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McEldrew Young Whistleblower Lawsuit Against INSYS Results in $225 Million Settlement of Allegations Involving Opioid Sales and Marketing Abuses

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insys

INSYS Agrees to Global Resolution of Claims Arising from Separate DOJ Criminal and Civil Investigations

The Department of Justice announced that INSYS Therapeutics, Inc. (“INSYS”) has agreed to pay $225 million to resolve allegations that it paid kickbacks and engaged in other illegal marketing tactics to promote sales of its fentanyl spray, Subsys. According to the terms of the settlement, INSYS will pay a criminal fine of $2 million and forfeit $28 million. The pharmaceutical manufacturer will also pay $195 million to settle civil claims based on allegations in five different qui tam lawsuits filed by separate relators.

McEldrew Young represents one of the five relators, a former INSYS sales representative who became concerned as the drug manufacturer continually pushed the boundaries of its marketing tactics to boost sales of its powerful opioid painkiller. In 2016, McEldrew Young filed a complaint under seal on behalf the relator in the United States District Court for the Central District of California. The complaint included allegations that INSYS promoted Subsys for various off-label, or unapproved, uses including musculoskeletal pain, fibromyalgia, neck pain, and back pain, despite the fact that the FDA only approved the drug for the management of breakthrough cancer pain.

Allegations of Improper Dosing Instructions and Meddling with Insurance Authorizations

INSYS management allegedly directed its sales representatives to encourage physicians to prescribe Subsys for continuous use, rather than only as needed, and to start new patients at twice the starting dose permitted by the FDA-approved label. Sales representatives were also allegedly instructed to complete prior authorization forms on behalf of the patient or physician. They also provided physicians with an appeal letter template that would be filled out if patients could not obtain prior authorization from their insurer.

The TIRF REMS Access Program

INSYS allegedly employed other less subtle tactics to remove certain “obstacles” purposely set in place to control distribution of the dangerous class of fentanyl-based painkillers, such as Subsys. For example, the FDA requires that physicians and pharmacists enroll in a program known as the TIRF REMS (Transmucosal Immediate Release Fentanyl – Risk Evaluation and Mitigation Strategy) Access Program. The program was designed to reduce the risks of misuse, abuse, addiction, overdose and serious complications due to medication errors with the use of TIRF medicines. Prescribers and pharmacists must study educational materials and pass an online knowledge assessment exam is order to obtain certification.

In an effort to increase the number of prescribers in the TIRF REMS Access Program, INSYS sales representatives allegedly provided physicians with cheat sheets that contained all the correct answers to the knowledge assessment exam. The practice of distributing the test answers was allegedly considered commonplace among sales representatives. Physicians who allegedly received the cheat sheets could easily circumvent the educational requirement of the program which was intended to ensure that they had sufficient information to make informed risk-benefit decisions prior to starting a patient on a TIRF drug.

Allegations of Sham Speaker Programs and Other Physician Incentives

Much like a number of other pharmaceutical manufacturers, INSYS utilized “speaker programs,” which were purportedly intended to be educational programs through which physicians were paid to present medical information to their colleagues at lunch and dinner events. It was alleged that these events were, in reality, sham programs whose only purpose was to pay doctors and pharmacists to convince their peers to prescribe Subsys for various off-label uses.

According to allegations in the case, many of the speaking events were held at inappropriate locations, such as noisy restaurants and strip clubs, and were nothing more than a pretense to provide attendees with free food, alcohol, and monetary compensation. The alleged payment of bribes and kickbacks to attending prescribers was designed as a way to increase the number of Subsys prescriptions written, as well as the dosage of those prescriptions. Many physician-speakers allegedly received compensation without ever having provided any educational content whatsoever at these events.

Another form of illegal kickbacks allegedly involved the use of gift cards. INSYS management allegedly encouraged sales representatives to provide gift cards to physicians as an incentive to continue prescribing Subsys. Sales representatives allegedly employed covert techniques to conceal the details of the transactions involving the purchase of the gift cards. Under one such scheme, an INSYS sales representative would allegedly purchase gift cards at a local food establishment and persuade the store owner to create fraudulent receipts for the value of the purchase price of the gift cards. The doctored receipts would falsely reflect the purchase of coffee and other small food items which could permissibly be given to a physician’s office. The sales representative would allegedly submit the fraudulent receipts for reimbursement by INSYS and then directly give the gift cards as a form of illegal and untraceable kickbacks to the physicians who prescribed Subsys.

