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Home » Diabetes Drug Lawsuit » Diabetes Amputation Lawsuit
Diabetes Amputation Lawsuit2018-06-15T23:13:02+00:00

Modern medicine is incredible. It has the potential to save lives and preserve mortality far beyond what anyone could expect. Yet, new drugs often carry a plethora of side effects, some of which are serious and deadly. A new class of drugs treating diabetes is the subject of over 1,100 lawsuits around the country due to its debilitating side effects, including ketoacidosis, renal failure, and lower body amputation. Diabetic patients who have been prescribed certain SGLT2 inhibitors like Invokana and Invokamet were found to be at double the risk of lower body amputation over patients given a placebo in the same clinical trials.

What is Invokana?

Invokana is part of a brand-new series of drugs which helps reduce the amount of glucose in an individual’s bloodstream. The active ingredient, canagliflozin, is thought to be one of the causes of the more serious side effects of the drug, including amputations. Invokana was the first drug of the SGLT2 inhibitor series to be approved of by the FDA for consumption in the United States in 2013. Janssen Pharmaceuticals, a division of Johnson and Johnson, manufactures the drug. Since its release, the FDA has had to review the dangers and side effects of taking this drug multiple times, to the point of labelling the medication with a ‘black box,’ the most serious warning that can be administered by the FDA.

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Amputation Risks

Diabetics often struggle with good circulation, especially with their lower limbs, feet, and toes. The FDA instituted a clinical trial to study the effects of Invokana on the cardiac health of patients taking the drug. Instead, researchers made the startling discovery that patients taking the drug were at twice the risk of suffering from a toe, mid-foot or lower limb amputation than if they had not been taking the drug at all.

Amputation Risks: FDA Clinical Trial Results

The report finds that 5.9 of 1,000 patients suffered lower body amputations, while those taking a placebo suffered an amputation every 2.9 per 1,000 patients. A second trial found an even higher rate – 7.5 of 1,000 patients over a 12-month period, versus 4.2 with the placebo. Amputations of the toe and middle of the foot were the most frequent type of amputation seen; however, there were amputations involving the leg – above and below the knee. Sometimes, patients suffered double amputations, involving both limbs. Out of the 140 patients who suffered amputations and took Invokana, half lost a toe, 16 percent had mid-foot amputations, and 1 person had an amputation at the ankle. Eighteen percent had full below-the-knee amputations, while another 10 percent suffered an above-the-knee amputation.

Amputation Risks: Cause

Doctors are not sure why Invokana increases the risk of amputation yet, although there are some theories. One is that these inhibitors cause individuals to urinate more frequently, resulting in dehydration. When someone is dehydrated, their blood vessels have to constrict in order to maintain blood pressure. This leads to lower blood flow, especially in the legs, feet, and toes. The link between the drug and amputations was not confirmed until May 2017 when the FDA required the black box warning, and therefore, the issues with amputation and Invokana are the newest aspect of this litigation. Patients taking Invokana who experience tenderness in the legs or feet, see ulcers and sores or have cuts that are not healing must speak to their physician immediately to avoid the risk of amputation.

Legal Claims

The vast majority of claims assert that the manufacturer, Janssen Pharmaceuticals and its parent company, Johnson and Johnson, negligently created a drug that is defective and unreasonably dangerous. They are also alleged to not properly test the medication and failed to warn of the increased risk of injuries, including amputation. Most seriously, there are claims against the company that they concealed the evidence of the dangers of the drug from both the FDA and the public, and actively misrepresented the merits and safety of the drug in its marketing. Pharmaceutical litigation is largely controlled by modern products liability claims.

Responsibility to Research and Report

Drug manufacturers must ensure the safety of their pharmaceuticals continuously – even after the FDA has approved of their use. They must report any detrimental side effects or reactions to the drug in a prompt manner to the FDA. Risks must be continuously evaluated, so that the FDA can disseminate warnings timely and, if necessary, institute a recall and remove the product from the market entirely. Failure to do this opens up the manufacturer to lawsuits and products liability tort claims.

