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Dangerous Drugs - Philadelphia Injury and Malpractice Attorneys - The Beasley Firm

FDA Finds Further Proof Diabetes Drugs Cause Pancreatic Cancer

By Max Kennerly, Esq. on December 16, 2014 - No comments

For more than a year now, our firm has been entrenched in litigation against the manufacturers of several “incretin mimetic” diabetes drugs, including Januvia, Janumet, Victoza, Byetta, and Onglyza, which, we allege, cause pancreatic cancer.

No trials have been held, and so much of what has occurred there remains confidential, but two recent developments may fundamentally alter the course of the lawsuits — and may help protect unwary patients from one of the most feared diseases known to man. 

The drug companies still vehemently deny any connection between these drugs and pancreatic cancer. Their drugs mention all kinds of nuisance side effects, like flatulence and burping, but not one has a word about pancreatic cancer. That may be about to change.

First, in a study published in October 2014, one of the FDA’s own labs confirmed that giving a GLP-1 agonist to mice causes precancerous injuries to the pancreas, particularly if the mice eat a high fat, high carbohydrate diet. (“Extended Exenatide Administration Enhances Lipid Metabolism and Exacerbates Pancreatic Injury in Mice on a High Fat, High Carbohydrate Diet.”)

In people with type 2 diabetes, the beta cells in the endocrine pancreas don’t work as well as they should, and the incretin diabetes drugs are supposed to work by making the beta cells in the endocrine pancreas function better. For example, the incretin diabetes drugs could cause more beta cells to proliferate, or could cause them to grow bigger, or live longer. 

Problem is, you can’t pick and choose which cells you make proliferate, and at some point, when cells proliferate too much, they become cancerous. Pancreatic cancer is, in many ways, just too many cells growing, and growing too quickly, in the duct of the pancreas.

Technically, the FDA researchers found injuries to the pancreatic ducts consistent with “focal proliferation of the exocrine pancreas and possibly pre-neoplastic PanIn lesion development.” That is, they saw the drug — specifically, Byetta — causing mice to develop more cells in their exocrine pancreas. Worse, those cells were damaged in a lot of worrying ways, damage that could make them become “PanIn lesions,” which are precancerous.

As the FDA researchers said, they didn’t quite see cancer, their findings were “consistent” with the extremely worrying results reported back in 2013 by a team of researchers that found people treated with Januvia and Byetta had evidence of precancerous changes in their pancreas. (“Marked Expansion of Exocrine and Endocrine Pancreas With Incretin Therapy in Humans With Increased Exocrine Pancreas Dysplasia and the Potential for Glucagon-Producing Neuroendocrine Tumors.”) That’s a pretty big deal, and the FDA researchers said the next step was to look at mice with genetic mutations that made them better mimic pancreatic cancer in humans.

Second, also in October 2014, Health Canada revealed in a communication to physicians that, “[a]s of July 31, 2014, Health Canada received 13 reports of pancreatic cancer suspected of being associated with all incretin-based therapies.” Further, the agency “has initiated an epidemiological study through the Drug Safety and Effectiveness Network (DSEN) to assess the potential association between pancreatic cancer and incretin-based therapies and will continue its ongoing monitoring of this potential safety issue.”

The study covers Nesina (alogliptin)‎, Tradjenta (linagliptin), Onglyza (saxagliptin), Januvia / Janumet (sitagliptin), Byetta (exenatide), and Victoza (liraglutide). 

We’ll see if either action causes some serious change in these products, like perhaps a withdrawal, as Public Citizen has recommended for Victoza, or at least better warnings. Patients have the right — the legal, ethical, and moral rights — to know the risks of the drugs they pay for and put into their bodies.

If you or a loved one developed pancreatic cancer after taking Byetta, Januvia, Janumet, Victoza, or another diabetes drug, please read more about our pancreatic cancer lawsuits.

 

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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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Do Some Diabetes Drugs Shorten, Rather Than Extend, Lives?

