The report showed 105 cases of severe bedsores, 24 cases of foreign objects being left in the body of a surgery patient and 23 cases of a surgery being performed on the wrong body part.

Clarian Health which runs Methodist Hospital, Indiana University Hospital and Riley Hospital For Children, all in Indianapolis reported the most errors of any hospital in the state with 10, according to the report.

Among other Indianapolis-area hospitals, St. Vincent Hospital in Indianapolis reported five errors, Wishard Hospital in Indianapolis reported three errors and St. Vincent Heart Center in Carmel each reported three errors and St. Vincent Carmel Hospital and Community North Hospital in Indianapolis each reported one error.

This is the second-annual report of the Medical Error Reporting System (MERS), which was called for by Gov. Mitch Daniels.

The 2006 report revealed 77 serious medical errors, although health officials had said they expected the number of errors reported to rise over the next few years as hospitals learn more about the program.

“MERS is a valuable tool to help improve patient safety. The data we get from this report will help reduce the frequency of medical errors by promoting awareness of patient safety, revealing causes of medical errors and identifying statewide trends,” said State Health Commissioner Dr. Judy Monroe in a press release on August 25, 2008.

The reporting system requires hospitals, surgery centers, abortion clinics and birthing centers to report any errors in categories including surgical, products or devices, patient protection, care management, environmental and criminal.

The Department of Health began collecting the information in 2005 following an executive order by Daniels, and in 2006 approved permanent regulations requiring hospitals to report the mistakes.

Name of Product: Signature Gourmet™ and Crofton® Personal Blenders

Units: About 124,000

Importers: Atico International USA Inc., of Fort Lauderdale, Fla. (for the Crofton® model) and East West Distributing Co., of Deerfield Ill. (for the Signature Gourmet™ model)

Hazard: While placing the cup on or off the base of the blender, the blender can be inadvertently turned on, activating the blade. This can pose a serious laceration hazard to consumers.

Incidents/Injuceries: The firm has reived 14 reports of lacerations, including 11 that required medical treatment and stitches.

Description: This recall involves the Signature Gourmet™ (item number W14A3691) and the Crofton® (model number SB-19) personal blenders. The blenders are white and have 3 components parts – a base containing a power button, a blade assembly, and a blending cup. Signature Gourmet™ or Crofton® is printed on the front of the base of the unit. “SB-19” or “W14A3691” is located on a label at the bottom of the unit.

Sold at: The Signature Gourmet™ blenders were sold at Walgreens stores nationwide from July 2006 through March 2008 for about $16. The Crofton® blenders were sold at Aldi stores nationwide from May 2007 through March 2008 for about $13.

Manufactured in: China

Remedy: Consumers should stop using the recalled blenders immediately and call Atico International USA for instructions on returning the product for a full refund.

Consumer Contact: Consumers should call Atico International USA toll-free at (877) 546-4835 between 9 a.m. and 5 p.m. ET Monday through Friday or visit the company’s website at www.aticousa.com

In recent months, several doctors have complained that the device, a hip socket known as the Durom cup, was failing in their patients, who then had to undergo replacement surgery.

Zimmer said its investigation had determined that the product was not defective. But it stated that even some experienced surgeons had found it difficult to implant. The company said it expected to resume sales once specialized training for doctors had begun.

Since it was first sold in the United States in 2006, the Durom cup has been implanted in over 12,000 patients. Zimmer said it expected the overall need for early replacement in patients would be low. But Zimmer data and interviews with doctors suggest that hundreds of patients might need such procedures in coming years.

Some doctors said their patients had not had problems with the cup.

“They had given hints that there would not be a recall but this came as a surprise,” Mr. Nudell said.

The issue with the device surfaced in April when a surgeon in Los Angeles, Dr. Lawrence Dorr, publicly warned other orthopedists about cup failures his patients were experiencing. In response, Zimmer said it would start an investigation but said it saw no reason to take added action like halting sales.

At the time, Zimmer also cited European data showing that the device was doing well there. But the version of the device used outside the United States is slightly different from the one used here. Also, while doctors here use it in traditional hip replacement, surgeons in other countries used it in a relatively new kind of hip surgery known as resurfacing, which involves somewhat different surgical techniques.

