INVOKANA


Ohio Product Liability Lawyer representing plaintiffs nationwide in Pharmaceutical Litigation and drug injury cases
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Since May, 2017, two clinical studies have concluded that there is a link between the popular diabetes drug Invokana (canagliflozin) and an increased risk of lower limb amputations. Researchers have said the drug may double amputation risk in diabetes patients.

As a result, the U.S. Food and Drug Administration (FDA) has required Johnson & Johnson and Janssen Pharmaceuticals to revise and strengthen its Invokana warning. The FDA has advised doctors to discontinue Invokana for patients who experience serious pain or extremity infection and Fournier’s Gangrene.

Thus far in legal proceedings, thousands of personal injury claims have been filed against the drug manufacturers. Around 50 percent of reported amputations among patients were of toes—remaining amputations in patients were at the foot, ankle, below the knee and above the knee. Some patients have reported more than one amputation and severe Fourniers gangrene infection.

Prior to amputation risk concerns in 2017, Invokana use was already associated with kidney issues, ketoacidosis and serious cardiac events. Plaintiffs and attorneys claim the manufacturers, Johnson & Johnson failed to properly test the medication, failed to warn consumers of the risks, and may have even concealed evidence of some health hazards from the FDA during the approval process.

Joe Lyon is a highly-rated Ohio product liability attorney and Ohio Invokana lawyer representing plaintiffs nationwide in a wide variety of civil litigation claims against pharmaceutical companies.


What is Invokana Used to Treat?


Invokana (Canagliflozin) is a drug primarily prescribed to patients with type 2 diabetes—and sometimes type 1—to help lower blood sugar levels. Canagliflozin is an SGLT-2 inhibitor (sodium-glucose cotransporter-2 inhibitor) which assists the kidneys to remove sugar from the body. Experts worry that similar drugs carry similar risks to patients. Other SLGT-2 inhibitors on the market in the same drug class include:

  • Invokana
  • Invokamet XR
  • Farxiga
  • Xigduo XR
  • Jardiance
  • Glyxambi
  • Synjardy
  • Metformin

Invokana Injuries & Complications


Recent research shows an alarming rate of leg, foot and toe amputations, and has been hit with hundreds of adverse-event reports from the time the drug was released. Patients and medical professionals should monitor the following signs and symptoms of Invokana-related issues:

  • Sores on legs
  • Serious leg or foot pain
  • Leg infection
  • Low blood pressure
  • High levels of potassium in the blood
  • Urinary tract infections
  • Low blood sugar when combined with other diabetes medicine
  • Yeast infections
  • Bone fractures
  • Increased cholesterol

Serious complications from taking Invokana include the following:

  • Amputation: patients taking Invokana are twice as likely to need a leg or foot amputation as those taking a placebo. Toe amputations are the most common. Patients taking Invokana should be vigilant and look for signs of increased tenderness, sores, ulcers, and infections in their lower extremities. Contact an Ohio Invokana Lawyer following any catastrophic drug injury.
  • Ketoacidosis: Ketoacidosis is a condition where high levels of ketones (toxic acids) are produced in the body, resulting in diabetic comas, extended hospitalizations, and even death. Ketoacidosis develops when insufficient levels of insulin are produced within the body, and the body breaks down fat as an alternative source of energy.
  • Kidney Failure: Kidney failure occurs when a person’s kidneys stop functioning without the use of dialysis or a transplant. Kidneys help filter waste products from the blood, and help to control blood pressure, electrolyte balance, and red blood cell production. When kidneys stop functioning properly, the result is general weakness, shortness of breath, confusion, and abnormal heart rhythms.
  • Heart Attacks
  • Fournier’s Gangrene Infection

Ohio Drug Injury Lawyer investigating diabetes drug complications and reviewing amputation and Invokana Fourniers Gangrene Lawsuit settlements for injured plaintiffs nationwide


Fournier’s gangrene is an acute necrotic infection of the scrotum, penis, or perineum, which presents in pain, redness and a dangerous rapid progression to life-threatening gangrene. Fournier gangrene typically follows other infections associated with SGLT diabetes drugs like Invokana, trauma, surgery infections, or urinary tract disease.

