5 New Prescription Drugs That Are Causing Mass Lawsuits

www.cheatsheet.com/health-fitness/prescription-drugs-causing-mass-lawsuits.html

Whether you have trouble sleeping, struggle with symptoms of intense anxiety, or need help managing a medical condition, prescription medications are a necessity for many people. So, it can be extremely troubling when you see that your prescribed medication is causing a major lawsuit.You may feel as though you’re putting your own life at risk. With so many prescription drugs out there, it’s tough to know which ones are causing the most commotion in the medical world, so researching your medication or asking your doctor about risks is always a good idea. Here are five prescription drugs causing mass lawsuits you’ll want to keep on your radar.

1. Nexium

A doctor showing different prescription medications | iStock.com

If you’ve suffered from gastroesophageal reflux disease or peptic ulcer disease, you’ve probably been prescribed a proton-pump inhibitor for relief of your symptoms. Prilosec, the first proton-pump inhibitor introduced in 1998, needed some major improvements. This led to the creation of Nexium. This medication works by blocking the release of acid to the stomach.

While Nexium seems innovative for its new approach in the treatment of acid reflux, Drug Dangers explains lawsuits claim this prescription drug may increase the risk of chronic kidney disease, perhaps by as much as 50%. Proton-pump inhibitors have also been shown to increase the risk of heart attack, bone fracture, and may lead to a magnesium deficiency. Birth defects and liver toxicity are also risk factors associated with taking Nexium.

2. Avelox or Levaquin

Fluoroquinolones are class of antiobiotics used treat infections like pneumonia, bronchitis, or even urinary tract infections. While this class of antibiotics is known for its effectiveness, certain types, such as Avelox and Levaquin, are linked to serious side effects causing an uproar in the medical community.

Unfortunately, the negative side effects can take years to surface. Drug Watch explains these medications have lead to lawsuits regarding aortic dissection, aortic aneurysm, and nerve damage. Aortic dissection happens when blood seeps into the layers of the tissue in the aorta. This can lead to stroke, heart attack, or paralysis once the walls of the aorta begin to break down. Anneurisms and nerve damage can also be serious. Until recently, the risk of nerve damage wasn’t even addressed at the time the prescription was written.

3. Invokana

Doctor in blue gloves holding prescription drugs for patient | iStock.com

Diabetes can cause serious damage to the body, including blindness, nerve damage, kidney failure, heart disease, stroke, and high blood pressure. Invokana was developed to help sufferers better deal with this disease in conjunction with a healthful diet and daily exercise. This prescription drug helps to lower blood sugar by allowing the kidneys to remove sugar from the body via the urine.

Current lawsuits state Invokana manufacturers failed to tell patients and physicians this drug could increase the risk of kidney failure, heart attacks, and ketoacidosis, which is a condition that occurs when there is not enough insulin in the body and ketones enter the bloodstream, WebMD explains. Levin Papantonio Personal Injury Lawyers outlines the lawsuit, explaining doctors would have monitored their patients more closely had they known of these threats.

4. Byetta

Byetta is another prescription drug that works to help those who suffer from type 2 diabetes. This injectable medication should not be taken with insulin, Diabetes.co.uk explains. It’s meant to help lower blood sugar without promoting weight gain. Overall, users have reported Byetta has helped them lose weight, giving it an advantage over other drugs are used to treat diabetes.

So what’s the problem? According to The Schmidt Firm, this medication has been linked to kidney failure, pancreatic cancer, and thyroid cancer. Plaintiffs in the lawsuits say the drug-makers failed to warn them of these potential dangers.

5. Benicar

Doctor talking to a patient in an exam room | iStock.com

Benicar is one of the top 100 selling prescription drugs in the U.S., and it was introduced in the 2000’s to treat high blood pressure. This drug works by blocking a protein produced by the liver known as angiotensin II. This protein can narrow the blood vessels, which can limit or reduce the flow of blood. Benicar works to relax the blood vessels, which decreases the pressure in the veins and lets the heart work more efficiently. Many side effects of Benicar are mild to moderate, including nausea, rash, hair loss, and chest pain, though lawsuits against Benicar are for far worse side effects.

Drug Dangers explains Benicar was promoted as safer than other blood pressure medications of its kind, but it’s been linked to gastrointestinal complications and disease, including celiac-like symptoms and serious stomach pain. Some have even reported extreme weight loss and the inability to absorb nutrients.

