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Amputation Injury Lawyers
The diabetes treatment drug Invokana has been linked to kidney injuries, diabetic ketoacidosis, and amputations of toes, feet, and legs.
When you are already dealing with the struggles of daily diabetes management, suffering an injury from the very drug that was supposed to help you can be completely devastating. And Invokana injuries themselves have a tremendous effect on your life, rendering you in and out of medical treatment and unable to perform the everyday tasks you once accomplished easily.
Why Choose Parker Waichman LLP for Your Claim?
As skilled defective drug litigators, the attorneys at Parker Waichman LLP, understand the burdens placed upon you and your family by your Invokana injuries, and we are committed to bringing you the compensation you deserve. Our New York lawyers are ready to investigate your Invokana claim and determine whether you can file a lawsuit to hold the drug manufacturer liable for your injuries.
Parker Waichman LLP has produced near-unprecedented case results for our clients throughout The United States of America. We have garnered more than $2 billion in settlement awards and verdicts.
Honors Within the Legal Community
Fellow plaintiffs’ lawyers, defense lawyers, judges, and former clients have bestowed us with numerous honors, making us one of the top personal injury and product liability law firms in the country. As we litigate cases throughout the country, our name is associated with integrity, professionalism, and a zeal for client advocacy. When you hire our lawyers, you can feel confident your case is in the capable hands of a firm backed by decades of personal injury litigation experience.
Awards and Special Recognition
At Parker Waichman LLP, we are extremely proud of the level of compensation we have secured for our clients — we are one of only a few law firms to achieve more than $2 billion in settlement awards and court verdicts — and we are equally proud of the national reputation we have earned inside and outside the legal community.
We are extremely proud of the reputation we have earned inside and outside the legal community, which includes receipt of the following honors:
- 8 out of 10 Rating by AVVO
(A service that rates every attorney in the United States)
- Martindale-Hubbell® “Preeminent Lawyers” listing and AV Peer Review Rating
(Martindale-Hubbell® – a company that, for more than 100 years, has rated attorneys across the United States and the world based on feedback from judges and their peers)
- Highest Ranking of “5 Dragons,”
Based on peer review by Lawdragon
- Listing in Best Lawyers Publication
Determined by Extensive Peer Review
What is Invokana Used for?
Invokana is part of a class of drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors used to treat adults with type 2 diabetes. Type 2 diabetes is a disease in which a person has high levels of sugar in his or her blood, due to the pancreas not making enough of the hormone insulin to regulate blood sugar. Invokana is manufactured by Janssen Pharmaceuticals, Inc., (a division of Johnson & Johnson) and is a tablet that, when combined with specialized diet and exercise, is supposed to help patients achieve glycemic control.
How Does Invokana Work?
Invokana is designed to balance glucose levels by preventing the kidneys from reabsorbing glucose through the waste-expelling process. The kidneys are like your body’s filtration system, sending chemicals and waste out of your body through urine. A protein in your body — sodium-glucose co-transporter 2 — allows your kidneys to reabsorb glucose for your body to use as energy, instead of expelling it through urine. But in a person with diabetes who already has high glucose levels, this kidney re-absorption is problematic. Invokana is supposed to prevent glucose re-absorption by blocking the SGLT2 protein that facilitates this process inside the kidneys.
What is the Problem with Invokana?
The problem is Invokana does not work properly and can actually exacerbate diabetic complications, leading to patients developing kidney injury and kidney failure, diabetic ketoacidosis, and toe, foot, or leg amputations.
Who Manufactures Invokana?
Invokana is manufactured by Janssen Pharmaceuticals, Inc., which is a division of the well-known corporation Johnson & Johnson.
What Injuries and Side Effects are People Reporting from Ivokana?
Invokana use in diabetic patients can lead to a number of injuries. Diabetes is an already complex disease that can cause patients to develop many painful subsequent medical issues. That’s why patients turn to medications like Invokana to help them regulate blood sugar and prevent more serious problems. However, Invokana presents a strong risk to patients, and its side effects are very similar to complications associated with uncontrolled diabetes. The most serious Invokana injuries include:
Kidney Injury and Kidney Failure
The kidneys are a vital component in the workings of Invokana, but the drug can actually damage the kidneys. Patients who use the drug can develop reduced kidney function or kidney failure. When this occurs, the kidneys are unable to filter out waste, leading to numerous complications, including possible death. Many people can end up requiring a kidney transplant or ongoing dialysis to restore proper waste-elimination function.
