Judge Invalidates Patent for Johnson & Johnson Rheumatoid Arthritis Drug

TRENTON, N.J. — A cheaper version of Johnson & Johnson’s top-selling drug, the expensive rheumatoid arthritis treatment Remicade, could be available in the United States two years early after a federal judge ruled that a key patent on the drug is invalid.

Johnson & Johnson said Wednesday it planned to appeal a summary judgment issued by the District of Massachusetts federal court in a high-stakes patent fight with rival drugmaker Pfizer Inc. The appeal process could take a year or more, Johnson & Johnson said.

Pfizer likely will make the somewhat-risky move of launching its competing version, called Inflectra, within a few months.

That could bring patients and insurers savings analysts have estimated at 15 to 30 percent. Remicade is approved for treating chronic conditions in which the immune system goes haywire and attacks part of the body, including rheumatoid arthritis, ulcerative colitis, psoriasis and Crohn’s disease.

The drug costs roughly $1,600 a month or more without insurance, depending on the condition being treated, the patient’s weight and whether they have just started on Remicade or are on continuing therapy. Pfizer hasn’t announced a price for Inflectra.

Remicade is an injected biologic drug, “manufactured” in living cells rather than by mixing chemicals. Its just-invalidated patent would have blocked so-called “biosimilars” — nearly identical copies of biologic drugs — until September 2018.

Remicade has been Johnson & Johnson’s biggest revenue generator for several years, pulling in $6.6 billion in 2015, two-thirds of that from United States sales. Pfizer is seeking a big slice of that pie after having won Food and Drug Administration approval in early April for Inflectra — only the second biosimilar drug approved in the United States.

The approval allows sales of Inflectra beginning Oct. 3. It would be made by Pfizer’s Hospira unit, bought last year to bring Pfizer to the top of the nascent field of biosimilars.

Hospira specializes in making biologic medicines and other sterile injectable medicines. While only one biologic has reached the United States market, more are on the horizon and several have been on sale for a few years in Europe. Government health programs there negotiate drug prices and press for cheaper versions.

“We are committed to bringing biosimilars to patients in the U.S. as quickly as possible, and are continuing with the preparation of our launch plans for Inflectra for 2016,” Pfizer said in a statement Wednesday. A spokeswoman could not provide a more-specific time frame.

But if Johnson & Johnson wins its planned appeal of the federal court ruling and Remicade’s patent is upheld, Pfizer could be on the hook for paying its rival drug maker big financial damages.IF YOU LIKE THIS Post Please Like My Page :Rheumatoid Arthritis

Scientists trial ground-breaking new nasal spray that could be used to treat autism within five years

A nasal spray could become a ground-breaking new treatment for autism that has already shown increased levels of responsiveness and awareness from trial patients.

A synthetic oxytocin nasal spray (pictured) could become what researchers hope will be a ground breaking new treatment for autismA synthetic oxytocin nasal spray (pictured) could become what researchers hope will be a ground breaking new treatment for autism

A synthetically made version of oxytocin, also known as the ‘cuddle hormone’, will allow individuals with autism to become more social and has proved to have incredible results.

Professor Adam Guastella from the University of Sydney’s Brain and Mind Centre, who is leading the project, has said trials had proved to be extremely promising so far.

‘The sorts of results that we have in our trials suggest children show more responsiveness and awareness of the important social information in a relationship,’ Prof Guastella told 9News.

‘They seem to be able to remember that information more effectively.’

Autism spectrum disorder and autism are both general terms for a complex group of disorders that affect brain development.

It is characterised with varying degrees of difficulties in social interaction both verbal and non-verbal.

Christine Blue’s son Hayden who was diagnosed with autism when he was only two years old said that he has been a participant in the trial.

‘Hayden was happy to be included in a group, he wouldn’t go off on his own and his eye contact was better,’ she told 9News.

‘His general engagement with another person is better.’

Professor Adam Guastella (pictured) from the University of Sydney¿s Brain and Mind Centre who is heading the project has said that trials have proved to be extremely promising so far

Professor Adam Guastella (pictured) from the University of Sydney’s Brain and Mind Centre who is heading the project has said that trials have proved to be extremely promising so far

New drug trialled to treat social awareness for people with autism
Christine Blue¿s son Hayden (pictured with mother Christine) who was diagnosed with autism when he was only two-years-old said that he has been a participant in the trial

Christine Blue’s son Hayden (pictured with mother Christine) who was diagnosed with autism when he was only two-years-old said that he has been a participant in the trial

It is believed the new treatment could also be proved useful to treat anxiety and other neurological conditions and participants who would like to take part in the trial are being advised to contact the centre.

