Originally published in The Legal Intelligencer
By: Saranac Hale Spencer
August 14, 2014
In another blow to the plaintiffs alleging that Pfizer’s antidepressant, Zoloft, causes birth defects, the federal judge handling the case rejected the testimony of three of their expert witnesses.
In June, the judge tossed their key expert on causation. The three witnesses at issue in the most recent opinion will be allowed to testify to their conclusions about general biological plausibility regarding the drug’s effect on developing embryos, but they won’t be allowed to testify to the drug’s causation of birth defects in humans.
Zoloft has been on the market for 20 years, said U.S. District Judge Cynthia Rufe of the Eastern District of Pennsylvania, and it has been prescribed to pregnant women that whole time, so there is a significant amount of epidemiological research available.
The experts—Thomas Sadler, a teratologist and embryologist; Robert Cabrera, a teratologist; and Michael Levin, a molecular developmental biologist—needed to address the existing epidemiological research, some of which is at odds with their opinions about human causation, the judge said. But, they didn’t.
“The experts’ failure to reconcile inconsistent epidemiological research with their opinions regarding human causation is a significant methodological flaw, undermining their reliability under Daubert,” Rufe said.
In April, she had held a weeklong Daubert hearing—so named for the 1993 U.S. Supreme Court case Daubert v. Merrell Dow Pharmaceuticals, which created a route for parties to challenge expert testimony before the start of trial—which had focused primarily on Dr. Anick Bérard, who was a key expert for the plaintiffs.
Rufe excluded Bérard’s testimony in an opinion issued in June.
“The court notes that Drs. Cabrera, Sadler, and Levin were retained for their expertise on biological mechanisms, and although they each reviewed the epidemiological literature, it was Dr. Bérard who was retained for her expertise in that field,” Rufe said in a footnote. “Had the court found Dr. Bérard’s methodology was sound, they would have been justified in relying upon her report as evidence in support of their own human causation opinions. However, without Dr. Bérard’s opinion to rely upon, the court must examine whether each of these experts adequately addressed the epidemiological evidence in forming their opinions on human causation.”
Rufe had found that Bérard’s methods wouldn’t pass muster for the court.
Bérard, a professor at the University of Montreal, researches the effect of medications on pregnancy, within the field of teratology, which is the study of congenital abnormalities.
“The court finds that the expert report prepared by Dr. Bérard does selectively discuss studies most supportive of her conclusions, as Dr. Bérard admitted in her deposition, and fails to account adequately for contrary evidence, and that this methodology is not reliable or scientifically sound,” Rufe said in her opinion excluding Bérard’s testimony.
Sadler, Cabrera and Levin, however, are experts in biological mechanisms and their testimony in that regard will be allowed at trial, Rufe said.
“Biological plausibility is one of the criteria scientists need to address in opining as to whether an association between a substance and an adverse outcome reflects a causal relationship (i.e., whether the substance is a teratogen),” Rufe said, explaining that the plaintiffs’ steering committee had intended to use Sadler, Cabrera and Levin to testify as to Zoloft’s adverse impact on fetal development.
“All three experts opine that there is at least one plausible biological mechanism by which SSRIs generally, and Zoloft particularly, may alter embryonic development,” Rufe said.
Zoloft is part of a class of antidepressant drugs called selective serotonin reuptake inhibitors, or SSRIs, which regulate the amount of serotonin available to the brain.
The experts’ research on in vitro and in vivo animal studies—an example of an in vitro study being an animal embryo removed from the mother and observed in a lab dish as it was exposed to medication, whereas in vivo studies observe the impact of a drug on the whole animal system—is sufficient to establish their views that there is a plausible biological mechanism triggered by altered concentrations of serotonin in a developing embryo that could cause birth defects.
So, they can testify to the issue of plausible biological mechanisms.
That research doesn’t necessarily translate to show that Zoloft causes defects in human embryos, Rufe said, ruling that they can’t testify as to human causation.
One of the reasons that those studies can’t be used directly to show human causation, the judge stressed, is that the dosage level for the drug can be much higher in those studies than would be prescribed for people.
“In order to reliably opine as to human causation, the experts must address whether the children of pregnant women taking Zoloft in typical (or even maximum) clinical doses are at an increased risk of birth defects. The in vitro and in vivo animal studies have found associations between exposure and adverse outcomes only at concentrations well above the maximum recommended human dose,” Rufe said. “The experts have not reconciled the dose-response evidence with their opinions on human causation.”
Pfizer released a statement about the ruling, saying, “We are pleased that the court agreed to limit the testimony of the plaintiffs’ expert witnesses under the Federal Rules of Evidence.” It also noted Rufe’s earlier ruling on Bérard’s testimony, saying that it “plainly describes the difficulty plaintiffs will have in establishing general causation in this litigation, an essential element to prove their case.”
