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Legislators Push For FDA Dangerous Drug Recall Authority With Recall Unsafe Drugs Act

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In light of recent discoveries from the scientific community that heartburn drug Zantac may cause cancer, some U.S. lawmakers are pushing for legislation that would give the U.S. Food and Drug Administration (FDA) the authority to issue mandatory recalls for dangerous drugs.

Connecticut Rep. Rosa DeLauro Reintroduces Recall Unsafe Drugs Act

Representative Rosa DeLauro (D-CT) has introduced a bill called the Recall Unsafe Drugs Act (RUDA), which would allow the FDA to issue mandatory recalls for unsafe medications.

At the moment, the FDA only has the authority to recall dangerous medical devices, contaminated food, and infant formula. They cannot issue mandatory recalls for dangerous drugs, but instead can recommend that pharmaceutical companies conduct their own tests and consider recalling products over safety concerns.

DeLauro has also specifically called for a total ban on ranitidine sales (the active ingredient in Zantac). In late 2019, she wrote a letter to FDA Commissioner Stephen Hahn and the Department of Health and Human Services, urging them to recall all drugs containing ranitidine due to high levels of probable carcinogen N-Nitrososdimethylamine (NDMA).

Release of JAMA Study on Ranitidine and NDMA Delayed

During a recent Capitol Hill press conference, DeLauro and Valisure CEO David Light both spoke in favor of the Recall Unsafe Drugs Act. Valisure is the company that first studied the connection between ranitidine, NDMA, and cancer and reported their findings to the FDA, which led to recommendations for testing and recalls by pharmaceutical companies.

During this press conference, Light mentioned a new study that was jointly conducted by Valisure, the Memorial Sloan Kettering Cancer Center, and Stanford University. This study was scheduled to be published in the scientific journal JAMA on January 10th, 2020, but that publication has been delayed.

The study has been withheld for further review, which Light claims is extremely unusual. DeLauro also voiced concerns over this delay, suggesting that JAMA management may be facing "inappropriate pressure" to withhold the study.

Legal Action Against the Makers of Zantac For Cancer Links

As this story continues to develop, many Zantac users who have been diagnosed with cancer are exploring their legal options. Some have filed lawsuits against the manufacturers of Zantac for alleged negligence.

Pharmaceutical companies have a legal duty to make sure their drugs are safe and to warn consumers about possible dangers. Those who fail to do so can be held liable in civil courts by consumers who have suffered injuries or health problems due to taking a dangerous drug.

You can learn more about your legal rights as a Zantac user with cancer by contacting our experienced defective drug lawyers for a free consultation.

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statute of justice

There is a new development in the legal battle over health problems allegedly caused by popular heartburn medication Zantac. Last week, the U.S. Judicial Panel on Multidistrict Litigation transferred all Zantac claims to the U.S. District Court for the Southern District of Florida. This transfer will coordinate and consolidate pretrial proceedings for these cases.

In a petition filed on November 4th, 2019, the plaintiffs argued that the litigation should be consolidated "because the NDMA in Zantac is not an impurity that only recently made its way into the drug through shoddy manufacturing but is instead inherent to the drug's molecular structure."

Judge Gobin L. Rosenberg to Preside Over Zantac Cases

Over 140 lawsuits were sent to the Southern District of Florida and will be presided over by U.S. District Judge Robin Rosenberg. Both individual personal injury lawsuits and class actions have been filed against the makers of Zantac, alleging that these pharmaceutical companies were aware that the drug was potentially carcinogenic.

According to the transfer order:

“The district is a relatively convenient and accessible forum, with the resources and the capacity to efficiently handle what could be a large litigation. Additionally, centralization before the Honorable Robin L. Rosenberg allows us to assign this litigation to an able jurist who has not yet had the opportunity to preside over an MDL. We are confident that Judge Rosenberg will steer this litigation on an efficient and prudent course.”

All of these cases share several common questions of fact and the creation of a multidistrict litigation docket is necessary in order to establish consistent pretrial and motion practice standards, according to the plaintiffs.

Several Pharmaceutical Companies Named in Zantac Claims

Several of the world's largest pharmaceutical companies have been named in lawsuits for cancers that plaintiffs say were caused by Zantac. These companies include Sanofi-Aventis U.S., GlaxoSmithKline, Boehringer Ingelheim Pharmaceuticals Inc., and Pfizer Inc.

Sanofi-Aventis U.S. recalled over-the-counter Zantac in October of 2019 after the FDA announced that they had discovered unacceptably high levels of N-nitrosodimethylamine (NDMA). Scientists have discovered that Zantac's active ingredient, ranitidine, metabolizes in the body and forms NDMA, which is a carcinogen.

GlaxoSmithKline was the first company to receive FDA approval for selling Zantac and recalled prescriptions in October of 2019 as well.

Legal Rights of Families Affected by Zantac-Related Cancers

Due to the widespread popularity of Zantac and the fact that it has been on the market since 1983, the plaintiffs and their attorneys expect more lawsuits to be filed in federal courts throughout the United States. There are at least ten other cases that have been filed.