The Rochester Connection

As the manufacturer of Subsys, INSYS was only the first link in the chain of bad actors who allegedly put profit ahead of preventable harm to thousands of vulnerable patients. Rochester Drug Cooperative (“RDC”), the sixth largest distributor of pharmaceutical products in the country, was charged as a corporate entity with conspiring to distribute drugs, conspiracy to defraud the United States, and failing to file suspicious order reports.

Last month, the CEO of RDC signed a Deferred Prosecution Agreement (“DPA”) in connection with the pending charges against the company. Under the DPA and a related consent decree, RDC agreed to: 1) accept responsibility for its conduct by making admissions and stipulating to the accuracy of an extensive statement of facts; 2) pay a $20 million penalty; 3) reform and enhance its Controlled Substances Act compliance program; and 4) submit to supervision by an independent monitor. If RDC remains compliant with the DPA, the government will defer prosecution and seek to dismiss the charges after five years.

The recent charges against RDC stem from a two-year investigation by the Drug Enforcement Administration (“DEA”) after RDC violated the terms of a prior civil settlement. The disclosure of the prior investigation and resulting civil settlement came to light after RDC’s former CEO, Laurence Doud III, filed a lawsuit against the company last year. In the suit against RDC, Doud claims he was fired so that RDC could shift responsibility to him for the recent DEA criminal investigation.

Mr. Doud and RDC’s former chief compliance officer were both recently charged with conspiring to distribute drugs and defrauding the government. The indictments mark the first time that federal criminal charges have been brought against company executives for conspiring to illegally distribute opioids

Linden Care Specialty Pharmacy

In his lawsuit against RDC, Mr. Doud also alleged that two members of RDC’s executive team defamed him by asserting that he and BelHealth Investment Partners had an improper financial relationship. BelHealth Investment Partners is a private equity firm that acquired Linden Care LLC (“Linden Care”), a company that ran a now-defunct specialty pharmacy based in Woodbury, New York.

The recent investigation by the DEA was based, in part, on the inaccurate reporting, or lack of reporting, of pharmaceutical sales between RDC and Linden Care. Prior to going out of business, it is believed that Linden Care was one of the largest, if not the largest, distributors of Subsys in the nation.

McEldrew Young’s initial investigation of the allegations against INSYS identified the critical role that Linden Care played as the leading dispenser of Subsys throughout the country. The complaint filed by McEldrew Young on behalf of its client was the only one to name Linden Care as a defendant in the INSYS qui tam lawsuit. Although the case against INSYS has settled, McEldrew Young’s suit against Linden Care and Belhealth Partners is currently pending before the United States District Court for the Central District of California.

The False Claims Act

The INSYS case demonstrates the importance of whistleblowers in identifying and reporting fraud. Fraud against the government takes many forms, and employees and contractors are often in the best position to detect and report such conduct. The government simply doesn’t have the resources to identify and prosecute every instance of fraud. Consequently, many unscrupulous actors continue to defraud the government, and American taxpayers, for years without detection or prosecution.

The False Claims Act provides a monetary incentive to whistleblowers who provide original information. If the government makes a monetary recovery based on the information provided, a whistleblower can receive between 15 and 30 percent of the recovery. The False Claims Act also contains provisions that protect a whistleblower from retaliation by an employer.

If you have information about fraud against the government, the experienced attorneys at McEldrew Young can assist with all aspects of the process, from investigating your claim, filing a complaint, and successful recovery of a reward.

What should I know about the Fisher Price Rock’n’ Play Sleeper recall?

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If you are a parent, caregiver of a child, grandparent, or guardian and are using a Fisher Price Rock’n’ Play Sleeper, it is in your best interest to stop using it immediately.

 

On April 12th, 2019 Fisher Price officially recalled 4.7 million Rock N’ Play Sleepers.