Professor Guastella said if all went to plan the drug could be used commercially for people with autism within the next five years.

Autism lasts is a lifelong condition and affects about one in 100 Australians or 230,000 people.

Interview: Food Allergy Counseling with Dawn, Mother to Twins with Food Allergies

Every day, I receive emails asking me how I work as a psychotherapist and
specialist in food allergy management. To answer this, I interviewed a client, a parent with twin girls who have food allergies. I asked them three simple questions.

What brought you to counseling with Sloane Miller, LMSW?

I am a mother of teens with life-threatening food allergies.  Together, our family has been successfully managing these allergies for 12 years, but life is different now, as these teens go to high school 45 minutes from our home, attend various social events and week-long camps.  It was easier for me to feel certain that my kids were “safe” when they were younger, closer to home, and when I had more control over their environment.  With their newfound freedom, I became more worried and anxious for their safety, and I did not want to pass this on to them.  I really wanted to be able to help them grow in independence, engage in new experiences, and not miss out on opportunities.  I looked for someone who had already achieved this – living life fully with food allergies – and I found Allergic Girl.

I needed to first address my own anxiety.  Second, I needed practical advice on managing situations and finding solutions to keep my teens safe and involved in any activity they choose.

What changed for you/how are things different after working with Sloane Miller, LMSW?

Sloane talked with me and with my teens as well.  After getting to know us, she led me to realize that I was seeing their lives through my own non-allergic perspective, whereas my teens simply accept “this is how life is.”  I learned that they are capable of taking the lead on how to manage situations.  They often have innovative solutions and are very comfortable with taking their own food when needed.  They even bought tickets to prom (meal included) without knowing whether they would be able to eat the meal provided.  They decided they would be fine taking their own meals if they had to.  I was so proud of them for being willing to be different from everyone else, but not letting that stop them.  (In the end, the chef was amazing and plated safe meals for them!)  Before talking with Sloane, I was busy being sad for my teens and the challenges they have to face.  While I still struggle sometimes with that grief, I am mostly overwhelmed at their resilience and proud of them for living life to the fullest.

Pokémon Go’s paying user base has reached a plateau

Pokémon Go may be the most downloaded app in its first week post-launch ever, and is said to be raking in some $1.6 million daily on iOS alone, but a new report out on Friday suggests that the popular game’s paying user base may have already shrunk. According to data from Slice Intelligence, the app’s paying users peaked mid-July when the game had 56 percent more paying players than all other mobile games combined — a remarkable figure. But since July 15th, the game’s group of paying players has shrunk by 32 percent, the report claims.

Players spend real money to buy PokéCoins in Pokémon Go, which allows them to buy items that can be used in the game, like Poké Balls, Lure Modules, Lucky Eggs, Incense and more.

Because of Pokémon Go’s massive footprint and traction, as of July 15th, the purchase of these PokéCoins accounted for 52 percent of the entire mobile gaming market’s revenue, making Pokémon Go potentially the most lucrative game ever.

indexed_growth-1

That being said, it’s common for mobile games to see its buying population decline at some point after launch.

And even though Pokémon Go may have already hit that point, if Slice’s data is accurate, it still held out a lot longer than any other mobile game. For example, Clash Royale’s paying users topped out the fourth day after launch, while Pokémon Go grew an entire week before it reached its plateau.

growth_poke_clash

Slice’s data, for background, is extracted from e-receipts, including those that reference in-app purchases on iTunes and Google Play. For this study, the firm says it looked at receipt data from 237,484 players.

In addition, Slice found that the game has been strong with repeat buyers — again, more so than its peers. Half of paying users who bought an item in the game during its first week returned the next week, and spent, on average, $20 each. Clash Royale, on the other hand, only saw 39 percent of its players make a repeat purchase.

orders_second_week

Also worth noting is the fact that Pokémon Go has managed to tap into a user base that historically hasn’t spent money in mobile games — at least, not in 2016. The report found that over 40 percent of those who spent in Pokémon Go hadn’t made even one other purchase in a mobile game all year.

previous_purchases

Slice’s report didn’t speak much as to why Pokémon Go may have reached its plateau, in terms of paying players, besides noting that it’s common for games to do so after launch.

