According to the Associated Press (7) people have died from tainted steroids produced by The New England Compounding Center in Massachusetts.
So far 60 cases have been discovered in 9 states; including right here in Florida. There are (8) facilities in Florida confirmed to have received the tainted lots:
Lot No. 05212012@68,
Lot No. 06292012@26
Lot No. 08102012@51)
These include health care centers Florida Pain Clinic, Marion Pain Management Center (Ocala) and Surgery Center of Ocala and the Orlando Center for Outpatient Surgery. And, potentially affects patients who received the injection from July 30 through September 28, 2012.
The Center for Disease Control (CDC) and the Florida Department of Health (DOH) are actively working on quarantining the distributed medication. It is believed that due to ineffective quality controls a dangerous fungus has been grown out in these lots of medicines. Experts advise consumers to watch for symptoms like fever, headache, and nausea. Some of these symptoms can take weeks to develop, but should not be casually dismissed.
As someone who represents and speaks with injured victims of negligence and tragic accidents every day, I can understand the terror these folks are experiencing as all this unfolds. The ominous fear of not knowing and having to wait to see whether you develop symptoms is terrifying.
The threat of viral meningitis is real and has potentially life threatening results. Meningitis is an inflammation of membranes, called meninges, protecting the brain and the spinal cord. In these cases the infective agent seems limited to a virus, but meningitis can also be caused by bacterial and other microorganisms. Viral meningitis requires a lumbar puncture to obtain cerebrospinal fluid and determination of whether the virus is present. Most often, it is treated with antiviral and corticosteroid medications.
Our firm is working to help those exposed to this tainted medication. Through our investigation and research we intend to better understand how these contaminated lots occurred and were then released to unsuspecting consumers.
Once the cause of this tragedy is better understood, we will be in a position to craft the best advice and the most effective course of action for our clients.
On March 10, 2010, the Stryker Orthopaedics Division announced the release of a new hip replacement, the ADM X3 Mobile Bearing Acetabular System. Calling it the “next-generation of technology” in hip replacements, the company announced that Hall of Famer, Johnny Bench, would become the first patient in the world to receive the device. What is missing from that press release and all associated “speaking tour” videos cut by Mr. Bench is what stem was implanted in Mr. Bench.
Stryker was aggressively trying to distance itself from the complications associated with metal-on-metal hip implants that have been generating news headlines, thousands of injured patients around the globe, and defective product lawsuits.
A deeper look into the company’s website shows this latest generation is made of precisely engineered polyethylene, “designed to help minimize the risk of wear and consequently help prolong the life of the implant.” And the X3 mobile bearing hip system offering a large head, thought to be more stable than a smaller diameter head.
Good luck on the newest generation of hip replacements if the past is any indication. And, perhaps the silence is because Mr. Bench was the unfortunate recipient of either a now recalled Rejuvenate or ABG II modular stem.
Bench became a paid spokesman for Stryker after he received his first hip implant in 2004. The former professional baseball catcher, who played in the Major Leagues for the Cincinnati Reds from 1967 to 1983, blamed the 400,000 squats he did during his 17-year career for his arthritic and deteriorating left hip.
Bench received a Stryker ceramic hip that year. But by 2005, complaints began to surface about the poorly-fitting and squeaking implant which wore unevenly causing pain, bone fractures, and difficulty walking in some patients.
The U.S. Food and Drug Administration (FDA) warned Stryker about the complaints in a six-page letter. Bench had experienced some squeaking in his left hip but was quoted as saying, “I don’t care if it plays ‘Dixie’”.
The FDA inspected the Stryker manufacturing plants in Cork, Ireland and in Mahwah, New Jersey and found quality control problems at different stages of manufacturing including the discovery of staph bacteria in New Jersey. The FDA then sent a warning letter to Stryker at its Kalamazoo, Michigan headquarters to president and CEO Steven MacMillan dated November 2007, saying it could seize products if the problems were not corrected.
Stryker recalled two products in the Trident line including the two hip replacement cups, the Trident Acetabular PSL Cup, and the Trident Hemispherical Cups made in Cork, Ireland.
