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What are the Laws Surrounding Invokana?
Every year tens of thousands of American suffer severe injury by a dangerous or defective product, including medications like Invokana. Some of these injured victims choose to file a lawsuit against the manufacturer claiming product liability. Through a defective product lawsuit, the plaintiff can seek and obtain financial compensation to recover their damages. Below are the laws that surround designing, manufacturing, promoting, marketing, and selling Invokana, Invokamet, and Invokamet XR in the medical marketplace.
Rosenfeld Injury Lawyers LLC represents victims of injury caused by taking Invokana and other forms of professional negligence. Our law firm has successfully prosecuted cases for our clients who were never informed of the dangers of taking defective medications. Our attorneys are available to answer any legal questions on how to receive the monetary compensation you deserve if your injuries were a result of someone else's negligence. Should you have additional questions, we invite you to contact our office for a free review of your legal rights.
Invokana Statute and Laws
The laws and statutes surrounding an Invokana case are similar to those of any other product liability suit. Some basic instructions on these lawsuits are spelled out in 735 ILCS 5/2-2106 including the following:
- "Alteration, modification, or change" or "altered, modified, or changed" means an alteration, modification, or change that was made in the original makeup characteristics, function, or design of a product or in the original recommendations, instructions, and warnings given with respect to a product. This includes the failure to properly maintain and care for a product.
- "Product" means any tangible object or goods distributed in commerce, including any service provided in connection with the product. Where the term "product unit" is used, it refers to a single item or unit of a product.
- "Product liability action" means any action based on a theory or doctrine brought against the seller of a product on account of personal injury (including illness, disease, disability and death), or property, economic, or other damage. The plaintiff's damages could be caused by the manufacture, construction, preparation, assembly, installation, testing, makeup, characteristics, functions, design, formula, plan, recommendation, specification, prescription, advertising, sale, marketing, packaging, labeling, repair, maintenance or disposal of, or warning or instruction regarding any product. This definition excludes actions brought by State or federal regulatory agencies pursuant to statute.
- "Seller" means one who, in the course of business conducted for a purpose, sells, distributes, leases, assembles, installs, produces, manufactures, fabricates, prepares, constructs, packages, labels, markets, repairs, maintains, or otherwise is involved in placing a product in the stream of commerce.
Obviously, in these circumstances, the "product" is Invokana; the "seller" is Janssen, Johnson & Johnson, or another member on the supply chain; and the "product liability action" would be your lawsuit against one of the sellers.
Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, develop, market, and promote their SGLT2 (sodium-glucose cotransporter 2) inhibitor products including Invokana, Invokamet, and Invokamet XR for the treatment of type II diabetes. Before the drug was approved by the Food and Drug Administration (FDA), the company was required to prove its safety and efficacy.
Defining a Defective Product
Drug makers, like all product manufacturers, have a legal responsibility to ensure that the products they distribute and sell function as designed when being used as intended. Typically, a defective product lawsuit will be based on a company or individual's negligence, strict liability, or breach of warranty.
Pharmaceutical manufacturers can be held legally liable if they were negligent at any stage of designing, manufacturing, or marketing the product. Product liability lawsuits that involve consumer injury are usually based on one or more of the following problems associated with the product.
- A Design Defect – Any flaw in the design of the drug could cause severe side effects including death. While these problems usually occur before the drug is even manufactured, serious health concerns usually do not arise until comprehensive clinical trials have completed. Unfortunately, not all medications go through the rigorous testing phase before the FDA approves the drug.
- A Manufacturing Defect – If the design is correct, but the manufacturing process is defective, serious issues can arise before the product is used by the consumer. Unfortunately, if the drug maker is unaware of the manufacturing defect, hundreds or thousands of patients can suffer severe injuries or die before the problem is detected.
- A Marketing Defect – The pharmaceutical manufacturer and their distributors must follow established procedures and protocols when marketing and promoting their drugs to doctors and patients. The company can only market the drug based on approved treatments. Any promotion by the company to use the drug for off-label use is illegal. To sell the product, the company must clearly state the product's purpose and instructions printed on the warning label.
A failure to warn doctors and patients of the dangerous, serious side effects and defects of a bad drug is often the negligence of the drug maker. However, others involved in the sale of the drug might also offer bad advice on taking the medication including the sales representative, medical provider, hospital, medical center, pharmaceutical distributor or others. Because of that, an attorney working on behalf of an injured patient might determine that there are other defendants to the lawsuit including the laboratory, clinic, hospital, pharmacist, doctor or sales rep.
Invokana is especially dangerous because the SGLT2 inhibiting drug has been linked to severe medical conditions including diabetic ketoacidosis. This horrific health issue develops when the body produces elevated levels of key tones (blood acids) that often necessitates hospitalization to avoid falling into a diabetic coma or dying. Just a few of the indicators of ketoacidosis include:
- Difficulty in breathing
- Abdominal pain
- Unusual fatigue
- Hypersensitivity reactions to the skin including swelling, redness, and rashes
- Kidney problems including renal failure
- Sepsis (bloodstream infection)
- Sensitivity to light
- High cholesterol
- Excessive thirst
- Fainting or dizziness
- Extreme water loss
- Increase urination
- Elevated magnesium, potassium, and phosphate levels in the bloodstream
- Abnormally low blood pressure
- Decalcification (diminished bone density)
- Elevated levels of hemoglobin
- Candida infection
- Genital itching
- Yeast infection
- Bone fractures
The doctor should monitor patients undergoing treatment who are taking SGLT2 inhibitor medications including Invokana, Invokamet, and Invokamet XR. It is important for patients to seek medical attention immediately if they experience any of the signs and symptoms listed above.