Dianne Nast of NastLaw, who is on the plaintiffs’ steering committee, couldn’t be reached for comment.
(Copies of the 24-page opinion in In re Zoloft, PICS No. 14-1263, are available from The Legal Intelligencer. Please call the Pennsylvania Instant Case Service at 800-276-PICS to order or for information.) •
Leave a Comment August 14, 2014SHOW LESS..........
Originally published in New York Law Journal.
By: Joel Stashenko
July 10, 2014
ALBANY – An Albany judge will get some help at a long-awaited trial in weighing the adequacy of the defense in criminal matters that indigent people receive in New York.
Overturning a lower court decision, a unanimous panel of the Appellate Division, Third Department, agreed last week that the testimony of three expert witnesses will assist in determining the issues raised by Hurrell-Harring v. State of New York, 8866-2007.
Presiding Justice Karen Peters (See Profile) noted that the state Court of Appeals has placed the burden on Hurrell-Harring plaintiffs to show that “the basic constitutional mandate for the provision of counsel to indigent defendants at all critical stages is at risk of being left unmet because of systemic conditions” in New York’s public defense system.
Peters said that if Hurrell-Harring was “simply about individualized claims of denial of counsel at a critical stage of a criminal proceeding,” her court might agree with Justice Eugene Devine’s decision last fall to preclude the expert testimony because it would not contain anything that is “beyond the ordinary experience and knowledge of the average Supreme Court justice.”
But Peters wrote that Hurrell-Harring, at its core, is “about system-wide conditions relating to and affecting the delivery of public defense—such as caseloads, funding and oversight, among others.”
“Such particularized knowledge is, manifestly, beyond that of a typical Supreme Court justice, whose experience is oft confined to case-by-case determinations,” Peters concluded.
The New York Civil Liberties Union, which filed the case in 2007, contends that New York has shirked its constitutional responsibility under Gideon v. Wainwright, 372 U.S. 335 (1963), by allowing an underfunded, county-based system to provide representation.
Hurrell-Harring was brought on behalf of defendants following their arrests for relatively minor crimes in Onondaga, Schuyler, Suffolk and Washington counties. Its result is expected to apply in other counties as well.
Acting Albany County Supreme Court Justice Gerald Connolly (See Profile) will preside at the bench trial scheduled to start on Sept. 3.
Connolly was assigned the case after Devine, who had the matter from its inception and made a number of pre-trial determinations in the case, was assigned to the Third Department bench by Gov. Andrew Cuomo in April (NYLJ, April 16).
The Third Department approved the presentation of testimony from Robert Boruchowitz, a professor at Seattle University School of Law; Norman Lefstein, a professor of the Indiana University School of Law, and Robert Spangenberg, president of the West Newton, Mass.-based criminal justice research group the Spangenberg Group.
According to the plaintiffs, Lefstein and Boruchowitz will testify that competent representation in the defendant counties has been impaired by a number of factors, including high public defender caseloads, insufficient resources and inadequate training.
Spangenberg will testify about a report on public defense services in 22 New York counties that his group compiled with the work of the Commission on the Future of Indigent Services appointed by former chief judge Judith Kaye. In 2006, the commission recommended forming a statewide office to take over the public defense obligation under Gideon.
In addition, Harvard Professor Gary King will present statistics on criminal matters handled by public defenders in the counties named in the litigation. Devine had agreed to allow King’s testimony, and the Third Department did not disrupt that ruling.
A spokeswoman for the state Attorney General Eric Schneiderman’s office said the Third Department’s determination will not be appealed and that the office is focusing on preparing for the upcoming trial.
In papers urging the Third Department to uphold Devine’s decision, Assistant Solicitor General Victor Paladino argued for the state that the experts would provide the court with opinions about defense services that are not supported by scientific fact.
“Expert testimony regarding legal conclusions is impermissible,” Paladino’s brief argued. “It is the province of the court itself to decide issues of law.”
The state also has argued that many of the problems named by the Hurrell-Harring plaintiffs should be attacked on an individual rather than a class basis in post-conviction litigation related to the effectiveness of counsel. It contends that any systemic grievances should be directed to the Legislature rather than the courts.
But Chief Judge Jonathan Lippman, (See Profile) writing for the Court of Appeals in Hurrell-Harring v. State of New York, 15 NY3d 8 (2010), said few issues concern the courts more than compliance with the right to counsel, and its adequacy is properly before the courts.
Assistant NYCLU Legal Director Christopher Dunn said the testimony from the three experts will improve the plaintiffs’ chance of meeting the burden of proof, as defined by the Court of Appeals, that a systemic failure in public defense exists.
