SAN DIEGO — Under current law, generic drug companies can rarely be sued when their products cause serious harm. Patient advocates are slamming the FDA for dragging its feet on a new rule to fix the so-called generic safety loophole.
The FDA recently announced it won't finalize the rule, which was proposed in 2013, until at least April of 2017. 17-year-old Taylor Smoot from San Diego said four years ago she took Zarah, a generic form of the birth control pill Yaz, to regulate her cycle. She developed dozens of blood clots and has since suffered through 24 surgeries.
"I have almost died many times,” Smoot said. "I've gone through a coma. All because of this generic drug. On the labels, they did not have a warning. I would have been warned if I had taken the brand name. That is why I'm going to be living with this for the rest of my life."
The risk of blood clots was known. Bayer, the maker of brand name Yaz, paid out more than a billion dollars to settle lawsuits. But Smoot and others like her can't sue for a dime. That's because in 2011, the U.S. Supreme Court determined that since federal regulations don't require generic companies to update their labels, makers of generic drugs have very limited liability in drug injury lawsuits.
Smoot's former attorney, Tom Lamb, said insurance companies often insist that patients take the cheaper generics - and millions of Americans have no idea they're giving up their legal rights when they fill the prescription.
"80 percent of the drugs that are dispensed at pharmacies are generic,” Lamb said. "And people are unaware of this rule that if they've got a prescription filled with a generic as opposed to the brand name drug that they have no legal recourse against a manufacturer if they suffer a drug injury."
According to Lamb, generic drug companies claim it would be confusing to doctors if the labels were different on ten versions of the same drug. But the new federal rule would give the FDA the power to evaluate reported risks and require all brand name and generic versions to carry the same warnings.
To learn more about the 2011 Supreme Court ruling, visit supremecourt.gov.
get more stories like this via email
Air travelers could face fewer obstacles in securing a refund if their flight is canceled or changed under new federal rules announced Wednesday.
The moves are being praised by watchdog groups. The Department of Transportation said airlines are now required to promptly provide passengers with automatic cash refunds when they are owed one.
Teresa Murray, consumer watchdog director for the U.S. Public Interest Research Group, said some carriers have not adhered to standards, leaving passengers in a bind.
"They would drag their feet, and they would say, 'Well, you bought your ticket from a ticket agent, so we don't know where your money is. Or, here, have a voucher,'" Murray explained.
Amid higher complaint volumes, companies will be forced to act quickly. The new rules, which are being phased in, provide clearer definitions for travel disruptions, including delays of at least three hours on a domestic flight and six hours on international flights. A key industry group responded to the announcement by touting transparency efforts among carriers.
Murray acknowledged most people are not frequent flyers, and it is hard for them to keep up on all the least practices and policies among airlines.
"The average person only flies once every 18 months," Murray pointed out. "This will just bring transparency to that process and it kind of evens the playing field."
Murray added it could come in handy for Midwestern customers when a winter storm wreaks havoc on air travel. The new rules also require refunds for baggage fees when a piece of luggage is delayed by 12 hours or more for domestic flights. And there must be upfront disclosure on fees for first and second checked bags and carry-on bags.
get more stories like this via email
Wisconsin lawmakers recently debated reforms for payday loans. Efforts to protect consumers come amid new research about financial pain associated with cash advances offered through smartphone apps. The Center for Responsible Lending is out with findings that detail how "earned wage advances" from digital platforms come with extra costs disguised as things like tips. Traditional payday lenders are often criticized for charging excessive interest rates on loans that are usually around $500.
Lucia Constantine, a researcher with the Center for Responsible Lending, said customers are usually seeking smaller amounts from the apps, but she warns they can be just as costly.
"They are trapping consumers in a cycle of borrowing that is similar to that of a payday loan, " she said.
The report said after using these financial products, customers are seeing overdrafts on their checking accounts increase by 56% on average. Industry leaders deny they're barraging consumers with hidden fees, stressing that features such as suggested tips are optional. More broadly, a bipartisan payday loan reform bill in the Wisconsin Legislature failed to advance this month.
Constantine said like longstanding payday lenders, these cash advance apps can be hard to regulate. Meanwhile, she urged those in a bind to explore other options.
"[They should] try talking to their friends and family as a first source. The other option which I would recommend is reaching out to their credit union or banking institution to see if they can get some sort of small-dollar loan," she said.
She noted places such as credit unions typically provide more transparency on loan costs. According to the report, three-quarters of consumers took out at least one advance on the same day or day after a re-payment was posted.
get more stories like this via email
Food prices remain high, in Montana and across the country.
A new report by the Federal Trade Commission says the country's largest grocery companies are gouging consumers, by keeping prices artificially high.
Many grocers, retailers and wholesalers have consolidated to cut costs. Grocers continue to blame supply chain problems, even though regulators have said most of those issues have been resolved.
President of the advocacy group Farm Action, Angela Huffman, said retailers were doing more than making up for lost revenue during the pandemic-era supply chain disruptions - and the FTC report says they continue to do so.
"In 2021, the retailer revenues, they rose to more than 6% higher than their total costs, and that those profits are still going up," said Huffman. "So, in the first nine months of 2023, the profits increased to 7%."
At nearly 6.5%, Montana had the nation's ninth-highest grocery price increase in 2023.
The FTC data show Amazon, Kroger and WalMart each gained market share during and after the pandemic - while profits continued to rise.
Other large retailers and wholesalers have consolidated, which they say gives them more buying power and the ability to pass those savings on to customers.
Huffman said that isn't what's happening, and calls on regulators to fine the grocers, or more.
"This would be kind of the farthest extent of what they could do, but go so far as breaking them up," said Huffman. "In years past, they broke up the telephone companies and the railroads and, you know, that would be the ideal outcome for us, is to take away their excessive power."
Huffman also points to a 150% increase in egg prices in 2023, which producers blamed on the avian flu. The FTC says the disease did not justify the drastic price hike.
get more stories like this via email