Fraudulent Concealment

Another claim being filed against Invokana and other SGLT2 inhibitors is that they actually did know of the link between amputation and ingestion, but instead actively concealed this information from the FDA, doctors and the public at large. If the plaintiffs can prove the elements of this claim, then they could stand to receive more compensation in the form of punitive damages. The plaintiff has to show that the company knew of the established risk of the side effect at the time they were taking the drug, failed to disclose it, and then, on top of that, intentionally and successfully concealed it from them after the fact. This is a fairly heavy burden of proof and would likely require extensive discovery and experts to prove.

Damages and Compensation

If the plaintiff can show that the manufacturers of Invokana breached their duty and are liable for their amputation, then there are multiple kinds of damages and compensation that they could be awarded if they can justify it.

Medical Expenses

First, an amputation is a serious medical procedure. Depending on the patient’s insurance, they might be out of pocket several thousand dollars for the operation. If the manufacturer is liable for the amputation, then the plaintiff would be entitled to reimbursement on the medical costs, both past, and future, for the operation.

Pain and Suffering

Of course, the plaintiff also probably experienced pain and suffering because of their amputation. A court can award damages for this pain and suffering, and might even be able to include damages for mental suffering. Losing a limb, or part of one can be a traumatic experience that might require psychological counselling. A drug manufacturer responsible for a patient’s amputation might be required to compensate the victim for these kinds of damages.

Lost Earnings

Other damages are a little bit easier to calculate, such as lost wages or lost earning potential. Clearly, if you lose a foot, part of one, or your leg, your mobility is going to be affected, which could have an impact on your ability to make a living. If there is liability on the part of the manufacturer, and the plaintiff claims loss of income, then they will have to show the court what they were making before the amputation happened, and then show the difference in earnings afterward. Even if the person was off work only temporarily, if they can show that their income decreased during this period, then the manufacturer might be ordered to make up the difference.

Punitive Damages

One of the most difficult things to prove, but more lucrative, is whether or not the court should issue punitive damages. As the name suggests, punitive damages are designed as a deterrence and punishment for companies where the court believes they have acted particularly egregiously – such as by knowing about serious reactions or side effects of drugs, and actively hiding this fact from the public. In 2014, a Louisiana jury awarded $9 billion in punitive damages to patients over a diabetes drug that was linked to bladder cancer, manufactured by Japanese company Takeda Pharmaceutical, and marketed in the United States by Eli Lilly. This was one of the biggest verdicts in pharmaceutical litigation history and speaks to the outrage jurors felt at the behavior of these companies.

Affected States

Diabetes detrimentally effects millions of citizens across the United States. The Center for Disease Control reports yearly on the rise of citizens affected throughout states, counties, and local communities. Some of the states most affected by diabetes, and debatably most vulnerable to Invokana’s increased risk of amputation, include:

  • West Virginia
  • Tennessee
  • South Carolina
  • North Carolina
  • Rhode Island
  • Pennsylvania
  • Oklahoma
  • Ohio
  • Nevada
  • Mississippi
  • Missouri
  • Kentucky
  • Indiana
  • Illinois
  • Hawaii
  • Georgia
  • Florida
  • Arkansas
  • Alabama

If you are a resident of one these states and required a lower-limb amputation while taking Invokana you may be entitled to compensation.

Complex Litigation

Pharmaceutical lawsuits are some of the most complex litigation there is. Currently, the lawsuit involving Invokana has been consolidated in federal court into a Multidistrict Litigation (MDL), and there are Bellwether trials set for September 2018. There are state law cases currently pending in New York, Pennsylvania, California, and others. Whether or not you wish to file in federal or state courts will depend on a multitude of factors which should be discussed thoroughly with a qualified pharmaceutical litigator. Drug companies keep experienced and aggressive lawyers on their payroll to defend against product liability lawsuits. They have vast resources and experience, and the company has a nearly unlimited budget to fight the lawsuit. It is crucial for patients who have suffered injuries from taking a drug to find a qualified lawyer to fight for their rights. In most cases, personal injury and mass tort litigators will accept cases on a contingency fee basis. This means that if they do not win the case, then you will not have to pay anything.

If you were prescribed Invokana and suffered an amputation prior to August of 2017, you might still be eligible to file your own lawsuit in either federal or state court. Contact the law offices of Paul Schiffer at 832-920-0434

Invokana™ is a registered trademark of Janssen Pharmaceuticals, Inc. The use of any trademarks marks are solely for informational and product identification purposes