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FDA Finds Contaminant in Baxter’s Recalled Heparin Products

WEDNESDAY, March 5 (HealthDay News) — Tests have found a heparin-like contaminant in heparin blood-thinning products made by Baxter Healthcare Corp. that have been linked to hundreds of adverse reactions and at least four deaths in the United States, federal health officials said Wednesday.”While the FDA has not determined the root cause of the adverse events, we have found a heparin-like compound, which is not heparin, present in some of the active pharmaceutical ingredients produced by Scientific Protein Laboratories,” Dr. Janet Woodcock, acting director of the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research, said during an afternoon teleconference.

Ray Godlewski, vice president of quality for Baxter’s medication delivery business, said during a subsequent teleconference that “all the contaminated heparin came from China.”

Scientific Protein Laboratories, of Waunakee, Wisc., and its Changzhou SPL plant in Changzhou City, China, is Baxter’s main supplier of the active pharmaceutical ingredient in heparin, Woodcock said.

“This contaminant is present in significant quantities in some of the active pharmaceutical ingredients, accounting for approximately 5 to 20 percent of the substance tested,” Woodcock said.

The substance reacts like heparin in the conventional tests that are used for heparin, which is why those tests of ingredients might not detect the contaminant, Woodcock said.

Heparin is a blood-thinner whose main ingredient comes from pig intestines. The drug is often given to dialysis patients and people undergoing heart surgery.

“At this point, we do not know how the heparin-like compound got into a heparin active pharmaceutical ingredient,” Woodcock said. “Whether it was deliberately or accidentally added it is not known,” she added.

The tests that found the contaminant were conducted by the FDA and Baxter, as well as some university laboratories.

Woodcock said the FDA hasn’t uncovered a direct link between the contaminant and the adverse events and deaths. “We know that some of the suspect batches of heparin that were causing the adverse events have this contaminant in it. So there is an association between the contaminant in the presence of adverse events, but it is not a direct causal link yet,” she said.

The FDA is also unsure if other heparin products used in the United States or other countries contain this contaminant, Woodcock said. The FDA will be releasing data on how companies can screen heparin for this contaminant, she said.

Following Wednesday’s teleconference, Scientific Protein Laboratories released a prepared statement that said it was “premature to conclude that the heparin active pharmaceutical ingredient (API) sourced from China and provided by SPL to Baxter is responsible for these adverse events.”

“During the call with the media, FDA speculated that the source of the adverse events may be a contaminant. It is important to note that this theory is speculation at this point, and SPL is participating actively in working with the FDA to pursue this theory, as well as others, so that we can understand the cause of the adverse events,” the statement said.

Contaminated products from China have been an ongoing worry for the FDA. If the heparin contamination turns out to be deliberate, it would be reminiscent of last year’s scandal when a Chinese company was charged with adding the toxic chemical melamine to an ingredient used in U.S. pet food that killed thousands of dogs and cats. The melamine let the ingredient pass chemical inspections for protein content, the Associated Press reported.

On Feb. 28, Baxter Healthcare, of Deerfield, Ill., which had provided about half the nation’s supply of heparin, announced it was recalling any remaining multi-dose vials of heparin as well as single-dose heparin vials. The company also recalled its Hep-Lock heparin flush products, which include a small amount of heparin and are used to prevent blood clots in intravenous lines.

The recall was made possible because the other manufacturer of multi-dose heparin vials, APP Pharmaceuticals of Schaumburg, Ill., was able to assure the FDA that they could meet all the demand in the United States.

At that time, the FDA also said it had completed its inspection of Scientific Protein Laboratories’ Changzhou SPL plant. The plant was no longer producing heparin, inspectors found. The inspectors did find deficiencies in the way the plant removed impurities and dealt with testing results that didn’t meet specifications. In addition, they found problems in waste disposal and equipment, according to the FDA.

Since the end of December, there have been 785 reports of adverse reactions associated with Baxter’s heparin product. This compares with less than 100 reports of adverse reactions in all of 2007.

