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Pharmaceutical Litigation - Philadelphia Injury and Malpractice Attorneys - The Beasley Firm

Can We Prove In Court That Testosterone Gel Causes Heart Attacks and Strokes?

By Max Kennerly, Esq. on February 23, 2014 - No comments

In early February, the media exploded with reports that the FDA was investigating(1) whether low-testosterone therapies like Axiron, Androgel, Testim, and Fortesta might be tied with an increased risk of heart attacks and strokes. Yet, as the FDA said in its safety announcement, “At this time, FDA has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death.” A plaintiff bringing a lawsuit thus can’t run to court and point to the FDA announcement as definitive proof that testosterone therapy caused their (or their husband’s) heart attack or stroke. So evidence can they use to prove or disprove such a causal link? It’s a question I’ve been getting a lot lately, so I thought I’d discuss it here.

The FDA’s investigation is based upon a November 2013 study in the Journal of the American Medical Association(2) and a January 2014 study posted on PLOS ONE(3). The JAMA study found “Among a cohort of men in the VA health care system who underwent coronary angiography and had a low serum testosterone level, the use of testosterone therapy was associated with increased risk of adverse outcomes” like death, myocardial infarction, or stroke, and the PLOS ONE study found “In older men, and in younger men with pre-existing diagnosed heart disease, the risk of [myocardial infarction] following initiation of [testosterone therapy] prescription is substantially increased.”

These results didn’t come entirely out of the blue — for example, a study in 2010 that was supposed to look at the effects of testosterone had to be discontinued when the participants suffered an unusual number of cardiovascular events(4) — but the latest two studies together form the strongest evidence showing a connection between testosterone therapy and cardiovascular events like heart attack and stroke. The situation is not altogether different from Vioxx, the litigation over which also began with a study showing a connection between Vioxx and cardiovascular events. The questions are if, like with Vioxx, future studies will demonstrate that “Low T” therapy causes these conditions and, perhaps, that the drug manufacturer concealed evidence that would have revealed this link sooner.

Let’s back up for a moment. The FDA has approved testosterone therapy to treat a single condition: hypogonadism. The FDA-approved prescribing information describes this as occurring as a result of “testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol or heavy metals,” or “idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation.” The FDA did not approve the use of testosterone therapy to treat fatigue, or muscle weakness, or depression, or low libido, or erectile dysfunction, or for “anti-aging” purposes — yet most testosterone therapy prescriptions today are for those conditions, which for most purpose aren’t related to hypogonadism. Some of them are just part of aging.

After about 30 or so, men’s testosterone levels decline as they get older. (A study back in 2012 calculated that athletes’ “peak performance” generally occurred around 26 years old, and that the mean age of world record-setting athletes was 26.1 years.(5)) For some men, this shift can be sublime or even exciting*, but, for most of us, the shift comes too quickly or with severe side effects, and let’s face it: most of us would be more than happy to find the fountain of youth.

That’s where the drug companies saw a chance to make a buck. Although testosterone therapy is only approved to treat hypogonadism (or to be even more specific, hypoandrogenism), doctors are allowed to prescribe virtually any medication for virtually any purpose. There’s nothing wrong with that — doctors and patients need to have room to make their own medical decisions — but the drug companies routinely exploit that situation by engaging “off label” marketing, in which they try to convince doctors to prescribe patients medications for unapproved conditions, or to convince patients (by way of relentless television, Internet, and magazine advertisements) to lobby their doctors for the medication. Off label marketing is illegal, and pharmaceutical companies have paid the federal government billions in penalties for doing it, but they keep doing it anyway, concealing it when they can and then, if they’re caught, writing off the penalties as a cost of business. There’s too much money to be made.

The “Low T” companies have engaged in that sort of off-label marketing in spades, like the website “Is It Low T?”, for the purpose of encouraging men to wrongly believe that a variety of ailments are really the symptoms of low testosterone, and that the ordinary effects of aging can be safely treated with testosterone therapy. E.g., the website asks visitors if they are “sad” or “grumpy,” if they have “a lack of energy,” and if they aren’t as good at sports as they used to be — something that is to of course be expected as a person ages, particularly into their 60s and beyond.

All of that marketing (Abbott Laboratories spends over $80 million annually marketing AndroGel) worked: testosterone therapies are a $4 billion market, well over the size it should be based on the prevalence of the condition the medication was designed to treat. A review of prescribing information on low testosterone therapy found that one third of men on testosterone therapy were diagnosed with “fatigue,” and that one quarter of men on testosterone therapy did not even have their testosterone levels tested before they received a prescription(6).

Now, let’s move to the mixed question of science and law that I used for the title of this post: can we prove in court that testosterone gel causes heart attacks and strokes?

Ideally, we would prove (or disprove) such a causal link with a randomized controlled trial, putting one group of men on testosterone therapy and another on a placebo and then watching for heart attacks and strokes. But we need to be realistic: such a trial would be extraordinarily difficult to construct correctly given the huge number of factors at work, and it might even be dangerous to complete the trial. In many prior examples, like with Vioxx, clinical trials looking for potentially fatal conditions had to be stopped as soon as the initial evidence of a risk became apparent, because it would be unethical to knowingly expose patients to a risky medication.