On July 6, 2012, the company recalled the Stryker Rejuvenate and ABG II Modular-Neck Stems due to 60 reports of metal toxicity that led to an early revision or removal of the hip. The surgeon who implanted Mr. Bench with the new ADM bearing surface in 2010 is known to have been a user of the Rejuvenate and ABG II stems.
The Stryker Rejuvenate and ABG II had metal neck components of chromium and cobalt and a stem coated with titanium that led to complications including metallic debris in the bloodstream even without a metal-on-metal junction. Since they do not involve a metal ball and socket, they were not considered metal-on-metal hip replacement devices. But a revision of a stem component, which is placed deep inside the patient’s femur, can be a complicated and difficult surgery.
The Rejuvenate was approved by the FDA in June 2008, with the ABG II was approved in November 2009. Both systems received 510(k) notification approval as Stryker said they were similar enough to other devices already on the market.
That meant the company got a pass on providing clinical studies to prove safety and efficacy. That’s the problem.
The newer Stryker devices are modeled on systems that were already found to be defective and resulted in adverse events such as neck fractures, bone fractures and dead tissue response.
So far there has been no press release from Stryker telling us how Johnny Bench is doing with his right hip replaced with the latest and greatest version of a hip device that may or may not have been based on the design of the defective models preceding it. How embarrassing would it be for Stryker if Mr. Bench in fact had been implanted with defective and recalled Stryker products in both hips?
Word of caution – never volunteer to become the first person to receive a newly issued medical device that is permanently implanted – especially if there were no safety inspections required under the fast-track 510(k) FDA approval process.
Don’t hold your breath for an updated press release.
Do cigarette manufacturers know their customers, or do cigarette manufacturers know their customers?
A recent article in the New York Times found that “low-income smokers in New York spend 25% of their income on cigarettes.”
While statistics like this might come as a surprise to regular folks like you and me (and seem far-fetched), the notion that an addicted smoker will continue to buy cigarettes to feed his addiction – no matter what the cost – is old news to cigarette makers (http://legacy.library.ucsf.edu/action/document/page?tid=leq11b00). As one Philip Morris research scientist so matter-of-factly put it in 1969, during a presentation to the Philip Morris Board of Directors:
The cigarette will even preempt food in times of scarcity on the smoker’s priority list.
Cigarette makers have been studying smokers for years. And they have used this research to design their products. But don’t take my word for that – all one must do is look at the previously confidential internal business records of the major cigarette makers to find out about the lengths they went to study their customers. And why they did it.
Of all the previously confidential cigarette business records, one of the documents that sums up this aspect of cigarette/smoker research the best, in my opinion, is a Philip Morris business record from 1977. The document’s title alone is simple, yet informative – SMOKER PSYCHOLOGY PROGRAM REVIEW– and can’t help but conjure up images as cigarette researchers as evil puppet masters who have taken it upon themselves to learn more about smokers than even smokers know about themselves. And if the title alone doesn’t bring the puppet-master visual to mind, let me highlight some things that the author – who wrote this believing it would never see the light of day – states:
I’ve taken this as an occasion to review our basic premises – to ask
myself why are we doing the things we’re doing.
First, every undertaking has to have some mission. I would state
our charter from Philip Morris in this fashion:
Study the psychology of the smoker in search
of information that can increase corporate
Our charter is unique in that we are given the smoker to study.
Meanwhile, back in the lab, we continue to ask what it is that the
smoker derives from smoking.
I’ll try to explain the conceptual model that we are using.
We sell a product that is bought often and used from 10 to 60
times a day, day in and day out.
You are all familiar with Pavlov’s dog. Present a dog food,
he salivates. Ring a bell each time you present food, and in
due time you can ring the bell without the food and he will
salivate. This is classical conditioning.
Operant conditioning is quite different. Consider the classical
operant experiment. Put a hungry rat in a cage. Put a lever in
a cage. Make it so that a push on the lever delivers a pellet of
food. In its random movements the rat will push the lever.
He’ll get the pellet. The rat will soon associate lever pushing
Consider the smoker. Smoking the cigarette is the lever press.
The effect of that smoking act upon his person is the reward.
That effect reinforces the smoking act. He comes to push the
lever 10 to 60 times per day.
This, then, is how we have translated our corporate charter
into a scientific model.
