FDA Considers New Social Media Rules for Drug Manufacturers

February 2nd, 2012

From now through March 26, the FDA is accepting public comments on its proposed rules to govern how pharmaceutical companies use social media sites such as Facebook, Twitter and Google+.

According to the draft rules, unsolicited requests for information made via social media sites should be responded to privately and not via social media.

Pharmaceutical companies are asking for more guidance from the FDA. They want to know how to handle other potentially tricky social media situations such as:

  • Whether they are liable for information posted by others on their social media site. For example, if a doctor or patient posts bad information on a social media site for particular drug or drug company, who is liable if someone relies on that information?
  • What to do about drug adverse event, or side effect, reports left on social media sites instead of through proper channels?

What do you think about drug companies’ use of social media? Is it useful to you or do you think it could be potentially dangerous? Please leave a comment with your thoughts on this important topic.

Tougher Teen Driving Law Vetoed by New Jersey Governor

January 31st, 2012

The 214th New Jersey legislature approved a bill that would have required new teen drivers to have significantly more behind the wheel practice before getting a driver’s license and that would have required their parents to complete a training course before a teen could get a license. Governor Christie failed to sign the bill in a move known as a pocket veto and the bill did not become law.

However, the bill is expected to be reintroduced in the 215th session of the New Jersey legislature this year. Do you think this bill is important to prevent New Jersey teen accidents or do you think it goes too far and is deserving of the Governor’s veto? Please leave a comment and share your thoughts with our New Jersey car accident lawyers.

Attention Walkers! You Might Want to Put Away Those Headphones

January 27th, 2012

We’ve talked before on this blog and elsewhere about the dangers of distracted driving and the tragic consequences of distracted driving accidents. Now we want to talk about a similar danger on our streets – the danger caused by distracted pedestrians.

A recent study published in the journal Injury Prevention found that distracted pedestrians can be at fault for accidents, just as distracted motorists may be at fault. Between 2004 and 2011, the study found 116 cases of death or injury to pedestrians where the pedestrian was wearing earphones or earbuds. The majority of the reported accidents occurred in young people (under age 30) and the majority involved pedestrians being hit by trains. In about one third of the cases, the train or other vehicle sounded its horn or let out a warning prior to the accident.

There is no doubt that trains, cars, and other vehicles have a duty of care to watch for pedestrians. However, pedestrians also have a duty of care and need to be aware of their surroundings when walking on public streets or in other public places.

Accordingly, our South Jersey injury lawyers recommend taking off the headphones and being aware of your surroundings when walking on South Jersey streets so that you can protect yourself from harm

FDA to Conduct Safety Review of Pradaxa

January 25th, 2012

Last month, the FDA announced that it would be conducting a safety review of Pradaxa. Pradaxa is a blood thinning drug typically used in patients who suffer from non-valvular atrial fibrillation. The drug is intended to thin the blood to prevent blood clots from traveling to the brain and causing stroke.

Currently the FDA is investigating whether dangerous bleeding in Pradaxa patients is occurring more commonly than should be expected.

While the FDA believes that Pr૚axa provides important benefits, it is urging doctors to closely follow the recommendations on the drug warning label. Patients taking Pradaxa should continue to do so as directed by their doctor and review any concerns or potential warning signs of dangerous side effects with their physicians.

Could Cholesterol Lowering Statins be Linked to Type 2 Diabetes?

January 23rd, 2012

A recent study from the University of Massachusetts Medical School has found a possible link between the use of statin drugs to lower cholesterol and diabetes in postmenopausal women. While the study, published in a recent issue of the Archives of Internal Medicine could not definitively connect an increased risk of diabetes due to statins, this study joins others that have concluded there is a possible link between the potentially dangerous drugs and the disease.

If you take statins and are concerned about your risk of developing Type 2 diabetes then it is important to speak to your doctor about your concerns and about the right treatment for you.

Should Single Surgery Sites Operate Under Same Rules as New Jersey Hospitals?

January 19th, 2012

Last week the New Jersey legislature approved a bill that would put all surgeries performed in the state under the oversight of the New Jersey Department of Health. While the Department of Health currently has oversight of hospitals and ambulatory care facilities, it does not have control over single room surgeries or ambulatory facilities with only one operating room. That would change if this bill becomes law.

Every facility, even if it has just one operating room, would need to be licensed and inspected by the state Department of Health. The bill has widespread support and is expected to become law. Do you think it will have a positive impact on patient safety in New Jersey?

Some Antidepressants linked to Increased Risk of Pulmonary Hypertension in Newborns

January 17th, 2012

Last week, the results of a new study that looked at the effect of SSRI antidepressants on newborn children were released. The study found that children born to mothers who used SSRIs (such as Prozac and Zoloft) during pregnancy were more likely to be born with pulmonary hypertension or high blood pressure in the lungs. Specifically, women who take SSRIs late in pregnancy were twice as likely to have an infant born with pulmonary hypertension.

Pulmonary hypertension can create difficulties breathing and heart failure. While the study stops short of saying that the SSRIs caused pulmonary hypertension, the researchers are encouraging women to talk to their doctors about their risks and about other possible ways to treat depression during pregnancy.

 

2011 New Jersey Accident Fatalities Highest in Four Years

January 13th, 2012

The number of 2011 fatalities on New Jersey roads was the highest that they’ve been since 2007 according to the New Jersey State Police. In 2011, there were 594 fatal accidents that caused 635 deaths on New Jersey roads. Of the 635 deaths:

  • 371 were drivers.
  • 144 were pedestrians.
  • 103 were passengers.
  • 17 were bicyclists.

Additionally:

  • Middlesex County had the highest number of fatalities.
  • Ocean County saw the highest number of bicyclist fatalities.
  • Essex County saw the highest number of pedestrian deaths.
  • Atlantic County saw the highest number of passenger deaths.

Our New Jersey car accident lawyers extend our sincere condolences to everyone who lost a loved one in a 2011 motor vehicle crash and we hope for a safer 2012.

FDA Issues Transvaginal Mesh Order

January 10th, 2012

Last week, the FDA made a significant move regarding transvaginal mesh. The agency announced that it will require 33 manufacturers of transvaginal mesh, including Johnson & Johnson, CR Bard and Boston Scientific Corp, to study the risks posed by these medical devices and submit reports to the FDA.

The FDA is said to be considering reclassifying transvaginal mesh to make it a high risk medical device. Such a move, which could take years, would require manufacturers to prove the safety of their products.

Currently, hundreds of transvaginal mesh lawsuits have been filed alleging that the medical devices have resulted in infections and other complications. Many more adverse events have been reported to the FDA.

If you have had transvaginal mesh surgery or you are considering surgery for pelvic organ prolapse or stress urinary incontinence then please talk to your doctor about the risks or potential signs of complications.

New Jersey Accident Victims Include 6 Cows and 4 Pigs

January 9th, 2012

A common car accident had an unusual consequence in Mannington Township last week. According to the New Jersey State Police a minivan crossed the center line on Route 540 and collided head on with a tractor trailer. The trailer part of the truck was turned on its side and there were significant casualties among the animals being transported in the trailer. 6 cows and 4 pigs were killed. The driver of the minivan was airlifted to the hospital and two children in the minivan were taken to the hospital as a precaution. The truck driver was not injured.

While New Jersey head on collisions are, unfortunately, common, the death of so many animals as a result of an accident is unusual. The cause of this New Jersey accident remains under investigation.

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