Ketoacidosis is a condition associated with diabetes in which a person’s body produces high levels of blood acids called ketones. When the body does not have enough insulin, the muscles are prevented from using glucose for energy and instead break down fat for energy. The fat breakdown releases ketones into the bloodstream, which can start to build up. Symptoms of ketoacidosis can appear within 24 hours and include:
- Excessive thirst
- Frequent urination
- Abdominal pain
- Weakness and fatigue
- Shortness of breath
Complications from ketoacidosis can entail irregular blood sugar and potassium and swelling of the brain.
Patients taking Invokana are at a significant risk for requiring amputations of their toes, feet, and sometimes legs. Diabetic patients are already at risk of feet and lower limb issues because they develop narrow blood vessels, reduced blood flow to the lower extremities, and nerve issues known as neuropathy. These conditions reduce pain sensation and make it more difficult for diabetics to feel when they have wounds or ulcers on their feet. Wounds and ulcers can then become infected and lead to tissue damage and death (also known as gangrene). Infections can then spread to the bone and only be remedied by surgical amputation of the affected body parts. It is not completely understood how Invokana leads to increased risk amputations, but the connection has been clearly established and reported by the FDA. These amputations have a tremendous effect on people’s lives, as they deal not only with extreme pain but also with inability to walk or maintain balance, need for prostheses, and potential phantom limb sensations.
If you took Invokana and developed kidney damage or ketoacidosis, or required amputation of your toes, feet or legs, you could be entitled to seek compensation from the manufacturer of the drug. The attorneys at Parker Waichman LLP know how traumatic your Invokana injuries are, and we are prepared to fight for your rights.
Brand Names of SGLT2 Inhibitors
Parker Waichman LLP has joined numerous law firms around the country in pursuing lawsuits against Janssen’s Invokana, claiming it defectively designed and manufactured the drug, failed to adequately warn patients and their doctors about the risks associated with the drug, and sold the drug in an unreasonably dangerous condition. We are also alleging that Janssen misled the public through its marketing and advertisements of Invokana.
Several other SGLT2 inhibitors are on the market, including two additional SGLT2 inhibitors manufactured by Janssen Pharmaceuticals. Other brands of these drugs include:
- Invokana (canagliflozin), manufactured by Janssen Pharmaceuticals (of Johnson & Johnson)
- Invokamet (canagliflozin and metformin), also manufactured by Janssen Pharmaceuticals
- Invokamet XR (canagliflozin and metformin extended release), also manufactured by Janssen Pharmaceuticals
- Farxiga (dapagliflozin), manufactured by AstraZeneca
- Xigduo XR (dapagliflozin and metformin extended release), manufactured by AstraZeneca
- Jardiance (empagliflozin), manufactured by Boehringer Ingelheim and Eli Lilly
- Glyxambi (empagliflozin and linagliptin), manufactured by Boehringer Ingelheim and Eli Lilly
- Synjardy (empagliflozin and metformin), manufactured by Boehringer Ingelheim and Eli Lilly
While some lawsuits connect these additional SGLT2 inhibitors to various injuries, litigation remains strongly focused on Janssen, Johnson & Johnson, and Invokana, based on research and studies definitively tying this drug’s particular chemical contents to several serious injuries.
FDA Research and Warnings
In May 2015, the U.S. Food and Drug Administration (FDA) issued a Safety Announcement in which it warned that use of SGLT2 inhibitors, including Invokana, could lead to ketoacidosis. The FDA stated it was continuing to investigate this safety issue but noted that it had identified 20 cases of acidosis — reported as diabetic ketoacidosis, ketoacidosis, or ketosis — in patients treated with SGLT2 inhibitors between March 2013 and June 6, 2014. All of these patients required emergency room visits or hospitalization to treat the ketoacidosis. It warned that patients should pay close attention to any signs of ketoacidosis and seek medical attention immediately if they experienced symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, or unusual fatigue. The FDA also cautioned healthcare providers in the same Announcement to evaluate patients for the presence of acidosis, including ketoacidosis, if they presented with any of these symptoms.
In December 2015, the FDA required a label change for all SGLT2 inhibitors after conducting a safety review that indicated a risk of ketoacidosis and urinary tract infections associated with the drugs. In announcing the label change, the FDA reported that it had identified 73 cases of ketoacidosis among patients treated with SGLT2 inhibitors, including Invokana, between March 2013 and May 2015. All of these patients required hospitalization or treatment in an emergency department. It also identified 19 cases of life-threatening blood and kidney infections in patients treated with these drugs between March 2013 and October 2014. All of these 19 patients were also hospitalized, and several required treatment in intensive care units and dialysis for kidney failure.