So if you read the above article and are left shaking your head how, in this extremely difficult and sometimes desperate economic climate, a smoker can spend one quarter of their income on cigarettes, somewhere, cigarette executives and researchers read the same article; and that after they did, they congratulated each other on a job well done, and saying to one another “I told you so … just like rats in a cage.”
This is a case where two central Florida CVS pharmacies were filling highly suspect prescriptions for powerful pain medications for patients, including for non- Florida residents. The facts of this case were egregious and no serious effort to stop financially lucrative and improper filling of fraudulent prescriptions ever occurred until after the Drug Enforcement Administration (DEA) conducted its investigation.
CVS has maintained they were a “busy” pharmacy. I find the comments to this article as interesting as the article itself. Many in the pharmacy industry want to blame the doctors and evade any professional responsibility in the pill mill epidemic sweeping our country. Allowing that to happen is a prescription for nothing corrected.
CVS now has “enhanced” its guidelines and submitted a new plan to the DEA. “Enhanced” is code for ok we will really plan to do something now. Rightfully, the DEA has said CVS has done too little, too late. The truth is the DEA hit them where it hurts, at the bottom line. Sadly that is often what it takes.
What if…now I’m just “spit-balling”, but what if we actually had government oversight in certain industries? What if real policing of these companies occurred and real penalties could always be handed down in exchange for bad conduct?
Yes, monitoring the disbursement of powerful pin pills might even mean a little extra work, but it is needed and it is necessary. We all need to do our part; the public, the doctors, the pharmacies and the government. However, the last real and professional gatekeeper is the pharmacy and its time they step up and look at the dispensing of dangerous medications as something other than just another way to generate an enhanced bottom line.
Kudos to the DEA. These actions will lead to future arrests to slow or stop the problem, but more importantly, future lives saved.
What are they thinking? After publicly admitting its Rejuvenate and ABG II hip implants fail because they cause heavy metal poisoning in patients, Stryker has not stepped up to the plate and promised affected patients it will pay for their revision surgeries. Stryker recalled both its Rejuvenate and ABG II hip implants the first week of July, 2012. Since that time thousands of patients have received notice from their doctors that the hip implanted in them is defective and has been recalled. Most doctors have been telling their patients that when it fails it has the potential for causing soft tissue necrosis and systemic metallosis.
After returning to their doctor many of these patients now have an explanation for the months of pain they have been experiencing for which they have received little or no explanation. Their doctors have checked their blood levels for metal ion contamination and found them to have excessive levels of cobalt in their blood. In addition many have had metal artifact reduction sequence (MARS) MRI scans that have revealed pseudo tumor formation and a collection of fluid around hip joint.
In my experience most doctors faced with these findings have suggested to the patient they need revision surgery. However, many of these patients just had their hip implanted last year. They paid a large deductible and spent weeks out of work recuperating and rehabilitating. Some of my clients are still paying for their original surgery on a monthly basis. Although their doctor is recommending surgery, their hip implant is poisoning them and they are in pain, they can’t afford to have their defective hip removed.
If Stryker recalled this product the first week in July they obviously have known about this problem for some time. I’ve personally spoken with doctors who say that before the recall they were telling Stryker about the problems they were experiencing with these hips. If Stryker knew about this problem well before the recall that means they’ve had plenty of time to establish an efficient and objective system for paying the medical expense and lost wages for the victims of these hip implants upfront. Despite all that time, all Stryker is currently offering these victims is,”the opportunity to file a claim.” Stryker is providing absolutely no assurance to its victims that they will in fact pay the expense associated with revision surgery.
Stryker’s reaction to having marketed a device that has hurt thousands of patients stands in stark contrast to Johnson & Johnson DePuy’s response after it recalled its defective ASR hip implant. Almost immediately after the recall Johnson & Johnson DePuy announced it had established an objective, efficient and prompt means for victims to have the defective device removed from their body. They hired Broadspire, an independent adjusting company to process victim’s claims for medical expenses, lost wages and other out-of-pocket expenses associated with having their devices removed. While this didn’t compensate victims for their pain and suffering, and having to undergo a revision surgery, or the real exposure to metallosis, it was the responsible thing to do.
