Reports: Is Bey $300 Million Richer from Uber IPO?

Last week, car-sharing service Uber went public and Beyonce is rumored to have scored big money as a result.

People magazine reports that Queen Bey received $ 6 million in restricted stock units (RSUs) from Uber co-founder Travis Kalanick to perform at an event.

With the IPO, speculations abound that she made $ 300 million from her shares.

MarketWatch calls Uber’s IPO, “the biggest in years” and that the company “raised more than $ 8 billion”; the IPO still fell short of an expected valuation of $ 100 billion.

Beyoncé Giselle Knowles-Carter has proven time and time again that there is nothing that she cannot do. At 37, the multifaceted entertainer has earned 23 Grammy wins, the 2019 Vanguard Award at the GLAAD Media Awards with her husband Sean “Jay-Z” Carter, and her second Entertainer of the Year Award at this year’s NAACP Image Awards. Yet, in spite of her mounds of success and accolades, the mother of three doesn’t seem to be slowing down anytime soon.

In 2017, Black Enterprise reported that Bey and Jay-Z had an estimated combined net worth of $ 1 billion. With the Uber IPO and her deal with Netflix worth $ 60 million, according to Variety, the power couple may be destined to exceed $ 1 billion net worth in the very near future.

—Additional reporting by Selena Hill

The post Reports: Is Bey $ 300 Million Richer from Uber IPO? appeared first on Black Enterprise.

Lifestyle | Black Enterprise


Emirates reports weakest full-year profit in a decade

Emirates reported its weakest full-year profit in a decade on Thursday as higher oil prices, a strong dollar and intensifying competition eroded profits at one of the world's largest airlines.
Top News & Analysis


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Ex-lawyer Cohen reports to prison, blasts Trump for ‘injustice and lies’

Michael Cohen, President Donald Trump’s former personal lawyer, took a parting shot at his former boss – denouncing “xenophobia, injustice and lies” – before reporting to a U.S. federal prison on Monday to begin a three-year sentence.
Reuters: People News


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FDA To End Program That Hid Millions Of Reports On Faulty Medical Devices

The Food and Drug Administration announced it is shutting down its controversial “alternative summary reporting” program and ending its decades-long practice of allowing medical device makers to conceal millions of reports of harm and malfunctions from the general public.

The agency said it will open past records to the public within weeks.

A Kaiser Health News investigation in March revealed that the obscure program was vast, collecting 1.1 million reports since 2016. The program, which began about 20 years ago, was so little-known that forensic medical device experts and even a recent FDA commissioner were unaware of its existence.

Former FDA official Dr. S. Lori Brown said ending the program now is a “victory for patients and consumers.”

“The No. 1 job of the FDA — it shouldn’t be ‘buyer beware’ — is to have the information available to people so they can have information about the devices they are going to put in their body,” Brown said.

FDA principal deputy commissioner Dr. Amy Abernethy and its device center director, Dr. Jeff Shuren, announced the decision to terminate the program in a statement on increasing transparency about the safety of breast implants.

The agency has for years allowed makers of breast implants to report hundreds of thousands of injuries and malfunctions out of the public eye, federal records show.

“We believe these steps for more transparent medical device reports will contribute to greater public awareness of breast implant adverse events,” Abernethy and Shuren said in a Thursday statement. “This is part of a larger effort to end the alternative summary reporting program for all medical devices.”

FDA spokeswoman Angela Stark said the agency will also end “alternative summary reporting” exemptions still in place for makers of implantable cardiac defibrillators, pacemakers and tooth implants. The FDA has said the program was originally designed to allow for more efficient internal review of well-known risks.

The agency said it began winding down the program in mid-2017, revoking many reporting exemptions, including those for saline breast implants and for balloon pumps used inside patients’ blood vessels.

At that point, the agency required device makers with ongoing exemptions to file quarterly reports in its public device-harm database known as MAUDE, short for the Manufacturer and User Facility Device Experience.

Still, FDA data provided to KHN shows that during the first nine months of 2018 the FDA continued to accept more than 190,000 injury reports and 45,000 malfunction reports under the hidden “alternative summary reporting” program.

Ronni Solomon, vice president and chief policy officer of the ECRI Institute, which studies device safety, said the staff uses the FDA’s open data on a daily basis to look for signals that might show heightened risks with a particular device.

“We think it’s really vital for the sake of transparency, for the sake of policy, for sake of science,” she said. “We’re really glad to see this, the sooner the better.”

The agency said its forthcoming data release will be for the alternative summary reports filed before mid-2017. The FDA for years reached agreements with makers of about 100 devices, allowing them to cease public reports of certain types of problems. The agency previously said the agreements and resulting records were available only by filing a Freedom of Information Act request, a process that can take months or even years.

Going forward, device makers will be required to file individual reports describing each case of patient harm related to a medical device.

The FDA has not said it will stop allowing device makers to file other types of device-harm exemption reports that are withheld from the public, such as when there is mass litigation over a device or when a company is submitting reports from an independent device-tracking registry. Nor has a plan been announced to open those records, which contain reports of harm related to pelvic mesh and surgical robots and reports of deaths related to several cardiac devices.

The FDA had granted Covidien, now a division of Medtronic, a long-standing “alternative summary reporting” exemption for its surgical staplers, a device used to cut tissues and vessels and quickly seal them during a variety of surgeries.

In 2016, when just 84 reports of stapler-related harm were disclosed in the FDA’s MAUDE database, almost 10,000 more malfunction reports were sent directly to the FDA’s in-house database, the agency acknowledged.

The device has been subject to numerous lawsuits over patient deaths and grave harm.