We’re not saying you should avoid taking all prescription drugs, but you should always have a thorough discussion with your physician before beginning a new treatment to make sure you understand the potential benefits and risks.

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Ohio man’s morphine needs caught in pain-pill crackdown

http://www.dispatch.com/content/stories/local/2016/09/14/state-probes-of-mans-huge-morphine-doses-scare-off-prescribing-doctor.html

MIDDLETOWN — For more than 20 years, Kevin Morgan has been a prisoner of his pain.

Just to get out of bed and hobble with a cane, Morgan requires as much as 70 times the amount of painkiller a doctor would normally prescribe. The normal average is the equivalent of 80 to 120 milligrams of morphine each day. Morgan takes almost 5,700.

“It’s enough to kill an elephant,” said Konrad Kircher, Morgan’s attorney.

Those massive amounts of painkillers caught the attention of government agencies. When officials see such high doses prescribed, they become suspicious that the drugs might be going to an addict or a dealer. Investigations led Morgan’s pain-treatment doctor to drop him as a patient out of concern that he could lose his medical license.

Now, Morgan is tired of the pain, tired of fighting the bureaucracy and, at times, tired of fighting to live.

“They told me I’d only live to 37, 38 years of age,” Morgan, 51, said between heavy breaths as he sat slumped on a couch in his Middletown home, barely able to lift his chin from his chest because of pain. “I have no quality of life.”

Morgan requires those ultra-high opioid doses, three doctors determined, to cope with the pain after a 1994 horse-riding accident. The horse that Morgan was riding fell on him, rolling over him. Then it stomped his head several times, leaving Morgan , who was 29 at the time , an “incomplete paraplegic” with little feeling from his mid-chest down. He stayed in a hospital bed and wheelchair for seven years and was told he’d never walk again.

His case, supporters say, is such an exception that something needs to be done to help him, even changing the law.

Before the horse stomping, the Middletown man was a paramedic and a small-business owner. He was so concerned about his southwestern Ohio community that he became a special Butler County deputy sheriff — a state-certified volunteer who helps other officers with tasks such as traffic control.

The horse’s hooves damaged his brain’s pain receptors. That, combined with genetic defects, causes Morgan to need massive doses of painkillers.

That is “much higher than any I’ve personally heard,” said Rep. Stephen Huffman, R-Tipp City, who is a physician but who had never heard of or examined Morgan.

Dr. Forest Tennant has. He is the California pain-medication expert who has examined Morgan several times and concludes that he is a “tragic and rare patient.”

“Frankly, we get a case like this once every 10,000 patients,” Tennant said.

Tennant was so intrigued by Morgan that he tested him twice. Each time, he gave Morgan a blood test to determine what drugs were in his system. Hours later, he watched as Morgan took his medication. Then he gave Morgan another blood test. It showed that Morgan’s body properly absorbed the medication, but it did not make him high. Instead, he remained lucid and able to cope with pain.

“I don’t know if you would call it a life,” Morgan said. “When I think of life, I think of being able to function, being happy, not feeling like a prisoner.”

The State Medical Board of Ohio, the State Board of Pharmacy and the federal Drug Enforcement Administration all investigated. They concluded that Morgan was taking all the medication and not abusing it.

“There’s a difference between a drug addict and being drug-tolerant,” Morgan said. Without the medication, he said, the pain can become so severe that he has seizures.

Extremely high prescribed doses are unusual, but in extremely rare circumstances, they “may be legitimate,” State Medical Board spokeswoman Tessie Pollock said.

Morgan’s original pain doctor, Tim Smith, agreed to surrender his medical license in 2013 after the State Medical Board said he inappropriately prescribed high doses of controlled substances and failed to properly document treatment for some patients. Because the patients weren’t named publicly, it’s unclear whether Morgan was among the 12 whose cases the state cited.

Morgan’s second pain doctor, Thomas Knox, then treated Morgan, but again state regulators noticed the high doses of opiates. Under Knox’s treatment, Morgan again submitted to tests conducted by Tennant, who again found that despite the high doses, Morgan wasn’t selling the drugs or using them to get high.

“He has to take a gallon in order to make a pint work,” Tennant said. “He’s very open about everything. He’ll take a urine test or blood test whenever and wherever you want.”

Knox tearfully told Morgan, who has never been arrested, that he could no longer treat him for fear of losing his license.

Ohio law and privacy rights prevent the government agencies involved from discussing Morgan’s case even though Morgan signed a consent form allowing release of his medical information.

