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Illinois Pharmaceutical Manufacturer Sued For Injuries To Kentucky Resident – Injuries Believed To Be Caused By Contaminated Blood Thinner

CHICAGO, Illinois (May 14, 2008) – The blood thinner Heparin continues to make headlines as more people are found to have suffered serious injuries and/or death after using the contaminated drug – a group of which appears to include many Kentucky residents.

On Friday, May 2, 2008, another lawsuit was filed against Chicago-area pharmaceutical giant, Baxter International Inc. on behalf of Louisville, Kentucky resident, Artemus Banks. The complaint was filed by Nolan Law Group in Federal Court located in Chicago, Illinois. Nolan Law Group has already been responsible for filing several lawsuits on behalf of victims and the families of victims who have suffered a personal injury and/or death caused by the use of this contaminated drug. Due to the enormity and severity of the contamination, Nolan Law Group expects to file many more similar cases.

This most recent lawsuit names Scientific Protein Laboratories L.L.C. (the company which manufactures the active pharmaceutical ingredient API in Heparin) as well as certain corporate officers of Baxter. The lawsuit asserts that Baxter International and its wholly-owned subsidiary, Baxter Healthcare Corporation, manufactured the drug with a contaminated API and that Baxter failed to recall the defective drug in a timely fashion. The suit cites four causes of action against Baxter and Scientific Protein Labs including Products Liability, Negligence, Breach of Warranties and Willful and Wanton Misconduct.

Baxter’s Heparin has been implicated in more than 400 life-threatening incidents and may be responsible for as many as 81 deaths. In February 2008, Baxter initiated a voluntary recall of nine lots of Heparin Sodium Injection Multi-Dose Vials. According to Baxter International, they recalled the lots due to a spike in adverse reports associated with the use of Baxter Heparin Sodium Injections. After receiving additional reports of similar adverse reactions from other lots of their Heparin Sodium Injection Products, Baxter recalled their remaining multi-dose and single-dose vials, as well as HEP-LOCK Heparin Flush Products.

In January of 2008, Mr. Banks received a box of 25 vials of Baxter Heparin from Fresenius Medical Care for use during home dialysis treatments. Banks used the product as prescribed but began experiencing numerous physical symptoms, such as wheezing, shortness of breath, coughing, dizziness, increased perspiration and sudden weakness. Today, Mr. Banks continues to suffer as a result of his Heparin use.

The suit falls on the heels of a recent finding by the Food and Drug Administration (FDA) identifying an unknown contaminant found in the Baxter Heparin. In early April of 2008, researchers confirmed the FDA’S suspicion that the contaminant found in the Heparin is Oversulfated Chondroitin Sulfate (OSCS), a derivative of a popular supplement used to relieve arthritis, and a chemical which does not occur naturally during Heparin production.

Raw Heparin is derived from pig intestines and is often processed by small, unregistered “mom-and-pop” workshops in China. The key to establishing causation in this case, despite all of the issues with unsanitary conditions, etc., will be Baxter’s failure to perform a chemical test on the Heparin which would have been sensitive enough to identify the difference between Heparin and OSCS. The abhorrent conditions in China from where Heparin was being imported (and the fact that the FDA was not doing significant inspections) required the need for more sensitive testing.

According to the FDA inspection, the Changzhou SPL Facility was unable to provide FDA with any assurance “that processing steps used to manufacture heparin sodium, USP are capable of effectively removing impurities.” FDA also found that the facility failed “to have adequate systems for evaluating the suppliers of crude heparin materials, or the crude materials themselves, to ensure that these materials are acceptable for use.” Moreover, the methods employed to test Heparin Sodium United States Pharmacopoeia (USP) had not been verified to ensure suitability under actual conditions of use and the equipment used to manufacture the product was “unsuitable” for its intended use.

China’s Ministry of Commerce is now requiring local Heparin makers to increase testing of raw materials, improve post-sale tracking and ensure that their raw material comes from registered suppliers. This requirement follows U.S. Congressional inquiries into the FDA’s overseas inspection process.

The House Oversight and Investigations Subcommittee held a hearing on April 15th of this year regarding the distribution of contaminated Heparin. A follow-up hearing took place on April 22nd at which time the committee asked FDA Commissioner Andrew von Eschenbach how the agency will address concerns regarding its efforts to inspect foreign drug facilities.

Mr. Banks is seeking judgment against all defendants for compensatory and punitive damages arising from the personal injuries that he suffered from the use of a pharmaceutical drug commonly known as Heparin.

Nolan Law Group is a Chicago-based personal injury law firm concentrating in aviation accidents, construction accidents, brain injury litigation, medical malpractice, premises liability, product liability, and trucking accidents.

