On January 10, 2007, the FDA expanded its recall of the Bard®, Composix®, Kugel® Mesh Patch. The expanded recall concerned the memory recoil ring that opens the hernia patches. The recoil ring has been prone to break under the stress of placement in the intra-abdominal space. Davol notified customers of the hernia patch in December 2005 and informed healthcare professionals of the problem in March 2006 of additional recalls.
However, Bard, Davol’s parent company, knew prior to 2005 that the ring was causing problems. The medical device company now claims that it acted responsibly in not notifying healthcare officials sooner because, according to them, the number of incidences were too few and the data was too random. Yet the truth is that the company had received 10 reports of problems with the hernia patch including one fatality. Additionally, the reports were coming out of Germany, three of them from the same doctor so Bard concluded that the problem resulted in the surgeon who was using the patch.
The real problem lies in the defective design of the recoil ring. Tests on failed patches have revealed a ring weld defect. This defect makes the device prone to breaking, sending pieces of the device into the body cavity causing bowel perforations and obstructions, serious infections, and chronic fistulae.
In response to Davol’s inaction, the FDA ordered Davol to begin an investigation into the defective device. It also accused the company of withholding important information about the defect. A subsequent FDA inspection of a Davol plant that manufactures the Kugel Mesh hernia patch revealed other problems: an ineffective complaint tracking system as well as a defective manufacturing procedures.
The FDA has laid the blame squarely on the shoulders of the company. It has accused Davol’s ineffective plant procedures for causing delays in dealing and correcting the issue.
The FDA has received more than 100 complaints about the Kugel Mesh hernia patch and is subject to further punitive measures by the governmental agency if it doesn’t start to comply with the law and FDA regulations.

Senator Joe Biden, D-Del. has been a Catholic all his life. He’s frank, outspoken, and one who doesn’t shy away from fights if the fight is just. Speaking about his Catholic faith, Biden has talked about a principle that “animates” his faith and that is the abuse of power. Biden has dedicated his life to fighting what he sees as a real evil in the world. That abuse of power is at the root of the priest abuse crisis. For Biden, he’s not going to tolerate someone who abuses his authority, even if that person is a priest or a bishop. He doesn’t see a problem with remaining Catholic and speaking out against the priest abuse scandal. Perhaps his courage and willingness to speak frankly on even sensitive issues is why Senator Obama has chosen him as his Vice Presidential running mate.

In the midst of growing concern about the nation’s foodborne illnesses such as E.coli bacteria and salmonella contamination, the FDA has decided to allow for the radiation of spinach and lettuce products to prevent the spread of foodborne illnesses. Meat, in particular ground beef has been radiated for years to help kill E.coli bacteria which may be lurking undetected in the meat.
The Grocery Manufacturers Association had previously petitioned the FDA for such approval back in 2006. The recent spate of contaminated foods carrying such bacteria as E.coli and salmonella prompted the FDA’s move.
The FDA is considering allowing the radiation of peppers and tomatoes which were raw foods in the center of the most recent food contamination scare. While originally thought to come from tomoatoes, the recent food contamination was eventually linked to peppers from Mexico.

As deaths linked to the diabetes drug Byetta continue to climb, federal regulators are seeking a stronger warning label for the controversial drug. The FDA reported this week that they’ve receive six new reports of patients developing a dangerous form of pancreatititis while using Byetta. Two of those six have died. Byetta manufacturers Amylin Pharmaceuticals and Eli Lilly & Company have downplayed the news saying diabetics are already more prone to pancreatitis than the general non-diabetic population.
This week’s FDA announcement came on the heels of last October’s announcement that 30 Byetta patients had contracted the rare form of pancreatitis. More than 700,000 patients have used the injectable drug marketed for type 2 diabetes since it was first introduced on the market in 2005.

Monsignor Dale Fushek, the charismatic former leader and founder of Life Teen as well as the former Vicar General of the Diocese of Phoenix, has had his trial pushed back from this October to the middle of November in order that the judge in the case can hear and rule on motions filed in his criminal sex trial. Fushek has been charged and will be tried on 7 counts of misdemeanor sex crimes. The sexual abuse incidents occurred in the 1980’s and early 1990’s when Fushek was head to St. Timothy Catholic Church. The allegations came to light three years ago when the victims came forward to tell their story of abuse.
At the time of his arrest, Fushek was one of the highest ranking priests accused of sexual abuse of minors. Since that time, Jesuit Father Donald McGuire, Mother Theresa’s spritual director, has been accused of multiple instances of sexual abuse.
Most recently, a very popular Harlem pastor, Monsignor Wallace Harris, has stepped down due to allegations that he molested two 13 or 14 year old boys in the 1980’s.

The Florida Office of Insurance Regulation has been battling Allstate Insurance Company for ten months to try to get the Company to comply with Florida consumer insurance laws. Allstate had tried to raise rates on homeowners policies by 42 percent.Allstate had also refused to turn over documents requested by the Florida Insurance Commissioner Kevin McCarty. The Commissioner had banned Allstate from selling policies in Florida for a day as punishment for the insurance company. The settlement agreement provides that Allstate shall pay $5,000,000 into the Florida Insurance Regulatory Trust Fund. The settlement agreement also requires that Allstate agree to write 100,000 new home and condominuim owners policies. Allstate is also licensed to sell auto liability insurance in Florida. I doubt that this will affect Allstate’s notorious delay, deny defend policy of dealing with consumers claims.

Raytheon announced on Thursday that it would begin cleanup efforts at its site in St. Petersburg within 90 days. However, more than likely the cleanup will be a slow process-it could take up to 5 years to complete.
Raytheon is using a pump and treat process designed to break down 1.4-dioxane into carbon dioxide and water through an oxidation process. Equipment Raytheon is acquiring will pump about 30 to 40 gallons of water a minute from the underground plume. The wastewater will then be sent to a wastewater treatment facility.

Despite Boston Scientific’s success claims, an independent review of clinical data by the Wall St. Journal shows that the stent has significant flaws. Boston Scientific’s Taxus Liberte already enjoys strong sales abroad but is in the midst of seeking approval by the FDA. The Journal’s analysis, “Boston Scientific’s claim was based on a flawed statistical equation that favored the Liberte stent.” The equation known as the Wald interval has been criticized for exaggerating the certainty of research results. According to the Journal article, rival stent makers Abbott Laboratories and Medtronic Inc. have used the same equation in order to leverage research results in their favor. The Wall St. Journal noted the less rigorous nature of approving medical devices as opposed to pharmaceutical drugs.

The German luxury auto maker is recalling 200,000 vehicles because of a defect in the front passenger airbag. The German automaker said the recall involves the 2006 3 Series, the 2004-2006 5 Series, and the 2004-2006 X3 compact sport utility vehicles in the United States. The National Highway Transportation Safety Board posted on its website that small cracks could develop in a seat detection mat and deactivate the front passenger air bags.

For years now they’ve marketed their brand as the “good hands people” yet the American Association of Justice has ranked them the country’s worst insurance company for the manner in which they handle claims. The Association has labeled Allstate’s tactics as deny, delay, and defend when it comes to how Allstate makes huge profits on the backs of policy holders and the general public. The ranking is based in part by the book From Good Hands to Boxing Gloves which uncovered Allstate’s relationship with the influential consulting group McKinsey & Co. According to the book, McKinsey showed Allstate officials how to deny claims including Katrina victims. The reprehensible practices have lined the pockets of the insurance company for years while leaving honest, hard-working policy holders with burdens they presumed they were insured against.
One of the largest examples of corporate greed and public malfeasance is Allstate. For them, it’s all about profits over people. They surely aren’t the Good Hands People.