By Max Kennerly, Esq. on December 27, 2013 - No comments

As part of the pancreatic cancer litigation that has been taking up a lot of my time, I’ve spent a lot of my time lately thinking about diabetes in general. Diabetics know all too well the merry-go-round they can end up on as doctors switch them from one medication to another in search of perfect control of their blood sugar levels.

That’s the only reason any of my clients ended up on Januvia, Victoza, Byetta or the like. No one truly needed one of those three drugs in the same way that, say, a person having a stroke needs a blood clot buster or a person at risk for heart attacks needs aspirin. Rather, those drugs just seemed to be the best fit for the patient; our concern in the litigation is that the drug manufacturers never warned patients about the true risk of the drugs, i.e., the increased risk of pancreatic cancer.

But maybe we’ve all been thinking about diabetes itself in the wrong way. A new study in the British Medical Journal, “Comparative effectiveness of exercise and drug interventions on mortality outcomes: metaepidemiological study,” reported widely (including by Philadelphia Magazine) found that, in patients with heart disease and diabetes, exercise did just as well as medication in extending patients’ lives. Similarly, despite all kinds of hype, it remains unproven that moderate fluctuations in glucose / blood sugar levels — or even sustained moderate elevations — cause much long-term damage in the end.

In short, there’s no magical number that patients need to reach to avoid long-term harm, even death. Outside of severe cases, diabetes management is more about a happy, productive lifestyle than it is about extending life or preventing diseases.

Which brings into sharp focus the true horror of the pancreatic litigation: most people really, truly don’t need these drugs to be healthy. They need better support for diet and exercise routines, and the use of these drugs on the whole shortens their lives, rather than extending them.

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The Tylenol Acute Liver Failure Epidemic Goes To Multi-District Litigation

By Max Kennerly, Esq. on May 3, 2013 - No comments

Extra Strength Tylenol, one of the most aggressively-marketed consumer products in the country, has been making news again lately. The media focus has been on how researchers built on previous findings that “acetaminophen reduced neural responses to social rejection in brain regions previously associated with distress caused by social pain” and found that Tylenol can reduce existential unease and cause people to be less morally judgmental. It is an undeniably powerful drug.

But the bigger news from a patient safety standpoint has been the creation of “multidistrict litigation” against McNeil Pharmaceuticals. The order means that the bulk of Tylenol injury lawsuits while be handed, at least for pretrial purposes, here in the federal court in Philadelphia, a couple blocks from our office.  A year and a half ago, I wrote a post about how courts were lagging behind the science on acetaminophen, and it seems that the tide is changing on that.

 

The Long History Of Tylenol Liver Failure Lawsuits

The risk of acute liver failure when using Tylenol certainly isn’t new, and even Tylenol lawsuits aren’t new. As just one example, more than twenty years ago Antonio Benedi, a regular wine-drinker (but by no means an alcoholic) “had been taking Extra-Strength Tylenol in normal, over-the-counter doses since February 5, 1993 for flu-like aches,” when, five days later, he “was admitted to the hospital on February 10, 1993 in a coma and near death due to liver and kidney failure.” Benedi v. McNeil-PPC, Inc., 66 F.3d 1378 (4th. Cir. 1995).

The hospital’s pathologist examined Benedi’s damaged liver and concluded that the injury was characteristic of acetaminophen toxicity. In the lawsuit that followed, Benedi’s lawyers proved that even “therapeutic” doses of Tylenol — i.e., doses within the limits given on the label — could cause acetaminophen hepatotoxicity and acute liver failure when combined with ordinary amounts of alcohol. The Tylenol warning label was subsequently updated to warn about alcohol use while taking acetaminophen.

 

The Continued And Commonplace Danger Of Tylenol Liver Injuries

Since then, not much has changed even while acetaminophen liver injuries continue to mount. Researchers knowacetaminophen hepatotoxicity far exceeds other causes of acute liver failure in the United States,” and that the incidence of Tylenol-induced acute liver failure is on the rise. Some estimates by the American Association of Poison Control Centers suggest more than 50,000 emergency department visits every year related to acetaminophen.