I have written about this before but it was some time ago. A lot of time has passed. I have urged Stryker to put some objective claims process in place that assures qualifying victims their medical expenses and lost wages will be reimbursed if they undergo the surgery to have the defective device removed. Stryker remains silent to the damage it has caused.
Every day I receive several calls from clients in pain, have elevated levels of cobalt circulating in their bloodstream, have fluid collecting around their implant and a pseudo tumor growing in their hip who have been told by their doctor:
Their hip needs to come out.
The longer the hip stays in, the more likely they suffer irreversible, permanent damage to the tissues around their hip.
The longer revision surgery is put off the more fixed and difficult to remove the stem is and the more complicated and risky the revision surgery.
Unfortunately, many of these victims cannot afford multi-thousand dollar deductibles and weeks out of work. This is a terrible position in which to find oneself.
A quick Internet search revealed a very nice analyst report from 2010 regarding Stryker’s cash position. That year Stryker reported $3.4 billion in available net cash. The company could certainly afford to pay for these victims to have Stryker’s defective device removed from their bodies.
While I certainly share in the singer/songwriters desire for peace and am moved when I hear this song, it is the above passage from his song that too often jumps to the forefront of my mind in the current day and age.
One second he was pitching; the next second he had stopped breathing – and for the next 15-20 minutes his brain was deprived of oxygen. Good Samaritans tried CPR until paramedics took over. His life was saved, but the oxygen deprivation left the boy permanently brain damaged; a condition that leaves him unable to perform any functions of daily life on his own and one that will require full time care for as long as he lives.
Tragic. Devastating. Consult the thesaurus for synonyms, and all would apply here.
I was able to read this story, as I do most of the news stories I read now, online. But I also did something that I normally do not do, and that is, to continue on to the comment section to see what folks had to say about this sad story.
Appalling. Nauseating. Consult the thesaurus for synonyms, and all would apply here.
Fortunately, at the time I read the article, there were only 7 comments.
And here are some of the things that people – fellow human beings (although based upon what these people said that certainly is now debatable) – had to say:
“the boy wasn’t fast enough to catch the ball …”
“I feel bad for the kid, but that’s just sports …”
“sorry for the kid, but that is sports …”
“it’s sad that this boy was injured. It’s more sad that the manufacturer and retailer settled and are paying out such a large sum of money.”
And while it is true that the focus of the story was the fact that the boy and his family received $14.5 million dollars in settlement of their lawsuit against the makers of the metal bat and the retail store that sold the metal bat, and while lawsuits as a topic in this current age of tort-reform mania no doubt elicits strong feelings, hate-filled comments such as these follow just about every on-line news story that appears.
Naturally, this is not an indictment of freedom of speech and an individual’s right to say what he is thinking. Rather, this is the memorialization of a realization that dawns on me anew nearly every day - we live in a world, and an age, filled with hate. And the hate is intense, and the haters are vocal. And the intensity of their hatred is increasing daily, and the legion of haters is growing exponentially by the day too.
And while inside I weep when I read sad story after sad story, day after day, about misfortunes that befall our fellow human beings, I also weep for the state of our world. A world that is consumed with hate, a hate so extant that people would actually feel more sorry for the manufacturers of a metal bat who settled a lawsuit than for a boy who is now permanently brain damaged, and have no reservations about saying so.
Over the past few months (and well before the recall), our law firm has been investigating Stryker Rejuvenate and ABG II failed hip implant cases on behalf of patients from Florida, Arizona, Ohio, Minnesota, Illinois, and other parts of the country where these Stryker devices were heavily marketed. As a byproduct of our Stryker Rejuvenate investigations, we have noticed a number of patients who have experienced serious adverse effects associated with their implants (such as metallosis, elevated cobalt levels, corrosion of the device at the junction of the modular pieces, pseudotumor formation, presence of milky inflammatory fluid around the implant, etc.) and the failure of their respective hip implants is strikingly similar to the device failures experienced by patients implanted with Rejuvenate hip implants. However, these patients have been implanted with a different product manufactured by Stryker – Accolade TMZF implants.
The Stryker Accolade TMZF implant is a one-piece implant made of a titanium alloy. The alloy is advertised by Stryker as a proprietary blend of titanium, iron, molybdenum, and zirconium developed by Howmedica Osteonics. According to Stryker’s website, this combination of metals is supposed to have superior strength, flexibility and notch resistance when compared to other alloys used in hip implants manufactured by Stryker’s competitors.
