Product Recalls

News & Analysis as of

You Should Know - April 2015

In This Issue: - Devices Go Awry - Protect Against Risks - Insiders Talk - Excerpt from Faulty Products Put Patients at Risk: Some Popular Medical Devices Escape FDA Scrutiny: Countless patients around the...more

Child Injury and Delayed Product Recalls

Graco Fined $10M for Failure to Timely Recall Dangerous Car Seat - Last year saw a number of product recalls. Indeed, the sheer number of vehicles involved in the Takata airbag recall alone has been staggering. Graco,...more

Recall Mishandling and Dangerous Child Products

Last year, Graco recalled almost 6 million car seats due in large part to a safety defect. The recall began with around 3.8 million car seats, but it grew over the course of 2014. When the buckle mechanism on the car seats...more

An Error-free Seventh Circuit Medical Device Case

Today is National Grammar Day. Before anyone of our posts goes online, it dashes thorough a gauntlet of reviewers. Those reviewers collectively possess just the right amount of neurotic fastidiousness to ensure that what...more

Manufacturing Matters – Winter 2015

In This Issue: - Pre-action costs protection in environmental claims - Shared Parental Rights – what you need to know - Due diligence on your partner in China – are you talking to the right person? - An Interview...more

Regulators Fine Automaker for Failing to Report Fatalities

Honda Hit with $70 Million Fine - We just might end up remembering 2014 as the year of fatal car accidents caused by auto defects. Automotive recalls totaled more than 60 million last year alone. GM recalled tens of...more

SHE Matters - Winter 2014/2015

In This Issue: - Fee For Intervention – Is It Set To Stay? - How To Protect Brand Reputation And Sales From The Risks Associated With A Product Recall - Review Of The Proposed Changes In The Sentencing Of Health...more

CPSC and E-Commerce Giant Alibaba Ink Deal to Block Sale of Recalled Products to U.S. Consumers

Following an ABC 20/20 investigative story where CPSC Chairman Elliot Kaye called Craigslist’s failure to block the sale of recalled products “morally irresponsible,” the agency announced yesterday that it has entered into an...more

Class Action Lawsuits – Risks and Mitigation Strategies for Component Manufacturers

Manufacturers of components incorporated into consumer products increasingly find themselves involved in product liability class action lawsuits. Manufacturers can be drawn into these types of lawsuits when their own customer...more

How Effexor Recalls Can Leads to Lawsuits

When a manufacturer recalls a dangerous drug, how does that medication become the topic of a lawsuit? In the case of Effexor, an antidepressant drug, many lawsuits have already been filed in relation to birth defects and...more

Focus Newsletter - December 2014

In this issue: - ABC's of a Product Recall - Amazing Clients® Lumenpulse Inc. - A Bright Future for a Company That Is Lighting Up the World - Delaware Corporate Law Becomes More User-Friendly -...more

Sports, Media and Entertainment Intelligence (Global) - December 2014

BRAND REPUTATION - Global: How to protect brand reputation and sales from the risks associated with a product recall - The power of regulatory authorities to order product recalls is growing, meaning that it is more...more

Recalled Dangerous Dietary Supplements Remain for Sale

When the Food and Drug Administration (FDA) issues a dietary supplement recall for a product that contains banned substances, are we still at risk of inadvertently buying this defective product? According to a recent article...more

Growing Safety Risk for Hospitals: Spiraling Medical Device Recalls

Everyone knows that the number of medical device recalls is on the rise. Here are two telling examples of the growth. In 2003 a total of 604 recalls were reported to the FDA, while last August a single manufacturer recalled...more

A “Good” Deed Goes Unpunished

Alabama Supreme Court Rejects “Good Samaritan” Liability in Gray Market Case - Last month, I wrote about the “Good Samaritan” rule, codified in Restatement (Second) of Torts, section 324A, “Liability to Third Persons...more

GLOBAL: How to protect brand reputation and sales from the risks associated with a product recall

In the past decade or so, manufacturers in the developed world that would previously have created their entire product in their own country now outsource manufacture to other parts of the world. This has had significant...more

Protect Your Safety Investigations and Deliberations From Prying Eyes

Every day companies deal with an ongoing safety analysis of their own products. These Safety Teams are routinely interdepartmental. The Safety Teams must consider design changes, manufacturing issues, potential recalls,...more

Airbag Automotive Recalls Continue

New Takata Air Bag Recall For Infiniti SUVs - Can you trust that your airbags will function properly if you are in a car accident? Over the last year, the automotive parts maker Takata has been responsible for airbag...more

FDA Regulatory and Compliance Monthly Recap - October 2014

In This Issue: - FDA issues final guidance on discerning device recalls from market withdrawals related to medical device enhancements in apparent bid to appease industry concern over draft being overly broad, lacking...more

Medical Device Update: Distinguishing Medical Device Recalls from Medical Device Enhancements

On October 15, the U.S. Food and Drug Administration (FDA) issued the final guidance “Distinguishing Medical Device Recalls from Medical Device Enhancements.” This guidance revises and finalizes the draft version that...more

Stop Product Liability Claims Now!

More and more recalls mean more and more product liability claims. Even without recalls, for companies in the Automotive Industry product liability claims are a way of life. So, what do you do to prevent such claims? Knowing...more

How to protect brand reputation and sales from the risks associated with a product recall

Q: I am in charge of risk management for a global organisation and have been asked to investigate product risk. What suggestions can you offer on managing global supply and distribution? A: in the past decade or so,...more

FDA Issues Final Medical Device Recalls Guidance - Explains How to Distinguish Enhancements from Recalls

On October 15, 2015, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (“CDRH”) issued a final guidance document, Distinguishing Medical Device Recalls from Medical Device Enhancements (“Final...more

Is There Anything “Good” about the “Good Samaritan” Rule?

Every first-year law student can recite the “Good Samaritan” rule: The ordinary bystander has no legal duty to rescue a drowning person, but if you voluntarily undertake the duty to rescue her, you must not be negligent in...more

CPSC Clarifies Changes to Monthly Recall Report Form

In May, we advised readers conducting recalls that the CPSC’s new monthly “recall progress report” form may catch you by surprise. Among other changes, the form included new provisions requesting companies to report recall...more

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