Fournier Gangrene is highly-associated with diabetic patients taking SGLT2 medications, long-term alcohol abuse and non‐obvious immune compromised patients. Many cases of Fournier’s Disease have been documented in adult males taking Invokana or other SGLT diabetes drugs that raise the risk of infection and amputations. The disease has been identified, even more rarely, in women and children.

Recent clinical trials have concluded that the use of the popular diabetes drug, Invokana (canagliflozin), may increase the risk of lower limb amputation. The drug is said to double amputation risk in diabetes patients.

Since May, 2017, when two clinical studies demonstrated a link between Invokana and an elevated risk of lower limb amputations, the U.S. Food and Drug Administration (FDA) has required Invokana to revise and strengthen its warning, and has advised prescribing doctors to discontinue Invokana for patients who experience unusual pain, sores or extremity infection.

As a result, thousands of injury claims have been filed against Johnson & Johnson and Janssen Pharmaceuticals by individual patients. About half of reported amputations among patients in the trial noted above were of toes. The remaining amputations were across the foot, at the ankle, below the knee and above the knee. Some patients have had more than one amputation, sometimes involving both limbs.

Prior to May, 2017, Invokana use was already linked to kidney damage, ketoacidosis and heart attack events. Lawyers claim the drug manufacturers failed to properly warn consumers of the dangers of gangrene infection injuries, failed to properly test the medication, and possibly concealed evidence of the dangers from regulatory bodies and the public.

Joe Lyon is an experienced Drug Injury Attorney reviewing cases of SGLT2 medication amputation and Invokana Fourniers Gangrene Lawsuit settlements for victims and plaintiffs.


Fournier’s Gangrene Symptoms


Symptoms of Fournier Disease include fever, general discomfort, pain and swelling in the genital areas and a smell of the affected tissues affected by gangrene. Affected gangrene tissue can extend to the thighs and abdomen. Fournier’s disease can be found in conjunction with other conditions that weaken the immune system, like diabetes mellitus, obesity, cirrhosis, and blood disorders.

A diagnosis is necessary to distinguish between Fournier Gangrene and another acute inflammatory condition like epididymitis or orchitis.


Invokana FDA Black Box Warning


The most recent FDA warning is more visible for patients, and goes further to suggest physicians carefully consider certain factors before prescribing the drug which may predispose patients to amputations, such as prior amputations, peripheral vascular disease, neuropathy and diabetic foot ulcers.

This 2017 warning is in addition to another in 2016 when the FDA strengthened a warning to users of canagliflozin for an increased risk of acute kidney injury. In 2015, the FDA warned that Invokana (canagliflozin) presents an increased risk of bone fractures.

Though the drug companies are not as forthcoming, the FDA has been clear about the dangers and severe risks of the drug. They stress to all patients taking Invokana, Invokamet and Invokamet XR the importance of contacting their doctors immediately if they notice unusual pain, sores, ulcers or infections on their legs or feet.


Fournier Gangrene Classification


The disease is rare and has been called several variations, including:

  • Fournier disease
  • Fournier’s disease
  • Fourniers disease
  • Fournier’s gangrene
  • Fourniers gangrene
  • Necrotizing fasciitis of the perineum and genitalia

Fournier’s Gangrene Causes & Treatment


Bacteria, fungi, and viruses can each be responsible for a case of Fournier gangrene. Existing abscesses, infections, surgical intrusion and contributing SGLT2 diabetes drug factors may be related. Not everything about Fournier’s Gangrene is understood, though diabetes and drugs appear to be of some association.

In the average patient, the mean age is about 50 years, and Fournier gangrene is diagnosed more frequently in males. Illnesses such as diabetes, alcoholism, HIV infection, and malnutrition will increase the risks, though how much is unknown.

Treatment involves broad-spectrum intravenous antibiotics followed by urgent surgical removal of all gangrene areas. Patients with a blood infection (sepsis) are at an increased risk for developing blood clots. Complications are likely and the outlook varies from patient to patient.