However, unlike other games to have hit the market, Pokémon Go saw a significant number of more casual players join, thanks to its viral spread. Some of these players may have checked out the game and played actively for several days, including spending money, before dropping off to less obsessive levels of engagement. That doesn’t mean they’re gone for good, however.

Another factor that could have come into play is that the game has suffered from its popularity, with overwhelmed servers, crashes and freezing, leading to delayed launches in other regions. That could have impacted users’ ability to spend in the app, if not their desire.

Unrelated to spending, Slice also looked at the demographics of Pokémon Go users, and discovered that its male-female split is nearly 60:40 — like the gender makeup of the total gaming population. Players are also largely millennial (now 44 percent of users), and Gen Xers (one-third are.)

When my employer realized I was on the autism spectrum

To disclose or not to disclose my autism to an employer has been one of the more challenging questions I’ve faced during my adult years. Today it’s one of the more challenging issues for those with autism facing potential employment opportunities. For many on the spectrum, it can be a daunting task due to society’s general lack of acceptance of disabilities and differences.

The question of disclosure first came up for me during one of my first part-time positions working in New York City. I had accepted a research position with the responsibility of looking up different analytics for professional athletes and teams. Technology and numbers had become an asset for me. My job responsibilities, mainly plugging names and numbers into an excel spreadsheet, were clear and I didn’t feel overwhelmed.

I didn’t need any accommodations, and my first few weeks were going by very well. I had already made several friends and was feeling like a part of the team. Than one day my employer was listening to me talking about my volunteer work in the autism community. He than asked me a question that froze me completely…

“Why did you get involved in the autism cause?”

I blurted out, “I have autism myself, so I got involved to help people like me.”

My employer responded with a smile and said, “That’s awesome that you are volunteering towards the cause.”

His response left me ecstatic. I felt confident about disclosing to him after his positive reaction. Two years earlier, I came out to my peers in college for the first time about being on the autism spectrum, so I could become a disability advocate. Since then, whenever someone would find out that I have autism, their usual response would be, “I would never have known!” But I’ll never forget that day when my employer decided to appreciate my volunteer work.

My advice for those on the spectrum who are joining the workforce is to self-reflect on your strengths and weaknesses every single time you go into a new employment situation. As a motivational speaker, I share this message when I talk to employers about hiring and retaining employees with disabilities.

When accepting a job, carefully read the job guidelines and see what accommodations if any you may need to succeed in that position. After that, figure out whether disclosing is the right thing for you. Whether you talk to your employer about receiving accommodations is an individual decision. If you believe you need them though, go in with confidence, because those accommodations will maximize your potential at your
workplace.

Around 80-90% of adults with autism today are unemployed or underemployed. Children with autism will grow up to be adults with autism and I cannot emphasize enough the importance of helping them find meaningful employment opportunities when that transition happens.

I hope you find something you love to do every day. People with autism tend to thrive when we are working with our key interests — but that is true of anyone. I’m doing something I enjoy, something I hope to keep doing my entire life, and I hope you can do the same.At Autism Speaks we’ve just launched a new initative called TheSpectrumCareers to help individuals with autism find employment. You can learn more about TheSpectrumCareers.com here

The Autism Speaks blog features opinions from people throughout the autism community. Each blog represents the point of view of the author and does not necessarily reflect Autism Speaks’ beliefs or point of view.

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Bad News Flash: Scientists Did Not Cure Autism, Cancer Or Alzheimer’s

This week I’m calling out some recent headlines about medical “breakthroughs” that were wildly misleading. Even when the science itself is good, bad reporting raises false hopes and eventually undermines the public’s confidence. At some point, people will just no longer believe the headlines claiming that someone has once again cured cancer.

My first example of bad news is from a couple of weeks ago. I was struck by a headline that showed up in one of my news feeds that read:

Neuroscientists reverse autism symptoms

Wow, I thought. This would be a real breakthrough if it were true. I traced the headline back to the MIT press office, where I then saw the subheading: “turning on a gene later in life can restore typical behavior in mice.” Uh oh: Extrapolating any treatment from mice to humans is fraught with problems, and studying a complex behavioral disorder like autism is even more difficult.