In May 2016, the FDA issued a Safety Announcement specifically related to use of Invokana. The Announcement reported interim safety results from an ongoing clinical trial that found an increase in foot and leg amputations (mostly affecting the toes) in patients treated with this drug for diabetes. In this clinical trial, called Canagliflozin Cardiovascular Assessment Study (CANVAS), an independent data monitoring committee identified a risk of amputation about two times greater for patients using Invokana (and Invokamet) compared to patients using a placebo. An interim analysis showed that during a year, the risk of amputation for patients involved in this trial was equivalent to:
- 7 out of every 1,000 patients treated with 100 mg daily of Invokana
- 5 out of every 1,000 patients treated with 300 mg daily of Invokana
- 3 out of every 1,000 patients treated with a placebo
The FDA stated that patients taking Invokana should immediately notify their doctors if they noticed any new pain or tenderness, sores or ulcers, or infections in their legs or feet. It also advised doctors to monitor their Invokana patients for signs of any of the above.
In June 2016, the FDA required a label change for Invokana, Invokamet, Farxiga, and Xigduo XR based on recent reports showing these drugs were linked to acute kidney injuries in type 2 diabetes patients. The FDA issued a Safety Announcement regarding the label change in which it stated that it had received 101 reports of confirmable cases of acute kidney injury among patients taking these drugs between March 2013 and October 2015. In approximately half of these cases, the acute kidney injury occurred within one month of starting the drug, and most of the patients improved upon discontinuation of the drug. Some of them required hospitalization. The FDA warned patients to seek medical attention immediately if they experienced signs and symptoms of acute kidney injury, such as decreased urine output or swelling in the legs or feet. It also advised doctors to consider factors that might predispose patients to acute kidney injury — decreased blood volume, chronic kidney insufficiency, congestive heart failure, usage of diuretics, usage of blood pressure medications and non-steroidal anti-inflammatory drugs — before beginning treatment with Invokana, Invokamet, Farxiga, or Xigduo XR.
In May 2017, the FDA required addition of a Black Box warning on the label for Invokana (and Invokamet/Invokamet XR) regarding the risk of leg and foot amputations when taking the drug for type 2 diabetes. A Black Box warning is the strongest possible warning for a drug and features severe risk information at the top of the drug label, bordered in a thick, black box. It is intended to immediately catch the attention of healthcare professionals and indicate to them that the drug should only be used in narrow circumstances when the benefits of treatment outweigh the substantial risks presented by the drug.
The FDA was prompted to require a Black Box warning for Invokana after receipt of the final results from the CANVAS trial and a follow-up trial, called CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus as cited by: ModernMedicine.com). The results again showed that patients treated with Invokana had a two-times-greater risk for amputations than patients treated with a placebo. The final results of the CANVAS trial showed that during a year, the risk of amputation for patients involved in this trial was equivalent to:
- 9 out of every 1,000 patients treated with Invokana
- 8 out of every 1,000 patients treated with a placebo
The final results of the CANVAS-R trial showed that during a year, the risk of amputation for patients involved in this trial was equivalent to:
- 5 out of every 1,000 patients treated with Invokana
- 2 out of every 1,000 patients treated with a placebo
Inadequate Testing of Invokana
These clinical trial results are astounding and show that Janssen did not conduct adequate testing prior to marketing Invokana or properly warn patients about the severe risks of taking the drug. While every prescription drug has side effects, and it is impossible to produce a drug completely free of them, drug manufacturers have an absolute and ongoing legal duty to make sure that the drugs they sell to doctors and patients are safe.
Invokana was approved for sale in March 2013, so for more than four years, patients did not understand, nor did they have the opportunity to fully appreciate, the potential complications of taking the drug. The attorneys at Parker Waichman LLP find this wholly unacceptable and will aggressively pursue litigation to hold Janssen accountable. It is only when drug manufacturers are forced to pay for their negligence that they will change their practices. If you have been injured from use of Invokana, we can make the industry safer together.
Invokana Black Box Warnings
In a Safety Announcement about the Black Box warning, the FDA cautioned patients taking Invokana to notify their doctors right away if they developed new pain or tenderness, sores or ulcers, or infections in their legs or feet. It also told healthcare professionals to monitor patients closely and to consider factors that could predispose patients to amputations before beginning treatment with Invokana. These factors might include a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers.