Doris Levering alleged in court that a stapler malfunction during liver surgery caused profuse bleeding that left her husband, Mark, 62, with serious brain damage and unable to walk. She applauded the agency’s decision to open the database. “It’s just wonderful to know that this information is going to be out in the open and not covered up,” she said. “Now doctors who need to find the information will be able to find it.”

The surgeon, hospital and device maker have all denied wrongdoing in an ongoing legal case.

The FDA has announced a May 30 advisory board meeting to review the agency’s oversight of surgical staplers.

The FDA will leave in place a newer summary-reporting program that allows makers of more than 5,500 types of devices to send the agency spreadsheets logging device malfunctions. Unlike the “alternative summary reporting” program, device makers will not be allowed to report serious injuries using that approach.

Over the years, the FDA has had an uneven record of disclosing its “exemption” reports to advisers who review the safety of individual devices.

In February, FDA officials presented an advisory panel on gynecological devices with data showing 476 adverse events in 2017 related to a certain type of pelvic mesh. That panel was not briefed on nearly 12,000 reports filed by eight mesh makers in 2017, under a special exemption for lawsuit-related reports, according to an agency spokeswoman and a review of public records.

FDA spokeswoman Deborah Kotz said in an email that those “litigation” summary reports did not contain enough detail for the FDA to determine whether they shed any light on the safety question at hand.

The FDA ultimately took decisive action, though, ordering makers of the type of mesh under review to stop marketing those products, which were used to support sagging pelvic organs.

In late March, after KHN’s investigation landed, the FDA convened another panel to review breast implant-related injuries and a rare form of lymphoma. For that meeting, the agency did provide a full tally of previously unreported injury and malfunction reports related to breast implants.

As of Thursday, though, the agency said it would leave the textured breast implants linked to a rare lymphoma on the market.

Matt Baretich, a Denver-area biomedical engineer who advises health systems on device safety, is eager to examine the hidden reports as they’re released by the FDA.

“I’m really interested to see what information has been hidden so I can go back,” Baretich said. “I may have been looking for that information and not found anything and thought there was not a problem.”

Kaiser Health News


North Korea Test Fires ‘New-Type Tactical Guided Weapon,’ State Media Reports

North Korean leader Kim Jong Un supervised and guided a test firing of a “new-type tactical guided weapon,” state media reported, in a move probably intended as a provocation after nuclear talks with U.S. President Donald Trump stalled.

The Korean Central News Agency’s report didn’t refer to the weapon as a ballistic missile or nuclear, so the test may not scuttle prospects for continuing negotiations with the Trump administration. Trump has long defended his decision to hold two high-profile summits with Kim by citing the North Korean’s decision to halt nuclear and ballistic missile tests. The White House didn’t respond to a request for comment.

Kim’s move to undertake a new weapons test is likely to be interpreted as a bid for attention after the U.S. hardened its stance in negotiations with North Korea. Trump last week rejected a call for confidence-building joint economic projects between Seoul and Pyongyang, and his national security adviser said Wednesday that the U.S. would need to see more evidence that Kim was ready to give up nuclear weapons before scheduling a third summit.

“The president is fully prepared to have a third summit if he can get a real deal,” national security adviser John Bolton said in an interview Wednesday with Bloomberg News. The White House would need to see “a real indication from North Korea that they’ve made the strategic decision to give up nuclear weapons.”

The White House’s more skeptical tone comes after Trump walked out of a Feb. 28 summit with Kim, saying the North Korean leader was seeking significant sanctions relief without indicating a willingness to fully dismantle his nuclear program. Kim has escalated his rhetoric since the summit, asking top ruling party members to deal a “severe blow to hostile foreign forces” earlier this month.


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North Korea test-fires new tactical guided weapons, state media reports

The test would mark the country’s first public weapons test since its failed summit with President Donald Trump.
ABC News: Top Stories

SPECIAL NEWS BULLETIN: -As millions of Americans strive to deal with the economic downturn,loss of jobs,foreclosures,high cost of gas,and the rising cost of prescription drug cost. Charles Myrick ,the President of American Consultants Rx, announced the re-release of the American Consultants Rx community service project which consist of millions of free discount prescription cards being donated to thousands of not for profits,hospitals,schools,churches,etc. in an effort to assist the uninsured,under insured,and seniors deal with the high cost of prescription drugs.-American Consultants Rx -Pharmacy Discount Network News


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Canadian province considers mandatory annual math tests for all public school teachers: reports

A Canadian province is considering a measure that would require teachers to pass an annual math test even if math is not the primary subject they teach as part of an initiative to boost student performance in the subject.
FOX News

SPECIAL NEWS BULLETIN: -As millions of Americans strive to deal with the economic downturn,loss of jobs,foreclosures,high cost of gas,and the rising cost of prescription drug cost. Charles Myrick ,the President of American Consultants Rx, announced the re-release of the American Consultants Rx community service project which consist of millions of free discount prescription cards being donated to thousands of not for profits,hospitals,schools,churches,etc. in an effort to assist the uninsured,under insured,and seniors deal with the high cost of prescription drugs.-American Consultants Rx -Pharmacy Discount Network News



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Aaron Paul Addresses ‘Breaking Bad’ Movie Reports: ‘It Has to Star Jessie’

News on the “Breaking Bad” movie seems to be coming in fits and starts. At the Sun Valley Film Festival on Friday, series star Aaron Paul didn’t confirm whether he was involved in the upcoming movie sequel, which will first air on Netflix and then AMC, as Variety reported in February, but did indicate that […]



Candace Owens Laughs Off Reports She Inspired New Zealand Mosque Shooter

Conservative grifter Candace Owens responded to reports that she allegedly inspired the gunman who opened fire on two mosques in Christchurch, New Zealand, on Friday, killing 49 people in slaughter that in part was streamed on Facebook Live.

In addition to those killed, 20 were seriously injured. Jacinda Ardern, New Zealand’s prime minister, called it “an extraordinary and unprecedented act of violence.”