Bad Drug Recalls
The FDA is a regulatory agency and does not do any testing of medications under review for approval. Instead, the administration relies on the pharmaceutical company to submit all their testing results that showed the effectiveness and safety of the medication as a part of the application process. The government agency can only approve the drug after its advisory committee has completely reviewed the adverse events experienced by patients participating in clinical trials. The pharmaceutical company must present all mild to severe side effects and injuries experienced by patients using their drug through the clinical trials.
Unfortunately, every pharmaceutical manufacturer is a profit-driven corporation that is beholding to its shareholders, not its patients. Often, the drug maker will push their newly designed drug through the FDA approval system by taking shortcuts when possible to begin generating profits, usually at the public's expense. Sometimes, the real testing of the drug safety is conducted after the manufacturer receives approval for sale, where patients are used as guinea pigs to help identify severe side effects and adverse events.
Some research studies estimate that millions of Americans are placed at risk every year by taking bad, defective drugs. Many of these medications increase the patients' medical complications or cause severe injuries or death. Statistics maintained by the CDC (Centers for Disease Control and Prevention) shows that:
- The FDA receives more than half a million reports of adverse drug events each year
- Over 60 million devices are removed from the medical marketplace each year through recalls
- Over 100 million bad drug capsules, liquids, tablets, and pills are recalled every year
- Pharmaceutical manufacturers pay billions to injured patients each year to settle lawsuits or as a result of a jury trial award
- Many pharmaceuticals entering the medical marketplace were insufficiently tested even though the drugmaker could afford the cost of testing the medication properly
The business strategies used by many pharmaceutical manufacturers lead to renal failure, organ damage, bone fracture, other severe injuries, or even death. In many incidents, the drug maker attempted to hide the evidence that their new medication is dangerous and defective. It often takes years for the FDA to take action to stop the marketing, promoting, and sales of defective drugs and medical devices through an agency or voluntary recall. Typically, by the time the product is recalled, it is too late because the patients taking the drugs have already been hurt.
A Legal Right to sue
Any patient who was injured by a defective drug has the legal right to file a compensation claim or lawsuit against the pharmaceutical company that designed, manufactured, marketed, promoted or sold the medication. Defective drug lawsuits are usually handled by competent personal injury attorneys and individually filed cases, as a part of multidistrict litigation (MDL) or class action suits. Typically, federal judges will consolidate MDL lawsuits and class action cases that present “mass tort” evidence. The consolidation will ensure a quicker response from the drug company to provide injured victims financial compensation to recover their damages.
Participating in a class action suit is not always as financially beneficial to the injured plaintiff when compared to involvement in MDL. Class action lawsuit participants typically split the jury's verdict award collectively where the individual's unique circumstances are never shown as evidence in front of the jury. Alternatively, in MDL cases, the various plaintiffs who have filed hundreds of lawsuits will share the same discovery, pretrial hearings, and motions, before each case is heard individually by judge and jury.
Resolving a medical lawsuit can be extremely complicated. Because of that, the case should only be represented by an experienced, professional, personal injury attorney with experience in defective drug cases. An attorney working on your behalf can ensure you pursue adequate compensation to recover all your damages that could include:
- Hospitalization costs
- Medical bills
- Out-of-pocket expenses
- Lost wages due to your permanent or temporary disabilities
- Lost earning capacity in the future due to your inability to maintain your current job
- Non-tangible injuries including pain, suffering, mental stress, emotional trauma, and anxiety
- Funeral expenses and burial costs involved in a wrongful death lawsuit
The Statute of Limitations
The federal or state statute of limitations controls how long the injured patient can file a lawsuit or claim for compensation against the drug manufacturer. However, determining the length of time can be difficult. An attorney can review the specific circumstances of your injuries and review your medical records to determine how long you have until the statute expires.
Typically, the statute will begin at the time that you reasonably knew or should have known you had a medical problem that might be associated with taking Invokana, Invokamet and Invokamet XR. The actual amount of time you have will be based on civil tort “discovery rules.”
Resolve Your Case Through Legal Representation
The Invokana lawsuit attorneys at Rosenfeld Injury Lawyers LLC understand that the harm you experienced after taking a defective medication was not your fault but the responsibility of the drug maker. We have successfully obtained millions on behalf of the victims and their family members to ensure they were adequately compensated to cover their medical expenses, household bills, lost wages, loss of future earnings, pain, suffering, and emotional damage and we can help your family too.
Our legal team encourages you to contact our attorneys today to schedule an initial, no-obligation case consultation to discuss the merits of your monetary recovery claim at no charge to you. We accept all personal injury cases, wrongful death lawsuits, and dangerous drug injury claims through contingency fee arrangements. This legal contract postpones the payment of legal services until after we have successfully completed your case through a negotiated settlement or a jury verdict.
Our law firm gets results quickly because we understand you need money now. We probably offer every client a “No Win/No-Fee” Guarantee, meaning if we are unable to secure financial compensation on your behalf you owe us nothing. All information you share with our law office will stay confidential.
For additional information see the following pages:
- What is Invokana?
- What are the risks of taking Invokana?
- Has the FDA taken any action against the makers of Invokana?
- What does an Invokana lawsuit look like?
- Have there been any cases or settlements involving Invokana?
- What damages could I recover in my Invokana lawsuit?
- Is there a time limit by when I have to file my Invokana lawsuit?
- Is there a class action lawsuit against Invokana?
- Why hire Rosenfeld Injury Lawyers LLC?