After $500 Million Judgment, Teva Says It Will Stop Making The Anesthetic Propofol

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Posted on 29th May 2010 by gjohnson in Uncategorized

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Less than a month after a jury ordered Teva Pharmaceutical Industries to pay $360 million in a product liability/negligence case involving propofol, the drug giant said it will stop making the anesthetic. http://online.wsj.com/article/SB10001424052748704269204575270900368773506.html?KEYWORDS=Teva+and+propofol

In a statement to federal regulators last week, Teva announced it was stopping production of propofol, according to The Wall Street Journal. 

It’s no wonder that Teva is dropping the drug, which has been under fire by federal officials and consumers alike.

 Most recently, just earlier this month, Teva and Baxter Health Care Corp. lost a suit filed by a Nevada man who contracted hepatitis C  after undergoing a routine colonoscopy where he was anesthesized with propofol. 

 http://heparin-law.com/blog/2010/05/jury-orders-baxter-teva-to-pay-500-million-in-largest-award-in-nevada%e2%80%99s-history.html?preview=true&preview_id=528&preview_nonce=f654a8d83e

 In that case, a jury in Las Vegas awarded Henry Chanin and his wife half a billion dollars in punitive damages, the largest award in Nevada’s history. Teva was ordered to pay $356 million, while Baxter was hit for $144 million.

As many as 114 patients were infected with hepatitis C, when medical workers used single-dose vials of propofol on more than one patient, spreading the incurable disease to those undergoing colonoscopies. Chanin’s lawyer is representing 40 other patients who contracted hepatitis from the vials, and another 4,500 who were among 50,000 who got notices that they may have been exposed to hepatitis during their colonoscopies. 

Teva has had other problems with propofol. The pharmaceutical company had to recell some of the anesthetic last July when high levels of toxins wre found at its Irvine, Calif., plant. The Food and Drug Administration in a letter in December told Teva that it had found “significant” violations at that plant, according to The Journal.

In its statement last week saying it was ending its manufacturing of propofol, Teva said, “Our data supports that these products, when used and stored as directed, continue to be safe and effective and perform within the appropriate specifications.”

Propofol and a combination of other drugs were blamed for causing the death of singer Michael Jackson, who used the anesthetic to help him sleep.

Propofol is widely used for surgeries across the country, and federal officials have been worried that there might be a shortage of the anesthetic. So Teva’s news has federal regulators worried, despite the past problems the drug maker and the FDA have had over the drug.

  

 

 

Bagged Romaine Lettuce Recalled Over Possible Salmonella Contamination

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Posted on 25th May 2010 by gjohnson in Uncategorized

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Here’s the second romaine lettuce recall in about a week, this one involving salmonella.

Monday Fresh Express, a unit of Chiquita Brands International, recalled a variety of its Fresh Express Romaine-based ready-to-eat salads with the expired use-by dates of May 13 through May 16 and an “S” in the product code because they may be contaminated with salmonella. http://www.fda.gov/Safety/Recalls/ucm213247.htm

 There was just a romaine lettuce recall involving produce that had E. coli, Roughly 30 people got sick in that outbreak. 

The Fresh Express recall extends only to products with the specified Use-by Dates and product codes and sold in the following states: Michigan, Minnesota, Wisconsin, Louisiana, Nebraska, Montana, Missouri, Iowa, Kansas, Oklahoma, Arkansas, Nevada, Arizona, California, Colorado, New Mexico, Texas, Oregon, Washington, Alaska, Hawaii, Idaho, Utah, Wyoming, North Dakota and South Dakota.

No other Fresh Express salads are included in the recall.

“The recall notification is being issued out of an abundance of caution based on an isolated instance in which a single package of Fresh Express Hearts of Romaine Salad with a use by date of May 15 was confirmed positive for salmonella in a random sample test conducted by the U.S. Food and Drug Administration,” the press release on the recall said.

Salmonella is an organism that may cause fever, nausea, vomiting, abdominal pain and possibly bloody diarrhea in healthy individuals. It can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Because it is still possible that products bearing the Use-by Dates of May 13 to 16 and an “S” in the product code could be on store shelves, the recall extends to retailers as well as consumers.

 Fresh Express claimed it was ”highly unlikely” that any of the potentially affected salads are still on store shelves or for sale to consumers due to the expired Use-by Dates, but said it wants to alert consumers who might still possess one of the potentially affected expired salads to immediately dispose of it.

