Healthcare Whitepapers

Don't Let Missed Appointments Affect Your Financial Health

Connie Walsh — Thu, 09 Feb 2012 13:16:59 -0500

This white paper captures specific figures for missed appointments and associated lost revenue, and describes how cross channel patient interactions (text, smartphone, voice and email) can help providers decrease no-shows, reduce readmissions, boost clinical measures and more.

Whitepaper: Five Little Ways to Improve Nurse Recruiting and Retention...That Lead to Big Results

Caroline Soderstrom — Wed, 16 Nov 2011 16:42:52 -0500

Recruit and retain nurses in ways that are non-traditional and proven to work. Some, in fact, are so logical -- even so simple -- that you will read them and say, "Why didn't I think of that?". Download now.

Using Analytical Chemistry Experts in Patent Litigation

Tue, 15 Nov 2011 07:23:57 -0500

Using Analytical

Chemistry Experts in

Patent Litigation

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Understanding When and How to Use

Analytical Chemistry

Shri Thanedar, Ph.D., CEO and Chief Scientist

Ross Faith, J.D., Litigation Support Specialist

Contents

The Problem: Understanding When and How to Use Chemical Analysis in Patent Cases 2

Analytical Chemistry: The Science 3

Analytical Chemistry in Litigation A Case Study of In re Omeprazole Patent Litigation 4

Background 4

The role of chemical analysis experts in the case 4

Conclusion 5

The Problem: Understanding When and How to Use Chemical Analysis in Patent Cases

Patent litigators encounter many different types of cases involving varied branches of science throughout their careers. When a case involving the chemistry of a product, such as a pharmaceutical product, is at issue, the patent litigator may have only a hazy idea of which experts to call on to help further her clients claim or defense. The attorney will likely encounter cases involving issues of chemical composition infrequently and therefore may lack a network of experts who deal with chemical analysis problems. Analytical chemistry laboratories with litigation support practices offer one solution that may work for these attorneys.

Scientists in analytical chemistry study the separation, identification, and quantification of the chemical components of natural and artificial materials. Analytical chemists can provide significant support to litigators involved in patent disputes by breaking down the chemical composition of a product to demonstrate whether the product infringes on a patent and explaining their theory to a jury.

This paper explains the background and nature of this area of science and explores the role that experts in this area can play in resolving a complex patent case..

Analytical Chemistry: The Science

Analytical chemistry has been around for many years, with the first use of instrumental techniques dating back to the 1860s. Modern analytical chemistry labs use instrumental methods almost exclusively. These methods include: chromatography, spectroscopy, microscopy, molecular characterization, and testing of thermal and mechanical properties.2 These methods can be used to deformulate (separating and identifying chemicals in a composition) a sample, identify contaminants, provide a product defect analysis, or test for materials identification and physical and thermal properties, among other services.

Analytical Chemistry in Litigation A Case Study of In re Omeprazole Patent Litigation

Background

In re Omeprazole Patent Litigation demonstrates the significant role that chemical analysis expert witnesses can play in a high stakes patent dispute. In that case, the issue was whether several pharmaceutical manufacturers had violated AstraZenecas patent for its blockbuster drug, Prilosec, where the competing pharmaceutical companies marketed drugs to address heartburn with the key ingredient in Prilosec, omeprazole.

AstraZeneca holds patents for an omeprazole formulation under the name Prilosec. AstraZeneca claimed that several manufacturers were infringing two of the patents (the 505 and 230 patents). The alleged infringers included: Mylan Laboratories, Inc. and Mylan Pharmaceuticals, Inc. (Mylan), Esteve Quimica, S.A. and Laboratorios Dr. Esteve, S.A. (Esteve), Apotex Corp., Apotex, Inc., and Torpham, Inc. (Apotex), Lek Pharmaceutical and Chemical Company D.D. and Lek USA , Inc. (Lek), and Impax Laboratories, Inc. (Impax). The district court held that Mylan, Esteve, and Lek did not infringe on AstraZenecas patents, while Apotex and Impax did infringe claims of both patents.

