Pfizer Pays $35 Million in Rapamune Settlements

August 18th, 2014

According to the Associated Press, Pfizer plans to pay $35 million to resolve allegations by 42 states that its subsidiary, Wyeth Pharmaceuticals, illegally marketed an organ transplant drug for unapproved uses.

The states’ attorneys general said on August 6, 2014 that Wyeth, which New York-based Pfizer acquired for $68 billion in 2009, trained sales representatives to encourage doctors to prescribe Rapamune for uses other than preventing rejection of transplanted kidneys. Rapamune was approved by the Food and Drug Administration in 1999 only for use in kidney transplant patients, and promoting drugs for uses not cleared by the FDA is illegal.

Rapamune (generic name sirolimus) lowers a person’s immune system to prevent the rejection of a transplanted kidney. It can also lower blood cells that help a body fight infections, making it easier for an individual to bleed excessively from an injury or get sick from being around others who are ill.

Other potential side effects include joint pain, nausea, vomiting, diarrhea, constipation, stomach pain, headache, acne, and skin rash.

Under the terms of the settlement agreement, Pfizer will reform its marketing and promotional practices to avoid unlawfully promoting Rapamune or any Pfizer product, and will not:

  • Make false, misleading, or deceptive claims
  • Make any claim comparing the safety or efficacy of a Pfizer product to another product when that claim is not supported by substantial evidence
  • Promote any Pfizer product for uses not approved by the US Food and Drug Administration
  • Provide incentives to encourage sales for off-label uses
  • Seek to have Rapamune included in hospital protocols or standing orders unless it is to be used for an FDA-approved purpose
  • Share information describing any off-label or unapproved use of Rapamune unless such information complies with FDA regulations
  • Seek to influence the prescribing of Rapamune in hospitals or transplant centers in any manner that does not comply with federal law banning kick-backs, including through funding clinical trials

Pfizer said in a statement that the alleged illegal activity occurred before it acquired Wyeth, and did not admit any wrongdoing or liability as part of the settlement. The company agreed to pay nearly $491 million in July 2013 to resolve a similar investigation by the Department of Justice.

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RegenESlim Recalled Due to Presence of DMAA

August 15th, 2014

Regeneca Worldwide, a division of VivaCeuticals, Inc. in Las Vegas, is voluntarily recalling its RegenESlim appetite control dietary supplement due to the confirmed presence of DMAA in certain lots of the supplement. DMAA, also known as dimethylamylamine, methylhexanamine, or geranium oil/extract, is typically used as a stimulant, pre-workout, and weight loss ingredient in dietary supplement products.

The FDA has warned that DMAA is dangerous because it can narrow blood vessels and arteries and cause a corresponding rise in blood pressure or other cardiovascular problems, such as:

  • Shortness of breath
  • Arrhythmias
  • Elevated blood pressure
  • Tightening in the chest
  • Heart attack
  • Death

Until 2012, DMAA, which was first discovered by Eli Lilly and Company in 1944, was sold by numerous companies. It was marketed as the nasal decongestant Forthane until 1983, and reappeared as a dietary supplement in 2006. The FDA reported that by April 2013, it had received 86 adverse event reports from people who used DMAA, and in response sent warning letters to a total of 11 companies advising them that DMAA-containing products marketed as dietary supplements are illegal and must be taken off the market. These companies include:

  • Exclusive Supplements – Biorhythm SSIN Juice
  • Fahrenheit Nutrition – Lean Efx
  • Gaspari Nutrition – Spirodex
  • iSatori Global Technologies, LLC – PWR
  • Muscle Warfare, Inc. – Napalm
  • MuscleMeds Performance Technologies – Code Red
  • Nutrex Research – Hemo Rage Black, Lipo-6 Black Ultra Concentrate, Lipo-6 Black, Lipo-6 Black Hers Ultra Concentrate, Lipo-6 Black Hers
  • Regeneca, Inc. – RegeneSlim
  • SEI Pharmaceuticals – MethylHex 4,2
  • SNI LLC – Nitric Blast
  • USP Labs, LLC – Oxy Elite Pro, Jack3D

Although there have been no reported illnesses to date, the voluntary recall was the result of FDA analysis confirming the presence of DMAA in RegenESlim. Regeneca Worldwide is conducting a continuing investigation on the problem.