There were two inadequate changes over the past decade. In 2005, the over-the-counter Tylenol label was modestly updated to warn that “severe liver damage may occur if more than 4,000mg of acetaminophen is taken.” In 2011, Tylenol changed the label on its Extra Strength Tylenol formulation (the 500mg pills) to impose a maximum of 6 caplets every 24 hours, or 3 grams a day.

Neither of these changes really get to two biggest problems: many routine medical conditions increase Tylenol toxicity and Tylenol has no safety margin for its use.

 

Even Taking The Recommended Dose Of Tylenol Can Cause Acetaminophen Related Hepatotoxicity, Acute Liver Failure, Or Death

Starting with the first problem, McNeil Laboratories and Johnson & Johnson are simply wrong that a patient has to take more than 4 g of Tylenol to run the risk of acute liver failure or death. Way back in 1987, researchers confirmed the metabolic process by which, when mice weren’t fed as much, their livers didn’t produce as much glutathione, and the liver had much greater difficulty clearing acetaminophen. It’s easy to see that and think, well, how often do people really “fast” — as in, go without any food at all — and take a significant amount of Tylenol?

But “fasting” in this context doesn’t mean abstaining from food entirely, and, more to the point, think about when people consistently take the maximum dose of Tylenol – for example, when they are sick with a cold or the flu, or when they are recovering from surgery, times when people don’t tend to eat much. Last time you had the flu, even if you could keep food down, you weren’t hungry, so you didn’t eat much, but your fever kept going up and you felt aches and pains throughout your body, and so you took Tylenol as often as the label said you could. They even market it for this purpose, like “Tylenol Cold & Flu Severe.”

Bad idea. That’s where the “increased hepatotoxicity” comes in. In just a few days, you can go from “having a flu” to “in the hospital with ‘Acetaminophen related hepatotoxicity,” to the liver transplant list — or worse. It’s scary, and it happens to consumers all the time. Indeed, the problem might be even worse than we think: as researchers noted two years ago, “the cause of liver injury in 14% of patients with acute liver failure remains unknown.” Their data lead them to conclude there was a “high prevalence of unrecognized or uncertain acetaminophen toxicity among subjects with indeterminate acute liver failure.”

If you have any other condition that affects the liver, or if you’re anything other than a perfectly healthy adult, then the risks are even worse. Consider this 2001 article from the American Academy of Pediatrics, which lists “Conditions and Situations That May Increase the Risk of Acetaminophen Toxicity” including Diabetes mellitus, Obesity, Chronic undernutrition, Prolonged fasting, Family history of hepatotoxic reaction, and Concomitant viral infection.

 

Consumers Don’t Realize The Potentially Fatal Consequences Of Going Even Slightly Over The Recommended Tylenol Dose

Moving to the second problem, there’s no denying that, even in perfectly healthy patients, at some dosage Tylenol is likely cause acute liver failure. The question are: what is that level, and how often do people cross it? Many studies have found, for example, “that there is a narrow therapeutic margin and that consistent use of as little as 7.5 g/day may be hazardous.” The phrase, “narrow therapeutic margin,” is a euphemism for “the recommended dose brings you awfully close to permanent injury and potentially death.” Other studies have found the number could be much lower, so that consumers who frequently take just a little bit more Tylenol than recommended — the so-called “staggered overdose” — are at far greater danger of liver injuries, and some slight tipping point like a flu or some alcohol use can push them over the edge.

We’re all familiar with cases of people attempting suicide by overdosing on Tylenol, but that’s not the whole story: there are literally hundreds of published medical studies describing unintentional overdoses on Tylenol, typically referred to as “therapeutic misadventures.” How does this happen? I have one guess: patients don’t know just how dangerous acetaminophen can be. Although that warning references “liver damage,” it doesn’t convey the two most serious potential side effects: acute liver failure and death. As the Washington Post noted in a long article earlier this week about Medicare, one of the biggest contributors to health problems today is “non-compliance” with medications. The consequences of just a few days of “non-compliance” or a “therapeutic misadventure” with Tylenol, however, are far worse than with any other over-the-counter pill — but consumers don’t know that.