Illinois Pharmaceutical Manufacturer Named In Yet Another Heparin Lawsuit After Virginia Resident Dies

CHICAGO, Illinois (May 14, 2008) – The blood thinner Heparin continues to make headlines as more people are found to have suffered serious injuries and/or death after using the contaminated drug – a group of which appears to include several Virginia residents.

On Friday May 2, 2008, a lawsuit was filed against Deerfield, Illinois-based Baxter International Inc. on behalf of Coeburn, Virginia resident, Angela Lawson-Greear who suffered the tragic loss of her father, Thomas Troy Lawson, on February 13, 2008. This is the third lawsuit of its kind filed by Nolan Law Group and follows a recent finding by the Food and Drug Administration (FDA) identifying an unknown contaminant found in Baxter Heparin. Due to the enormity and severity of the contamination, the firm expects to file several similar cases in the near future.

The complaint was filed in the Circuit Court of Cook County by Nolan Law Group and alleges that Thomas Lawson’s untimely death was caused by his exposure to contaminated Heparin. The complaint cites multiple counts of Products Liability, Negligence, Breach of Warranties and Willful and Wanton Misconduct on the part of Baxter International and Baxter Healthcare Corporation.

The lawsuit filed by Mrs. Lawson and Nolan Law Group asserts that Baxter International and its wholly-owned subsidiary, Baxter Healthcare Corporation, was responsible for the manufacture, sale and distribution of a product containing toxic chemicals. It also claims that the product was manufactured with a contaminated API and that Baxter failed to recall the defective drug in a timely fashion.

Baxter’s Heparin has been implicated in more than 400 life-threatening incidents and may be responsible for as many as 81 deaths. In February 2008, Baxter initiated a voluntary recall of nine lots of Heparin Sodium Injection Multi-Dose Vials. According to Baxter International, they recalled the lots due to a spike in adverse reports associated with the use of Baxter Heparin Sodium Injections. After receiving additional reports of similar adverse reactions from other lots of their Heparin Sodium Injection Products, Baxter recalled their remaining multi-dose and single-dose vials, as well as HEP-LOCK Heparin Flush Products.

Prior to February 13, 2008, Thomas Lawson was receiving home dialysis for a medical condition and was prescribed Baxter Heparin as part of his Heparin Sodium Injection Therapy. Mr. Lawson used the product as prescribed but began experiencing numerous physical symptoms, such as wheezing, shortness of breath, coughing, dizziness, increased perspiration and sudden weakness. Mr. Lawson ultimately died as a result of his contaminated Heparin use.

In early April of 2008, researchers confirmed the FDA’S suspicion that the contaminant found in the Heparin is Oversulfated Chondroitin Sulfate (OSCS), a derivative of a popular supplement used to relieve arthritis, and a chemical which does not occur naturally during Heparin production.

Raw Heparin is derived from pig intestines and is often processed by small, unregistered “mom-and-pop” workshops in China. The key to establishing causation in this case, despite all of the issues with unsanitary conditions, etc., will be Baxter’s failure to perform a chemical test on the Heparin which would have been sensitive enough to identify the difference between Heparin and OSCS. The abhorrent conditions in China from where Heparin was being imported (and the fact that the FDA was not doing significant inspections) required the need for more sensitive testing.

According to FDA’s inspection, the Changzhou SPL Facility was unable to provide FDA with any assurance “that processing steps used to manufacture heparin sodium, USP are capable of effectively removing impurities.” FDA also found that the facility failed “to have adequate systems for evaluating the suppliers of crude heparin materials, or the crude materials themselves, to ensure that these materials are acceptable for use.” Moreover, the methods employed to test Heparin Sodium United States Pharmacopoeia (USP) had not been verified to ensure suitability under actual conditions of use, and the equipment used to manufacture the product was “unsuitable” for its intended use.

China’s Ministry of Commerce is now requiring local Heparin makers to increase testing of raw materials, improve post-sale tracking and ensure that their raw material comes from registered suppliers. This requirement follows U.S. Congressional inquiries into the FDA’s overseas inspection process.

The House Oversight and Investigations Subcommittee held a hearing on April 15th of this year regarding the distribution of contaminated Heparin. A follow-up hearing took place on April 22nd at which time the committee asked FDA Commissioner Andrew von Eschenbach how the agency will address concerns regarding its efforts to inspect foreign drug facilities.

Angela Lawson has been appointed special administrator of her father’s estate and as such is seeking personal and pecuniary damages from Baxter International Inc. for the loss of her father in a sum in excess of the minimal jurisdictional limits of the Cook County Circuit Court.

