I will soon have the honor of co-chairing CBI’s Rx and OTC Product Recalls Boot Camp at the Conrad Indianapolis Hotel in Indianapolis.

Over the past seven years, CBI’s Product Recalls Series has continued to attract leading professionals from the biotech, pharmaceutical, and medical device industries as well as distributors, wholesalers, reverse logistics providers, law firms and consulting organizations from around the country.

This year’s Boot Camp, which is scheduled for June 11 and 12, 2012, will focus on preparation and communication strategies for the efficient and compliant execution of product recalls. The two-day event will consist of 13 sessions presented by 15 distinguished speakers from a number of industries.

Attendees will learn about a number of informative topics on the planning, execution and evaluation phases of a recall event, including:

• Preparation Strategies for Managing Global and International Recalls
• Cross-Function Training for Business Teams on Effective Execution of Product Recalls
• Best Practices for Continuous Communication Improvement

Additionally, attendees will also have the opportunity to take a recall logistics tour of Stericycle’s Indianapolis facility and hear from U.S. Food and Drug Administration (FDA) personnel on how to effectively work with local FDA offices during a recall.  The Recall Team Leader of the FDA’s Division of Compliance Management and Operations will also address the agency’s current state on product recalls affecting the life sciences industry.

Registration to the event is still open. Sign up here!

Will you be attending CBI’s Rx and OTC Product Recalls Camp? If so, what sessions are you the most excited about? We welcome your comments below.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.

Medical device recalls saw a dramatic 160 percent increase in the first quarter of 2012, according to the first quarterly ExpertRECALL™ Index of 2012.

From alcohol prep pads, to needles, and latex gloves, medical device recalls affected nearly 82 million units, a 508 percent increase over the previous quarter –  a five-quarter high. Joining this rise in recall activity were consumer products. Pharmaceutical recalls and food product recalls declined.

What is the cause behind the recent surge in medical device recalls?

While the quarter-over-quarter increase in medical device recalls may seem surprising at first glance, it should be expected given that recalls documented in fourth quarter 2011 U.S. Food and Drug Administration (FDA) Enforcement Reports were at an unprecedented low.

What is more alarming is the number of companies who are becoming repeat offenders and the large increase of units these recalls are affecting. With more and more Americans relying on these devices to maintain and improve their health and life, companies would be smart to reiterate their number-one priority – consumer and patient safety. Especially given that the media has been paying close attention to medical device safety and scrutinizing the government’s approval process. FDA has even responded to such criticisms by publicly reassuring its dedication to device safety.

The ExpertRECALL Index examines recall trends and issues that affect consumers and manufacturers alike. Additional takeaways from first-quarter findings in the ExpertRECALL Index include:

• 150 million units were recalled by pharmaceutical companies in the first quarter of 2012, recording a five-quarter high.
• First quarter Enforcement Reports saw a 90 percent decrease in the number of units affected by food recalls.
• 35 million units were affected by consumer product recalls across all 15 product categories.
• Recalls of children’s and infant products affected 1.1 million units during the first quarter.

You can read the full ExpertRECALL Index here. What first-quarter findings surprise you the most?  How do you believe FDA will react to the ongoing scrutiny it faces from consumer advocates and the media about its approval process? Your thoughts are most welcome.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.

The goal of any recall is to get the product out of the marketplace with zero chance of re-entry and ultimately ensure that safety is the first priority. But once recalled products are collected, where do they go?

Do they eventually end up in the landfill alongside the 250 million tons of trash we produce in the U.S. each year?

Eco-friendly trends have led many consumers, and subsequently businesses, to consider how they can minimize waste. Whether it’s purchasing products that don’t have a lot of packaging, using reusable lunch bags, or recycling, there are many ways in which we can all refrain from throwing away so much trash.

At Stericycle, we admire such efforts and work to curb waste production when managing product recalls.  When permitted by our clients, our company utilizes sustainable business practices that allow for recalled items to be broken down and taken apart. Rather than throwing all of the individual product components away, defective parts can be separated from those that can be reused or recycled.

For instance, Stericycle ExpertSUSTAINABILITY can remove batteries from laptops that were recalled due to a faulty keyboard so they can be reused by the manufacturer.  The ability to categorize materials based on whether they can be re-used or recycled is just one of the many core services offered by our sustainability services group.

