On Monday, during an interview with The Associated Press, U.S. Health and Human Services Secretary, Mike Leavitt, represented that the heparin in the United States is now safe in light of tighter testing and controls. (5/12/08 Chicago Tribune Article: “U.S. Health Secretary: Chinese Heparin Now Safe.”) He discussed the additional guidelines regarding quality and safety that exporters must now meet. I hope he is right. I hope that after months of Americans dying from contaminated heparin, import alerts at the borders and proper testing, heparin and all drugs coming into the United States are now safe. (Although based on the evidence presented to the U.S. House Commerce Committee on Energy and Commerce at the April 29, 2008 hearing entitled, “The Heparin Disaster: Chinese Counterfeits and American Failures,” I doubt this is the case.) But what about what is on our shelves already?
Unfortunately, just a week ago, the FDA stepped up its heparin alert to hundreds of hospitals, medical societies and pharmaceutical organizations after learning that some medical facilities still had contaminated heparin among their supplies. (5/9/08 Wall Street Journal, “FDA Issues Update Heparin Alerts to Medical Facilities.”) The notice to the facilities read, "Please help FDA spread the word about recalls of injectable heparin products and heparin flush solutions that may be contaminated with oversulfated chondroitin sulfate (OSCS). Affected heparin products have been found in medical care facilities in one state since the recall announcement…Although product recall instructions were widely distributed, they may not have been fully acted upon at all sites where heparin is used.”
Indeed, many manufacturers and distributors of medical products containing or coated with heparin have only recently begun to identify and recall products containing the contaminant, as requested by the FDA last month. For example, on Monday, Atrium Medical Corporation recalled selected lots of HYDRAGLIDE™ Brand Heparin-Coated Thoracic Drainage Catheters that were manufactured with heparin that was contaminated with OSCS. Likewise, on May 7, 2008, Medtronic, Inc. recalled selected products with a “Carmeda BioActive surface” that were manufactured with heparin found to have been contaminated with OSCS. The affected devices are disposable products used during cardiopulmonary bypass (CPB) for heart surgeries. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs.
This delayed response is unfortunately consistent with the experience of our clients, some of whom we believe received recalled heparin after the date of recall, or who never received notice of the recall from their pharmacy or medical facility. Authorities must continue to focus not only on what is being imported, but what is already within our borders. A blanket promise of safety to the unsuspecting American public should only be made when it is certain that it is a promise that can be kept.

-Submitted by Pamela A. Borgess

Labels: Atrium, Baxter, Changzhou, China, Chinese, FDA, Heparin, Leavitt, Medtronic, OSCS, oversulfated chondroitin sulfate

A hearing today before the House Committee on Oversight and Government Reform will address the question of immunity for drug companies. The drug companies want complete protection from lawsuits even when they fail to properly manufacture, market or package their drugs.

But a formerFood and Drug Administration commissioner told Congress today that FDA approval of a drug or medical device shouldn't bar suits against the product's manufacturer, saying the agency's lack of resources diminishes its ability to detect emerging risks.

"Even if the FDA's funding were doubled or tripled, its resources and ability to detect emerging risks on the thousands of marketed drugs and devices would still be dwarfed" by the resources of drug companies, according to David Kessler, FDA commissioner from 1990 to February 1997.

The Bush administration has followed a two-pronged strategy for protecting big pharma. First, seek legal immunity in the Supreme Court for companies on the basis that the FDA's approval amounts to a "preemption" of the rights of individuals injured or killed by the defective drugs to purse claims under state laws.

Second, the Bush administration intentionally underfunds the FDA, thereby preventing it from performing its obligation of inspection and enforcement.

Actor Dennis Quaid also testified today. His six-month-old twins, Thomas Boone and Zoe Grace, were accidentally given adult-doses of the blood thinner heparin in November 2007 because the product looked similar to another drug used to flush IV lines. The overdose of heparin was potentially lethal, but Quaid's children fully recovered.

Quaid said in opening testimony that the similarity of heparin to Hep-Lock, a weaker blood thinner used to flush IV lines, also led to the deaths of three infants in Indianapolis in 2006. Both Hep-Lock and heparin are made by Baxter International Inc. (BAX).

Quaid sued Baxter in November 2007, and the Deerfield, Ill., company has moved to dismiss the case, relying on the preemption doctrine.

Quaid said a federal ban on lawsuits "would relieve drug companies of their responsibility to make products as safe as possible, and especially to correct drug problems when they are most often discovered - years after their drugs are on the market."

Quaid and the former FDA Commissioner are right. Both the FDA and the manufacturers have absolute non-delegable duties to insure our drugs are safe. The preemption doctrine significantly diminishes the safety of our drugs, permitting companies to hide behind the fallacy that FDA approval amounts to a guarantee of safety.