Nolan Law Group is a Chicago-based personal injury law firm concentrating in aviation accidents, construction accidents, brain injury litigation, medical malpractice, premises liability, product liability, and trucking accidents.

The Crash of Air Philippines 541

Eight years ago April 19, 2000, Air Philippines Flight 541, with 131 passengers and crew members, left Manila at 5:21 a.m., flying to Davao City, on Samal Island, about 600 miles southeast of Manila.

As it approached the airport at around 7 a.m., another aircraft was on the runway. Flight 541 began to circle in low clouds, waiting for the plane on the ground to move off the runway. As it circled, Flight 541 slammed into the side of a mountain, 500 feet above sea level. The plane caught fire and disintegrated, killing everyone on board. It was the worst air disaster in the history of the Philippines. But there is more to this story than another horrible air crash. As airplanes in the American fleets wear out when they reach a point where the cost of overhauling the planes, which can run between $2 million and $8 million, is no longer worth it they are retired to the Arizona desert. There are thousands of worn-out planes lined up in the desert waiting for a second life. From there, leasing companies purchase the planes and lease them to other, usually foreign, usually developing, airlines.

Flight 541 was a Boeing 737, a 22-year-old plane that had been put out to pasture by Southwest Airlines, and bought by AAR Aircraft & Engine Group, a publicly traded company based in Wood Dale, Ill. AAR leased the plane to Air Philippines in January 1999 and sold the plane in April 1999 to Fleet Business Credit Corp., now a division of Bank of America, and assigned Fleet its rights under the lease.

The lawsuit against AAR and Fleet was filed in Cook County Circuit Court and, following litigation over the forum issue, including an appeal, stayed here. The lead plaintiff was a Chicago resident, Boeing’s corporate headquarters are here, and AAR is in Wood Dale. Donald J. Nolan of Chicago’s Nolan Law Group, who represented 47 of the plaintiffs, was appointed lead counsel. There were three other firms representing plaintiffs, all from the San Francisco Bay Area: Sterns & Walker; Bowles & Verna; and O’Reilly & Danko. Gary W. Westerberg, Christopher R. Barth, T. Patrick Byrnes, and Mark A. Deptula of Locke, Lord, Bissell & Liddell, represented the defendants.

The case settled in November 2007 for $165 million, which, Nolan said, worked out to about $1.5 million per victim.

Aside from the inherent interest of a huge settlement, the case is interesting as yet another feature of globalization in this case, the globalization of the airline industry, and the ethical and legal obligations of the companies that buy and lease the planes to airlines in countries where the safety standards are well below American and European standards and where even the culture plays a role in the safety of airlines. In the last five years, there have been more than 10 fatal commercial airline crashes involving aircraft leased to developing countries, the latest occurred on April 15 in the Democratic Republic of the Congo, killing at least 75 people.

Chicago Lawyer sat down recently with Nolan to discuss the case.

Chicago Lawyer: What were the liability issues in the case?

Nolan: There were four main issues: crew resource management, the failure to provide an enhanced ground proximity warning system under our product liability theory and spoliation for the destruction of the wreckage and failure to perform maintenance under negligent entrustment.

Chicago Lawyer: Let’s start with crew resource management. First, what is it, then, how is that an issue?

Nolan: Prior to the crash, the FAA mandated in the U.S. that crews have crew resource management (CRM) training, and what that deals with is a culture of deference in the cockpit, where human factors engineers learned and taught, and the FAA adopted, the idea that you have to have a system of checks and balances in the cockpit.

A co-pilot might notice something of imminent danger that the pilot did not notice, and it’s necessary to call that out complete deference is not afforded to the pilot in command. Whereas the FAA mandated that and has a directive in place for crews in the U.S. to have this CRM training, the government in Philippines did not so require.

Asian countries have a storied past with deficiencies in CRM, because it’s a clash with Asian culture, with deference to seniors.

For example, there was a Singapore Air crash in October 2000, on an international flight bound for Los Angeles international flight SQ006 when the crew took off in a typhoon in Taipei. There, none of the crew, even though they knew that it was not an appropriate takeoff, ever checked the action of the pilot in command.

In the Air Philippines case, the pilot was being supervised at the time of the crash by a check airman, meaning a superior on a check ride, and the check airman was one whose actions were not countered by a lower pilot, so we knew there were issues of CRM training.

Chicago Lawyer: How can the lessor be held liable for the crew’s training?

Nolan: AAR never checked to see what the standards were in the Philippines, and just presumed the Philippines would be following the FAA standard, when, in fact, they were not. So, under negligent entrustment law, which deals with what someone knew and should have known [they could be held liable].

