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Defective Drug and Medical Device

Millions of Defective Catheters Recalled
Millions of Defective Catheters Recalled 150 150 CMZ Law Lufkin/Houston

How does the FDA’s 501(k) clearance rule put consumers at risk?

Four million catheters reported to be defective have been recently recalled. Because catheters are used in so many common medical procedures, it is expected that many personal injury lawsuits are in the offing. If you have suffered a personal injury as the result of catheter usage, you should contact a skilled defective drug and medical device attorney to advise you of your best options. An experienced personal injury lawyer will help you to obtain the compensation you’re entitled to.

What are catheters?

Catheters are flexible tubes inserted through a narrow openings into body cavity. Though most people think of urinary catheters first, the catheters that have been recalled are those used for other medical procedures, such as injecting dye for angiograms, or removing small blood clots from veins and arteries (thrombectomies).

The Defect in the Devices

The problem with the affected catheters is the fact that they are prone to degrade and fracture. There have been incidents in which catheter tips and other components have broken or separated, resulting in serious patient injuries, and even in patient death. The riskiest aspect of these fractures is that parts of the catheter, once broken loose, are capable of floating freely in the bloodstream and traveling to the heart, lungs, or other vital organs. The presence of these flecks of foreign matter in these organs can be disastrous.

Questions of Liability

It has not yet been definitively determined at what point during manufacture the catheter defects occurred. Many manufacturers have recalled various models of a great many catheters. These manufacturers include Cook Medical, Boston Scientific, Centurion, Medtronic, and Vascular Solutions. Investigators are now looking into the possibility that corners have been cut in attempts to streamline costs, resulting in products that are less sturdy and more prone to fail during use. One aspect of the investigation is focused on whether having products manufactured offshore, in an attempt to improve efficiency and lower costs, has resulted in inadequate testing and insufficient supervision that may underlie the problems.

Why 510(k) Clearance Is Problematic for Consumers

Because the field of medicine in this country is profit-driven as well as life-giving, manufacturers are always trying to lower their bottom line at the same time as they create and improve medical devices. This can sometimes result in insufficiently tested materials hitting the market.

Of concern to many is the 510(k) Clearance, a loophole of the U.S. Food and Drug Administration (FDA) designed to allow medical products to come to market more quickly.

This regulation, to the dismay of some who seek to protect the public, allows an existing product to be updated without rigorous clinical testing if its design is similar to that of the device already on the market. Unfortunately, there is room in the 510 (k) clearance for missing alterations that may present serious risks to patients.


Invokana Lawsuits: Miracle Diabetes Medication or Defective Drug?
Invokana Lawsuits: Miracle Diabetes Medication or Defective Drug? 150 150 CMZ Law Lufkin/Houston

What are the problems with Invokana?

Since the Judicial Panel on Multidistrict Litigation consolidated federal cases in New Jersey last month, the number of lawsuits involving Invokana, a medication designed to treat Type II diabetes, has risen steadily. By December 15, 2016, 63 cases involving problems with the medication had already been filed; by January 17, 2017, that number had jumped to 100! Attorneys all over the country expect this number to continue climbing.

If you have suffered ill effects from Invokana, you should contact a personal attorney in your state who is experienced in working on cases involving defective drugs. Since drug companies are known to be particularly difficult to fight, it is essential that you have a highly competent personal injury attorney to vigorously defend your rights.

What type of personal injuries are associated with the use of Invokana?

Hundreds of patients have suffered injuries due to their use of Invokana. During the 2 years since Invokana was approved by the FDA, that agency has received over 100 reports of serious kidney damage. This led to stronger warnings of risk of kidney injury being placed on the Invokana label. In addition to kidney injury, Invokana has been associated with the following serious medical issues:

  • Heart attack
  • Stroke
  • Respiratory failure
  • Diabetic ketoacidosis

Legal Actions

Four patients have died after being hospitalized for adverse reactions to Invokana, two of them as a result of heart attacks. Invokana lawsuits are being brought to court on behalf of loved ones whose deaths were due to reactions to the drug. Cynthia Freeman, whose husband died at the end of 2016, filed a lawsuit on behalf of him and herself against Janssen Pharmaceuticals Inc., a subsidiary of Johnson & Johnson that markets Invokana in the United States.

Concealed Knowledge

The Freeman lawsuit alleges that Janssen has concealed, and continues to conceal, its awareness of “unreasonably dangerous” risks connected to Invokana. The suit asserts that Janssen failed to warn the public about the drug’s risk, and engaged in negligence and fraud when marketing the product

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