Put simply, there are no other over-the-counter drugs with such a narrow window that, if you merely take an extra four or five pills, you could die, and yet Tylenol is labeled and advertised not just as being like everything else, but as being safer than other drugs.

 

Where The Tylenol Lawsuits Go From Here

As noted above, Tylenol litigation isn’t new, but the creation of the multi-district litigation (“MDL,” which is different from a class action) really changes things. Over 50,000 people go to the emergency room with these injuries every year, but Johnson & Johnson and McNeil aren’t going to do anything. They sell over $1 billion a year of Tylenol. (Read more about their branding initiatives over the past fifty years here). The FDA isn’t going to do anything, either.

These days, there’s only one way unsafe drugs are ever pulled from the market or given better warnings: when the company is held accountable to its victims, it makes less of a profit, and so moves on to something else. The creation of the multidistrict litigation is important because it will help gather together these hundreds, potentially thousands, of cases, allowing them to have strength in numbers, and preventing the company from spending literally millions of dollars fighting each one of them to try and dissuade other plaintiffs and their lawyers from bringing individual lawsuits.

 

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Why doesn’t the Motrin label warn about Stevens-Johnson Syndrome?

By Max Kennerly, Esq. on February 15, 2013 - No comments

A $63 million verdict awarded by a jury earlier this week in Maine shows the lengths to which drug companies will go to make a profit.

It’s well known that NSAID pain relievers like Motrin (ibuprofen) can cause Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis; the life-threatening complication is well-known in the medical literature, and there have been successful lawsuit against Johnson & Johnson and its consumer drug subsidiary, McNeil Consumer & Speciality Pharmaceuticals, the maker of Motrin and children’s Motrin, in the past. (I wrote about one such lawsuit here in Philadelphia two years ago.)

There’s also nothing new about the difficulty in holding pharmaceutical companies liable for the catastrophic side effects of their medications. The United States Supreme Court has taken a very hostile approach to drug injury lawsuits; while lawyers can raise a number of legal claims, like negligence and strict liability, in the end all of the lawsuits have to be proven the same way, i.e., by proving that the prescribing information or warning label did not adequately disclose the actual risks of the drug. If it’s a prescription drug, the injured patient has to prove the doctor would not have prescribed it (that’s called the “learned intermediary doctrine,” and it’s a terribly unfair rule). If it’s an over-the-counter drug, the patient has to prove they would not have taken it had they known.

In practice, that means that drug manufacturers can usually escape responsibility for any of the harm they cause as long as they stick a warning somewhere on the label, in tiny print, that a horrific complication like Stevens-Johnson Syndrome might happen. That means for Johnson & Johnson and McNeil that, if they wanted to stop facing these Stevens-Johnson / Toxic Epidermal Necrolysislawsuits, all they need to do is update the label of Motrin and Children’s Motion to better warn consumers about the risks of taking the medicine, and to instruct them, in big bold letters, to stop taking Motrin immediately if they develop any sort of rash or hives.

Samantha Reckis would have had a different life if her parents had been warned. I have young children, and I know how easy it is to get into the routine of treating your child with Tylenol or Motrin for every illness the child has, and to give more of the medicine – so long as you have not given in the past four hours – if the child continues to be sick. After all, when the kids were babies, that’s usually the best thing to do, because it’s the only thing that can keep the baby’s temperature down, and thus let the baby rest and get over the virus on their own.

The problem for NSAIDs is that, once a child or even adult has started to develop any signs of Stevens-Johnson Syndrome, giving more is — almost literally — adding fuel to the fire, any additional medication will turn what would have been a really awful experience into a lifetime of agonizing injuries, like the ones that Samantha suffered, including blindness, burns over most of her body, and such injuries to her internal organs that she had to be put into a medical coma.

Now that Johnson & Johnson has faced more than $125 million in jury awards against them for failing to warn about the rare but horrific complications of Motrin, why don’t they just change the label already? The answer, I think, is obvious: it is more profitable for them to pay tens of millions of dollars in jury awards, and millions of dollars in defense attorneys fees, then it is for them to update the label and thus potentially reduce sales. And that is a terrible, tragic shame.

