Ad Law Tool Kit Show – Episode 1 – Product Safety and Recalls
Foreign device manufacturers should anticipate greater chance of FDA inspection under new FDA leadership
On December 17, 2024, recent amendments to the Food and Drug Regulations (FDR) and the Medical Devices Regulations (MDR) relating to the recall of drugs and medical devices will come into force....more
In Palmer v. Teva Canada Limited, the Ontario Court of Appeal upheld the lower court’s decision to deny certification of a proposed product liability class action seeking damages for the alleged increased risk of being...more
Robins Kaplan Secures Historic $12.2 Million Settlement in a Section 1983 Jail Deliberate Indifference Case - Scott County Jail officials failed to report detained man’s injuries and allowed video evidence to be deleted. ...more
ACI’s FDA Boot Camp – now in its 42nd iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under the Food and Drug Omnibus Reform Act (FDORA). This...more
Several companies have recently recalled eye drops due to contamination. However, the risk of contamination is not new, and scientific studies have identified several types of contaminants commonly found in eye drops over the...more
Several companies have recently issued recalls for contaminated eye drops. These eye drops can present severe risks—including the risk of total vision loss due to infections—so it is important to know if your eye drops have...more
Minnesota Passes Survivorship Bill, Expanding Justice for Victims of Medical Malpractice and Wrongful Death - On May 20, 2023, Minnesota became the last state to pass a Survivorship Bill, expanding the damages that...more
ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more
Recently Colleen and Brad had a debate about whether Medical Device Reports (“MDRs”) tend to trail recalls, or whether MDRs tend to lead to recalls. Both Colleen and Brad have decades of experience in FDA regulation, but we...more
In June 2021, Philips notified the ANSM of a field safety action that related to the potential risk of degradation and inhalation of carcinogenic compounds from the sound-absorbing foam used in its ventilation devices for...more
Earlier this year, the US Center for Disease Control and Prevention (“CDC”) spotted an outbreak of a rare bacterial infection in 11 (now 16) different states, associated with multiple different infection types, particularly...more
On March 22, 2023, at the request of the U.S. Food and Drug Administration (“FDA”), Ascend Laboratories LLC. (“Ascend”) issued a voluntary nationwide recall of certain lots of Dabigatran Etexilate Capsules, a blood thinner...more
In recent months, the Food and Drug Administration (FDA) announced several recalls related to natural supplements that were found to contain tadalafil and its analogs, the active ingredients in Viagra and Cialis. In its...more
Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks....more
In 1969, The Beatles told Jo Jo and Loretta to “get back to where you once belonged.” In 2021, we could view a documentary series by the same name about the recording sessions behind the classic Let It Be album. FDA officials...more
Recently, the medical device manufacturer Exactech, Inc. announced a recall of more than 140,000 knee and ankle implants over concerns that the product packaging failed to protect the devices from potentially harmful exposure...more
In January of 2018, Robins Kaplan LLP filed a lawsuit against the nation’s largest opioid manufacturers and distributors on behalf of three Tribal Nations in South Dakota. It was one of the first complaints filed by a Tribe...more
The U.S. Food and Drug Administration (FDA) recently issued final guidance regarding the initiation of voluntary product recalls “to help companies prepare to quickly and effectively remove violative products from the...more
What is the latest with the CPAP lawsuits? As 2022 begins, the thoughts of sleep apnea patients and their families are, naturally, returning to the Philips CPAP machine recall 2021....more
Two pharmaceutical companies have issued recalls in December due to manufacturing issues that may impact the safety and quality of their drug products. ...more
Manufacturer Has Ceased Sales and Issued Urgent Letter Warning Physicians to “Stop Using” Unused Implants - Medtronic, the manufacturer of a medical implant that is alleged to have led to more than a dozen deaths,...more
Millions of patients with serious, diagnosed sleep disorders now are wrestling with a daytime nightmare: Medical devices designed to help them avoid damage from their conditions have been recalled for major and concerning...more
Could Your CPAP Machine Be Putting You at Risk of Cancer? Millions of Philips sleep apnea machines and ventilators are being recalled for an alarming reason: a potential risk of cancer or other health issues, according to...more
Thanks to defective hernia mesh implants, not all hernia repair surgeries go as planned. The patients who received defective mesh often end up in worse shape than they were before surgery and, sometimes, have to undergo an...more
ACI’s FDA Boot Camp returns in a completely interactive virtual format to help life sciences attorneys and executives to master the fundamentals of FDA Regulation... Gain essential working knowledge of core FDA concepts,...more