Fresh Express is cooperating with the FDA,  and after learning of  the single confirmed positive test ran and completed a companywide product traceability review.

 

Alfalfa Sprouts Recalled After Salmonella Outbreak In 10 States

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Posted on 23rd May 2010 by gjohnson in Uncategorized

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 Just about two weeks ago, Americans were at risk of being sickened by romaine lettuce with E. coli. Last week, raw alfalfa sprouts carrying salmonella were the health culprit. We can’t help but wonder why federal food regulators don’t seem capable of protecting U.S. consumers.

There was a nationwide recall of raw alfalfa sprouts after roughly 22 people in 10 states got ill from what is normally considered a very healthy food stuff. http://www.aolnews.com/nation/article/salmonella-outbreak-sickens-people-in-10-states/19487557irst

Caldwell Fresh Foods of Los Angeles Friday recalled the alfalfa that is sells under the brand names Caldwell Fresh Foods, Nature’s Choice and California Exotics.

Caldwell company officials said that alfalfa sprouts are controlled by the Food and Drug Administration, and that they had followed all that agency’s guidelines.

The recalled sprouts had been sent to restaurants, as well as being sold to grocery stores, such as Trader Joe’s and Wal-Mart.

 Of the 22 people who had symptoms of salmonella after eating alfalfa sprouts, six had to go the hospital. Cases were reported in California, Wisconsin, Nevada, Arizona, Oregon, Idaho, Illinois, Missouri, New Mexico and Colorado.  

 Those who contract salmonella typically suffer from abdominal pains, fever and diarrhea anywhere from 12 to 72 hours after being infected.

Alfalfa spouts can pick up bacteria because they are grown in a damp environment.    

Earlier this month, more than two dozen people got sick afte eating romaine lettuce contaminated with E. coli. That lettuce was recalled. 

Teva, Baxter Acted Out of Corporate Greed, Sparking The Biggest Recorded Hepatitis Outbreak In History

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Posted on 12th May 2010 by gjohnson in Uncategorized

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Last week a Las Vegas jury delivered the largest award ever, $500 million, in the state of Nevada’s history. That’s a very generous verdict, rendered – I think – because the panel believed that two giant drug companies valued their profits much more than the public’s safety.   http://www.lasvegassun.com/news/2010/may/07/jurors-reach-verdict-over-hepatitis-c-damages/

As I wrote in a blog yesterday, the judgment was awarded in a case where a man in his 60s went to a clinic in 2006 for what should have been a routine colonoscopy. He left with an incurable liver disease, hepatitis C.  

That man, Henry Chanin, and his wife Lorraine won $356 million in punitive damages from Teva Parenteral Medicines and $144 million from Baxter Health Care, the manufacturer and distributor, respectively, of the anesthetic propofol. Teva and Baxter plan to appeal the verdict.

The case raises many questions about corporate responsibility and safety.  Baxter is no strange to such questions. It faces a flood of lawsuits from survivors of people, estimated in the hundreds, who died after getting doses of contaminated heparin, a blood thinner, that was imported to the states from China in 2008. 

Last week’s $500 million verdict is only the beginning for Teva and Baxter. There are dozens of lawsuits stemming from the hepatitis C outbreak pending against the two pharmaceutical giants, but the Chanins’ case was the first to go to trial. After the award in their trial, if I was representing Teva and Baxter, I would advise them to settle those other lawsuits, pronto.  

Patients at several facilities, including the Desert Shadow Endoscopy Center, were exposed to HIV and hepatitis strains C and B when single-dose vials of propofol were used on multiple patients after the vials had been contaminated by nurses reusing syringes on the same patients.

During the opening statements in April for the four-week trial on the Chanins’ lawsuit, attorneys told the jury that Teva and Baxter’s negligent actions sparked the largest recorded hepatitis outbreak in history. http://www.lvrj.com/news/lawer-targets-drug-companies-in-hepatitis-case-opening-statements-91533874.html

 Henry Chanin’s lawyer, Robert Eglet, said that a company called SICOR Pharmaceuticals opted to sell propofol in 20 milliliter and 100-milliter vials in order to boost its production and profits. As a result, SICOR was sold at a premium price, $3.5 billion, to Teva in 2003.

 But there was a problem with the 50-millimeter vials: That large a dose was enough to knock out a 600-pound gorilla, an anesthesiologist testified at the trial. A human would only need to get 10 to 20 milliliters of the drug in order to undergo a colonoscopy.  http://www.lvrj.com/news/doctor-in-endoscopy-trial-testifies-vials-of-sedative-were-too-large-91684569.html

 Rather than throw out the leftover propofol in a vial, medical workers were tempted to re-use the single-use vials, which became contaminated when nurses reused syringes on the same patient.