So let’s start with what we already have. The JAMA study and the PLOS ONE studies are both observational studies, not randomized controlled trials. Medical researchers looked at a bunch of data they already had on patients, performed statistical analysis with the hope of removing any “confounding variables” — e.g., you have to make sure you’re not accidentally comparing heart attacks among obese smokers in their 80s and normal weight non-smokers in their 60s — and then saw the worrying conclusions that have prompted all this attention. These observational studies are a great way to learn about complex medical issues that defy easy analysis; a prominent, and perhaps foreshadowing, example was the Women’s Health Initiative, which identified the potentially fatal risk posed by women’s hormone therapy treatment, particularly as women got older.(7)

As the Executive Editor of Harvard Health notes, “neither was the type of study that can prove cause and effect. They can only show associations, or links. That means there’s no smoking gun here that testosterone therapy is harmful. But the studies do suggest caution.”(8) I disagree. Both as a matter of science and as a matter of law, although observational studies primarily show associations, observational studies can also be enough to show that a drug causes a particular disease — if they are done properly. As the Federal Judicial Center’s Reference Manual on Scientific Evidence says(9):

[O]bservational studies can be very useful. For example, there is strong observational evidence that smoking causes lung cancer. Generally, observational studies provide good evidence in the following circumstances:

• The association is seen in studies with different designs, on different kinds of subjects, and done by different research groups. That reduces the chance that the association is due to a defect in one type of study, a peculiarity in one group of subjects, or the idiosyncrasies of one research group.

• The association holds when effects of confounding variables are taken into account by appropriate methods, for example, comparing smaller groups that are relatively homogeneous with respect to the confounders.

• There is a plausible explanation for the effect of the independent variable; alternative explanations in terms of confounding should be less plausible than the proposed causal link.

In other words, well-done observational studies can be good enough, as long as they’ve approached the subject from different angles, have accounted for other possibilities, and have suggested “a plausible explanation” for the effect.

The JAMA and PLOS ONE studies have already been criticized, but, frankly, the criticisms I’ve seen are just plain wrong, to the point of being irresponsible. Over at Huffington Post, an OB/GYN who sells hormone therapy argues that the studies are “essentially meaningless,” because they didn’t assess testosterone levels “to tell if a patient is a proper candidate for therapy and if they are tolerating the therapy well.”(10) There’s no reason to believe those results would be different, but, the biggest issue is that she missed the point of the study: the point wasn’t to see if a narrow class of “proper” patients were at risk, but whether all patients on testosterone were at risk. Part of the problem with testosterone therapy is that it’s overprescribed, and artificially limiting a study of its risks would be tantamount to willful blindness to the real problem.

That said, the second factor — “effects of confounding variables” — is likely going to be the biggest issue in the testosterone therapy litigation. Heart attacks and strokes aren’t like, say, mesothelioma, which can only be caused by asbestos exposure. As they get older, men are at an increased risk of both, particularly after age 65. Observational studies have shown that there are nine major factors that increase the risk of heart attack in both men and women (11):

  • HDL to LDL cholesterol ratio;
  • current smoking;
  • former smoking;
  • hypertension;
  • diabetes;
  • abdominal obesity;
  • psychosocial (e.g., (depression, locus of control, global stress, financial stress, and life events including marital separation, job loss, family conflict);
  • physical inactivity;
  • very low alcohol intake;
  • high risk diet

If a man had any of those factors, then the drug companies will jump on it and claim that it’s impossible to prove the testosterone therapy increased his risk of suffering a heart attack or stroke.

To which I say: rubbish. We’ve seen those sorts of attacks before by drug companies as a way to avoid responsibility, but this isn’t the place to start explaining how we intend to do that in the litigation, beyond saying those issues are better left for cross-examination at trial. There’s no “smoking gun” here but there’s enough smoke to know there’s a fire, which is why we’re actively pursuing these cases. A company can’t just sit back and reap billions off a false wonder drug while being silent about its potential to kill its users.

 

 

REFERENCES:

(1) “FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products,” an FDA Drug Safety Announcement.

(2) “Association of Testosterone Therapy With Mortality, Myocardial Infarction, and Stroke in Men With Low Testosterone Levels” at JAMA Network.

(3) “Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men” at PLOS ONE.

(4) “Adverse Events Associated with Testosterone Administration” available at PubMed.

(5) “Exponential growth combined with exponential decline explains lifetime performance evolution in individual and human species” at Springer.

(6) “Trends in Androgen Prescribing in the United States, 2001 to 2011” at JAMA Network.

(7) “The Last Word On Hormone Therapy From the Women’s Health Initiative” at NPR Health News.

(8) “New study adds caution to testosterone therapy for “low T”” at Harvard Health.

(9) Federal Judicial Center’s Reference Manual on Scientific Evidence, at fjc.gov.

(10) “Testosterone Therapy Does Not Cause Heart Attacks” at Huffington Post.

(11) “Risk factors for myocardial infarction in women and men: insights from the INTERHEART study” at European Heart Journal.

* Anyone despairing of getting older should read “My Dear Son” and “The Joy of Old Age.”

