News & Analysis as of

Failure to Report

Hogan Lovells

MDR single report exemption and ASRs: Coming to an end for most reporters

by Hogan Lovells on

The Medical Device Reporting (MDR) regulation provides a mechanism for the U.S. Food and Drug Administration (FDA or the Agency), as well as medical device manufacturers, to identify and monitor adverse events (deaths,...more

Skadden, Arps, Slate, Meagher & Flom LLP

Failure to Report Adverse Events Results in Criminal Misbranding Settlement and Individual Liability

On December 10, 2018, Olympus Medical Systems Corporation and a former quality manager at the company pleaded guilty to introducing misbranded medical devices into interstate commerce in violation of the Federal Food, Drug...more

White & Case LLP

The implementation of the 4th anti-money laundering directive in France

by White & Case LLP on

Directive 2015/849/EU of 20 May 2015 on the prevention of the use of the financial system for the purposes of money laundering or terrorist financing (the "Fourth EU AML Directive") requires Member States to set up, in a...more

Bradley Arant Boult Cummings LLP

Don’t Ignore the Kissing Supervisor—Court Rules that Employer’s Knowledge of Past Behavior Negates Faragher-Ellerth Defense

Employment lawyers and most HR professionals are familiar with the Faragher-Ellerth defense to a claim of sexual harassment. In short, if an employer can show that (1) it exercised reasonable care to prevent and correct...more

Pepper Hamilton LLP

Employer May Not Have Affirmative Defense to Harassment Claim even if Employee Fails to Report Harassment

by Pepper Hamilton LLP on

Q: Does my company have an affirmative defense to a sexual harassment claim if the company has a policy for reporting sexual harassment and an employee never makes a report of sexual harassment under that policy? ...more

Seyfarth Shaw LLP

Failure To Follow Company Own Internal Procedures Can Be Used Against It In OSHA 11(c) Retaliation Case

by Seyfarth Shaw LLP on

A recent Eastern District of Wisconsin case held that an OSHA 11(c) retaliation claim will survive summary judgment where the employer failed to comply with its own investigation procedures....more

Pepper Hamilton LLP

NIH May Own Gilead's Blockbuster Hepatitis Drug Due to Misstep

by Pepper Hamilton LLP on

Every year, the National Institutes of Health (NIH) spends billions of federal dollars on research and development of new drugs and therapies for treating and preventing serious illnesses....more

Mintz - Health Care Viewpoints

Are HCT/Ps a Dark Spot in the Sunshine Act Requirements?

On February 22, the Wall Street Journal published an article about the tissue graft manufacturer MiMedx Goup, Inc. and its failure to report payments to physicians under CMS’s Open Payments Program established by the Centers...more

Weiner Brodsky Kider PC

Bank Agrees to $613 Million Settlement Over Failings of Anti-Money Laundering Program

by Weiner Brodsky Kider PC on

On February 15, 2018, a national bank agreed to pay $613 million because of its failure to implement an effective anti-money laundering program, and because of its failure to report suspicious transactions....more

SmithAmundsen LLC

Are You In Possession Of Unclaimed Property?

by SmithAmundsen LLC on

Each state has unclaimed property laws for the purpose of assisting its citizens with locating and recovering their unclaimed property. Under these laws, financial institutions as well as other businesses, commonly referred...more

Poyner Spruill LLP

The Importance of Adopting Effective Policies and Procedures for Handling Harassment in the Workplace

by Poyner Spruill LLP on

The news has been filled lately with reports of harassment allegations against all sorts of famous people. From politicians to movie stars, many public figures are finding themselves embroiled in legal battles based on their...more

Kelley Drye & Warren LLP

[Webinar] Keeping Up with the Consumer Product Safety Commission: Update on Recent CPSC Developments - March 29th, 12:00pm EST

by Kelley Drye & Warren LLP on

With the complexity of today’s product safety regulatory environment and the civil penalty amounts for failure to report safety hazards, it is more important than ever for manufacturers and retailers to identify and resolve...more

Proskauer - Whistleblowing & Retaliation

Ninth Circuit — Dodd-Frank Protects Internal Whistleblowers

On March 8, 2017, a split three-judge panel of the Ninth Circuit Court of Appeals affirmed a Northern District of California decision declining to dismiss a Dodd-Frank whistleblower retaliation claim because the plaintiff did...more

Bradley Arant Boult Cummings LLP

Are Federal Courts Increasingly Likely to Grant Rescission of Insurance Contracts?