The shooter, Brenton Tarrant, mentioned Owens in his white supremacist manifesto before carrying out the mass shooting.

In a series of tweets on Friday morning, Owens argued that she has never created content about the 2nd Amendment or Islam. In her first tweet, she wrote,“LOL! FACT: I’ve never created any content espousing my views on the 2nd Amendment or Islam. The Left pretending I inspired a mosque massacre in…New Zealand because I believe black America can do it without government hand outs is the reachiest reach of all reaches!! LOL!”

But several of her critics were quick to call BS on her claim and provided receipts in the form of her own tweets about Muslims and the NRA, which Candance considers a civil rights group.

“in addition to being an awful human being you are a liar,” wrote one Twitter user who posted the following to remind Owens of how she really feels:

And then there’s this…

In a second tweet, Candace wrote, “To be clear: We played the ‘Candace is Hitler’ game. We played the ‘Candace is anti-rape victims’ game. If the media attempts this ‘Candace inspired a mosque shooting in New Zealand’ bit—they better all lawyer the f*ck up. I will go full Covington Catholic lawsuit. Try me.”

Owens is reportedly mentioned in Tarrant’s manifesto once, where he writes, “The person who has influenced me above all is Candace Owens. Each time she spoke I was stunned by her insights and her own views helped me push further and further into the belief of violence over meekness. However I will have to disavow some of her believes, the extreme actions she calls for are too much, even for my tastes.”

However, as reported by, many believe Tarrant wrote that for the purpose of trolling American media. He goes on to allege that the video game “Spyro” taught him ethno-nationalism.

A number of experts on the alt-right have warned people not to take his words too seriously with regards to Owens.

NBC’s Ben Collins tweeted, “There are a couple of things in there that ring obvious bells. No joke, call somebody fluent in YouTube or alt-right garbage before writing up your pieces on this. Or just ignore it. Some of these thoughts are clearly authentic, others clear traps. It’s the nature of the chans.”

Tech columnist Kevin Roose also tweeted, “Media: be careful with the NZ shooter’s apparent manifesto. It’s thick with irony and meta-text and very easy to misinterpret if you’re not steeped in this stuff all the time (and even if you are).”

Roose added, “Seriously, this entire thing is a minefield. I am Very Online and I don’t feel 100% certain about what’s genuine and what’s just trolling/posting/media-baiting. Please be careful.”

Police said three people were in custody including 28-year-old Australian-born Brenton Tarrant, who has been charged with murder. He will appear in court on Saturday.

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Black America Web


Hidden FDA Reports Detail Harm Caused By Scores Of Medical Devices

Dr. Douglas Kwazneski was helping a Pittsburgh surgeon remove an appendix when something jarring happened. The surgical stapler meant to cut and seal the tissue around the appendix locked up.

Kwazneski later turned to the Food and Drug Administration’s public database that tracks medical device failures and “there was nothing,” he said. Yet when he surveyed leading surgeons on the matter, he discovered that more than two-thirds had experienced a stapler malfunction, or knew a peer who did. Such failures can have deadly consequences.

Kwazneski had no idea the FDA had quietly granted the makers of surgical staplers a special “exemption” allowing them to file reports of malfunctions in a database hidden from doctors and from public view.

“I don’t want to sound overdramatic here, but it seemed like a cover-up,” said Kwazneski, who practiced in Pasco County, Fla., from 2016 through earlier this year.

After Dr. Douglas Kwazneski witnessed a surgical stapler malfunction, he surveyed leading surgeons and discovered that more than two-thirds had experienced a stapler malfunction, or knew a peer who did.(Kendra Stanley-Mills for KHN)

The FDA has built and expanded a vast and hidden repository of reports on device-related injuries and malfunctions, a Kaiser Health News investigation shows. Since 2016, at least 1.1 million incidents have flowed into the internal “alternative summary reporting” repository, instead of being described individually in the widely scrutinized public database known as MAUDE, which medical experts trust to identify problems that could put patients in jeopardy.

Deaths must still be reported in MAUDE. But the hidden database has included serious injury and malfunction reports for about 100 medical devices, according to the FDA, many implanted in patients or used in countless surgeries. They have included surgical staplers, balloon pumps snaked into vessels to improve circulation and mechanical breathing machines.

An FDA official said that the program is for issues that are “well-known and well-documented with the FDA” and that it was reformed in 2017 as a new voluntary summary reporting program was put in place for up to 5,600 devices.

Yet the program, in all its iterations, has been so obscure that it is unknown to many of the doctors and engineers dedicated to improving device safety. Even a former FDA commissioner said he knew nothing of the program.

KHN pored over reams of public records for oblique references to reporting exemptions. After months of questions to the FDA, the agency confirmed the existence of reporting-exemption programs and thousands of never-before-acknowledged instances of malfunctions or harm.

Amid the blackout in information about device risks, patients have been injured, hundreds of times in some cases, lawsuits and FDA records show.

“The public has a right to know about this,” said Dr. S. Lori Brown, a former FDA official who accessed the data for her research. She said doctors relying just on the public reports — and unaware that many incidents may be omitted — can easily reach the wrong conclusion about the safety record of a particular device.

The FDA has also opened additional — and equally obscure — pathways for device makers to report thousands of injuries brought to light by lawsuits or even deaths that appear in private registries that medical societies use to track patients. Those exemptions apply to risky and controversial products, including pelvic mesh and devices implanted in the heart.

FDA spokeswoman Deborah Kotz confirmed that the “registry exemption” was created without any public notice or regulations. “Any device manufacturer can request an exemption from its reporting requirements,” she said in an email.

I don’t want to sound overdramatic here, but it seemed like a cover-up.