They also advised parents to cease all use of the sleeper. The reason behind the massive recall is related to at least 32 infant deaths. Before the recall, The American Academy of Pediatrics had encouraged the Consumer Product Safety Commission, or CPSC, to recall the sleeper product after a Consumer Reports Investigation brought to lit the large number of infant deaths since 2011.

 

Just before the recall of millions of sleepers, the Consumer Reports officially called for a recall of another infant sleeper, the Ingenuity Moonlight, made by Kids II. This was done after at least 4 infants died while using the sleeper.

 

Since the recall, there are Fisher-Price Rock’n’ Play Sleeper defective product lawsuits underway. We, at [law firm name[, are currently investigating cases that involve infant deaths attributed to the Fisher Price Rock’n’ Play Sleeper. If you lost a child, and believe this popular product may have been the cause, we urge you to call us as soon as possible.

 

What You Should Know

 

The Consumer Reports investigation sought advice from doctors and medical experts who suggested infants be placed on their backs and away from any soft bedding, so as to minimize the risk of asphyxiation. To add to this the American Academy of Pediatricians does not advise parents to allow their babies to sleep at an incline, especially while restraining a baby while they rock.

 

The Fisher Price Rock’n’ Play Sleeper has been designed in a way that allows babies to sleep at an inclined position, as the product rocks. The company even marketed the sleeper as being a product that a baby could sleep in all night long.

In addition to this, the CPSC has issued  a warning in the past which asked the consumers of the sleeper to discontinue use as soon as the child turned three months of age, or was exhibiting signs of being able to roll over – whichever came first. Both Fisher Price and the CPSC acknowledged 10 infant deaths, and said they occured after the baby rolled from the back to the stomach. This was not exactly true, according to the Consumer Reports. What the investigation showed was that the babies were younger than three months old. Rolling over was not likely.

 

At this time Fisher Price has stated they are aware of at least 32 infant deaths since the introduction of the sleeper in 2009. However, they also said the infants may have had mental or physical health conditions that attributed to the deaths, or the sleeper was being used in a way that contradicted the manual and it’s warnings.

 

It should be noted the investigation did note in select cases, there may have been other factors to consider. Even so, Consumer Reports found there were enough causes for concern that a recall should occur as soon as possible.

 

At least 4.7 million sleepers have been sold to consumers. They are one of the most popular sleepers on the markets, but should no longer be used as they are not safe for infants or babies of any age. If you or someone you know is using this sleeper, please discontinue its use.

 

If you are one of the parents who tragically lost a child, and you believe the Rock n’ Play Sleeper is the cause, our firm is investigating these cases. We understand what it takes to build a case against a large corporation like Fisher Price and will do our best to get justice for you and all the other families.

 

To learn more about the  Fisher-Price Rock’n’ Play Sleeper defective product lawsuits, call McEldrew Young.

Fisher-Price Rock n’ Play Sleeper Defective Product Lawsuits: Are They Right for You?

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The number of Fisher-Price Rock n’ Play Sleeper Defective Product lawsuits are on the rise, and if your family lost a child after using this defective product, contact us at McEldrew Young without delay. Our legal team has the experience and resources necessary to successfully fight this corporate subsidiary on behalf of grieving parents. A lawsuit cannot turn back time but it can send a message that a company cannot knowingly sell a product that is harmful to its users. Gross negligence is not acceptable, and taking legal action in the form of lawsuits against the Fisher-Price Rock n’ Play Sleeper defective product is a way to get justice. A substantial settlement from the manufacturer can also ease the financial burden that families may suffer in the wake of losing a loved one.

 

Contact our office today to learn more about how we might be able to assist your family during this difficult time.

 

How do I file defective product lawsuits against Fisher-Price after their Rock n’ Play Sleeper harmed my child?

 

At least 32 infant deaths are linked to the use of Fisher-Price’s Rock n’ Play Sleeper. The primary issue is that the product allows a child who is capable of rolling over while sleeping to asphyxiate. Product liability laws are intended to protect consumers from dangerous products. When a consumer uses a product in the manner as specified by the manufacturer, and if that product causes harm as a result, the manufacturer may be held liable for the consumer’s damages. McEldrew Young represents injured victims and surviving family members who lost a loved one in a fatal accident. Call us to schedule a free and confidential case review to learn if you are eligible to file one or more Fisher-Price Rock n’ Play Sleeper defective product lawsuits against the culpable parties.