If you or someone you love has been diagnosed with cancer after taking Zantac and believe your diagnosis is related to the drug, you may also have grounds for a lawsuit against the makers of Zantac.

You can learn more about your legal rights by discussing your case with one of our experienced defective drug lawyers. We are offering free consultations to those who have been diagnosed with Zantac-related cancers.

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During the 2019 Annual Meeting of the American Academy of Ophthalmology (AAO) in San Francisco, a new study was presented which revealed new evidence of links between popular bladder medication Elmiron (pentosan polysulfate sodium), maculopathy, and retinal damage.

Kaiser Permanente Investigators Find Retinal Damage in 25% of Elmiron Patients

Investigators from Northern California's Kaiser Permanente found that the use of Elmiron caused retinal damage in approximately 25% of the patients they analyzed. Elmiron is the only FDA-proved pill used for treating interstitial cystitis - a condition characterized by pain and pressure in the bladder, along with pelvic pain in some sufferers.

Furthermore, the investigators determined that it can be difficult to realize that this damage has been caused by Elmiron due to the fact that the damage often resembles other retinal conditions, like pattern dystrophy and age-related macular degeneration.

This study was conducted in response to a 2018 study that showed 6 patients in Atlanta, GA had experienced unusual macula changes while taking Elmiron. Kaiser Permanente clinicians conducted the study to determine if this correlation could be found in their patients as well. An initial assessment found that a patient on long-term treatment had been misdiagnosed with retinal dystrophy, prompting clinicians to examine their entire database of 4.3 million patients.

Method of the AAO Elmiron Retinal Damage Study

Kaiser Permanente investigators found a group of 140 patients who had taken an average of 5,000 Elmiron pills over 15 years. 91 of those 140 agreed to participate in an examination for the study.

Investigators photographed the back of the 91 patients' eyes and classified them into three groups based on abnormalities: normal, possible abnormality, and definite abnormality. 22 of these 91 patients showed "clear signs of drug toxicity."

The study also found that toxicity levels increased in correlation with the amount of Elmiron patients took. Those who took 500 to 1000 grams had a toxicity rate of 11%, while users who took 1500 grams or more saw a drastic jump to a toxicity rate of 42%. Investigators also noted that late-stage damage often appears to be late-stage dry atrophic macular degeneration and can lead to permanent loss of vision.

Kaiser Permanente ophthalmologist Robin Vora, MD has advised Elmiron users who show no signs of toxicity to undergo annual toxicity screenings. Those who have shown signs of retinal damage have been advised to speak with a urologist or OB/GYN about possibly discontinuing their use of Elmiron.

Defective Drug Lawsuits For Eye Problems Caused by Elmiron

Our defective drug lawyers believe that there could be many more people affected by Elmiron-related eye issues than have been discovered in this study. Many sufferers may not realize that their issues have been caused by Elmiron due to the fact that symptoms often mimic other retinal issues.

Pharmaceutical companies are responsible for ensuring the safety of the drugs they put on the market. When a drug causes severe damage to users, those affected by the defect often have grounds for a lawsuit against the pharmaceutical company.

If you or someone you love has suffered from eye problems and you believe that Elmiron may be to blame, our defective drug lawyers would be happy to help you explore your legal options in a free consultation.

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pills in hand

In late 2019, the U.S. Food and Drug Administration (FDA) began releasing alerts to patients and health care professionals regarding potentially cancer-causing chemicals found in Zantac (ranitidine), one of the world's most popular heartburn medications.

The FDA recommended that ranitidine manufacturers test for NDMA levels and issue recalls if the levels exceed safe levels, which the administration considers 96 nanograms per day or 0.32 parts per million.

Since the release of this information, multiple pharmaceutical companies have issued voluntary recalls of ranitidine.

November 8, 2019 - FDA Alert Regarding Voluntary Ranitidine Recall by Aurobindo

On November 8, 2019, the FDA issued an alert to patients and health care professionals regarding a voluntary recall of the following medications by Aurobindo Pharma USA:

These three medications were found to have unsafe levels of NDMA.

12/18/2019 - FDA Alert For Voluntary Ranitidine Recall by Glenmark Pharmaceutical Inc.

The FDA issued another alert on December 18, 2019, after Glenmark Pharmaceutical Inc. issued a voluntary recall for prescription ranitidine tablets (150 mg and 300 mg). These tablets were recalled due to potentially high levels of NDMA.

1/8/2020 - FDA Alert Issued For Voluntary Recalls by Appco Pharma LLC and Northwind Pharmaceuticals

On January 8, 2020, the FDA issued another alert to patients and health care professionals after two more pharmaceutical companies issued voluntary ranitidine recalls.

Appco Pharma LLC has voluntarily recalled prescription ranitidine hydrochloride capsules.

Northwind Pharmaceuticals has issued a voluntary recall for prescription ranitidine tablets (150 mg and 300 mg), which are manufactured by Glenmark Pharmaceutical Inc.