While “going green” may seem to be just the latest trend to some, those businesses who do implement environmentally-friendly initiatives certainly experience some perks. It can help you preserve resources, increase your bottom line and lead to positive publicity.

As you celebrate the 42^nd anniversary of Earth Day, take a moment and evaluate your business’ “go green” initiatives.  What changes can you make in the workplace to help maintain the health of the environment? Your thoughts are welcome below.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.

Safety advocacy group Kids In Danger (KID) recently announced findings from its annual children’s product hazard report, “A Measure of Safety: Children’s Product Recalls in 2011.” This report examines data and trends in children’s products that have been recalled by the U.S. Consumer Product Safety Commission (CPSC).

This year, KID found that while children’s product recalls have dropped 24 percent since 2010, injuries and other adverse events associated with these recalls grew by an alarming 7 percent. The group also reported that nursery products were the most-recalled category with 30 percent of children’s recalls, followed by toys at 26 percent.

While it is difficult to pinpoint reasons for the ups-and-downs in recall activity, this recent decline in recalls is for the most part likely due to the passage a few years ago of the Consumer Product Safety Improvement Act (CPSIA). More concerning, is the report’s assertion that the average recall response rate to these safety recalls remains an issue, as many parents are not returning the products in question.

With an increasing number of companies offering consumers incentives for returning recalled items, what is causing this lack of response? Are consumers getting lost among the recalls?

CPSC reports that only 15 to 30 percent of products are sent back or repaired when a recall is announced. The Juvenile Products Manufacturers Association (JPMA) agrees with the agency’s findings and states that the rate of return has “traditionally been very low.” However, the KID report found that 50 to 60 percent of companies offer full refunds, 14 percent replace the product and six percent offer store credit for returned recalled products.

One of the factors leading to a low recall response rate, includes a company’s failure to reach affected consumers and identify an appropriate remedy. Additionally, recall notices have become so frequent across a range of goods — foods, consumer products, cars — that the public is suffering from “recall fatigue.” Product recalls are announced every day. This may lead to consumers being inundated with recall notices and feeling overwhelmed. The problem is twofold: Some people never learn that a product they own has been recalled, and others know they have a recalled product but don’t think anything bad will happen. In order to overcome this issue, companies need to utilize all avenues of communication to ensure all affected parties are reached during a recall event.

According to KID, the best way to prod consumers to respond to recalls is for manufacturers to notify them directly. In its report the group calls for CPSC to require “more aggressive” recall outreach and asks Congress to require annual CPSC reports on recall effectiveness. Time will tell whether the group’s recommendations amount to a change in the regulatory landscape.

Do you think their recommendations will be considered by CPSC and result in more stringent regulatory requirements? What is your company doing to get consumers to act? We welcome your comments below.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.

Two years ago, Toyota had to fork over nearly $50 million to the federal government over how it handled auto recalls announced in 2009 and 2010. And just last month, luxury car manufacturer BMW was fined $3 million for failing to notify the National Highway Traffic Safety Administration (NHTSA) about safety defects and recalls in a timely manner.

There is no question that NHTSA is serious about timely reporting.

Currently, the maximum amount of money automakers can be ordered to pay in civil penalties is $17 million. However, U.S. regulators and legislators are considering imposing even more substantial fines.

NHTSA Administrator David Strickland recently argued before a congressional hearing that while car companies have become better about promptly alerting the regulatory agency to potential safety issues or recalls, the impact of the Toyota crisis on the industry is simply not enough to ensure long-term compliance. Delaying a recall has an enormous impact on an automaker’s reputation in the marketplace and on its sales, production, and profits. As a result, Strickland called for an increase in the maximum fine to reflect the size of the auto industry, an astounding $250 million.

Other lawmakers have echoed Strickland’s statements and have rallied in support of a provision included in transportation legislation approved by the Senate that would increase civil penalties. However, the auto industry believes a hike in fines in an era of increased vehicle safety in which investments are being made to the tune of millions of dollars to protect motorists would be “excessive” and is in favor of a competing House bill that does not include such a proposal.