Knox cooperated with state investigations and produced documentation of his treatment of Morgan, but “repeated inquiries” by both the State Medical Board and the State Pharmacy Board made the doctor think that if he didn’t drop Morgan as a patient, the investigations could end badly.

“If it becomes a threat to your practice, tough decisions have to be made,” said Daniel Zinsmaster, Knox’s attorney. “It was a decision made reluctantly and, I think, with sadness. I think his desire would have been to try to assist Mr. Morgan.”

Knox, ironically, at the time was a contract worker for the State Medical Board on pain management, including examining allegations of over-prescription of painkillers. After the state investigated Knox, it canceled his contract.

Morgan’s attorney and Tennant believe that the patient is caught in a bureaucratic morass because officials saw doctors over-prescribe medications through “pill mills,” and doctors now are wary of being accused of over-prescribing.

The result is a life that Morgan isn’t sure is worth living even when he gets the medication.

“It feels like a buzzing and a constant stinging that never stops, to the point where I go three, four days and I don’t eat, even with the pain medication,” Morgan said.

Kircher, who is representing Morgan for free, isn’t sure the case merits a lawsuit. He prefers a change in Ohio law to address rare cases such as Morgan’s.

“The goal is to create exceptions,” Kircher said. “Kevin can be the example for people who have slipped through the cracks. The only goal is to get Kevin the treatment he needs.”

Tennant suggested a law to appoint a few physicians to handle cases such as Morgan’s — to ensure that drug addicts or dealers aren’t tricking the system but that those who genuinely need high doses to survive get them.

“I don’t know another way out for him,” Tennant said.

Huffman, the state legislator and doctor, isn’t sure such legislation is necessary because the State Medical Board has stringent requirements for reporting.

“I think it’s a very unfortunate situation,” Huffman said. “It has to be frustrating for the patient.”

Morgan won’t say how he is getting his pain medication, but he said he has spent $80,000 on it since his doctor stopped treating him nine months ago. Now, he’s broke and doesn’t know what to do.

“This state has done everything but put me in a coffin and nail the nails in there. I have nothing to hide,” Morgan said.

“I did nothing wrong.”

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Poor Correspondence Between Pain Data and Actual Symptoms Hurts Patients

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DEA wants to criminalize deadly ‘Pinky’ drug suspected of killing Park City teens

http://kutv.com/news/local/dea-wants-to-criminalize-deadly-pinky-drug-suspected-of-killing-park-city-teens

They show an image of LEGAL FENTANYL PATCHES BOXES… and the article is about a “opiate substance” ..not scheduled… not commercially available as a prescription item in the USA… and how does the death of these two teenagers have anything to do with the legal treatment of  pain by prescriptions generated by legally licensed prescribers for people with legit medical necessity ?

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When Information Breaches Lead to Lawsuits

http://www.renalandurologynews.com/hipaa-compliance/when-information-breaches-lead-to-lawsuits/article/522626/

When it enacted HIPAA, the Department of Health and Human Services (HHS) chose to use a “carrot” rather than “stick” approach to enforcing the law. Penalties have been given for major breaches, but aside from that, there is little financial skin in the game for providers. At least until now.

When a provider wrongfully discloses protected health information, HIPAA does not provide patients with a legal remedy other than reporting the incident to HHS. But courts have begun to look at the issue differently, ruling, in some cases, that providers can be sued under state rules pertaining to privacy and negligence for breaches.

“Courts are beginning to say that just because the federal government didn’t give a remedy, it shouldn’t preclude patients from bringing a suit in states,” said Chad Eckhardt, a member in the regulated business group at Frost Brown Todd, which has its headquarters in Cincinnati, Ohio. 

Recourse at the state level

It was a 2014 Supreme Court decision in Connecticut that set a precedent allowing providers to be sued for HIPAA violations.  A patient filed a lawsuit against her obstetrician when the provider mailed her medical records to a court in response to a subpoena related to paternity suit filed by her ex. She was not informed of the subpoena by her provider and she filed for negligence, negligent emotional distress, breach of contract, and negligent misrepresentation as to the safety of her records. Although originally dismissed, her case ended up at the state supreme court, which ruled that her case stated a claim for which relief may be granted and remanded it for trial.

There are numerous torts for which individuals can seek redress for personal injury, but some are not suitable for filing lawsuits related to HIPAA violations. Two such torts are invasion of privacy and public disclosure of private facts, Eckhardt said.  Plaintiffs have to prove damages. Those torts rarely result in physical damage, so plaintiffs have to prove mental or emotional distress. Courts, he said, are reluctant to provide a remedy for non-physical damage under torts.

