Posts Tagged ‘ Drug Lawsuit ’

Top 10 Drug Legal News Topics For 2012

December 24th, 2012. By AbiK

LawyersandSettlements.com recently shared its list of the hottest consumer-related pharmaceutical legal news stories during the last year. Of note is that while the top drug-related topic on the legal news website in 2011 had been Tylenol—prompted by concerns over a series of Tylenol recall notices as reported by The New York Times; for 2012, the most sought out pharmaceutical topics have shifted to women’s health.

Third-generation contraceptives such as Yasmin/Yaz, NuvaRing and Mirena top the list this year as numerous birth control lawsuits either settled, or began the process of consolidation into multi-district litigation (MDL).

Reader interest in Yaz/Yasmin rose in response to Yasmin lawsuit settlements that were announced in April (In re Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Product Liability Litigation, 09-md-02100, U.S. District Court, Southern District of Illinois, East St. Louis). Bloomberg reported Bayer AG settled about 500 Yasmin lawsuits over claims of blood clots that had, in some cases, led to stroke or heart attack.

Along with Yaz, readers remained concerned about NuvaRing (etonogestrel/ethinyl estradiol) and blood clot risk even as a new study on non-oral hormonal contraception, published in the British Medical Journal (BMJ 2012;344:e2990), was presented at the annual meeting of the American College of Obstetricians and Gynecologists (May, 2012). The study, aimed at quantifying NuvaRing blood clot risk, indicated no significant difference in risk of venous thromboembolism when compared to oral contraceptives.

Still, NuvaRing lawsuits continue and have been consolidated into a federal MDL court in Missouri (In re: NuvaRing Products Liability Litigation, No. 08-md-1964, JPML, Eastern District Missouri). As of September 5, 2012, according to the U.S. Panel on Multidistrict Litigation, more than 1,000 NuvaRing lawsuits have been filed.

Mirena IUD (levonorgestrel) saw an increase in reader interest after August 2012, as Bayer Healthcare Pharmaceuticals, Inc. submitted an Application for Centralized Management of Certain Cases involving Mirena. As FoxNews reported (11/11/12), the request seeks to create a multi-district litigation (MDL) for 16 pending Mirena lawsuits in NJ that allege Mirena caused uterine perforation, infection and hemorrhaging injuries.

After the top three women’s health-related drugs, Pradaxa (dabigatran), an alternative to warfarin, joined the list this year making the Top 5. In November 2012, the FDA issued a Drug Safety Communication regarding Pradaxa bleeding events which in turn helped drive reader interest.

Thousands of LawyersandSettlements.com monthly readers have followed the latest legal news and information on these topics, many of which have fallen from the radar of traditional media outlets.

“We believe these issues are of great importance to the public, mostly due to the life-changing impact they can have on an individual,” said Stephen King, CEO. “Some of our most interesting stories of the year related to pharmaceuticals. Many of them have pending lawsuits or have had substantial settlements related to their life-altering side effects and it’s important to get this information out to the public. While many pharmaceutical companies continue to earn significant profits, people are suffering. They may think they have no recourse but in many cases they do. By keeping these topics alive, LawyersandSettlements.com is helping people stay up-to-date on these important topics every day.”

The LawyersandSettlements.com Top 10 Pharmaceutical Topics of 2012, along with the potential side effects readers were seeking information on, are:

1. Yasmin/YAZ (gall bladder disease, blood clots, deep vein thrombosis, pulmonary embolism)

2. NuvaRing & Mirena (blood clots, infection, perforation of the uterus)

3. Pradaxa (uncontrollable bleeding, lack of an available antidote)

4. Granuflo (elevated bicarbonate levels, risk for metabolic alkalosis)

5. SSRIs (birth defects including heart defects, spina bifida, cleft palate, club foot, PPHN)

6. Actos (bladder cancer, heart failure, kidney failure, rhabdomyolysis)

7. Diethylstilbestrol/DES (cancer)

8. Crestor / Statins (diabetes, cardiomyopathy, rhabdomyolysis)

9. Fosamax (bone fractures, esophageal cancer)

10. Propecia (sexual dysfunction, erectile dysfunction, sterility, prostate cancer)

LawyersandSettlements.com readers are looking for the latest and most comprehensive legal news available. Those seeking legal help can request assistance by completing a form which is then distributed to attorneys specializing in these cases. Over two and a half million people visit the site yearly, and hundreds of thousands of request forms have been submitted by qualified readers looking for legal guidance.

