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:
Low blood platelet counts
Enlargement of the spleen or liver
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.
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.
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
Disregard of stop sign or traffic signal
Driving under the influence of alcohol or drugs
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.
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.
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:
Lower back and neck pain
Traumatic brain injury
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.
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:
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.
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.”
“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.”
Richard Schlueter, a partner with Childers, Schlueter, & Smith, LLC, was recently quoted and appeared on cbatlanta.com regarding the DePuy Orthopaedics Recalled ASR Hip Implant.
DePuy recalled the ASR Hip System last year in August “because it was wearing out faster than expected in some patients.” According to Richard Schlueter, DePuy downplayed side effects that are far more serious. Schlueter and the firm of Childers Schlueter & Smith are representing more than 30 Georgians and dozens more citizens on a nationwide basis that have the recalled ASR hip implant from DePuy.
The video of this important news story by Stephany Fisher of CBS Atlanta News is shown here:
A very serious side effect from this recalled hip implant is metallosis. When the device wears, it is possible that it will shed metal particles and cause pain, swelling and permanent tissue damage. In addition to metallosis, Cobalt or Cobaltism, according to Schlueter, is the real concern.
DePuy declined an interview with cbatlanta.com after their request but did make the following statement:
“DePuy’s top priority is and always has been patient safety. In August 2010, DePuy issued a voluntary recall of the ASR Hip System after receiving new information from the UK National Joint Registry as part of the company’s ongoing surveillance of post-market data concerning the ASR Hip System. Read the rest of this entry »
After DePuy Orthopaedics made a major announcement recalling two of their major hip implant devices in August of 2010 (DEPUY ASR XL ACETABULAR HIP SYSTEM &DEPUY ASR HIP RESURFACING SYSTEM), the company recommended those patients directly affected get blood tests done by their doctors. The reason for this recommendation is to determine whether the patient, who is affected by the Recalled DePuy Hip Implant, has high levels of chromium and cobalt presented in their bodies. Elevated levels are a precursor to an inflammatory response that results in eventual necrosis and resorption of bone that leads to physical symptoms that the patient may experience from the ASR device. There are also significant other medical problems that a patient may experience by having toxic level of cobalt or chromium in their system as well. The really concerning part of this is that many patients do not know they are experiencing problems until the issue becomes critical and potentially life threatening.
From the Recalled ASR Hip Implant itself, the device can release metal particles and go into the patient’s bloodstream and/or tissue. A high level of cobalt released into a patient’s tissue and/or bloodstream can damage the patient’s tissues, bones and/or organs. Consequences of a toxic cobalt levels include, but are not limited to: tinnitus (ringing of the ears), blindness, pain, and other conditions.
Here is a close look at the Recalled DePuy Hip Implant.
What exactly is cobalt? According to the Agency for Toxic Substances & Disease Register (ATSDR), cobalt is a naturally occurring element that can be found in water, plants, animals, rocks, and soil. The element is used in the manufacturing of aircraft engines, grinding and cutting tools, magnets, and artificial hip and knee joints. Cobalt can benefit or harm human health. In the case of a hip implant, it can be extremely harmful. Although DePuy is suggesting patients to have a blood test performed to see the amount of cobalt present in affected patients, there are three ways to test for cobalt. The three tests include whole blood tests, blood serum tests, and urine tests.
Lap Corp is one of the laboratories reporting the blood tests for DePuy. From what we have seen in our cases, the test results returned to patients by Lab Corp. in regards to the reference levels of toxicology, do not quantify the numerical read out for what a Toxic level is.
Furthermore, Lab Corp. has contracted with MedTox Laboratories Inc. to perform the blood analysis and results that is reported to DePuy ASR patients. It is believed that the Lab Corp. method of reporting the value of Cobalt may be misleading or at the very least may not provide all the necessary information to fully be apprise patients of the potential dangers from them.
Below is an example of a report of Lab Corp. on a tested patient that according to studies demonstrate that this patient’s level of Cobalt is toxic. How will the orthopedic physician read this report? Though the report gives a reference value to the chromium value to be “high” in bold and identified, there is no similar info reported to the physician on Cobalt
What does this mean? If the Doctor does not independently research studies regarding toxic values of Cobalt, patients will likely not be informed if the level of cobalt present in their blood is actually toxic! Doctors can easily read this lab report and see “TOXIC: Not established” and assume the patients have nothing to worry about. This could be extremely misleading to patients and doctors alike and therefore it should be more thoroughly investigated and examined.
If you have any questions regarding this post or your own cobalt and chromium test results, you may want to contact our attorneys at CSS Firm. Although we are not doctors, our experienced team of injury lawyers will work closely with you and see that your medical and legal needs are properly considered and evaluated.
The most devastating crashes on the road resulting in the most serious types of injuries are tractor trailer crashes. Collisions between tractor-trailers, also known as semis and semi-trailer trucks, and regular two-door/four-door sedans result in some of the most catastrophic injuries. When a truck accident occurs, serious bodily injuries follow.
New safety features and mechanisms are constantly being developed to help prevent trucking collisions. However, all the new safety designs in the world can’t make up for poor decision-making out on the roads. And while accidents on the road are sometimes avoidable, the trucking industry as a whole is still responsible for many of the trucking accidents.
Many drivers involved in trucking accidents are injured as a result of a tractor trailer company expecting more from their drivers than they should. According to the U.S. Department of Transportation Federal Highway Administration, one out of nine traffic fatalities last year resulted from a collision involving a large truck or semi. On average, 380,000 large trucks are involved in crashes.
Getting evidence is extremely important. 911 recordings from police departments are only kept for a certain period of time, often as short as 90 days. If a request for the 911 records is not made to the police department in a timely fashion, the records can be lost. Similarly, “roadway evidence” such as skid marks – marks left on the roadway from a vehicle that has locked its breaks – and yaw marks – marks left on the roadway when a vehicle’s tires spin in a circular motion – are key pieces of evidence which get washed away within a few days after the crash. An accident reconstructionist can help with that process.
Also, operational documents that are maintained by the trucking company may disappear unless the company is instructed to hold onto the records. A spoliation letter from a trucking attorney telling the company to properly safeguard all reports and logs is needed to bolster the argument that the trucking company should have retained the records beyond the six months required by the Federal Motor Carrier Safety Regulations (see Part Two of this Article).
In addition to operational documents, the electronic control module (“ECM”) should be removed from the tractor and preserved. The ECM controls the systems on the tractor unit. It records data relating to the operation of the tractor. The information it records will include speeds, brake system operations and engine controls. This information can be downloaded by the manufacturer and may play an important role in determining what happened at the time of the crash.