As we have discussed in several items relating to other defective and recalled hip implants (including DePuy’s ASR and Pinnacle metal-on-metal devices and Stryker’s recalled Rejuvenate and ABG II hip revision devices), this appears to be yet another example of a failed “better” mousetrap.
True innovation in medical technology can be very beneficial for patients in need of more effective treatment options. Our world and lives are improved daily by these medical miracles. However, it seems that, of late, orthopedic device manufacturers are innovating for innovation’s sake, with only the device manufacturers benefitting. These “innovations” and breakthroughs are seemingly motivated by the need for device manufacturers to have something new and improved to promote, but many have led to so much avoidable pain and suffering for patients.
We already know that the Stryker Rejuvenate hip implant was an innovation that no one needed. Now, we have concerns that the Accolade TMZF may be headed down a similar path. With the convenience and variety afforded by modular devices comes the evil associated with mating metal devices and implanting them in the body. For over twenty years, scientists and surgeons have been writing about failed taper neck junctions with both similar and dissimilar metals. The taper neck junction is where either the neck is inserted into the stem or the ball is attached to the neck. Twenty years ago, scientists were warning about the risks associated with such devices and discouraging their use, only to have medical device manufacturers hoist them upon surgeons and consumers as being the latest and greatest technology.
We have received inquiries from all over the country as well as overseas regarding Accolade hip implant failures. They are failing in the exact same way as the Rejuvenate and ABG II hip implants, with the distinction being that the Accolade corrosion and galvanization appears at a different location. To date, it appears the Rejuvenate is failing at the junction between the neck and stem. The Accolade, however, appears to be failing at the junction between the stem and ball. The failure seems to be very similar to failures described twenty years ago in the literature talking about the inherent problems with use of modular implants, with erosion of the metals occurring once the implant is placed in the body which, in turn, causes metal ions to be cast off into the local area around the device and eventually dispersed throughout the body.
The picture included here depicts an actual Accolade explant. All of the black areas are the result of metal breakdown which occurred after the device was implanted. The patient from whom this implant was removed suffered from metal toxicity, and a hip arthroplasty revision surgery had to be performed within 18 months of the original implantation surgery. Apparently, as is obvious from the photographs, the titanium alloy in the TMZF didn’t agree with the chrome cobalt head.
School is still out on whether we are seeing isolated failures or whether our firm has uncovered the tip of another iceberg, as we did with the Rejuvenate implants a few months ago.
Finasteride, one of the most popular drug used in the fight against baldness, has been linked to long-lasting sexual dysfunction in men using the drug. Commercially sold as Propecia, the drug was originally approved by the Food and Drug Administration (FDA) to treat prostate issues. One side effect was that it caused hair growth in many of its users and in 1997 the FDA approved the drug for treatment in male pattern baldness. At the time of the clinical trials for Propecia, Merk, the company which manufactures Propecia, noted that some men reported sexual side effects. The FDA reported that those issues resolved once the man stopped taking the drug.
But after receiving more than 400 reports of sexual dysfunction from Propecia users, earlier this year the FDA required the makers of Propecia to add a label to the product warning of sexual side effects. The label indicated that the side effects could continue after use of Propecia stopped
Reports surfaced this week after scientists and researchers at George Washington University reported that men using the drug reported problems with sexual dysfunction. Side effects relating to sexual dysfunction have long been reported by users, but until this week, every indication was that stopping use of the drug led to the symptoms dissipating and ending. This week’s report, however, following the publication of a new study, has concluded that for many of the men who stopped using finasteride, they continued to report problems with sexual dysfunction, including erectile dysfunction, low libido, problems with orgasm and shrinking and painful genitals long after use of the drug ceased.
George Washington researcher, Dr. Michael Irwig, has published a new study in the Journal of Sexual Medicine entitled “Persistent Sexual Side Effects of Finasteride: Could They Be Permanent?” detailing the findings related to his study of 54 men who had experienced sexual problems at least three months after they stopped using Propecia. Although based on a small number of former users, the study has some startling results. One finding stated, “In a group of 54 otherwise healthy former users of finasteride who developed persistent sexual side effects that lasted for at least 3 months, 96% continued to experience these effects when reassessed after 9-16 months (mean 14 months), raising the possibility of permanent effects.” Many of the men interviewed also reported neurological and mental changes, relating to depression and changes in their sleep patterns.