FDA Recommendations For Ranitidine Users

The FDA recommends that users of OTC ranitidine consider using other OTC heartburn medications, such as Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole) and Prilosec (omeprazole), which show zero presence of NDMA.

Prescription ranitidine users have been encouraged to talk to a medical professional about alternatives. According to the FDA, there are several other similar drugs that have been approved for heartburn treatment.

Legal Options For Zantac (Ranitidine) Users Diagnosed with Cancer

In light of this new information regarding a possible link between Zantac use and cancer, many cancer patients who have taken Zantac are concerned that the drug may have caused their diagnosis.

Some patients have taken legal action with lawsuits against Zantac (ranitidine) manufacturers due to what they allege is a failure to properly warn consumers about the potential hazards associated with taking these medications.

If you've been diagnosed with cancer and have taken Zantac or another form of ranitidine, we advise discussing your legal options with an experienced defective drug lawyer.

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Two South Florida cancer patients have filed lawsuits against the makers of popular heartburn drug Zantac, alleging that the medication may have caused their cancer. These lawsuits were filed after the U.S. Food and Drug Administration (FDA) released a warning regarding the cancer-causing chemical N-nitrosodimethylamine (NDMA), which is found in the medication.

Joseph Galimidi Files Claim Against Zantac Manufacturer Sanofi

According to an article by NBC 6 South Florida, Aventura rabbi Joseph Galimidi was the first person to file a cancer claim against Sanofi, the manufacturer of Zantac. Galimidi has been diagnosed with male breast cancer. His lawsuit alleges that Zantac has also taken a devastating toll on his body.

Nancy Lopez Sues Sanofi For Alleged Cancer Link Found in Zantac

South Florida woman Nancy Lopez has also filed a claim against Sanofi for what she says is a failure to warn Zantac users of potentially cancer-causing chemicals in the drug. Lopez was diagnosed with breast cancer in 2012. In an interview with NBC 6, she said that she does not have a family history of cancer and that she started taking Zantac to treat her acid reflux at age 15.

In the same NBC 6 article, Lopez tells the station that she believes the company needs to do more to warn other Zantac users of the possible risks associated with taking the medication. She insists that the lawsuit is not about the money, but about protecting others from being diagnosed with breast cancer that may have been caused by longterm use of Zantac.

What Should I Do If I've Been Diagnosed with Breast Cancer After Taking Zantac?

With news beginning to surface regarding a potential link between longterm Zantac usage and the development of breast cancer and other types of cancers, many cancer patients with a history of Zantac use are beginning to explore their legal options.

At Banville Law, our team of experienced defective drug lawyers is offering free consultations to any cancer patients who have used Zantac and believe their illness may have been caused by the heartburn medication.

If you've been diagnosed with cancer and believe Zantac use may be to blame, our lawyers are prepared to help you explore all of your legal options, including a potential Zantac cancer lawsuit against the makers of the drug.

You can learn more about your legal options by contacting us for a free consultation.

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Two individuals have joined together to file a class-action lawsuit against several pharmaceutical companies for allegedly failing to warn consumers that prominent heartburn drug Zantac produces a carcinogen that far exceeds what the U.S. Food and Drug Administration (FDA) considers safe for human consumption. Major pharmaceutical companies GlaxoSmithKline (GSK) and Sanofi (SNY) and others are named as defendants in this lawsuit.

Class-Action Claims Pharmaceutical Companies Knew of Zantac Cancer Links

The named plaintiffs in this lawsuit are Lynn White and Nataliya Birman, who are represented by Beth Fegan - the founder and a managing member of consumer-rights law firm FeganScott. According to Fegan, the makers of Zantac touted the drug and its active ingredient, ranitidine, as completely safe. This allowed the heartburn medication to become of the best-selling drugs on the planet.

However, according to Fegan and the plaintiffs, the Zantac (ranitidine) is not nearly as safe as these pharmaceutical companies have claimed. According to the complaint, studies have shown that ranitidine creates cancer-causing chemical N-nitrosodimethylamine (NDMA) when metabolized. The EPA, FDA, and World Health Organization have all classified NDMA as a carcinogen.

The lawsuit claims that White and Birman used Zantac (ranitidine) under the impression that the pharmaceutical companies' safety claims were accurate. Concerns arose when the plaintiffs saw media coverage regarding scientific evidence of cancer-causing chemicals in Zantac.

According to Fegan, Zantac manufacturers were aware of studies disclosing the presence of the carcinogenic NDMA as early as the 1990s.

While the initial lawsuit only has two plaintiffs, FeganScott seeks to represent anyone who has purchased Zantac or a generic version of ranitidine. The plaintiffs and their attorney have also asked the court to initiate a medical monitoring program that can diagnose and treat any cancers brought on by the drug. Punitive damages have also been demanded due to what the plaintiffs characterize as egregious conduct and disregard for the safety of consumers.

