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Pharmaceutical Industry › Failure To Disclose

Morrison & Foerster LLP

True Facts About False Claims: MoFo's FCA Newsletter - October 2023

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Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more

Knobbe Martens

Arguments to the Patent Office That Contradict Information Submitted to the FDA Support Inference of Deceptive Intent

Knobbe Martens on

BELCHER PHARMACEUTICALS v. HOSPIRA, INC. Before Reyna, Taranto, and Stoll. Appeal from the District of Delaware. Summary: A patentee committed inequitable conduct by advancing an argument during patent prosecution...more

Stinson - Corporate & Securities Law Blog

Audit Committee Not Liable for Earnings Release

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Stockholders of Zimmer Biomet Holdings, Inc., brought a derivative law suit.  Zimmer is a company that manufactures and markets various products in the highly regulated medical device industry. The plaintiffs’ claims stemmed...more

Cadwalader, Wickersham & Taft LLP

Securities Litigation Update: First Circuit Holds That Future-Focused Risk Disclosures Are Not Misleading Absent “Grand...

Cadwalader, Wickersham & Taft LLP on

On July 9, 2021, in Karth v. Keryx Biopharmaceuticals, Inc., the U.S. Court of Appeals for the First Circuit affirmed entry of judgment for the defendants in a putative class action asserting violations of Section 10(b) of...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 7. In This Month’s E-News: July 2021

Health Care Compliance Association (HCCA) on

Report on Research Compliance 18, no. 7 (July 2021) - In a review of more than 500 NIH awards, the HHS Office of Inspector General (OIG) found that about one-fifth were funded “out of rank order,” and for more than a...more

Farrell Fritz, P.C.

Court explores the balance between a lawyer’s obligation to investigate the facts, and a lawyer’s reliance on what the client...

Farrell Fritz, P.C. on

Pursuant to Part 130 , attorneys are obligated to undertake an investigation of a case.  But is an attorney responsible for ignorance of facts which the client neglected to disclose?  “No,” says the Commercial Division....more

Kramer Levin Naftalis & Frankel LLP

SEC-Mylan Settlement: The SEC Filed Suit Regarding Investigation Disclosure

Kramer Levin Naftalis & Frankel LLP on

On Sept. 27, 2019, the Securities and Exchange Commission (SEC) announced that Mylan N.V., a global pharma company that manufactures and sells EpiPen, which is used to treat serious allergic reactions, agreed to pay $30...more

Faegre Drinker Biddle & Reath LLP

SEC: Here Is When Loss Contingencies Must Be Disclosed and Reserved

Faegre Drinker Biddle & Reath LLP on

When confronted with government inquiries, public companies commonly grapple with the issue of when events have escalated to the point that they are subject to disclosure obligations—or, further yet, require recognition as a...more

Dechert LLP

SEC and Drugmaker Allergan Reach Settlement over M&A Disclosure Violations

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The U.S. Securities and Exchange Commission and drugmaker Allergan settled claims that Allergan failed to disclose negotiations with third parties following the announcement of a hostile tender offer by Valeant and co-bidder...more

Skadden, Arps, Slate, Meagher & Flom LLP

"Two Court of Chancery Deal Litigation Decisions Provide Helpful Guidance"

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Chelsea Therapeutics: Post-Closing Bad Faith Claim a ‘Rare Bird’ in Delaware Absent Allegations of Self-Interestedness or Lack of Independence - In In re Chelsea Therapeutics International LTD Stockholders Litigation,...more

Sullivan & Worcester

Be Careful What You Say – Or Rather What You Don’t Say – AVEO Pays $4 Million to SEC to Settle Fraud Charges

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In March 2016, the Securities and Exchange Commission announced that AVEO Pharmaceuticals, Inc., a Massachusetts-based biopharmaceutical company, agreed, without admitting or denying the allegations, to pay $4 million to...more

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