News & Analysis as of

Food and Drug Administration (FDA) Bayer

Harris Beach PLLC

New York Medical and Life Sciences: Year in Review 2020

Harris Beach PLLC on

From contraceptives to mesh implants, shampoos to pasta, New York state and federal courts issued decisions in 2020 which further shaped the landscape in the medical and life sciences legal world. To prepare the best product...more

Spilman Thomas & Battle, PLLC

Product Lines - Toxic Torts and Products Liability Insights: Issue 2, 2020

Welcome to 2020's second edition of Product Lines, our e-newsletter that focuses on toxic torts and product liability issues. For this edition, we are reporting on several important and timely legal issues. As you will...more

Searcy Denney Scarola Barnhart & Shipley

Did Bayer Hide Behind Sealed Court Documents To Tout Essure?

Contraceptive Is Linked to Injuries and Deaths and Now Is the Subject of Lawsuits - Bayer, the company that manufactured and marketed the dangerous birth-control device Essure, is looking more and more like a bad actor as...more

Knobbe Martens

Bayer Receives Accelerated Approval for Aliqopa

Knobbe Martens on

On September 14, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval of Aliqopa to Bayer Healthcare Pharmaceuticals, Inc., for the treatment of relapsed follicular lymphoma. The FDA granted Aliqopa...more

McDermott Will & Emery

ANDA Update - March 2017 Volume 3, Number 1

McDermott Will & Emery on

Speculative Evidence of Irreparable Harm Sinks Bayer's Request for Permanent Injunction - Bayer Pharma AG, et al. v. Watson Laboratories, Inc. (D. Del. December 28, 2016) - Applying the eBay factors to Plaintiff...more

Robins Kaplan LLP

Bayer Pharma AG v. Watson Labs., Inc.

Robins Kaplan LLP on

Case Name: Bayer Pharma AG v. Watson Labs., Inc., 12-1726-LPS, 2016 U.S. Dist. LEXIS 179103 (D. Del. Dec. 28, 2016) (Stark, J.). Drug Product and Patent(s)-in-Suit: Natazia® (estradiol valerate/estradiol...more

Locke Lord LLP

Speculation of ANDA Product Launch Before FDA Approval Does Not Warrant Permanent Injunction

Locke Lord LLP on

On December 28, 2016, Judge Stark of the District of Delaware, despite having previously found infringement, held that plaintiffs Bayer Pharma AG, Bayer Intellectual Property GmbH, and Bayer HealthCare Pharmaceuticals Inc....more

Robins Kaplan LLP

Intendis GMBH et al. v. Glenmark Pharms. Inc., USA

Robins Kaplan LLP on

Case Name: Intendis GMBH et al. v. Glenmark Pharms. Inc., USA, 822 F.3d 1355 (Fed. Cir. May 16, 2016) (Circuit Judges Prost, Moore, and Taranto presiding; Opinion by Moore, J.) (Appeal from D. Del., Robinson, J.) - Drug...more

Searcy Denney Scarola Barnhart & Shipley

Xarelto’s Approval by the FDA

The controversy over Xarelto’s approval by the FDA and alleged irregularities in the conduct of the ROCKET-AF clinical trial continue to hang over the heads of Bayer and Janssen (a division of Johnson & Johnson), the...more

Searcy Denney Scarola Barnhart & Shipley

Xarelto Litigation — An Update

On February 23, 2016, Judge Fallon held another status conference in the national litigation over Xarelto. There are now over 5,600 individual lawsuits pending in MDL No. 2952, the coordinated federal court proceedings...more

Searcy Denney Scarola Barnhart & Shipley

Xarelto Litigation – February Updates

There have been a number of recent noteworthy developments in the national litigation involving Xarelto. Currently, there are approximately 5,000 individual lawsuits pending in state and federal courts against the...more

Searcy Denney Scarola Barnhart & Shipley

Xarelto — National Drug Litigation

November has proven to be a very busy month for Searcy Denney and its Xarelto clients, with the firm filing several new individual lawsuits on behalf of its clients besides participating in the national discovery efforts. ...more

Searcy Denney Scarola Barnhart & Shipley

Essure Medical Device Faces Attacks on Multiple Fronts

The threat of a hunger strike against the Food and Drug Administration, a Facebook page titled “Essure Problems Lawsuit” and a congressional bill calling for a recall of the female contraceptive manufactured by Bayer have...more

Kelley Drye & Warren LLP

United States v. Bayer: Preventing or Treating Disease Claims

In recent years, the FTC and the Center for Science in the Public Interest (“CSPI”) seem to have seen disease claims everywhere, regardless of whether the FDA has deemed the same claims appropriate, non-disease...more

Searcy Denney Scarola Barnhart & Shipley

June Xarelto Update – Science Day

Judge Fallon, the federal judge in New Orleans who oversees the MDL coordinated proceedings, held his most recent hearing for all of the pending Xarelto lawsuits on June 10, 2015. At that time, the judge was provided with a...more

Proskauer - Advertising Law

Tomorrow is Another One-A-Day: FDA Guidelines Preempt Vitamin Claims, but Consumer Class Still Has Opportunity to Supplement

Although consumer class actions in California are dime-a-dozen, a recent Northern District of California case involving One A Day vitamins stands out because it demonstrates how federal regulations can preempt certain state...more

Sheppard Mullin Richter & Hampton LLP

Court Finds that Class Action Plaintiffs’ False Advertising Claims are Stripped Bayer Based on Federal Preemption

In the recent case of Gallagher v. Bayer AG, Case No. 14-cv-04601-WHO (N.D. Cal. March 10, 2015), the plaintiffs asserted that the defendants Bayer AG and related entities (collectively, “Bayer”) engaged in false advertising...more

Searcy Denney Scarola Barnhart & Shipley

Xarelto Suits Sent to Louisiana

Xarelto (rivaroxaban) is a new generation anticoagulant in a class of drugs known as direct thrombin inhibitors. It is a blood thinner used to reduce the risk of blood clots and strokes. Xarelto has also been marketed as...more

McDonnell Boehnen Hulbert & Berghoff LLP

Bayer Healthcare Pharmaceuticals, Inc. v. Watson Pharmaceuticals, Inc. (Fed. Cir. 2013)

Contraceptives were the subject of the Federal Circuit's recent decision in Bayer Healthcare Pharmaceuticals, Inc. v. Watson Pharmaceuticals, Inc. But, unfortunately, it's a rather fact-specific case with nothing of prurient...more

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