There also have been 46 deaths, four of which were associated with an adverse reaction to heparin, according to the FDA.

Most of the reactions have taken place at hemodialysis centers, almost exclusively involving patients receiving a “bolus dose,” which is a high dose administered over a short period of time, according to the FDA.

Adverse reactions included difficulty breathing, nausea or vomiting, excessive sweating and falling blood pressure, which can lead to life-threatening shock. These reactions have been seen with as few as several thousand units per milliliter of heparin, and as much as 50,000 units per milliliter.

More information

For more on heparin, visit the U.S. National Library of Medicine.

SOURCES: March 5, 2008, teleconference with Janet Woodcock, M.D., Deputy Commissioner for Scientific and Medical Programs, Chief Medical Officer, and Acting Director of the Center for Drug Evaluation and Research, U.S. Food and Drug Administration; March 5, 2008, teleconference with Ray Godlewski, vice president of quality for Baxter’s medication delivery business;March 5, 2008, prepared statement, Scientific Protein Laboratories, Waunakee, Wisc.

Nolan Law Group Files Suit Against Cessna Caravan

In response to inquiries regarding the filing of the case Allan v. Cessna Aircraft Company, Nolan Law Group issues the following statement:

Cessna Lawsuit Alleges Fraud; Family Seeks $25 Million in Punitive Damages

Chicago, Illinois (October 6, 2006).-Nolan Law Group filed a lawsuit against Cessna and Goodrich on behalf of yet another family who has suffered human loss due to a crash of a Cessna Caravan airplane in icing conditions. The complaint was filed in the Southern District Court of New York alleging fraud, product liability, negligence and breach of warranty. The family is also seeking $25 million in punitive damages from Cessna for the loss of their mother, Nancy Chase Allan, an air cargo pilot for a FedEx feeder airline.

“This represents more than just one more accident,” says Donald J. Nolan of Chicago-based Nolan Law Group. “The fraudulent conduct alleged here relates to a breach of trust and confidence by Cessna. How can the owners and operators of these planes trust what Cessna is saying anymore?”

On October 6, 2005, the Cessna 208B, carrying cargo for FedEx Corp. crashed on railway tracks near a major downtown intersection in Winnipeg, Canada, killing the pilot. The Morning Star Air Express (Flight 8060) was completely destroyed upon impact.

The Canadian Transportation Safety Board (TSB) investigation of the accident is ongoing, but it has already cited in-flight airframe icing as a factor in this crash.

The Cessna Caravan is presently being marketed as a safe and secure aircraft for winter operations. A contention disputed by Nolan Law Group. “Innocent pilots and passengers are losing their lives while Cessna is continuing to promote this aircraft as safe and while icing accidents continue to occur, “offers Jerry Skinner, a Nolan Law Group attorney in Cincinnati, Ohio.

Nolan Law Group currently represents victims and families of victims from four separate accidents where Cessna Caravan planes have crashed (Illinois, Wisconsin, Texas and Idaho,) due to icing induced stalls. There is an undeniable pattern of design failure directly contributing to the growing number of people killed and injured in these crashes across the nation and the world. The recommendation of the NTSB for the FAA to take action related to safety of flight into icing conditions of the Cessna Caravan model airplane remains one of its “Most Wanted” items. In December 2004, the NTSB itemized 26 accidents of the Cessna Caravan in the previous 10 years related to icing.

About Nolan Law Group

Nolan Law Group helps individuals and families, in Chicago and around the world, after a tragic loss or serious personal injury. The law firm focuses its practice primarily on mass tort aviation and traumatic brain injury litigation.

Nolan Law Group is one of a small number of law firms with a niche in the highly complex and everchanging area of global and domestic aviation litigation.

The firm has earned recognition by the legal industry’s leading authority, Martindale, for impeccable professional ethics and for legal abilities of the highest caliber. Nolan Law Group provides strength in practice; greater results.