The role of chemical analysis experts in the case

The case turned on the testimony of more than 15 expert witnesses, many of whom had analytical chemistry backgrounds.5 AstraZenecas claim against Lek provides an illustrative example of how the court used these experts to resolve the various patent claims. Lek filed an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA), seeking approval for its 10-mg and 20-mg dosage of Omeprazole Delayed Release Capsules, which were generic versions of AstraZenecas Prilosec. One issue was whether Leks products had an alkaline reacting compound (ARC) or its equivalent.

In order to resolve the competing claims, the court examined testimony of expert witnesses for AstraZeneca and Lek. For AstraZeneca, the court accepted Dr. Martyn Davies as an expert in the testing, analysis, and characterization of drug formulations; Dr. Robert Langer as an expert in drug delivery and pharmaceutical dosage forms; and Dr. Klibanov as an expert in pharmaceutical chemistry and pharmaceutical formulation chemistry. For Lek, the court accepted Dr. Gary Christian as an expert in analytical chemistry; Dr. Phillip E. Russell as an expert in microsopy and microanalysis; Dr. John Coates as an expert in infrared spectroscopy, attenuated total reflectance Fourier spectroscopy (ATR-FTIR), analytical chemistry, and spectral data handling; Dr. Brian Herman as an expert in fluorescent spectroscopy and optical microscopy; Dr. Yuval Garini as an expert in optical microsopy and spectroscopy, including fluorescence microscopy and confocal laser scanning microscopy; and Dr. Albert Padwa as an expert organic and heterocyclic chemistry.

To determine whether there was an ARC, the court needed to know what the pH of the composition was. It was necessary for the court to find that the pH was alkaline in order to find that there was an ARC in the composition. Analytical chemistry helped resolve this question. Both Dr. Davies for the AstraZeneca and the Dr. Christian for Lek tested the pH of the omeprazole alone and pH after adding a small sample of water to the mixture of omeprazole and excipients that compose the core of Leks product.1 Both scientists found that the mixture with water had an acidic composition, but each came to a different conclusion about the omeprazole alone. The court concluded that the appropriate measure was the reading of the mixture with water because there was no discussion in the patent of measuring the pH of omeprazole alone. The court also held that the readings of the omeprazole alone were too inconsistent to warrant a conclusion that it was alkaline.

Finally, the court had to determine whether the addition of methylamine (MA), a colorless gas derivative of ammonia, to the solution resulted in an ARC. Again, analytical chemistry was instrumental in deciding the issue. Dr. Padwa claimed that Lek added MA during the crystallization process to purify the omeprazole in the manufacturing process. Dr. Davies asserted that the purpose of the MA is to [help] stabilize the omeprazole. Because MA is an alkaline organic base, if it survived the manufacturing process, then Leks formulation could be said to contain an ARC. To determine whether the MA survived, the court evaluated a mass spectrometry reading from Dr. Davies. After significant testimony on both sides, the court concluded that Lek had cast sufficient doubt on Dr. Davies particular use of mass spectrometry warranted a conclusion that the final product contained MA.6 As a result, AstraZenecas claim against Lek was dismissed.

Conclusion

As the Omeprazole case demonstrates, patent cases often benefit from chemical analysis expert witnesses. When the chemical formula must be broken down and separated in order to understand the nature of an alleged infringers product, chemical analysts with expertise in instrumentation such as mass spectrometry can shape the outcome of the case. Analytical chemistry labs that use a problem-solving approach can help attorneys to identify when chemical analysis expert witness services are needed.

For more information related to this white paper, please visit

www.avomeen.com/litigation-support.

7 Things to Look for in a Chemical Analysis Expert Witness

Tue, 15 Nov 2011 06:08:41 -0500

7 Things to Look for in

a Chemical Analysis

Expert Witness

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Important Criteria in Selecting Your Next

Expert

Shri Thanedar, Ph.D., CEO and Chief Scientist

Ross Faith, J.D., Litigation Support Specialist

Contents

Introduction

#1: Relevant Training 2

#2: Subject Matter Expertise 2

Case Study 2

#3: Reliable Methods 2

Case Study 2

#4: Courtroom Presence 2

Case Study 2

#5: Independence 3

#6: Unimpeachable Credibility 3

#7: Availability 3

Conclusion 3

Introduction

Choosing an expert witness in a case involving issues of chemical testing and analyses can be confusing to an attorney who does not have a background in chemistry. Many of the considerations for choosing a chemistry expert are similar to choosing an expert generally; however, it is particularly important to select an expert who has the right type of training and subject matter expertise within a relevant sub-discipline of chemistry. This white paper explores these issues and provides recommendations for lawyers who are looking to identify an expert witness in this complicated area of science.