Whether the conclusions of this study will be bolstered when new studies increase the number of former users being studied is unknown. Researchers who participated in preparing the report concluded, “prescribers of finasteride and men contemplating its use should be made aware of the potential adverse medication effects.”
When participants left a two-day public hearing convened by the U.S. Food and Drug Administration (FDA) to discuss metal-on-metal hips (MoM) there were few answers and a lot of questions. The goal of the 18-member FDA advisory panel made up of surgeons, industry reps, and consumer advocates was to try and come up with some policy recommendations for use of the MoM hip implants that have left so many with life-altering complications.
The panel was also convened, not to consider a recall or reclassification, but to provide recommendations to doctors caring for MoM hip injured patients. MoM hips were originally marketed as an alternative to the traditional ceramic or plastic hips and were targeted for the younger, more active hip recipient. Many patients are in their 40s and 50s and face a lifetime of injury and complications.
There was no consensus on how to treat patients who suffer from toxic levels of chromium or cobalt, caused by metal debris which can get into the bloodstream in patients implanted with MoM hips.
The FDA was urged to avoid making any blanket recommendation that might interfere with the doctor-patient relationship, but really, why convene a panel unless some guidance is issued? There was agreement that the current data was not sufficient given that none came from prospective randomized trials.
The bottom line and the reason the panel was convened was that MoM hips have had a significantly higher failure rate than metal-on-ceramic or metal-on-polyethylene implants where the failure rates including deterioration and pain at 5-years are in excess of 10 percent.
There was also consensus that the larger the head size of the implant, the more failures, and that women seem to be experiencing a higher failure rate than men. There is also a difference in failure rate between the MoM total hip replacements and resurfacing, which had a higher success rate.
So what is a clinician to do? With almost 17,000 complication reports sent to the FDA, there were largely few answers. However, a skin patch test for metal sensitivity was recommended. Once a patient shows elevated levels of chromium and cobalt, no one can say what level is too high or what should be done. Chromium and cobalt ions can damage the lymph nodes, liver, kidneys and spleen. The metal ions are linked to cancers.
So the FDA convenes an expert panel with disappointing results, even as the DePuy Orthopaedics A.S.R. hips have been recalled from the market because of patient complications.
In the three years sinceStryker first introduced the Rejuvenate and ABG II modular hip implant systems, thousands of patients have had these devices implanted. The devices were distributed by Stryker throughout the United States.
The promises made about the Rejuvenate seem to have all been false. Since the device does not contain a metal on metal ball and cup, the Rejuvenate was supposed to avoid all of the problems associated with metal on metal bearing surface metal toxicity failures. In addition, since the device was “modular” it supposedly provided the surgeon with more options to get the perfect “fit” thereby providing the prospect of longer lasting replacements in young, active patients.
Now that the device has been recalled, what are patients to do? Many have been experiencing unexplained pain for some time. For those patients, the decision to have the device removed is simple. Especially after the doctor explains the danger of tissue death, muscle loss and systemic effects of heavy metal poisoning. At least for them, they now know that metal toxicity is the most likely cause of their pain. They are not crazy.
For those patients who have no symptoms, the decision is much more complicated. Doctors and their patients will have to weigh the risks of undergoing a revision surgery against the potential that the device will ultimately fail and cause metal related toxicity issues.
Since we have spoken with and represent many victims of the defective, recalled Rejuvenate, we may be able to provide new clients with the benefit of other patient’s experiences to help guide them.
Florida, West Palm Beach and Tallahassee based Searcy Denny Scarola Barnhart & Shipley, P.A. is a full-service law firm specializing in aviation disasters, defective design, mass torts, railroad disasters, catastrophic vehicle accidents, environmental disasters, medical malpractice trucking accidents, commercial disputes, hospital infections, premises liability, unsafe products, construction defects, intellectual property, and professional liability, will & trust disputes. Lawyers and attorneys here are the most competent professional in handling any complicated cases.