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Illinois Plaintiff's Lawyer Personal Injury Blog- Legal News and Insights from Champaign Urbana Attorneys Koester & Bradley, LLP

Does FDA Clearance Mean a Medical Device is Safe? No!



The process by which the FDA approves of drugs and medical devices has recently come under fire.  At Koester & Bradley, we have seen these problems first-hand. --Ryan Bradley, Partner, Koester & Bradley LLP


If a medical device or a drug is "cleared" by the FDA, is the device or drug safe?  Surprisingly, the answer is No.

With the premiere of the Netflix Documentary, "The Bleeding Edge," Illinois residents and those across the United States are finally becoming aware of a startling fact that Illinois defective product attorneys at Koester & Bradley have been monitoring for over a decade.  Namely, that FDA approval does not make a medical device safe.

Pharmaceutical companies and medical device manufacturers are in business to make money.  Many companies put profits over safety in order to keep shareholders happy.  This attitude has dramatic and catastrophic impact on residents of Illinois who are victims of bad medical devices.  Although the FDA and other regulatory entities have to approve these goods, defective products still reach the market.  This is because drug and medical device companies do not always disclose all of the potential risks of the products they sell.

Our experienced products liability attorneys based in Champaign Illinois investigate claims related to defective drugs such as Uloric, Pradaxa, Xarelto, and Actos, and defective devices such as vaginal mesh, IVC Filters, knee implants, metal hips and other devices.

Koester & Bradley, LLP has decades of experience representing patients who have been harmed by defective medical devices and dangerous drugs.  We have represented injured victims in Illinois and across the country.  

Consumers should be educated about the risks associated with defective drugs and medical devices.   An educated consumer, whether in Central Illinois or another state must do their research before filling a new prescription or agree to have a medical device implanted.  Medical care providers are ready to help.  Ask your doctor about the risks including side effects and history of recalls and poor performance.  If you or a loved one has been injured by a defective device or drug, contact your doctor and Koester & Bradley, LLP.

Again, it is important to understand that a drug or medical device that has received approval by the Food and Drug Administration (FDA) does not necessarily mean it is safe for all uses for all people or that it is not defectively designed or manufactured.  Drug companies are often known for marketing drugs for uses for which they were not originally approved.  Medical device manufacturers know all of the loop holes in the federal approval process that can be used to bring a dangerous device to market faster.  This is known as the 510(k) process.

At Koester & Bradley, LLP we have a team of attorneys, located at home in Champaign-Urbana, Illinois, dedicated to holding the medical device and drug industry accountable.  We are constantly staying apprised with up-to-date information about dangerous products and continually updating our online resources.  If you or a loved one has been injured from a defective medical device or drug, call Koester & Bradley, LLP or submit a claim-- we have the experience to help.

By: Ryan Bradley and Tom Koester, Partners, Koester & Bradley, LLP

More Bad News for Invokana



The diabetes drug Invokana (Canagliflozin) could actually be more dangerous than helpful to patients. An initial study of the drug, the  CANVAS clinical trials in 2009, concluded that it caused "major adverse cardiovascular events, including CV death".
Although Canagliflozin was approved by the FDA in 2013, many medical professionals had  unanswered questions about its safety. A major concern was an elevated risk of stroke within the first thirty days of use.

Cardiologist Dr. William R. Hiatt, who voted against the FDA approval, said
"I feel that if you walk away with 100% voting to put it on the market, that sends a message to clinicians that this drug is okay. I'm not sure yet it's 100% okay, so I voted no." 
Seconds Count is  a patient education resource about cardiovascular health. The article entitled  Diabetes and Cardiovascular Disease includes a 50 second video by  Cardiologist Dr. Samir B. Pancholy. He shares why  diabetes is a major risk factor for heart disease. He reveals that patients with diabetes have the same risk of having a heart attack as if they'd had one previously. This is called a  coronary equivalent

Diabetic Ketoacidosis (DKA) is a common complication associated with the drug Invokana. DKA's link to cardiovascular problems has been well-documented for many years, as shown in this  medical journal article from 1995. 

Considering all the pre-existing medical data available, it appears that the manufacturers of Invokana underreported its cardiovascular risks. 

Have you or someone in your family suffered a heart attack or stroke after using Invokana? Personal injury lawsuits have been filed in many states, including Illinois. 
Please  contact us today to share your story with one of our experienced attorneys. You will be treated with respect. Your medical suffering is important to us. We want to help.  217-337-1400

Tom Koester

Tom Koester has been representing those injured by defective drugs and devices for decades throughout Central Illinois and the entire Country.

Illinois Plaintiffs Lawyer Personal Injury Blog by Koester & Bradley, LLP 

Legal News and safety tips with Illinois Impact from the Accident and Personal Injury Firm Koester & Bradley, LLP


Ryan R Bradley is a personal injury and litigation lawyer based in Champaign County Illinois focused on representing injured clients and businesses navigate the maze of litigation to financial recovery.  

Tom Koester is a personal injury attorney based in Champaign County in Central Illinois focused on representing the injured and victims of Medical Malpractice and Personal Injuries.