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Molecular Structure

Under the recently enacted FDA Reauthorization Act of 2017, drug and device manufacturers will have more time to report device malfunctions to the U.S. Food and Drug Administration (FDA).

Current standards require medical device malfunction reports to the FDA within 30 days. The 2017 Act maintains the 30-day deadline for reporting events that have already resulted in serious medical consequences to users—“adverse events.” But the Act expands the quarterly reporting function, allowing 90 days to report issues that may cause harm in the future but have not yet resulted in patient complications, injuries, or deaths—“malfunctions.” The Act also allows companies to submit summary malfunction reports when the incident reported is already known and understood by the FDA, rather than reporting incidents individually. Continue Reading New Legislation Gives More Time for Medical Device Reporting

Concrete blocks in the hardware store

Last week, Home Depot became the latest mass retailer to pay a civil penalty for selling products previously recalled by the U.S. Consumer Product Safety Commission (CPSC).

By our count, this is the third such penalty to be imposed, at least in recent years. In 2014, Meijer was penalized $2 million for selling 1,700 units of 12 different recalled products. In 2016, Best Buy agreed to pay $3.8 million for selling 600 units of 16 different products. Now, Home Depot has agreed to pay $5.7 million, having distributed just over 2,800 units cutting across 33 different recalls.

The size of these penalties should be sufficient to put other retailers on notice that the presence of a recalled product cannot be treated as just another inventory issue. Continue Reading Selling Recalled Products: CPSC Fines Home Depot

verdict

A Chicago jury awarded a single plaintiff $150 million in punitive damages, finding that AbbVie, Inc. fraudulently misrepresented the safety risks of its drug used to treat low testosterone, AndroGel. But the jury also decided in AbbVie’s favor on the plaintiff’s strict liability and negligence claims—meaning that they determined that AndroGel did not cause the plaintiff’s alleged injury. As a result, the jury awarded no compensatory damages. Continue Reading Who Won? The Verdict in the AndroGel Trial

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Consumer product companies that suspect a product either contains a defect or poses an unreasonable risk of injury are required to report that fact to the Consumer Product Safety Commission (CPSC) within 24 hours of reaching that conclusion – or risk a civil penalty, like Kawasaki received earlier this month. Continue Reading The Dangers of Partial CPSC Reports: The Kawasaki Penalty

US Supreme Court

We’ve been following a series of cases filed against Johnson & Johnson by plaintiffs alleging that using talc caused ovarian cancer.

Since 2009, over 2000 cases have been filed, mostly in Missouri, New Jersey, and California. Missouri has seen four trials: the first three resulted in plaintiffs’ verdicts, but the fourth and most recent resulted in a verdict for J&J.

Often in mass tort litigation, courts allow the parties to have a series of “bellwether trials” to show what is likely to happen in future trials. Rather than preparing to try all cases in a mass tort litigation, the parties can try fewer cases that involve the most contested issues. In Missouri, the bellwether trial plaintiffs are chosen by counsel, with each side taking a turn to select the next plaintiff. Continue Reading Talc Talk – One of These Things (Verdicts) Is Not Like the Others

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Consider the world today: Smartphone manufacturers have already introduced vehicle infotainment systems in automobiles. Vehicle safety technology may be next.

A recent safety proposal by the National Highway Traffic Safety Agency (NHTSA) raises intriguing questions about how our smartphones and automobiles may interface. The proposal may encourage smartphone manufacturers to add vehicle safety technology to their infotainment system applications. That may start to blur the lines between your vehicle and your smartphone.

Continue Reading Where Does Your Smartphone End and Your Car Begin?

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Consumer products companies may be eager to use Made in the USA labels to advertise, particularly given the political climate and increased publicity around domestic manufacturing. But they must pay close attention to the state and federal laws that regulate what Made in the USA actually means.

Continue Reading What Does Made in the USA Actually Mean?

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In an updated statistical analysis, Schiff Hardin’s Jonathan Judge examines how penalties handed down by the Consumer Product Safety Commission (CPSC) have abruptly veered upward over the last two years following the threat of CPSC’s then-Chairman Elliot Kaye, to do just that. These findings support our post last fall signaling higher civil penalties to come. Continue Reading The Troubling Increase in CPSC Penalties

Boy dissatisfied with christmas present

Most holiday seasons, an “it” toy stands at the top of children’s wish lists. With this instant rise in popularity frequently comes a corresponding rise in consumer complaints. Years ago, the consumer complaints might get some media attention—but that attention usually focused on the consumer competition to acquire the demand-exceeds-supply product.

Now, people turn to social media to detail in words, pictures, and video any perceived problem with their much-hyped purchase. This contributes to a manufacturer’s nightmare, trying to quickly determine which complaints are just disappointed expectation and which might actually be a consumer safety issue. Can manufacturers likewise use social media to help calm the storm? Continue Reading When Santa Brings a Dud