Drugs/Medical Archive

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 »

Surgical Mesh Implant Infographic Sums Up TVM Problems

December 24th, 2012. By AbiK

2013 will prove to be the “Year of the Transvaginal Mesh Lawsuit”, if a quick look at the upcoming court dates is indicative of anything. The first TVM lawsuit to go to trial will be the multi-district litigation (MDL) In re: C.R. Bard, Inc., Pelvic Repair Systems Products Liability Litigation (MDL No. 2187), which heads to court in February.

Three more transvaginal mesh (also referred to as “transvaginal sling”) MDL’s start heading to court in 2013 as well–though later in the year, with the first slotted for December 3, 2013. Those cases are: In re: American Medical Systems, Inc., Pelvic Repair System Products Liability Litigation (MDL No. 2325); In re: Ethicon, Inc., Pelvic Repair Systems Products Liability Litigation (MDL No. 2327); and In re: Boston Scientific Corp., Pelvic Repair Systems Products Liability Litigation (MDL No. 2326).

This transvaginal mesh infographic shows the history of the medical implant and also the problems the mesh has faced (or, allegedly created) along the way. The depiction was created for the Rottenstein Law Group in NYC.

Tags: Transvaginal Mesh, transvaginal sling, TVM, TVM lawsuit
Posted in Drugs/Medical, Emerging Issues, lawsuits | 3 Comments »

Mayo Clinic Phasing out Ambien after Slip and Fall Study

November 20th, 2012. By AbiK

The Mayo Clinic has decided to phase out use of Ambien, the prescription sleeping pill, over concerns that patients on the drug have a higher rate fall rate than those who are not on it.

In a study conducted by the Mayo Clinic in Rochester, MN and published in the Journal of Hospital Medicine (11/19/12), researchers reviewed fall data from more than 16,000 patients who were hospitalized. The study found that patients who were given Ambien while hospitalized experienced falls more than four times greater than those who were not given Ambien. According to the study, the fall rate for patients given Ambien was just over 3 percent compared to a fall rate of 0.7 percent for patients not given Ambien.

What’s interesting about the Mayo Clinic Ambien study as well is that the fall rate associated with the drug was greater than that associated with factors such as age, mental impairment, insomnia or delirium. And, that held true no matter what the Ambien dosage was.

According to a report at HealthDay News, the Mayo Clinic’s chief patient safety officer, Dr. Timothy Morgenthaler stated via news release, “As a result of our study, we are now phasing out [Ambien] and moving toward sleep enhancement techniques that are not based on drugs and which we believe are safer and probably as effective.”

While the Mayo Clinic is clearly backing off of Ambien as a sleep aid for in-patient care, the study did not find a cause and effect relationship between taking Ambien and falling; however, the association found between the two in the study was enough for the Mayo Clinic to begin to phase the drug out of use.

Tags: Ambien, Hospital Accident, Hospital Fall, mayo clinic, Slip and Fall
Posted in Accidents, Drugs/Medical, Personal Injury | 18 Comments »

After Alcohol Wipe Screw-Ups, Triad Decides to Play with Makeup

October 18th, 2012. By AbiK

Ok, could be makeup. Could be some anti-aging wonder. Could be your run-of-the-mill hand soap. Who knows? The initial reports regarding Triad Group’s foray into cosmetics have been a bit lacking in detail as to what exactly will be coming of the manufacturing lines at Triad’s Hartland, WI production plant.

Triad, if you recall, was at the heart of the alcohol prep pad, alcohol swab and alcohol swabstick, aka alcohol wipe recall of last year—the one connected to the death of 2-year old Harrison Kothari in Texas who contracted acute bacterial meningitis caused by Bacillus cereus bacteria. The Kotharis have settled with Triad—as have a dozen others who filed contamination lawsuits (details of the settlements have not been disclosed).

Fast-forward a year. The Milwaukee Journal Sentinel reported that Triad, which filed for bankruptcy protection on the heels of its $5 million insurance policy being drained on the lawsuits just mentioned, has indicated it would like to re-establish itself as a cosmetics company.

Every cat has nine lives, right?

The Journal Sentinel quoted Triad’s COO, Eric Haertle, as saying at the company’s first meeting with creditors in bankruptcy court, “We are in the infancy stage of these opportunities. We have talked to industry vendors. I am encouraged and optimistic about the support we are receiving if we can put a plan together and resume operations.”

What’s interesting here is not so much that Triad even wants to emerge like a phoenix from the ashes—hey, it’s a business wanting to cut its losses and get on with things—no, the interesting thing is their costume change; they’ll now wear the i.d. of “cosmetics company” rather than that of “medical device” company—and that has benefit for a company whose odds of reincarnation under their former classification are next to nothing.

