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

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 know “acetaminophen 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.

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.

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.

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.

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.

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.

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.

More than 700 women had filed lawsuits alleging they developed blood clots or strokes while using NuvaRing, and the first bellwhether trials are schedule to take place early next year in New Jersey. Just last month, the Court entered an order precluding several of Merck’s research scientists from giving opinion testimony at the trials unless they provide the plaintiff’s lawyers, before the trial, with expert reports explaining the basis of those opinions.

In the meantime, the scientific evidence demonstrating that NuvaRing itself has a higher risk of blood clots, pulmonary embolism, DVT, stroke and death than oral birth control pills continues to mount. Back in 2011, the Food and Drug Administration’s own internal researchers found an increased risk. In May 2012, the British Medical Journal published a study showing an incidence rate of venous thrombosis of 7.8 per 10,000 years of exposure among women, or 8 patients a year with a serious blood clot for every 10,000 patients using NuvaRing — double the risk of oral contraceptives like Plan B.

Merck has responded by going on the offensive. Since 2007, Merck has sponsored a clinical trial, called the “Transatlantic Active Surveillance on Cardiovascular Safety of NuvaRing,” that is supposed to look for the following:

The primary objective of this study is to characterize and compare the risks of short- and long-term use of NuvaRing® with marketed combined OCs. The main clinical outcomes of interest for the short and long-term follow-up are:

• Deep Venous Thrombosis (DVT)
• Pulmonary Embolism (PE)
• Acute Myocardial Infarction (AMI)
• Cerebrovascular Accidents (CVA)

In response to the British Medical Journal study, Merck has started referencing the data in that trial at health care professional conferences, and has sent letters complaining (Microsoft Word file) about the BMJ article, but they have not opened up the results to peer review by independent scientists.

We think that silence speaks for itself. If they had favorable data, they wouldn’t just talk about it, they would show everyone. We’re confident that NuvaRing is more likely to cause blood clots, and that the patients injured and their NuvaRing lawyers will be able to prove in Court that Merck failed to properly warn patients that NuvaRing wasn’t just more convenient than the birth control pill — it was also more dangerous, just like Ortho Evra, the other major non-pill contraceptive, turned out to be.

As we have discussed before on this blog, more than 11,300 Yaz / Yasmin lawsuits have been filed against Bayer, the drugs’ manufacturer, typically alleging the drugs caused blood clots in legs or arms (deep vein thrombosis), blood clots in lungs (pulmonary embolism), or a stroke involving venous thrombotic event. Back in April, the Beyaz, Safyral, Yasmin and Yaz side effect warning labels were updated to reflect that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins.

Back in April, Bayer reported paying over $140 million in settlements for Yaz and Yasmin, at an average settlement amount of about $218,000 a case. Given the pace at which the cases are settling — normally in negotiated batches — that number could be $200 million by now. The lawsuits themselves are all on hold pending court-ordered mediation, which for the time being seems to be working in getting the cases resolved. As we mentioned in the prior posts here, the evidence against Bayer is quite strong, with the consolidated plaintiffs’ lawyers calling a former FDA Commissioner as an expert witness to testify his opinion that:

• “Bayer violated its duties under FDA regulations and state law by selectively presenting data as to thromboembolic events, which did not adequately inform FDA, doctors or consumers of the thromboembolic risks, from premarketing to the present”;
• “Bayer engaged in extensive off-label promotion of Yasmin and YAZ for unapproved uses, in violation of FDA regulations, to increase sales”
• “[t]hat off-label promotion increased the risk of thromboembolic events in patients in violation of state law duties.”

(That comes from the expert’s report.)

Further underscoring the problems with these medications — and, most pertinently, Bayer’s failure to warn patients about the risks — is a study just released in the New England Journal of Medicine (“Thrombotic Stroke and Myocardial Infarction with Hormonal Contraception“) which analyzed nearly two million Danish women without a prior history of heart disease. The researchers found:

Although the absolute risks of thrombotic stroke and myocardial infarction associated with the use of hormonal contraception were low, the risk was increased by a factor of 0.9 to 1.7 with oral contraceptives that included ethinyl estradiol at a dose of 20 μg and by a factor of 1.3 to 2.3 with those that included ethinyl estradiol at a dose of 30 to 40 μg, with relatively small differences in risk according to progestin type.

In layman’s terms, the study found that hormonal contraceptives that rely on estradiol and other progestins raised the risk of heart attacks and strokes by nearly 50%, and sometimes even doubled it.

If you suffered a blood clot injury, like venous thrombosis (whether DVT or pulmonary embolism), or a heart attack or stroke while taking Yaz or Yasmin, contact our dangerous drug lawyers for a free, no-obligation consultation. We’ve been representing injured patients for over 50 years, recovering over $2 billion in jury verdicts and settlements.

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.