Invokana Claims Process
At Parker Waichman LLP, we realize filing a prescription drug product case against a corporation as large as Janssen or Johnson & Johnson can seem overwhelming, but our professional legal team works hard to make the process as smooth as possible for our clients. We are experienced drug product lawyers who have decades in the business, going up against the biggest corporations to make them pay for their wrongdoings.
The process of seeking justice for your Invokana injuries starts with one simple phone call to our office. During that call, you will be able to speak with a seasoned attorney who can explain the services we provide and help you understand your options moving forward. Thereafter, when you sign up your case with Parker Waichman LLP, your dedicated lawyer will immediately go to work investigating your case to determine whether you can file a lawsuit. The basic case process from intake to filing will include all of the following:
- Obtaining a detailed account of your Invokana prescription history and the injuries you suffered while taking the drug;
- Ordering pharmacy records showing that you took brand-name Invokana (which we call establishing “proof of use”);
- Ordering records documenting the treatment you received related to your Invokana injuries;
- Identifying the governing statute of limitations for your claim (the state-determined time during which you must file your lawsuit);
- Consulting with medical experts and industry experts to obtain support for your claim;
- Determining where your case should be filed (whether in Multidistrict Litigation or elsewhere);
- Drafting and preparing a petition for filing.
When you work with Parker Waichman LLP, you can rest easier knowing your claim is being managed by top professionals who value their clients. We pride ourselves on maintaining excellent client communication and strive to always keep our clients informed and comfortable with the progress of their cases. At our firm, you are not just a file number or a dollar sign; you are a person with a story and real injuries, who needs a timely claim resolution.
Statute of Limitations Considerations
A statute of limitations is a state-imposed time limit on filing a lawsuit. If you do not file a claim for injuries within the appropriate amount of time and in the appropriate court, your claim can be forever barred, regardless of its merits. States create statutes of limitations to encourage swift action, which preserves the integrity of evidence. For instance, your memory about something will be much more vivid one year later versus five years later. There is also a lower likelihood that records and business documents will have been misplaced or destroyed if someone must file a claim sooner. And moreover, potential defendants will not have to prepare for anticipated litigation in perpetuity.
Some states have what are called “discovery rules” that operate to ease the restrictions of statutes of limitations by allowing the clock to only begin running after a person discovers that he has been injured and, sometimes, also after he discovers — or has reason to discover — why he was injured and by whom he was injured. Generally, New York does not recognize a discovery rule, but New Jersey and Florida do.
The only way to definitively determine the statute of limitations on your Invokana claim is to work with an experienced lawyer, like the lawyers at Parker Waichman LLP. When we sign up a case, we immediately go to work calculating the appropriate statute of limitations and preserving all relevant evidence to make sure we have time to file a lawsuit and have everything we need to build the best possible case for our client. If you think you have a potential Invokana claim, contact our office today.
Frequently Asked Questions About Invokana Injuries
Because so many Invokana cases have been filed, they are centralized in one court in the U.S. District Court for the District of New Jersey in what is called a Multidistrict Litigation (MDL). The MDL court oversees all the cases to ensure uniformity of decision in pretrial matters. This court also presides over the first trials, called “bellwether” trials.
More than 700 cases were pending in the Invokana MDL as of September 2017 in front of U.S. District Judge Brian R. Martinotti. The first Invokana bellwether trial in the MDL is scheduled to begin sometime in the fall of 2018. Before this trial, plaintiffs’ counsel and defense counsel will conduct discovery, including written interrogatories and depositions, and will attend multiple hearings with the judge to sort through discovery matters and information related to designated experts. The bellwether trials sometimes jumpstart settlement negotiations but should not be taken as a sure sign of results either way.
In addition to the MDL, numerous Invokana cases are also pending in the Eastern District of Pennsylvania, awaiting an order transferring those cases into the MDL.
One of the interesting and beneficial aspects of having an MDL for a particular set of cases is that it opens the door for clients to file cases from all around the country. Ordinarily, for our office to pursue a claim for someone in, say, Washington, we would have to be admitted to practice law in that state. But in an MDL, that requirement is waived by an order from the court, and attorneys and clients from coast to coast can file claims in the same court.
In addition, we work with some of the best drug product litigators in the nation, so we likely have access to members of the bar in your state, too. Even if you live thousands of miles from us, we can still take your case and would be happy to speak with you about your potential claims.