Customers who have purchased RegenESlim Lot #EX0616R15814 and Lot #11414RE5516 are advised to stop using the product immediately and return it to the place of purchase for a full refund. Adverse reactions to the supplement may be reported to the FDA’s MedWatch Adverse Event Reporting program online, fax, or via regular mail.

RegenESlim is purchased by and distributed through direct sales in the U.S. and Puerto Rico, and also through online sales for both personal use and retail sales.

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Childers, Schlueter & Smith Continue to Investigate Stryker Claims Related to Recalled Hip Implants

August 8th, 2014

Our personal injury lawyers are still investigating claims on behalf of anyone who has had revision surgery due to complications from the recalled Stryker Rejuvenate or ABG II modular-neck stem implant. In July of 2012, the Stryker Corporation issued a voluntary recall of the Rejuvenate and ABG II modular-neck stem hip implants due to the risks associated with corrosion of the modular neck joint of the implant. For more information, check out the “Top 10 Things all Stryker Hip Implant Patients Need To Know

depuy-recallAccording to a study published in the Journal of Bone and Joint Surgery, 48 percent of the total hip arthroplasties measured in the study resulted in elevated metal ion levels for the patients that received them. The study also indicated that the rate of revision surgery administered to hip implant patients was 28 percent. We believe those numbers will continue to increase in the months and years ahead based on our own specific findings.

Those patients in the study who received a modular hip implant had the Kaplan-Meier survivorship (a measure of the life cycle of a product) of their devices measured at 40 percent after 4 years even though they are intended (and marketed to patients) to last for at least 15 years.

It comes as no surprise to us that results from this new study are consistent with what our clients have been alleging all along: The Stryker Rejuvenate or ABG II are defective and should have never been placed on the market. Our national hip implant attorneys are currently investigating Stryker hip implant recall claims on behalf of all persons who have received a Rejuvenate or ABG II modular-neck stem implant. This includes those that have already had a revision (replacement) of the hip device as well as those that have yet to have the recalled implant replaced.

If you or a loved one has suffered medical complications from the Stryker Rejuvenate or ABG II, contact the national personal injury lawyers at Childers, Schlueter & Smith LLC for a thorough investigation into your claim. All inquiries are kept confidential and all initial consultations are free of charge.

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Class Action Filed Against Cerezyme Manufacturer

July 5th, 2014

A class action lawsuit has been filed against Genzyme Corporation, the maker of the drug Cerezyme, after a Colorado man claimed the company distributed and sold impure and untested drugs. Cerezyme, which costs $200,000 a year or more, is prescribed to treat Gaucher disease, a rare enzyme deficiency that is inherited from an individual’s parents.

What is Cerezyme?

Cerezyme is a modified form of the human enzyme, glucocerebrosidase. It is produced using genetic engineering technology, also called recombinant DNA technology, and has been shown to be effective in the treatment of Type 1 Gaucher Disease. It is prescribed for adults and children with Type 1 Gaucher disease that results in one or more of the following symptoms:

  • Anemia
  • Low blood platelet counts
  • Enlargement of the spleen or liver
  • Bone disease


Once considered a miracle drug for those suffering from Gaucher Disease, Cerezyme was contaminated with vesivirus sometime prior to July 2009 and according to the complaint, the company cut doses to less than a third for many Gaucher patients due to a shortage of the drug. The company allegedly knew the diluted medication was experimental and dangerous and still elected to give it to certain patients, including the plaintiff, who now suffers from an incurable cancer.

According to court documents, after Genzyme contaminated its bioreactors with the dangerous virus, the company was forced to temporarily close its main factory in Boston, greatly reducing the output of Cerezyme. Genzyme did not restore full supplies of Cerezyme until January of 2011, much later than initially expected.

Because Genzyme could not meet customer demand for Cerezyme, the company implemented a plan that was designed to ration the drug that was allegedly illegal to sell or market in the first place, according to the complaint, because it was “experimental, mislabeled, impure, contaminated, ineffective, diluted and illegally substituted but marketed as if it were a beneficial treatment for Gaucher Disease,” although it was never previously tested in animals or human beings.