“The experts are going to bring a national perspective and expertise to the central question of whether the state does have a system in place to ensure that public defense is adequately provided to indigent defendants,” Dunn said. “We certainly believe that [adequate representation] is not the case. We have 30 years of state commissions and reports that back us up.”
Dunn said that the attorney general’s office consistently sought to narrow the focus of the case as much as possible to the particulars of the defense that the named plaintiffs received in the counties where they were arrested and tried.
“The state has to get in the game,” he said. “They have to create a system that provides oversight and funding and supervision and actual staffing, all of which is designed and will ensure that every day of the week, poor people in court are represented.”
Officials in a fifth county originally named in the suit, Ontario, recently reached a settlement with the NYCLU under which that county agreed to enhance public defense services for the poor (NYLJ, June 27).
Corey Stoughton has been the lead counsel for NYCLU through most of the litigation. Pro bono lawyers at Schulte Roth & Zabel led by Gary Stein have worked in tandem with NYCLU attorneys from the case’s inception.
Assistant Attorney General Adrienne Kerwin will lead the defense team for the state at trial.
Leave a Comment July 16, 2014SHOW LESS..........
By: Verdict Search
*A Florida FEATURED Verdict*
Venue: Okaloosa County
Court: Okaloosa County County Court
arm; arm-scar and/or disfigurement, arm; head-ear; brain-coma; burns-third degree; burns-second degree chest; other-death; other-physical therapy; other-loss of parental guidance; face/nose-face; face/nose-scar and/or disfigurement, face; hand/finger-hand; surgeries/treatment-skin graft; mental/psychological; mental/psychological-anxiety; mental/psychological-depression; mental/psychological-emotional distress; mental/psychological-post-traumatic stress disorder; pulmonary/respiratory-respiratory
Wrongful Death – Survival Damages; Worker/Workplace Negligence – Negligent Training, Negligent Assembly or Installation
Michael C. Blanchard, as personal representative of and for the Estate of Michael R. Blanchard, deceased; Claudia Faye Boroughs; and William David Blanchard, a minor acting by and through his mother, guardian and next friend, Claudia Faye Boroughs v. Panhandle Plumbing Inc., Andrews Cooling & Heating Inc., Professional Moving Services of Northwest Florida Inc., Timm Shores, Linda Shores, and Okaloosa Gas District, No. 2010 CA 000611 S
Date: March 25, 2014
Michael C. Blanchard (Male, 22 Years),
Claudia Faye Boroughs (Female, 40 Years),
William David Blanchard (Male, 3 Years),
Estate of Michael R. Blanchard (Male, 49 Years)
Robert L. Mitchell; Cunningham Bounds, LLC; Mobile, AL, for Michael C. Blanchard, Claudia Faye Boroughs, William David Blanchard, Estate of Michael R. Blanchard ■ George W. Finkbohner III; Cunningham Bounds, LLC; Mobile, AL, for Michael C. Blanchard, Claudia Faye Boroughs, William David Blanchard, Estate of Michael R. Blanchard ■ T. Shane Rowe; Emmanuel Sheppard & Condon; Pensacoloa, FL, for Michael C. Blanchard, Claudia Faye Boroughs, William David Blanchard, Estate of Michael R. Blanchard ■ Warren R. Todd; Emmanuel Sheppard & Condon; Pensacoloa, FL, for Michael C. Blanchard, Claudia Faye Boroughs, William David Blanchard, Estate of Michael R. Blanchard
John Frost; P.E.; Safety; Huntsville, AL called by Robert L. Mitchell, George W. Finkbohner III, T. Shane Rowe, Warren R. Todd ■ Larry Ballard; C.B.O., M.C.P.; Inspection; Destin, FL called by Robert L. Mitchell, George W. Finkbohner III, T. Shane Rowe, Warren R. Todd ■ Arnold Luterman; M.D.; Burn Medicine; Mobile, AL called by Robert L. Mitchell, George W. Finkbohner III, T. Shane Rowe, Warren R. Todd ■ Deborah Simkin; M.D.; Child Psychiatry; Destin, FL called by Robert L. Mitchell, George W. Finkbohner III, T. Shane Rowe, Warren R. Todd ■ Catherine Brock; Life Care Planning; Fairhope, AL called by Robert L. Mitchell, George W. Finkbohner III, T. Shane Rowe, Warren R. Todd
Okaloosa Gas District,
Panhandle Plumbing Inc.,
Andrews Cooling & Heating Inc.,
Professional Moving Services of Northwest Florida Inc.