The HuffPo fell for it, though. Their headline read, “Some Autism Symptoms May Be Reversed By Gene Editing, Scientists Suggest.” So did the Daily Mail, which went with this headline:
Reversing autism ‘at the flick of a switch’: ‘Turning on’ a single gene in mice has been found to reduce autistic behaviours

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At least they mentioned mice in the headline. But then they wrote that “scientists have announced a major breakthrough in treating the genetic cause of the spectral condition.” Sorry, but there’s no new treatment available. (Never mind the poor writing that used “spectral condition” to describe autism spectrum disorder.)

What did the researchers actually do? They studied a gene (see the paper here) that is already known to be associated with autism in humans–though only about 1% of cases–and that has already been shown to affect the behavior of mice as well. They created a means of “fixing” this gene in mice, and showed that it can restore some of the mouse behaviors to normal. My assessment: This is nice incremental work on a gene that seems to affect behavior in both mice and humans. I don’t see it leading to any advances in the treatment of human autism for at least a decade, if ever.

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SundanceTV’s New Autism Drama ‘The A Word’ is a Window onto How Families Communicate (Or Don’t)

“You can’t hide behind any tricks. You just need a good story and good characters.”

If there’s one thing that unites us all, it’s our fondness for criticizing other people’s parenting skills. The A Word — a new SundanceTV drama about a small-town English family coping with their son’s autism diagnosis — provides plenty of fodder on that front. As the Hughes family struggles to come to terms with the reality that their five-year-old son, Joe (Max Vento), will likely need special care for the rest of his life, Joe becomes a “lightning rod for family tension,” in the words of a child therapist on the show. The A Word uses autism as a window onto the failure of so many families — let’s be real here, all of them — to communicate effectively.

Adapted for the BBC by British screenwriter Peter Bowker, The A Word — which premiered on SundanceTV last week and aired in the U.K. earlier this year — is based on an award-winning 2010 Israeli series created by Keren Margalit, Yellow Peppers (Pilpelim Zehubim). Margalit, an executive producer on The A Word who also wrote for the original Israeli version of HBO’s therapy drama In Treatment (BeTipul), based Yellow Peppers on her own experience raising a son with autism.

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“For a long time I couldn’t accept for myself that he was autistic,” Margalit says over the phone from Tel Aviv. “So I couldn’t write the words myself on paper. Only when I could say it could I also write it.”

The A Word adds to SundanceTV’s expanding network of international series, from The Returned (France) to Top of the Lake (UK/Australia/New Zealand) toDeutschland 83 (Germany) to, most recently, Cleverman (Australia). (The A Word is a co-production between the BBC and Keshet UK, Keshet International’s UK production company, which is part of the global wing of the Israeli production company Keshet Broadcasting.) Two seasons of Yellow Peppers have aired in Israel, and a second season of The A Word has already been commissioned by the BBC.

The A Word is a departure from most of SundanceTV’s series in its focus on everyday life. Alison and Paul Hughes (Morven Christie and Lee Ingleby) live in a modest flat in the Lake District; Alison’s father (The Leftovers’ Christopher Eccleston) runs a local brewery, where Paul’s worked since he was a teenager, and Alison runs a mobile café near the site where Paul is struggling to turn his dream of owning a restaurant into a reality.

The show’s elements are transplanted fairly directly from the Israeli version, which centers on a farming family (they grow yellow peppers, of course) living in a remote desert village with few resources for families with children who have special needs. Margalit says the show’s emphasis on regular people living in unglamorous circumstances — and dealing with a common, if life-altering situation — is a symptom of the Israeli TV industry’s budget limitations. “You can’t hide behind any tricks. You just need a good story and good characters. You have flour, sugar, water — that’s it, and you make a dish.”

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The A Word taps into a familiar anxiety: Am I living my life the way other people are living theirs? Is what’s normal to me normal to everyone else? When Alison’s sister-in-law (Sherlock’s Nicola Daniels), a doctor, gently suggests she take Joe to a specialist, Alison responds with defensive denial. The word “autism,” Margalit says, “becomes an assumption that it’s a dead end, and no one accepts a dead end.” Alison’s father, Maurice, is more willing to look the situation in the eye, but he’s a 50-something British man; when a doctor tells the family that Joe has trouble communicating his emotions, Maurice says, “That sounds like every man I know.”