Recent court decisions across a variety of industries highlight the importance of submitting complete and accurate insurance applications and renewals. When submitting an application for insurance, the applicant should...more

Foodman CPAs & Advisors

Are Compliance Officers at Financial Institutions Now in the Hot Seat for Fines?

by Foodman CPAs & Advisors on

Otherwise reputable Financial Institutions continue being sanctioned for regulatory non-compliance. Well known “household” names continue receiving fines for failing to establish and implement adequate Anti-Money Laundering...more

Morrison & Foerster LLP - Class Dismissed

CPSC Pledges Higher Penalties

Earlier this month, CPSC Chair Elliot Kaye told regulators, industry, and lawyers about the CPSC’s priorities for the coming year. At the top of the list were increased civil penalties for failure to report potentially...more

Alston & Bird

CPSC Snapshot: CPSC Multimillion Dollar Penalty With a Twist

by Alston & Bird on

Earlier this month, the CPSC announced an agreement to yet another multi-million dollar settlement. However, in an unusual course of conduct, the CSPC agreed to suspend all but $200,000 of the penalty based on the company’s...more

Kelley Drye & Warren LLP

Office Depot Agrees to Pay $3.4 Million CPSC Civil Penalty

by Kelley Drye & Warren LLP on

On May 27th, the Consumer Product Safety Commission (“CPSC”) announced that Office Depot agreed to pay a $3.4 million civil penalty for allegedly failing to report potential safety issues for two models of office chairs....more

Katten Muchin Rosenman LLP

Software Company to Face Suit Over Contract Restructuring

The United States District Court for the Northern District of California sustained a securities fraud complaint alleging that the defendants, a software company and its executives, had defrauded investors by failing to...more

McAfee & Taft

Gavel to Gavel: Failure to report costly

by McAfee & Taft on

Employers have many reporting requirements, but there is one many overlook – the Unclaimed Property Act, Oklahoma Statute title 60, §§ 651 et seq. The statute requires that a person holding property, tangible or intangible,...more

Shumaker, Loop & Kendrick, LLP

Counsel Not Required to Check Online Docket as Alternative to Service

The trial court dismissed Plaintiff’s claims after the Plaintiff (1) failed to serve one of the parties and (2) failed to submit a joint status report. The trial court claimed the authority to dismiss the case based on...more

Orrick, Herrington & Sutcliffe LLP

Therasense Revisited: In re Rosuvastatin Calcium Patent Litigation

In the United States, patent applicants and their counsel owe a duty of candor and good faith to the Patent Office. This duty is breached when the applicant or its counsel knowingly fails to disclose material prior art...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Dishonest Response on an Initial Application Can Come Back to Haunt an Employee

In a non-precedential opinion, the Third Circuit Court of Appeals recently upheld a hospital’s firing of a security guard who had admitted that he was a recovering drug addict. Because that firing was based upon the fact that...more

Traub Lieberman Straus & Shrewsberry LLP

Fifth Circuit Holds Direct Action Barred By Insured’s Untimely Claim Reporting

In its recent decision in First Am. Title Ins. Co. v. Cont'l Cas. Co., 2013 U.S. App. LEXIS 4153 (5th Cir. Feb. 28, 2013), the United States Court of Appeals, applying Louisiana law, had occasion to consider whether an...more

Womble Bond Dickinson

Healthcare Alert: Better Late than Never - The Sunshine Act Final Regulations are Finally Here!: Payments or Other Transfers of...

by Womble Bond Dickinson on

“Payments or Other Transfers of Value” Payments or Other Transfer of Value Must Have a Discernible Economic Value.In the Final Rule, CMS interprets value as the discernible economic value on the open market in the United...more

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JD Supra Privacy Policy

Updated: May 25, 2018:

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Links to Other Websites

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Information for EU and Swiss Residents

JD Supra's principal place of business is in the United States. By subscribing to our website, you expressly consent to your information being processed in the United States.

