May 14, 2008 — /PRNewswire/ — CHICAGO, IL — Last month a lawsuit was filed against Deerfield, IL-based Baxter International Inc. on behalf of Davenport, IA resident, Mark Scott who suffered the tragic loss of his wife, Melissa Scott, on Nov. 30, 2007. The complaint was filed on April 1, 2008 in the Circuit Court of Cook County by Nolan Law Group and alleges that Melissa Scott’s untimely death was caused by her exposure to heparin sodium injection therapy. The complaint cites two counts of product liability and negligence on the part of Baxter International.

The lawsuit filed by Nolan Law Group and Mark Scott asserts that Baxter International was responsible for the manufacture, sale, and distribution of a product containing toxic chemicals. It also claims that the product was manufactured with insufficient amounts of the active pharmaceutical ingredient (API) and that Baxter International failed to provide adequate warnings or instructions to assist users in identifying adverse reactions.

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.

It was around this same time that the Food & Drug Administration (FDA) issued its initial Public Health Advisory warning doctors and other health practitioners not to use Baxter heparin products. The report stated that serious injuries and deaths have been associated with the use of heparin. The adverse effects have included allergic or hypersensitivity-type reactions with symptoms such as low blood pressure, shortness of breath, nausea, vomiting, diarrhea, and abdominal pain and death.

Since the original complaint was filed, FDA has conducted a formal investigation in which they identified an unknown contaminant found in the Baxter heparin. In early April of 2008, researchers confirmed 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 that does not occur naturally during heparin production. Additionally, the FDA investigation revealed more information about inadequate testing and supply-chain issues associated with the Baxter heparin.

Raw heparin is often processed by small, unregistered “mom-and-pop” workshops in China. However, the key to establishing causation in the Scott 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 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.

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

Source: Nolan Law Group

May 15, 2008 — /FDA News/ — The U.S. Food and Drug Administration today announced the shut down of cream cheese and seafood operations at Lifeway Foods, Inc. and its subsidiary, LFI Enterprises, Inc., both Illinois companies, until they are found compliant with food-safety laws. A consent decree of permanent injunction, signed by both corporations and two of their top executives, Julie and Edward Smolyansky (the defendants), halts cream cheese and seafood processing in facilities in Skokie,
IL, and Philadelphia, PA.

The FDA’s enforcement action follows the defendants’ extensive history of violations of the Federal Food, Drug, and Cosmetic Act dating back to at least 2004. The complaint, filed by the U.S. Department of Justice, alleges that the
defendants:

• Labeled and distributed cream cheese products with inadequate labels, including labels that did not disclose major food allergens, trans fat levels, and complete ingredient lists.
• Processed and distributed products with seafood, including whitefish salad, ground nova salmon, and lox cream cheese and lox cream cheese spreads, without adequate Hazard Analysis and Critical Control Point (HACCP) plans to ensure the safe and sanitary processing of seafood containing products.
• Failed to document that they monitored sanitation conditions to keep food contact surfaces clean, to prevent cross-contamination from unsanitary objects, and to maintain hand washing, hand sanitizing, and toilet facilities.

“We simply can’t allow companies to put the public’s health at risk by not having adequate procedures and plans to produce safe food and proper labeling,” says Margaret O’K. Glavin, associate commissioner for regulatory affairs. “We will work to take action against companies and their executives that violate the law.”

Under the consent decree, operations may resume only after the FDA determines that the defendants have come into full compliance will all food-safety requirements. The consent decree requires the defendants to hire a seafood-processing expert to prepare a HACCP plan and to submit the plan to the FDA.

The HACCP violations pose a public health hazard because, without adequate controls, the defendants’ seafood products could foster dangerous bacteria, such as Vibrio species, Salmonella, Escherichia coli, Campylobacter jejuni, Staphylococcus aureus, and Listeria monocytogenes. Food products with these kinds of pathogens can cause serious illnesses for people who eat them. Further, foods sold with labels that do not disclose major food allergens and complete ingredient lists can cause severe or life-threatening allergic reactions in people who are allergic to the undisclosed allergens.

The decree does not include other products manufactured by Lifeway including kefir, Farmer’s cheese, and spreadable cheese products. The decree was signed by Judge Wayne R. Andersen on May 15, 2008, in the U.S.
District Court for the Northern District of Illinois.

Visit www.fda.gov

May 16, 2008 — /FDA News/ — The U.S. Food and Drug Administration (FDA) today announced that Scientific Laboratories Inc., and its president, Rajeshwari Patel, and chief executive officer, Amit Roy, have signed a Consent Decree of Permanent Injunction and are barred from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with law and obtain approval for their products.

Scientific Laboratories is a contract manufacturer and distributor of various prescription cough and cold products. The government’s complaint, filed by the U.S. Department of Justice, alleged violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The company failed to seek required FDA approval for some of its products and failed to comply with current Good Manufacturing Practice requirements (CGMP).

“The FDA will not allow a company to put the public’s health at risk,” says Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. “These unapproved new drugs have not undergone FDA review for safety and efficacy and may pose potential health risks.”

The unapproved new drugs manufactured and marketed by Scientific Laboratories as prescription cough and cold products include: B-Vex Suspension, Ben-Tann Suspension, D-Tann Suspension, D-Tann AT Suspension, D-Tann CT Suspension, D-Tann DM Suspension, D-Tann HC Suspension, Dur-Tann DM Suspension, Duratan DM Suspension, L-All 12 Suspension, Nazarin Liquid, and Nazarin HC Liquid. Because these drugs have not undergone FDA review nor received approval, their safety and effectiveness have not been established. Additionally, the FDA has not reviewed the adequacy and accuracy of the directions and warnings in their labeling.

The FDA had warned Scientific Laboratories against violating the FD&C Act and about the risk of enforcement action if it failed to take corrective measures. “The FDA will take action against companies and their executives who violate the law and endanger public health,” says Margaret O’K. Glavin, associate commissioner for Regulatory Affairs. “The FDA will carefully monitor the provisions of this injunction as well as investigate and take action against other marketers of unapproved drugs.”

The consent decree bars the defendants from manufacturing and distributing any drug until they obtain required FDA approval and fully comply with CGMP requirements. The defendants must destroy their illegal drugs. The consent decree also allows the FDA to order the defendants to shut down in the event of future violations. It also subjects the defendants to liquidated damages in the amount of $5,000 per day if they fail to comply with any of the provisions of the decree, and an additional sum of $5,000 for each violation, up to $1 million per year.

If patients have these products in their homes, they should discuss with their health care provider whether to discontinue use of the products and to find alternative therapy. Pharmacies should discontinue dispensing these products. In June 2006, the FDA issued a guidance document titled, “Marketed Unapproved Drugs

May 16, 2008 — /FDA News/ — The U.S. Food and Drug Administration today directed Hope Food Supply Inc., a Pasadena, TX, food processing company, to shut down and immediately recall all products manufactured from its Texas facility since 2007.

The company, under a different name, had manufactured dried smoked catfish steaks and other smoked seafood products and had been subject to a consent decree of permanent injunction requiring it to develop and implement an adequate Hazard Analysis and Critical Control Point (HACCP) plan for its fish and fishery products. The firm had not developed this plan. The company cannot restart manufacturing until they have implemented an FDA-approved HACCP plan.

“We simply will not allow a company to put the public’s health at risk by not implementing adequate procedures and plans to produce safe food,” says Margaret O’K. Glavin, associate commissioner for regulatory affairs. “The FDA will take action against companies and against their executives who violate the law and endanger public health.”

FDA’s HACCP regulations require that all seafood processors develop and implement adequate HACCP plans that identify all food safety hazards that are likely to occur for each kind of seafood product that they process, and set forth preventative measures to control those hazards.

The HACCP violations documented by the FDA pose a public health hazard because, without adequate controls, Hope Food Supply’s seafood products could harbor pathogenic bacteria such as Staphylococcus aureus and Listeria monocytogenes. Food products with these kinds of pathogens can cause serious illnesses in people who eat them.

The company’s products have been distributed nationwide. FDA is advising consumers who bought smoked seafood products to check with the place of purchase to determine if the products came from Hope Foods. If so, consumers should throw the products out by placing them in a trash receptacle.

Consumers who have been eating Hope Seafood Supply’s dried smoked catfish or other smoked seafood products and have experienced adverse reactions should consult their health care professional. Consumers and health care professionals can also report adverse events to the FDA consumer complaint coordinator in their geographic area. Contact numbers may be found online at www.fda.gov/opacom/backgrounders/complain.html.

For more information, consumers can call the FDA’s toll-free Food Safety Hotline at 1-888-SAFEFOOD.

Visit www.fda.gov

May 8, 2008 — /Prime Newswire/ — ALAMEDA, CA — Proton Laboratories Inc., a biotechnology company that develops practical uses for electrolyzed water, is pleased to announce that it has obtained positive testing results through application of its electrolyzed water on MRSA, ATCC 6538 (Methicillin-resistant Staphylococcus aureus).

The company has attained these results through the study sponsorship of Dr. Robert Lawrence, who requested Hill Top Research to conduct the efficacy test on MRSA, ATCC 6538. The summary of the result reads: “The test article was tested, in duplicate, as outlined in the protocol (three puffs of spray at a distance of 8 inches) with exposure periods of 1 and 2 minutes. Results showed that a greater than 99.98 percent (3.71 log(10)) reduction in numbers of the test bacteria was shown after 1 minute exposure to the test article and a greater than 99.99 percent (greater than 5.06 log(10)) reduction in numbers of the test bacteria was shown after 2 minutes exposure to the test article” (HTR Study No. 06-127661-106).

As noted in a separate press release, “Proton Laboratories Announces Its Proprietary Stabilization Properties for Its Anti-microbial Electrolyzed Water When Provided As An Off-The-Shelf Consumer Product,” as a first consumer product the company will contract in the fourth quarter of 2008, manufacturing of its anti-MRSA ATCC 6538 spray, which will allow a user to use the product on hard surfaces for the reduction to MRSA ATCC 6538 levels.

As noted in recent news coverages, MRSA ATCC 6538 is becoming a concern that has appeared in various health care areas such as in nursing homes and hospital environments. Of recent, MRSA has moved out of historically MRSA-prone areas to areas that are in common alignment with daily interactions such as school locker rooms and athletic surroundings.

Additionally, Proton’s spray product and electrolyzed water is a non-alcohol-based product that minimizes the concerns parents may have with accidental consumption of alcohol-based products. The use of this product will provide an optional medium in minimizing MRSA ATCC 6538 that is non-toxic, highly effective, and difficult for the microbe to develop an immunity against.

About Proton Laboratories Inc.
Based in Northern California, Proton Laboratories is a biotechnology company that develops new practical applications for electrolyzed water. The company alters the properties of water via electrolysis with electrolyte separation. Based upon proven technology, science, engineering, product design, and products that have been successfully developed by our Japanese counterparts, and further enhanced by Proton Laboratories, Proton Laboratories will expand the marvel of electrolyzed water throughout North America.

Visit www.protonlabs.com

May 12, 2008 — /PRNewswire/ — DUBLIN, OH — Cardinal Health, a global provider of products and services that improve the safety and productivity of health care, today announced it has completed the acquisition of assets of privately held Enturia, Inc., the manufacturer of infection prevention products sold under the ChloraPrep(R) brand name.

ChloraPrep(R) brand products are used widely in U.S. hospitals and surgery centers as a patient preoperative skin preparation to help prevent blood stream and surgical site infections, two of the most common types of health care associated infections (HAIs) among surgery patients. The products use proprietary disposable applicators to deliver a clinically preferred concentration of chlorhexidine gluconate (CHG) that penetrates the first five cell layers of the skin to help reduce skin-dwelling microorganisms that cause infections. The applicator design eliminates direct hand-to-patient contact, helping prevent cross contamination.

The ChloraPrep(R) product line expands the company’s offerings that help providers lower infection rates. Cardinal Health’s infection prevention portfolio ranges from MedMined(TM) electronic infection surveillance services to medical products and surgical apparel. Cardinal Health plans to accelerate sales of ChloraPrep(R) products to both hospital and alternate-care customers through its U.S. and international sales networks.

About Cardinal Health
Headquartered in Dublin, OH, Cardinal Health, Inc. is an $87 billion global company serving the health care industry with products and services that help hospitals, physician offices, and pharmacies reduce costs; improve safety, productivity, and profitability; and deliver better care to patients. With a focus on making supply chains more efficient, reducing hospital-acquired infections, and breaking the cycle of harmful medication errors, Cardinal Health develops market-leading technologies, including Alaris(R) IV pumps, Pyxis(R) automated dispensing systems, MedMined(TM) electronic infection surveillance service, VIASYS(R) respiratory care products and the CareFusion(TM) patient identification system. The company also manufactures medical and surgical products and is one of the largest distributors of pharmaceuticals and medical supplies worldwide. Ranked No. 19 on the Fortune 500, Cardinal Health employs more than 40,000 people on five continents.
Source: Cardinal Health, Inc.

Visit www.cardinalhealth.com

May 5, 2008 — /PRNewswire/ — DUBLIN, OH — A voluntary recall has been issued for an alcohol-free mouthwash manufactured by Hydrox, Inc. and labeled with the Cardinal Health brand name. Hydrox and Cardinal Health have initiated the voluntary recall of individual mouthwash bottles and those contained within Cardinal Health Presource(R) kits.

The mouthwash has been tested and been found positive for Burkholderia cepacia (B. cepacia). The Centers for Disease Control and Prevention (CDC) has confirmed the use of the affected mouthwash is associated with hospital illnesses in one state. The Food and Drug Administration (FDA) has been apprised of this action.

The product was distributed to hospitals, medical centers, and long-term care facilities nationwide. The product is not sold in retail stores.

B. cepacia poses little medical risk to healthy people. However, people who have certain health problems such as weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be more susceptible to infections with B. cepacia. B cepacia is a known cause of infections in hospitalized patients. B. cepacia bacteria are often resistant to common antibiotics. The effects of B. cepacia on people vary widely, ranging from no symptoms at all to serious respiratory infections, especially in patients with cystic fibrosis.

The recall includes the following product: Alcohol-Free Mouthwash, Cardinal Health Label, 4 oz. (reorder number AG-210).

Product lot 26228 is affected. Affected product can be identified by checking the lot code stamped on the bottom left side of the label.

Patients who have received Cardinal Health branded alcohol-free mouthwash from their health care provider are advised to check the reorder number and lot number on the label. Patients who have mouthwash with a reorder number of AG-210 and lot number of 26228 should stop using the product immediately.

As the nationwide distributor of this product, Cardinal Health is notifying customers via overnight mail and is arranging for all products to be returned for credit.

Presource customers with alcohol-free mouthwash in their kits should contact the sales operations group toll free at (800) 766-0706. Hospitals that have individual bottles of Cardinal Health labeled alcohol-free mouthwash should contact Cardinal Health Customer Service toll free at (800) 964-5227.

About Cardinal Health
Headquartered in Dublin, OH, Cardinal Health, Inc. is an $87 billion, global company serving the health-care industry with products and services that help hospitals, physician offices, and pharmacies reduce costs, improve safety, productivity and profitability, and deliver better care to patients. With a focus on making supply chains more efficient, reducing hospital-acquired infections and breaking the cycle of harmful medication errors, Cardinal Health develops market-leading technologies, including Alaris(R) IV pumps, Pyxis(R) automated dispensing systems, MedMined(TM) electronic infection surveillance service, VIASYS(R) respiratory care products, and the CareFusion(TM) patient identification system. The company also manufactures medical and surgical products and is one of the largest distributors of pharmaceuticals and medical supplies worldwide. Ranked No. 19 on the Fortune 500, Cardinal Health employs more than 40,000 people on five continents.

Visit www.cardinalhealth.com

May 6, 2008 — /PRNewswire/ HONG KONG — DuPont today announced it will soon begin construction on a research center in Hong Kong and a manufacturing facility in Shenzhen to support the rapidly growing photovoltaic (PV) solar energy industry.

“Through investments in materials, technology development, and manufacturing, DuPont is accelerating its ability to deliver innovations that will improve the lifetime and efficiency of photovoltaic modules, and also have enough production capability to help keep pace with the fast rising global demand,” says David B. Miller, group vice president, DuPont Electronic & Communication Technologies.

