Posts Tagged ‘ NEJM ’

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 »

The Risk of Sleepy Surgeons

January 11th, 2011. By Hunter West

There was a study recently that demonstrated sleepy drivers were just as careless, just as accident-prone and just as dangerous as people who were driving drunk. Sleep deprivation, the researchers found, was just as much an impairment as being high on alcohol. 

So what about doctors? What about surgeons? 

An editorial that came out December 30^th in the New England Journal of Medicine (NEJM) makes that same point for medical professionals. To wit, sleepy doctors are potentially as impaired as drunken doctors. 

It’s something, as patients, we never think about. But think about it—how many times have you been caught yawning on the job? How many times have you nodded off at the computer? How many times have you had to pull over while driving endless miles along a highway, in order to catch a bit of rest because you feel yourself nodding off? 

Should we not assume that surgeons are capable of the same sleepiness? 

The concern is certainly warranted, according to the authors of the NEJM editorial. And one can certainly understand the issue. As an example, a surgeon who has not slept all night following emergency bowel surgery throughout the wee hours is seen scrubbing up for an elective colostomy at nine the following morning. 

Pretty scary thought, huh? 

The editorial authors say that sleepy surgeons should not be allowed to operate without a patient’s Read the rest of this entry »

Tags: medical malpractice, NEJM, Sleep, Surgeon
Posted in Drugs/Medical, Emerging Issues | No Comments »