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A recently released study by independent testing lab Emery Pharma claims that popular heartburn medication Zantac produces dangerously high levels of the probable carcinogenic chemical NDMA when exposed to heat. The laboratory is now calling on the U.S. Food and Drug Administration (FDA) to recall all versions of this popular drug. This is one of the latest developments in the Zantac cancer scandal.

Lab Results Suggest NDMA Levels Can Rise After Manufacturer Analysis

According to the study by Emery Pharma, NDMA levels can rise in Zantac long after the manufacturer has analyzed samples to make sure a batch is safe to release. In an article by Bloomberg, Emery CEO Ron Nafaji told the magazine that "The more you heat it, the more NDMA you generate. I am worried that if it just sits at home at room temperature, it could gradually generate NDMA."

The results of the Emery tests are based on an analysis of three ranitidine samples. The FDA has capped the limit for safe levels of NDMA at 96 nanograms. During these tests, a high dose of ranitidine exceeded this limit after five days of exposure to temperatures of 158 degrees Fahrenheit (70 degrees Celcius). The NDMA levels in that same sample rose to 142 nanograms after 12 days.

A test using lower temperatures also found increases in NDMA levels. An identical sample was tested at 77 degrees Fahrenheit (25 degrees Celcius) and NDMA levels increased to 25 nanograms over a 12-day period.

This poses a serious problem to Zantac users, according to Najafi - especially those who take multiple doses of Zantac each day. These multiple-dosage users are at an increased risk of exposure to higher levels of NDMA.

Emery Pharma Files Citizens Petition with FDA

Emery filed a Citizen Petition with the FDA on Thursday, January 2, 2020. The lab has asked the FDA to suspend sales of all ranitidine products, to recall those that are already available to the public, and to require stability testing before the sale of ranitidine products can resume.

Emery has also requested that ranitidine be shipped in temperature-controlled vehicles and that warning labels be added to the product regarding the possibility for carcinogenic byproducts that are potentially produced during exposure to heat.

“Manufacturers should have a strong warning on the label that if the product has been heated above a certain temperature, they shouldn’t use it,” Najafi said in the same phone interview with Bloomberg. "Or else you may be exposing yourself to large quantities of this cancer-causing agent."

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Yes, you can file an NYC personal injury lawsuit without representation or counsel.

In legal terms, this is called pro se, which translates from Latin to "for oneself."

In fact, there's no legal situation in which you must retain a lawyer. You always have the right to represent yourself. But even though you have the right to do something, doesn't mean it's a good idea (as anyone who has tested the bounds of "free speech" is well aware).

So how do you decide? Allegory of justice

Should I Represent Myself In Court?

The question is really about money: how much are you asking for? Every lawsuit asks for some sort of compensation. You have to prove that you were wronged, and that you lost out on something because you were wronged. Usually, plaintiffs argue that they lost out on a certain financial amount; they ask for money.

Whether or not you should represent yourself is usually a matter of how much you're asking for. Small amount? Maybe representation isn't necessary. Large amount? You should probably hire an attorney.

But how do you know what "small" and "large" mean?

Is My Lawsuit Right For Small Claims Court?

It turns out that there are courts designed to hear pro se cases, ones on the smaller side of the spectrum. In New York, "small claims courts" handle lawsuits that involve claims of $5,000 or less.

To pursue these small-value cases, you actually can't have a lawyer. New York's website has a whole section on "Representing Yourself" if you want to learn more about what that entails.

Cases with higher values at stake aren't eligible for small claims court. Instead, you'll be filing your lawsuit in a traditional civil court. Most likely, you can't afford to lose a case like this. Filing and administrative fees are higher, so it's crucial to give yourself a fighting chance.

Usually, that means hiring an experienced lawyer.

How Does Small Claims Court Work?

But if you suffered a small, demonstrable loss (one you can prove to a judge), you should consider small claims court.

According to the New York State Unified Court System, you can use small claims court only to sue for money. "You cannot sue...to force a person or business to perform a task...or to fulfill a promise made in an advertisement." Only monetary claims will be heard.

There are small claims courts in every town, village and city of New York State. In towns and villages, your claim must be $3,000 or lower. In a city, you can ask for up to $5,000. And you have to use the court wherever the person you are suing lives, not your own if you live somewhere else.

Small claims courts are a little looser than civil courts; New York considers them "informal". But it's still your duty to be fully informed of the laws governing your complaint, so you'll need to do a lot of research to stay within the lines. Most courts have clerks who can help you file your claim. Judges will assist you if there's no clerk.

Courts also provide "self-help" sections with necessary forms that you can print and fill out.

Step 1: Find The Right Court

First, find the appropriate court, the one where the person you want to sue lives. You can find a list of small claims courts in New York City here or search for ones throughout the State here.

If the defendant you want to sue lives in a town or village, but you want to claim more than $3,000, you'll have to find a City court in their district.

Step 2: File Your Claim

Now go to the court and ask for the documents you need to file a claim. You'll fill out a short statement, describing the event that you are suing about and anyone who was involved.

Then you'll pay a filing fee, which can vary depending on how much money you're asking for and what kind of court you're in.

