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Pharmaceutical Industry › Manufacturing Defects

Searcy Denney Scarola Barnhart & Shipley

The Link Between Certain Medications and Cancer Risk

Searcy Denney Scarola Barnhart & Shipley on

When you take a medication your doctor prescribes, the last thing you expect is for it to do more harm than good. But, unfortunately, medications are not always as safe as they should be. In fact, some medications have been...more

Epstein Becker & Green

Unpacking Averages: Assessing the Products Included in FDA's Voluntary Malfunction Summary Reporting Program

Epstein Becker & Green on

At the end of 2022, FDA published a draft guidance on Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers. The draft guidance explains several aspects of the VMSR Program, including FDA’s approach to...more

Jones Day

Michigan Senate Votes to Repeal Pharmaceutical Immunity From Product Liability Suits

Jones Day on

The Michigan Senate recently passed a bill to repeal a long-standing state law immunizing pharmaceutical manufacturers and sellers from product liability suits where the pharmaceutical products were approved by the U.S. Food...more

Morrison & Foerster LLP - Class Dismissed

Pleading And Preemption: Immunization Against Vaccine Products Liability Claims

Morrison & Foerster LLP - Class Dismissed on

In a recent win for vaccine manufacturers, a district court found that federal law preempted claims against Merck, arising out of alleged injuries from the Gardasil vaccine. Herlth v. Merck & Co., Inc., No. 3:21-cv-438 (JAM),...more

Holland & Hart - Your Trial Message

Know What Drives Juror Perceptions of Medical Device Liability

Holland & Hart - Your Trial Message on

Medical practitioners know that, for all its wonders, modern medicine is still a matter of chances not guarantees. In other words, in practice, medical interventions are often a matter of improving the patient’s chances at...more

Shook, Hardy & Bacon L.L.P.

The Healing Touch: Haptic Feedback And The State-of-the-Art Defense

Shook, Hardy & Bacon L.L.P. on

As more and more surgical robots make their way into operating rooms, companies are learning valuable lessons about how their devices function in the real world. ...more

Hogan Lovells

CDRH's Voluntary Malfunction Summary Reporting Program

Hogan Lovells on

On August 17, 2018, the Food and Drug Administration (FDA) released the Medical Device Voluntary Malfunction Summary Reporting Program (VMSRP) agreed between industry and the FDA as a part of the Medical Device User Fee...more

Morrison & Foerster LLP

Sixth Circuit Sweeps State-Law Design Defect Claims Under the Rug of Impossibility Preemption

Morrison & Foerster LLP on

Last week, the Sixth Circuit Court of Appeals issued a groundbreaking opinion in Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc. that could change the liability landscape for brand-name drug manufacturers. No. 15-3104...more

Foley Hoag LLP

Product Liability Update - July 2015

Foley Hoag LLP on

Massachusetts Supreme Judicial Court Holds Failure-to-Warn Claim Against Drug Manufacturer Not Preempted Because There Was No “Clear Evidence” FDA Would Not Have Approved Plaintiffs’ Suggested Warning; Also Holds...more

Morrison & Foerster LLP

Lance v. Wyeth: A New Cause of Action in Pennsylvania?

Morrison & Foerster LLP on

Issuing an opinion over two years after oral argument, the Pennsylvania Supreme Court ruled last week in Lance v. Wyeth that pharmaceutical companies can be held liable for negligence in the design and marketing of drugs....more

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