Regardless of whether the Senate-approved bill becomes law or not, NHTSA will continue to crack down on those within the automotive industry that fail to promptly notify the agency of safety-related issues. Auto companies would be well advised to review their recall plans and ensure that all procedures are in compliance. Adapting to the current regulatory environment now will limit any substantial problems in the future.

Will higher fines ensure timely responses by automakers? How do you ensure that your company’s recall procedures are in compliance with current federal regulations? We welcome your comments below.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.

By Mike Rozembajgier

Only two percent of food manufacturers feel their company is behind the curve on food safety. But consumers disagree. They argue that food safety is still at risk and believe manufacturers could do more to ensure the quality and safety of their products. Those were the findings of a recently released survey  authored by independent safety science company Underwriters Laboratories’ (UL).

The UL survey, titled “Navigating the Product Mindset”, documents 2,430 interviews with consumers and manufacturers in four countries. It shows that perceptions of consumers and manufacturers differ on a surprising majority of questions and opinions relating to the current state of the food and beverage industry. The one thing they did agree on was the increasing importance of global food safety.

The Food Safety Modernization Act (FSMA) and other initiatives proposed by the U.S. Food and Drug Administration (FDA) have brought attention to issues affecting the global food supply and identified solutions to prevent and efficiently respond to such ailments. However, as the FDA does not currently have the resources available to implement some of their proposed guidelines and standards, it is not surprising that the majority of manufacturers surveyed by UL said they believed they were responsible for food safety above federal government agencies, consumer groups, or retailers alike.

While inspiring to hear a large majority of food manufacturers around the world recognize the importance of producing quality products and holding themselves accountable for the safety of their consumers, it is troublesome to hear that the public remains concerned about the freshness, performance and safety of the food they eat.

Because consumers now command greater influence across the supply chain, it’s increasingly important that manufacturers and retailers implement the notification process quickly when a food product has been tampered with or contaminated. Alerting all affected parties early on is a critical step that can make the difference between a successful and unsuccessful product recall. And an effective recall can actually increase the level of trust your consumers and other stakeholders have in your product.

What are your thoughts about the UL survey’s findings? Do they surprise you? How will your business effectively notify all affected parties during a product recall? Your thoughts are most welcome below.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.

What do you as a product safety professional do to keep up with the changing regulatory environment? Do you know how to use all the new technologies that help you monitor your supply chain? We often talk about what it takes to be prepared for a recall. A big part of that is preparing yourself and your company about product safety and recall risks.

There are a lot of recall specialists out there who offer recall planning and consulting services, logistics services and turn-key solutions that help your company prepare for recalls and other product safety risks. Product safety webinars and conferences are among the easiest ways to facilitate discussions among regulators and industry representatives about safety concerns and regulatory changes.

Another excellent resource is the Certificate in Product Safety Management offered by The Center for Supply Chain Management Studies at Saint Louis University’s John Cook School of Business. The program, developed in cooperation with ADK Information Services, is accepting applications for its third class, which starts April 16, 2012.

Because we know how difficult it can be in this economy to allocate funds to outside resources, ExpertRECALL is offering one full scholarship to the program. If you are a full-time product safety professional employed by a manufacturer, retailer, wholesaler or importer, you are eligible to apply.

We evaluate candidates based on their interest in the program and their need for financial assistance.  Education and preparation are the keys to success. And we’re here to help your company and its employees succeed.

If you’d like to apply for a scholarship, please contact ksutton@stericycle.com. Applications are due March 1, 2012.

Food recalls are on the upswing. For the fourth quarter of 2011, they increased 50 percent and affected over 80 percent more units than they did the previous quarter, according to the latest ExpertRECALL™ Index report.

On its face, this trend is troubling for food manufacturers and retailers. But it presents another more subtle, but serious, problem for companies legally responsible for notifying consumers about recalls. That’s the phenomenon known as “recall fatigue,” a condition causing people who are so used to seeing recalls to ignore recall announcements and fail to return or dispose potentially dangerous products.

When consumers are disinterested in product recalls, the challenges of recall notification are more severe. Manufacturers and retailers should keep this in mind and take care to “over-communicate” with consumers by using the most effective and direct communication channels possible, such as email or phone.