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Blood Clot, Stroke Or Heart Attack Risk With Pradaxa And Heart Valves Warns The Food And Drug Administration (FDA).

By The Beasley Firm on December 21, 2012 - No comments

The U.S. Food and Drug Administration (FDA) is warning doctors, health care providers and the public that Pradaxa (dabigatran etexilate mesylate), a blood thinner or anticoagulant, should not be used to prevent stroke or blood clots in patients with mechanical or prosthetic heart valves. A clinical trial in Europe (the RE-ALIGN trial)1 was recently stopped because it was noticed that patients on Pradaxa were more likely to experience strokes, heart attacks, and blood clots on the mechanical heart valves than were users of the anticoagulant warfarin or Coumadin. There were also more bleeding episodes after aortic, mitral, tricuspid or pulmonic valve surgery in patients taking Pradaxa instead of warfarin.

Pradaxa is a blood-thinning medication that was used to help reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation (AF) or a fib, a common abnormal heart rate where the upper portion of the heart, or atria, beats faster or irregularly.  Patients who have atrial fibrillation are at a higher risk of dislodging blood clots to other areas of the body that could lead to the development of a stroke or heart attack.   Pradaxa is not approved for patients with atrial fibrillation caused by heart valve problems.  The FDA is issuing a warning against the use of Pradaxa in patients with artificial heart valves.

Boehringer Ingelheim, the German manufacturer of Pradaxa is already involved in over 120 Pradaxa lawsuits. The lawsuits allege that Boehringer Ingelheim failed to warn doctors and patients about the risk of uncontrollable bleeding or hemorrhage because there currently is no medication to reverse Pradaxa in the event of over anti-coagulation or blood that is too thin.  Here at the Beasley Firm, our dangerous drug lawyers have been accepting and preparing Pradaxa and bleeding lawsuits for many consumers who were injured by this unsafe medication.

Since 1958, The Philadelphia Beasley Firm has fought for injured patients and consumers, recovering over $2 billion for our clients through hundreds of multi-million dollar settlements and jury verdicts. If you or a loved one had excessive bleeding, kidney failure, stroke, developed blood clots or a heart attack while on Pradaxa, please feel free to contact one of our lawyers, doctors or nurses at 1.888.823.5291 for a strictly confidential and free consultation.

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Heart Attack After Dialysis Lawsuits – Information About Fresenius Class Action Over Cardiac Injuries And Deaths

By Max Kennerly, Esq. on October 27, 2012 - 2 comments

Since 1958, The Beasley Firm has fought for injured patients and consumers, recovering over $2 billion for our clients through hundreds of multi-million dollar settlements and jury verdicts. If you or a loved one suffered a heart attack or other cardiac problem within 48 hours of receiving dialysis, at any point between 2008 and July 2012, contact us for a free and confidential consultation by filling out our online form or by calling (888) 823-5291.

 

Yesterday, I received a call from a man in his fifties who, two years ago, had suffered a heart attack a day after receiving his routine dialysis from Fresenius Medical Care. He had recently seen a television commercial — coincidentally while receiving his dialysis treatment — with an actor in a dark suit standing in front of law books and pointing his finger at the camera urging anyone who had suffered a heart problem while on dialysis to call the number now to make sure they had a claim. He called, and a day later two lawyers showed up at his house with a lot of paperwork, telling him he had to sign the attorney’s fee agreement now or lose out on a lot of money. In other words, he just wanted answers and instead he got the same “hard sell” that has become all too common in personal injury law. It’s disturbing and embarrassing.

Thankfully, the man had two friends who were lawyers, so he asked them what to do, and they both told him to call us. Like most mass torts lawyers, I’ve been following the GranuFlo and NaturaLyte litigation with interest, but I haven’t written about it yet. With that call, I suppose it’s time to explain what’s happening — unfortunately, most of the law firm websites out there are filled with so many advertising hooks it’s hard for affected dialysis patients (or their survivors) to figure out what’s going on. First, a little bit of history.

 

The “Bicarbonate” Problem With Fresenius’ GranuFlo and NaturaLyte, Which Are Used In Dialysis Clinics Nationwide

Hemodialysis involves using machines to remove waste products like creatinine, urea, and water from the blood in kidney failure patients. Those waste products, in turn, break down proteins, which in turn produce acid when they break down. One of the complications of kidney failure is metabolic acidosis, because the kidney can’t remove acid and can’t produce bicarbonate, which is a base. So, hemodialysis involves both removing waste and adding bicarbonate, and a patient’s nephrologist will include with the dialysis prescription some particular level of bicarbonate to be maintained in the patient’s blood.

That’s where GranuFlo and NaturaLyte come in. The “dialysate” in dialysis is a mixture of purified water, a bicarbonate concentrate (usually sodium bicarbonate), and an acid concentrate (either acetic acid, citric acid, or sodium diacetate). GranuFlo and NaturaLyte are used as the acid concentrate: GranuFlo is a solid sodium diacetate concentrate, while NaturaLyte is a liquid acetic acid concentrate. Both are made by Fresenius (and used by Fresenius and sold to other dialysis centers), and together they’ve been the most widely used dialysate acid concentrates for years.

