New Legislation Gives More Time for Medical Device Reporting

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

Selling Recalled Products: CPSC Fines Home Depot

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

Who Won? The Verdict in the AndroGel Trial

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

No Delay for Proposition 65 Listing of Glyphosate

For the past several months, Monsanto has been in court challenging California’s decision to add the chemical glyphosate—the active ingredient in its herbicide Roundup—to the Proposition 65 list. It recently faced a setback when the California Supreme Court rejected Monsanto’s request to stay a lower court’s decision to include glyphosate among the 960 chemicals on the list.  California’s Office of Environmental Health Hazard Assessment (OEHHA) wasted no time after the decision and added glyphosate to the list on July 7, 2017. Continue Reading

Checking Out of Hotel California: The U.S. Supreme Court Holds That Plaintiffs Cannot Sue Companies Anywhere They Do Business

On June 19, 2017, the U.S. Supreme Court decided Bristol-Myers Squibb Co. v. Superior Court of California (BMS), an action brought in California state court that included some non-California plaintiffs alleging injuries not suffered in California. The Supreme Court – for the second time this term – narrowed where plaintiffs can constitutionally sue companies.

The decision already is impacting mass tort actions. On the same day as the BMS decision, a Missouri state court declared a mistrial in an action alleging that Johnson & Johnson’s talc products cause ovarian cancer.

BMS provides product liability defendants with an opportunity to argue that state courts do not have personal jurisdiction over them when the claims have no connection with the defendants’ activities in the forum state. Continue Reading

The Dangers of Partial CPSC Reports: The Kawasaki Penalty

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

Spinning Out of Control? Fidget Spinner Regulation and Safety

Children of all ages—and many adults—can’t keep their hands off fidget spinners, the best-selling toys of the spring and one of hottest new fad toys on the market. Schools in some states have banned them, while others find them helpful for children with attention-related difficulties. Predictably, fidget spinner manufacturers and distributors are feeling the heat of the spotlight, as reports emerge that children are hurting themselves with these toys. Regulators, distributors, and consumers now must sort out how the toys should be marketed and used. Continue Reading

Safe Crossing: The U.S. Supreme Court Gets State Courts on Track with Daimler

On May 30, 2017, the U.S. Supreme Court issued its opinion in BNSF Railway Co. v. Tyrrell (BNSF), another case that defines the constitutional limits of general personal jurisdiction over companies.

The major issue in BNSF was whether a railroad company had a substantial enough presence in Montana for the Montana courts to assert general jurisdiction over the company. The Court’s decision also answered whether a federal law, the Federal Employers’ Liability Act (FELA), conferred personal jurisdiction to state courts over railroad companies wherever they are “doing business.” Continue Reading

It’s a Federal Question: Can Defendants Remove Under the Grable Doctrine?

A Missouri federal court recently retained jurisdiction over state-law claims under the rarely used “Grable doctrine.” The doctrine arose from a 2005 U.S. Supreme Court case, and supports removal when (1) a plaintiff’s state-law claim raises a disputed and substantial federal question, and (2) removal would not disturb the balance between state and federal judicial responsibilities.

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Three Ways to Deal with the FDA Calorie Labeling Delay

On April 25, 2017, the U.S. Food and Drug Administration (FDA) again delayed the deadline for restaurants and grocery stores to implement new calorie labeling rules. Originally set for May 5, 2017, the agency pushed back the deadline a second time, now requiring compliance by May 2018.

However, the delay may have come a little too late. Delaying compliance less than 10 days before the deadline provides little help to businesses that have already worked to comply. And uncertainty still remains as to what the labeling rules will be when compliance is required. Continue Reading

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