Zimmer, which announced the sales suspension late Tuesday, said that its investigation found that using the cup required a higher degree of precision.

Dr. Dorr, who said he had stopped using the device last year, said he did not plan to start reusing it.

“It is a bad design,” he said.

As a result of halting sales, Zimmer said that it was also suspending United States premarketing trials of its system for resurfacing, the process that is used in Europe. That decision will put it further behind competitors that already have such products on the American market.

The Durom Cup went on the market in 2006 and has been implanted in over 12,000 patients. Dr. Lawrence Dorr, an orthopedic surgeon in California who has performed over 5,000 hip replacements, warned Zimmer Holdings in 2007 about pain and other problems his patients were experiencing after hip replacement surgery. In April 2008, Dr. Dorr voiced similar concerns to his colleagues at a conference and quickly discovered that other doctors and their patients had similar experiences. When doctors complained to Zimmer, they were largely told that the implantation technique, not the device, was to blame.

In May, Zimmer announced to doctors that it was investigating complaints like Dr. Dorr’s. On July 22, 2008, Zimmer Holdings suspended sales of its Durom Cup hip replacement, citing the need for doctor training before it reintroduces the device. But many doctors disagree that the implantation technique is to blame and believe that the poor design of the Durom Cup is the reason that the device is failing in such a large number of patients.

Problems with the Zimmer Durom Cup involve the hip socket separating from the bone rather than fusing with it. The metal cup’s movement in the socket was causing extreme pain in some patients after hip replacement surgery. Doctors estimate that potentially hundreds of patients who received a Zimmer Durom Cup replacement hip will experience failure and need a second hip replacement surgery to replace the defective device.

Mark & Associates, P.C. condones the withdrawal of Zimmer’s Durom Cup hip replacement but believes that retraining doctors on implantation techniques will be ineffective and that the defective device should remain off the market permanently. The firm also believes that Zimmer Holdings is failing to take responsibility for poor design of the hip replacement device by blaming doctors for improper implantation techniques. The firm strongly supports the creation of a national artificial joint registry system, which would allow for identification of problems with artificial joints sooner and save countless patients from needless pain, suffering, and the risks associated with additional replacement surgeries.

Mark & Associates, P.C. encourages patients who experienced problems following hip replacement surgery to request a free legal consultation immediately. To learn more information about Zimmer Holdings’ Durom Cup hip replacement and to request a free consultation, please visit http://www.ZimmerHipLawsuit.com. For more information on Mark & Associates, P.C. please visit http://www.YouHaveRights.com.

About Mark & Associates, P.C.

Mark & Associates, P.C. is a leading products liability and personal injury law firm with offices in Boston, Massachusetts and Long Island, New York. The firm aggressively represents victims of defective pharmaceuticals and medical devices, dangerous consumer products, bad faith insurance denials, toxic exposure and serious auto and common carrier accidents.

CONTACT: Mark & Associates, P.C.
Jason Mark, Esq.
1-866-507-4448
info@youhaverights.com

“I think it is a good idea, and it is something we are considering,” said Dr. Bob Rappaport, the director of the division of Anesthesia, Analgesia and Rheumatology Products at the FDA. But the agency itself does not have the authority to take such a step, Dr. Rappaport said.

Typically, state medical boards, rather than the federal government, impose licensing requirements on doctors, including the type of continuing education they must receive. A few states, including California, now provide doctors with education about the treatment of pain patients. But nationally, state medical boards have shown little interest in mandating added training in the use of potent pain medications or in screening patients for those prone to drug abuse.

Pain experts say they support increased education for doctors, but some fear that mandatory training may harm pain patients by limiting the number of doctors prescribing such drugs.

Under existing federal law, doctors need only show they are licensed to practice medicine in order to register with the Drug Enforcement Administration (DEA), which will permit them to prescribe narcotics.

An exception is if a doctor wants to prescribe the drug buprenorphine as in-office treatment for narcotics addiction; federal rules require eight hours of specialized training first. Prescribing that same drug for pain treatment, however, does not require such training.