In a town or village:

In a city:

The clerk will assign you a hearing date and "serve" the defendant by sending them a notice to appear at the hearing.

Step 3: Prepare Your Argument

How are you going to prove your case? With evidence! If you slipped and fell on an unsafe staircase, bring thorough photographic evidence of the defects. If you were assured of a product's good quality, but found out that it was broken, bring the merchandise.

Anything that can help prove your case should be brought to your hearing. Testimony, the statements you give in court, are also considered evidence. If you had an accident, contact any witnesses and ask them to testify on the day of your hearing.

Sometimes, for whatever reason, people are unwilling to testify in court. But if you need them to, you can have the small claims clerk issue a "subpoena," which will legally command them to appear at your hearing. In New York State, a "subpoena" will cost you $15, and you may have to cover their travel costs, too.

Step 4: Appear At Your Hearing & Argue Your Case

Arrive at least 15 minutes before the time of your hearing. If you're late, your case will be dismissed. If the defendant is late, the case will probably be decided based only on your testimony. This is called a "default judgement."

You'll have to wait until your case is "called" by the court clerk. When it is, the clerk will usher you into the courtroom, along with the defendant you're suing.

You, the "claimant" or "plaintiff," go first. You'll be sworn in as a witness and then proceed to explain your side of events. If you're presenting any evidence, you should bring it up now and present any necessary documents to the judge. The judge and defendant are allowed to ask you questions if they need to clarify any points.

You can present witnesses if you need to. They'll be sworn in and testify as you did.

Then the defendant is allowed to testify, telling their side of the story after being sworn in.

And that's pretty much it. After hearing all testimony, and reviewing all the evidence, the judge will make a decision. In the vast majority of small claims, there's no jury. Defendants are allowed to request one, comprised of six people, but they have to pay several fees.

4 Reasons To Consider Hiring A Lawyer

Claim below $5,000? A court of small claims is probably the way to go. But even at higher values, you don't necessarily need an attorney. So why do most plaintiffs end up hiring one?

1. We already know the rules.

Every court has its own particular procedures and rules. You'll need to learn the specifics where you plan to sue.

An experienced attorney in your area already knows these rules, and they've worked appropriately within them for years.

2. We know the law.

Law, the intricate body of statutes governing what we do and do not have the right to do, is massive and complex. It's also far and away the best reason to hire a lawyer.

You may know one law, but how can you be sure that it's the right one to file a claim under? And what if you're interpreting it incorrectly? What if you are, but not in the same way that the court you're suing has interpreted it in the past?

Matters of law quickly become overwhelming. An attorney has spent their life learning the law inside and out, so you don't have to.

3. Deadlines are big.

If you miss one, and forget to file the right documents at the right time, your case will be dismissed out-of-hand.

Staying on top of a time limit might sound easy, but you also have a life. Can you take the time away from your family and work to properly prepare your case?

4. We know jurisdiction.

Are you suing in the right place? Different courts have authority over different areas and separate legal matters; they rarely overlap.

File a lawsuit in the wrong court and your case will be dismissed.

You Can Discuss Your Case With A Lawyer For Free

Still wondering whether you should hire an attorney or file a small claim?

Contact the personal injury lawyers at Banville Law for a free consultation. You'll hear from an attorney within 24 hours - just describe your situation, and we'll offer our take with no obligation. Who knows? You may have a bigger claim than you think.

 

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Bristol-Myers Squibb and Otsuka Pharmaceutical Co. have ended the massive litigation surrounding Abilify, an antipsychotic drug linked to addictive behavior. Bringing the Abilify litigation to a close, the two companies have entered a confidential global settlement to resolve all outstanding lawsuits filed over the antipsychotic's association with compulsive urges, including compulsive gambling, shopping, eating and sex, according to Bloomberg News.

Abilify Lawsuits Settled In Global Deal

The settlement agreement, brokered on February 15, 2019, was revealed to the public on February 27, 2018 through a court filing in the US District Court of Northern Florida, where over 2,300 Abilify product liability lawsuits are consolidated. While additional Abilify lawsuits have been filed in state courts across the country, the new settlement agreement is designed to resolve claims in both federal and state courts.

Pills In Blister Pack

The terms of the settlement agreement have not been made public. We don't yet know how much money cases are being settled for, or whether the agreement requires an admission of liability from Bristol-Myers Squibb and Otsuka Pharmaceutical.

What's The Problem With Abilify?

Abilify is an atypical antipsychotic drug prescribed to treat various mental disorders, including schizophrenia, bipolar disorder and, as an adjunct to traditional treatments, major depressive disorder. Approved by the US Food & Drug Administration in 2002, Abilify is now the nation’s best-selling drug, with annual sales over $7.5 billion.

But in May 2016, a new warning appeared on the drug’s label. As experts at the FDA wrote at the time, Abilify had been linked to rare, but potentially life-altering, impulse-control problems. Public health researchers have received reports of compulsive, or uncontrollable, behaviors in Abilify patients, the vast majority of whom had never experienced these problems before.