Dr. Douglas Kwazneski, surgeon

Agency records provided to KHN show that more than 480,000 injuries or malfunctions were reported through the alternative summary reporting program in 2017 alone.

Alison Hunt, another FDA spokeswoman, said the majority of device makers’ “exemptions” were revoked that year as a program took shape that requires a “placeholder” report to be filed publicly.

More than a million reports of malfunctions or harm spanning about 15 years remain in a database accessible only to the FDA. But with the agency’s new transparency push, the public may find a public report and submit a Freedom of Information Act request to get information about incidents. A response can take up to two years.

The long-standing exemption program “has allowed the FDA to more efficiently review adverse events … and take action when warranted without sacrificing the quality of our review or the information we receive,” Hunt said in an email.

Madris Tomes(Courtesy of Madris Tomes)

To those outside the agency, though, the exceptions to the reporting rules are troubling. They strike Madris Tomes, a former FDA manager, as the agency surrendering some of the strongest oversight and transparency powers it wields.

“The FDA is basically giving away its authority over device manufacturers,” said Tomes, who now runs Device Events, a website that makes FDA device data user-friendly. “If they’ve given that up, they’ve handed over their ability to oversee the safety and effectiveness of these devices.”

Doctors, like Kwazneski, who have turned to the public data to gauge the risks of surgical staplers have seen little. He wrote about the “unacknowledged” problem of stapler malfunctions in a 2013 article in the journal Surgical Endoscopy. In 2016, while reports of 84 stapler injuries or malfunctions were openly submitted, nearly 10,000 malfunction reports were included in the hidden database, according to the FDA.

Device maker Medtronic, which owns stapler maker Covidien, has been described as the market leader in surgical staplers. A company spokesman said that the firm has used reporting exemptions to file stapler-related reports through July 2017. Ethicon, the other major stapler maker, said it has not.

The public database shows that Medtronic has reported more than 250 deaths related to staplers or staples since 2001.

Mark Levering, 62, nearly lost his life after a stapler malfunction early last year, according to a lawsuit filed by his family. His surgeon has testified that a surgical stapler misfired during his liver surgery at ProMedica Toledo Hospital in Ohio.

Staff performed CPR for 22 minutes while surgeons rushed to suture the severed vein. He emerged from a coma unable to walk or consistently recognize his wife and son. The surgeon, hospital and device maker Covidien have denied allegations of wrongdoing in an ongoing legal case.

Told of the reporting “exemption” for surgical staplers, his wife, Doris Levering, was incredulous.

“Why would this information not be made available to doctors? The true information — I mean the actual numbers …” she said. “People’s lives are at stake. Mark’s life will never be the same.”

Doris Levering says her husband, Mark, underwent a procedure to remove an abscess from his liver and ended up in a coma for weeks.(Heidi de Marco/KHN)

Phil Levering (left) says his father, Mark Levering, used to have a calm demeanor but now exhibits signs of aggression due to a brain injury he suffered after a surgery gone wrong. (Heidi de Marco/KHN)

Doris Levering holds a photograph of her and her husband predating his surgery. Levering says it’s clear that the man who used to tend to stray cats and enjoy dinner out with his family is gone. “People’s lives are at stake. Mark’s life will never be the same,” she says.(Heidi de Marco/KHN)

The Stapler Problem

The sheer number of malfunctions made surgical staplers an easy pick for the new alternative summary reporting program at its inception nearly 20 years ago, according to Larry Kessler, a former FDA official and now a University of Washington health services professor.

Surgical staplers have a unique ability to help — or harm — patients. The device is designed to cut and seal tissues or vessels quickly, often during minimally invasive surgeries. When it fails to seal a major blood vessel, medical staff can quickly shift into “code blue” mode to rescue a patient from bleeding to death.

The severity of some of the injuries caught former FDA official Brown’s attention in the early years of its reporting exemption. Her 2004 article on stapler mishaps, published in the Journal of the American College of Surgeons, accounts for one of the few places in public records where an FDA authority mentions the “alternative summary” program. She found that in the first 28 months of filing to the hidden database, stapler makers filed more than 5,100 reports of malfunctions or injuries.

Mark Levering, now 62, was in a medically induced coma and had several surgeries after a surgical stapler malfunctioned during a Feb. 17, 2018, liver surgery. His wife, Doris Levering, said in a deposition that he did not open his eyes after the initial surgery until March 13.(Courtesy of Doris Levering)

She also noted that the publicly reported 112 stapler-related deaths in patients aged 22 to 91 from 1994 to 2001 were a “reason for concern.”

In the public data filed since, it would appear that the staplers rarely misfire. In 2011, only 18 injury or malfunction reports were filed publicly. Last year, the number was 79.

Lawsuits detail how quickly a stapler failure can turn a smooth surgery into a catastrophe.

In Michigan, Eugene Snook’s surgeon was in the process of removing part of his lung when he cut but couldn’t seal a major vessel due to a “stapler malfunction,” the surgeon said in sworn court testimony. Snook, then 59, had no detectable blood pressure for four minutes during the 2012 surgery.

The damage to Snook’s artery was so great, his surgeon decided to remove his lung completely, medical records filed in court say. Snook sued stapler maker Covidien, which in court records said there was no proof the stapler was unsafe when it left Covidien’s control and also that the surgeon used it improperly. The case reached a confidential settlement in 2017.

Another surgeon attempting to remove a benign liver growth from April Strange, 33, in 2013, testified that a stapler malfunction caused the woman to bleed to death. Strange, of central Illinois, left behind a husband and two daughters, then 6 and 8.

The stapler was thrown out after surgery, court records say. Covidien argued in court records that Ryan Strange couldn’t prove that the stapler had a specific defect.

Covidien reached an agreement to settle the family’s claims for $ 250,000, part of a larger settlement in the case.