But there’s a problem: from 2008 through early 2012, GranuFlo and NaturaLyte included more bicarbonate than it should, and so the patients received too much bicarbonate. The excess bicarbonate then produces metabolic alkalosis (the opposite of metabolic acidosis), which dramatically increases the risk of heart attacks, cardiac arrest, arrhythmia, and stroke, and thus increases the risk of death, too.

 

Fresenius Should Have Known Its Dialysis Mixtures Were Dangerous, And Failed To Take Action When It Learned Of Its Patients Having Heart Attacks

The shocking part is that this is all basic chemistry that should have been revealed by basic pre-market testing — and Fresenius apparently knew for some time that there was a serious problem. According to complaints filed in court, some Fresenius employees were told as early as 2008 to cut the acetate dose below the prescription, which, if true, would be an admission that the GranuFlo and NaturaLyte were producing too high levels of bicarbonates. By 2009 or 2010, Fresenius had change the operator’s manual for some of its machines to instruct operators to cut the acetate dose in half, again showing awareness of the problem. But Fresenius didn’t change the GranuFlo and NaturaLyte mixtures themselves.

Instead, apparently, they just studied it more, and the results were shocking. An internal memorandum at Fresenius (PDF copy here), sent only to the directors and attending physicians of their dialysis clinic in November 2011, revealed that its patients’ serum pre-dialysis bicarbonate levels gradually increased from 2004 to 2011, and found that that 941 patients had suffered cardiac arrest inside Fresenius clinics in 2010. The internal researchers at Fresenius concluded that their patients had a six-fold increase in the risk of cardiopulmonary arrest and sudden cardiac death.

Fresenius knew its patients were suffering heart attacks — and many of them were dying — but they still didn’t do anything about it. A whistleblower leaked the memo to the Food & Drug Administration, which took swift action, and in March 2012 the FDA issued a class 1 recall for the GranuFlo and NaturaLyte produced from January 2008 through 2012.

 

The Coming “Class Actions” Over Heart Attacks After Dialysis, And How They Really Work (Hint: They’re Not Actually Class Actions)

Now comes the legal fall-out, and the inevitable “class actions.” I write “class action” in quotes because there won’t be any class actions, but there will be what’s known as “consolidated litigation.” (So far, only a handful of lawsuits have been filed, but, given the scope of the damage, we are confident there will be so many lawsuits the courts will order consolidation.) Here’s the core difference between the two: how individuals are treated.

In a class action, all of the plaintiffs are treated the same, i.e., they are win or lose together, and they all recover roughly the same in a settlement or jury verdict. In consolidated litigation, most of the pre-trial work in the case is done in a coordinated manner (e.g., depositions of corporate executives, gathering of scientific evidence, etc.), but each plaintiff will win, lose, or settle on their own. Each injured Fresenius will need to prove their individual injury was caused by the GranuFlo / NaturaLyte, and each will prove their own level of damages and thus be awarded their own amount of compensation. (Read here for more about how the value of a wrongful death lawsuit is calculated.)

We, as lawyers for the injured Fresenius patients, are confident that we will be able to prove Fresenius was negligent (1) in designing the product improperly; (2) in failing to test it; (3) in failing to act on the reports of problems; and (4) in failing to warn patients, doctors, and clinic staff of the problem. It will take a year or more of consolidated discovery proceedings to do it, but we are confident we will.

The real issue in each case will likely be “causation.” That is, proving the patient suffered a heart attack, or cardiac arrest, or died as a result of the excessive bicarbonates in the mixture, as compared to something else, like their pre-existing risk factors for heart problems, including the fact that they are already kidney patients.

How do we evaluate “causation?” By the time in between the last dialysis treatment and the cardiac event. Of course, every patient follows a different dialysis schedule (in general, more dialysis is better than less, but everyone has their own life to attend to, and no one wants to sit in a dialysis clinic for even longer than they need). We’re not in the business of filing frivolous lawsuits or wasting our client’s time, we in the business of helping seriously injured people obtain adequate compensation, and so we limit our cases to those supported by the science and the medicine.

 

Free Consultation And Contingent Fee (We Pay All Expenses) Lawyers For Patients Who Suffered Heart Problems Within 48 Hours Of Receiving Dialysis

Based on we know and have studied, we have set an internal timeline of 48 hours, and a time frame of 2008 through July 2012: if you or a loved one began to suffer a heart attack within 48 hours of receiving dialysis at any point between 2008 and July 2012, and you received GranuFlo or NaturaLyte (which is possible even if you were not at a Fresenius clinic) we think you might have a viable claim, and we’re happy to review it and, if it lines up then we’ll represent you in a lawsuit on a contingent fee.

Since 1958, The Beasley Firm has fought for injured patients and consumers, recovering over $2 billion for our clients through hundreds of multi-million dollar settlements and jury verdicts. If you or a loved one suffered a heart attack or other cardiac problem within 48 hours of receiving dialysis, contact our dangerous drug lawyers for a free and confidential consultation by filling out our online form or by calling The Beasley Firm’s main line at (888) 823-5291.

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Could The Contaminated Epidural Injections That Caused Fungal Meningitis In New Jersey And Other States Been Avoided?

