Articles Posted in Expert Witness Testimony

The Federal Trade Commission has reached a settlement resolving the antitrust suit charging Cephalon, Inc. with illegally blocking generic competition to its sleep disorder drug Provigil. Teva Pharmaceutical Industries, Ltd. will make a total of $1.2B available to compensate purchasers, including drug wholesalers, pharmacies, and insurers, who overpaid because of Cephalon’s illegal conduct. The FTC’s pharmaceutical expert witness had previously estimated that the amount could be anywhere between $3.5B and $5.6B.

As part of the settlement, Teva also has agreed to a prohibition on the type of anticompetitive patent settlements that Cephalon used to artificially inflate the price of Provigil. Teva is the largest generic drug manufacturer in the world, and this prohibition applies to all of its U.S. operations.

The May 28th FTC.com press release states:

The settlement stems from a 2008 FTC lawsuit, which charged that Cephalon unlawfully protected its Provigil monopoly through a series of agreements with four generic drug manufacturers in late 2005 and early 2006. The FTC alleged that Cephalon sued the generic drug makers for patent infringement and later paid them over $300 million in total to drop their patent challenges and forgo marketing their generic products for six years, until April 2012.
This type of settlement, in which the generic drug firm agrees not to market its product for a period of time and the brand name drug manufacturer pays the generic- whether in monetary or non-monetary form – is commonly referred to as a “reverse-payment” patent settlement. In 2013, in FTC v. Actavis, the Supreme Court confirmed that reverse payments can violate the antitrust laws.

Trial in the case is scheduled to begin June 1 in the U.S. District Court for the Eastern District of Pennsylvania. If approved by the court, the settlement will resolve the FTC’s charges.

A Northern District of Illinois jury ruled in favor of defendants ExxonMobil and Owens-Illinois and against plaintiff Charles Krik. The retired pipefitter claimed his lung cancer was caused by exposure to asbestos from the 1970 to the 1990s while working in refineries in Illinois and Indiana where asbestos was present. However, the jury ruled that the plaintiff’s asbestos expert witnesses, Dr. Arthur Frank, Dr. Arnold Brody and Frank Parker, needed to offer more specific testimony pertaining to Krik’s potential exposure to asbestos, rather than the effects of asbestos exposure in general. They also found that his cigarette smoking was the “sole proximate cause” of his lung cancer.

In CHARLES KRIK v. CRANE CO.; EXXONMOBIL OIL CORPORATION; OWENS-ILLINOIS,INC.; and THE MARLEY WYLAIN COMPANY, Case No. 10-cv-7435 Judge John Z. Lee writes:

Krik nevertheless asserts that because the precise exposure to asbestos cannot be calculated, even de minimis exposure satisfies the substantial contributing factor test. The Court disagrees. As the MDL court explained in its opinion denying Crane’s summary judgment motion, under maritime law, “[a] mere ‘minimal exposure’ to a defendant’s product is insufficient to establish causation.

In Nursing Standard of Care Guidelines: Why a blank or incomplete medical record suggests conduct that falls below the standard of care, attorney Kristin Miller answers the question “Why does a blank or incomplete medical record indicate a likelihood of nursing conduct that falls below the standard of care?”

“Nurses are required to routinely conduct assessments and reassessments, and they are required to document all of their findings in the patient’s medical record. A blank or sparsely filled in medical record at a time when the patient is receiving intensive care is a strong indicator of below standard conduct by the nursing staff.” Says Gayle Nash with Nash Legal Nurse Consulting, and a Chief Nursing Officer with twenty-seven years of executive nursing leadership experience.

A myriad of patient care considerations go into each patient assessment and reassessment. Nash preaches that a skilled nurse performing their work pursuant to standard of care will practice due diligence in their charting practices thoroughly performing as well as documenting each assessment and reassessment. The medical record, after all, is the patient care fingerprint indicating both the patient’s health status as well as how the nurses are performing and completing their patient rounds. A sparsely complete medical record should be investigated as a possible indicator of below standard nursing conduct.