Doctors initially thought Mark Levering had liver cancer. So when the diagnosis came back as an abscess that needed to be surgically removed last February, it came as a relief to his wife, Doris.

That relief turned to dread the day of surgery. The procedure was supposed to last two hours, she said. But the surgery hit a snag when the stapler “misfired,” according to the surgeon, causing so much bleeding that the minimally invasive procedure was converted to an open procedure so the doctor could suture the vein.

Levering underwent CPR for 22 minutes. A code blue was called, a nurse testified. Levering lost 3 quarts of blood — about half the blood in his body. He was put on life support and would remain in a coma for weeks.

After Levering reopened his eyes, it was clear that the man who used to tend to stray cats and enjoy dinner out with his family was gone. Levering could no longer walk, comb his hair or recognize the letters of the alphabet.

Doris and Mark Levering have sued the doctor, hospital and surgical stapler maker, alleging that the device caused Mark’s bleeding and brain injury. The surgeon has acknowledged in sworn testimony that the stapler malfunctioned, but denied other wrongdoing. The hospital said in a legal filing that its actions were “prudent, proper” and “lawful.”

Covidien denies any defect with the stapler or that it caused Levering’s injuries. A spokesman for parent company Medtronic declined to comment further on any lawsuit but said that “we always make patient safety our top priority” and that the company complies with FDA requirements.

The company’s reports of stapler problems in the public database remain relatively low. But in 2018, with the reporting exemption gone, a spike of reports emerged for Covidien’s staples — not to be confused with staplers. While Medtronic reported 1,000 staple malfunctions or injuries in 2015, the number soared to 11,000 for 2018.

Rolling Out The Program

The alternative summary reporting program started two decades ago with a simple goal: to cut down on redundant paperwork, according to officials who were at the FDA at the time.

Kessler, the former FDA official, said the program took shape after scandals over under-reporting of device problems spurred changes allowing criminal penalties against device companies.

Soon, thousands of injury and malfunction reports poured into the agency each month, with about 15 staff members dedicated to reviewing them, Kessler said. Many reports were so similar that reviewing them individually was “mind-numbing.” Kessler went to the FDA’s legal department and to device manufacturers to propose a solution.

Device makers would be able to seek a special “exemption” to avoid reporting certain complications to the public database. The manufacturers would instead send the FDA a spreadsheet of injury or malfunctions each quarter, half-year or year.

That way, Kessler said, reviewers could quickly look for new problems or spikes in known issues. When the program launched in 2000, the list of exempted devices was made public and only a few devices were involved, Kessler said.

“I don’t know why it’s not [made public] now,” he said. “I’m surprised about that.”

Starting in September, KHN filed Freedom of Information Act requests for “exemption” agreements and reports for several medical devices. Health and Human Services officials denied an appeal to provide some of the records quickly, concluding there was no “compelling need” for haste. For one request, the records were estimated to arrive in 22 months.

The FDA did provide some top-level data. It shows that from 2014 through 2017, the overall number of alternative summary reports filed by device makers rose from 431,000 to 481,000.

The FDA declined to provide a complete list of “about 100” devices that have been granted reporting exemptions over the years, but confirmed that exemptions have been used for mechanical breathing machines and balloon pumps, known as intra-aortic balloon pumps, inserted in the vessels of people with circulation problems.

An FDA spokeswoman said “alternative summary” exemptions remain in place for pacemaker electrodes and implantable defibrillators.

Matthew Baretich, a biomedical engineer in the Denver area, said he helps several area health systems analyze device-related patient injuries and make equipment-purchasing decisions.

He said he regularly scans the FDA’s public device-injury reports. Asked about “alternative summary” reports, he said, “I’ve got to tell you, that’s a new term to me.”

Bruce Barkalow, president of a Michigan-based biomedical engineering firm, said he’s the guy government officials, attorneys or device makers call if someone gets a pacemaker and dies in the shower three days later.

In an interview, he said he was not aware of the reports, either. He said they may appear to the FDA to be a “nothing burger,” but the data would be meaningful to his forensic investigations.

The ECRI Institute, a nonprofit leader in medical device safety, declined to provide an engineer for an interview. Educating hospital leaders and health providers, the institute issues an annual “Top 10” in medical technology hazards. Its tagline: “Separating fact from fiction in healthcare.”

Among the institute’s “top medical device subject matter experts,” spokeswoman Laurie Menyo said in an email, “none of them had any familiarity with FDA’s Alternative Summary Reporting Program.”

Even Dr. Robert Califf, former FDA deputy commissioner and commissioner from 2015 to 2017, said in an interview that he was unaware of the program. “Never heard anything about it,” he said. “It’s interesting.”

Companies that get the exemptions tend to be very “tight-lipped” about them, said Christine Posin, a former device firm manager and consultant to device companies.

The relative secrecy around the program can give them an advantage, she said. For instance, sales representatives can print out only the public reports of device problems, ignoring what’s buried elsewhere.

That creates a business opportunity to persuade a doctor to try a different device. “‘We have a good product that does the same thing,’” Posin said a sales representative might tell a physician.

Exemptions Multiply

The FDA has spent millions, convened experts and pledged to improve its work in device safety in recent years. All the while, it has quietly opened new avenues for the makers of controversial and risky devices to file injury and even death reports with little public review.

Pelvic mesh is one example. The fabric-like device has long been used to hold up pelvic organs in women experiencing organ prolapse. In 2011, the FDA issued a “safety communication” saying “serious complications” like pain or infection were “not rare.”

The agency soon reclassified the device, ordered safety studies and saw most mesh makers remove the device from the market.

Behind closed doors, though, the agency has since granted pelvic mesh makers a special exemption from reporting injuries to the public, according to the FDA and mesh makers who were asked about the practices.