#1: Relevant Training

An expert's education and training must be top-notch to withstand scrutiny from the other side and build trust with judges and juries. In the field of chemical analysis, this means that the expert should have strong academic credentials, preferably a Ph.D. in a relevant subfield of chemistry, and years of experience using the applicable instrumentation. Oftentimes, the most qualified chemists will spend additional years doing post-doctoral work or working in industry to hone their skill at analytical chemistry.

#2: Subject Matter Expertise

As one practitioner notes, "[n]o matter how impressive the expert's qualifications, they must closely match the subject matter of the testimony. "1 Chemistry has many sub-disciplines, including analytical chemistry, biochemistry, inorganic chemistry, organic chemistry, and materials chemistry, among others. When a case calls for a chemistry expert, lawyers should first consult experts with a broad-based problem-solving approach to chemical analysis problems. These experts can then identify the appropriate individual with a background relevant to the proposed testimony.

Case Study

In a products liability case that our Chief Scientist handled during his career, plastic pipes were breaking inside of a tank, causing leakage and damage to the interior of people's homes. The attorney on the case found a number of prospective chemical experts for litigation support - all of whom had Ph.D.'s in their respective fields. One expert with a mechanical engineering background specialized in the structure of materials. Another Ph.D. chemist had an analytical chemistry degree and experience in the study of small molecules. The third Ph.D. was an organic chemist with expertise in chemical structure and the synthesis of materials.

The attorney decided to use a polymer chemistry expert who was knowledgeable about the composition of polymers because the case hinged on the role of additives in protecting polymers. Because polymers are unstable and can degrade quickly without certain additives, the expert needed to know about the effect that the lack of certain additives had on polymers. In this case, the expert analyzed the polymers for identification and quantitation of polymer additives. This case illustrates that not all engineers are alike in their background. Their subspecialties need to be matched carefully with the problem at hand for effective problem solving and success of the expert in presenting his case with scientific credibility.

#3: Reliable Methods

Rule 702 of the Federal Rules of Evidence allows a witness "qualified as an expert by knowledge, skill, training, experience, or education" to testify if, among other requirements, "the testimony is the product of reliable principles and methods." In Daubert v. Merrell Dow Pharmaceuticals, the Supreme Court held that "the requirement that an expert's testimony pertain to 'scientific knowledge' establishes a standard of evidentiary reliability."2 If an expert lacks sufficient scientific knowledge in the specific area of chemistry at issue in the trial, a motion to strike his or her testimony under Daubert is more likely to be successful.

In order to analyze chemistry issues in litigation, a chemistry expert must perform experimental work. Such work is often is conducted in a laboratory. While some experts have access to labs of their own, many experts outsource such work to other commercial labs. Integrity of the data is essential in establishing the credibility of the expert's report. For example, can the expert testify that an instrument he or she uses is calibrated regularly? Furthermore the expert must have a valid method for collecting the data. After data collection, the expert must interpret the chemical data. The question then is whether the interpretation is based on a scientific method.

Case Study

In one case involving the corrosion of metallic components in an automobile, the issue was who would be liable for the product failure. Did the problem arise with the vendor who supplied the initial parts, the vendor who provided the polymer coatings, or the automaker who assembled the parts into the final product? The right expert was able to perform the necessary testing in a lab to which he had full access and where he directly supervised the technicians. The expert was able to choose the appropriate methods from the directory ASTM (American Society of Testing Materials). He used the correct, peer-reviewed methods and was able to draw conclusions that were not vulnerable to attack under Daubert.