None reported; for Timm Shores, Linda Shores, Okaloosa Gas District ■ J. Michael Grimley Jr.; Galloway, Johnson, Tompkins, Burr and Smith A PLC; Pensacola, FL, for Panhandle Plumbing Inc. ■ Benjamin J. Zimmern; Galloway, Johnson, Tompkins, Burr and Smith A PLC; Pensacola, FL, for Panhandle Plumbing Inc. ■ Charles F. Beall Jr.; Moore, Hill & Westmoreland, P.A.; Pensacola, FL, for Andrews Cooling & Heating Inc. ■ Douglas S. Woodward; Moore, Hill & Westmoreland, P.A.; Pensacola, FL, for Andrews Cooling & Heating Inc. ■ Bobby L. Whitney Jr.; Seymour, Whitney & Pappas; Fort Walton Beach, FL, for Professional Moving Services of Northwest Florida Inc.
Paul Kinnunen; Engineering; Fort Myers, FL called by J. Michael Grimley Jr., Benjamin J. Zimmern ■ Geralyn Pennachio; Life Care Planning; Lakeland, FL called by J. Michael Grimley Jr., Benjamin J. Zimmern ■ Winston Richards; Burn Medicine; Gainesville, FL called by J. Michael Grimley Jr., Benjamin J. Zimmern
On Nov. 19, 2009, plaintiffs’ decedent Michael Blanchard, 49, and his partner, plaintiff Fay Boroughs, a woman in her 40s, were renting a residence at 217 Calhoun Ave. in Destin when a natural gas explosion ignited in the home’s laundry room. According to Boroughs, in February 2002, Andrews Cooling & Heating Inc. installed a gas dryer for the previous homeowners, Timm Shores and Linda Shores, who moved out of the residence in November 2006 and brought the gas dryer with them. When Boroughs and Blanchard moved into the residence in February 2008, they had an electric dryer installed where the Shoreses’ gas dryer was formerly located. Boroughs alleged that an open gas line was located where the gas dryer used to be. Boroughs alleged that the line had been installed by Panhandle Plumbing Inc., immediately prior to the installation of the Shoreses’ gas dryer. On the morning of the explosion, Boroughs turned on the furnace only to have natural gas escape through an uncapped gas outlet into the laundry room. The accumulation of gas was ignited minutes later with Blanchard and Boroughs within feet of the explosion’s epicenter. Blanchard later died from his injuries, and Boroughs suffered burn injuries to nearly 33 percent of her body. Boroughs and Blanchard’s estate sued Andrews Cooling, Panhandle and the Shoreses for claims of negligence. Boroughs also sued the gas provider for the home, Okaloosa Gas District, and the moving company the Shoreses hired that unhooked and moved their gas dryer, Professional Moving Services of Northwest Florida Inc. The plaintiffs, the Shoreses and Okaloosa Gas District resolved Boroughs’ and the estate’s claims prior to trial, and the defendants were subsequently dismissed. The plaintiffs and Professional Moving Services entered into a confidential high-low agreement, and the defendant proceeded to trial along with Andrews Cooling and Panhandle. Plaintiffs’ counsel maintained that Panhandle, despite its denial, installed the gas line in the Shoreses’ residence. There was no documentation or bills recovered to prove that Panhandle installed the gas line, but plaintiffs’ counsel maintained that Timm Shores (who testified over objection regarding his belief that Panhandle installed the line in his home) and Panhandle were engaged in a long-standing business relationship, in which Panhandle performed approximately 30 jobs for Shores’ contracting company, before and after the gas-line installation. Shores claimed that he thought he would be billed for the gas-line installation, but never was. Plaintiffs’ counsel asserted that it was Shores and Panhandle’s business relationship that prompted Panhandle to run 25 feet of copper line through two rooms and an attic, during a half-a-day job, for no charge. The plaintiffs’ expert in safety engineering opined that gas-safety codes require that a gas line be labeled in order to delineate which appliance the line is being used for. In the plaintiffs’ home, there was a source of gas coming out of the wall, with the gas line traveling in two directions: one to a heater and the other to another room. The expert said that there was no labeling on either side of the break in separation to indicate where the gas was going. He opined that Boroughs, before turning on the furnace, would not have opened both valves of the gas line. In addition to its failure to label the gas line, Panhandle did not install a safety shut-off valve in the laundry room, concluded the expert. Plaintiffs’ counsel faulted Panhandle for not acquiring a permit from the city of Destin before installing the gas line in the Shoreses’ residence. The plaintiffs’ expert in building inspection, who was Destin’s master-code inspector, discussed the history and purpose of the code, and opined that installation of the gas line would require an inspection under the regulations, and Panhandle never applied for a permit. Had Panhandle applied for a permit, city officials would have conducted an inspection that would have disclosed the problems of the line and prevented it from ever being used, he opined. Plaintiffs’ counsel contended that Andrews Cooling installed the Shoreses’ gas dryer without complying with the dryer’s installation instructions, which required the gas appliance only be