Margalit recalls a story a friend told her when Yellow Peppers was airing its second season in Israel. A high-ranking member of the military, her friend noticed an officer in his crew acting strange, obviously bothered by something. He approached the officer and asked him what was going on, and the man started to cry. “My son is a yellow pepper,” he said. “He was just diagnosed.”

Ironically, a show about the failure of communication has itself provided a shorthand for the “a” word in Israel. Margalit was touched at the thought of “these two macho men” being able to “communicate without being too exposed.”

“The tagline of Yellow Peppers, was, ‘The battle to be normal can drive you insane,’” Margalit says. “It’s about communication, always. And sad stuff happening to funny people. It was never this drama about an autistic kid. It’s about this family which has the craziest set-up for communication and how fucked it is.”

The A Word airs Wednesdays at 10 p.m. on SundanceTV.

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Be Aware Of This: These 9 Changes on the Tongue Reveal Almost All Your Diseases

The colour, texture and moisture of your tongue can provide ‘tell-tale’ signs of what’s going on inside your body.

Many complementary therapies, including Traditional Chinese Medicine (TCM) and naturopathy, use the tongue to aid diagnosis.

If a person is unwell, the problem can often be detected by simply looking at the tongue.

 tongue_changes

According to Chinese herbalist Giovanni Masiocia, the tongue accurately reflects the state of your health.

‘In Chinese medicine, it acts like a map where certain areas of the tongue correlate to specific organs of the body,’ he says.

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Stick out your tongue in front of a mirror, say “ahh”, and here’s what to look for:

1. Dark coloration

Dark patches on the tongue indicate you aren’t using good oral hygiene. Use a good toothpaste and always floss and rinse.

2. Bright red

If your tongue looks strawberry red, it means you may not be getting all the vitamins you need. Improve your diet or add multivitamins

3. White and powdery

White and powdery looking tongue indicates that you may have a yeast infection. See a doctor to take care of it.

4. White patches

White patches mean that something might be bothering your mouth. It could be your toothpaste, mouthwash, or even food you’ve been eating lately.

5. Cracking

Cracking and fissures in the tongue is a normal sign of aging. You are at a higher risk of infection. Make sure you’re taking extra good care of your oral hygiene.

6. Small red lumps

This is a certain sign of oral cancer. See a doctor at once!

7. Burning sensations

If your tongue is burning, it’s a signal that you’ve entered menopause. If you know for sure that you haven’t, it’s likely that your tongue is being irritated by your toothpaste.

8. Painful sores

Painful sores are often caused by stress. Take time to relax and lower your stress levels!

9. Yellow coating

A thick yellow layer on your tongue is usually a sign of fungal infection. These are most common in children and teens. It is also common within people wearing braces. Make sure you go to the dentist to see what possible solutions there could be if your tongue looks like this.

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You can use these helpful tips to improve your digestion and the appearance of your tongue:

  1. Eat fermented foods and drink probiotic beverages to bring your inner ecosystem back into balance.
  2. Use the Principle of 80/20 at every meal.
  3. Warm up your digestion with cooked foods.
  4. Add herbs and spices to improve digestion.
  5. Drink warm ginger tea 20 minutes before a meal to benefit digestion and relieve nausea.

Take digestive enzymes to increase mineral absorption.

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Young mother allegedly on meth when Hastings crash killed her daughter

Police said Valencia Skipper’s car appeared to have crossed the centre line, rolled and ended up in a ditch. Saphire died at the scene.

A young mother is facing a rare charge of causing the death of her own daughter while driving under the influence of methamphetamine.

Police have charged 21-year-old Hastings mother Valencia Marie Skipper with causing the death of 2-year-old Saphire Te Aroha Skipper-Hira while under the influence of the Class A drug.

The charge carries the same maximum penalty as drink-driving causing death – up to 10 years in prison, or a $20,000 fine.

Valencia Skipper and daughter Saphire, who died in a crash in Hastings in January. Skipper has now been charged with ...

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Valencia Skipper and daughter Saphire, who died in a crash in Hastings in January. Skipper has now been charged with driving while under the influence of methamphetamine, causing the 2-year-old’s death.