#4: Courtroom Presence

"Probably the greatest intangible factor in selecting an expert is how the individual will appear to a jury."3 There are many highly qualified chemists who have sterling credentials and academic reputations, with many publications in their field. However, not all of these individuals can communicate complicated ideas concisely and simply to a jury of laypeople. Furthermore, as one practitioner notes, "cross-examination at trial is very different from scientific peer review, and issues that may not affect a fellow scientist's appraisal of the expert's work may significantly affect a jury's perception of the expert's credibility as a witness."4

Case Study

In a jury trial involving product failure, each side offered experts to testify about issues in the case. One side hired a professor who was renowned his field, had 25 years of experience, conducted pioneering research, and authored two-dozen research papers. On the other side of the case was a Ph.D. scientist who owned and operated a small laboratory. The professor presented matter using very complicated and hard to understand scientific terms. He did not look at the jury, instead looking largely at his notes while he was talking. Furthermore, he did not speak clearly enough, nor did his voice project.

The relatively younger Ph.D. Chemist explained scientific matters in layperson's terms and used everyday examples for the jury to understand the cause of the failure. He maintained eye contact, spoke clearly, and was able to successfully convince the jury of his point of view.

#5: Independence

Juries give greater weight to the testimony of chemistry expert witnesses if they perceive the expert's judgment to be independent of his or her relationship with the party or the attorney in the case.5 This is why seasoned practitioners almost always recommend using outside, rather than in-house, experts.6 Juries are often skeptical of paid experts to begin with - the problem is made worse by experts who are employed by the very people for whom they testify. In the area of analytical chemistry, one option is to select experts who work with independent analytical chemistry laboratories. These experts generally do not spend most of their time testifying in cases, as the bulk of their work is working for manufacturers and other companies who require failure analysis and deformulation of products.

#6: Unimpeachable Credibility

An expert's testimony is only valuable if the jury or judge believes the expert to be an honest person. If the expert can be attacked for bias, or for a history of lying or professional misconduct, attorneys should reconsider hiring the expert, no matter how qualified he or she may seem. During the selection process, look for experts who are frank and willing to disclose all information requested.7

#7: Availability

Potential chemical analysis expert witnesses should be available for potentially long and distant trials. According to one report, "[t]he typical patent case takes two years to resolve."8 Often, these cases may also require the expert to travel across the country for depositions, court appearances, and other meetings. As a result, even the most qualified expert may be useless if he or she cannot commit the time and travel necessary to work on a case. Attorneys should look for experts who can sign an agreement to make themselves available for the needs of the trial.

Conclusion

Finding an expert witness in a case involving chemical analysis requires a confluence of factors, including: 1) relevant training, 2) subject matter expertise, 3) reliable methods, 4) courtroom presence, 5) independence, 6) unimpeachable credibility, and 7) availability. Where a case involves issues of chemical analysis and testing, one approach is to contact an analytical testing laboratory. Avomeen Analytical Services has an extensive network of relationships with faculty members at the University of Michigan and Wayne State University, along with a set of Ph.D. expert witnesses on staff. We can match the needs of the case with a relevant and qualified expert.

If you require litigation support or expert witness services, please contact Avomeen Analytical Services at (800) 930-5450 or visit our website at www.avomeen.com/litigation-support.

1 Cecil C. Kuhne III, A Litigator's Guide to Expert Witnesses, American Bar Association GP/Solo, 2006, p. 68. See also Richard Fried, Jr., Feature: Choosing and Using an Expert Witness, 12 Hawaii B.J. 4, 2008 ("First and foremost, it is essential that the expert's testimony be firmly within his or her area of expertise.").

2 509 U.S. 579, 590 (1993).

3 Kuhne, p. 69.

4 Fried, 12 Hawaii B.J. 4.

5 See Kuhne, p. 68.

6 Id.

7 See Kuhne, p. 70.

8 Jim Landers, "Trouble Impending in Patent Process," The Dallas Morning News, May 1, 2007, p. 1D.

Home Healthcare Equipment: An Overview

Mon, 14 Nov 2011 15:43:37 -0500

The market for home healthcare equipment is expected to grow exponentially in the coming years, as the delivery of healthcare services shifts from clinical settings to the home. But manufacturers face a series of unique challenges in supplying home healthcare equipment that is both effective and safe. This white paper takes a look at the current and anticipated regulatory landscape for home healthcare equipment, and provides a brief look at what to expect in the future.