Dr. Rappaport said the FDA was most concerned about potent and longer-acting narcotics like methadone, fentanyl and certain formulations of the drug oxycodone, the active ingredient in OxyContin.

With methadone, fentanyl, which is available in patches, has been associated with patient deaths and injuries resulting from physician misprescribing or inadvertent patient misuse.

In recent years, the FDA has faced pressure to take added steps on such drugs. Dr. Rappaport said recommending additional education was one of the responses the agency might unveil by early next year.

He said the FDA would probably require that makers of such drugs develop programs to monitor how they are prescribed.

In the last two years, the agency has sent out alerts to doctors about both methadone and fentanyl, but officials acknowledged that preventable patient deaths were continuing.

“We are putting out communications,” said Dr. Gerald Dal Pan, who directs the FDA office of surveillance and epidemiology. “We don’t know why they are failing.”

“This is just a very sad day here in Quincy,” Norfolk District Attorney William R. Keating said during an afternoon press conference at the shipyard. “It’s a sad day when a landmark has become a tragic memorial.”

“It did collapse in the manner it was designed to collapse,” Quincy Fire Chief Joseph Barron said at the press conference. “It just did not collapse when it was supposed to, obviously.”

The collapse did not affect the structural stability of the rest of the crane, Barron said.

The US Occupational Safety and Health Administration dispatched three inspectors to the scene. The federal inspectors are trying to determine the cause of the collapse and whether any workplace safety rules were violated by the workers or companies involved, OSHA spokesman Ted Fitzgerald said. The investigation could take several months to complete, he said.

The collapse of the support leg sent an enormous thud echoing throughout the neighborhood.

Quincy police and firefighters responded to a flood of 911 calls that began at 12:26 p.m. Two of the four injured ironworkers were taken to Quincy Medical Center, where they were treated and released. The other two were treated at the scene.

Standing outside the shipyard, Don Gauthier said he spent 22 years working at Fore River, many of them as a crane supervisor. Over the years, he said, the shipyard helped build 12 liquefied natural gas tankers.

Gauthier said he had been watching how the crane was dismantled and had been concerned about the decision to take it apart from the bottom up. “It’s a shame. They should have taken the main girder off first and then removed the support beams,” Gauthier said. “Personally, I don’t think they went about it in the right way.”

Gregory Nordholm of Norsar LLC, the Washington state-based company that was hired to dismantle and move the crane, said he was about 15 feet away from the 370-foot crane when it collapsed. The work crew was preparing the crane so it could be lowered closer to the ground, he said. The plan was to lower it 80 feet.

“I don’t know exactly what happened,” he said.

It appeared to be part of the leg of the crane that initially failed, he said. “That leg section landed right on him and killed him instantly.”

Nordholm said he did not know the cause of the failure.

“We’re determined to figure out what happened and why it happened, so this doesn’t ever happen again,” he said. “The crane is safe and secure now.”

The crews stopped working on the crane and will not resume until investigators determine what occurred, he said.

Nordholm said that in addition to OSHA, the Quincy Building Department is also investigating.

Investigators from the state Department of Public Safety were at the scene to check the crane operator’s licensing, according to spokesman Terrel Harris.

“It’s early and preliminary, but they haven’t found any problem with the operator,” he said. “All his licensing is current.”

Federal regulators before have cited Norsar. In 2006, the company received 10 citations for workplace violations at a job site in Seattle related to health violations, according to federal Occupational Safety and Health Administration records posted on the agency’s website.

And in 2001, the company was fined $7,100 for five workplace hazard violations at a site in South Carolina, according to records. The violations were related to safety issues such as wiring, equipment use, and access to deck openings.

General Dynamics Corp. closed the shipyard in 1986. The Massachusetts Water Resources Authority purchased the property the following year for $49.5 million. In 1997, the MWRA sold most of the property for $10 million to Massachusetts Heavy Industries Inc., a firm led by Greek entrepreneur Sotiris G. Emmanuel, who planned to reopen the shipyard.

But his plans to revive the local shipbuilding industry were never realized. After his company defaulted on federally guaranteed loans, the US Maritime Administration seized the property.