Fourniers Gangrene Lawsuit


The Lyon Firm specializes in drug injury cases and pharmaceutical defect lawsuits on behalf of injured patients nationwide. We work with industry experts to determine the root cause of injury. Contact medical professionals for healthcare and for legal assistance and to consider a Drug Injury Lawsuit, call an experienced attorney.

Invokana has been bogged down in adverse-event reports almost from the beginning. About one year after the drug gained FDA approval, the Institute for Safe Medication Practices issued a report indicating a link between kidney damage, Fourniers Gangrene, renal failure and SGLT2 inhibitors. The next year, the FDA issued a warning that it may also cause ketoacidosis. The FDA has warned of other side effects that may include:

•    Low blood pressure
•    High amounts of potassium in the blood
•    Serious urinary tract infections
•    Low blood sugar when combined with other diabetes medicine
•    Yeast infections
•    Bone fractures
•    Increased cholesterol


Contact an Ohio Invokana Lawyer


Black Box Warning on Packaging: The FDA has warned of a serious Fournier’s Gangrene Infection Risk. 

The 2017 FDA-approved packaging warning is made more visible for patients, and strengthens their previous amputation warning. The new black box warning suggests physicians consider certain factors before prescribing, which could predispose patients to amputations—prior amputations, peripheral vascular disease, neuropathy and foot ulcers are red flags to doctors and patients.

The warning also says doctors should consider discontinuing the use of the drug if infections and sores develop on patients’ lower extremities.

The FDA has been clear about the dangers and severe risks of the drug. The warnings may be too late, however, in many cases. Many patients have suffered injuries. Attorneys are filing claims, arguing the following:

  • Johnson & Johnson failed to properly test the medication
  • Johnson & Johnson failed to warn of increased risk of amputation, kidney failure and ketoacidosis
  • Johnson & Johnson misrepresented the safety of the drug in marketing material.
photo of attorney Joe Lyon
A Voice for Those who have suffered 

Why are these cases important?

By taking the initiative and filing drug injury lawsuits, plaintiffs can receive proper compensation and hold a corporation accountable for their negligent actions. Consumer safety depends largely on making sure companies operate within the law and within ethical boundaries.

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Questions about Pharmaceutical Litigation

What is Pharmaceutical Litigation?

When drug makers and large corporations are negligent and produce dangerous products that lead to serious illness and injury, legal action can be necessary. In the current corporate environment, filing lawsuits is one of the only ways to keep drug companies from selling untested and dubious pharmaceuticals in the name of profit. Pharmaceutical litigation – through a lawsuit against a drug manufacturer- helps bring awareness to these companies as to the necessary changes that need to occur in order to keep people safe a healthy while taking a  certain drug. 

By taking the initiative and filing drug injury lawsuits, plaintiffs can receive proper compensation and hold a corporation accountable for their negligent actions. Consumer safety depends largely on making sure companies operate within the law and within ethical boundaries.

How does the drug label come into play?

In past litigation, it has been discovered that drug companies often delay adding serious side effects to a drug’s label due to concerns about the impact on the sales and marketing. If a drug carries more serious side effects, physicians and patients look for alternative treatments with less risk and the same or similar benefit.  As a result, there is a financial incentive not to strengthen the warning label.

However, the label is the source of information that physicians and patients rely upon when making these important health decisions.  There is no excuse for a company not to update its label when the science is sufficient to show an association with the medication.

How does this related to the FDA?

Most experts would agree that the FDA is not designed nor does it have the resources to monitor every product through the post approval process once it has been granted clearance. Very simply, the volume of medical devices that are presented for review is too demanding, so, while the FDA is a good initial step in the process, the responsibility of providing safe and effective pharmaceutical companies remains on the companies that profit from the sales.

While the pharmaceutical companies have yielded more influence over the review process, ultimately, the law is very clear that it is the company’s responsibility to run the appropriate tests, track the data, and to identify the side effects and then warn consumers and physicians adequately and in a timely manner. Government approval is not a shield for liability. The Failure to timely and sufficiently warn of side effects operates as the primary cause of action for pharmaceutical claims.

Most importantly, the FDA and the government do not provide for compensation when someone is injured by a pharmaceutical product.  The civil justice system provides the means for an individual harmed by a pharmaceutical product to obtain justice and recover for the losses suffered.