Alongside compulsive gambling, newer results found an association between Abilify’s active ingredient, a chemical called aripiprazole, and compulsive behaviors in general.

Abilify Increases Risk Of Addictive Behaviors

Abilify patients can also be struck by uncontrollable urges to eat, shop and have sex. Within the span of 13 years, the FDA’s adverse event report database logged at least 184 reports linking Abilify to impulse-control disorders. 167 of these cases pertained to US patients. And while pathological gambling accounted for the largest portion of reports, Abilify had also been mentioned in reports of:

Overwhelmingly, this compulsive behavior was being reported in patients with no prior history of impulse-control problems.

"Pathological Urge” To Shop, Eat & Gamble

In the majority of cases, FDA reviewers said, the problems only began when the patients started taking Abilify. The issue also appeared to stop soon after the drug was discontinued. In medical circles, this is known as a dechallenge reaction. When patients stop taking Abilify (their body systems are no longer “challenged” by the medication), the compulsive urges appear to subside. This positive dechallenge result provides us with evidence that Abilify is causing the adverse effect, rather than some other as-yet-unspecified factor.

So while the issue of compulsive behavior seems to be rare (about 1.6 million people receive a prescription for aripiprazole every year), it’s probably connected to the antipsychotic drug. “The drug triggers a pathological urge to gamble constantly,” according to Thomas Moore, a senior researcher at the Institute for Safe Medication Practices. “It might be people starting to spend $300 a week on lottery tickets, and in other cases people will gamble away tens of thousands of dollars.” Moore spoke with the Daily Beast in November 2016.

Elevated Risk Of Impulse-Control Disorders

Compulsive behavior is a very rare side effect of pharmaceuticals, regardless of what drug we’re talking about. So 184 reports may sound small, but it’s actually a high number where medications are concerned. In fact, studies of FDA data show that Abilify is between 8.6 and 64-times more likely to be linked to compulsive gambling than other drugs.

US Abilify Label Changed In 2016

By August 2016, a new warning on Abilify’s label cautioned patients and healthcare providers to watch for new signs of compulsive behavior:

“because patients may not recognize these behaviors as abnormal, it is important for prescribers to ask patients or their caregivers specifically about the development of new or intense gambling urges, compulsive sexual urges, compulsive shopping, binge or compulsive eating, or other urges while being treated with aripiprazole […] consider dose reduction or stopping the medication if a patient develops such urges.”

Abilify’s manufacturers now warn patients and providers of the drug’s link to compulsive behavior. It’s troubling, however, that this warning was only released in 2016, since the drug’s labels in Europe and Canada have carried warnings about these side effects for years.

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This week's Banville Law weekly accident report has two DWI charges- one involving a DWI with children in the car and the other killing an elderly pedestrian.

View other resourceful pages we offer on construction accidents: https://banvillelaw.com/construction-injury/forklift-accident/

Dansville, NY: Motorcycle Accident On Route 63 Kills 51 Year Old Man

November 15th, a pick-up truck hit and killed a motorcyclist in the western part of New York. The accident happened on State Route 63 in Dansville, which is 40 miles south of Rochester.

The pick-up driver is reported to have stopped at an intersection, but failed to yield to oncoming traffic, therefore leading to him hitting the motorcyclist. The motorcycle driver was 51-year-old David Congdon from Perkinsville.

Congdon moved 50 yards away after being hit, and his motorcycle got stuck underneath the vehicle.

The pick-up driver had not been charged and the police do not suspect any use of drugs or alcohol in this crash.

Buffalo, NY: Wrong-Way Crash Kills One Driver

A wrong-way accident took place on I-90, Saturday, November 14th in Buffalo.

The accident killed one driver, left one in critical condition, and a third driver was not injured. An Audi driver headed south in the northbound lane smashed into a Toyota pickup truck. The vehicle involved in this crash swerved in an attempt to avoid crashing and hitting the other two vehicles.

The Audi driver was pronounced dead at the accident scene. The Toyota driver was rescued from his vehicle and taken to a hospital where he is in critical condition. The third driver was not injured.

For five hours, northbound lanes were closed as police investigated the accident.

Central Islip, NY: DWI Driver Kills Pedestrian

37-year-old James Fitzpatrick, of Central Islip, hit and killed a pedestrian on Long Island.

Suffolk County police arrested Fitzpatrick for drunk driving. The victim he struck was 63-year-old Robert Fornasier. He was pronounced dead on the scene.

Fitzpatrick was scheduled to be arraigned later on.

Queens, NY: DWI Driver Crashes Into Garbage Truck With Children In Car

A driver from East New York, Brooklyn, smashed her Honda Pilot into a garbage truck 76th St. and Atlantic Avenue in Woodhaven.

The 36-year-old driver, identified as Rishma Sookdial, was charged with drunken driving. Authorities state that Sookdial had alcohol on her breath and she was slurring her words. In addition, she had four children in the car-including an 18-month-old.