Under what the FDA calls the “litigation complaint summary reporting” exemption, device makers can file a single placeholder “injury” report. Attached to the summary report, device makers have sent the FDA a spreadsheet with as many as 1,175 reports of patient injuries, based on allegations in lawsuits. 

To someone tallying the overall number of injuries related to pelvic mesh, the report would appear as a single injury. It would take a sharp eye to find the summary report and a special request — taking up to two years to be filled — to get the details on the 1,175 cases submitted directly to the FDA.

According to the FDA, in 2017 alone, eight mesh makers used their exemptions to send nearly 12,000 injury reports to the FDA.

The FDA is basically giving away its authority over device manufacturers. If they’ve given that up, they’ve handed over their ability to oversee the safety and effectiveness of these devices.

Madris Tomes, former FDA manager

Dr. M. Tom Margolis, a urogynecologist in the San Francisco Bay Area and an expert medical witness for those who are suing mesh makers, said a program that might hinder doctors relying on open FDA data to assess the risks of mesh is “horrible” and “unethical.”

“We need to know the good and the bad,” said Margolis, who treats patients in his urogynecology practice. “If you’re trying to hide complications from me, well that’s … wrong, my God, it’s heinous.”

The FDA issued the same kind of exemption to the makers of da Vinci surgical robots months after Johns Hopkins University School of Medicine researchers pointed out that the company was filing a notably small number of injury reports in the public database. Johns Hopkins professor Dr. Marty Makary noted in 2013 that the handful of reports sent to the FDA at the time were signs of a “haphazard” system that is “not independent and not transparent.”

Within months, the FDA allowed the makers of the robots to file a single report, noting that a spreadsheet sent straight to the FDA summarizes about 1,400 injuries alleged in lawsuits, with some injuries dating to 2004. Since then, the device maker has reported smaller batches of 99 and 130 injuries at a time.

Homa Alemzadeh(Courtesy of Homa Alemzadeh)

“This is very frustrating,” said Homa Alemzadeh, an assistant professor of computer engineering at the University of Virginia who is working with MAUDE data to create software to identify errors in real time or before they happen in surgeries performed by robots. She said she was not aware of the reporting exemption.

Under another reporting exemption, the FDA is allowing device makers to report hundreds of death cases in spreadsheets sent directly to the agency.

Under the “registry exemption,” device makers can summarize what they learn from registries that tend to be held by specialty medical societies, and track the use of a certain kind of device, according to FDA spokeswoman Kotz. 

Kotz said the data in registries often falls short of the level of detail that the FDA seeks for the more thorough death reports that device makers are required to file.

Device makers filing such reports include Edwards Lifesciences, which makes the Sapien 3 valve that’s snaked through a vessel and implanted in the heart. Some hail the device as a breakthrough for saving patients from the trauma of open-heart surgery to replace a valve. Others raise concerns over limited data showing how long the valve will last in the body.

The summary reports offer potential patients few answers. Such reports document as many as 297 deaths or 1,800 injuries in a single filing, with virtually no detail readily available to the public. In all, Edwards has filed more than 1,800 Sapien 3 valve patient deaths as summaries since 2016.

Edwards spokeswoman Sarah Huoh said in an email that the FDA mandated the tracking of every patient who has the valve in the registry to provide “comprehensive evidence for device safety.”

“The approval of alternative reporting protects against duplicate reports coming from multiple sources,” Huoh said.

Another device, the MitraClip, is used to attach two flaps in the heart that are allowing blood to flow backward. The device has been controversial, with some scientists saying it is crucial for a certain subset of patients, and others pointing to the harm it can cause to the heart.

The FDA has allowed Abbott Vascular, which makes the MitraClip, to report as many as 347 deaths or 1,000 injuries in a single filing, also shipping the details straight to the agency, FDA records show.

An Abbott spokesman said in an email that the company has done clinical trials with thousands of patients to establish the MitraClip’s safety. He said the exemption was granted because data in the registry was stripped of patient identifiers, making it hard to know whether the company would be filing redundant reports to the FDA.

We need to know the good and the bad. If you’re trying to hide complications from me, well that’s … wrong, my God, it’s heinous.

Dr. M. Tom Margolis, urogynecologist and expert medical witness

Last year, the FDA finalized regulations for yet another summary reporting program. Under the newest system, device makers do not have to seek an exemption or notify the FDA that they’ll be filing a public summary report in MAUDE.

The FDA has deemed the makers of more than 5,600 types of devices eligible to file “voluntary malfunction summary reports.” Among them are some of the riskiest devices the agency oversees, including cardiac stents, leadless pacemakers and mechanical heart valves.

The growing cadre of exceptions to the injury- and death-reporting rules strikes Dr. Michael Carome, director of the Public Citizen Health Research Group, as a retreat by the FDA from making crucial information available for researchers and patients.

“It’s just another example of a flawed oversight system,” he said, “bent toward making it easier for industry rather than making protection of public health the primary goal.”

California Healthline reporter and producer Heidi de Marco contributed to this report.

Kaiser Health News


Erykah Badu Wants You To Know Reports About Her Stalker Are ‘Overblown’

Erykah Badu has taken to social media to set the record straight about recent reports that a stalker broke into her home.

The eccentric singer shared a video discussing the incident, which she describes as “overblown.”

WFAA reported that a young male had been detained after allegedly trespassing on Badu’s property. A source says the singer referred to him as a “stalker,” adding that he allegedly flew from Detroit to Dallas to meet her and possibly collaborate on a project.

Peep what Erykah had to say about him via the clip below:


News of the stalker went viral after Rebecca Lopez at WFAA-TV tweeted that a stalker had been found inside Badu’s home.

“Dallas Police detained a man who was found trespassing in singer Erykah Badu’s home,” Lopez tweeted Monday evening. “Sources say the singer called him a stalker. He was issued a criminal trespass warning.”

