In This Issue
- Congress Pushes for Looser Rules on Trucking
- FDA Calls Essure Birth Control a High Priority, Expect New Guidelines
- Mass Tort Consolidation Sought for Cipro, Avelox and Levaquin Antibiotics
With nearly 4,000 Americans killed each year in big-rig crashes, you would think Congress would be working on tightening rules for the trucking industry. Instead our lawmakers are working in the opposite direction.
It is just one more example of how industry has its way with government. The proposals represent a wish list for the trucking industry, which includes major carriers such as Federal Express and UPS, as well as lobbying efforts by the American Trucking Association.
Many of the pro-industry proposals have made it through the House or Senate or are attached to appropriations bills. The Center for Responsive Politics has tracked almost $20 million in campaign contributions from the trucking industry.
What’s on the list? Rep. Lamar Alexander (R-TN) voted to allow trucks to haul two 33-foot trailers, five-feet longer than the current limit. The news website, Fairwarning.org equates that to an eight-story building on its side running down the highway.
Other proposals include:
- Raising the weight limit of big-rigs from 80,000 to 91,000 pounds.
- Remove the trucking company’s safety ratings from the internet where it can be seen by the public.
- Eliminate a rule truckers have at least two consecutive nights rest when they work long weekends.
- Allowing truck drivers as young as 18 behind the wheel of a big-rig. The current age limit is 21.
- Slow efforts to increase the minimum insurance requirements for trucking companies.
Overweight, tired and inexperienced drivers hauling goods down our highways does not sound like a move in the right direction. The Federal Motor Carrier Safety Administration, that should be overseeing truck safety, appears to be taking its marching orders from an industry front group, the Coalition for Efficient and Responsible Trucking, made up of nine trucking firms.
Unfortunately some of these proposals are close to becoming reality. In October, a $325 billion high bill allowed the safety scores of trucking companies to come off the internet. Drivers may now be as young as 19-and-a-half to drive large trucks on the interstate.
Much of the advocacy for consumers comes from people who have suffered the loss of loved ones on our nation’s highways. Jane Mathis of St. Augustine lost her 23-year-old son and his new wife in 2004. They were killed in a crash with a truck after the driver fell asleep and rear-ended their car, which exploded. She is the newly elected vice president of the Truck Safety Coalition.
It is concerned citizens harmed by lax laws that must finally say enough is enough.
The U.S. Food and Drug Administration (FDA) says Essure birth control is intended to be safe and permanent. However, after a well-attended public hearing before an expert panel convened by the FDA in September, the agency says it will issue some new Essure guidelines by early next year.
Essure, made by Bayer, is supposed to be a permanent form of birth control. Metal coils are inserted through the vagina and into the fallopian tubes. There is no general anesthesia involved and no hormones are released. The blockage in the tubes prevents pregnancy by denying the release of eggs into the uterus.
Bayer purchased the Essure device for $1.1 billion from Conceptus two years ago.
There are about 750,000 women who’ve been implanted with Essure since it was approved in 2002 and there is no stopping the complaints of adverse events that are coming forward. At least 15,000 complaints have been received by the FDA, such as the perforation of the pelvic organs, a migration of Essure through the fallopian tubes, chronic pain and infection, rashes and itching, which may be due to the nickel used in the implant and even unintended pregnancy.
Essure is made of nickel titanium allow and a fiber called polyethylene terephthalate (PET) which many claim can incite an inflammatory response.
At least five unborn children and four women have died due to the Essure and uncontrolled bleeding.
Bayer says Essure is a 100 percent effective alternative to tubal ligation. But a study of more than 52,000 New York state women, published in the British Medical Journal (BMJ), reviewed patients from 2005 to 2013. Those implanted with Essure were ten times more likely to have follow-up surgery within a year, according to the survey from Weill Cornell Medicine.
With nearly 20,000 women on social media, namely Facebook, on a group, Essure Problems, affected women call themselves E-Sisters. At the FDA hearing they proposed a hunger strike. Did the FDA listen? Apparently the agency had extra police officers and threatened arrest if the women stayed too long.
Now the agency says a review of Essure is a high priority and it will review the evidence.
However, on a more proactive front, one month after the FDA panel gathering, U.S Rep. Mike Fitzpatrick took his fight against Essure to Congress, introducing a bipartisan bill asking that Essure be removed from the market. Rep. Fitzpatrick authored the E-Free Act called the FDA’s stamp of approval unacceptable and urged Congress to act on behalf of the women by supporting the bill in Congress until it becomes law.
The E-Free act is written specifically to revoke the Pre-market approval status given to Essure which protects the manufacturer from any legal challenges. This PMA in essence is what has kept this device on the market this long, as without it, Bayer no doubt would have been taken to court years ago and made to stand accountable for the lack of data and damage this device has caused thousands.
Plaintiffs have asked Pennsylvania to consolidate 32 cases against the makers of antibiotics, known as fluoroquinolones into a mass tort litigation. That happened after plaintiffs from 32 cases claim they endured permanent nerve damage after being prescribed fluoroquinolones. Anxiety is another side effect some patients find to be intolerable as well as bad headaches, tendonitis and tendon ruptures.
Specifically, the request went to the Philadelphia Court of Common Pleas for consolidation. The petition filed is Whitters v. Bayer and attorneys say they have 30 more cases ready to be filed. Consolidating cases allows for coordinated discovery and consistent rulings from the court.
In August, multidistrict litigation was created in Minnesota federal court and 200 cases have been transferred there. Although the drugs may have different manufacturers, the plaintiffs have similar injuries and damages.
Patients must be their own advocate if they are prescribed the drugs known as – Cipro, Cipro XR, Avelox (Bayer), Proquin XR, Factive, Penetrex (Aventis), Tequin (Bristol-Myers Squibb), Noroxin (Merck), Floxin (Daiichi-Sankyo), Levaquin, Loroxin made by Janssen Pharmaceuticals. Corp.
These are broad-spectrum antibiotics which are prescribed for a variety of ailments such as infections of the lung, urinary track or sinus.
Cipro was approved by the U.S. Food and Drug Administration in 1987 and soon became the best-selling antibiotic in the world. In 1996, the FDA approved Levaquin and it gained wide popularity and was often prescribed. Three years later, Avelox was approved bringing blockbuster profits of $700 million to drugmaker Bayer in 2007.
In 2004, the label on Levaquin was amended but this petition says it is still misleading by saying that peripheral neuropathy is “rare” and can be avoided if the patient just stops taking the drug. In reality, peripheral neuropathy is often irreversible.
By August 2006, Public Citizen requested the FDA put a black box warning on the risk of tendon rupture associated with fluoroquinolones. Just two years ago fluoroquinolone’s label was changed to include peripheral neuropathy. It also removed the statement that nerve damage is rare.
The plaintiffs allege the companies knew and failed to inform doctors about the risks association with the antibiotics. The companies are alleged to be negligent, made negligent misrepresentation, defrauded the public, breached a warranty and strict liability.