ICD-10-CM/PCS

Thu, 10 Nov 2011 13:47:36 -0500

The Gathering Storm:

ICD-10 Coding Changes Will Have a Far-reaching Effect on Your Practice

What is ICD-10? What are the benefits of ICD-10? How will this new code set affect the financial performance of a physician practice? What's the best way to plan for the transition? These questions and many more are addressed in this ICD-10 white paper that takes an in-depth look at ICD-10 and it's affect on physician practices.

Physician Employment, Engagement & Productivity

Tue, 04 Oct 2011 16:26:11 -0400

View industry research results on Physician attitudes on Employment, Engagement & Productivity. Gain insight into what physicians believe about the future of employment and what key factors drive physician productivity and engagement.

All Physicians Wear Lab Coats and Nine Other Myths Healthcare Executives Need to Know

Tue, 04 Oct 2011 16:17:48 -0400

Learn the 10 common misconceptions about how to engage physicians and drive productivity in an employed or independent group practice.

Executive Summary Report: Health Plan Communication Channels with Members

Connie Walsh — Mon, 12 Sep 2011 16:58:07 -0400

Despite explosion of smartphone use, health plans are slow to adopt texting as a routine communication channel. Fast, effective, secure communication with health plan members is increasingly important as more emphasis is placed on patient outcomes. And with more than 63 million consumers owning smartphones in the U.S., it would seem that communications targeted directly at these popular devices would be a routine part of most payers' communication strategies by now. But a new survey by Varolii and FierceHealthPayer has found that only a minority of payer organizations use text messages to directly interact with their members.

Nonprofit Healthcare: What does the future hold?

Mon, 15 Aug 2011 14:37:11 -0400

Key provisions of the Health Care and Education Reconciliation Act of 2010 and other legislation passed last year introduced new requirements for section 501(c)(3) organizations operating a state-licensed hospital. This paper discusses new reporting requirements, as well as tax and legal challenges arising from this regulatory change.

Will ACOs Keep Hospitals and Insurers Out of Critical Care?

Mon, 01 Aug 2011 15:29:38 -0400

L.E.K. addresses healthcare reform requirements for holistic patient care by outlining key considerations that hospitals and payers should address to establish an Accountable Care Organization (ACO) model. L.E.K. also forecasts how new healthcare legislation will impact consumers, providers and insurers - and may cause hospitals to operate at an annual net loss.

Leveraging Uptime and Availability to Improve Productivity with EMR/EHR

Mon, 01 Aug 2011 14:33:21 -0400

In this Industry Brief, IDC Health Insights discusses how the rush to EMR/EHR adoption has many neglecting to mitigate risk in the supporting infrastructure. They go on to give different perspectives on how to alleviate these risks in a balanced way.

qMetrix for Healthcare

Fri, 29 Jul 2011 15:10:23 -0400

Hospitals and healthcare providers in recent years have been challenged to manage costs while delivering higher quality health care to patients. Government, regulatory agencies such as the Centers for Medicare and Medicaid Services (CMS) and The Joint Commission, and private payers are increasing requirements for reporting of quality metrics and indicators. Value-based purchasing is being dis- cussed as all components of the healthcare industry begin to address the issue of bending the cost curve to control escalating expenses. IT solutions are likely to be of benefit, and various software sys- tems utilizing conventional computer input methodologies have been developed in both the hospital and clinic settings. The burden is increasing, however, and it has been estimated that a 250 bed com- munity hospital may collect almost 1500 quality indicators of different types in a variety of software pro- grams. There is a growing interest in refining these information systems and many types of products have been proposed, but in general the current methodology used to collect data is inefficient, costly, and often delayed and untimely. The qMetrixTM for Healthcare system represents a new method for collecting and managing healthcare performance metrics utilizing a tablet device platform (the Apple iPadTM) with integrated data collection designed to streamline the collection and reporting of quality and/or operational data. The second key feature of the system is that it provides immediately actionable information derived from the collected operational data.

Leveraging Uptime and Availability to Improve Productivity with EMR/EHR

Thu, 28 Jul 2011 08:58:52 -0400

Meaningful Use Requirements for Patient Education

Wed, 27 Jul 2011 12:42:51 -0400

There are lots of ways that EHRs can be used to meaningfully engage and inform patients. How do you unlock this “automated” potential? Download this new Whitepaper to learn how providers are using their EHRs to involve patients in their care and help improve outcomes.