http://www.yourlawyer.com/topics/overview/baxter_dialysis_filter Sat, 21 Nov 2009 14:43:03 -0800 pixel-app en http://www.yourlawyer.com/articles/read/13717 Mon, 21 Jan 2008 00:00:00 -0800 http://www.yourlawyer.com/articles/read/13717 Heparin, and one death at a Florida hospital could be linked to the Baxter Heparin recall.  

According to the Baxter Heparin recall notice, a variety of reactions have been reported in relation to the recalled Heparin, including abdominal pain, abdominal pain (upper), decreased blood pressure, burning sensation, chest pain, diarrhea, dizziness, drug ineffectiveness, dyspepsia, dyspnea, erythema, flushing, headache, hyperhidrosis, hypoesthesia, hypotension, lacrimation increased, loss of consciousness, malaise, nausea, pallor, palpitations, paresthesia, paresthesia (oral), pharyngeal edema, restlessness, vomiting/retching, stomach discomfort, tachycardia, thirst, trismus, and unresponsiveness to stimuli.

Involved in the Baxter Heparin recall are nine lots of Heparin Sodium 1000 unit/mL for injection.   They include:

•    NDC# 0641244045, Lot #107054 , Heparin 1000units/mL 1OmLvial, expiration date 10/2009
•    NDC# 0641244045, Lot# 117085, Heparin 1000units/mL 1OmLvial, expiration date 11/2009;
•    NDC# 0641245045,  Lot# 047056, Heparin 1OOOunits/mL30mL vial, expiration date 10/2008
•    NDC#0641245045, Lot# 097081, Heparin 1OOOunits/mL30mL vial, expiration date  09/2009
•    NDC#0641245045, Lot# 107024, Heparin 1OOOunits/mL30mL vial, expiration date  10/2009
•    NDC# 0641245045, Lot# 107064 Heparin 1OOOunits/mL30mL vial, expiration date 10/2009
•    NDC# 0641245045, Lot# 107066 Heparin 1OOOunits/mL30mL vial,  expiration date 10/2009
•    NDC# 0641245045, Lot# 107074 Heparin 1OOOunits/mL30mL vial, expiration date  10/2009
•    NDC# 0641245045, Lot # 107111 Heparin 1OOOunits/mL30mL vial, expiration date 10/2009

This is not the first time that Baxter’s Heparin vials have caused problems.  The Food & Drug Administration (FDA), in collaboration with Baxter, issued a two-page safety alert in February 2007 warning of the fatal dangers of mistaking high 10,000 unit and low 10 unit dose vials of Heparin. The memo advised hospitals to double-check their inventory to ensure dispensing errors do not occur.  The 2007 alert was issued after three infants died in Indiana after they were mistakenly given adult doses.  In December, actor Dennis Quaid and his wife named Baxter in a lawsuit after their newborn twins were mistakenly given potentially fatal overdoses of heparin because of a vial mix up.  In addition to the Quaid twins, at least six newborns and two other patients are known to have received an overdose of heparin since 2001.

According to the Baxter recall notice, no deaths have been reported in connection with the recalled Heparin vials.  However, on Friday, a Florida TV station reported that one patient had died, and four others had suffered reactions that could be linked to the recalled Baxter Heparin. An official at HealthPark Medical Center in Lee County Florida told nbc2.com that they had removed all of the Baxter Heparin from the facility.  State and Federal authorities are investigating the incident, and according to the report, Baxter is expected to visit the facility this week to see if the patient’s death and the other reactions were linked to the recalled Heparin.  

]]> http://www.yourlawyer.com/articles/read/1413 Sun, 25 Aug 2002 00:00:00 -0700 http://www.yourlawyer.com/articles/read/1413
The US medical products maker said it had reached a settlement with most of the 21 patients' families, with the remainder to be settled in the coming days. That settlement means the Chicago based company has settled its significant cases in Croatia, Spain and the US - the locations of most of the estimated 55 deaths from dialysis.

Last November, the company agreed to pay Pta550m ($2.89m) to the families of 10 victims in Spain, and it said in July it had settled cases in Croatia and the US. The settlement value in Spain is thought to be a rough guide for the Croatian settlements, as Baxter has said it would attempt to treat all cases in an equitable manner.

Baxter started receiving reports of deaths of dialysis patients in Spain about a year ago, and subsequently withdrew some of its blood filters from the market there. A month later, Croatian health authorities reported at least 21 deaths of kidney patients.

Dialysis deaths connected to Baxter's products were also reported in Texas, Colombia and Taiwan.

Investigators found the deaths were connected to a filter used in the dialysis machines. Baxter recalled all the related filters worldwide and later took responsibility for the deaths after finding a solvent chemical used in manufacturing present in the filters.