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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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Did You Develop A Skin Rash, Tissue Death, Gangrene Or An Amputation After Taking The Blood Thinner Coumadin Or Warfarin?

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

Warfarin-induced skin necrosis (WISN), Coumadin-induced skin necrosis (CISN), Anticoagulant-induced skin necrosis  or warfarin dermal gangrene is a condition in where there is skin and tissue death or necrosis due to a protein C deficiency  after being started on  Coumadin or warfarin, which are anti-vitamin K anticoagulants.

Warfarin necrosis is a rare but severe complication of treatment with warfarin or related anticoagulants. The skin necrosis occurs in approximately 1 of 10,000 patients treated with warfarin or Coumadin.   As anticoagulation is a component of therapy for many major chronic illnesses such as blood clots, deep vein thrombosis (DVT’s), strokes and atrial fibrillation, prompt diagnosis and treatment is crucial to minimize tissue death, amputations or death.

The skin reaction or drug eruption usually occurs in between the third and tenth day after starting the blood thinning medication.  It starts with pain and redness of the affected area and then progress to petechial or little purple bruises that then become hard. If continued on the medication, the lesions can progress into large fluid filled blisters or bullae that lead to gangrene, necrosis or tissue death, and eschar or a severely burned skin appearance.  The lesions usually start in areas where there is subcutaneous fat such as the breasts, thighs, buttocks or penis. In some severe cases, the fascia, connective tissue or muscle may also be involved.

Since Coumadin works on inhibition of Factor VII to prevent clotting, the prothrombin time (PT) or international normalized ratio (INR) may be therapeutic even though the patient is developing clots.  When a clot forms in a blood vessel, it leads to an interruption of blood flow, oxygen and nutrients to the skin and tissues, causing cell death, skin necrosis and gangrene.  If the skin death is extensive, surgical debridement or amputation may be necessary.

If a patient is started on warfarin or Coumadin and develop skin lesions the first element of treatment is to stop the medication.  Because the patient may still require anticoagulation or blood thinning, Heparin or low molecular weight heparin (LMWH) may be started. Vitamin K may be given to reverse the effects of the Coumadin.  Since there may also be low levels of Protein C, fresh frozen plasma (FFP) or pure activated protein C may also be administered.

If you or a loved one was started on the medication warfarin or Coumadin and developed tissue death, skin necrosis, gangrene or amputation you may be eligible for compensation.  For over 50 years, the Beasley medication error medical malpractice teams have had over $2 billion awarded on behalf of our injured clients. Our full time legal, medical, and nursing teams often find hospital errors and medication mistakes that other law firms miss in their review. If you or a loved one has suffered due to Coumadin, warfarin or other blood thinner medication, please feel free to contact one of our Philadelphia medical negligence lawyers, doctors, or nurses at 1.888.823.5291 for a strictly confidential and free consultation. When you call us, you will only speak to someone on our experienced medical and legal team.

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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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First Pradaxa Legal Win For Patients: Court Denies Pharma Company’s Motion To Dismiss

By The Beasley Firm on August 3, 2012 - No comments

As we have discussed before, the atrial fibrillation anticoagulation medication Pradaxa, which was meant as a safer alternative to warfarin (with supposedly the same ability to prevent strokes and systemic embolism), has a big problem: if a patient develops some type of serious bleeding or hemorrhaging, there’s no way to stop it.

Unlike warfarin / Coumadin, which can be reversed a number of ways (like a vitamin K shot), there’s no way to reverse the effects of Pradaxa. Emergency medicine physicians, neurosurgeons, and internal medicine specialists have been working frantically for months to come up with some sort of reversal procedure – trying everything from dialysis to injecting a cocktail of proteins – but nothing seems to work.

