How to Ensure That You Receive Full Compensation for Your Sodium-Glucose Cotransporter 2 Inhibitor Amputation Lawsuit
Synjardy is a Sodium-Glucose Cotransporter 2 inhibitor (SGLT2) drug manufactured by Boehringer Ingelheim and Lilly. Synjardy is the brand name for the generic drugs empagliflozin and metformin hydrochloride. Synjardy is available in an extended-release formula whose brand name is Synjardy XR. SGLT2 medications have made an impact on people who live with Type 2 diabetes. The impact has not been all positive. SGLT2 drugs have been linked to serious medical problems such as diabetic ketoacidosis and amputations of lower extremities. While SGLT2 medications are effective in lowering blood sugar in Type 2 diabetics, these drugs have increased the risk of users of these medicines suffering severe injuries and illnesses. If you or a loved one experienced a severe illness or amputation from taking Synjardy, or any other SGLT2 drugs, you could be eligible to receive substantial financial compensation.
Parker Waichman LLP Investigating Potential Personal Injury Claims Involving Sodium-Glucose Cotransporter 2 Inhibitors
Parker Waichman LLP is a law firm whose Synjardy amputation attorneys have dedicated their careers to assisting people who suffered severe, life-threatening injuries, or the family members of those who died, at the hands of companies who manufacture defective goods. Parker Waichman’s drug defect attorneys are not afraid to take on the massive and powerful drug manufacturers who produce inadequate and harmful medications. Parker Waichman’s drug defect lawyers have earned the reputation for their zealous representation of personal injury victims by aggressively pursuing damages on behalf of their clients.
The Problems with SGLT2 Inhibitors
In 2017, the U.S. Food and Drug Administration (FDA) warned consumers that SGLT2 inhibitors had been connected with severe and potentially life-threatening side effects. SGLT2 inhibitors, specifically the Invokana brands of diabetes drugs, have been linked to people suffering a high rate of foot and leg infections. These infections resulted in the patients’ infected feet to turn into gangrene. Once flesh dies and becomes gangrenous, it can penetrate the skin, then deeper into muscles, and bone. The limb must be amputated when the infection progresses that far.
Hopefully, the infection can be contained and will not spread that far and grow that severe. Most of the victims of amputations have lost toes, but some have progressed to the point in which the entire foot was amputated. The most severe cases resulted in men suffering their legs from their knees down.
People living with diabetes commonly suffer from diabetic neuropathy. The severity of diabetic neuropathy ranges from mild to fatal. The most common symptom of diabetic neuropathy is pain and numbness in the patient’s feet and legs. Neuropathy affects the nerves because of high blood sugar. SGLT2 inhibitors compound those problems.
These powerful diabetes drugs have caused other side effects as well. In 2015, the FDA announced that SGLT2 drug consumption could lead to diabetic ketoacidosis Diabetic ketoacidosis is a critical medical condition that occurs when ketones build up in the patient’s bloodstream because there is insufficient insulin in the blood to manage insulin. As a result, the body begins to consume fat deposits for fuel.
Diabetic ketoacidosis is a potentially fatal medical condition. Without therapeutic intervention, ketoacidosis can cause a loss of consciousness and lead to death. Newly diagnosed diabetic patients can suffer from brain swelling, which is clinically known as cerebral edema.
Regulatory Agency Action
The FDA has only required Janssen Pharmaceuticals, the manufacturers of Invokana, to include a “Black Box Warning” on its label. The FDA’s Black Box Warning is the highest level of visibility for a warning that the FDA can require a drug manufacturer to put on its product label. The drug manufacturer must call the user’s attention to the potential danger described within the black box. Other SGLT2 inhibitor manufacturers have not received that mandate from the FDA.
Thus, Synjardy does not have a Black Box Warning for amputation risk. The Synjardy label does contain a Black Box Warning for lactic acidosis. Lactic acidosis is acid that builds up in the muscles from lack of sugar in the muscles. Metformin has been identified as a medication that causes lactic acidosis. Lactic acidosis can be very dangerous and is even deadly in some circumstances.
The European Medical Agency (EMA) took more aggressive action as it relates to the risk of amputation. The EMA required every manufacturer of an SGLT2 drug to place a specific warning drawing consumers’ attention to the threat of amputation risk. The EMA indicates that the risk was shown to be most significant with Invokana. But quite wisely, the EMA required all manufacturers to include a warning on their label, including the makers of Synjardy, because the active ingredients are nearly identical in each SGLT2 drug, and the drugs work the same way, that is by decreasing blood sugar levels so that the pancreas does not need to make more insulin.
It stands to reason that if one SGLT2 inhibitor drug can create an increased risk of amputation, then the entire class of SGLT2 medications carries the same risk. Despite that logic, the FDA does not see the need to issue the same warning as the EMA despite having the same information.
Hundreds of Lawsuits Are Pending Due to SGLT2 Drug Defects
At this time, hundreds of plaintiffs have filed claims against SGLT2 drug manufacturers for causing side effects about which the drug manufacturer failed to warn their consumers. Most complaints involved patients suffering amputation or diabetic ketoacidosis. Boehringer Ingelheim, the company that manufacturers Synjardy has been named in several of these lawsuits.
The drug defect lawyers with Parker Waichman LLP have the experience, skill, knowledge, and resources to take these massive drug companies head-on. In fact, Parker Waichman’s drug defect attorneys filed civil actions against the manufacturers of Invokana, Janssen Pharmaceuticals and its parent company Johnson & Johnson, seeking to recover damages for two of their clients who suffered lower leg amputations from taking the SGLT2 drug Invokana.
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