Chicago Lawyer: And your negligent entrustment theory also relates to maintenance?

Nolan: This airplane was taken off the desert floor by AAR. It was purchased from Southwest Airlines, which is a high-mileage operating fleet, and this was a [22-year-old] airplane. Southwest Airlines is high-cycle, high-time. They really work their airplanes. Southwest made a decision somewhere along the line not to continue with that airplane a cost-benefit analysis of maintenance, upkeep, and the returns they’re offered on that.

Chicago Lawyer: How much was the lease for?

Nolan: The lease was on a per-month basis. The transactions were seven-figure transactions. I think when the plane crashed they made seven figures just on the insurance. When the plane crashed they had a financial return and a profit on the hull liability clause.

Chicago Lawyer: Who’s responsible for the maintenance?

Nolan: Both the lessor and the lessee. The lessor, having in the lease reserved to itself rights of inspection, and requiring that maintenance and safety be followed under that scenario on a legal basis it can face responsibility for the loss of life. Here, this fleet was not equipped with up-to-date manuals from Boeing.

AAR never ascertained whether Air Philippines was aware of what Boeing’s schedule of maintenance requirements were.

AAR had it checked by a company that makes appraisals, and they were warned that this was going to be a plane that would have problems with maintenance in the future, yet they purchased it because the returns were great.

So there was a cost-benefit analysis conducted in which the financial returns even though it was acknowledged that it was with a start-up airline in a foreign country the returns were higher than normal and, therefore, the financial return warranted the lease.

[Southwest] wrote that off, but Air Philippines takes it because it’s a cheaper acquisition for them. They take that [plane] and AAR knows it has increased maintenance as it goes on, but they never did the review of maintenance facilities and programs of Air Philippines. They didn’t check to see if the maintenance manuals were coordinated or any of those things. The pre-lease inspection said, “You’re going to have ever-increasing maintenance costs, use caution.”

Chicago Lawyer: Can airplanes be brought up to speed after so many miles?

Nolan: There are metal fatigue issues that we commonly deal with. Aging and metal fatigue is a common problem in the commercial aircraft industry, and it’s exacerbated in the situation of aged aircraft.

Metal fatigue issues are especially important when you’ve leased an airplane in an ocean environment like the Philippines, where you have accretion of salt as a corrosive factor, so taking an old airplane like this, not performing maintenance, with old parts, and then exposing it to a salt-water environment is especially difficult.

Chicago Lawyer: You’ve talked about the lack of training and maintenance how does the ground warning issue relate to the crash?

Nolan: When the plane was inspected and leased by AAR and brought to Philippines, the airplane was not equipped with an up-to-date ground proximity warning system, an enhanced ground proximity warning system, which was then available and widely sold to airlines for safety reasons.

Instead, the plane was sold with the original old, outdated ground proximity warning system, which gave much lesser warning to the pilot of impending disaster.

The plane flew into a mountain. It was coming in, there was another plane on the runway, so it had to do a missed approach.

It was circling the airport in inclement weather and flew into a mountain, and that’s precisely why the enhanced ground proximity warning system would have prevented the crash. It would have given a 24-second warning to the crew, at a minimum. They almost avoided the crash they clipped trees but the old system only gave them a few seconds’ warning.

Had this plane been equipped for a few cents more per passenger with an enhanced ground proximity warning system, the plane crash would never have taken place.

Yet AAR elected even though the FAA had set a schedule for incorporating the enhanced ground proximity warning system into the American fleet to place it over in the Philippines when, in fact, the outdated system was not suited for the mountainous regions of Philippines.

We took the deposition of the designer of both systems and he noted that the old system was not designed for that terrain. The enhanced system was available and being employed by other operators.

Chicago Lawyer: What was the spoliation issue?

Nolan: We, through discovery, found that the insurers had hired an insurance adjusting company in Singapore called Air Claims. After we instituted our product liability lawsuit, Air Claims went to the scene of the crash and buried the wreckage in concrete. This was paid for by the insurers. Illinois law recognizes spoliation, so we had a motion for sanctions pending at the time the case settled.

AAR and Fleet, the successor company, now part of Bank of America, both of the defendants knew or had to know that maintenance was not being performed as required on this airplane, and so, certain key elements the component parts of the aircraft, the distance measuring equipment and the altimeter were buried by the insurance company and that prevented us from ever looking at it, even though maintenance records show these parts had been in the shop just days before the occurrence, so that was very critical.

Chicago Lawyer: The settlement works out to about $1.5 million for each of the victims how does that match with other settlements?