Quincy car dealer Dan Quirk, who acquired the property in a 2003 government auction for $9 million, currently owns the former shipyard. Quirk plans to redevelop the property into a “waterfront village” for industrial, commercial, and residential use.

The shipyard, which employed 32,000 people at its peak, stopped using the Goliath after General Dynamics sold the facility.

The crane, for decades a towering fixture on the Quincy landscape, has been sold to Daewoo Shipbuilding & Marine Engineering of South Korea and was to be broken down into nine pieces, loaded onto a barge, and shipped to its new home in Mangalia, Romania.

In January 2005, another crane failure in the shipyard killed two workers.

In July 2005, OSHA cited Testa Corp. for 15 alleged violations of safety and health standards at the shipyard. The agency found that Testa, which had been hired to remove a 190-foot craneway, failed to do an engineering survey to determine its stability.

On August 14, 2008, the FDA said the tip of the device used to place the stent could break off during implantation, potentially causing stroke or internal injury.

Boston Scientific (BSX) made doctors aware of the voluntary recall in a June 6 letter, according to the notice posted to the FDA’s Web site. The company said the recall applies to more than 2,200 devices distributed to hospitals worldwide between June 2007 and May 2008.

“All U.S. hospitals have responded to Boston Scientific, and a significant number of the distributed devices have been returned,” the company said in a statement.

The FDA approved NexStent in 2006 for patients with clogged neck arteries, which carry blood between the heart and the brain. The stent is threaded up to the neck with a catheter through a small incision made in the groin.

Since problems with the nickel-titanium tubes only occur during placement, Boston Scientific said patients who already have NexStent are not at risk.

The use of bare-metal stents has gradually declined since 2003, when manufacturers introduced drug-coated stents. Boston Scientific does not break out sales of NexStent, but its interventional cardiology division which includes several stents, contributed nearly 40% of company revenue last year.

Recently Chantix was pulled from at least one military pharmacy in the Pacific following strong warnings linking the drug to serious psychiatric problems. The drug, however, is still an option in many military smoking-cessation programs in the region, with health care providers saying Chantix has proved to be effective against nicotine addiction and can be used safely with proper screening and close monitoring.

The health benefits of a smoke-free life, for some, outweigh the risks of using Chantix, typically prescribed over 12 weeks, doctors say.

But medical officials at Yokota Air Base in Japan were concerned enough with the drug’s potential safety risks that they voted recently to remove Chantix from the base pharmacy, according to Maj. Tam Dinh, 374th Medical Support Squadron pharmacy element chief.

The decision came after a May 21 report from the Institute for Safe Medication Practices, a nonprofit organization devoted to medication error prevention and safe medication use.

It found a suspected association between the Pfizer drug varenicline (marketed as Chantix in the United States) and sudden loss of consciousness, seizures, muscle spasms, vision disturbances, hallucinations, paranoia, psychosis and other adverse reactions, according to Dinh.

The report noted that in the fourth quarter of 2007, varenicline accounted for 988 serious injuries in the U.S. reported to the FDA, more than any other individual drug in this time period.

Two days after the institute’s report, the Defense Department’s Office of the Chief Medical Officer recommended, “varenicline should not be used by personnel operating aircraft (including aircrew and air traffic controllers) and missile crew members.”

The DOD safety notice stated additional recommendations for “vehicle operators, operational personnel, and other DOD personnel are under consideration.” Those were just the latest warnings for Chantix.

The FDA earlier this year pushed Pfizer for new Chantix safety labels, citing a possible link to dozens of reports of suicides and hundreds of suicidal behaviors, according to the Associated Press. Pfizer added warnings to the drug’s label and said that although a link to serious psychiatric problems had not been proved, it could not be ruled out, The Associated Press reported.

At Yokota, Dinh said no patients on Chantix have reported any adverse reactions.

A patient with approval from his doctor can opt to continue the medication, and special order the drug, Dinh said in an e-mail to Stars and Stripes.

In the meantime, Yokota has suspended all refills of Chantix until patients review with their health care provider the potential risks and benefits of continuing the drug.

But at some of the region’s other base hospitals overseas, Chantix remains on the shelf, though air crewmembers can no longer take the drug per the DOD recommendation, officials said.