By The Beasley Firm on October 11, 2012 - No comments

In 2003, Sarah Sellers, a young pharmacist, worked in a compounding pharmacy and was shocked by what she described as unsterile conditions.  She told a Senate Committee that “the pharmacy was purportedly making sterile injections from scratch using non-sterile ingredients,” and “When I asked permission to order and substitute FDA-approved products because of safety concerns, I was cautioned that it would be less profitable for the pharmacy.”

In 2005, Sellers began working at the Food and Drug Administration (FDA) with the hopes of writing new federal sterility guidelines for compounding pharmacies.  “I expected the guidelines to come out when I was working at the agency in 2006,” Sellers said. “But it never happened. It was so frustrating.”  More than six years later, those guidelines still have not come out.

In 2003, the Government Accountability Office testified that the FDA knew of at least 200 adverse events associated with drugs from compounding pharmacies since 1990.  In 2011, nine people in Alabama died from contaminated intravenous total parenteral nutrition (TPN) manufactured at a compounding facility.  Earlier this year, 33 people developed severe fungal eye infections from eye drops made at a compounding pharmacy in Florida.  Currently, there are now 137 cases and 12 deaths due to fungal meningitis linked to contaminated steroid injections manufactured by New England Compounding Center (NECC).  The two newest cases are in New Jersey where patients were given their epidural steroid injections at South Jersey Healthcare.

As it stands now, the FDA does not have jurisdiction over compounding pharmacies unless there is a problem. The FDA has been trying to change that for over 20 years. The compounding pharmacy industry has challenged those efforts each and every time, and courts have ruled that individual state health departments are the ones in charge.

If someone would have listened to Sarah Sellers over the years, many people may not have become seriously ill, blind or fatally injured due to contaminated medications.

For over fifty years, the Philadelphia experienced drug injury lawyers of The Beasley Firm have helped patients injured by defective products, and have obtained over $2 billion in settlements and jury verdicts. We can help you understand your legal rights and options. Please feel free to contact one of our lawyers, doctors or nurses at 1.888.823.5291 for a strictly free and confidential consultation.

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Epidural Steroid Pain Injection Medication That May Be Linked To Fungal Meningitis Has Been Shipped To Pennsylvania, New Jersey And New York.

By The Beasley Firm on October 8, 2012 - No comments

Eddie C. Lovelace, a Kentucky judge, was still on the bench into his late 70s, despite suffering from severe neck pain due to a car accident.  Like many other patients in chronic pain, Judge Lovelace sought epidural spinal injections for pain relief.  Unfortunately, he was the first victim to die from fungal meningitis possibly related to contamination of the injection he received in his neck.

Fungal meningitis is usually seen in patients with weakened immune systems and rarely seen in healthy individuals.  However, since the steroid medication is injected directly into the epidural space, it bypasses the body’s normal defense mechanisms rendering them useless to fight off the fungal aspergillus infection.  Symptoms of bacterial or fungal meningitis are irritability, fever, nausea, vomiting, stiff neck, sensitive to light, and hallucinations.  If not diagnosed and treated appropriately it could lead to seizures, coma or even death.  Even if medical treatment is given, there is still the risk of hearing loss, brain damage, speech complications, stroke, and paralysis.

To date, there have been 91 confirmed fungal meningitis cases and seven deaths reported in nine states, causing the epidural medication to be pulled from pain clinics, doctor offices and hospitals.  It is feared that hundreds or even thousands of people who received the injections for neck or back pain could be affected.  According to the Centers for Disease Control and Prevention (CDC)  the states that received the tainted steroid medication are:

  • California,
  • Connecticut,
  • Florida,
  • Georgia,
  • Idaho,
  • Illinois,
  • Indiana,
  • Maryland,
  • Michigan,
  • Minnesota,
  • North Carolina,
  • New Hampshire,
  • New Jersey,
  • Nevada,
  • New York,
  • Ohio,
  • Pennsylvania,
  • Rhode Island,
  • South Carolina,
  • Tennessee,
  • Virginia,
  • Texas, and
  • West Virginia.

Here is a complete list of facilities that received the potentially contaminated drug.

Facilities in Pennsylvania (PA) that received the potentially contaminated steroid medication are Allegheny Pain Management in Altoona, PA and South Hills Pain and Rehabilitation in Jefferson Hills, PA.

On Friday, New Jersey (NJ) officials identified the six health care facilities that dispensed medication that has been associated with this deadly outbreak of fungal meningitis were:

  • Central Jersey Orthopedics Specialists in South Plainfield;
  • Edison Surgical Center in Edison;
  • IF Pain Associates/Isaiah Florence in Teaneck;
  • Premier Orthopedics Surgical Associates in Vineland;
  • South Jersey Healthcare in Elmer and Vineland, and
  • Richard Siegfried of Sparta.

It has been determined that the contaminated steroid drug came from New England Compounding Center in Framingham Massachusetts. In recent years some doctors and clinics have turned compounding centers for their medications instead of major drug companies because they can get the medication at a lower cost.  In addition, as drug shortages have become more complex and common, pharmacies are turning to compounding companies to help keep up with supply and demand and all of this is done with little federal oversight. Drugs manufactured by compound drug pharmacies do not go through the Food and Drug Administration (FDA) mandated pre-market approval. Instead, oversight and licensing of these pharmacies comes from state health pharmacy boards.