installed to a gas line if the line was in accordance with the codes. According to plaintiffs’ counsel, Andrews Cooling admitted that it knew of code compliance but failed to train its employees to follow it, despite the dryer’s instruction manual explicitly instructing gas-code compliance. Plaintiffs’ counsel also contended that Professional Moving Services left the gas line open after it unhooked and moved the gas dryer. Defense counsel for Panhandle maintained that Panhandle did not install the gas line; there was a discussion with Shores to install a line, but it never materialized. Additionally, Shores admitted that he never saw Panhandle install the line, and that the failure to obtain a permit and the alleged failure to comply with safety code requirements was inconsistent with his long-standing experience with Panhandle Plumbing since the company always applied for permits and used a licensed master plumber to perform its gas jobs. Counsel for Andrews Cooling argued that an appliance installer owed no duty to inspect the existing gas line for defects. They maintained that, because the equipment used by Andrews Cooling to connect the dryer to the gas line had been removed prior to the explosion, there was no evidence that the dryer was not installed in accordance with the gas codes. They further argued that the cause of the explosion was the failure to cap the gas line when the dryer was removed six years after it was installed. Counsel for Professional Moving asserted that it did not disconnect the gas dryer, and that it was not its responsibility to ensure gas-piping systems were appropriately installed. Professional Moving also suggested that it did not, in fact, move the appliances in the residence.
Blanchard and Boroughs were taken by an ambulance to a hospital. Blanchard suffered burns to 98 percent of his body and was placed into a medically induced coma. The severity of the burns prevented any artificial skin grafting to occur, and Blanchard died three weeks later. His estate sought to recover $280,477.06 in past medical costs. Boroughs, suffering second- and third-degree burns throughout her body, was put into a medically induced coma for two weeks and placed on a ventilator, due to inhalation damage sustained by the blast. She received skin grafting to her hands, arms, chest, face and ears. Upon her discharge on Dec. 21, she underwent a month of occupational and physical therapies and continued wound-care treatment, in addition to receiving psychological counseling for post-traumatic stress disorder. She sought to recover $286,501.58 in past medical costs. In his testimony, Boroughs’ expert in burn medicine discussed the science of burns, the resultant pain, grafting procedures, psychological consequences, and the body’s reaction to burns, i.e., an increased metabolism. Boroughs, who requires cosmetic treatment in the future, said that she wears loose-fitting clothing to conceal her burns on her arms and chest, and wears a lot of makeup on her face. She said that she continues to take psychiatric medication to control her depression, anxiety attacks, post-traumatic stress disorder, and sleeplessness. She claimed that she occasionally tenses up when she hears sirens or sees anything fire-related, like fire trucks. She sought to recover unspecified amounts in non-economic damages for past and future pain and suffering. Boroughs and Blanchard’s son, William, was in the house at the time of the accident and sought damages for emotional distress. The plaintiffs’ expert in child psychiatry discussed the effects on William of growing up without a father. According to plaintiffs’ counsel, the testimony of Panhandle’s expert in burn medicine corroborated with the plaintiffs’ alleged damages and the degree of harm inflicted onto Boroughs and Blanchard.
The jury determined that Panhandle Plumbing and Andrews Cooling & Heating were each 30 percent negligent, Okaloosa Gas District 15 percent negligent, and the Shores 25 percent negligent. Jurors found that there was a physical impact to William Blanchard. No negligence was found against Professional Moving Services. The jury determined that the plaintiffs’ damages totaled $14,887,640.52.
Estate of Michael R. Blanchard: $280,477 Personal Injury: Past Medical Cost; Michael C. Blanchard: $1,500,000 Personal Injury: loss of parental companionship, instruction and guidance, pain and suffering; William David Blanchard: $4,260 Personal Injury: Past Medical Cost; $3,500,000 Personal Injury: loss of parental companionship, instruction and guidance; $2,500,000 Personal Injury: pain and suffering, mental anguish, and loss of capacity for the enjoyment of life; Claudia Faye Boroughs: $286,502 Personal Injury: Past Medical Cost; $6,000,000 Personal Injury: pain and suffering, disability, physical impairment, disfigurement, and mental anguish
Judge: Michael A. Flowers
This report is based on information that was provided by plaintiffs’ counsel and defense counsel for Andrews Cooling & Heating. Defense counsel for Panhandle Plumbing and Professional Moving Services of Northwest Florida did not respond to the reporter’s phone calls. Timm Shores, Linda Shores and Okaloosa Gas District were not asked to contribute.