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Nolan Law Group Files Suit in Wisconsin Plane Crash

Chicago, Illinois.-A lawsuit arising from the crash which killed three people near Burlington, Wisconsin was filed today by Nolan Law Group in the Circuit Court of Kenosha County. The lawsuit names defendants D&G Supply of Niles, Michigan, Blackhawk Aircraft Maintenance of Janesville, Wisconsin and Precision Airmotive of Seattle Washington. Allegations include product liability and negligence due to a faulty fuel servo on the right engine of the airplane. Nolan Law Group represents the wife and four children of deceased passenger Henry “Herb” Grochowske from Genoa City, Wisconsin.

On September 30, 2004, the privately owned Beech B95A, piloted by Grochowske, was destroyed when it impacted trees and terrain after takeoff from Burlington Municipal Airport, Burlington, Wisconsin. The aircraft was en route to Westosha Airport, Wilmont, Wisconsin and operating in clear weather conditions. All three passengers died at the scene of the crash.

“Henry Grochowske’s loss of life could have been avoided had the engine parts of this plane been properly overhauled and installed,” says Charles Barnett, attorney of Chicago based Nolan Law Group. “The devastation Mr. Grochowske’s family and the other two passengers’ families have endured is enormous. Accidents like this one can be prevented.”

Suit alleges product liability, negligence and wrongful death against maintenance and service companies as well as against the manufacturer of the original part.

The National Transportation Safety Board determines the probable cause(s) of this accident as follows:

The improper maintenance of the fuel servo resulting in a loose adjustment nut and subsequent failure of the fuel injection servo which led to a complete loss of power on the right engine.

About Nolan Law Group

Nolan Law Group helps individuals and families, in Chicago and around the world, after a tragic loss or serious personal injury. The law firm focuses its practice primarily on mass tort aviation and traumatic brain injury litigation. Nolan Law Group is one of a small number of law firms with a niche in the highly complex and ever-changing area of global and domestic aviation litigation. The firm has earned recognition by the legal industry’s leading authority, Martindale, for impeccable professional ethics and for legal abilities of the highest caliber. Nolan Law Group provides strength in practice; greater results.

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Nolan Law Group Files Wrongful Death Lawsuit against Mitsubishi’s Defectively Designed MU-2 Aircraft

Chicago, Illinois. – A wrongful death lawsuit was filed yesterday in Oakland County, Michigan on behalf of the Mother of a 33 year old pilot who died when the Mitsubishi MU-2B-36, N201UV, operated by Royal Air Freight Inc. crashed during a freight transport from Hagerstown, Maryland, to Bangor, Maine.

The suit was filed by Chicago based Nolan Law Group and claims at the time that the subject aircraft left the control of the defendant, MITSUBISHI HEAVY INDUSTRIES, LTD., (NYSE:MHI) that the aircraft contained certain conditions which rendered the aircraft defective, unreasonably dangerous and/or unfit for its intended use.

On March 25, 2004, Brian Templeton, 33, of Waterford, Michigan a certificated airline transport pilot, was fatally injured when his plane plunged 12,000 feet before hitting the ground and exploding into flames near a populated area in Pittsfield, Mass.

“The failure of this plane to operate safely in icing conditions is nothing new. Mitsubishi will be held responsible for its repeated inability to remedy this defective design,” says Donald J. Nolan of Nolan Law Group.

Nolan Law Group also represents the family of an Illinois couple who died when their Mitsubishi MU-2 airplane crashed during a routine landing out of state leaving behind four adult children. Ian White wrote in a letter to Senator Barack Obama “My parent’s crash is one of at least 108 instances (14.1% of only 764 ever made) where an MU-2 plane has stopped flying and fatally crashed.”

Tom Tancredo, a Colorado Congressman is “extremely critical of the FAA’s oversight of the horrendous safety record of the Mitsubishi MU-2,” he states in a letter written directly to the FAA on November 3, 2005. While a special type rating certificate requirement would help in the proper operation of the dangerous MU-2, (SFAR – Special Federal Aviation Regulation,) “stronger action is needed from the FAA, given the questions that have been raised about the airworthiness of the aircraft.”