We have learned the hard way that the FDA does not and cannot protect us from defective drugs. Drug companies that fail to perform their duties should be held to the same standard as every other corporation or person in America, and required to make good the harm caused by their breach of duty.

You can watch the hearing on C-Span here: Hearing: Should FDA Drug and Medical Device Regulation Bar State Liability Claims?

Labels: David Kessler, Dennis Quaid, FDA, Heparin Class Action, House Committee on Oversight and Government Reform, preemption

Most of the Heparin cases have been either filed in or removed to federal court. The federal court system has jurisdiction over the cases because of diversity of citizenship between the Plaintiffs and Defendants.

A motion has been filed to consolidate all of the federal cases into a single case for purposes of discovery and related proceedings. This motion will be heard on May 29, 2008 before a special panel of federal judges who will sit in Asheville, North Carolina.

The Judicial Panel on Multi-District Litigation ("MDL") has two issues to decide. First, they must decide if the cases should all be consolidated. It is highly probably that they will agree that the cases should be consolidated. In fact no one has opposed the motion to consolidate so far.

The second issue for the Panel to decide is to which District the cases should be sent. So far there have been a number of options presented to the panel. Baxter and SPL have argued that the cases should be decided in the home districts of Baxter, namely, New Jersey or Illinois. We have argued that the cases should be sent to the Northern District of Ohio. At the hearing I will present the argument for Ohio while other attorneys will request the panel to send the cases to Pennsylvania, Florida or Puerto Rico.

I expect that the panel will act quickly on this matter. I do believe there is a fair chance that the cases will be sent to our district.

Once the cases are assigned to a particular judge the parties will begin the discovery process. This involves obtaining copies of all relevant documents and taking the depositions of the Baxter and SPL employees and officers, as well as experts in the relevant fields of specialty.

Other MDL's have resulted in settlements. For example, we have recently worked on the Vioxx and Sulzer Hip MDLs which resulted in negotiation of a universal settlement. At this stage, though, the primary goal is to lock in the liability of SPL and Baxter for this tragedy. Once the evidence has established their irrevocable responsibility we can start to focus on the other issues.

Labels: Heparin Class Action, MDL

One of the key issues in the Heparin Disaster litigation is whether Baxter and SPL should have taken reasonable steps to insure the safety and purity of the raw materials used in the finished heparin product.

We now know that a test called NMR Spectroscopy can easily distinguish over sufated chondroitin sulfate ("OSCS") contaminated heparin from the real thing. So what is NMR Spectroscopy?

According to Wikipedia:

Nuclear magnetic resonance spectroscopy, most commonly known as NMR, is the name given to a technique which exploits the magnetic properties of certain nuclei. This phenomenon and its origins are detailed in a separate section on nuclear magnetic resonance. The most important applications for the organic chemist are proton NMR and carbon-13 NMR spectroscopy. In principle, NMR is applicable to any nucleus possessing spin.

Many types of information can be obtained from an NMR spectrum. Much like using infrared spectroscopy to identify functional groups, analysis of a 1D NMR spectrum provides information on the number and type of chemical entities in a molecule.

The impact of NMR spectroscopy on the natural sciences has been substantial. It can, among other things, be used to study mixtures of analytes, to understand dynamic effects such as change in temperature and reaction mechanisms, and is an invaluable tool in understanding protein and nucleic acid structure and function. It can be applied to a wide variety of samples, both in the solution and the solid state.

Over the past 50 years NMR has become the preeminent technique for analysis of organic compounds. Here is a very good explanation (with pictures!) as to how NMR works from an undergraduate level course in Organic Chemistry at Michigan State University:

NMR Spectroscopy

While the science and theory maybe complex to a layman, NMR has been around a long time and is a very common analysis method taught at the undergraduate level. We intend to find out from Baxter and SPL why they failed to use this common test method in the analysis of raw materials from unknown sources before inclusion in such an important and sensitive product as heparin.

We continue to investigate cases from patients or their families around the country who have been killed or injured by this counterfeit product.

Labels: Heparin Class Action, NMR, nuclear magnetic resonance spectroscopy, OSCS, over sulfated chondroitin sulfate

Baxter held its annual meeting yesterday in Chicago. According to press reports:

Although the hourlong meeting focused on Baxter's record sales last year and rising share price, about 15 minutes was devoted to the heparin imbroglio. One investor wondered whether Baxter has taken steps to "close the loopholes" in its supply chain to make sure such a situation did not happen again.

Parkinson acknowledged "challenges associated with managing the supply chain," but that Baxter and other companies were making changes for the better.

Parkinson said Baxter and other companies get heparin's raw ingredient from China because "that's where the pig population is," adding that the Chinese supply of hogs is five times larger than in the U.S.