Nolan: When Air Philippines first made offers of settlement to Philippine families, they were offering $20,000. Roughly six months after this crash, there was the Singapore Airlines crash. Singapore Airlines immediately offered families $400,000, so we had a disparity in 2000 between what the London market was offering Filipinos and what they were offering other Asian families.

What we’ve seen take place is the globalization of how claims are valued. We have a history of low payments internationally for crashes from the London market which is being challenged, and we have seen from the $20,000 offer to six months later the $400,000 offer, to what this case is in terms of a settlement of $1.5 million per decedent, a trend in international cases that is the beginning of an equalization of how claims are being handled and evaluated.

For that reason alone it’s significant for how London and U.S. insurers are going to assess premiums and approach air disasters in the future. From what I’m told, $165 million is believed to be the largest foreign domestic settlement for Asia.

Chicago Lawyer: Aside from the size of the settlement, what is the significance, if any, of this case?

Nolan: The issue of aged aircraft being sold or leased by American companies to foreign countries is a continuing problem of international dimension, and the problem it creates is not only a disaster, but the problem of foreign countries not having the sophistication or experience to legally resolve the international disputes.

As the American fleet has aged, those planes are being dumped into foreign markets. Those aged aircraft that are recycled for foreign airlines will ultimately have Americans flying on those airplanes in domestic situations. This is a problem aged aircraft are not only a problem in the U.S., but it’s magnified when those products are brought to a foreign country not equipped to handle the loss.

When those old airplanes crash in foreign countries, they represent the worst aviation tragedy those countries have ever faced the greatest loss of life.

On an increasing basis people are turning to courts in the U.S.; they are looking to the U.S. for the sophistication of our legal system because they are not equipped by law and precedent to attend to cases of the magnitude of an air crash disaster. Many of their laws are outdated and have not dealt with mass torts.

When you have a truly international setting, the forum of the U.S. is something they look to because we have experience in resolving mass disasters and sophisticated international tort claims. The Circuit Court of Cook County has become a leader in handling those claims, through the efforts of Law Division Judge [William] Maddux.

When Boeing moved to Chicago, it brought international focus to this courthouse for claims involving Boeing aircraft, which are in fleets worldwide. Judge Maddux has supervised a number of lawsuits with complexities unique to air disasters which have come from these foreign crashes.

Air Philippines represents one of those foreign cases. The suit was originally brought in the Circuit Court of Cook County, the defendants appealed the ruling of Judge Kathy Flanagan that this was a convenient forum, and the case came back down, where it was ultimately settled before Judge Jennifer Duncan-Brice.

There are international aspects to it with respect to how claims are resolved. It has importance for American leasing companies as a precedent because American leasing companies view the leasing of commercial aircraft the aged American fleet as in part a financial transaction and yet, a company like AAR, which is international as well, provides other services. It’s a leader in the industry.

We have in this case a clashing of reviewing product liability and leasing law from a legal standpoint, and how that interfaces with the financial leasing industry, and what obligations exist for a finance company that turns to leasing of aircraft. Our product liability law and negligence law for negligent entrustment view responsibility differently from how financial companies historically have looked at these issues.

The importance of the case was reflected by how London views the results of the case.

The London and American insurers are reviewing this case because, historically, premiums were assessed to lessors in a different, lesser capacity than as to airlines, so this case was closely watched by insurance markets to see how it would be resolved.

Chicago Lawyer: Beyond the insurance issues, what do you think is the broader significance of the case?

Nolan: We believe this case is significant because insurers, lessors, and operators will focus more on safety and prevention when entering into transactions than they had in the past. We also believe that there will be more safety audits conducted by lessors of operators to whom they intend to lease, and the requirements for keeping with FAA standards will more likely take place.

In this instance, there was no safety audit conducted by AAR or Fleet of Air Philippines prior to the crash to know what their own safety practices were, and never any safety audits to determine whether Air Philippines was meeting FAA standards.

As globalization takes place, this case will be one that’s considered in requiring the safety audits that are common practice in U.S. airlines. I think this case will help in terms of globalizing safety for domestic foreign routes. Hopefully, cases like this will help to increase safety.

Suit alleges Baxter’s heparin killed wife

Baxter International Inc. faces a growing number of lawsuits from families who blame the company’s blood-thinning drug heparin for deaths of loved ones. Heparin was used by millions of people to prevent blood clots during dialysis and other medical procedures.