The effects of a company’s negligent and/or deceptive actions can potentially cause catastrophic injury, disability and, ultimately, death, as well as undue financial and emotional hardships, for the victim and their family. If you or a loved one developed meningitis as the result of contaminated epidural steroid injections, you and your family may be entitled to compensation for the losses and damages you’ve suffered.

For over fifty years, the Philadelphia experienced drug injury lawyers of The Beasley Firm have helped patients injured by defective products, and have obtained over $2 billion in settlements and jury verdicts. We can help you understand your legal rights and options. Please feel free to contact us at 1.888.823.5291 learn more about how our pharmaceutical error attorneys can help you.

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A Cardiac Arrest, Sudden Death, Brain Damage, Or Organ Failure During Dialysis Treatment May Have Been Caused By GranuFlo or NaturaLyte Dialysate Solutions.

By The Beasley Firm on September 11, 2012 - No comments

After almost 1000 dialysis patients developed cardiac arrest or irregular heartbeats at Fresenius Dialysis Clinics, the U.S. Food and Drug Administration (FDA) issued a Class I recall for GranuFlo and NaturaLyte dialysis concentrates. The FDA issued a recall notice for Fresenius Medical Care North America Naturalyte Liquid Acid Concentrate and Naturalyte GranuFlo (powder) Acid Concentrate.

The dialysate is a solution prescribed by nephrologists or kidney doctors for use in the treatment of acute or chronic renal failure and end stage renal disease (ESRD) during dialysis.  The solution is used to help remove wastes from the body that the kidneys can no longer excrete.  The dialysate acid solution can contain acetic acid, citrate or acetate which are substances that can be converted in the body to bicarbonate.  If the body has too much bicarbonate it can cause the dialysis patient to develop metabolic alkalosis or too much buffer in the blood.  If a patient on hemodialysis or peritoneal dialysis develops alkalosis it could lead to  low blood pressure (hypotension), hypokalemia (low potassium), hypoxemia (low oxygen level), hypercapnia (high carbon dioxide level)  and cardiac arrhythmia, which, if not diagnosed and treated, could result in cardiopulmonary arrest, hypoxic ischemic encephalopathy (brain damage), organ failure and sudden death.

In November 2011, Fresenius internally informed physicians and nephrologists at its own dialysis clinics of the high rate of cardiac arrests in 2010, but failed to warn the general public until an anonymous copy of the letter was sent to the FDA.  Once the FDA became aware of the situation and investigated, a recall notice was released and Fresenius issued an Urgent Product Notification to all of its customers.

If you or a loved one suffered cardiac arrest, brain damage, organ failure or other serious bodily injury while undergoing a dialysis treatment you may be eligible for compensation.  Please feel free to contact one of our experienced pharmaceutical litigation lawyers, doctors or nurses at 1.888.823.5291 for a strictly confidential and free consultation.

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Do The Proton Pump Inhibitors (PPI’s) Prevacid, Nexium, Prilosec, Aciphex Or Protonix Cause Birth Defects?

By The Beasley Firm on June 7, 2012 - No comments

Proton Pump Inhibitors (PPI’s) were first introduced to the market in the 1980’s for treatment of heartburn, Gastroesophageal Reflux Disease (GERD), acid reflux, and ulcers.  The American Gastroenterological Association estimates that approximately 33 percent of people in the United States (US) have acid reflux disease.

If you are a woman and have been pregnant before you may have had problems with heartburn during the pregnancy due to the changing hormones and pressure from the expanding uterus.  While many pregnant women can control their heartburn discomfort with diet modifications or intermittent use of over-the-counter antacids others may have been placed on a PPI to help control their stomach symptoms.  Unfortunately, some women who were placed on PPI’s during their pregnancy went on to give birth to children with birth defects.  Recent studies have concluded that there may be a connection between PPI’s and congenital heart defects.

One study that was performed in 2001 that evaluated 900 pregnancies showed that Prilosec appeared to increase the risk of cardiac defects in newborns.  Since that study, an additional research study was performed to add more evidence to this potential drug and birth defect connection.  Researchers at the University of Pennsylvania examined data that looked at 200,000 pregnancies and found that nearly 2,500 cases of newborn heart defects when the mother took a PPI medication during the first trimester of pregnancy.  Some of the birth defects that were seen were: ventral septal defects (VSD), atrial septal defects (ASD), holes in a heart chamber, hypoplastic left heart syndrome, Tetralogy of Fallot and cortication of the aorta.  The PPI’s that were evaluated in the studies were Prevacid, Nexium, Prilosec, Aciphex and Protonix.

If you are pregnant or thinking about becoming pregnant and are currently taking a PPI medication for reflux disease or heartburn, talk to your doctor or obstetrician about your options for symptom control during pregnancy.

If you were unaware that taking a PPI medication during pregnancy could lead to potential birth defects and your baby was born with a congenital heart defect you may be eligible for compensation.  Please feel free to contact one of our experienced dangerous drug lawyers, doctors or nurses at 1.888.823.5291 for a strictly confidential and free consultation.