The filters were manufactured in a Swedish plant, which Baxter closed. It took a $150m charge to cover costs for the incidents. ]]> http://www.yourlawyer.com/articles/read/104 Thu, 29 Nov 2001 00:00:00 -0800 http://www.yourlawyer.com/articles/read/104
The announcement came three weeks after Baxter said a processing fluid used in routine testing of blood filter products made at its manufacturing plant in Ronneby, Sweden, likely played a role in some kidney dialysis patient deaths in the United States and in several other countries. The chemical, used to test for leaks in the company's Althane blood filters, called dialyzers, was not fully removed prior to the products being shipped, and ended up in patients' bloodstreams.

The U.S. Food and Drug Administration and other health authorities, including the Spanish Health Ministry, have been investigating more than 50 deaths from this summer and fall linked to the Baxter filters or dialyzers. The deaths have occurred in Croatia, Spain, Taiwan, Colombia, Texas and Nebraska. All of the patients were using dialyzers, which help remove waste from the blood of patients with failed kidneys.

Last week, the Spanish government said it would take legal action against Baxter over 11 kidney patient deaths in Spain.

The families involved in the settlement have asked Spanish authorities to end a criminal investigation into the matter, said Baxter spokeswoman Sally Benjamin Young. She said as part of the nearly $3 million settlement, the families have agreed not to sue Baxter.

The Spanish health ministry's investigation into the deaths remains open. A ministry spokesman in Madrid said there's no connection between the Baxter deal and the investigation.

"We feel that the settlement each family reached with Baxter is fair and reasonable," Manuel Mata, an attorney who represents nine of the families in Spain, said in a released statement. "Baxter has treated the families with great respect during this unusually difficult time. The families are comforted in knowing that Baxter continues looking into the science surrounding these tragic events to ensure it will never happen again."

A negligence lawsuit filed against the company in Cook County Circuit Court in the death of Calvin Loverling, a New Jersey resident who died a day after undergoing dialysis on a Baxter machine, seeks class-action status.

Baxter hopes to reach settlements with other affected families, Young said.

"We have a very strong interest in working with all families who have been affected by these unfortunate circumstances and reaching a fair and respectful settlement," she said.

Baxter has stopped production of all three dialysis product lines made at its Ronneby plant and said it will permanently cease production of its Althane series dialyzers.

It has said it expects to take a charge of $100 million to $150 million in the fourth quarter to cover the cost of discontinuing the products and expected lawsuits by patients.]]> http://www.yourlawyer.com/articles/read/103 Wed, 28 Nov 2001 00:00:00 -0800 http://www.yourlawyer.com/articles/read/103
The announcement came three weeks after the company said it had identified a probable link between its Althane blood filters, or dialyzers, and certain patient deaths.

Each of the 10 families will receive 55 million pesetas, or about $289,000. Settlements in wrongful death cases in Spain usually range between 20 million and 60 million pesetas.

Baxter spokeswoman Sally Benjamin Young declined to comment on whether Baxter was considering settlements with other families of patients who died, but she said, "We have a strong interest in working with these families."

Analysts said they expect Deerfield, Illinois-based Baxter to settle all outstanding cases as soon as possible.

Bruce Cranna, an analyst with ABN Amro, said $289,000 per family "struck me as slightly low, but it varies by geography."

He added, "You can't use that figure to extrapolate domestic liability. They'll settle the U.S. cases for more than that."

Kenneth Moll, the Chicago-based attorney who filed the first lawsuit against Baxter two weeks ago, called the settlement "totally inadequate."

"It's not fair that the people in Spain should get such a minuscule amount," he said. "We want to treat each claimant the same around the world."

Moll said the cases should settle for $2 million to $15 million each, excluding punitive damages.

U.S. STILL INVESTIGATING DEATHS

U.S. health officials are investigating deaths linked to Baxter kidney dialysis filters in Germany, Croatia, Italy, Colombia, Taiwan and two U.S. states, Texas and Nebraska.

In a recent interview with Reuters, an official with the U.S. Food and Drug Administration said he believed Baxter's filters were linked to the deaths. The number of deaths is believed to be 51 to 53.

Earlier this month, Baxter determined that a fluid used in manufacturing the filters appeared to play a role in the deaths of more than 50 people, 11 of whom were in Spain. The dialyzers filter toxins from the blood of kidney patients.

At that time, Baxter said it had ceased production of the Althane dialyzers, recalled the product and closed production plants in Ronneby, Sweden, and Miami Lakes, Florida.

It also said it would take a fourth-quarter charge of up to $150 million to cover discontinuing the product line, legal expenses and all other related costs.

Baxter said it has not been contacted by anyone representing the 11th Spanish kidney patient who may have died as a result of treatment with the dialyzer.

The 10 families with whom the company reached a settlement have asked Spanish authorities to drop a criminal investigation into the matter, Baxter said.

"It was a fair agreement," a Spanish lawyer told Reuters.

But under Spanish law, a public investigation related to the suits could continue, lawyers said.

Baxter said it has not been served with a lawsuit filed by the Spanish government. It said the settlement does not preclude the government from pursuing legal action.

CROATIAN GOVERNMENT HAS NOT SUED

The Croatian government has not sued Baxter and has not indicated that it will, although Ana Stavljenic Rukavina, who stepped down as Croatia's health minister after the dialysis scandal, said she would file a private suit.