The latest wrongful death suit was filed Wednesday in Cook County Circuit Court by the widower of an Iowa woman who died at home during kidney dialysis Nov. 30. Mark Scott of Davenport accuses Baxter of selling defective heparin that caused her death.His wife, Melissa Scott, 53, began experiencing nausea and vomiting after treatment began in August, said Tom Ellis, a spokesman of the Nolan Law Group in Chicago

Chicago, which brought the suit on behalf of Mark Scott. On Nov. 30, Ellis said, an allergic reaction to the heparin caused Scott to fall and as a result disconnect from the machine. Mark Scott found his wife on the floor after she called out to him during a treatment. The death certificate said death was caused by an air embolism in the heart, Ellis said. An autopsy was not performed.”Mark wants to know for sure what happened to his wife,” Ellis said. “His wife was well trained on the dialysis machine.”

A Baxter spokeswoman said the company had not yet seen the Scott suit and declined to comment on its specific allegations. But she said the company is aware of at least four other wrongful death suits in the

U.S.
U.S.

“No patient deaths have been confirmed by medical or epidemiological evaluation by Baxter or [the U.S. Food and Drug Administration] to have been caused by the allergic-type reactions associated with the current heparin recall,” said Baxter spokeswoman Erin Gardiner. “None of these suits includes any credible medical information to allow the company to medically evaluate these claims.”The Deerfield-based company also is defending at least five suits brought by patients who allege they were harmed by tainted heparin.

The FDA is investigating whether heparin is connected to as many as 19 deaths and more than 700 serious illnesses since

Jan. 1, 2007
. Baxter insists that four deaths so far may be connected to adverse reactions to heparin.Baxter recalled the drug in February after a spike in severe allergic reactions in patients. Further investigation revealed a significant amount of an unidentified foreign substance contaminated batches of heparin.

The suspect active ingredient originated at a

Changzhou, China, plant owned by Scientific Protein Laboratories, a Baxter supplier based in Waunakee, Wis. Last month the FDA disclosed that low-cost animal cartilage made its way into Baxter’s heparin but has not determined a specific link to allergic reactions.
Changzhou, China, plant owned by Scientific Protein Laboratories, a Baxter supplier based in Waunakee, Wis. Last month the FDA disclosed that low-cost animal cartilage made its way into Baxter’s heparin but has not determined a specific link to allergic reactions.

Insurers Settle Lawsuits over Philippines Crash for $165M

Insurance companies have agreed to pay $165 million (euro104.63 million) to settle lawsuits brought by relatives of those killed in a 2000 plane crash in the Philippines, lawyers for the families said.

The families of about 100 of the 131 people killed in the crash sued the American companies that owned the plane and leased it to Air Philippines accusing them of providing a worn-out plane in need of constant maintenance that the airline was incapable or unwilling to do.

The case, filed in state court in Chicago, was scheduled for trial in September but was settled in late February by Air Philippines’ insurers, who negotiated on behalf of the plane’s suppliers. Neither the American companies, Air Philippines nor the insurers admitted responsibility.

Donald J. Nolan, whose Chicago law firm took the lead in the case, said the amount of the settlement will improve safety in developing countries, where carriers often buy aging aircraft no longer wanted by U.S. airlines.

Nolan said after legal fees of about one-third the award, families will get on average more than $1 million (euro630,000) each. The judge must still approve disbursements from a trust fund to individual families, which will receive varying awards.

The lawyer said Air Philippines offered families about $20,000 (euro12,682) each.

The Air Philippines Boeing 737 that crashed was made in 1978 and operated for 20 years by Southwest Airlines Co., which faces a $10.2 million (euro6.47 million) fine by U.S. regulators for flying 737s without making required inspections for cracks in the fuselages.

Lawyers said the plane had cracks and a faulty altimeter when it was delivered to Air Philippines, but they did not sue Southwest because it had no role in selling the jet to the foreign carrier.

The plane was purchased in 1998 by AAR Corp., an Illinois-based company that sells aircraft parts and leases planes to some of the world’s largest carriers. AAR leased the plane to Air Philippines and then sold the plane and the lease to Fleet Business Credit Corp., which is now a subsidiary of Bank of America Corp.

AAR “did some cosmetic work, didn’t do a (heavy-maintenance) ‘D’ check … and shipped it out to the Philippines,” said Gerald C. Sterns, an aviation lawyer in Oakland, Calif., who also represented some of the families. “They are in the business of providing cheap aircraft to lease.”

In 1999, AAR obtained an airworthiness certificate from the Federal Aviation Administration judging the planes sound enough to export to that country.

While on a commuter flight from Manila to Davao in the Philippines in April 2000, the plane crashed into the side of a hill as the pilot made a second attempt to land on the runway. All 124 passengers and seven crew members were killed.