About Nolan Law Group

Nolan Law Group helps individuals and families, in Chicago and around the world, after a tragic loss or serious personal injury. The law firm focuses its practice primarily on mass tort aviation and closed brain injury litigation.

Nolan Law Group is one of small number of law firms with a niche in the highly complex and ever-changing area of aviation litigation and is active all over the world. With regard to traumatic brain injury litigation, Nolan Law Group has pioneered the use of sophisticated technology to demonstrate the extent of brain damage that can occur as a result of accidents.

The firm has earned recognition by the legal industry’s leading authority, Martindale-Hubbell, for impeccable professional ethics and for legal abilities of the highest caliber.

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Nolan Law Group Files Suit in Southwest Crash at Midway

Chicago, Illinois.-A lawsuit arising from the crash of Southwest Airlines Flight 1248 at Midway Airport was filed today in the Circuit Court of Cook County by Nolan Law Group on behalf of one of the passengers in the crash. The lawsuit names Southwest Airlines and the City of Chicago, which operates Midway Airport, as defendants.

The Southwest Airlines Boeing 737-700 was landing in a snowstorm at Midway Airport at about 7:15 p.m. at the northwest corner of the airport when it skidded off the runway and crashed through a barrier and into traffic. Ms. Bonnie James, a medical technician and the plaintiff in this case, was one of the passengers taken by ambulance to a hospital after the crash. She has not returned to work since the accident. Ms. James is a resident of Chicago, Illinois.

“Ms. James and other passengers – as well as the people on the ground – were let down by everyone who had a hand in allowing that plane to land under the conditions that prevailed at the time,” aviation attorney Donald J. Nolan said in announcing the filing of the lawsuit. “Our hope is that this lawsuit will draw attention to the systemic weaknesses in place to protect the safety of our air travelers. One of the dreadful aspects of this tragedy is that it didn’t have to happen. It was completely avoidable if everyone entrusted with the safety of the aircraft had simply decided to divert the plane to a neighboring airport.”

“What makes this accident even worse is that runway overruns such as this are preventable with technology already in place at similar urban airports,” Nolan added. “Engineered Material Arresting Systems (EMAS) are in place at LaGuardia, JFK, Burbank, Little Rock and Baton Rouge airports,” he added, “and they have proven effective in averting such disasters.”

The arresting material, made of soft concrete, has stopped three dangerous overruns since May 1999 at Kennedy Airport in New York., Nolan said. “We know the system works,” Nolan says. “I think there is an urgent need to install the EMAS at Midway.”

National Transportation Safety Board member Ellen Engleman Conners said the braking condition of the runway at the time of accident was rated by air traffic controllers as “fair for most of the runway and poor at the end.” The plane hit the fence 32 seconds after it touched down. The plane’s ground speed was 152 miles per hour as it landed and it hit the fence at about 46 miles per hour, Conners said. A non-standard EMAS installation, which would be required at Midway, would be designed to stop aircraft traveling at 40 knots – which is exactly 46.1 mph, Nolan observed.

Nolan added that crashes like this one often result in mild trauma brain injury to passengers from being buffeted during extreme acceleration / deceleration of the aircraft. “There may be little or no apparent indication of physical injury,” Nolan explained, “beyond the victim saying he or she doesn’t ‘feel right’, and they spiral downward from the skeptical reception they receive. Neuroimaging techniques today show actual physical changes in the brain in cases of post-traumatic disorder, which is seen in virtually all cases like this.”

About Nolan Law Group

Nolan Law Group helps individuals and families, in Chicago and around the world, after a tragic loss or serious personal injury. The law firm focuses its practice primarily on mass tort aviation and closed brain injury litigation.

Nolan Law Group is one of small number of law firms with a niche in the highly complex and ever-changing area of aviation litigation and is active all over the world. With regard to traumatic brain injury litigation, Nolan Law Group has pioneered the use of sophisticated technology to demonstrate the extent of brain damage that can occur as a result of accidents.

The firm has earned recognition by the legal industry’s leading authority, Martindale-Hubbell, for impeccable professional ethics and for legal abilities of the highest caliber.

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