Posts Tagged ‘ Adverse Events ’

Why are there NuvaRing Lawsuits? Here’s NuvaRing by the Numbers…

May 25th, 2012. By AbiK

As NuvaRing lawsuits continue to wind their way through litigation, it’s interesting to look at some of the numbers on the contraceptive—as numbers tend to tell a story.

NuvaRing was also in the news recently for another reason: in a newly published study, apparently longer-term reversible contraception was found to be more effective in preventing pregnancy than shorter-term methods. Longer-term contraception would include IUDs and implants; shorter-term would be birth control pills, patches and rings. The study, published in the New England Journal of Medicine (5/24/12), found longer-term contraception to be 20 times more effective in preventing pregnancy (of course, one of the reasons cited for this was human error–such as forgetting to take the pill).

So here we go…

NuvaRing by the Numbers

2001: Year in which NuvaRing received FDA approval

950+: Number of NuvaRing lawsuits pending, as reported in Merck’s 10-K earnings report, fiscal year 2011

56%: Percent by which FDA study found NuvaRing raised risk of blood clots vs. older birth control pills.

6: Types of serious NuvaRing adverse events alleged in lawsuits (blood clots, pulmonary embolism, deep vein thrombosis, heart attack, stroke, sudden death)

6.5x: Times higher risk for NuvaRing blood clots compared to non-users of hormonal contraception, according to British Medical Journal study (5/10/12)

5,493: Total number of adverse events reported at the FDA AERS database for NuvaRing, 1Q’04-2Q’11*

30: Average age of women who have had a NuvaRing adverse event reported to the FDA*

1,953: Number of NuvaRing adverse events categorized under “Pulmonary Vascular”, 1Q’04-2Q’11*

1,921: Number of NuvaRing adverse events categorized under “Embolism & Thrombosis”, 1Q’04-2Q’11*

1,648: Number of NuvaRing pulmonary embolism adverse events reported, 1Q’04-2Q’11*

1,274: Number of NuvaRing deep vein thrombosis adverse events reported, 1Q’04-2Q’11

*Source: FDA NuvaRing AERS reports via drugcite.com

Tags: Adverse Events, AERS, BJM, blood clots, DVT, FDA, NEJM, NuvaRing, NuvaRing lawsuit, PE
Posted in Drugs/Medical, Emerging Issues, Personal Injury | No Comments »

Yaz Scandal? Doc’s Accusations v. Bayer Unsealed, Revealed

December 7th, 2011. By AbiK

Admittedly, it lacks the titillating quality of Warren Commission Report—but it could, in its own right, be linked to what some plaintiffs would likely describe as murder, and also conspiracy theory.

Earlier this week, expert opinion regarding Yaz birth control was unsealed in a federal court in Illinois. The expert opinion was in the form of a 196-page document written by Dr. David Kessler.

What’s interesting—or take your pick of adjectives here: damning, alarming, scandalous—is that Dr. Kessler’s report point-blank accuses Bayer of hiding critical data regarding Yaz’ blood clot link (the basis for numerous Yaz lawsuits right now).

According to Kessler’s conclusion, “By failing to disclose all thromoembolic event risk information and marketing Yaz and Yasmin off-label, Bayer needlessly exposed large numbers of women to risks of serious or fatal thromboembolic events.”

Kessler’s accusation of failure to disclose comes as a result of his claim that, in 2004, Bayer wrote a white paper draft—the white paper being what would ultimately be submitted to the FDA for review—that initially stated that Yasmin had a “several-fold” increase in DVT (deep vein thrombosis), pulmonary embolism and VTE (venous thromboembolism) when compared with three other commonly used birth control pills.

That was the draft version.

The version that Kessler states was submitted, according to Medpage Today, said, “The spontaneous reporting data do NOT signal a difference in VTE rates for Yasmin and other [oral contraceptive] uses. We see NO signal of a difference.”

Key to those edits, according to Kessler’s accusations, is that there was no additional data presented by Bayer to support the 180-degree turnaround in their conclusion.

According to MedPage, Kessler went on to state “…that Bayer presented a selective view of the data, and that presentation obscured the potential risks associated with Yasmin.”

Compounding this is Kessler’s assertion that Bayer extensively marketed Yaz off-label for PMS—for which Bayer did get a wrist-slap fine—but the aggressive marketing, it’s alleged, exposed a greater number of women to the potential risks of the drug.

The unsealing of the Kessler report comes mere days before the FDA Reproductive Health Drugs Advisory Committee is to meet. Their agenda: the risks and benefits of oral contraceptives that contain drospirenone (including Yaz, Yasmin, Ocella, Safyral). LawyersndSettlements.com has reported extensively on drospirenone-based birth control and its link to DVT and VTE.

Is a new warning label in the offing? Stay tuned.