A commission appointed by the president of the Philippines blamed the crash on pilot error and found no evidence of mechanical failure. But lawyers for the families said no one will ever know what caused the crash because parts of the mangled plane were dumped in a pit and buried in concrete before they could be examined by independent experts.

David P. Storch, the chairman and chief executive of AAR, said the burial of the plane probably played a role in the insurance companies’ decision to settle. “I believe they felt they had a problem with what the Philippines authorities had done with the aircraft,” he said.

But Storch defended his company’s overhaul of the plane and the lease to Air Philippines.

“We delivered a very good aircraft in good working condition to a very good airline,” he said. “Unfortunately, this aircraft had an accident because the pilot got in some clouds and got disoriented.”

Gary W. Westerberg, a lawyer for the London insurers, said his clients settled because of court rulings that AAR and Fleet controlled documents, witnesses and disposal of the wreckage. The companies also failed in an effort to try the lawsuits in the Philippines.

Nolan and Sterns said companies such as AAR that buy planes and lease them to foreign airlines will face higher insurance premiums as a result of the settlement.

But Storch, the AAR chief executive, said the settlement won’t have any financial impact on his company, which he said was indemnified for its costs by Air Philippines’ insurers. He also said the case will not deter AAR from leasing planes to customers that include British Airways, UAL Corp.’s United Airlines and Continental Airlines Inc.

“We have an impeccable safety record,” Storch said.

Families of victims in White Pass plane crash sue Cessna

The families of nine skydivers killed when their plane crashed in Washington’s Cascade range have filed suit against Cessna Aircraft Co., claiming the aircraft-maker knew the plane performed poorly in icy conditions.

The lawsuits were filed separately in U.S. District Court in Seattle. Relatives of Ralph Abdo, who died in the Oct. 19 crash with eight other passengers and the pilot, were the latest to file suit on March 6.

The lawsuits seek punitive damages and other damages in excess of $25 million, alleging wrongful death.

The skydivers were returning to Western Washington from a weekend trip in Idaho when the Cessna Caravan 208 crashed into thick timber about 45 miles west of Yakima near the Goat Rocks Wilderness Area. A hunter in the crash area reported seeing the low-flying plane and said the engine seemed to be whining loudly, followed by silence.

A cold front had just swept through the area near White Pass where the plane went down. The Federal Aviation Administration had warned in recent years that pilots should avoid flying the Cessna Caravan 208 in many icy conditions after receiving reports that pilots had difficulty maintaining altitude and control of the aircraft during such conditions.

Dean Brett, a lawyer representing the families, said they hope to see that the airplane is decertified from flying into icy conditions.

“The plane operates fine in good weather, but because of its design characteristics, it should not be flown in icing conditions and should not be certified to do so,” Brett said in a telephone interview Tuesday.

Brett’s firm has teamed with a Chicago firm, Nolan Law Group, which is handling several other lawsuits involving the aircraft. The cases have been consolidated and are in the discovery process in Kansas. Cessna is based in Wichita, Kan. Spokesman Doug Oliver said the company’s policy is not to comment on pending litigation.

A report on the crash has not yet been issued by the National Transportation Safety Board.

The plane was registered to Kapowsin Air Sports of Shelton, located near Olympia. The skydivers were affiliated with Skydive Snohomish, a company that operates a training school and skydiving flights at Harvey Field in Snohomish County, about 20 miles north of Seattle.

Killed in the crash with Abdo were Casey Craig, Hollie Rasberry, Michelle Barker, Landon Atkin, Jeff Ross, Cecil Elsner, Andrew Smith, Bryan Jones, and pilot Phil Kibler. All lived in Western Washington

FDA finds unidentified substance in Baxter’s blood-thinning drug heparin

A significant amount of an un-identified foreign substance contaminated Baxter International Inc.’s blood-thinning drug heparin, the U.S. Food and Drug Administration said Wednesday, raising the possibility of intentional tampering in a supply chain that begins with pig farms in China
.The mysterious substance, which has a chemical makeup similar to heparin, comprises as much as 20 percent of the active ingredient in nine suspect lots produced by Baxter since September, the FDA said Wednesday. The suspect lots are connected to at least four deaths reported nationwide since Baxter noted a spike in adverse reactions to the drug in late December.