 

What is involved in filing lawsuits against Fisher-Price for their Rock n’ Play Sleeper defective product?

 

When McEldrew Young takes a case representing parents who lost their child due to a defective product, our lawyers will determine who should be held liable. There may be more than one culpable party. After we identify who should be held accountable for our client’s loss, we may do the following:

 

  •         Build a damage claim that includes proof of liability and a detailed accounting of the resulting damages, with an assessed value for each type of damage.
  •         Submit the claim to the responsible party or parties.
  •         If the settlement offer from the responsible party is too low, our attorneys will enter into negotiations with the company to arrive at a fair amount. If the company refuses to negotiate in good faith, McEldrew Young may initiate a lawsuit against them.
  •         If the client’s case advances to the courtroom, we will argue the case in front of a jury.

If you are considering filing one or more lawsuits against Fisher-Price for their Rock n’ Play Sleeper defective product, contact us at McEldrew Young to learn how we can help you.

DANGEROUS BRITAX STROLLER MAY HAVE INJURED PARENTS AND CHILDREN

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DEFECTIVE PRODUCT LAWYERS PA

Parents often assume that the products intended for use by their children are safe. Unfortunately, this is not always the case, and there are many situations in which companies put profits ahead of consumer safety and release defective or dangerous products to the market. This was demonstrated recently when news stories broke about a jogging stroller that had caused injuries to parents and children. The popular stroller maker Britax was sued on February 16th by the Consumer Product Safety Commission (CPSC) for failure to issue a recall of models of their B.O.B. jogging strollers.

Injuries When Using the Britax BOB Jogging Stroller

The BOB jogging stroller produced by Britax is intended to keep children safe and secure when parents are using it to run on sidewalks, streets, or even dirt paths. This three-wheeled stroller, which typically costs between $400 and $600, appears to be rugged and sturdy. However, hundreds of reports were sent to the Consumer Product Safety Commission (CPSC) between 2012 and 2018 stating that the front wheel of the stroller could suddenly become detached. When moving at high speeds, the strollers could then flip over, causing serious or life-threatening injuries to both children and parents. Some of the reported injuries included broken bones and teeth, torn ligaments, and severe lacerations. According to the consumer complaints, B.O.B. jogging strollers have caused these injuries listed below:

Infant/Child Injuries

  • Concussions
  • Injuries to the head and face requiring stitches
  • Dental injuries
  • Contusions and Abrasions

Adult Injuries:

  • Torn labrum (cartilage in the shoulder)
  • Fractured bones
  • Torn ligaments
  • Contusions and abrasions

In 2017, the CPSC requested that Britax voluntarily recall these strollers, but the company refused to do so. Even though the quick-release lever used to secure the wheels to the strollers was prone to cause these wheels to detach, the company claimed that the product was completely safe when used correctly because it had passed all safety tests. While the company ultimately took steps to address the issue in later models of the stroller and put out information intended to help owners use the strollers safely, there are still nearly 500,000 strollers which may be unsafe in American homes.

Contact Our Philadelphia Defective Product Lawyers

At McEldrew Young, our lawyers are experienced in holding negligent companies responsible for injuries caused by defective products. Our experience investigating the causes of injuries, obtaining evidence showing the negligence of product manufacturers, and securing compensation for our clients demonstrates that we can provide you with the representation you need in a product liability lawsuit. If you or a member of your family have been injured by a Britax BOB Jogging Stroller or other product, we will work with you to secure the compensation you deserve that fully addresses the damages you have suffered. To arrange a free consultation with our Philadelphia product liability attorneys, contact us at 215-545-8800.