Dozens of patients who suffered uncontrollable gastrointestinal bleeding or brain hemorrhages have filed suit against the manufacturer of Pradaxa, Boehringer Ingelheim Pharmaceuticals, Inc. Roughly half of the federal cases are pending in the Southern District of Illinois, all of which are assigned to Chief United States District Judge David R. Herndon. Last week, Judge Herndon issued his first order, denying the pharmaceutical company’s motion to dismiss the cases, a significant victory for patients injured by Pradaxa.

As the Court recounted in its opinion:

In May 2011, the plaintiff’s physician prescribed the prescription drug Pradaxa for treatment of the plaintiff’s medically necessary blood thinning needs. Doc. 2 at ¶ 41. Pradaxa is a member of a class of anticoagulants known as direct thrombin inhibitors and is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (patients with atrial fibrillation have an increased risk of stroke). Id. at ¶ 11. Shortly after being prescribed Pradaxa, on or about July 7, 2011, the plaintiff suffered a severe gastrointestinal bleed causing her to be hospitalized for 5 days in St. Mary’s Hospital. Id. at ¶ 41. During this time, the plaintiff allegedly suffered from uncontrollable bleeding which was caused and/or worsened by her use of Pradaxa. Id. The Pradaxa prescribed to and ingested by the plaintiff was allegedly ‘designed, manufactured, marketed, advertised, distributed, promoted, labeled, tested and sold’ by BIPI. Id. at ¶ 10.

The plaintiff contends, inter alia, that despite being aware of certain safety risks associated with use of Pradaxa, BIPI failed to adequately warn or disclose information about such risks to the medical community and consumers. 5 See e.g., Id. at ¶¶ 18-22, 26 (a-m), 27. Specifically, the plaintiff contends that (1) BIPI failed to adequately warn or disclose information regarding the risk of serious and sometimes fatal irreversible bleeding events associated with the use of Pradaxa; (2) failed to warn or disclose information regarding the protocol, or lack thereof, for reducing the anticoagulation effects of Pradaxa in patients who experience a severe bleeding incident; (3) failed to provide adequate warnings and information regarding the increased risks of bleeding in certain patient populations; (4) failed to provide adequate warnings and information regarding the ability or need to assess certain factors in patients taking Pradaxa; and (5) failed to warn that patients taking Pradaxa are at an increased risk for excessive and/or uncontrollable bleeding. See e.g., Id. at ¶¶ 18, 20-22, 26 (a-m), 39. The plaintiff also contends that BIPI made affirmative misrepresentations regarding the efficacy, safety risk profile, and additional benefits of Pradaxa. See e.g., Id. at ¶¶ 14, 18, 20, 21. Finally, the plaintiff contends that BIPI failed to adequately research or investigate the safety profile of Pradaxa and failed to adequately research or investigate patient weight as a variable factor in establishing recommended dosages of Pradaxa. Id. at ¶ 26(c),(d).

Sellers v. Boehringer Ingelheim Pharms., Inc., 2012 U.S. Dist. LEXIS 102959, at *8–10 (S.D. Ill. July 25, 2012).

The key issue at this stage is whether the FDA-approved warning label for Pradaxa, which says that there is a risk of “serious and sometimes fatal bleeding,” was sufficient as a matter of law to preclude the plaintiffs from bringing any lawsuits. The judge held that the Pradaxa warning label failed to warn that “if a serious bleeding event occurs, there is no effective means for reversing the anticoagulation effects of Pradaxa,” and failed to warn about “the increased risk of excessive or uncontrolled bleeding in patients taking Pradaxa” as compared to warfarin.  The judge did not conclude that either of those allegations were true or false, because that issue is not yet ripe, but rather just concluded that, if those allegations were true, the manufacturers of Pradaxa could be liable for failing to warn.

Those cases will thus move into discovery where they can obtain information about what Boehringer Ingelheim really knew about the risks of Pradaxa. In other news, the judicial panel on multidistrict litigation last week also heard arguments on a motion to create a single consolidated litigation for the cases. Consolidated litigation is different from a class action, because the cases are still filed individually and would be tried in a jury eventually, but it has many of the same benefits for plaintiffs, particularly in the ability of plaintiffs to use proof from one case in proving another case.

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