Tags: Actos, Birth Control Side Effects, Class Action Lawsuit, Crestor, DES, Drug Injury, Drug Lawsuit, Fosamax, Granuflo, Lawsuit, Legal News, Mirena, NuvaRing, Pradaxa, Propecia, SSRI, statins, Yasmin, Yaz
Posted in Class Action, Drugs/Medical, Emerging Issues | No Comments »

How Generic Drugs Discriminate Against the Poorest Patients

April 10th, 2012. By AbiK

No one wants to come right out and say it, but that’s basically what’s going on with generic drugs. Poor patients are effectively discriminated against simply by having no choice other than to buy the cheapest version of whatever pill they’ve been prescribed. Cheaper meds are fine—until you factor in that the more expensive brand name equivalents come with a bit of an extra ‘insurance policy’—no, not the type of insurance you’re thinking of—it’s insurance in the sense of legal recourse should something go wrong as a result of taking the drug.

Let’s face it, outside of those who claim to buy the cheaper equivalent on ‘principle’, for the most part the folks who are buying generics are those who either simply cannot afford the brand-name drug or those who’ll lose prescription coverage benefits unless they opt for the generic shown on the approved formulary from their insurance company. We’re not talking the 1% here, folks.

Sure, it’s great that cheaper generic versions of big-name blockbuster drugs are available—we’d all be broke otherwise. But generics have a hidden cost, too…

Legally speaking, that cost can be tremendous. How so? Well, what if something goes wrong—horribly wrong—upon taking the drug? What if there’s a serious reaction to the drug, like a ruptured tendon from a fluoroquinolone? Or tardive dyskinesia from a ‘good as Reglan’ generic? Sure, the generic drug should in most instances perform like its pricier twin—but there’s a catch: unlike with brand name drugs, if something goes wrong, there’s not much legally at present that can be done (from a strict product liability standpoint—not talking malpractice here).

The issue with generic drugs has to do with liability—being liable when harmful side effects occur. And simply put, generic manufacturers are not held liable.

Currently, it’s the brand name drug manufacturers who are responsible for ensuring their drug has gone through a rigorous FDA-approval process and they’re also responsible for making any label changes should new warnings be applied to a drug they’ve produced.

Generic manufacturers, however, don’t have quite the same responsibility. The Hatch-Waxman Act—officially, the Drug Price Competition and Patent Term Restoration Act of 1984—made it easier for generics to find their way to market. Generic drugs do not have to go through a lengthy FDA approval process if they’re able to prove that the generic drug is equivalent to the brand name version. And, as such, the generic drug simply picks up the labelling information and package insert information from the brand name drug. When any changes are necessary (e.g., adding a black box warning), the generic is required to duplicate what’s happened with the brand name drug.

The most significant benefit of the Hatch-Waxman Act for blockbuster brand name drug manufacturers is that it allows the big pharma companies a period of exclusivity in the marketplace before the generic drug enters the market.

Now, the difference between a drug liability lawsuit for a generic vs a brand name is most glaring when you look at lawsuit outcomes. One of the most publicized examples showing the difference between a brand name drug lawsuit and a lawsuit with the same, but generic, drug involves phenergan.