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California Counties Wage War Against Narcotics Industry

July 3rd, 2014

With language reminiscent of the government’s legal attack against the tobacco industry beginning in 1999, officials from Orange and Santa Clara counties in California filed suit against five of the world’s largest narcotics manufacturers last month. Both counties have been hit hard by overdose deaths, emergency room visits, and rising medical costs associated with prescription narcotics.

The lawsuit names Actavis, Endo Health Solutions Inc., Johnson & Johnson’s Janssen Pharmaceuticals, Purdue Pharma, and Teva Pharmaceutical Industries’ Cephalon Inc. and alleges that the companies essentially caused the nation’s prescription drug epidemic through false advertising, deceptive business practices, and by creating a public nuisance to manipulate doctors and reap huge profits.

According to court documents, the companies are accused of encouraging patients to ask their doctors for painkillers such as OxyContin to treat relatively common conditions such as headaches, arthritis, and back pain. The drug manufacturers promoted these narcotic painkillers as safer than they actually and promised unproven benefits like improved sleep and quality of life, the suit says.

The drug manufacturers’ marketing campaigns, carried out over the past 20 years, have encouraged doctors to turn to narcotic prescriptions as a first resort rather than the last for all types of pain, and many patients stay on the drugs indefinitely.

Twenty years ago, the narcotics industry was selling to a relatively small market because of the long-held fear of addition that stopped doctors from prescribing the powerful painkillers for anything but cancer and end-of-life pain. The lawsuit claims that to expand their market, drug companies engaged in a dishonest campaign to reeducate doctors and revolutionized the treatment of pain associated with a wider array of ailments.

According to the suit, it was the marketing and not any medical breakthrough that heightened the prescribing of narcotics for chronic pain and increased the potential for use and abuse. Painkillers are reportedly involved in over 16,000 fatalities in the U.S. each year, beating out traffic accidents as a leading cause of death.

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Georgia Car Accident Basics

February 26th, 2014

When a vehicle collides with another vehicle, pedestrian, or other obstruction, a car accident results. Car collisions can cause minor or more serious injuries, vehicle damage, property damage, and even death.

Factors Affecting the Risk of Car Accidents

Many factors contribute to the risk of car accidents, including the design of a vehicle, road conditions, debris, as well as driver skill, behavior, reaction time, and impairment. Some common types of impairments that may contribute to a higher frequency of car accidents include alcohol, physical impairments, sleep deprivation, drug and alcohol use, and driver distraction.

According to the Georgia Governor’s Office of Highway Safety, the top contributing factors of all crashes and fatal accidents in the state include:

  • Following too close
  • Failure to yield
  • Changed lanes inappropriately
  • Driver lost control
  • Object or animal in roadway
  • Improper backing
  • Disregard of stop sign or traffic signal
  • Driving under the influence of alcohol or drugs
  • Improper turn

I’ve Been in an Accident – What Should I Do? 

If the accident resulted in injury or death of any person or property damage over $500, you are required to report the accident to the authorities immediately.

Georgia law requires the driver of any vehicle involved in an accident to do certain things, including:

  • Stop and remain at the accident scene.
  • Render reasonable assistance to anyone injured, including transporting or making arrangements to transport them to the hospital if necessary.
  • Exchange information with the other driver, including name, address, driver’s license information, and vehicle registration number.
  • Move the vehicle off the roadway onto the shoulder, emergency lane, or median if it can be safely driven and does not require towing.

You will also need to notify your insurance company of the accident, and if possible, take photographs of the accident scene, the damage to the vehicles, and any physical injuries. Always be careful about what you say after an accident. Although you have an obligation to cooperate with law enforcement and your own insurance company, you are not required to give a statement to the other driver or his insurance company – the best way to proceed is to seek legal advice first.

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When Minor Impact Causes Major Injuries

February 22nd, 2014

When someone is injured in a seemingly minor collision with minimal property damage, a popular insurance defense tactic is to say that such minor impact could not have caused the plaintiff’s injuries. But no amount of expert testimony and excuses can change the fact that severe injuries often result from minor impact.

Speed and Motor Vehicle Collisions

Many people assume that the greater the speed and impact, the more serious the injuries sustained. While this may be true, it is not always the case. In the case of an automobile wreck with major or minor impact, common sense says that but for the car crash, the victim would not have suffered the injuries they did.