Negligence is another category that requires plaintiffs to prove damages. Under this tort, physicians can be considered negligent because they did not comply with a standard of conduct (HIPAA). “If the federal government says this is the minimum standard of confidentiality and you don’t meet those minimum standards, you are negligent as a matter of fact,” Eckhardt said.

Breach of contract is another option for plaintiffs, though the damages are much less than with a tort, Eckhardt said. Some states, like Ohio and West Virginia, have also created torts specifically for the unauthorized disclosure of medical records.

“More states are creating this tort for unauthorized released of records and if they don’t have one, courts are going to try to find a remedy for harm done if there is actual damage to an individual,” Eckhardt said.

Setting precedent

A case out of Indiana was the first to show that employers can be held accountable for their staffs’ HIPAA violations. A patient sued Walgreens and one of its pharmacists when she found out the pharmacist had looked up and released medical records to the plaintiff’s ex-boyfriend. The pharmacist was currently married to the woman’s ex, to whom she provided prescription information. The woman won $1.4 million in damages, holding Walgreens accountable for the employees’ breach of confidentiality under HIPAA for reasons including negligent supervision.

Physicians need to ensure they are training all employees upon hiring them and annually thereafter, he said. Consistent training can help a provider prove they have not been negligent in supervision of their employees and reduce their liability.

As part of training, the importance of caring for hyper-sensitive information like HIV status and mental health conditions should be emphasized. In addition, practices need to review office processes to determine where people can get tripped up. For example, if a subpoena is received, what should employees at each level do with the request?

“Courts are going to try to find a remedy for harm done if there is actual damage to an individual,” Eckhardt said. “Courts are allowing awards for individuals, especially for hypersensitive information because it is so stigmatizing.”

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Wisconsin teen who plans to die avoids of media spotlight

http://www.foxnews.com/health/2016/09/13/wisconsin-teen-who-plans-to-die-avoids-media-spotlight.html

The bureaucracy and our judicial system ALWAYS knows what is best for each of us… but none have live in the shoes of those they are protecting from “themselves” ?

At 14 years old,  a typical American girl might be thinking about school, hanging out with friends, and going on dates, but an Appleton, Wisconsin teenager is focused on something very different. Jerika Bolen wants to die.

Jerika was born with a rare incurable disease called spinal muscular atrophy type 2.  She has almost no control of her muscles and requires a wheelchair to get around. She’s undergone 30 surgeries so far, she said she’s in pain every single day and doesn’t want to continue to live that way. 

The girl’s mother, Jennifer Bolen, supports her daughter’s decision.

“I said, ‘Jerika I love you that much that I will not let you suffer if it’s that bad,'” Jennifer told WLUK-TV.

Jerika wants to go into hospice care, turn off the device that helps her breathe and let her life slip away.

In July, friends and family threw a prom-like party for the teen called “Jerika’s Last Dance.”

“It makes my heart explode!  It’s so crazy that people want to come for little old me!” Jerika told WLUK-TV.

Her story has gained attention and evoked strong emotions nationwide, with supporters saying that the girl has a right to decide what to do with her own life, and while others are outraged that a child would be making such a heartbreaking choice. 

“She’s only 14 and we know that the brain is not fully matured,” Carrie Ann Lucas, founder and executive director of the Colorado-based Disabled Parents Rights, told Fox News. The group is asking Wisconsin’s Department of Children and Families to intervene in the girl’s case.

 “There’s a reason why we don’t let 14-year-olds join the military, there’s a reason why we don’t let 14-year-olds vote.  We don’t let 14-year-olds make their own medical decisions” Lucas, 44, added.

Lucas, who has a form of multiple sclerosis and is reliant on a ventilator, doesn’t believe the disease Jerika suffers from is imminently fatal. She also believes Jerika may be in pain because she isn’t getting the medical care she needs.  If a doctor can help ease the pain, Lucas thinks Jerika might have a better quality of life.

Lucas said she also fears Jerika’s decision to end her life might have been formed from the negative way disabled people are portrayed on TV or in movies.

“We very often see our lives devalued… not being dignified and really that we’re in many ways better off dead than disabled,” she said.

Wisconsin law is murky on how to handle Jerika Bolen’s situation.

