Pennsylvania Lawyer Interviews

York, PA: Last month a group of women, including "Essure Problems" Facebook representatives and Madris Tomes from Device Events, met with FDA chief Scott Gottlieb in an attempt to have the Essure sterilization device withdrawn from the U.S. market. At the meeting, Tomes presented data from the FDA's own MAUDE ((Manufacturer and User Facility Device Experience) database that the FDA and their legal counsel in attendance were seemingly unaware of. One would think the FDA may be embarrassed being caught off-guard like this, to say the least.

Orlando, FL:At the beginning of last year, Takata—the automotive parts company behind the largest automotive recall in the nation’s history—entered into a plea agreement with the United States Department of Justice (DOJ). The company then declared bankruptcy a few months later, setting off an avalanche of legal filings throughout the world, with an international corporate restructuring effort continuing to this day. “It’s critical to remember that as this process plays out, consumers have and will continue to be hurt and killed by rupturing airbags,” says attorney Frank Melton of Newsome Melton, PA.

Philadelphia, PA Final results from two independent clinical trials indicate the amputation risk for users of the Type 2 Diabetes drug Canagliflozin, marketed as Invokana, Invokamet, Invokamet XR, are much greater than previously understood.


The FDA was so concerned about the information the studies provided that it moved immediately to ensure consumers are warned about the increased risk of leg and foot amputations through a Boxed Warning label on all Invokana prescriptions.


“I think the fact that the independent clinical trials lead to a situation where the FDA went straight to a black box warning, its highest level of scrutiny, just shows how important and how critical this information is to the public,” says Brian J. McCormick Jr., a Philadelphia attorney from the firm of Ross Feller Casey.


To McCormick, Jr. the studies confirm and add significant weight to the many personal injury claims he and his firm are bringing forward on behalf of diabetic Americans that allege they have been injured as a result of using Invokana to control their Type 2 Diabetes Mellitus.


The studies (CANVAS Canagliflozin Cardiovascular Assessment Study) and the CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants with Type 2 Diabetes Mellitus) showed, according to a FDA website safety warning (May 2017), that leg and foot amputation occurred about twice as often in patients treated with Canagliflozin compared to patients taking a placebo.


“It is a terrible progression for some of these patients,” says McCormick. “They go in and they have a diabetic foot ulcer and they don’t how bad it is. They have one amputation and then they go back and have another toe removed – and next thing they know they have half their foot removed.”


According to the FDA safety communication on May 15, 2017, “Amputations of the toe and middle of the foot were the most common; however, amputations involving the leg, below and above the knee, also occurred. Some patients had more than one amputation, some involving both limbs.”


“Our firm is investigating both Ketoacidosis cases and we are also investigating amputation cases,” says McCormick. “We have a number of clients we are working with and I think at the end of the day what this new information shows, and will show in court, is that Johnson & Johnson did know that this risk existed and chose not to do anything about it.”


Canagliflozin is licensed for sale in North America by Johnson & Johnson subsidiary Janssen Pharmaceuticals. The drug is designed to be used in combination with diet and exercise to lower blood sugar levels in Type 2 diabetes patients. The drug is a sodium-glucose cotransporter-2 (SGLT2) inhibitor that causes sugar to be eliminated through the urine.


Invokana was first approved for sale by the FDA in March 2015. Within three months the FDA had 100 reports of Ketoacidosis and kidney damage in Invokana users. In May 2015, the FDA ordered the label contain a Ketoacidosis warning. By 2016, the FDA had added possible kidney damage to the Invokana warnings. In May 2017, it added increased risk of amputation.


“Some of these patients are otherwise healthy but for this terrible injury all of a sudden. They have been on this drug for a few months, or perhaps a few years and now they are seeing this Box Warning and putting two and two together,” McCormick says. “All of a sudden this is happening. No one told them about this and it would have changed how they handled their diabetes.”


The Invokana lawsuits have been consolidated in an MDL in New Jersey. The cases are going through case management process with discovery expected at a later date. It will be some time before the cases go to trial.

Philadelphia, PA Eight Manufacturers of a generic form of Taxotere known as Docetaxel are also being included in the ongoing MDL in U.S. District Court, Eastern District of Louisiana (New Orleans). As a result, more women will likely join the approximately 1,000 women already involved in the litigation.

Philadelphia, PA More and more women are coming forward with complaints and complications related to the use of Bayer’s Essure contraceptive device.

Philadelphia, PA The letters sent to recovering cardiac surgery patients was alarming to say the least. A medical device used during their recent heart operation, known as the Stockert 3T, might have infected them with a deadly bacteria that can lay dormant for months or years and then suddenly start to make them very sick.

Bakersfield, CA Just when you think the water situation in California can’t get much worse, fracking in Kern County has resulted in contaminated water that has so far killed one plaintiff’s cherry orchard. A RICO lawsuit filed two days ago claims that Governor Jerry Brown’s office ordered the California Division of Oil, Gas, and Geothermal Resources (DOGGR) to approve permits to inject contaminated water, which violates the Safe Drinking Water Act.

Washington, DC Matt Wessler, an attorney at Public Justice, is defending James McCutchen (U.S. Airways v. McCutchen) who has been sued by his self-funded employer-based health plan for the money it paid to cover his medical expenses after he was seriously injured in an auto accident.

Bradford County, PA Depending upon how you look at it, fracking may be good news--if it doesn’t affect you personally. It helps with the global climate because burning gas emits less carbon dioxide into the atmosphere than burning coal. And by supplying 30 percent of America’s natural gas, it’s arguably better for national security. But fracking comes at a cost: Attorney Ben Stewart has some advice for people who have suffered personal injury, property loss and more.

Seattle, WAZoloft birth defects lawsuits, alleging infants suffered Zoloft birth defects after being exposed to the drug prior to birth, are now consolidated in a multi-district litigation. Although the litigation process is underway, Dr. Shezad Malik, founder of the Dr. Shezad Malik Law Firm, says there is still time for women to file a lawsuit.