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FDA Alerts

Continuous Surgical Staple Recalls Lead to Increased Litigation

For many years, defective surgical staples have caused irreparable harm to patients, but these dangers remained hidden. In 2019, the Food and Drug Administration (FDA) acknowledged that thousands of surgical staple malfunction reports were hidden from the public. Here, the medical device litigation team at Peter Angelos Law discusses the various companies under scrutiny for defective surgical staple malfunction and…

The FDA Issues Warning Letter to Vivitrol Manufacturer Alkermes for Omitting Risk Information

In December 2019, the Food and Drug Administration (FDA) sent a warning letter to Alkermes, the manufacturers of the drug Vivitrol, for a print advertisement that misled consumers by omitting important risk information. By failing to admit the potentially fatal consequences of opioid intoxication, the safety of Vivitrol is now being called into question. Here, the pharmaceutical liability attorneys at…

The FDA Requests Allergan Voluntarily Recall

In August 2019, the Food and Drug Administration (FDA) requested that Allergan recall its BIOCELL textured breast implants and tissue expanders due to an increased risk of cancer among implant patients. Here, the product and medical device liability litigation attorneys at Peter Angelos Law discuss the connection between Allergan’s BIOCELL products and the increased risk of breast implant-associated anaplastic large…

The FDA Releases Safer Alternatives to Zantac As Investigation Into Contaminated Ranitidine-Based Medication Continues

As the FDA continues its investigation into the carcinogenic contamination of Zantac and other ranitidine-based drugs, the agency also released an extensive list of alternative medications that are deemed safe from toxic contaminants. Here, the Baltimore pharmaceutical liability attorneys at Peter Angelos Law discuss updates to the Zantac contamination investigation as well as provide an overview of the FDA’s list…

An Overview of the FDA Death Database Malfunction

Researchers have reported that the miscategorization of a slew of patient deaths by the FDA points to the potential unreliability of their adverse events database. Here, the pharmaceutical liability attorneys at The Law Offices of Peter Angelos discuss how current protocols for reporting patient death through the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database may not account for…

Zantac Manufacturer Recalls Medication Due to Confirmed Contamination

Sandoz Inc. has voluntarily recalled the generic version of common medication Zantac after the medication was confirmed to be contaminated with a human carcinogen. Here, the pharmaceutical liability attorneys at The Law Offices of Peter Angelos discuss the updates to the ongoing Zantac claims. Global health regulators recently raised concerns about the possibility that the widely used drug, Zantac, could…

FDA Issues Black Box Warning for Xeljanz and Xeljanz XR

In July 2019, the Food and Drug Administration (FDA) placed a Black Box Warning, the highest possible warning the FDA can mandate, on Pfizer’s blockbuster immunology drugs Xeljanz and Xeljanz XR. These new warnings will alert patients of risks including an increased risk of blood clots—and potentially, death. Here, the Baltimore pharmaceutical liability attorneys at The Law Offices of Peter…

The FDA Takes Action to Protect Patients from Risk of Certain Textured Breast Implants

In response to the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) linked to Allergan BIOCELL textured breast implants, the Food and Drug Administration (FDA) has requested that Allergan voluntarily recall select breast implants and tissue expanders. As a result of the request for recall, Allergan has agreed to take its products associated with increased lymphoma risks off the…

FDA Releases Millions of Records of Incidents Involving Medical Devices

On Friday, June 21st, the Food and Drug Administration (FDA) published previously undisclosed reports of incidents and post-surgical complications involving medical devices, including reports on implantable cardiac defibrillators, pacemaker electrodes and dental implants. Here, the product liability attorneys at The Law Offices of Peter Angelos outline the details of these incidents. Advocates for public transparency cheered the announcement after approximately…

FDA Includes Black Box Warning on Gout Medicine Uloric

As of February 2019, the U.S. Food and Drug Administration has stated that there is a higher risk of death associated with gout medicine Uloric (febuxostat) compared to other gout medicines. The FDA has now included a Black Box Warning for Uloric as a result of the recent findings. Here, the pharmaceutical liability attorneys at The Law Offices of Peter…