As a minor, Jerika is legally considered to be “incompetent” by the state.  Her mother’s support might make a difference, however. According to a Wisconsin court ruling on the 2014 case of Disability Rights vs. University of Wisconsin Hospital and Clinic, “…in the absence of a persistent vegetative state, the right of a parent to withhold life sustaining treatment from a child does not exist.”

According to Wisconsin attorney Kristen Scheuerman told Fox News, “In the absence of any litigation, it’s a moral question with legal implications because if a mom or someone else acts there could be potentially legal consequences to those choices.”

Many of those who live near Jerika’s hometown of Appleton are defending her right to choose how to handle her life. 

“She’s in a body that’s nearly paralyzed and painful all the time,” Alton Olson, who was hired as the DJ for “Jerika’s Last Dance” told Fox News. “Think about how you would feel.”

Initially Jerika said she wanted to enter hospice by the end of the summer.  Since the prom in July, Jerika and her mother have mostly remained silent and behind closed doors, avoiding the media attention.

Jerika’s last public comments have left her friends and supporters with a heavy heart. 

“In your life you need to like yourself…because for a while, probably up until I decided (to end her life) I didn’t like myself,” Jerika told WLUK-TV. “…but then I realized this is the end and you’ve got to make it the best.” 

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Half of Patients Have Trouble Getting Pain Meds

www.painnewsnetwork.org/stories/2016/9/12/half-of-patients-have-trouble-getting-pain-meds

The online survey of over 1,000 patients was conducted in 2015, before guidelines were issued by the Centers for Disease Control and Prevention that discourage primary care physician from prescribing opioids for chronic pain. Although the guidelines are voluntary, they’ve had a chilling effect on many doctors and pharmacists since their release in March.  

“General practitioners who don’t have as much experience are having somewhat of a knee jerk reaction. Either they’re not prescribing opioids at all or taking a very cautious approach,” said Dayno.

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Appeals court: No drug retests needed for Texas executions

http://wtop.com/government/2016/09/appeals-court-no-drug-retests-needed-for-texas-executions/

https://en.wikipedia.org/wiki/Eighth_Amendment_to_the_United_States_Constitution

Is the creation of guidelines/rule/laws that restrict access to medication to treat  their various chronic medical issues… such as chronic pain.. is this a violation of our 8th Amendment ?

HOUSTON (AP) — A federal court rejected a lawsuit by five Texas death row inmates who said the lethal drugs intended for their executions should be retested before their punishments are carried out to ensure they suffer no unusual pain.

Lawyers for the five prisoners argued to the 5th U.S. Circuit Court of Appeals that an agreement between the Texas Department of Criminal Justice and two other inmates to test the pentobarbital for their lethal injections should be extended to them. Failure to do so would violate their constitutional right to equal protection under the law, they said.

The appeals court on Monday agreed with a Houston federal judge’s dismissal of the lawsuit filed a month ago, calling it a “novel and flawed invocation of equal protection doctrine.”

Texas has put 537 prisoners to death since 1982, more than any other state. It replaced its previous three-drug combination for executions in 2012 with a single dose of pentobarbital and the last 32 lethal injections have used pentobarbital from a compounding pharmacy. Attorneys for the five inmates argued the compounded drug created significant risk of unnecessary pain prohibited by the Eighth Amendment and needed to be retested as the punishments neared.

“The reality is that pentobarbital, when used as the sole drug in a single-drug protocol, has realized no such risk,” the appeals court panel said in its 12-page ruling.

Michael Biles, the lead attorney for the inmates, said he was disappointed with the decision, was considering an appeal to the Supreme court and believed the 5th Circuit had applied the wrong standard to his equal protection claim.

“The state of Texas violated our clients’ rights under the Equal Protection Clause of the U.S. Constitution because the testing that it promised to provide shortly before some, but not all, executions implicates a fundamental right … to be free from cruel and unusual punishment,” he said. “When the state of Texas promised to provide additional safety measures for some executions, it must provide those same safety measures for all executions.”

Texas Department of Criminal Justice spokesman Jason Clark noted that the agency had carried out the 32 executions using compounded pentobarbital without incident.

Two of the five inmates have been on death row for more than two decades, a situation that “more surely taxes the Eighth Amendment’s prohibition of undue suffering than does the elusive search for minimum pain for those brief moments of passage across the river,” Judge Patrick Higginbotham, writing for the three-judge appellate court panel, said.

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Protesters fight ban on herbal pain killer

http://www.wtsp.com/news/health/protesters-fight-upcoming-ban-on-herbal-pain-killer/317975492

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