Diabetes Drug Invokana and Atrium Medical C-Qur MDLs ProceedMar 27, 2017
Two separate federal multidistrict litigations (MDLs) concerning the diabetes drug Invokana and the Atrium Medical C-Qur hernia mesh device are moving forward. Plaintiffs suing over Invokana or the C-Qur hernia mesh in federal court may file directly into the MDL, according to separate pretrial orders. In the Invokana (canagliflozin) MDL, plaintiffs claim that the diabetes drug caused kidney damage. Atrium Medical C-Qur lawsuits maintain that the allegedly defective hernia mesh caused allergic reactions along with other complications.
National law firm Parker Waichman has extensive experience representing clients in product liability and personal injury litigation. Attorneys at the firm are available to answer any questions about filing a potential drug or medical device injury lawsuit.
What is an MDL?
When there are a growing number of lawsuits with common allegations, they are sometimes consolidated into a federal multidistrict litigation (MDL). This is a kind of mass tort, where the U.S. Judicial Panel on Multidistrict Litigation (JPML) transfers the case to one court before one judge. Establishing an MDL is a way of streamlining the legal process, leading to a faster resolution, by creating a generally more efficient procedure, including lessening court costs.
The JPML established the Invokana MDL in the U.S. District Court for the District of New Jersey before U.S. District Brian R. Martinotti. Court records show that the MDL contains a minimum of 126 Invokana lawsuits. The MDL was created in December 2016. Alleged injuries are diabetic ketoacidosis and kidney damage.
What is Ketoacidosis?
Ketoacidosis is the accumulation of substances called ketones and ketone bodies in the blood. Acidosis is increased acidity in the blood. Symptoms of ketoacidosis include slow, deep breathing with a fruity odor to the breath, confusion, frequent urination (polyuria), poor appetite, and eventually loss of consciousness.
The Atrium Medical C-Qur MDL was also created in December 2016. C-Qur (pronounced "secure") hernia mesh lawsuits are consolidated in the U.S.District Court for the District of New Hampshire. U.S. District Judge Landya B. McCafferty is presiding over the litigation. Court documents indicate that at least two dozen lawsuits have been transferred into the MDL so far.
Invokana Lawsuits Claiming Kidney Injuries and Ketoacidosis
Johnson & Johnson (J&J) is facing Invokana lawsuits alleging that the diabetes drug was the cause of kidney damage and ketoacidosis. Lawsuits allege that J&J had knowledge of these risks, but neglected to warn patients or the medical community.
The U.S. Food and Drug Administration (FDA) increased the warning in June 2016, on Invokana and other diabetes drugs to alert consumers about the risk of acute kidney injury. In patients that have acute kidney injury, the kidneys stop working suddenly, resulting in the buildup of dangerous waste products. Symptoms of acute kidney injury may include decreased urine or swelling in the legs or feet, warnings stated.
According to the FDA notification, 101 confirmable reports were received of acute kidney injury from the time canagliflozin was approved in March 2013 through October 2015. In addition, in May 2016, the FDA said that interim clinical trial data suggested an increased risk of amputations in patients taking canagliflozin.
Atrium Medical C-Qur Hernia Mesh Lawsuits and Allegations
The C-Qur is a product designed for hernia repair. Plaintiffs suing over the hernia mesh allege that the product is defective and caused injuries including allergic reactions as well as other complications. Atrium C-Qur lawsuits allege that the company was aware of the risks but failed to warn patients or their physicians.
Some plaintiffs allege injuries due to the fish-oil (omega-3) coating, which was touted as an anti-adhesion, anti-inflammatory barrier. Lawsuits claim that the hernia mesh presents a risk of infection, rejection, organ perforation, inflammation, chronic pain, additional surgery, rash, neurological changes, dental problems, bowel obstruction, and abnormal liver function. In addition, lawsuits allege hernia recurrence, where the hernia returned after the mesh was implanted.
In 2012, the FDA sent a warning letter to Atrium Medical due to manufacturing violations. Regulators said that, as a result, products including the C-Qur hernia mesh were adulterated. Specifically, it was claimed that the allegedly sterile mesh contained foreign substances, including human hair.
In 2013, the Atrium Medical recalled the C-Qur Edge mesh, because the coating can adhere to the inner lining of the packaging under humid conditions. "If the Product is exposed to excessive humidity for an extended period of time, then the increased humidity occurring inside the pouch can potentially cause the coating on the mesh to strongly adhere to the inner handling sleeve."
Plaintiffs in the Atrium Medical C-Qir litigation note that the product was approved through the 510(k) FDA fast-track program, allowing devices to be approved without substantial clinical testing provided they are "substantially equivalent" to a similar previously FDA approved product.
Filing a Drug or Medical Device Injury Lawsuit If you or someone you know has been injured by a medical device or a medication, you may be eligible for valuable legal compensation. The attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).