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FDA Warning-Teething Gels Such As Anbesol, Hurricaine, Orajel, Baby Orajel, Orabase, Can Cause A Lack Of Oxygen To Your Baby’s Brain Or Even Death

By The Beasley Firm on June 7, 2012 - No comments

The U.S. Food & Drug Administration (FDA) just issued a warning on some teething gels. These topical gels are frequently rubbed on the gums to help teething pain in infants and toddlers.  It has been found that these teething gels can lead to a serious condition called methemoglobinemia that can lead to oxygen deprivation and even death.

Methemoglobinemia is a blood disorder where there is an abnormal amount of methemoglobin, a form of hemoglobin, in the blood.  Hemoglobin is responsible for carrying oxygen to the rest of the body.  If there is too much methemoglobin or methemoglobinemia, the hemoglobin is unable to release the oxygen and it could result in tissue or brain hypoxia.

The FDA warning is related to any of the over-the-counter (OTC) toothache or teething medications that contain benzocaine.  Even though adults also use these topical gels for tooth pain, the risk is most significant in children under the age of two, which is when most of the teething process is taking place.  To date, the FDA has received 29 reports of known benzocaine gel-related cases of methemoglobinemia with 19 of those cases occurring in children and 15 cases in children under 2 years of age.

Since these medications are over-the-counter the concern is that consumers or parents may not be able to recognize the signs and symptoms of methemoglobinemia.  Symptoms can include pale, gray or blue colored (cyanotic) skin, lips or nail beds, shortness of breath, fatigue, lethargy, confusion, headache, light-headedness and a rapid heart rate.  An arterial blood gas would have a chocolate-brown color instead of the normal bright red, oxygen rich, blood color.

If methemoglobinemia is diagnosed it must be treated right away with oxygen administration and methylene blue 1% solution.  The Methylene blue helps to restore the iron in the hemoglobin to it’s normal oxygen-carrying state.  Any failure in a delay in diagnosing and treating methemoglobinemia can lead to permanent brain damage or even death.

The FDA is advising consumers and parents to not use OTC benzocaine teething products on children under the age of 2 except under the advice and supervision of a healthcare professional.  If a benzocaine product is used, it must be used sparingly and not more than four times a day.  The American Academy of Pediatrics (AAP) recommends using chilled teething rings or gently massage the baby’s gum with your finger instead of using OTC benzocaine products.  For a list of OTC benzocaine products you can visit the FDA’s web site.

If you or your baby was injured due to OTC tooth pain or teething gel medications please feel free to contact one of our experienced dangerous drug lawyers, doctors or nurses at 1.888.823.5291 for a strictly confidential and free consultation.  Our nationally recognized pharmaceutical error attorneys at The Beasley Firm have successfully fought for individuals who have sustained illness or injury because of dangerous drugs. We have successfully obtained dozens of six, seven, and even eight figure settlements and verdicts on behalf of injured clients.

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Taking Trimethoprim While Pregnant Can Cause Spina Bifida And Other Birth Defects

By The Beasley Firm on April 25, 2012 - No comments

Trimethoprim-sulfamethoxazole is a commonly prescribed antibiotic for urinary tract infections (UTI), community-acquired methicillin-resistant Staphylococcus aureus (MRSA) and other bacterial infections including ear infections, bronchitis, traveler’s diarrhea and pneumonia.  Bactrim, Septra, Trimpex, Proloprim, and SMX-TMP, sometimes called cotrimoxazole, are a few drugs that include trimethoprim.

All women of childbearing years or those desiring to become pregnant or who are already pregnant are instructed to take 400 micrograms of folic acid each day to help prevent neural tube defects, spina bifida and other serious birth defects.  Trimethoprim interferes with the metabolism or absorption of folic acid so any woman who is prescribed an antibiotic with trimethoprim in it is at risk for not having the proper recommended levels of folic acid for themselves or their developing fetus.  A recent study showed that the use of trimethoprim or other medications that interfere with folic acid absorption, during the first trimester or first three months of pregnancy increases the likelihood of having a child with birth defects. Some of the more common birth defects that have been linked to trimethoprim are:

  • Spina Bifida – a condition where the neural tube does not close properly and the spinal cord is on the outside of the body that could lead to permanent nerve damage or paralysis in the lower extremities or legs.
  • Anencephaly – a condition where the neural tube does not close to form the brain and spinal cord that results in the absence of certain parts of the skull, brain and scalp.  A baby with anencephaly will either be stillborn or not survive long after birth.
  • Cleft Lip or Cleft Palate – a condition where there is an opening in the roof of the mouth and incomplete formation of the upper lip.
  • Polydactyly – a condition where there is more than 5 fingers or toes on each foot or hand.
  • Hypospadias – a condition where there is a defect in the urethra and the opening is on the bottom of the penis.
  • Heart Defects
  • Short bones or limbs
  • Urinary tract defects or malformations

Trimethoprim should also be avoided if a mother is breast feeding because it is excreted in the breast milk.  Trimethoprim that is passed onto an infant while nursing and can cause an elevated bilirubin level (jaundice) and cause kernicterus, or permanent brain damage and cerebral palsy.