Without the civil justice system, companies would not be required to pay for the harm they cause, and the public tax system, in terms of Medicare and Medicaid, would have to absorb that loss. In other words, without pharmaceutical lawsuits, the tax payers would pay for corporate malfeasance and neglect.

What are some examples of Pharmaceutical Settlements?

The current opioid crisis is a good example of how over-prescribing medications can lead to a huge public health crisis. Pain medications have been a great tool for physicians in treating a wide variety of conditions, however, the abuse of prescribing and using pain medication has turned into one of biggest areas of pharmaceutical litigation today.

It is not only opioids that have been prescribed in huge numbers. Other drugs that have only been tested in short trials are released to the market each year and injure patients. A few examples of drug injury:

Testosterone: Low T clinics are under investigation after many patients receiving testosterone therapy have reported strokes and heart attacks. Experts say doctors may be pushing the therapy when not every aging man requires testosterone therapy.

AntibioticsAntibiotic injuries are being reported at record rates as the drugs are prescribed more than ever before. Drug resistance and drug injury rates are on the rise, concerning the medical community and consumer protection attorneys.

Diabetes Drug Injury: Severe side effects are being reported by diabetes patients taking Invokana and other diabetes medications. Amputations and gangrene cases have opened the eyes of many taking the drugs, and lawsuits have been filed on their behalf.

Drug Contamination: Valsartan and Losartan contamination cases have raised the risk of patient cancer. Drug companies have failed to control the production process and put consumers at unnecessary risk.

Opioid Painkiller Lawsuits: Purdue Pharma, Johnson & Johnson and other large drug companies are deep in pharmaceutical settlement talks many years after the beginning of the opioid addiction crisis. Thousands of Americans die each year in opioid-related overdose deaths, many of which begin with doctors over-prescribing pain medications.

Depo Provera: Confidential settlement from Pfizer to resolve all of the claims currently pending in the New Jersey State coordinated litigation. Joseph Lyon represented 13 females who suffered osteoporosis due to the failure of Pfizer to properly warn them and their physicians.

Seroquel: AstraZeneca resolved claims for $198 Million regarding claims that the company failed to warn about risks of diabetes and excessive weight gain. The Lyon Firm participated in this settlement and represented numerous claimants. In addition to the individual claims, Federal prosecutors and authorities from several U.S. states investigated whether AstraZeneca promoted Seroquel off-label, or for uses not approved by the U.S. Food and Drug Administration. The company announced a settlement of $520 million with the U.S. Justice Department over the matter.

Trasylol: Bayer resolved certain claims for $60 Million for patients who suffered heart failure and death as a result of the drug Trasylol.  Trasylol was a drug used to prevent excessive bleeding during heart surgery. The science unequivocally showed Trasylol can cause kidney damage, heart failure and strokes, and greatly increase patients’ risk of post-surgery death when compared to rival treatments.

In 2006, a study by Dr. Dennis Mangano was published in the New England Journal of Medicine concluding that the drug more than doubled the risk of renal failure.  After fourteen years on the market, Bayer suspended sales in November 2007. The Lyon Firm participated in this settlement.

Vioxx: Merck settled the outstanding Vioxx claims for $4.85 billion. The Lyon Firm participated in this settlement.  In 2004, after a study showed Vioxx doubled the risk of heart attacks and strokes, Merck pulled Vioxx from the market. The case was then litigated with 16 trial ultimately going to the jury for a decision. Merck prevailed in 11 of the 16 trials.

Despite the settlement, Merck has not admitted that that Vioxx caused injuries. Each claim under the settlement was analyzed under an protocol that weighed such factors as a user’s age, their length of use, and their health risks such as obesity or hypertension. The individual extraordinary payout for a heart attack case was capped at $600,000.

How are the cases handled?

Pharmaceutical litigation is a complex area of law that combines dense regulation, developing science, and multi-jurisdictional questions of law. Most cases involving claims of drug injury and pharmaceuticals become centralized in the federal multidistrict litigation process. Pharmaceutical litigation involving injury claims are not in most cases not class action lawsuits, but they are very similar.