She was charged with four counts each of DWI with a child passenger and child endangerment.

The children's ages are 15, 11, 10, and 18 months; all were taken to Jamaica Hospital with the 11-year-old suffering a broken leg.

Medford, NY: Long Island Man Dies In Utility Pole Crash

A 31-year-old man was killed after his car smashed into a utility pole. The accident took place on Granny Road in Medford on Wednesday.

The driver, Alan Bradley was headed east when his car crossed over into the westbound lane where it struck the pole.

The driver's car was impounded for a safety check and the investigators are looking into what caused this crash.

Volney, NY: Two Car Crash In Central New York

A two-car crash in central New York killed one woman and injured another. The accident took place in Volney, Oswego County, which is 23 miles northwest of Syracuse.

According to police reports, a Toyota was headed westbound on Route 3 when a Kia crossed over the road and crashed with the Toyota.

Unfortunately, the Toyota driver, 72-year-old Joyce Rice, was dead on the scene. The other driver of the car, a 56-year-old woman, was taken to University Hospital in Syracuse with non-life-threatening injuries. According to Troopers, charges against her are pending.

Up next: https://banvillelaw.com/new-york-state-february-19-accident-report/

In Norway, they call them pirattaxi, or "pirate taxis." In Malaysia, the term prebet sapu, or "sweep privates," is used. Residents of Baltimore call their unregulated drivers "hacks," a nod to the hackney coach rather than cybernetics. And in New York, we've chosen the title "gypsy cab."

These phrases suggest evocative images: lawless open seas, populated by eye patch-wearing marauders who employ hit-and-run guerrilla tactics. No rules, no regulation, just competition red in tooth and claw. As we'll see, that's not far from the truth.

Gypsy Cabs In New York City

New York City is home to a thriving unlicensed taxi industry, a disconnected fleet of unregulated cabs, serving residents ignored by the city's traditional, medallion-licensed cabs.

As an unregulated industry, there are no firm statistics on how many gypsy cabs are trolling New York City's streets. But one indication of the industry's size could come from enforcement. In 2012, the Taxi & Limousine Commission (TLC) confiscated a record 5,776 illegal livery vehicles, an increase of more than 230% from 2011.

What A Licensed Yellow Taxi Has, & A Gypsy Doesn't

liscenced cabs in new yorkHere's what the TLC's strict regulations guarantee:

Gypsy cabs are just cars and drivers. There's no guarantee of insurance, vehicle maintenance, or driver reliability. There's no guarantee at all. And if a gypsy is insured, it might only be for the New York State minimum: $25,000 for bodily injury and $50,000 for death.

How Did The Taxi & Limousine Commission Produce A Black Market?

Much like the pirates of old, gypsy cabs are the simple result of economic reality in many large cities.

Economics: Barriers To Entry & An Under-served Market

Taxi medallions, which mark a cab as regulated, licensed, and certified to accept fares by the TLC, cost as much as $1.25 million apiece as recently as November 2013. An intensely high sum for drivers who make a median annual income of $38,615.

And while only 13,437 taxi medallions are available, rider demand is much higher than the regulated fleet can meet on its own. By strictly limiting the number of yellow cabs, the TLC has constructed a high barrier to entry for potential drivers. In concert with New York City's unmet demand for taxi travel, the medallion system has effectively produced its own black market.

Geography: Island Travel Is Expensive

Certified drivers generally stay within the boundaries of Manhattan. According to the Taxi & Limousine Commission (TLC), 90.3% of all pick-ups occur in New York's Central Business District, and another 3.5% serve the airports. These areas, full of life and travel-ready residents, guarantee fares, and most drivers choose to remain within the most robust market. Cabbies also feel that better tips can be found in wealthier neighborhoods.

But the physical structure of New York also plays a role in the gypsy cab industry. As an island, travel in New York City is made possible by tunnels and bridges, which carry their own set of costly tolls, a disincentive to drivers and passengers alike. As a result, residents of the city's outer boroughs become used to a lack of taxis and find alternate modes of transportation. Cab drivers pick up on this decrease in demand, reinforcing their reliance on Manhattan's market.

When residents of the Bronx, Brooklyn, Queens, and Staten Island do take cabs, they're faced with an extra disincentive. Most unlicensed cabs don't have meters, and fares are agreed-upon in advance. Metered fares, on the other hand, may calculate rates in relation to the rate of travel, the time it takes, in addition to distance. Traveling longer distances, especially in congested traffic, can be a significant hit to one's pocketbook, one many passengers aren't willing to bear.

Livery Cabs: The New "Gypsy"?

In recent years, the name "gypsy cab" has become attached to a type of legal taxi, too. "Livery cabs," generally black sedans, came into existence to serve neighborhoods with less foot traffic, and less customers, than Manhattan.

In order to find fares, livery cabs relied on radio dispatchers, rather than trolling for street hails. The TLC enshrined this distinction, and it's now illegal for a livery cab to pick you up on the street. But they do, and New York's licensed yellow cab drivers routinely complain about this unlawful competition.