Leave a Comment June 26, 2014SHOW LESS..........
by Jason Michael Cutright, an ALM Listing Expert
Unfortunately patients that have experienced work related spinal injuries follow a clinical pathway that is typically longer than the average private practice patient. Numerous scientific publications state the clinical outcomes of patients treated for work related spinal injuries are significantly poorer long term in regards to leg or arm pain, weakness, and or numbness when compared to patients involved in the spinal treatment clinical pathway provided by conventional third party payers.
Workers Compensation organizations tend to have a rigorous process for reporting possible work related injuries. In the case of a spinal injury resulting in a symptomatic pinched nerve a race against time before the onset of permanent nerve damage begins. Patients relying on workers compensation benefits to assume financial responsibility for their medical claims, have to not only seek medical treatment, but first prove to their employer’s workers compensation carrier that they have the right for benefits to be applied to their medical condition. This process of obtaining approval for workers compensation benefits can take up valuable time (several months) when a nerve is possibly at risk for permanent damage.
The tactics used by the workers compensation carriers to shake out false claims is understandable. However, it seems the stance that all workers compensation claims are false until proven legitimate can have long term consequences for these patients. Some legitimate claims lack witnesses or significant documentation while other legitimate workers compensation patients become frustrated by the process and abandon it altogether and seek medical treatment in other capacities. In either scenario a financial benefit to workers compensation is obtained. The patient with legitimate claims that perseveres through the approval process is usually physically too impaired to perform work. Before treatment on this patient population can begin the symptoms relating to their work related spine injury are usually more advanced than when they initially set out to seek medical treatment. In the clinical pathway, for patients whose medical financial obligations are tied to a conventional third party payer the valuable time wasted on an approval process is not a factor unless a primary care physician referral to a specialist is needed to satisfy HMO requirements. This extra step for the conventional third party payer environment only represents one extra patient encounter.
Once benefits are approved, the WC patient must only visit the physician approved by the workers compensation carrier. Once the treatment process begins, WC compensation patients cannot schedule tests, treatments, follow up appointments, and surgeries like normal conventional third party paid patients. Each future encounter must be approved by the workers compensation carrier prior to being scheduled. Other potential delays in the WC clinical pathway come by way of peer to peer conferences between the treating physician and the approving physician for the WC carrier.
The significantly poorer long term clinical outcomes of workers compensation spine claim patients compared to the long term clinical outcomes of patients who have entered the medical care system by way of a conventional third party payer can also be linked to the following statistics. The majority of workers compensation claims are filed by employees that perform physical tasks and are at a higher risk of injury than employees who are assigned to a desk full time. Published scientific data suggest long term professional physical labor can be a catalyst for degenerative disc disease. This condition can make the disc more vulnerable to a disc injury causing a pinched nerve and make the employee’s spinal column more prone to developing spinal stenosis due to a loss of disc height at multiple levels. Using return to work as a metric of comparison is not in favor of most WC spinal injury patients also due to the physical nature of the employed position in which they were functioning.
Chronic degenerative spine diseases have been linked to permanent nerve damage in the regions of the central or peripheral nervous systems. Patients that have been treated well after the onset of a symptomatic pinched nerve vs those who are treated immediately experience a higher instance of nerve damage. The scientific publications that deal with patient spinal treatment clinical outcomes with respect to the workers compensation population have not addressed the lag time or extra measures and the amount of time that is spent on them.
In conclusion, workers compensation patients experience an approval process that wastes valuable time when a nerve is at risk for permanent damage. Can this process be negligent in the cases of permanent nerve damage if a timely intervention could have save the nerve from permanent damage?
Reposted with permission from author.
Jason Michael Cutright
Cutright Legal Consulting
Leave a Comment June 12, 2014SHOW LESS..........
head-closed head injury
Motor Vehicle – Lane Change
Products Liability – Automobiles, Design Defect, Crashworthiness, Manufacturing Defect
Paul Allred, Sr. and Jimmy Lou Reeves Allred v. American Honda Motor Co., Inc., TK Holdings Inc., and John Parker, No. 117,886
January 31, 2014
Paul Allred Sr. (Male),
Paul Day Allred Jr. (Male, 18 Years),
Jimmy Lou Reeves Allred (Female)
Gerald L. Burnett; ; Shreveport, LA, for Paul Allred Sr., Jimmy Lou Reeves Allred
Brian Benda; Ph.D; Biomechanical; Penns Park, PA called by Gerald L. Burnett
Michael Markushewski; Ph.D; Accident Reconstruction; New Town, PA called by Gerald L. Burnett
TK Holdings Inc.,
American Honda Motor Co. Inc.
Joel H. Smith; Bowman and Brooke LLP; Columbia, SC, for TK Holdings Inc., American Honda Motor Co. Inc.
Courtney Crook Shytle; Bowman and Brooke LLP; Columbia, SC, for TK Holdings Inc., American Honda Motor Co. Inc.