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You can make a request to exercise any of these rights by emailing us at privacy@jdsupra.com or by writing to us at:

Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

You can also manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard.

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California Privacy Rights

Pursuant to Section 1798.83 of the California Civil Code, our customers who are California residents have the right to request certain information regarding our disclosure of personal information to third parties for their direct marketing purposes.

You can make a request for this information by emailing us at privacy@jdsupra.com or by writing to us at:

Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

Some browsers have incorporated a Do Not Track (DNT) feature. These features, when turned on, send a signal that you prefer that the website you are visiting not collect and use data regarding your online searching and browsing activities. As there is not yet a common understanding on how to interpret the DNT signal, we currently do not respond to DNT signals on our site.

Access/Correct/Update/Delete Personal Information

For non-EU/Swiss residents, if you would like to know what personal information we have about you, you can send an e-mail to privacy@jdsupra.com. We will be in contact with you (by mail or otherwise) to verify your identity and provide you the information you request. We will respond within 30 days to your request for access to your personal information. In some cases, we may not be able to remove your personal information, in which case we will let you know if we are unable to do so and why. If you would like to correct or update your personal information, you can manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard. If you would like to delete your account or remove your information from our Website and Services, send an e-mail to privacy@jdsupra.com.

Changes in Our Privacy Policy

We reserve the right to change this Privacy Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our Privacy Policy will become effective upon posting of the revised policy on the Website. By continuing to use our Website and Services following such changes, you will be deemed to have agreed to such changes.

Contacting JD Supra

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JD Supra Cookie Guide

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How We Use Cookies and Other Tracking Technologies

We use cookies and other tracking technologies to:

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There are different types of cookies and other technologies used our Website, notably:

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JD Supra Cookies. We place our own cookies on your computer to track certain information about you while you are using our Website and Services. For example, we place a session cookie on your computer each time you visit our Website. We use these cookies to allow you to log-in to your subscriber account. In addition, through these cookies we are able to collect information about how you use the Website, including what browser you may be using, your IP address, and the URL address you came from upon visiting our Website and the URL you next visit (even if those URLs are not on our Website). We also utilize email web beacons to monitor whether our emails are being delivered and read. We also use these tools to help deliver reader analytics to our authors to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

Analytics/Performance Cookies. JD Supra also uses the following analytic tools to help us analyze the performance of our Website and Services as well as how visitors use our Website and Services:

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Facebook, Twitter and other Social Network Cookies. Our content pages allow you to share content appearing on our Website and Services to your social media accounts through the "Like," "Tweet," or similar buttons displayed on such pages. To accomplish this Service, we embed code that such third party social networks provide and that we do not control. These buttons know that you are logged in to your social network account and therefore such social networks could also know that you are viewing the JD Supra Website.

Controlling and Deleting Cookies

If you would like to change how a browser uses cookies, including blocking or deleting cookies from the JD Supra Website and Services you can do so by changing the settings in your web browser. To control cookies, most browsers allow you to either accept or reject all cookies, only accept certain types of cookies, or prompt you every time a site wishes to save a cookie. It's also easy to delete cookies that are already saved on your device by a browser.

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Updates to This Policy

We may update this cookie policy and our Privacy Policy from time-to-time, particularly as technology changes. You can always check this page for the latest version. We may also notify you of changes to our privacy policy by email.

Contacting JD Supra

If you have any questions about how we use cookies and other tracking technologies, please contact us at: privacy@jdsupra.com.

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