart attacks and strokes. Ironically, studies funded by the drug industry showed no increased risk, collectively, compared to 14 independent studies which collectively showed a highly significant increase in cardiovascular risk. Yet currently, the FDA-approved labels on the drugs...
by Spencer Aronfeld | Mar 11, 2014 | Defective Drugs, Low Testosterone
Black Box warnings issued by the FDA are reserved for drugs that can cause problems leading to death or serious injury. In January, the FDA announced that it was investigating claims, in large part based upon reports of patients who have taken testosterone replacement drugs and then suffered heart attacks or strokes. In January the FDA issued a “Safety Announcement,” claiming that it is now monitoring the risks of Low T therapy to reassess its safety. This should be alarming news for the over five million men in America who last year received prescriptions for testosterone and who fill nearly 13,000 prescriptions a day for low testosterone, a condition that occurs when the testicles fail to produce testosterone because of genetic problems, injury, or chemotherapy. (Leer en Español) According to the medical literature, testosterone drugs should be used only by men who have a documented condition known as Low T, NOT simply as the anti-aging, sex-drive-increasing panacea depicted in hundreds of advertisements in magazines, on TV, and over the internet. Low T can be diagnosed only by a series of blood tests. Most people do not know that the warning labels on drugs are actually designed by the pharmaceutical companies that make the drugs; those labels must only be approved by the FDA. I am a lawyer who has sued drug companies for more than 20 years, and I believe, based upon these studies, that the FDA should now require Low T drugs to have a “Black Box” warning. As of today, the FDA has not required any Low T drug makers to change their packaging labels. FDA Testosterone:...