See, in order for Triad to go back to being a medical device company and manufacturing as it had before, it faces some intense scrutiny by the FDA. According to the Journal Sentinel, both the FDA and Triad would need to agree to the FDA’s consent decree which would impose a $15,000 per day fine—per violation—should Triad fail to comply with FDA policies. Additionally, the decree would subject Triad to FDA inspections without prior notice–and those inspections could cover everything from equipment to raw materials to finished products to packaging. The decree also calls for the company to post a $4 million bond.

No small undertaking to set up shop again.

But, there’s an escape hatch: re-establishing itself as a cosmetics company means less rigorous regulation and oversight by the FDA. And given that the consent decree to operate as a medical device company again could cost Triad millions—with no guarantee they’ll even pass with flying colors—well, the land of lipstick bullets, lotions and potions suddenly has tremendous appeal.

On second thought, maybe there is a clue as to what cosmetics will be coming off Triad’s production line—those Triad alcohol swabsticks look a lot like those cotton swabs used to smudge eyeliner (for that smoky eye look) or to clean up little makeup mistakes…hmm…just wondering…

Tags: Alcohol Prep Pad, Alcohol Swab, bankruptcy, Cosmetics, FDA, Lawsuit, Recall, Settlement, Triad
Posted in Defective Products, Drugs/Medical, lawsuits, Settlement | No Comments »

UPDATE 2: Multi-State Fungal Meningitis Outbreak by the Numbers

October 9th, 2012. By AbiK

(Updated Information as of 10/12/12 shown in RED below)

Here’s the latest on the multi-state fungal meningitis outbreak.

– Reuters is reporting a member of the U.S. Senate has requested the U.S. Justice Department to conduct a criminal probe of possible fraud violations by NECC, the supplier of the contaminated steroid injections.

-Also, new estimates suggest as many as 14,000 individuals may have received the contaminated steroid—previously that number had been estimated to be 13,000.

-See updated ‘by the numbers’ information below.

If you or someone you know have had a steroid injection—an epidural (according to the CDC, epidurals given for childbirth do not use the same medication involved in this outbreak), a shot given by an orthopedist, etc.—check with your doctor and/or healthcare facility to find out if you may have been affected. Also, be aware of the symptoms associated with meningitis (some are listed below) and seek immediate medical help should you suspect that you may have been affected by a contaminated steroid injection.

While the source of the contamination that has led to so many cases of fungal meningitis has not yet been determined, an investigation continues. Meningitis victims may also wish to seek legal help and can do so by submitting the form here.

Most importantly though, be sure to talk to your medical provider if you suspect you may have received a tainted steroid injection. Symptoms of meningitis include new or worsening headache, fever, sensitivity to light, stiff neck, new weakness or numbness in any part of your body, slurred speech, and/or increased pain, redness or swelling at the injection site.

Here, the latest numbers on the meningitis outbreak:

Date of Recall:

September 26, 2012

Number of Lots Recalled:

3 lots of preservative-free methylprednisolone acetate (80mg/ml); the 3 lots contained 17,676 vials of medicine (Reuters)

Number of Suppliers who have Issued a Recall:

1—New England Compounding Center (NECC) issued a voluntary recall on September 26, 2012

Start Date in which Recalled Lots of Steroid Injections may have been used:

May 21, 2012

Number of States with Healthcare Facilities that received Recalled Lots of Steroid Injections:

23  (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, Texas, Virginia, West Virginia)

First State to Detect a Case of Fungal Meningitis related to the Recalled Steroid Injections:

Tennessee, which has had the most reported cases to date (35) and 4 reported deaths

Number of States with Reported Cases of Fungal Meningitis:

11 states have reported cases–Florida (4), Idaho (1), Indiana (12), Maryland (8), Michigan (25), Minnesota (3), North Carolina (2), Ohio (1), Tennessee (39), Virginia (24), New Jersey (1)

Number of Reported Cases of Fungal Meningitis:

170 cases of fungal meningitis have been reported to date

Number of Deaths related to Fungal Meningitis Outbreak:

14 deaths have been reported to date in the following states: Florida (2), Indiana (1), Maryland (1), Michigan (3), Tennessee (6), Virginia (1)

Number of Individuals who may have Received an Injection from the Recalled Lots:

An estimated 14,000 individuals may have received a steroid injection from the recalled lots

Source: Centers for Disease Control (CDC.com), unless otherwise noted. A full list of healthcare facilities by state that had received part of the recalled lots from NECC is available at the CDC website.

 

 

Tags: CDC, Fungal Meningitis, Meningitis Outbreak, NECC, rare-meningitis-outbreak-steroid-injections, Steroid Injection
Posted in Drugs/Medical, Emerging Issues | No Comments »