News & Analysis as of

Food and Drug Administration (FDA) Board of Directors

Goodwin

Third Circuit Affirms Dismissal of Complaint, Finding Investors Failed to Sufficiently Allege Amarin’s Statements Were False or...

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On June 14, 2022, the U.S. Court of Appeals for the Third Circuit affirmed the dismissal of a securities suit brought by investors in pharmaceutical company, Amarin Corporation, PLC, holding that the investors had failed to...more

Troutman Pepper

The Latest Successful Caremark Claim

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In Teamsters Local 443 Health Services & Insurance Plan v. Chou, the Delaware Court of Chancery held, at the pleading stage, that plaintiff stockholders had stated a claim for Caremark oversight liability against certain of...more

Orrick, Herrington & Sutcliffe LLP

Board Oversight of Clinical Trials During the Pendency of the COVID-19 Pandemic

COVID-19 has had far-reaching social, economic and regulatory impacts. Nearly all companies (private and public, large and small) have had reason to more frequently convene their boards of directors to review and monitor...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2020 Virtual Orange County Regional Conference - June 12th, 8:25 am - 4:30 pm PDT

Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...more

Foley & Lardner LLP

Health Care Provider Director and Officer Liability: Important Takeaways from Clovis and Marchand

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Health care provider boards of directors have been put on notice—given these two recent Delaware court decisions - Clovis and Marchand—that courts may be willing to significantly extend a corporate board’s Caremark duty to...more

WilmerHale

Another Reminder from Delaware About the Duty of Oversight

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Following this summer’s much publicized decision by the Delaware Supreme Court in the Marchand v. Barnhill (Blue Bell Creameries) case, the Delaware Court of Chancery’s holding in In re Clovis Oncology, Inc. Derivative...more

The Volkov Law Group

Delaware Court Increases Scrutiny of Corporate Board Oversight and Monitoring of Compliance Programs

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On October 1, 2019, in In re Clovis Oncology, Inc. Derivative Litigation, a Delaware Chancery Court denied a motion to dismiss the plaintiffs’ claims under the Caremark decision against individual directors for failing to...more

Faegre Drinker Biddle & Reath LLP

A Director’s Mission: Understanding, Monitoring and Accurately Reporting Mission Critical Operations

On October 1, 2019, the Court of Chancery rendered an opinion in In re Clovis Oncology, Inc. Derivative Litigation, denying a motion to dismiss a Caremark claim for breach of fiduciary duty and reinforcing a director’s duty...more

Goodwin

Caremark Round II: Beware Red Flags in Drug Development

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On October 1, 2019, the Delaware Court of Chancery applied the Delaware Supreme Court’s recent decision on Caremark board oversight claims in the context of operating in a highly regulated industry to allow derivative claims...more

Sheppard Mullin Richter & Hampton LLP

Delaware Supreme Court Allows Caremark Claim to Proceed Against Directors of Ice Cream Manufacturer Following Listeria Outbreak

In Marchand v. Barnhill, No. 533, 2018, 2019 Del. LEXIS 310 (Del. June 18, 2019), the Delaware Supreme Court (Strine, C.J.) reversed a Delaware Court of Chancery (Slights, V.C.) order dismissing a derivative claim alleging...more

Troutman Pepper

Delaware Supreme Court Issues Guidance On Board Oversight Responsibilities

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A director’s duty to make a good faith effort to oversee the operations and management of a Delaware company is well-established. In a recent case, Marchand v. Barnhill, the Delaware Supreme Court provided guidance to boards...more

Arnall Golden Gregory LLP

SEC Charges Biotech Company and Its Officers with Misleading Investors by Failing to Disclose FDA Concerns and Recommendations

On March 29, 2016, the Securities and Exchange Commission (SEC) announced charges against a biotech company and three of its officers for securities fraud. The company has agreed to pay $4 million to resolve the charges...more

Arnall Golden Gregory LLP

Officer/Director Liability for Violations of the US Federal Food, Drug, and Cosmetic Act

Officers and directors of Irish and Northern Irish companies whose products would be regulated by the US Food and Drug Administration (life sciences companies, specifically) should be aware of developments on the issue of...more

Katten Muchin Rosenman LLP

“Sophisticated Plaintiff” Found to Be Adequate Class Representative

The US District Court for the Western District of Texas certified a class of common stock purchasers in an action against Pain Therapeutics, Inc. (PTI) and its directors. The plaintiff’s complaint, which alleges that PTI...more

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