The DNA of Medicare Fraud & the False Claims Act

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False Claims Act

Genetic Testing Laboratory Pays $2 Million to Settle Allegations of Medicare Fraud

The Justice Department announced a settlement last month with GenomeDx Biosciences Corp. (“GenomeDx”), a genetic testing laboratory based in Vancouver, British Columbia with offices in San Diego. GenomeDx agreed to pay nearly $2 million to resolve alleged violations of the False Claims Act. According to the complaint, GenomeDx committed Medicare fraud by submitting false claims for its “Decipher” post-operative genetic test. The Decipher test measures the activity of genes in prostate tumors to evaluate the risk of cancer recurrence.

Southern District of New York Federal Court Greenlights McEldrew Young’s False Claim Act Case Against Teva Pharmaceuticals for Trial Involving Allegations of Nationwide Kickback Scheme

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TEva

Chief U.S. District Judge Colleen McMahon ruled on February 27th that a False Claims Act suit brought by two former employees of Teva Pharmaceuticals USA, Inc. will proceed to a trial on the merits.  In a detailed seventy-page opinion, the Court rejected numerous arguments asserted by Teva Pharmaceuticals USA, Inc. and two of its subsidiaries (“Teva”) in its motion for summary judgment.  The ruling preserves all of the relators’ claims asserted against Teva under the federal False Claims Act.

The High Price of Attempted Whistleblower Retaliation

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The High Price of Attempted Whistleblower Retaliation

Barclays fined $15 Million for CEO’s Attempt to Identify Whistleblowers

The New York Department of Financial Services (DFS) issued a press release this past December  announcing a $15 million penalty against Barclays Bank PLC for violations of New York state banking laws. The sanctioned conduct involved Barclays CEO, James E. Staley, who attempted to discover the identity of an anonymous whistleblower or whistleblowers.  The saga began in 2016 when an anonymous person or persons sent two letters to a senior member of Barclays’ management.

5G Cancer Risks: Asbestos of a New Generation?

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5G Cancer Risks: Asbestos of a New Generation?

The next generation of cell phone technology could pose serious cancer risks to the public

You have probably already heard about 5G and the plans to roll out the new technology over the next two years. 5G is the new fifth-generation wireless broadband technology that promises big improvements in bandwidth (projected speeds up to 50 or 100 times faster than current 4G networks), decreased latency (delay) times, energy efficiency, and greater network capacity. While the benefits of 5G have been widely touted by the telecom industry, there are potential downsides that have received scant media attention. The new 5G standard will require a massive investment to build new infrastructure to support the technology. More importantly, numerous studies suggest that 5G could expose the public to increased risks of cancer and other maladies.

When a Slip-And-Fall Leads To Wrongful Death

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Personal Injury Lawyer

Slip-and-fall accidents are some of the most common accidents to occur. This is because there are many things that can cause it to happen, including uneven pavement, icy roads, unseen puddles, and upturned rugs. For some, a slip-and-fall accident may result in no injury or non-life threatening injuries, but for others, it may be mean wrongful death. If your loved one recently passed away after they sustained a slip-and-fall injury, you may be wondering if you can pursue a wrongful death lawsuit. Like any lawsuit, there are certain pieces of evidence that you must provide to a court and certain factors that must be present for your case to be successful.

What Should You Prove In This Lawsuit?

There are similar components you must prove for both the slip-and-fall injury and for bringing forth the wrongful death lawsuit. Just like you would for a personal injury claim after your loved one suffered a slip-and-fall accident, you must show that they were not at fault. For example, if your loved one was walking through a grocery store, tripped over their own feet, fell, and hit their head, they were likely the cause of their injury. If this case, you would not have had substantial evidence to bring forth a personal injury claim had your loved one survived. Thus, you likely would not have enough evidence for a wrongful death lawsuit either. On the other hand, if your loved one slipped on a wet puddle in the middle of the grocery store that had no warning signs, hit their head and later died because of these injuries, you likely have what you need for a lawsuit.

Components Of the Wrongful Death Lawsuit

You must present certain elements to have a successful wrongful death lawsuit. These are:

  • Your loved one died.
  • Their death was not their own fault but someone else’s negligence caused it.
  • The negligence directly caused your loved one’s death.
  • You or surviving family members are suffering in some way (typically financially) because of their death.