Licensed cab drivers often fear perceived dangers in the outer boroughs: theft, kidnapping, or worse at the hands of unscrupulous riders. They may be right; driving a livery cab is extremely dangerous. According to Columbia University's News Service, more than two livery cab drivers are murdered every month by their passengers.

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legal paperworkAround 95% of lawsuits end before they begin, in pre-trial settlements. In fact, the likelihood of a settlement is so high that most good personal injury lawyers prepare for it specifically, in addition to a full-blown court case. Many of the most experienced attorneys craft their arguments to make settlement seem the defendant's best option.

If you were injured, and want to pursue a lawsuit, settlement should be in the front of your mind. It should also be foremost in your attorney's thoughts. So what is a settlement in reality? How does it actually work?

Settlements & Personal Injury: A Case Example

First, some quick explanations:

If you were injured in a cab accident, and decided to sue the cab owner for negligence, you would be the plaintiff in the case. The cab owner you sue would be the defendant.

Lawsuits, and the court system itself, exist to create a neutral, relatively objective space. Within this space, the validity of facts can be disputed, or argued. For example, you believe that the cabbie ran a red light, causing the accident in which you were injured. The cab driver vehemently denies this. In court, your attorney can introduce exhibits, like a video of the cabbie running the red light, to corroborate your version of events.

What Is A Settlement?

In theory, settlements are very simple. Rather than proceeding to court, and arguing the facts of a case before judge and jury, the dispute is resolved before things get to that point. In most cases, one party offers to pay the other a certain amount of money, after which the issue is dropped.

Settlements can be agreed upon before a lawsuit is filed, pre-trial, or during the course of a lawsuit. Many states, although not New York State, require parties to attempt settlement negotiation before filing suit.

Why Do Defendants Settle Out Of Court?

It's cheaper. Lawsuits can be expensive, for both defendants and plaintiffs. Attorneys, court fees, travel, time, and even expert witnesses need to be paid. Settlements, on the other hand, can save both parties money, even the defendant who has to pay the plaintiff.

It's easier to control. When you go to court, you assume a lot of risk. If the judge or jury doesn't accept your arguments, you're out of luck. It's in someone else's hands. Settlement allows defendants and plaintiffs to steer negotiation directly, toward mutual benefit if possible.

It's safer. The chances of winning a court case, on average, aren't very good for defendants. Over 90% of all personal injury trials that come before a judge or jury are decided in favor of the plaintiff's case.

There's no "guilt." In all but the rarest instances, cases end in a verdict. Defendants are found either "guilty" or "not guilty." This finality isn't required in a settlement, allowing defendants to solve the problem without formally accepting wrongdoing.

Why Would A Plaintiff Settle?

It's quicker. There are no accurate statistics on the average length of a civil lawsuit, but many experts would tell you anywhere from one to three years from start to finish. Settlement allows injured victims to receive the compensation they desperately need in a more timely fashion.

It's flexible. In court, every statement is governed by strict regulations. Someone's always looking "over your shoulder," in a sense. Settlement proceedings are looser, freer, and allow for more innovative approaches to dispute resolution. They're private, too, which can be a plus.

There's less risk. As reported by the New York Times, a wide-scale study of civil lawsuits found that "most of the plaintiffs who decided to pass up a settlement offer and went to trial ended up getting less money than if they had taken that offer."

Alternative Dispute Resolution: How We Settle Our Differences

Bringing a lawsuit is risky. Unless you have a watertight case, you could spend a lot of time and money, but end up with nothing. Settlement negotiations allow plaintiffs and defendants to negotiate, present their sides of the argument in a cogent way and seek a mutually acceptable resolution. So how does it play out in real life?

There are three basic forms of settlement negotiation: face-to-face conversation, mediation and arbitration. Lawyers aren't required, but are definitely recommended for spotting potential loopholes in any agreements that you make.

Face-To-Face

Definitely your simplest option, this is just a good old conversation. Present your side of the story, and see how the other party responds. People are often more reasonable than you'd expect. In the event that you do agree on a solution, ask an attorney to draft an agreement and sign it with witnesses present.

Mediation

In mediation, you call in an objective third-party to help you out. This mediator doesn't have any special legal authority, and can't force either party to do anything they don't want to. They just listen, and try to steer the conversation toward productive solutions.

If you come to an agreement, a mediation agreement, which is legally-binding, can be written up.

Arbitration

Arbitration is a mix of mediation and true litigation. Bring in another objective third-party, this time an "arbiter," and try to come to an agreement. But this time, the arbiter has the power to make a lawful ruling on your dispute, making it a great idea to bring a lawyer to any arbitration session.

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Laurence P. Banville
Date Published: February 11, 2020
Laurence P. Banville is the managing partner of Banville Law. As an experienced personal injury attorney, Mr. Banville helps clients recover compensation from those responsible for his clients' injuries. Our firm is located in New York City, serving clients from the five boroughs: Manhattan, Brooklyn, Queens, The Bronx, and Staten Island.
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