Well it wasn't the Chinese pigs that added oversulphated chondroitin sulphate (OSCS) to their intestines. It was someone looking to substitue a counterfeit product that was 100 times cheaper than Chinese raw heparan made from pig intestines. Someplace between the workshop that received the raw intestines and the bottling of the finished heparin, someone substituted counterfeit OSCS.

We have obtained a translated copy of a Chinese patent for the manufacture of OSCS. The Chinese patent was filed December 20, 2005 by Shandong University in Shandong China. This patent claims that OSCS can be cheaply manufactured using the claimed technique and the resulting OSCS product "has anticoagulant activity of 10 IU/mg," "anti-inflammatory and pain killing activity," and "inhibits tumor growth and metastasis."

It doesn't take a great leap of imagination to figure out that this or a similar product might be used as a substitute for heparin, particularly when disease in China had caused a sharp increase in the price of the raw product.

I commend the responsible Baxter shareholders who are challenging their company to act responsibly and "close the loopholes" that let this counterfeit product into the Baxter products.

All manufacturers of food and drug products owe a non-delegable duty to the consumers to insure the safety of their products, even if this means they have to use only those raw materials that can be securely monitored.

Labels: annual meeting, Baxter, Heparin Class Action, SPL

The director of China's "FDA" told a press conference that Baxter had failed to cooperate with Chinese experts sent to the U.S. to investigate the Heparin Disaster. The director, Jin Shauhong, also claimed that there was no "confirmed" link between the Over Sulfated Chondroitin Sulfate ("OSCS") and the deaths of patients in the United States.

Chinese representatives claimed that Baxter and the FDA failed to provide them with medical records, medical histories, and information on Baxter's manufacturing practices. The Chinese also complained that they had not been given samples of the contaminated product. Baxter now says it will give the Chinese samples of the product to test.

The FDA tried to inspect the Changzhou Techpool Pharmaceutical Co. ("CZTP") in Changzhou, China on February 27, 28 and 29, 2008. This company supplied SPL Changzhou with raw heparin and may have been a source for the contaminant.

During those inspections the FDA was accompanied by a representative of the U.S. Embassy from Beijing. This facility was NOT regulated by the Chinese because it did not sell any product within China. Instead its products were all made for export; therefore neither the Chinese nor the FDA inspected this plant.

Changzhou SPL, a defendant in the cases we have filed, owns 45% of CZTP. During the FDA inspection CZTP refused to provide the FDA with records for review.

Now the Chinese are complaining that U.S. companies are not cooperating with them in their investigation. What a surprise.

This illustrates a number of critical shortcomings in our drug system. First, as admitted by the FDA last week, the FDA is woefully underfunded and unable to inspect foreign manufacturers. Second, the manufacturers themselves cannot be relied upon to self-regulate their suppliers. Third, China and the United States have been unable to cooperate with each other to insure that good manufacturing practices are followed throughout the chain.

The only regulation that is truly reliable is that obtained by our common law. Companies that fail to insure the safety of ingredients in their products must be held strictly accountable for all injuries and deaths they cause. They must be held strictly accountable.

SPL used to be called Oscar Mayer. It used the small intestines of American grown hogs to make the raw heparin. There was no adulteration by counterfeit heparin because Oscar Mayer was an American company with a reputation to protect and a business to run. It would be unthinkable.

Yet somewhere along the way, through free trade agreements, the drive for ever higher shareholder return, corporate profits, deregulation, and business - friendly agencies we have lost our way. As we go through the documents and take the depositions of these corporate officers we are going to learn a lot more. And it isn't going to be a pretty picture.

By the way, if the Chinese are really worried about the relationship between the counterfeit heparin and the injuries and deaths, I suggest they read the recent article in the New England Journal of Medicine. We have a link to it on our web site. Maybe we should translate it into Mandarin.

Labels: Baxter, Changzhou, China, Heparin Class Action

• Oral swelling


• Abdominal pain


• Burning sensation


• Chest pain


• Diarrhea


• Dizziness


• Drug ineffectiveness


• Painful, difficult, or disturbed digestion


• Dyspnea [unpleasant or uncomfortable breathing]


• Erythema [redness of the skin]


• Flushing


• Headache


• Hyperhidrosis [excessive sweating]


• Hypoesthesia [reduced sense of touch or sensation]


• Increased lacrimation [production, secretion, and shedding of tears]


• Loss of consciousness


• Malaise [general discomfort or uneasiness]


• Nausea


• Pallor


• Palpitations


• Paresthesia [tingling, pricking, or numbness of a person's skin]


• Pharyngeal edema [swelling in throat]


• Restlessness


• Vomiting/retching


• Shortness of breath


• Stomach discomfort


• Tachycardia [rapid beating of the heart]


• Thirst


• Trismus [Inability to open the mouth fully]


• Unresponsiveness to stimuli


• Severe hypotension [abnormally low blood pressure]

Labels: Heparin Class Action