Considering all the possible diabetes medications on the market (and the similarity of their names), combined with the likelihood that doctors switch their patients’ medications based on their blood work and comfort levels, we expect that some of our clients will not be 100 percent certain that they took brand-name Invokana. But in order to file a lawsuit against Janssen, we have to be able to prove that you did, in fact, ingest a drug manufactured by Janssen.
If you do not remember the names of all your medications, you do not need to worry. We will do that investigation for you. When you hire Parker Waichman LLP, we will order your pharmacy records right away to determine whether you took brand-name Invokana. Even if your records do not show the exact name of the drug, we can track down National Drug Codes (NDCs) from your pharmacies to prove what medications you took and when.
The attorneys at Parker Waichman LLP know your Invokana injuries have changed your life, and we are committed to helping you receive just compensation. When you file a claim for damages against Janssen Pharmaceuticals and Johnson & Johnson, you can recover for all of the ways you have been harmed by their diabetes medication. This includes claims for the following types of compensation:
- Lost wages, if you missed work or cannot currently work because of your Invokana injuries;
- Lost future wages, if you will not be able to return to work;
- Past medical bills for treatment related to your Invokana injuries;
- Future medical bills, if you will need additional treatment for your Invokana injuries;
- Compensation for the physical and mental pain and suffering you have incurred and will incur as a result of your Invokana injuries;
- Loss of consortium damages for the ways in which your injuries have affected your marriage, including loss of love, society, companionship, affection and support; and
- Punitive damages, where the circumstances of the litigation show an award that carries the effect of punishment for the manufacturers would be appropriate.
When you hire our firm, we will help you calculate the full extent of your economic and non-economic damages to maximize the amount you and your family receive. We know you need to be compensated appropriately, and we will work steadfastly to make that happen.
Compassionate, Caring, and Experienced Representation
When you’re trying to hire a lawyer for a product liability lawsuit, it’s not always easy to know where to begin. At Parker Waichman LLP, we make the process simple. All you need to do is call our office, and you’ll be on your way to investigating your claim. Right when you call, you’ll be able to schedule a consultation with one of our skilled drug product attorneys, who will listen to your story and present you with possibilities to hold the manufacturer accountable.
We understand that because of your Invokana injuries, you are likely already struggling under the weight of costly medical bills. Invoices are piling up, and you cannot afford anything else or bear to take on any additional stress. Product liability litigation, especially up against some of the drug industries biggest giants, is extremely expensive, and it involves great financial risk. But not for you.
No Fee Unless We Recover for You
You have enough to worry about at home, so let us take this on for you. We offer confidential consultations at absolutely no cost, and we contract our Invokana cases on a contingency-fee basis. That means we take on all that financial ourselves. We will advance the costs of litigating your claim, and if you don’t get paid, neither do we. Even if we perform a thorough investigation and incur out-of-pocket expenses and decide we cannot move forward with your claim, you will never receive a bill from us. There has never been a better time to stand up for your rights, so call us today.
We Take on the Big Pharmaceutical Corporations
Cases involving pharmaceutical or medical devices where you are potentially filing a lawsuit against one or more global pharmaceutical manufacturers, the legal system can be extremely intimidating. However, when you retain Parker Waichman LLP, you can rest assure knowing that our law firm has the experienced and resources to bring you and your family the legal justice that you deserve. Our firm also tackles some of the most complex litigation in the country.
Parker Waichman Holds Drug Manufacturers Accountable for Injuries to the Public
Product liability cases are very complicated cases. When litigating against giant pharmaceutical companies, we face off against fierce corporate counsel with enormous litigation defense budgets. Parker Waichman LLP has significant and unique experience in handling representing injury victims in these types of cases. We know how to win.
At Parker Waichman LLP, we understand that when you sign your case to our firm, you are placing significant trust in our firm. We take this responsibility very seriously. We will work tirelessly in order to obtain maximum results for you. Together, we will hold drug manufacturers accountable for the injuries you have sustained. Together, we will help prevent these same injuries from occurring to others.
Contact Parker Waichman LLP for Your Free Case Review
At Parker Waichman LLP, we take on the most complex cases and advocate for our clients with intensity. We are fiercely dedicated to protecting victims’ rights, and we have a reputation for results. If you or a loved one took Invokana for type 2 diabetes and developed a kidney injury, ketoacidosis, or required an amputation, contact our firm today for your free consultation by calling 1-800-YOURLAWYER (1-800-968-7529).