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FDA said it never inspected dental lab that made controversial AGGA device

FDA said it never inspected dental lab that made controversial AGGA device

Brett Kelman, Anna Werner, CBS News | (TNS) KFF Health News

The FDA never inspected Johns Dental Laboratories during more than a decade in which it made the Anterior Growth Guidance Appliance, or “AGGA,” a dental device that has allegedly harmed patients and is now the subject of a criminal investigation.

According to FDA documents obtained through the Freedom of Information Act, the agency “became aware” of the AGGA from a joint investigation by KFF Health News and CBS News in March 2023, then responded with its first-ever inspection of Johns Dental months later.

That inspection found that the Indiana dental device manufacturer didn’t require all customer complaints to be investigated and the company did not investigate some complaints about people being hurt by products, including the AGGA, the FDA documents state. The FDA requires device companies to investigate complaints and forward them to the agency. Johns Dental had “never” alerted the FDA to any such complaints, according to the documents. read more

Undergrads are unionizing, in a sign of labor’s resurgence

Undergrads are unionizing, in a sign of labor’s resurgence

Elaine S. Povich | Stateline.org (TNS)

Junior psychology major Erin Green works part time at the children’s preschool at Sonoma State University, caring for university employees’ kids ages 1 to 5. Some of the non-student workers in her center belong to a union. But she didn’t, until just a few weeks ago.

Green, a 49-year-old returning student who works 20 hours a week, said she makes $16.25 an hour, just above the state’s minimum wage of $16.

“I was appalled at how little we were getting paid,” Green said. “When I started to hear the buzz around the campus that we were about to become unionized, I thought that was something I should get involved in.”

Green and more than 7,000 undergraduate student workers across California State University’s 23 campuses overwhelmingly voted in an election this year to join a union. Now, about 20,000 undergrads are members of the California State University Employees Union, the largest union of undergraduate student workers in the country.

Green is at the tip of the growing movement toward undergraduate unionization on state college campuses. University of Oregon undergraduates voted in October to form a union covering about 4,000 students, one of the nation’s first such unions at a public university. read more

Their first baby came with medical debt. These parents won’t have another

Their first baby came with medical debt. These parents won’t have another

Noam N. Levey | (TNS) KFF Health News

Heather Crivilare was a month from her due date when she was rushed to an operating room for an emergency cesarean section.

The first-time mother, a high school teacher in rural Illinois, had developed high blood pressure, a sometimes life-threatening condition in pregnancy that prompted doctors to hospitalize her. Then Crivilare’s blood pressure spiked, and the baby’s heart rate dropped. “It was terrifying,” Crivilare said.

She gave birth to a healthy daughter. What followed, though, was another ordeal: thousands of dollars in medical debt that sent Crivilare and her husband scrambling for nearly a year to keep collectors at bay.

The Crivilares would eventually get on nine payment plans as they juggled close to $5,000 in bills.

“It really felt like a full-time job some days,” Crivilare recalled. “Getting the baby down to sleep and then getting on the phone. I’d set up one payment plan, and then a new bill would come that afternoon. And I’d have to set up another one.” read more

People on the move

People on the move

Employment

Chris Sloan was appointed executive vice president of medical operations at Loyal Source Government Services, Orlando.

Jerry MacLellan was promoted to chief business officer at Loyal Source Government Services, Orlando.

Law

Walter A. Ketcham Jr. was appointed a shareholder at Fisher Rushmer P.A., Orlando.

Michelle L. Bilsky has joined Winderweedle, Haines, Ward & Woodman, P.A., Winter Park, as an attorney in the firm’s Trust & Estates and Corporate/Employment Law departments.

Real estate

Hillary Bressler has joined NAI Realvest, Orlando, as a director of commercial real estate.

Al Fishalow has joined NAI Realvest, Orlando, as a director of commercial real estate.

Submit professional appointments, management-level promotions and significant awards for individuals, along with photos as .jpg attachments, to peopleonmove@orlandosentinel.com.

First look: DreamWorks Land at Universal Studios

First look: DreamWorks Land at Universal Studios

The new DreamWorks Land may feel both new and familiar when it debuts at Universal Studios theme park next month.

The area, which is built generally on the footprint of the old Woody’s KidZone, rethinks the use of its structures and gives them an animated spin a la “Shrek,” “Kung Fu Panda” and “Puss in Boots.”

For instance, where Barney the purple dinosaur once frolicked in a fountain, there are now a couple of trolls. So it’s more than a fresh coat of paint happening back here.

Universal gave members of the media a sneak peek Thursday just before the park closed for the day. Not everything was available and operating, but here are five things that were seen.

In ogre words

Most visible upon entrance is an area devoted to “Shrek” characters. A giant grassy stump, which has been visible from beyond the construction wall, dominates the area, and a meet-and-greet with the big green ogre and Donkey is built in. This interaction is much like it has been in a couple of previous locations at Universal. read more