 ”The pharmaceutical companies were responsible for providing 50 milliliter vials of propofol to ambulatory centers that would require no more than 10 milliliter to 20 milliliter bottles because profit dictated the decision to do so,” Eglet said in a statement after the jury’s verdict. “The larger size vials encouraged multi-dosing becoming weapons of mass infection.”

Teva and Baxter could have remedied the situation. Eglet pointed out that there were 148 reported cases of hepatitis C contamination throughout the U.S. and globally – all before Chanin contracted the disease – and yet Teva and Baxter didn’t take any action. If they had, Chanin would not have the chronic liver disease today. 

It was also unfortunate for those who became infected in Nevada because of “double-dipping” in those large vials.

 Teva and Baxter were acting out of greed, the public be damned. So many, many people because infected in Nevada, all because of nurses “double-dipping” in those large, cost-effective vials.

 Even though the $500 million award is a tidy sum, it’s almost a drop in the bucket to Teva and Baxter, which combined made $13.4 billion last year.

 “The $500 million verdict represents two weeks of income to these companies,” Eglet said. “The jury understood the importance of sending a message to stop putting profit over patient safety and making sure this never happens again.”

Jury Orders Baxter, Teva to Pay $500 Million In Largest Award in Nevada’s History

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Posted on 11th May 2010 by gjohnson in Uncategorized

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 Baxter Health Care Corp. and Teva Parenteral Medicines were asked to pay a mere $1.7 million to settle a lawsuit filed against them by a Nevada man who contracted hepatitis C after undergoing a routine colonoscopy. The two drug giants ignored the offer, according to Robert Eglet, the plaintiff’s attorney. http://www.lasvegassun.com/news/2010/may/07/jurors-reach-verdict-over-hepatitis-c-damages/

 Well, hindsight is 20/20, as they say. That’s because last Friday a Clark County District Court jury in Nevada awarded Henry Chanin and his wife a half a billion dollars in punitive damages. Teva was ordered to fork over $356 million and Baxter was hit for $144 million, a whopping $500 million total.

 That’s the largest award in Nevada’s history.

 The Chanins’ complaint against Teva and Baxter alleged product liability, negligence and disregard of known and accepted medical procedures, resulting in Henry Chanin contracting hepatitis C from exposure to contaminated vials of the anesthetic propofol. Baxter was the distributor and Teva the manufacturer of the drug.

 This hepatitis case isn’t the only litigation that Baxter has pending against it. The drug maker also faces a barrage of lawsuits stemming from hundreds of people dying after taking tainted heparin, the blood thinner, that had been imported from China in 2008.

 Both Baxter and Teva said they plan to appeal the $500 million jury verdict in Nevada, which stems from a hepatitis C outbreak two years ago.

 Patients were exposed to HIV and hepatitis strains C and B when single-dose vials of anesthesia medication, propofol, were used on multiple patients.  Nurse anesthetists were re-used syringes to withdraw medication from the single-dose vial, creating a back flow of blood resulting in contamination. http://www.lvrj.com/news/teva-plans-appeal-of-hepatitis-verdict-93223949.html

 Teva maintains that it has done nothing wrong.

 “Teva is reviewing the full judgment and continues to believe that the evidence shows the company acted responsibly,” the drug maker said in a statement.

 “The label for its propofol product clearly states that it is for single patient use only and that aseptic procedures should be used at all times. “ Teva said. “Further, the company believes that the Jury should have been allowed to hear all of the evidence in this case. Teva believes that the evidence clearly showed that if the plaintiff contracted hepatitis as alleged, it was because a properly labeled product was blatantly misused at the clinic in question. Teva believes that there are numerous grounds for appeal, and plans to contest the verdict vigorously.”

 Anywhere from nine to 114 patients were infected with the incurable disease. In addition to Chanin, Eglet represents 40 more patients who contracted hepatitis C and another 4,500 who were among the 50,000 people who had gotten colonoscopies at the Nevada clinic in question and were notified that they needed to be tested. Not the kind of message you ever want to get.

 Chanin’s story is particularly heartbreaking, which is perhaps why the Nevada jury was so generous. He is the headmaster of The Meadows School, a private school founded by Carolyn Goodman, wife of Las Vegas Mayor Oscar Goodman.