With the above example, the components would be that your loved one slipped and sustained injuries due to the negligence of the store manager or staff, died because of these injuries, and you and other family members are suffering for various reasons because of their death.

What Kind Of Damages Can Someone Claim?

When your loved one was the victim of wrongful death after a slip-and-fall, there are certain damages you can claim. Some of these are:

  • Burial and funeral expenses
  • Medical bills prior to your loved one’s death
  • The loss of the victim’s income
  • The loss of the victim’s benefits
  • The loss of consortium or love
  • The pain and suffering your loved one went through before dying
  • A loss of companionship

Why Slip-And-Fall Accidents Are So Dangerous

Many people walk away from slip-and-fall accidents without a scrape. Others may have mild injuries. Slip-and-fall accidents are particularly dangerous because brain injuries (like concussions or hemorrhages) may not have any signs until it is too late. If your loved one died after a slip-and-fall accident, don’t hesitate any longer in seeking help from a compassionate attorney, like a personal injury lawyer in Melbourne, FL

Thanks to our friends and contributors from The Law Offices of Arcadier, Biggie, & Woods for their insight into personal injury and wrongful death.

Can I Get a Settlement with 3M for Hearing Loss Caused by Combat Earplugs?

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3M Combat Earplug Hearing Loss Claims

 

In July 2018, the popular company, and brand 3M, was ordered to compensate victims of hearing loss and tinnitus by the U.S. Department of Justice. The lawsuit was filed by a whistleblower, and later on the D.O.J., for selling the government defective earplugs which were used by millions of deployed military personnel. To date, a very large number of veterans have suffered from hearing loss and tinnitus which was likely caused by 3Ms Combat Arms Earplugs (CAEv2).

 

Is a Settlement with 3M for Hearing Loss Caused by Combat Ear Plugs Available for You?

If you are a U.S. military veteran, a current service member, or a military contractor, and you used 3Ms Combat Arms Earplugs (CAEv2), it may be possible to file a lawsuit against the company. McEldrew Young is currently reviewing cases that involve 3M earplug claims.

If the following apply to you, please call us as soon as possible:

  • You were on active duty in foreign combat zones between 2003 and 2015.
  • You used 3Ms Combat Arms Earplugs (CAEv2).
  • You have been diagnosed with temporary,, long term, or permanent hearing loss or tinnitus while you served or after.

 

A settlement with 3M for hearing loss caused by Combat earplugs may be available to cover:

  • Medical care
  • Hearing aids
  • Treatment to improve your hearing
  • Loss of income
  • Pain and suffering
  • Temporary or permanent damages
  • + More

 

How Does 3Ms Combat Arms Earplugs (CAEv2) Cause Damage to the Ears

3Ms Combat Arms Earplugs (CAEv2) were originally created by Aearo Technologies, Inc. In 2008, 3M acquired the company and its employees. According to the lawsuit, Aearo knew about the defective earplugs as early as 2000. It was also claimed that Aearo was manipulating test results in order to meet the strict standards of the U.S. Government.

 

In 2003, Aearo was able to convince the government to purchase the earplugs, via military contract, for U.S. military personnel. Troops in all branches of the U.S. Military were issued these ear plugs. Those were were in combat zones like Iraq or Afghanistan expected these ear plugs to block out loud noises like gunfire, aircraft, and explosions. Consequently, the 3Ms Combat Arms Earplugs (CAEv2) did not work in the way they were supposed to; thereby, allowing dangerous levels of sounds to penetrate through the ear canal and into the eardrum, leading to:

 

  • Partial or full hearing loss
  • Tinnitus
  • Chronic tinnitus

 

The U.S. Department of Veterans Affairs has said that there is a sharp increase in hearing related problems in service personnel. Over 1 million people have been diagnosed with hearing loss and nearly 2 million with tinnitus. This is likely to be attributed to 3Ms Combat Arms Earplugs (CAEv2).

 

If You Have Suffered from Hearing Loss or Tinnitus while Serving in U.S. Combat Zones, Call McEldrew Young

Even though you might have worn the 3M earplugs many years ago, it may be possible to recover compensation. The first thing you should do is to contact a lawyer for 3M Combat Arms Earplugs lawyer as soon as possible.

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