“A properly charted medical record pursuant to standard of care will be complete,”
explains Nash. “We train our newly registered nurses to practice under the principle that any information left off the medical record will be interpreted as work not done.”
Complete charting on a head to toe assessment requires documenting a substantial amount of information. For example, if a patient presents to the hospital with pressure ulcers, a nurse has a duty to conduct a thorough assessment. Documenting on the medical record that a pressure ulcer exists is not enough to comport with standards of care. The nurse attending that patient must also document the ulcer location, size,
degree of severity or stage, any healing of the ulcer, odor or dying tissue, any drainage,
presence of undermining tunneling tracts, color, and temperature. The nurse is also required to conduct timely reassessments to monitor changes of that ulcer and the patient’s overall health condition while under that nurse’s care.

Q: Where the medical record is blank or incomplete, why should leadership and clinical experience be a hiring factor in the nurse expert’s qualifications?

Identifying where a medical record is missing critical patient information that points to below standard conduct requires hiring the right expert witness.

Nash urges Attorneys in need of an expert report on a sparsely complete medical record to consider hiring experts with leadership experience. Nurses in a management role are more likely to identify where the incomplete record points to issues in the hospital’s chain of command.

“Hospitals operate under a series of complex command chains. Nursing Directors are held accountable for all work not completed, and as such, make routine reviews of nurse charting and notes documented. Nursing Directors are also expected to know the standard of care guidelines set by accrediting organizations such as the Centers for Medicaid and Medicare and The Joint Commission.” A Nursing Director will, therefore,
have more experience identifying where the medical record is missing critical patient information.

Lastly, a nursing expert witness hired to review medical records will be expected to know where the medical record indicates below standard conduct, missing assessments or otherwise, for all nursing care provided. Because much of the charting and documenting requirements are learned on the job, Nash recommends hiring experts with actual clinical experience in the health care department most applicable to the case.

Kristin Miller, JD

British Petroleum expert witnesses will testify before U.S. District Judge Carl Barbier in an effort to lower the possible $13.7B fine as a result of the Deepwater Horizon oil spill. BP hopes to prove the damage was not as devastating as originally projected. Dr. John W. Tunnell Jr., marine biology expert at the Harte Research Institute for Gulf of Mexico Studies at Texas A&M University – Corpus Christi, will testify regarding the spill’s impact on fish, shellfish and birds in the Gulf of Mexico. The marine biology expert witness is Associate Director and Endowed Chair of Biodiversity and Conservation Science.

The Harte Research Institute website explains that the 2010 Deepwater Horizon blowout was unprecedented not only because of the volume of oil that leaked from the well but also the location wehre the oil was escaping was almost a mile beneath the Gulf’s surface, “creating problems with which responders had never before been confronted….”

During all previous spills the oil rose to the surface and drifted with the wind so modern oil spill response equipment and techniques have been designed to deal with that scenario. However, in the case of Deepwater Horizon, plumes of oil drifted with currents at various depths, settled to the bottom or dispersed throughout the water column making the use of skimmer ships, floating booms and controlled burns less effective.

The Bureau of Safety and Environmental Enforcement is working on updating regulations on Oil and Gas Production Safety Systems.

The Bureau of Safety and Environmental Enforcement is proposing to amend and update current regulations regarding production systems and equipment that is used to collect and treat oil and gas from Outer Continental Shelf (OCS) leases. The proposed rule will address recent technological advances involving production safety systems, subsurface safety devices, safety device testing, and life cycle analysis. Production systems play a critical role in protecting personnel and the environment. This rule will help to reduce the number of production incidents resulting in oil spills, injuries and fatalities.

Background There are more than 3,000 facilities located on the OCS that are involved in the collection and treatment of oil and gas collected from oil and gas wells. These facilities range in size and scale from unmanned single well caissons to huge, manned deepwater facilities containing state of the art technology. All of the facilities contain equipment, sensing devices, and control systems to ensure that the oil and gas can be moved from the well to a pipeline in a safe and environmentally protective manner.