The FDA on Wednesday said heparin is connected to as many as 19 deaths and 785 serious illnesses since

Jan. 1, 2007
Jan. 1, 2007

. But the FDA timeline extends well beyond the period from September to November, when Baxter’s Cherry Hill, N.J., plant produced the heparin connected to the recent rash of serious allergic reactions. The suspect active ingredient in heparin originated at a Changzhou, China, plant owned by Scientific Protein Laboratories, a Baxter supplier based in Waunakee, Wis.
“We don’t know whether the introduction of the contaminant was accidental, as part of the biological process, or if it was deliberate,” said Dr. Janet Woodcock, acting director of the FDA’s center for drug evaluation and research.
At least one former top FDA official who helped lead the fight against counterfeit drugs indicated that some Chinese suppliers in the past have introduced foreign substances to boost production when supplies are tight. That’s what happened in the early 1990s with an antibiotic known as gentamicin sulphate, which produced adverse reactions and some deaths in the U.S.
“The obvious question is, ‘Are these plants back-dooring their supply in order to supplement their capacity?'” asked Benjamin England, who chaired the FDA’s Counterfeit Drug Working Group before leaving for a private law practice in

Washington, D.C.
, in 2003.Epidemic in

China
China

Heparin is produced from an enzyme in the mucous lining of pig intestines. The suspect lots of heparin were made beginning in September, just after the peak in an epidemic of an often-fatal disease known as “blue ear” that afflicted more than 250,000 pigs throughout

China
. More than half those pigs died or were exterminated.An FDA official at the press conference said it is possible supplies of the adulterated ingredient came from pig intestines. But FDA officials emphasized they have not pinpointed the source.

Conventional quality and safety testing typically does not discover a foreign substance,

England
England

added, because the tests are not designed for that purpose.The FDA in its press conference Wednesday said conventional tests performed by Baxter and Scientific Protein did not show any variation because the contaminant is so similar to heparin.

“It acts like heparin in this test, so it looks like everything is fine in the test,” Woodcock said.

Only after further testing, using nuclear magnetic resonance spectroscopy, did the differences in chemical makeup become apparent, the FDA said.
Scientific Protein’s plant obtains heparin from bulk providers of raw material. From its plant in

Changzhou, Scientific Protein ships raw heparin to the company’s headquarters outside Madison, Wis., then on to Baxter’s Cherry Hill
Changzhou, Scientific Protein ships raw heparin to the company’s headquarters outside Madison, Wis., then on to Baxter’s Cherry Hill

plant for final processing, packaging and shipping.Pointing fingers

Baxter, in its own press conference, sought to point the investigative spotlight back to

China
China

. Baxter executives said the active pharmaceutical ingredient sourced from its China-based supplier is the focus of the company’s investigation.”Either the problem lies further back in the supply chain, somewhere before the material gets to the processing plant, or there’s something in the processing before it comes to Baxter,” said Peter Arduini, president of Baxter’s medication delivery business.

Arduini said the company’s

Cherry Hill
Cherry Hill

manufacturing plant, where multidose vials of heparin are finished and filled before shipment to hospitals and dialysis centers, recently passed an FDA inspection.Arduini said Baxter’s investigation centers further into the “supply stream” in

China
China

. There could be “process issues” associated with Scientific Protein’s Chinese manufacturing plant, he said.Baxter also took issue with the numbers provided by the FDA, which said heparin has played a role in 19 patient deaths since

Jan. 1, 2007
Jan. 1, 2007

. Baxter insists that four deaths so far may be connected to adverse reactions to the suspect heparin.For its part, Scientific Protein disagreed with the FDA’s interpretation of test results that seems to focus the investigation on a possible adulterated material being added during Scientific Protein’s production process.

“During the call with the media, FDA speculated that the source of the adverse events may be a contaminant,” Scientific Protein said in a statement. “It is important to note that this theory is speculation at this point, and [Scientific Protein] 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.”
Scientific Protein’s

Changzhou
Changzhou

plant, owned in a joint venture with a Chinese partner, is preparing a response to an FDA inspection report last week that criticized the plant’s record-keeping, reporting and processes. “It is important to emphasize that the root cause of the heparin adverse events has not been tied to any of the agency’s observations,” Scientific Protein said in a statement.FDA inspections

Dr. Andrew C. von Eschenbach, commissioner of the FDA, declined to say whether the FDA physically inspects the more than 700 Chinese facilities that ship pharmaceutical ingredients and drug products to the

U.S. The FDA has deployed a “risk-based” system that seeks to focus inspection on plants that might potentially cause the most harm to U.S.
U.S. The FDA has deployed a “risk-based” system that seeks to focus inspection on plants that might potentially cause the most harm to U.S.

consumers.Von Eschenbach said the agency is beginning to reallocate resources to better address the problems presented by the huge growth in foreign-made drugs. “We recognize that the number of sites that we must pay attention to that are beyond our borders are going to require us to address this systematically,” he said.

The FDA plans to increase the number of inspectors, base inspectors in key foreign cities, and build stronger working relationships with foreign regulators, Von Eschenbach added.

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.

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