In South Korea, where Chantix is still available at Army military treatment facilities, Maj. Remington L. Nevin, U.S. Army Medical Department Activity Korea acting chief of preventive medicine, explained the peninsula’s Chantix policy: “Individual health care providers, after consulting with current DOD recommendations and FDA guidance, are free to exercise their clinical judgment in determining whether the potential risks of Chantix are balanced by its potential benefits to their patients.”

He noted DOD currently does not prohibit Chantix use and no DOD policy mandates a formal screening process prior to prescribing Chantix.

The medical community at U.S. naval hospitals Yokosuka and Okinawa are taking a similar approach, leaving the decision of whether to take Chantix up to the patient and his physician.

“If I can help someone stop smoking, it is among the most beneficial health changes that I can help them make for their entire life,” said Lt. Cmdr. Cormac O’Connor, a family practice physician at U.S. Naval Hospital Yokosuka.

At U.S. Naval Hospital Okinawa, Chantix is one of four medications available; the others are Zyban, nicotine gum and the nicotine patch, according to hospital spokesman Brian Davis.

Those undergoing smoking cessation must attend counseling, he said.

Patients on Chantix are told to stop taking the drug immediately if they experience any unusual behavior or psychological effects such as depression, irritable moods, thoughts of self-harm, or withdrawal from friends and family, Davis said.

Since January, 253 have been counseled for smoking cessation through the hospital’s health promotions department, Davis said. To date, he added, no one has reported any significant adverse psychological effects while using Chantix.

Nevin said Chantix has proved to be an effective aid in smoking cessation. He cited one study in which 44 percent of patients on Chantix successfully quit, compared to only 18 percent taking a sugar pill placebo.

“For many patients, the risks to their health posed by continued exposure to tobacco may far exceed the potential risks posed by Chantix,” he wrote.

Since Chantix was approved by the FDA in 2006, the number of military prescriptions for the drug has exploded.

In fiscal 2006, when Chantix was first licensed for use, DOD tracked 262 prescriptions in military treatment facilities, according to a May 23 DOD medication safety notice.

In fiscal 2007, the number of prescriptions jumped to 67,580.

In the United States, more than 5 million adults have been prescribed Chantix, according to Nevin.

But O’Connor cautioned, “there’s no magic bullet.” Chantix is “one of several medications. I think you have to choose which medication is best for your patient.”

The head of the Federal Motor Carrier Safety Administration, John H. Hill, said that the freeze would stay in place until his agency could find a way to detect when companies banned from interstate travel return to the road under a corporate alias without fixing their problems.

“I’m not granting any authority to any passenger carriers until I get my hands around this,” he said, promising an effort to match addresses, fax numbers and other details. The agency ordinarily approves about 100 carriers a month.

Federal officials said the bus that crashed early Friday morning near Sherman, Texas, killing 17 people, belonged to a man who was operating charter buses under two corporate names. The bus operator, Angel de la Torre, created a fresh company, Iguala Busmex, after federal investigators had shut down his previous bus company, Angel Tours, two months earlier for safety violations, investigators said.

The bus hit a guardrail and careened off a bridge after a retreaded tire on the front axle blew out and the driver lost control. Retreaded tires cannot legally be put on front wheels, investigators said. The driver also had a checkered history, having been stopped for drunken driving and speeding.

Mr. Hill acknowledged that enforcement of bans by his agency is spotty. The federal government relies on state police to stop buses randomly and pull them from the road if federal regulators have ordered them taken out of service. But some bus operators take the chance they will not be stopped and succeed.

Perhaps worse, Mr. Hill said that his authority extends only to interstate operations, but that many states have no mechanism for applying the federal findings to buses that operate within their borders.

Mr. Hill, who was a member of the Indiana State Police for 19 years before he became head of the federal agency two years ago, gave an example, saying that if the federal government had banned an Indiana bus company from interstate operations, the state of Indiana had no mechanism for shutting down the company’s in-state operation.

The United States Transportation Department has nationwide responsibility for hazardous materials transport and for commercial drivers licenses. But for all other operations that do not cross state lines, Mr. Hill said, “it’s a state issue.” He added he was not sure how many states are like Indiana.