Badu responded to the report with a video message, saying: “There was no break-in, stop it. Story overblown,” she explained. “The only thing that happened was there was a kid on Twitter[who] followed me. Had the hots for me. Came over, wanted to look at me. Wanted to do some music with me. Made a bad decision. Decided this might not be the best thing, then left.”

The Grammy-winning artist noted that it was her neighbors who called the cops after the suspicious male wandered around her neighborhood asking where she lived.

“The neighbors called the cops cause some strange kid was walking around asking where Erykah Badu lived,” she says. “Of course that’s a reason to raise a red flag, and everyone got upset. The city is in an uproar because a kid made a bad decision.”

The soulstress is not sure if the officers took the fanatic to jail or “to the bus stop.”



Entertainment – Black America Web


FDA reports additional cases of cancer linked to breast implants

A rare and deadly cancer linked to breast implants has been diagnosed in additional women in the United States, federal health officials said. – RSS Channel – Health


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Google’s parent Alphabet reports strong earnings

Google parent company Alphabet delivered a strong earnings report Monday, beating expectations on profits and revenue — but the company’s stock sank on skyrocketing spending on small-project development. The Mountain View, Calif., search giant reported earnings per share of $ 12.77, exceeding Wall Street’s forecast $ 10.82. Alphabet took in $ 39.3 billion in revenue, against analyst forecasts…
Technology News & Reviews | New York Post


Patrick Whitesell Emerges After Reports That Wife Cheats With Jeff Bezos: Pics!

Putting on a brave face. Patrick Whitesell stepped out for the first time since the news of his wife Lauren Sánchez’s affair with Jeff Bezos broke.

The WME co-CEO appeared carefree while out for a drive in Beverly Hills on Thursday, January 10. Whitesell sported a huge smile and sunglasses behind the wheel of his black Mercedes-Benz.

The National Enquirer broke the news on Wednesday, January 9, that Bezos was cheating on his now-estranged wife, MacKenzie Bezos, with Sánchez. The magazine reported that the Amazon CEO and the former Extra host have been seeing each other for eight months and their spouses found out about the dalliance in the fall.

“Patrick was totally blindsided. He had no idea how serious the affair was or how long it was going on for,” a source told Us Weekly exclusively after the Enquirer’s findings came to light.

The insider noted that Whitesell and Sánchez “were having problems in their marriage for the last year.” However, they “were trying to work things out.”

Meanwhile, another source told Us that the talent agent “introduced Lauren to Jeff and suggested they work together on a documentary.”

Hours before news of the affair came out, Jeff announced his plans to divorce MacKenzie, whom he wed in 1993. “As our family and close friends know, after a long period of loving exploration and trial separation, we have decided to divorce and continue our shared lives as friends,” the businessman wrote on Twitter on Wednesday. “We feel incredibly lucky to have found each other and deeply grateful for every one of the years we have been married to each other. If we had known we would separate after 25 years, we would do it all again.”

The joint statement continued: “We’ve had such a great life together as a married couple, and we also see wonderful futures ahead, as parents, friends, partners in ventures and projects, and as individuals pursuing ventures and adventures. Though the labels might be different, we remain a family, and we remain cherished friends.”

Scroll to see more photos of Whitesell’s outing.

Us Weekly


Facebook reports steep rise in data requests from Indian government

NEW DELHI — Facebook says there was a steep rise in data requests from India’s government in the first half of this year as compared to the previous two years. The company said in a report released Friday that it received 16,580 data requests from the government in the January-June period as compared to 22,024…
Technology News & Reviews | New York Post


3 Ways Rental Inspection Reports Can Protect Landlords

As a landlord, it’s essential that you perform rental
inspections and record everything in a Residential Inspection Report when a
tenant moves in or out. Rental inspections ensure that you and your tenant are
aware of every aspect of the rental property’s condition at the beginning and
end of a lease.

Since an inspection report documents any and all issues
related to the property, expectations are set for your tenant on what condition
you expect them to keep the property in, and it also gives you a chance to
address any last-minute problems or repairs with the property before your
tenant settles in.

In this post, we explore three ways that having a detailed Rental Inspection Report can help protect you as a landlord.

1. Records the Condition of the Property Before the Tenant Moves in

Before the tenant moves in, you should perform a
walk-through of the property together. This will give you and your tenant a
chance to make sure the property is ready for them to move into.

By recording the condition of the property before the tenant
moves in, you can help prevent disputes about damage that existed before your
tenant lived there, and what damages were caused by your tenant.

Some examples of existing damage that you could record in
the inspection report are:

  • Chipped paint, marks, holes, or scratches on
    walls or floors
  • Torn or stained carpet
  • Damage to fixtures, such as a cracked sink,
    toilet, or bathtub
  • Gouges or holes in doors or baseboards

In addition to writing a detailed description of the existing property damage in your Rental Inspection Report, you may also want to take pictures for your own reference.

2. Records the Condition of the Property Before the Tenant Moves out

When your tenant is ready to move out, you should refer to the
same Rental Inspection Report you used when your tenant moved in, as most
include a section for a move-out inspection.

The purpose of the move-out inspection is to compare any
damages that you find to what you recorded in your move-in inspection report to
see when the damages occurred. For example, if there are damages to the
property that weren’t recorded in the move-in inspection, they were likely
caused by the tenant during their rental period.

It’s important to note that regular wear and tear, such as
worn carpet, small holes in the walls from hanging pictures, or other minor
damage caused by regular use of the property is generally not considered something
that you can charge your tenant for.

Helps Prevent Disputes about Security Deposits

Keeping clear records of the condition of your property can
help prevent disputes over whether the security deposit should be returned to
the tenant or not.