When a crash involves vehicles that are traveling very slowly and little or no property damage occurs, victims can still suffer significant injury and pain, particularly whiplash and other neck injuries. Although automobile bumpers may be built to withstand up to a five mile-per-hour crash without damage, the reality is that when the bumper doesn’t crumble and absorb the force of the impact, more of the crash is felt by the occupants, who are thrown forward with a severe jerking motion that causes necks to snap and backs to twist.

Injuries Can Manifest Later

What may appear to be minor injuries in the first few days and weeks after the accident can turn out to be serious injuries down the road. Some serious injuries that can occur after car crashes involving major as well as minor impact include:

  • Whiplash
  • Herniated discs
  • Lower back and neck pain
  • Concussions
  • Traumatic brain injury
  • Headaches
  • TMJ disorder

Never Underestimate Your Injuries

It’s very important that an individual exposed to impact as a result of a motor vehicle accident – no matter how insignificant the impact may seem to have been – be examined by a medical professional as soon as possible. When dealing with your body and related trauma, it is generally always better just to be safe and get checked out.

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Update: J&J Ordered To Pay $11.1 Million In Prolift Mesh Jury Trial

February 28th, 2013

In an update on our previous posts concerning the transvaginal mesh implant case of Gross v. Gynecare Inc., Atl-L-6966-10, Superior Court of Atlantic County, New Jersey, the same jury just returned a verdict of $7.76 Million more dollars in punitive damages. This amount is in addition to the compensatory verdict of $3.35 Million awarded earlier this week for a grand total of $11.1 Million in all.

Jurors in Atlantic City made the award today to punish J&J, the world’s largest seller of health-care products. The verdict came in the first of 4,000 lawsuits to go to trial over J&J’s pelvic mesh, including 2,100 in New Jersey. The jury of six men and three women declined to comment on its decision.

The total of $11.1 million goes to Linda Gross, a South Dakota nurse who complained of constant pain and underwent 18 operations after J&J’s Gynecare Prolift was implanted to shore up weakened pelvic muscles. On Feb. 25, the panel found that J&J and its Ethicon unit failed to warn her surgeon of the risks of the device and fraudulently misled her about the risks.

The Bloomberg news has just reported the events of the case here:

J&J Owes $7.76 Million in Punitives in Vaginal Mesh Case

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DePuy ASR Hip Implant Settlements Reached Prior To Jury Trial

August 19th, 2012

The first ever DePuy ASR hip implant cases set for a jury trial inNevada has recently settled. It was supposed to be the first courtroom battle in the country of patients with the defective ASR hip replacement against Johnson & Johnson subsidiary DePuy Orthopaedics, manufacturer of said hip implant. In December later this year, a Las Vegas Nevada state court judge was scheduled to preside over a jury trial of three plaintiffs against DePuy Orthopaedics for problems that the DePuy ASR hip replacement caused. All three of the patients had their ASR hip devices removed and replaced (revised). However, in what is breaking news, that Nevada trial is no longer going to go forward as originally scheduled because the parties have recently agreed to a confidential settlement. December 2012 was to be the first time that Johnson & Johnson subsidiary DePuy Orthopaedics was going to appear in court and explain what caused their hip product to create so many problems for patients who had their product implanted. This DePuy ASR hip implant settlement ends any showdown that was supposed to occur inLas Vegas. Like many settlements involving larger corporations like Johnson & Johnson, the terms of this settlement remain confidential. It is unfortunate that without the threat of a trial, the defendants DePuy and J&J has not compensated harmed patients that have had to undergo surgery to replace the defective device that they manufactured.

While the December 2012 trial is no longer moving forward given the settlement, there is another jury trial set by a Maryland state court judge set to begin in January 2013. The Maryland trial is also on behalf of three patients with recalled DePuy ASR hip implant that had to be replaced. In the event that a settlement is not reached prior to January 2013, Johnson & Johnson subsidiary DePuy Orthopaedics will have to explain what caused the defective hip product.