Brooks Miller; Bowman and Brooke LLP; Columbia, SC, for TK Holdings Inc., American Honda Motor Co. Inc.
Guyton Valdin; Duplass, Zwain, Bourgeois, Pfister & Weinstock; New Orleans, LA, for TK Holdings Inc., American Honda Motor Co. Inc.
Dennis Guenther; Accident Reconstruction; Columbus, OH called by Joel H. SmithThomas McNish; Biomechanics of Injury; San Antonio, TX called by Joel H. SmithMichael Klima; Seat Belts; Novi, MI called by Guyton Valdin
Self-Insured for American Honda Motor Co. and TK Holdings Inc.
On Aug. 21, 2004, plaintiff Paul Allred Jr., 18, was driving his 1995 Honda Accord on a secondary highway in Benton, Ill. A 1994 Ford Explorer driven by John Parker suddenly crossed into Allred’s lane, striking the Accord on the left front fender. Allred sustained injuries to the left side of his body. He also sustained a closed head injury to his right side, which proved to be fatal.
Paul Allred Sr. and Jimmy Lou Reeves Allred, on behalf of their son, sued Parker, alleging negligence in the operation of his motor vehicle, causing Allred’s death. The plaintiffs also sued American Honda Motor Co. Inc., the manufacturer of the vehicle Allred was driving, and TK Holdings Inc., the manufacturer of the seat belt Allred was wearing, on a products liability theory, alleging that defects with the Honda caused him to sustain a fatal injury. The plaintiffs’ claim was changed to Jimmy Lou Reeves Allred, individually and as successor-in-interest to Paul Allred Sr., after Allred Sr. passed away before the conclusion of the litigation.
The claim against Parker was severed from the litigation. The separate case has yet to go to trial.
Plaintiff’s counsel alleged that, when the vehicles collided, the Ford Explorer intruded into the Accord. He alleged that Allred’s head injury occurred when his body lurched forward after impact and struck the Accord’s sun visor.
According to plaintiff’s counsel, the 1995 Honda Accord structural’s elements were inadequate to withstand the crash. He contended that Allred was traveling 15 mph at the time of the collision, and based on the force of the collision at that rate of speed, Allred should have walked away uninjured from the collision instead of sustaining a fatal injury.
Prior to the trial, the judge dismissed the claims regarding the structure of the vehicle, leaving only the seat-belt claim.
Plaintiff’s counsel contended that the seat belt Allred was wearing failed to properly lock, instead allowing additional webbing to release from the contractor when the collision occurred.
According to testimony from the plaintiff’s severity analysis expert, the seat belt in the Accord failed tests, indicating that there was slack in the shoulder belt when the collision happened.
The plaintiff’s biomechanical expert testified that Allred’s head injury resulted from his striking the sun visor.
Defense counsel disputed the plaintiff’s claims. They contended that both vehicles were traveling at approximately 30 mph, sufficient enough to cause a fatality in the collision. They contended that the seat belt in question operated properly, and was not a contributing factor to the fatality. They contended that the seat belt did not release excessive webbing during the accident, and did not contribute to or proximately cause Allred’s fatal injuries.
The defense’s seat-belt design expert testified that the seat belt was not unreasonably dangerous, and worked properly in the accident. He opined that there was no excessive release by the belt. The defense’s biomechanical expert testified that the Explorer intruded enough to cause Allred’s head to turn to his right and strike the structure of the vehicle.
Defense counsel contended that there were no witnesses at the scene that saw anything unusual about Allred’s position after the collision occurred.
After the collision, Allred was transported by helicopter to Louisiana State Health Science Center Shreveport, where emergency head and brain surgery was performed for his closed head injury. He was pronounced dead the next day.
Allred’s mother sought recoveries for wrongful death and conscious pain and suffering. The survival action was not presented to the jury. Plaintiffs’ counsel did not present any number to the jury for the alleged damages.
Defense counsel disputed the survival action, contending that Allred was not conscious or responsive after the collision. They argued that there was no evidence of conscious pain and suffering for Allred.
The jury rendered a verdict in favor of Honda and TK Holdings.
Judge: A. Parker Self
Trial Length: 5 days
Trial Deliberations: 15 minutes
Leave a Comment May 9, 2014SHOW LESS..........
Pfizer Seeks to Winnow Experts in Zoloft MDL
Saranac Hale Spencer, The Legal Intelligencer
Both sides in the Zoloft MDL focused on the testimony of plaintiffs expert Dr. Anick Berard and her assertions that Zoloft causes birth defects as the Daubert hearing got started Monday.