For instance, if your tenant denies that they caused damage
to the property, you can show them the Rental Inspection Report that they
signed when they moved in to illustrate that you are simply comparing the
damage that was present when they moved in to the damage that exists now.

Keep in mind that each state has its own laws regarding when
and if a landlord can keep a tenant’s security deposit, so be sure to stay
up-to-date with your jurisdiction’s requirements.

Rental Inspection Report

It’s important to have a Rental Inspection report that
records the condition of your property before your tenant moves in, and when
they move out. Your Rental Inspection Report provides peace of mind for you and
your tenant, so you are both on the same page when it comes to the condition of
the rental.

The post 3 Ways Rental Inspection Reports Can Protect Landlords appeared first on LawDepot Blog.

LawDepot Blog


Oculus Disputes Reports That Rift 2 Has Been Canceled

Along with the departure of Brendan Iribe from Facebook, there had been reports that the Oculus Rift 2, which Iribe was leading development on, would also be cancelled. Facebook has since spoken up and now the future of the Rift 2 isn’t quite as clear.

As reported by TechCrunch, Iribe, who had been the co-founder and former CEO of Oculus, and the Facebook executive team had “fundamentally different views on the future of Oculus that grew deeper over time.” It was also mentioned the Brendan wasn’t “interested in a race to the bottom in terms of performance.”

Continue reading…



GameStop, Inc.

First child in Florida has died of flu this season, state reports

A Florida child died due to flu-related illness during the week ended October 6, according to the state’s Department of Health. The child, the first to die in the state, had not received a flu vaccination. – RSS Channel – Health


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Newlyweds Among 20 Killed in Most Deadly U.S. Transportation Accident in 9 Years: Reports

Authorities are shedding some light on the deadly limousine crash that occurred in Upstate New York on Saturday, resulting in 20 deaths.

The National Transportation Safety Board, which is conducting a separate investigation into the crash in Schoharie, said this has been the “most deadly transportation accident” in the U.S. since February 2009, when 50 people lost their lives during the crash of Colgan Air Flight 3407 in Buffalo.

On Sunday afternoon, the New York State Police held a press conference where they confirmed that “18 of the victims were in the limousine, including the driver,” and that “two pedestrians standing nearby were also struck and killed.” All of the victims were adults.

Lester Andrews, who lives nearby in Rochester, told the New York Times that two of his stepsons, Axel Steenburg, 29, and Rich Steenburg, 34, as well as Rich’s wife Amy, were riding in the limousine at the time of the crash. While he said that Amy and Rich, who were married in June, had rented the limousine, he was not certain why they had done so.

“They rented the limo with some families and I don’t know exactly what they were doing,” Andrews told the newspaper. “There’s just a lot of confusion, so many people died.”

Rich is survived by a 10-year-old daughter, a 14-year-old stepson and his wife, who wasn’t in the vehicle on Saturday because she wasn’t feeling well, a relative told the Times.

Local reports claimed a wedding party was inside the limousine at the time of the crash, the New York Times previously reported, but the aunt of one of the limo victims told the Associated Press that the vehicle was en route to a birthday celebration.

“Our lives have been changed forever,” said Valerie Abeling, whose daughter was invited but unable to attend the party.

Abeling also told the AP that two of the victims were newlyweds Erin Vertucci, 34, and Shane McGowan, 30.

RELATED: 20 Killed in ‘Horrific’ Limousine Crash Involving Wedding Party in Upstate New York: Reports

New York Gov. Andrew Cuomo released a statement on Sunday, sharing that his “heart breaks for the 20 people who lost their lives.

“State police are working with federal and local authorities to investigate the crash, and I have directed State agencies to provide every resource necessary to aid in this investigation and determine what led to this tragedy,” he wrote. “I join all New Yorkers in mourning these deaths and share in the unspeakable sorrow experienced by their families and loved ones during this extremely difficult time.”

Additionally, the New York State Police have created a phone line dedicated to assisting family members of the crash victims. Family members are encouraged to call 1-877-672-4911.

The crash, which involved two vehicles, occurred at approximately 1:55 p.m. on Saturday afternoon, according to police. Their preliminary investigation revealed that the accident occurred at the intersection of State Route 30 and State Route 30A.

All of the passengers inside the limousine had been killed in the crash, authorities stated later in the conference.

Though police said they were in the early stages of an investigation, authorities determined that the incident occurred after the limousine, a 2011 Ford Excursion, “failed to stop at the intersection of State Route 30A.” The limousine then “traveled across the intersection into a parking lot and struck a 2015 Toyota Highlander that was unoccupied and parked.”

The Highlander then struck and killed two pedestrians.

The New York State Police went on to state that the scene of the crash has been cleared “and the victims have been transported to Albany Medical Center where autopsies are now being conducted.”

While the police will not be releasing any information about the victims until all of the families have been notified, they did confirm that the license plate on the limousine was from the state of New York. All other information, such as where the limousine was coming from and where it was headed to, have yet to be announced.

Jessica Kirby, the manager of the Apple Barrel Country Store, told the Times that the crash occurred in the parking lot of the store, where multiple pedestrians were struck.

“That limo was coming down that hill probably over 60 miles per hour,” she told the newspaper.

RELATED VIDEO: 20 Killed In Upstate New York Limousine Crash

Addressing the crash in an emotional Facebook post on Saturday, the Apple Barrel Country Store and Cafe wrote, “As you may be aware, there was a horrific accident in front of our business today.”

“First, we want to thank all of the emergency services that responded. We are so thankful for all of you,” the store wrote, adding that they “will be open for business” on Sunday. Encouraging patrons to come by on Sunday, the store added, “we hope you will come and share your smiles, love, friendship and hugs with us.”

In response to the message, a woman commented that her family was “affected by three of the deaths” in the crash.

Fashion Deals Update: