Feds, states split $25M in settlement

WASHINGTON (Legal Newsline) - The U.S. Justice Department announced on Friday that a Danish pharmaceutical manufacturer will pay $25 million to resolve its civil liability arising from the allegedly illegal promotion of its hemostasis management drug.
The Food and Drug Administration approved Novo Nordisk's hemostasis management drug NovoSeven to treat certain bleeding disorders in hemophiliacs. After FDA approval, a manufacturer may not market or promote a drug for uses not specified in its new drug application or for uses not approved by the FDA. Unapproved uses are known as "off-label" uses.
Novo Nordisk's U.S. subsidiary, which is located in Princeton, N.J., allegedly promoted NovoSeven to healthcare professionals for off-label uses, including as a coagulatory agent for trauma patients, general surgery, cardiac surgery, liver surgery, liver transplants and intra-cerebral hemorrhage.
False claims were submitted to government healthcare programs that were not reimbursable because of Novo Nordisk's unlawful promotion, it was alleged. The federal share of the civil settlement is $21,425,790.59. The state Medicaid share of the civil settlement is $3,574,209.41.
"Health care patients should be able to trust that their prescription drugs are safe, effective and prescribed only for FDA approved uses," Maine Attorney General William Schneider said. "These off-label promotions waste Maine taxpayer dollars and we will seek recovery from pharmaceutical companies for this kind of healthcare fraud."
The settlement resolves a a whistleblower lawsuit filed under the qui tam or whistleblower provisions of the False Claims Act that is pending in the District of Maryland. Under terms of the resolution, the whistleblowers are set to receive more than $3.5 million from the federal share of the civil recovery.
Novo Nordisk also agreed to enter into an expansive corporate integrity agreement with the Office of the Inspector General of the Department of Health and Human Services as part of the settlement. That agreement creates procedures and reviews meant to avoid and promptly detect similar conduct in the future.

Jury Rules Against Baxter In Contaminated Chinese Heparin Case - "The Cheap Stuff"

An Illinois jury on Thursday awarded $625,000 to the estate of a Chicago-area man who was administered a blood-thinning drug that contained a contaminated ingredient medical-products company Baxter International Inc. (BAX) manufactured in China.
It was the first of hundreds of pending lawsuits against Baxter to go to trial.
The cases are related to a 2008 finding by the Food and Drug Administration, which discovered a link between contaminated heparin marketed by Baxter to Chinese suppliers of the active ingredient used in heparin. In the U.S., the contaminated heparin was linked to dozens of deaths and hundreds of allergic reactions.
Plaintiffs contended 63-year-old Steve Johansen received low doses of contaminated heparin during dialysis and a bolus dose during a subsequent hospitalization at Palos Community Hospital in late 2007.
The active pharmaceutical ingredient in the contaminated heparin received by Mr. Johansen and other Americans was obtained from Baxter/SPL's Chinese supplier, Changzhou SPL (a joint venture with SPL).  This crude heparin was referred to in the companies' own internal records as "the cheap stuff."  Baxter and SPL knew that the plant had never been inspected by the U.S. FDA (which the FDA later attributed to clerical error) or Chinese regulatory officials.  When the Chinese plant was finally inspected by the FDA after the heparin contamination crisis, multiple violations were found resulting in an import ban.  Additional evidence also brought to light during the trial established that Baxter and SPL failed to establish and comport with quality/purity specifications, including an impurity profile, and failed to trace and control their supply chain.  At trial, the Court granted partial directed verdict in favor of Mr. Johansen holding that the product sold by Baxter and SPL was defective as a matter of law.

According to the verdict, the award of compensation was for pain and suffering and was found against Baxter and the Chinese supplier, Scientific Protein Laboratories LLC.
Baxter spokeswoman Deborah Spak said the company is taking responsibility for legitimate cases of harm related to the contamination seriously, adding that Baxter will "vigorously defend claims that are not consistent with the definition established by public health authorities."
Baxter's therapies treat serious medical problems such as cancer, immune disorders and trauma. The company is coming off a challenging year due to economic weakness, costs pegged to the U.S. health-care overhaul and some product-quality and regulatory challenges.

Impact of Bleeding-related Complications and/or Blood Product Transfusions on Hospital Costs in Inpatient Surgical Patients

Inadequate surgical hemostasis may lead to transfusion and/or other bleeding-related complications. This study examines the incidence and costs of bleeding-related complications and/or blood product transfusions occurring as a consequence of surgery in various inpatient surgical cohorts. 
Methods: A retrospective analysis was conducted using Premier's Perspective hospital database.
Patients who had an inpatient procedure within a specialty of interest (cardiac, vascular, non-cardiac thoracic, solid organ, general, reproductive organ, knee/hip replacement, or spinal surgery) during 2006-2007 were identified. For each specialty, the rate of bleeding-related complications (including bleeding event, intervention to control for bleeding, and blood product transfusions) was examined, and hospital costs and length of stay (LOS) were compared between surgeries with and without bleeding-related complications.
Incremental costs and ratios of average total hospital costs for patients with bleeding-related complications vs. those without complications were estimated using ordinary least squares (OLS) regression, adjusting for demographics, hospital characteristics, and other baseline characteristics.
Models using generalized estimating equations (GEE) were also used to measure the impact of bleeding-related complications on costs while accounting for the effects related to the clustering of patients receiving care from the same hospitals. 

Results: A total of 103,829 cardiac, 216,199 vascular, 142,562 non-cardiac thoracic, 45,687 solid organ, 362,512 general, 384,132 reproductive organ, 246,815 knee/hip replacement, and 107,187 spinal surgeries were identified. Overall, the rate of bleeding-related complications was 29.9% and ranged from 7.5% to 47.4% for general reproductive organ and cardiac, respectively.

Overall, incremental LOS associated with bleeding-related complications or transfusions (unadjusted for covariates) was 6.0 days and ranged from 1.3 to 9.6 days for knee/hip replacement and non-cardiac thoracic, respectively. The incremental cost per hospitalization associated with bleeding-related complications and adjusted for covariates was highest for spinal surgery ($17,279) followed by vascular ($15,123), solid organ ($13,210), non-cardiac thoracic ($13,473), cardiac ($10,279), general ($4,354), knee/hip replacement ($3,005), and reproductive organ ($2,805). 

Conclusions: This study characterizes the increased hospital LOS and cost associated with bleeding-related complications and/or transfusions occurring as a consequence of surgery, and supports implementation of blood-conservation strategies.

In-vitro hemostasis test platform

An interesting new idea from Covidien could relieve the need for animal testing, while the pig and rats are used in most western countries, in China the animal of choice are dogs and rabbits. Regardless it is an interesting concept with other potential applications.

This paper appears in: Bioengineering Conference (NEBEC), 2011 IEEE 37th Annual Northeast 
Issue Date: 1-3 April 2011 
On page(s): 1 - 2 
Location: Troy, NY, USA 
ISSN: 2160-7001 
Print ISBN: 978-1-61284-827-3 
Digital Object Identifier: 10.1109/NEBC.2011.5778553  
Date of Current Version: 27 May 2011 

ABSTRACT

To avoid unnecessary preclinical testing of Covidien's hemostatic agent patch product, a test platform is needed to test the “time-to-hemostasis” of blood using the patch. The test platform needs to utilize in vitro testing, providing an alternative to in vivo testing. Understanding how “time-to-hemostasis” is affected by Covidien's various products will help surgeons prevent unnecessary bleeding when performing surgery, aid doctors healing large wounds from military events or other accidents, and will be useful in many other ways to prevent bleeding out that could fatally harm the patient. In order to stop the use of animal testing for this product, Covidien would like to have a bench-top in vitro testing device for their products. This device must be able to accurately simulate blood flow through a wound site, as well as simulate the hemostasis process of closing the wound through blood clotting. Important features of the finished device include accurate simulation of blood flow through a wounded tissue, accurately measure the time-to-hemostasis, and the ability to test multiple types of hemostat products efficiently. The device will provide Covidien with an in-house alternative to in vivo testing, saving time and expenditure when testing hemostats.

Perclot Vs. Haemocer

Small wonder! 

Surgical sealant co Lifebond raises $20m

Published by Globes [online], Israel business news - Biological surgical sealant developer Lifebond Ltd. has raised $20 million.Giza Venture Capital and Aurum Ventures MKI Ltd., the venture capital arm of Morris Kahn, led the round, and were joined by current investors Pitango Venture Capital, GlenRock Israel, Zitelman Group Inc., and Robert Taub, the founder and CEO of Omrix Pharmaceuticals, which he sold to Johnson & Johnson (NYSE: JNJ) for $425 million in 2008.
Lifebond co-founder and CEO Issay Attar told "Globes", "When the current investors are excited about a company, it's a lot easier to hold another financing round."
Lifebond was named one of Israel's most promising start-ups for 2010 by "Globes".
Lifebond's flagship product is a surgical sealant for tissue after surgery to shorten the bowel. The product is undergoing a Phase I clinical trial in Brazil, and is due to begin a larger trial in Europe later this year.
"Globes": The clinical trial you're planning costs less than $20 million.
Attar: "It's always a good idea to raise a lot of money in the life sciences, if possible. This amount will be enough for us to complete an US Food and Drug Administration (FDA) trial, which we'll conduct after the European trial.
"I believe that an investment of this size by Israeli venture capital funds at this stage was made possible because the company achieved good clinical results in the Brazilian trial, and because the difference between animals and people for a product like this is not great. Therefore, the risk-reward profile is attractive."
As for raising capital only from Israeli funds, Attar said, "We also spoke with foreign funds, but it's easier to talk with someone in your own language, and we gave them preference. Obviously, foreign funds have advantages and I hope to work with them later."
Lifebond is also developing the LifePatch, a biological hemostats to stop bleeding, and a product for hernias, both of which are just beginning clinical trials.

Dural repair with four spinal sealants: focused review of the manufacturers' inserts and the current literature.

Abstract

BACKGROUND CONTEXT:

Deliberate or traumatic dural fistulas are typically augmented by a "sealant" or "fibrin glue" to enhance the strength of dural closure.

PURPOSE:

Little is known about the risks and complications associated with two specific "sealants" and two specific "fibrin glues" used for dural closure.

STUDY DESIGN/SETTING:

Review of the manufacturers' inserts and a focused review of the literature concerning the pros and cons for two "sealants" (DuraSeal [Confluent Surgical Inc., Waltham, MA, USA] and BioGlue [Cryolife, Kennesaw, GA, USA]) and two "fibrin glues" (EVICEL [Johnson and Johnson Wound Management, Ethicon Inc., Somerville, NJ, USA] and Tisseel [fibrin sealant; Baxter International Inc., Westlake Village, CA, USA]) were assessed.

PATIENT SAMPLE:

A focused review of the literature using four different "sealants" or "fibrin glues" was performed.

OUTCOME MEASURES:

Documentation of persistent/recurrent postoperative cerebrospinal fluid fistulas was an end point for failure for the four different "sealants" and "fibrin glues."

METHODS:

Manufacturers' inserts and a focused review of the literature concerning the relative safety and efficacy of two "sealants" (DuraSeal and BioGlue) and two "fibrin glues" (EVICEL and Tisseel) used to augment dural closure were assessed.

RESULTS:

Although DuraSeal is approved by the Federal Drug Administration (FDA) for intracranial and spinal application, two instances of paralysis are described in the literature. BioGlue is classified by the manufacturer as neurotoxic. EVICEL, one of the "fibrin glues," appeared in just two animal studies, whereas Tisseel, the other "fibrin glue," has been used in many large clinical series without adverse events.

CONCLUSION:

Despite the lack of FDA approval, Tisseel (fibrin glue) has seen wide adoption in "off-label" use. DuraSeal, which is FDA approved, was associated with two instances of paralysis. Alternatively, BioGlue was described as neurotoxic even by the manufacturer.

Stryker Announces Definitive Agreement to Acquire Orthovita, Inc. for $3.85 Per Share in Cash

Kalamazoo, Michigan - May 16, 2011- Stryker Corporation (NYSE:SYK) announced today a definitive agreement to acquire Orthovita, Inc. (Nasdaq:VITA), a global developer and manufacturer of orthobiologic and biosurgery products through an all cash tender offer. Orthovita competes in the $5 billion orthobiologics market and is a global leader in synthetic bone grafts with its Vitoss(TM) product offering, and also competes in vertebral augmentation with its Cortoss(TM) product offering. In addition, the company's Biosurgery business manufactures hemostasis products such as Vitagel(TM) which are designed to control intra-operative and post-operative bleeding. Combined, Orthovita's product portfolio achieved sales of $95 million in 2010. The acquisition of Orthovita is highly complementary to Stryker's existing orthobiologics offering, which is currently sold through multiple Stryker divisions.
Under the terms of the agreement, Orthovita shareholders will receive $3.85 for each outstanding Orthovita share of common stock. The value of the transaction is estimated at $316 million, based upon Orthovita's 79 million fully diluted shares outstanding as well as net debt of $12 million.  
"With this acquisition we are meaningfully expanding our orthobiologics product portfolio and strengthening our competitive position in key segments of the Spine, Orthopaedics and Biosurgery markets," said Stephen P. MacMillan, Chairman, President and Chief Executive Officer of Stryker. "We believe the collective talent of our sizable sales forces across multiple franchises positions us to build on Orthovita's success and accelerate sales growth."  
The boards of directors at Stryker and Orthovita have approved the transaction, and the board of directors of Orthovita resolved to recommend that Orthovita shareholders tender their shares to Stryker in the tender offer.  In addition, shareholders holding approximately 14.5% of the outstanding shares of Orthovita common stock have entered into agreements with Stryker to support the transaction and to tender their shares in the offer.
The tender offer is scheduled to commence within 10 business days and is expected to close in the second quarter of 2011.  The tender offer is subject to customary closing conditions, including the tender of a majority of the outstanding shares of Orthovita common stock on a fully diluted basis and the expiration or termination of the Hart-Scott-Rodino Antitrust Improvements Act waiting period. Following the tender offer, Stryker will acquire the remaining outstanding shares of Orthovita common stock through a second step merger.  Upon closing, the transaction is expected to be neutral to Stryker's 2011 earnings per share excluding acquisition and integration-related charges.
Citi served as Stryker's exclusive financial advisor in connection with this transaction.
Stryker is one of the world's leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. For more information about Stryker, please visit www.stryker.com.

A Revolutionary Femoral Access Device Delivering Rapid and Secure, Implant-Free Arterial Closure

REDWOOD CITY, Calif., May 16, 2011 /PRNewswire/ -- Arstasis is pleased to announce the U.S. launch of its latest commercial product - the AXERA™ Access Device.  The AXERA Device enhances insertability into the femoral artery and overall procedural usage while continuing to deliver the clinical benefits of the implant-free Arstaotomy Procedure.
Since 1959, physicians have been using the Modified Seldinger Technique for femoral artery access.  At the end of every such case, patients are left with a substantial hole in the femoral artery which can command significant effort and cath lab resources to close.  The AXERA™ Access Device is a breakthrough femoral artery access tool that quickly creates a longer and shallower angle arteriotomy, the Arstaotomy, resulting in significant tissue-upon-tissue overlap through the artery. Upon sheath removal at the end of the procedure, arterial pressure is decreased across this longer Arstaotomy channel intended to provide an excellent environment for clot formation and rapid femoral artery hemostasis.
The AXERA Device's Arstaotomy Procedure requires only minimal manual compression to provide secure closure with no foreign body implants - eliminating the risk of infections and thromboembolic events related to a vascular implant. The Arstaotomy Procedure promotes rapid hemostasis resulting in excellent patient comfort with decreased bed rest and quicker ambulation.
"The AXERA Access Device delivers a truly unique way to gain access into the femoral artery for diagnostic and cath-possible procedures," commented Dale Wortham, MD from the University of Tennessee Medical Center, Knoxville.  "Unlike vascular closure implants, the AXERA Device delivers rapid arterial hemostasis but does not deposit any foreign material into the patient.  Our results have been excellent with patients generally sitting up in 15 minutes and ambulating in 1 hour.  It really has improved our cath lab throughput and patient satisfaction."
Physicians have also been noting that the new AXERA Device allows them to perform Arstaotomy procedures in almost all patients, instead of having to potentially exclude patients with complex anatomy.  "In my opinion, all patients are candidates for the AXERA Access Device.  The new AXERA Device is sturdier and allows me to more easily gain femoral artery access, even in the more complicated patient subsets of the obese and those with heavily diseased vessels," said Dr. Greg Sampognaro, a practicing interventional cardiologist at the P&S Surgical Hospital in Monroe, Louisiana.
Patient enrollment continues in the RECITAL study, a multi-center, prospective registry that is overseen by a medical monitor and anticipated to enroll up to 500 patients in at least seven U.S. hospitals.

ABOUT ARSTASIS, INC.
Arstasis, Inc., headquartered in Redwood City, California, is a medical device manufacturer dedicated to bringing innovative arterial access devices to cardiologists, interventional radiologists, their staffs, and patients.  Detailed information about the AXERA Access Device and the Arstaotomy procedure is available at www.arstasis.com.

Some Interesting Reading.....click on the thumbnails to read