 Chanin went to the Desert Shadow Endoscopy Center in June 2006 for a colonoscopy, and in addition to having that routine procedure he contracted hepatitis C.

 During a four-week trial that started April 19, Chanin said that he and his wife had stopped having sexual relations, for fear that he would spread the disease to her.

 ”A $1.7 million offer of judgment to settle was ignored by the defense bringing the Chanin’s to this point,” Eglet said in a press release.

 “At the core of this case is the responsibility of the pharmaceutical companies as well as that of the health care professionals,” he said. “The conduct of the doctors and nurses demonstrated a disregard for human life in the reuse of contaminated vials and syringes. Equally, the pharmaceutical companies were responsible for providing 50 ml vials of propofol to ambulatory centers that would require no more than 10ml to 20 ml bottles because profit dictated the decision to do so. The larger size vials encouraged multi-dosing becoming weapons of mass infection. The result is nearly immeasurable.”

Before Friday’s verdict, Henry and his wife had already been awarded compensatory damages of $3.25 million and $1.85 million, respectively. 

I’ll be writing more about the details of this case, and the significance of the vial sizes, this week.

Chinese Drug Maker Untainted By 2008 Heparin Tragedy Makes Strong Financial Debut

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Posted on 7th May 2010 by gjohnson in Uncategorized

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The world’s largest supplier of heparin products, which is also the only Chinese heparin maker accredited by the Food and Drug Administration, has become a publicly traded company. It got off to such a strong start that its founders have become “overnight” multi-billionaires.  http://www.nytimes.com/2010/05/07/business/global/07drug.html?scp=2&sq=heparin&st=Search

If you believe the claims of Shenzen Hepalink Pharmaceutical, which started trading on the Shenzen stock exchange Thursday, it is one of the few good guys, one of the few Chinese heparin makers with its hands clean, in the tragedy in 2008 when contaminated heparin imported from China was linked to the deaths of hundreds in the United States.

Shenzen Hepalink claims that it not only has accreditation from the FDA, but also from the European Directorate for the Quality of Medicines and Healthcare.

Officials at Shenzen Hepalink underpriced their initial public offering, as the company’s shares jumped 18.3 percent from the opening price. That put the drug maker’s valuation at $10 billion, and made very rich men of its founders, Li Li and his wife Tan Li.

The New York Times Friday described Shenzen Hepalink’s main product as “highly purified heparin, a substance made from the mucous membranes of pig intestines.”  Heparin is a blood thinner. 

The Times suggested that the reason Shenzen Hepalink’s shares did so well their first day on the market was because the company was guiltless, and never cited, as one of the Chinese companies that provided contaminated heparin to the states. Tainted heparin from 12 Chinese companies was sent to nearly a dozen countries, according to The Times.   

The paper also pointed out that in China, “pig intestines are often cooked in unregulated family workshops.” In 2008, a contaminant called oversulfated chondroitin sulfate was in the tainted heparin, undetected by normal testing.

The Food and Drug Administration has said that there were 149 deaths caused by allergic reactions to the contaminated heparin, according to The Times.

That’s way below our estimate. We believe that hundreds of deaths can be linked to the tainted heparin, and there are hundreds of wrongful-death suits pending in the matter. 

 Here’s a side note to this story. Another investor that did very well with Shenzhen Hepalink’s IPO was beleaguered Goldman Sachs. It paid $4.9 million for a 12.5 percent share in the heparin company back in 2007. That stake is now worth 200 times what Goldman first paid for it, according to Bloomberg News.   

    

 

      

 

Lettuce Recalled In 23 States After E. Coli Outbreak

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Posted on 7th May 2010 by gjohnson in Uncategorized

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Here’s more evidence that we need stronger food safety laws: There has been a recall of E. coli-tainted  lettuce that was sold in 23 states and the District of Columbia. So far, 19 people have gotten ill, with three of them having “life-threatening symptoms.” http://www.google.com/hostednews/ap/article/ALeqM5hEnc00D5YgQjLxbZqLLkjOw_fwzgD9FI2MS01

Freshway Foods of Sidney, Ohio, issued the recall for the romaine lettuce it sold under the names Freshway and Imperial Sysco because it’s believed the lettuce is linked to the E. coli outbreak.

The Food and Drug Administration said Thursday that 12 people had to be hospitalized, and 10 other cases were being investigated by the Centers for Disease Control. College students at the University of Michigan in Ann Arbor, Ohio State in Columbus and Daemen College in Amherst, N.Y., were among those striken in the E. coli outbreak.  