Any woman who is pregnant or at risk of becoming pregnant should not be placed on trimethoprim to treat a urinary tract infection (UTI) or other infection unless the benefits clearly outweigh the risks.  If you were placed on trimethoprim while you were pregnant and your baby was born with spina bifida or other serious birth defects, please feel free to contact one of our experienced dangerous drug lawyers, doctors or nurses online or 1.888.823.5291 for a strictly confidential and free consultation.

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What Causes Birth Defects During Pregnancy?

By The Beasley Firm on April 24, 2012 - No comments

When a child is born with a congenital defect or deformity at birth parents often try and think what may have caused the birth defect.  According to the March of Dimes, many birth defects have unknown causes while about 40% of birth deformities are as a result of genetic, environmental factors or toxic medications that were taken during pregnancy.

Genetics may be the cause of some birth defects. A genetic cause of a birth defect happens when one or both of the parents pass an inherited defective gene or missing gene onto the developing baby. Some of the more common birth defects that are inherited or genetic include Cystic Fibrosis, Tay – Sachs Disease, and Fragile X Syndrome.

Chromosomal abnormalities can also result in birth defects or certain syndromes.  If there is a disruption or damage to chromosomes that leads to either too many or not enough chromosomes, it could lead to a birth defect.  Trisomy 13 or Down’s syndrome occurs when there is an extra chromosome.

When there is no chromosomal or genetic explanation for a child’s syndrome or birth abnormality, physicians may look at other potential causes of your child’s birth defect, developmental delays, neurologic problems, mental retardation or cerebral palsy.  There are scientific studies that link certain infections, chemicals, or toxic substances to the development of birth defects or certain syndromes.  Some of the more common environmental factors that can lead to a birth defect are:

  • Infections during pregnancy such as Rubella (German Measles), toxoplasmosis and cytomegalovirus (CMV)
  • Alcohol consumption that can lead to Fetal Alcohol Syndrome (FAS)
  • Insecticide exposure
  • Radiation and x-rays
  • Petroleum products or distillates
  • Heavy metal ingestion such as lead, gold or mercury
  • Cleaning solutions
  • Paint or solvents
  • Volatile Organic Compounds (VOC)

At times, pregnant mothers may be unaware that they have been exposed to certain toxic environmental causes of birth defects during their pregnancy because the toxins or poisons could be hidden in contaminated soil, locally grown fruits and vegetables, ground water, well water or in the air.

Working in certain occupations or industries can also expose a pregnant mother to chemicals, solutions, or solvents that can cause birth defects.  Some work places that may expose the growing fetus to hazardous chemicals are:

  • Nail salons
  • Car or Automotive repair garages
  • Dry Cleaners
  • Paint factories
  • Printing places
  • Metal cleaning facilities
  • Agriculture
  • Beauty salons

If the mother or father of the unborn child did not work in an area where there are known toxins, the cause of the birth defect may be due to a prescribed medication the mother was taking just prior to conception, or becoming pregnant, or during the pregnancy.  Common medications or drugs that have been linked to birth defects or deformities at birth are:

  • Zoloft (sertraline) which is a selective serotonin reuptake inhibitor (SSRI) manufactured and sold by Pfizer.  It is used to treat depression, obsessive-compulsive disorder (OCD), panic disorders and anxiety disorders.  Mothers who took Zoloft while pregnant have had a baby born with birth defects such as clubbed foot, cleft lip, cleft palate, Persistent Pulmonary Hypertension (PPH), gastroschisis (intestines outside the body), heart defects, skull defects, brain malformations, spinal cord defects, mental retardation and developmental delays.
  • Topamax is a medication used for seizures, epilepsy or migraine headaches.  Mothers who took Topamax during pregnancy have had children born with cleft lips or cleft palates.
  • Depakote or Valproic acid is used to treat seizures, mania, bipolar disease, manic-depressive disorder, and migraine headaches. A woman who takes Depakote during pregnancy may have an increased risk of having a baby with spina bifida, anencephaly, neural tube defects,  atrial septal defects (ASD), ventricular septal defects (VSD), tetralogy of Fallot, cleft palate, craniosynostosis and other heart defects and birth defects that have also led to developmental delays.
  • Lexapro is an antidepressant that is a selective serotonin reuptake inhibitor (SSRI) manufactured by Forest Laboratories, which is pharmacologically very similar to Celexa (citalopram).  Mothers who took Lexapro during pregnancy have had newborns born with abdominal defects, omphalocele, anal atresia, cardiac or heart defects, autism spectrum disorder, cleft lip, cleft palate, clubfoot, craniosynostosis, skull defects, limb deformities, neural tube defects, spina bifida or Persistent Pulmonary Hypertension of the Newborn (PPHN).

Other medications that have been linked to neural tube defects or spina bifida are medications that block or prevent folic acid from being converted into its active metabolites. Medications such as trimethoprim, sulfasalazine, or Methotrexate are known to block the conversion of folic acid and can cause spinal cord birth defects if taken early on in the pregnancy when the spinal column is forming.

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