In both cases the plaintiffs—both women who were administered the anti-nausea drug in a hospital and then subsequently lost an arm due to gangrene—sued the drug manufacturers. In the brand-name case, it was v. Wyeth; in the other, the generic, it was v. Baxter Healthcare. The upshot was that the plaintiff who had the ‘good fortune’ to have been given the brand name version received a multi-million dollar settlement. The generic patient? Her lawsuit against Baxter was dismissed. She had also filed a malpractice lawsuit, the final terms of which were undisclosed. 

Both women had life-altering injuries; only one received settlement money from the drug manufacturer.

While the phenergan lawsuits began in a hospital setting where the choice of brand name or generic may not have been the patients’ to make, the outcomes of their lawsuits show the stark difference in terms of liability claims. And, for patients who simply cannot afford to choose a brand-name drug, choosing the generic becomes a more or less de facto decision to give up the right to sue the drug company. And in that sense, generic drugs do discriminate against the poorest patients.

Tags: Big Pharma, Discrimination, Drug Formulary, Drug Lawsuit, Generic Drugs, Preemption, Prescription drugs, Product Liability
Posted in Discrimination, Drugs/Medical, Emerging Issues | No Comments »

Top 10 Drugs with Heart Side Effects on LawyersandSettlements.com

January 31st, 2012. By AbiK

In recognition of American Heart Month, which kicks off tomorrow (Feb. 1st), and National Wear Red Day (Feb. 3rd), LawyersandSettlements.com takes a look at our most-viewed drug lawsuit topics for 2011 in which heart attack or heart side effects were the alleged primary injuries.

Unfortunately, while a lot of focus this month will be on the positive measures we all can take to improve heart health—and that’s certainly important—it can be easy to overlook the negative heart side effects some drugs can have—and attention should be given to those as well.

As the chart at left depicts, Actos, Paxil and Zoloft accounted for the majority of 2011 traffic related to heart side effects, with Actos receiving the most at 25 percent. The Type 2 diabetes drug was released as an alternative to Avandia, which as you’ll recall came off pharmacy shelves as a result of the new FDA REMS program that became effective in November, 2011. Still, Avandia came in as the fourth most popular heart lawsuit topic. 

Paxil, the popular antidepressant, has been linked to heart birth defects in infants and the drug drove in 18 percent of traffic last year. Ditto Zoloft, which accounted for 10 percent of the pageviews among readers concerned over the potential for heart birth defects. 

The ten prescription drugs on the list fall into four distinct classes: Actos and Avandia are prescribed for the treatment of Type 2 Diabetes; Vytorin helps to control cholesterol, which has a direct impact on heart health; Trasylol is used during surgery to mitigate blood loss; the remaining drugs address depression and anxiety. 

Reader interest in Prozac, Lexapro, Effexor, Celexa, Zoloft and Paxil shows continued concern surrounding pregnant women using selective serotonin reuptake inhibitors (SSRI) drugs and potential heart birth defects.

Here’s the full list: 

Top 10 Drug Lawsuit Topics for Heart Side Effects in 2011 

1. Actos (Pioglitazone HCl)
2. Paxil (Paroxetine)*
3. Zoloft (Sertraline)*
4. Avandia (Rosiglitazone)
5. Celexa (Citalopram)*
6. Effexor (Venlafaxine)*
7. Lexapro (Escitalopram)*
8. Prozac (Fluoxetine)
9. Trasylol (Aprotinin)
10. Vytorin (Ezetimibe/Simvastatin)

*SNRI (serotonin-norephinephrine reuptake inhibitor) or SSRI (selective serotonin reuptake inhibitors) drugs associated with heart birth defects when taken during pregnancy

Tags: Actos, American Heart Month, Avandia, birth defects, Celexa, Drug Lawsuit, Effexor, Heart Adverse Events, heart attack, Heart Side Effects, Lexapro, paxil, Prozac, SNRI, SSRI, Trasylol, Vytorin, Zoloft
Posted in Class Action, Drugs/Medical, lawsuits, Personal Injury | 5 Comments »