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Life Sciences Patient Safety Healthcare

Oberheiden P.C.

Understanding the Risks (and Costs) of Defective Abiomed Impella Heart Pumps

Oberheiden P.C. on

Abiomed, Inc., a subsidiary of Johnson & Johnson, is facing lawsuits across the country related to the company’s Impella heart pumps. Since June of last year, the company has issued multiple recalls for these implantable...more

Quarles & Brady LLP

New California Law Affects Pharmacy Operations, Staffing Ratios, And Much More

Quarles & Brady LLP on

On October 8, 2023, California Governor Gavin Newsom signed Assembly Bill 1286 into law. The new law, sponsored by Assemblymember Matt Haney and the California Board of Pharmacy, aims to reduce medication errors and...more

Console and Associates, P.C.

Several Manufacturers of SSRI Antidepressants Add Warnings of Postpartum Hemorrhaging

Depression during pregnancy, or prepartum depression, is a common condition that an estimated ten percent of women in the United States experience. The development of selective serotonin reuptake inhibitors (“SSRI”) offered...more

Dechert LLP

Unprecedented Escalation of Injunction by French National Agency for Medicines and Health Products Safety

Dechert LLP on

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

Gardner Law

FDA’s New Draft Guidance on Cybersecurity

Gardner Law on

The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more

Robinson+Cole Data Privacy + Security Insider

FDA Announces Playbook for Medical Device Cybersecurity

On October 1, 2018, the Food and Drug Administration (FDA) issued its “Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook” to address continued threats to medical devices that could affect...more

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