“DuPont is pleased and honored to be a part of this joint collaboration with Hong Kong and Shenzhen because we share a commitment to meet the needs for renewable energy as this region continues to grow,” says Douglas Muzyka, president, DuPont Greater China.

DuPont expects growth in the photovoltaic market to exceed 30 percent in each of the next several years. The company has made significant investments in product development and capacity expansions to help keep pace with the demand.

Accelerating its capability to meet emerging materials requirements is critical for DuPont, which has long been a leading supplier of materials primarily serving the crystalline silicon (c-Si) cell and module markets. The expansions in Hong Kong and Shenzhen will provide new offerings to serve the amorphous silicon (a-Si) thin-film market.

Thin-film technology is well-suited for large-scale utility applications such as “solar farms” and industrial installations. The growth rate for thin film is projected to be approximately twice as high as demand for c-Si, and DuPont expects this increase to drive specifications for both new and existing products that serve the thin-film industry. These include DuPont(TM) Butacite(R) PV sheet based on polyvinyl butyral (PVB), DuPont(TM) SentryGlas(R) PV sheet based on ionomer, and DuPont(TM) Elvax(R) ethylene vinyl acetate (EVA) that are offered as encapsulation materials for thin-film modules.

Significant further investment is planned for both a-Si and c-Si markets, including further capacity expansions for DuPont(TM) Tedlar(R) film and Solamet(R) thick-film metallization paste.

“The most important factor for continued rapid market growth is achieving continuous year-over-year cost reductions in installed photovoltaic system cost, and we will continue to invest in offerings that meet the needs of this market,” Miller says.

About DuPont
DuPont is a science-based products and services company. Founded in 1802, DuPont puts science to work by creating sustainable solutions essential to a better, safer, healthier life for people everywhere. Operating in more than 70 countries, DuPont offers a wide range of innovative products and services for markets including agriculture and food; building and construction; communications; and transportation.

Visit www.dupont.com

May 7, 2008 — /PRNewswire/ LYNDHURST, NJ — With its second acquisition in North America this year, Sika has added another long-respected player into its industrial flooring business in this region. The ICS Garland polymer flooring business, with its strong portfolio of epoxy, polyurethane, and ESD technology products, is an excellent fit for Sika’s focused growth strategy for North America. With an established, well respected range of products, people, and quality applicators, the ICS Garland polymer flooring business greatly enhances and complements Sika’s fast-growing position in this key market.

The parties have agreed not to disclose the sales price. Approximately 45 employees are expected to join Sika as part of the transaction, including the ICS Garland manufacturing facility and offices in Cleveland, Ohio.

Already a global leader in construction chemicals including adhesives and sealants, concrete admixtures, repair and strengthening products, this acquisition also creates for Sika the most comprehensive range of epoxy, polyurethane, and other key polymer flooring products and technologies in the industry. Sika is confident that the ICS Garland flooring business, when combined with Sika’s broad offering of sales and support services, will enable Sika to offer even greater value to its polymer flooring customers.

Sika Corp. is based in Lyndhurst, NJ.

About Sika Corporation Construction Products Division
Sika Corporation Construction Products Division, Lyndhurst NJ, is a technology leader with over 90 years of experience in concrete materials and restoration technology. Sika’s product line includes concrete admixtures, sealants, adhesives, corrosion inhibitors, specialty mortars, epoxy resins, structural strengthening systems, grouts, anchoring adhesives, overlays, and protective coatings. Full service sales and technical offices support our customers nationwide.

Visit www.sikaconstruction.com

About Sika Corp.
Sika Corp. is a supplier of specialty chemical products and industrial materials serving construction and industrial markets including transportation, marine, and automotive. Sika Corp. is a subsidiary of Sika AG, Baar, Switzerland. Sika has annual sales of approximately US $2.1 billion (CHF 2.9 billion), over 10,000 employees and operations in more than 70 countries.

Visit www.sikacorp.com

May 7, 2008 — KANSAS CITY, MO — Multivac completed the full market introduction of all models of its new thermoform machine generation at Europe’s Interpack trade exhibition. The worldwide market launch began in late 2007 with the high-speed Multivac R535 debuting at the Worldwide Food Expo in Chicago, IL. The seven-day Interpack show in D