Saphire died in January after being thrown from a rolling car in what police described at the time as a “violent crash” on the Hawke’s Bay expressway near Hastings.

There was a child restraint in the rear of the car, but police said they were looking at the possibility that Saphire was not restrained at the time.

Scene of the crash, on the Hawke's Bay expressway in January.

MEGAN HUNT/ FAIRFAX NZ

Scene of the crash, on the Hawke’s Bay expressway in January.

The crash occurred on State Highway 50A, on the outskirts of Hastings between Omahu Rd and Flaxmere Ave, just before 5pm on January 13.

Police said at the time that the Nissan Primera in which Saphire was travelling appeared to have crossed the centre line, rolled and ended up in a ditch.

Saphire died at the scene, despite attempts to resuscitate her by ambulance staff and motorists who had stopped to help.

Her mother and aunt, who was also a passenger in the car, were both taken to Hawke’s Bay Hospital with moderate injuries.

As well as being charged with causing her daughter’s death, Skipper faces a second charge of driving while forbidden.

According to court documents, she had initially been scheduled to appear in Hastings District Court on Monday, but court staff said her first appearance had been put back to next month.

Senior Constable Cory Ubels, of the Hawke’s Bay serious crash unit, said he could not comment on the case while it was before the courts.

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DRUG-IMPAIRED DRIVING LAWS

The type of charge laid against Skipper is relatively rare, according to Karen Harding, an Auckland lawyer specialising in driving cases.

From 2009, amendments to the Land Transport Act gave police new powers to prosecute drug-impaired drivers.

Officers who have grounds to suspect a driver is on drugs can carry out a compulsory roadside “impairment test”. They can also take a blood sample to check for the presence of a range of drugs if a driver fails that initial test.

If a person is injured in a crash, police can require them to have a blood sample taken while they are in hospital to determine whether they have a Class A drug, such as methamphetamine, in their system.

Hutt Valley-based criminal defence lawyer Geoff Fulton described the charge under section 61 2b of the Land Transport Act as unusual. “You’re not required to prove the level [of methamphetamine]; only that the drug is in the bloodstream.”

In 2012, West Auckland mother Toni Ericksen was sentenced to 12 months’ home detention and 200 hours’ community work after a crash that killed her 12-year-old daughter Bryer Greenwood, and injured her 8-year-old daughter Gemma.

Ericksen, 33, had pleaded guilty before trial to driving while under the influence of drugs causing death, two charges of driving under the influence of drugs causing injury, and driving while forbidden.

In March this year, Janine Elizabeth Carter, 37, was jailed for three years and two months for fatally injuring a 69-year-old woman in a crash while high on methamphetamine.

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Disabled St. Jude patient sues airport and TSA after bloody scuffle with Airport Police

Watch this video report posted online by WREG-TV:

MEMPHIS, Tenn. — Bloodied and bruised Hannah Cohen was led from Memphis International Airport in handcuffs.

The 19-year old was headed home to Chattanooga after treatment for a brain tumor at St. Jude Hospital June 30, 2015.

It’s a trip they’ve made for 17 years.

This time, an unarmed Hannah, set off the metal detector at a security checkpoint

“They wanted to do further scanning, she was reluctant, she didn’t understand what they were about to do,” said her mother Shirley Cohen.

Cohen told us she tried to tell TSA agents her daughter is partially deaf, blind in one eye, paralyzed, and easily confused, but said she was kept at a distance by police.

“She’s trying to get away from them but in the next instant, one of them had her down on the ground and hit her head on the floor. There was blood everywhere,” said Cohen.

Hannah was arrested, booked and on the night she should have been celebrating the end of her treatment, she was locked up in Jail East.

“Here we were with nowhere to go, not even a toothbrush, our bags had gone to Chattanooga,” said Cohen.

Authorities later threw out the charges but the family filed a lawsuit against the Memphis Airport, Airport Police, and the Transportation Security Administration.

None of them would comment citing the suit, but Sari Koshetz of TSA released a statement that said, “Passengers can call ahead of time to learn more about the screening process for their particular needs or medical situation.”

Cohen said after all the help here, she can’t believe it ended like this.

“She’s 19 but she’ll always be my baby. We’ve been through so much.”lawsuitagainst-tsa