The Croatian government has offered to assist the families of the deceased by offering information and legal support.

"It is in the government's interest that each family finds the best solution, and it must be decided by (the families) and their lawyers," a Croatian government official told Reuters.

Benjamin Andrew, an analyst with William Blair & Co., said he did not expect Baxter to incur additional charges as a result of settlements with families, and he noted that settlements would probably be for smaller amounts in Croatia, where about 40 percent of the deaths occurred.

"This is not a bad number," ABN Amro's Cranna said of Baxter's settlement. "Investors don't like uncertainty. They always like to see the beginning of the end, and I think that's what we're seeing here."

Bucking the trend in the broader market, Baxter shares, were up 99 cents to $50.51, about 9.5 percent off their peak of $55.90 set in late September. ]]> http://www.yourlawyer.com/articles/read/101 Mon, 05 Nov 2001 00:00:00 -0800 http://www.yourlawyer.com/articles/read/101
Tests completed over the weekend point to a processing fluid used at a facility in Sweden during the manufacture of the disposable filters used during dialysis, Baxter International Inc. said in a written statement.

Further tests are being conducted on the filters, called dialyzers, the company said.

Health authorities have been investigating the deaths of more than 50 people who used Baxter dialyzers. Four of the fatalities deaths occurred in the United States -- two in Nebraska and two in Texas. The rest occurred in Europe.

The dialyzer functions as an artificial kidney. Blood waste particles are drawn into dialysis fluid through the dialyzer as the patient's blood moves through the dialysis machine.

Baxter, based in Deerfield, recalled three models of dialyzers last month. With the findings announced Monday, the company says it will permanently discontinue production of series A and AF dialyzers, even though Baxter said only about 10 percent of those models were manufactured at the Ronneby, Sweden, facility, using the faulty processing fluid.

"We are greatly saddened by the patient deaths, and I would like to extend my personal sympathies to family members of those patients," said Harry Jansen Kraemer Jr., Baxter's chairman and chief executive.

The company will take a fourth-quarter loss of up to $150 million, the release said, but it expects to meet sales growth predictions ]]> http://www.yourlawyer.com/articles/read/102 Sun, 02 Sep 2001 00:00:00 -0700 http://www.yourlawyer.com/articles/read/102
Baxter, based in the Chicago suburb of Deerfield, Illinois, said today it took the action as a precautionary measure.

Spanish authorities, confirming the recall, said the patients died in the cities of Valencia and Madrid.

The government of Valencia, which runs its own regional health service, is investigating the death of 11 patients at the Virgen el Consuelo hospital, including six this month.

Baxter recalled two batches of the Althane A-18 dialysers, one of the dialysis products used by the centre.

In Madrid, four other people are reported to have died after receiving kidney dialysis treatment, health officials said.

"The patients who died were receiving treatment with different dialysis products and equipment, and some of them were manufactured by Baxter," said Tanya Tyska, spokeswoman for Baxter, today.

"Initial studies conducted by Baxter have shown no malfunctioning of our products and have not revealed any evidence linking a Baxter product to the unfortunate death of these patients," Tyska said. "However, as a precautionary measure, we have instituted a voluntary recall of two batches of our A-18 dialysers."

In dialysis treatment, a person's blood is removed and returned after being filtered for toxic substances.

The government has ordered the Valencia hospital's dialysis department closed while the investigation continues and transferred some 70 patients for treatment at other centres.

So far, the families of two victims have said they plan to take legal action against the hospital.]]> http://www.yourlawyer.com/topics/overview/baxter_dialysis_filter Sun, 02 Sep 2001 00:00:00 -0700 http://www.yourlawyer.com/topics/overview/baxter_dialysis_filter Baxter Dialysis Filter On November 5, 2001 Baxter International Inc. said that its recalled dialysis filters appear to have played a role in recent patient deaths being investigated in several countries. As a result Baxter said it has idled two production plants and decided to discontinue the products in question. Expecting numerous lawsuits from patients' families, Baxter has set aside $100 million to $150 million for litigation and related expenses.

Baxter, recalled the filters in mid-October, said they believe that a chemical used in routine testing at its manufacturing plant in Ronneby, Sweden, may have played a role in many of the deaths. Previously Baxter International, based in Deerfield, Illinois, said it found nothing to indicate its products were at fault in the dialysis patients' deaths. The fluid, a chemical solution known as 5070, is used to test for leaks and somehow was not fully removed from all filters before being packaged and shipped and evidently entered patients' bloodstreams, officials indicated.

The U.S. Food and Drug Administration and other health authorities are investigating 51 deaths from this summer and fall, including 23 in Croatia last month, 15 in Spain, seven in Taiwan, two in Colombia and two each in Texas and Nebraska. All were using Baxter dialysis filters, or dialyzers, which help remove waste from the blood of patients with failed kidneys.

If you or a loved one suffered injuries from a Baxter Dialysis Filter, please fill out the form at the right for a free case evaluation by a qualified defective medical device attorney.]]>