In the latest crash, Texas authorities were never told that Mr. de la Torre’s first bus company had been banned, said Tom Vinger, a spokesman for the Texas Department of Public Safety. “Occasionally, we are notified when an interstate carrier is put out of service, but to the best our knowledge we were not notified in this case,” he said.

Mr. Vinger added that under Texas law the bus should not have been operating anywhere in Texas once the federal government suspended the company. But the state did not find out about the suspension until after the accident, he said.

One issue in the investigation is which entity had control of the bus that crashed. The exact status of the bus that crashed is in dispute. Mr. de la Torre operated a company called Angel Tours Inc., and, according to Federal officials, later operated one called Iguala Busmex Inc. (Iguala is a town in the mountains north of Acapulco, Mexico.) Mr. Hill said Mr. de la Torre was denying any connection to Iguala Busmex.

Investigators have still not interviewed Mr. de la Torre, Mr. Hill said. “His attorney is keeping him pretty well away from us,” he said.

On August 12, 2008, no one answered the telephone at the two companies’ shared headquarters on Telephone Road in Houston.

At the American Bus Association, the trade association of the motor coach industry, Peter J. Pantuso, a spokesman, said the Texas crash showed several weaknesses. “That accident, as unfortunate and tragic as it was, shows a lack of federal and state enforcement,” he said.

Companies barred by Washington from interstate commerce should not be allowed to operate inside state boundaries, he said, and if Mr. Hill did not know what the practice of the states was, “that’s a problem by itself. He is the chief federal enforcement officer for commercial vehicles.”

If a company is told to shut down, Mr. Pantuso said, “whether it’s pulling the plates or impounding those vehicles, there has to be something of such magnitude that we know no one is going to be getting on a bus operated by those individuals.”

There are about 3,500 active bus companies, he said, running about 35,000 buses, which means that most of them are quite small.

Mr. Pantuso said that there were many legitimate reasons why a bus company might want to open a new operation for example, because it was diversifying into a new area, for example and that a freeze was not the right approach.

The aftermath of the Texas crash has been a clash of authorities. Mr. Hill’s investigators went to the headquarters of the two companies in the Texas crash and were “thrown out of the premises by the owner and his attorney,” he said. The transportation department’s inspector general, who has subpoena powers, later gained access, Mr. Hill said. Investigators are documenting interstate trips after the company was banned from making them; each can carry an $11,000 fine, and other criminal penalties, he said.

But generally speaking, companies that are banned but continue to operate will be noticed only if a driver is stopped for breaking a traffic rule or through some other spot-check, he said.

The bus belonged to Harrah’s Tunica and was carrying 43 people when it flipped over in a median at an intersection in Tunica, Tunica County spokesman Larry Liddell said.

Tourists on the bus were headed to the airport for a chartered flight to South Carolina, where many were from, officials said.

The bus was the only vehicle involved in the accident, which was still under investigation, Mississippi Highway Patrol Sgt. Leslie White said. The bus’s roof partially collapsed in the rollover. Its windows were knocked out and the sides were caked in mud.

The identities of the passengers who were killed were not immediately released.

Twenty-seven injured people were taken to Baptist Memorial Hospital in Southaven, spokesman Thomas Whitehead said. One was in critical condition and five were being held for observation. The rest had what Whitehead described as minor injuries.

Four people were taken to the Regional Medical Center in Memphis, Tenn., about 35 miles to the north. Three remained in critical condition and the other was discharged, spokeswoman Sandy Snell said.

Harrah’s Entertainment operates 50 casinos worldwide, including three in Tunica: Harrah’s Tunica, Horseshoe Casino and the Sheraton Casino & Hotel. The area along the Mississippi River in the northwest corner of the state is best known for its bustling casinos.

“At this time, we’re focusing on the health and welfare of the guests involved in this tragic accident,” company officials said in a statement. The company set up a telephone hot line to give information and assistance to relatives of the crash victims.

The passengers were in Mississippi on a promotional trip offered by the casino, said Harrah’s spokesman Patrick Collins.

Liddell said Harrah’s advertises gambling packages in other states and hosts about 60-chartered flights a month.