Tags: Adverse Events, Bayer, Dr David Kessler, Drospirenone, DVT, FDA, VTE, Warning Label, Yasmin, Yaz, Yaz lawsuit, Yaz side effects
Posted in Drugs/Medical, Emerging Issues, lawsuits, Personal Injury | No Comments »

Why Didn’t a Lawyer take my Drug Lawsuit?

July 27th, 2011. By AbiK

It’s a frequently asked question: Why didn’t a lawyer contact me about my drug complaint?

While, sadly, there have been many instances where someone has been badly harmed by a drug—or has even died—proving that the drug has been the direct cause of injury or harm can be tricky in a court of law. For starters, if the pharmaceutical company has provided a warning on the product, packaging, package insert or advertising about the side effect that caused the harm, chances are a lawsuit about it will be decided in favor of the defendant (i.e., the drug company).

We recently responded to a reader at LawyersandSettlements.com who asked this very question after a loved one who had been taking Enbrel sadly developed a brain tumor and died. The following is how we responded, and we thought we’d share our response as there may be other readers who are interested in it as well. This was the response:

“Let me provide you with some insight as to how these more major drug lawsuits work.

Unfortunately, when it comes to drug litigation and person injury, it is very difficult to prove that a victim was indeed harmed by a specific drug without a direct causal relationship being established between the drug and the injury involved. Typically, a court will not rule in favor of the plaintiff unless there have been major studies done that have been widely accepted by the medical and scientific communities—including such bodies as the Federal Drug Administration (FDA). Many times, the courts look to the existence of a drug recall, or a ‘black box’ warning on a drug’s label, or new warnings issued by the FDA in order to establish beyond a doubt that such a causal relationship exists between the drug in question and the specific injury of the plaintiff.
 
With Enbrel, the adverse events noted on the prescribing information involve the risk of lymphoma, particularly in children and adolescents, and the risk of fungal infections and tuberculosis. To date, there is not an ‘official’ warning or peer-reviewed, widely accepted study regarding Enbrel and brain tumors—though there is some anecdotal discussion online about it. In a court of law, however, stories and experiences such as those online—regardless of their real merit—are not seen as a concrete basis for finding in favor of a victim.
 
Having said that, a victim or their loved ones should not refrain from at least filing a complaint with an attorney for review if there has been an injury or death that may be related to a drug. The laws regarding pharmaceutical litigation are complex—and many times there may be other factors involved, such as medical malpractice or negligence, that may present a viable case. It is also in everyone’s best interest to pursue all their legal options, as one attorney may interpret the details of a complaint differently than another. We aim to mitigate that by having more than one attorney review a complaint–but it can be of benefit to explore several legal service providers.”

The bottom line is that while defective drug lawsuits can be challenging to fight in a court of law, victims have every right to pursue them and should do so–it’s often sadly the only means we as individuals have in order to hold pharmaceutical companies accountable once a drug is on the market. It’s also, sadly, often the only way a victim can afford to pay for medical costs incurred as a result of a drug injury. So should you think you might be the victim of a drug injury, have a lawyer review your complaint.

Tags: Adverse Events, Causal Effect, Drug Lawsuits, File a Claim, File a Lawsuit, Harmful Side Effects, Pharmaceutical Lawsuits
Posted in Drugs/Medical, lawsuits | No Comments »

Drug Advertising: “Side Effects May Include” MIA – Why?

March 3rd, 2011. By Hunter West

You know all those drug ads on TV, where new drugs for everything from erectile dysfunction to depression, to cholesterol are touted complete with a shopping list of side effects against a backdrop of shiny, happy people dancing in slow motion in the green grass of a city park, or cavorting across an idyllic beachfront? Case in point, Cialis ad at left.

All that damning voiceover information on side effects and adverse reactions can get lost in the visuals (which is probably the plan), but at least the requisite information is there. 

Why did that not happen with Tylenol, and the potential for acetaminophen toxicity? 

Why did that not happen with denture adhesive, and the potential for zinc poisoning? 

Most realize that most drugs have side effects. Fewer realize that all drugs have side effects at all. And the more intense the drug, the longer the list of adverse reactions. When a new drug designed to treat, say, the propensity to have to get up to pee several times in the night for aging Americans comes on the market, manufacturers know that in order to advertise the drug where their constituents are—parked on their sofas, watching television—they have to abide by advertising regulations and include the side effects. 

You may not recall every adverse reaction rattled off in such TV commercials. You may not remember even one. But you are left with the sense that this is serious stuff, and if you’re at Read the rest of this entry »

Tags: Acetaminophen, Adverse Events, denture cream, Durg Marketing, Fixodent, Side Effects, tylenol
Posted in Drugs/Medical, Emerging Issues | No Comments »