Both the December 2012 lawsuit and the January 2013 lawsuits were filed because Johnson & Johnson subsidiary DePuy, led thousands of patients with damaged hips to believe that their now recalled ASR Hip Replacement System, which uses a metal-on-metal device, would improve the pain and mobility of their hip. However, the danger of a metal-on-metal device has proven to be just as harmful as a damaged hip, if not more so in many cases based on our investigations. The implant contains the elements cobalt and chromium, which can be hazardous, and promote an inflammatory response that damages the surrounding tissue and bone. Shards of this metal have been known to grind off of the ASR hip implant damaging surrounding tissues and muscles, resulting in an increased level of these dangerous metal ions in the body. This can cause intense leg, hip, or groin pains, and in many cases patients have reported pain to the point of immobility.

To date there are more than 8,000 claims pending in the federal court and state courts. Childers, Schlueter & Smith, LLC is a leading firm in Georgia handling and litigating DePuy ASR hip implant claims. To date, our office has filed more than 160 individual claims on behalf of Georgians and other ASR victims from around the Country. It is unclear how many trials will have to be tried before DePuy and J&J will step up to do the right thing and acknowledge the harms and misery created by there ASR hip implant products and further agree to compensate the victims for the past, present and future harms expected from this recalled device.

For more information or assistance please visit CSSfirm.com or call us at 404-419-9500 for assistance or any questions in preserving a claim before any potential statute of limitations may run.

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DePuy ASR Hip Recall Featured on CBS Atlanta News with CSS Firm Partner Richard Schlueter

August 17th, 2012

The DePuy ASR hip recall initiated in August of 2010 has been a hot topic of discussion in the medical community over the last year and half. Surprisingly thousands of patients are still unaware of the detailed history and circumstances surrounding the hip implant recall. CBS Atlanta News, as anchored by Stephany Fisher, recently did an informative news piece called: Consumer Reports Investigation Warns of Dangerous Devices.

In discussing the DePuy ASR hip recall and the failures associated with it, Childers Schlueter & Smith founding partner, Richard Schlueter, was featured in the news piece along with Calhoun Police Lieutenant John McGivern who is a Childers, Schlueter & Smith client.

Atlanta attorney Richard Schlueter is representing more than a 150 clients who received the now-recalled implant. And it’s estimated that several thousand people in Georgia are affected.

Based on the initial FDA notice date of July 17, 2010 and subsequent DePuy worldwide recall date of August 24, 2010, the statute of limitations for most Georgians affected by this DePuy ASR recall will expire in less than 60-90 days, or as early as July 17, 2012 (if you go by the actual FDA notice date to doctors) or possibly August 24, 2012 (if you go by the actual product recall date). There may be exceptions to these dates for Georgia citizens based on the Discovery Rule, that can in limited circumstances extend the standard 2 year rule if the injured viticm was not aware they had a recalled ASR hip implant and/or that it has caused them injuries.

For this reason, and as denoted in the news story and video:

Richard Schlueter stressed that time is running out for victims to pursue legal claims, stating, “I would encourage anybody that has this device to consult with a lawyer to at least know their options and to make sure they bring a claim before the statute of limitation runs,” he said.

There have been numerous news articles and groundbreaking stories covering the DePuy ASR hip implant recall since 2010, and Consumer Reports recently joined in the cause to promote more awareness of this life altering, and potentially life threatening, problem.

“This particular type of hip was called the ASR XL,” said Consumer Reports’ investigator Nancy Metcalf. “It was made of chrome cobalt metal, but it was never clinically tested before the FDA cleared it to be sold. Because of high failure rates and complications like Dr. Tower experienced, it’s now off the market.”

Childers, Schlueter & Smith, LLC applauds the efforts of  Stephany Fisher and CBS Atlanta News for “Asking Tough Questions” to promote more awareness of the growing epidemic of 510(k) medical devices and the recalls affecting thousands of patients and consumers all over the United States.

In addition to viewing the CBS news report, if you are not familiar with the Safe Patient Project,  please review their website as soon as possible to learn about how they are working to keep Georgians and Americans safe from untested and dangerous medical devices, such as the recalled DePuy ASR metal-on-metal hip implants:

“Medical device industry lobbyists are working overtime to pressure Congress to preserve weak federal oversight that puts patient lives at risk,” said Lisa McGiffert, Director of Consumers Union’s Safe Patient Project (www.SafePatientProject.org).  “We need common sense reforms to assure consumers that these devices are safe and work like they are supposed to.”






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