The ExpertRECALL Index examines recall trends and issues that affect consumers and manufacturers alike. Additional takeaways from fourth-quarter findings in the ExpertRECALL Index include:

• Undeclared allergens or other allergen concerns were the primary cause of food recalls in the fourth quarter, followed by potential Listeria contamination.
• During the fourth quarter, laceration hazards were the leading cause of CPSC recalls followed by risks of structural collapse and entrapment/strangulation hazards.
• The number of units affected by pharmaceutical recalls shot up by over 200 percent when compared to past quarters.
• Within the fourth quarter, about 63 percent of recalls affected products in the nursery equipment & supplies category, while about 37 percent were toys.

You can read the full ExpertRECALL Index here. What fourth-quarter findings surprise you the most? How does your business reach out to consumers in a recall? Is your company prepared to handle a global product recall and international regulations? Your thoughts are most welcome.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.

During the recent State of the Union address, President Obama previewed his re-election campaign themes, introduced a number of specific proposals, reiterated his promise to stand firm on a number of important issues. He even told a rather dull joke.

While the President’s “spilled milk” line may have flopped, it segued into an important topic – food safety.  A little over a year after signing the Food Safety Modernization Act (FSMA) into law, the president asserted during his speech that he will continue pushing to enhance food safety. “I’m not backing down from protecting our kids from mercury poisoning, or making sure that our food is safe and our water is clean,” he declared. Obama’s declaration correlates well with his Federal Food Safety Working Group’s (FSWG) 2012 agenda to prioritize the implementation of the FSMA, which beefs up government surveillance and compliance.

Does the Obama administration’s reaffirmed dedication to the safety of our food mean more regulation? Not according to the President. He said that protecting the food we eat and the water we drink does not necessarily mean more rules, just smarter ones.

Many believe the Obama administration will try to consolidate the regulatory agencies that now regulate food and agriculture. Whether true or not, food safety regulations continue to tighten in response to consumer worries. Therefore, it is imperative that food companies and retailers stay a step ahead of the game by reviewing their recall readiness plans BEFORE they need them.

What were your thoughts on the inclusion of food safety in President Obama’s State of the Union address? Are you ready for your next recall? How will the presidential election affect government food safety initiatives? We welcome your comments.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.

President Obama recently nominated Democrat Marietta S. Robinson, a Michigan trial attorney with 33 years in practice, to fill a vacancy on the U.S. Consumer Product Safety Commission (CPSC).  If confirmed by the Senate, she will break the bipartisan gridlock following the departure of Democrat Thomas H. Moore in October.

The party split on the panel mirrors the ongoing partisan stalemate in Washington.  Ever since the passage of the 2008 Consumer Product Safety Improvement Act (CPSIA), the CPSC has been challenged by an ideological battle among its commissioners.  The Democrats have accused the Republicans of putting business’s financial interest ahead of consumer safety, and the Republicans have retorted that Democrats are advancing an “agenda” by pushing regulations through without thoroughly weighing the costs with the benefits.  Specifically, the Commission voted along party lines to launch a consumer complaints database, and they also spurred on enacting drop-side crib regulations pursuant to the CPSIA.

Inez Tenenbaum, the Chairman of the CPSC, in a more recent interview said she “bemoaned the bitterness on the board,” which in turn led Republican commissioners to compare the Chairman’s leadership style to that of a dictator.

Should the Senate approve Robinson’s nomination, the Democrats will have the upper-hand, which will likely result in more rigorous enforcement from the agency.  Consumer product manufacturers are well-advised to be prepared for quicker approvals of more stringent safety standards, an increase in regulatory enforcement, and an anticipated release of new federal regulations that will impact a broad array of toys, children’s products, and consumer goods.  Companies should also take extra steps to ensure that they are in regulatory compliance, so as to limit civil or criminal litigation and regulatory fines.

Meanwhile, what are your thoughts?  How will the Senate respond to President Obama’s nomination of Robinson?  If the nomination is approved, how will it impact your business?  Do you think it will result in more scrutiny of the consumer products industry and lead to additional stories of large civil penalty settlements and seized imported consumer products? Please feel free to share your comments below.

Thomas M. Barba is an experienced products liability litigator and advisor who is a partner in the Washington office of Steptoe & Johnson LLP. You may contact him at (202) 429-8127 or tbarba@steptoe.com.