This proposed rule will revise 30 CFR 250 subpart H – Oil and Gas Production Safety Systems and make the first major changes to this section of the regulations since 1988. This regulatory action will ensure that the regulations are keeping pace with industry’s recent technological advancements, which often rely of the use of equipment that is located on the seabed. These new technologies are more complex than those that were traditionally used for shallow water drilling on shelf areas, where safety equipment was traditionally placed on the rig itself, rather than on the seafloor. With the shift to deeper water in the past decade, more specialized requirements and regulations are required for these newer and emerging safety technologies.

Psychologist and child abuse expert witness Dr. William L Carter testified in the Waco, TX, case against Sergio Bezerra. The former Waco Baptist Academy teacher was convicted of abusing two students in 2008 and was sentenced to 80 years in prison. Four young women testified that Bezerra molested them. Dr. Carter did not evaluate the victims but described how the abuser brings victims into abuse, many times starting with favoritism.

Protocols involved in a Child Sexual Abuse Forensic Interview are discussed on the Forensic Pediatrics Experts – Child Abuse & Child Safety website:

General Protocols Child Forensic Interview Expert Analysis Components An objective assessment of a forensic interview involving a child who reports sexual abuse is a prudent component of quality improvement and assuring proper procedures were followed. A poor interview does not discount the possibility of sexual abuse. However, the format and process of the forensic interview have been developed to minimize leading questions and ensure as accurate a history as possible.

The interviewer of a child or adolescent presenting with concern for sexual abuse or sexual assault should remember the following principles:
audiotape or videotape the interview, if possible;
use a minimum number of interviews (perhaps two or three), as multiple interviews may encourage confabulation;
avoid repetitive questions, either/or questions, and multiple questions, and try to avoid leading and suggestive questions;
use restatement, that is, repeat the child’s account back to the child (which allows the interviewer to see if the child is consistent and ensures that the interviewer understands the child’s report)

Child Sexual Abuse Forensic Interview Process and Protocol conduct the interview without the parent present (if the child is very young, consider having a family member enter the room and separate thereafter;
if a camera or microphone is present, inform the child that people responsible for making them safe may be watching, but that no family member is observing the interaction. Only investigative team members should be observing a forensic interview;
use an examination technique that is appropriate to the child’s age and developmental level, such as drawings and play re-enactment;
determine the child’s terms for body parts and sexual acts; do not educate or provide new terms
Content of a Child Sexual Abuse Forensic Interview A forensic interview should not take the form of an interrogation. Note the child’s affect while discussing these topics and be tactful in helping the child manage anxiety. Young children may not be able to report all of the relevant information and disclosures commonly emerge over time. The examiner should explore the following:
whether the child was told to report or not report anything;
what relationship the child has to alleged perpetrator was;
what the alleged perpetrator did;
where it happened;
for multiple occurrences that are reported, when the abuse it started and when it ended;
number of times the abuse occurred;
if and how the child was initially engaged and how the abuse progressed over time;
if and how the alleged perpetrator induced the child to maintain secrecy;
whether the child is aware of specific injuries or physical symptoms associated with the abuse;
whether any photography or videotaping took place.

Read more: Forensic Pediatrics Experts – Child Abuse & Child Safety

Accident investigation expert witness Travis Webster testified in the case against 19 year old James Crosby in the death of Kathy Lattimore, 67, and Derek Nichols, 20. Crosby was found guilty of manslaughter in the December 31, 2013 Newfield, NY, crash. Webster, a New York state investigator, calculated that Crosby was driving over 84 mph when he hit the victims vehicle. Crosby was found guilty of manslaughter as well as second-degree assault, third-degree assault and reckless driving in the fatal crash.

The prosecution described Crosby’s driving as reckless while defense attorney Joseph Joch said freezing temperatures may have caused icy conditions when Crosby’s car crossed into the opposing lane. Eye witnesses testified that they saw Crosby passing other cars at high speeds on windy roads that night.

Accident investigation experts take into consideration collision analysis, collision speeds, skidmark analysis, and speed determinations, as well as related issues.