 Sources told the Associated Press that the FDA suspects that the E. coli outbreak is being caused by lettuce grown in Arizona.  

Whether the problem is contaminated peanuts or lettuce, there needs to be stricter laws involving the safety of what we eat. The House did its part, when it passed a bill last year that gives the FDA more authority to monitor food production. However, the Senate has yet to act on that bill.

So in the meantime, people get sick and may even die because of this tainted lettuce, which was sold to wholesalers, food service outlets, salad bars and delis. The three who had life-threatening symptoms were suffering from hemolytic uremic syndrome, which can lead to bleeding in the kidney and brain.

One reason why the E. coli contaminating the lettuce may not have been detected is because it is E. coli 0145, not the most common strain of E. coli 0517. The strain on the lettuce is harder to detect, according to the CDC.

The first to discover the source of the E. coli outbreak was the New York Public Health Laboratory in Albany, which found the bacteria in a bag of Freshway Foods shredded romaine lettuce on Wednesday.    

 Perhaps this latest outbreak will prompt the Senate to act on the food-safety legislation that’s been sitting before it.  

Citing FDA ‘Missteps,’ Congressmen Want Answers To ‘Unsolved Heparin Whodunnit’

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Posted on 5th May 2010 by gjohnson in Uncategorized

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Last week The Wall Street Journal leaked the contents of a blistering letter that two congressmen wrote to the Food and Drug Administration over the agency’s handling of a probe into the exact source of contaminated heparin from China, deadly blood thinner that was linked to hundreds of deaths in 2008.

The House Energy and Commerce Committee Republicans put out a press release about the heparin matter last Friday. http://republicans.energycommerce.house.gov/news/PRArticle.aspx?NewsID=7832

And that press release includes a link to a copy of the letter.

U.S. Reps. Joe Barton, R-Texas, ranking member on the House Energy and Commerce Committee, and Michael Burgess, R-Texas, ranking member of the panel’s Oversight and Investigations subcommittee, didn’t mince words with FDA Commissioner Dr. Margaret Hamburg.

The headline on their press release alone was “Barton, Burgess Reveal FDA Missteps in Unsolved Heparin Whodunnit.”

Then in their 10-page letter, the two lawmakers detailed what their investigation into the heparin tragedy has discovered, basically accusing the FDA of dropping the ball when it didn’t follow up on leads linking Chongqing Imperial and other Chinese drug suppliers to lots of contaminated heparin identified during the 2008 recalls.

“We are very troubled by how FDA has handled the investigation to find out who was responsible for the contaminated heparin,” wrote Barton and Burgess. “The staff has learned that FDA has specific and credible information about certain Chinese heparin firms that warrants further investigation as suspect entities responsible for contaminating the heparin supply.”

Barton, an ardent watchdog on the heparin issue, and Burgess asked Hamburg to provide details about the agency’s strategy regarding the unresolved investigation. And they want to know the FDA plans to do when it identifies manufacturers responsible for producing the contaminated blood thinner.

“Unfortunately, the case of who contaminated the heparin remains unsolved,” the letters says of the tainted blood thinner that killed in 2008, resulting in hundreds of lawsuits.

Barton and Burgess want answers to seven questions from Hamburg by the end of May.

Those questions include:

1.    What is FDA’s strategy for solving the question of who caused the contamination of the heparin supply? Please detail the strategy and when it was developed, the names and positions of the FDA officials who developed the strategy, and the names and positions of the FDA officials responsible for implementing the strategy.

2.    To what extent can FDA conduct a traceability investigation of various heparin supply chains in China on its own without the assistance of the Chinese government?

3.    Assuming FDA could solve the case on its own, what would FDA do with this information?

4.    What actions is FDA taking to follow up on the Chongqing Imperial issues raised in this letter?

5.    Does the FDA agree there is a basis to make another request to the Chinese government about the heparin contamination investigation? If not, why not?

6.    Is the FDA willing to cooperate and even share information with the Chinese government in an effort to solve the heparin contamination case? Would FDA be able to do this under current law and under the current agreement with the SFDA (State Food and Drug Administration)? If not, why not?

7.    Does FDA agree that the contamination of the heparin supply is an international issue? If so, why hasn’t the FDA sought international support from the World Health Organization and/or other countries to get more transparency and cooperation from the Chinese government, or to provide assistance to the Chinese government, in the heparin contamination-source investigation?

 It looks like Hamburg has her work cut out for her in the next few weeks.