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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.