Due to the volume of cases and number of similar issues, most pharmaceutical cases are handled through Multidistrict Litigation (MDL). The multidistrict litigation procedure is guided by the Judicial Panel for Multidistrict Litigation, where the case is centralized before one federal Judge for the purposes of pre-trial discovery.

The MDL process is appropriate where there are one or more common questions of fact in multiple cases pending in different federal district courts.  While there often are parallel state consolidated proceedings, the federal MDL process is generally supported by both Plaintiff and Defendants in these cases.

The MDL process allows for efficiency where there are millions of pages of documents, many expert witnesses across multiple disciplines from epidemiology, pharmacology, toxicology and the specific discipline for the relevant mechanism of injury.

Although 28 USC 1407 does not specify a specific number of cases required before the formation of an MDL is appropriate, the Judicial Panel for Multidistrict Litigation reviews the Motions and conducts a hearing to determine whether consolidation is ripe given the number and location of the pending cases.

What is an MDL?

Most people understand what a class action lawsuit is, and fewer are aware of what an MDL refers to. It is important for a claimant to know, however, that an MDL is not a class action, as the term is often misapplied in this context, and the original court (home or transferee jurisdiction) retains the authority to present the case at trial.

In most MDL settings, the case is resolved by way of settlement or a summary judgment motion on the questions of science (i.e., Daubert Motion). If either settlement or dismissal on Motion occurs, the case is not remanded to the originating court. If the case is not resolved at the MDL, then the case may be remanded to original jurisdiction for additional discovery on the case specifics and ultimately trial.

Why Hire the Lyon Firm?

Our Firm will help you find the answers.  The Firm has the experience, resources and dedication to take on difficult and emotional cases and help our clients obtain the justice for the wrong they have suffered. 

 Experience:  Joe Lyon is an experienced Cincinnati Pharmaceutical Lawyer. The Lyon Firm has 17 years of experience and success representing individuals and plaintiffs in all fifty states, and in a variety of complex civil litigation matters. Pharmaceutical lawsuits can be complex and require industry experts to determine the root cause of an accident or injury. Mr. Lyon has worked with experts nationwide to assist individuals understand why an injury occurred and what can be done to improve their lives in the future. Some cases may go to a jury trial, though many others can be settled out of court.

Resources/Dedication: Mr. Lyon has worked with experts in the fields of accident reconstruction, biomechanics, epidemiology, metallurgy, pharmacology, toxicology, human factors, workplace safety, life care planning, economics, and virtually every medical discipline in successfully representing Plaintiffs across numerous areas of law. The Lyon Firm is dedicated to building the strongest cases possible for clients and their critical interests.

Results:  Mr. Lyon has obtained numerous seven and six figure results in personal injury,  automotive product liability, medical Negligence, construction accidents, and auto dealership negligence cases.  The cases have involved successfully litigating against some of  the largest companies in the world 

Our Victories

The Lyon Firm aggressively, professionally, and passionately advocates for injured individuals and families against companies due to a drug to obtain just compensation under the law. 

IN RE: VIOXX

Nationwide Consolidation in U.S. District Court, E. Dist. of LA. 

This pharmaceutical case involved claims that the blockbuster painkiller was causing heart attacks and strokes in consumers. The FDA ultimately recalled the medication. Merck settled the outstanding Vioxx claims for $4.85 billion following multiple trials in both state and federal courts. Joe Lyon was co-counsel in a number of individual claims that were successfully resolved in the federal MDL. The funds received for Lyon Firm clients helped several elderly clients with additional medical and home health care.

IN RE: TRASYLOL

Nationwide Consolidation in Civil Complex Litigation Center Philadelphia, PA. 

A pharmaceutical case involving claims that a popular surgical medication was causing kidney failure and death. The FDA recalled the medication in question, but not before thousands of patients died due to related complications. Bayer resolved certain claims for $60 Million for patients who suffered kidney failure and death as a result of using the drug Trasylol. Joseph Lyon represented a widow from Kentucky whose husband died due to kidney failure following the administration of Trasylol. The recovered funds assisted the surviving family members in resuming farming operations.

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