Category Archives: Defective Medical Device
FDA Recalls Medical Device Inherited by One Company That Also Now Faces Litigation
In August, the Food and Drug Administration (FDA) issued a recall of Abbott’s Ellipse Implantable defibrillators; allegedly due to potential failure of the aluminum wires associated with the product and their ability to provide defibrillation therapy. According to allegations, the devices have wires that are not fully insulated and, as a result, could short… Read More »
Understanding The Difference Between FDA Approved and FDA-Cleared Is Crucial to Defective Medical Device Litigation
In general, the Food and Drug Administration (FDA) regulates the following products: Biologics; Cosmetics; Some Dietary supplements; Food additives; Infant formula; Medical devices (the FDA places them in one of three categories; class I, II, and III); Over-the-counter drugs; Prescription drugs; Products that emit radiation; Surgical implants; and Tobacco products. When it comes to… Read More »
FDA Makes Major Announcement Halting Sales of Medical Device Pelvic Mesh
On April 16, the Food and Drug Administration (FDA) made a significant announcement concerning the medical device known as the pelvic mesh. Specifically, the FDA ordered all medical device companies still selling the product to stop sales and distribution throughout the United States. The product was manufactured and has been used since the 1970s… Read More »
Circumstances That Allow Plaintiffs to Sue Manufacturers for Medical Devices Already Approved By the FDA
A recent ruling by a federal magistrate judge could have major repercussions for medical device manufacturers; specifically, manufacturers and other companies connected to spinal cord stimulators. The Case The case was brought against St. Jude Medical, Inc., St. Jude Medical S.C., Inc., Abbott Laboratories, Inc. and Advanced Neuromodulation Systems, Inc. (d/b/a St. Jude Medical… Read More »
FDA Moves to Change Medical Device Approval Process
Recently, the Food and Drug Administration (FDA) announced that it would be changing the 501(k) medical device approval rules in an effort to ensure that new devices are specifically incorporating up-to-date performance and safety standards. The 501(k) clearance process was designed to offer expedited approval for products that are “substantially equivalent” to those already… Read More »
How the Plaintiff Was Harmed Matters
When someone suffers a bodily injury while in the midst of committing a crime, they are generally prohibited from seeking a financial recovery for those injuries. This legal principle extends to the lawsuits alleging injuries from a prescription medication or medical device. For example, if someone suffers an adverse reaction after taking someone else’s… Read More »
Senate Passed “Right to Try” Legislation That Would Expose Drug Makers to Significant Civil Liability
The United States Senate recently passed, by unanimous approval, a piece of legislation titled the Trickett Wendler Right to Try Act. The bill would allow extremely ill patients across the country to request access to experimental medication that has not yet been approved by the Food and Drug Administration (FDA). The legislation was drafted… Read More »
Challenging Causation Testimony Under Daubert
In Texas courts, the 700 series of rules of evidence control the use of experts in civil cases. Under these rule, the trial judge acts as a gatekeeper for the admission of expert testimony. Judges review the expert testimony to ensure it meets a number of prerequisites established by the U.S. Supreme Court in… Read More »
Lawyer Advertising May Be Causing Serious Harm to the Public
You have probably seen television commercials, heard radio advertisements, and encountered a banner advertisement on your computer featuring a plaintiff’s attorney decrying the side effects of a drug or medical device. Advertising by plaintiff’s lawyers has surpassed $1 billion and continues to grow, according to the ABA Journal. Lawyer advertising exclusively in the prescription… Read More »
Prescriber Testimony Needed to Establish Causation in Medical Device Litigation
In mass tort litigation where thousands of claimants are involved, it is quite common or plaintiff’s lawyers to procrastinate in cultivating their cases and may neglect securing prescriber testimony. This is a big oversight that your Brownsville medical device defense attorney should seek to capitalize on. Why? Because if a plaintiff does not have… Read More »