Berard, a professor at the University of Montreal who researches the effect of medications on pregnancy, is an expert witness presented by the plaintiffs in the cases alleging that the Pfizer antidepressant Zoloft causes birth defects in the babies born to women who took the drug while pregnant.
“The real issue for this court … hotly debated by both sides [is] when we’re talking about birth defects, is there a difference between SSRI drugs” or can you lump them together and treat them as a class, said Sheila Birnbaum, a partner with Quinn Emanuel Urquhart & Sullivan in New York who is on Pfizer’s defense team. She was referring to antidepressant drugs that operate as “selective serotonin reuptake inhibitors” and showed a slide that pictured the chemical compounds for five different SSRIs, including Paxil and Zoloft, all of which looked different.
“They’re very different,” Birnbaum said, building the defense’s argument that SSRI drugs can’t be treated as a class of medicines with shared characteristics and effects.
Outside of the courtroom, though, Pfizer believes that SSRIs operate the same way, said Sean Tracey, of the Tracey Law Firm in Houston who is on the plaintiffs steering committee, in his introduction to the court.
“Why?” he asked. “Because it’s true.”
When Pfizer was trying to get Zoloft approved for use by juveniles in Europe, regulatory agencies there ordered it to perform various studies, to which it responded that pharmaceutical company Eli Lilly had already done those studies and Zoloft would perform similarly, Tracey said, adding, “And they’re right.”
From the start of the litigation, said Quinn Emanuel lead defense lawyer Mark Cheffo, the plaintiffs have said, “‘We’re lumpers, we’re going to lump everything together’… and, frankly, Dr. Berard is a lumper as well.”
Berard maintains that a host of more than a dozen birth defects—from problems with the development of the heart to club feet—are attributable to Zoloft and similar SSRIs, Cheffo said.
“What’s particularly troubling, well, troubling and instructive here, is that Dr. Berard looked at the same data that the world’s scientists and professional organizations and regulatory agencies have looked at, yet she’s come to the conclusion that Zoloft causes all of these birth defects, where all of the other scientists and professional organizations and regulatory agencies have determined that it doesn’t even cause one of these birth defects,” Cheffo said. “It’s Dr. Berard against the world.”
Tracey shot back during his introduction, saying that Berard isn’t “an island.” He pointed out that the defense hasn’t questioned her credentials, but, rather, her conclusions.
Berard has published more than 100 papers on issues in this case, Tracey said, and Pfizer Canada has given her grant money.
Berard is the only perinatal epidemiologist offered to the court in this litigation and, Tracey said, Pfizer, “with all their influence, all their money, all the experts they issue grants to each and every year” weren’t able to get a perinatal epidemiologist to be an expert for the defense.
Birnbaum relied on the U.S. Food and Drug Administration’s treatment of Zoloft, which was approved in 1991 and has been on the market since 1992.
She noted that the FDA put Paxil in category D for medications during pregnancy, a higher-risk category than C, where Zoloft and other SSRIs are situated. She read that as meaning that the FDA doesn’t see Zoloft as a risk to fetuses.
Tracey, though, pointed to the low budget and short resources of the FDA and said, “Believe it or not, the FDA gets things wrong sometimes.”
Topamax, a drug that treats epilepsy and migraines and has been the target of another major litigation brought by mothers who took the drug while pregnant and gave birth to children with defects, was marketed as a category C drug for 12 years, Tracey said.
In 2009, for litigation over GlaxoSmithKline’s antidepressant drug Paxil, Berard had said that antidepressant drugs like Zoloft, as opposed to Paxil, were suitable first-line treatments for pregnant women with depression, Birnbaum told the court.
Now, in this multidistrict litigation, Berard will testify that Zoloft, too, can cause birth defects, Birnbaum said.
“We believe these are litigation-driven opinions,” she said.
Responding to that characterization of Berard, Tracey said, “They have accused our experts, each and every one of them, of coming into court with litigation opinions, whatever that means.”
“The way I, essentially, take litigation opinions is: They’re getting paid to say something,” he said, before launching into a discussion of the methodology used by all four of the plaintiffs’ experts, including Berard.
U.S. District Judge Cynthia Rufe of the Eastern District of Pennsylvania is handling the case and invited Philadelphia Court of Common Pleas Judge Lisa Rau, who is handling all of the Zoloft cases on the Philadelphia docket, to sit.
Leave a Comment April 14, 2014SHOW LESS..........
Eric Gould Bear, patent inventor and ALM listing expert, discusses the case Alice v. CLS Bank for IPWatchdog.com. In this three part interview, Bear gives expert insight on a case the New York Times says has, “the potential to reshape the software industry.”
Read part 1 of this informative interview here.
Leave a Comment April 2, 2014SHOW LESS..........
By Verdict Search
*A D.C Metro FEATURED Verdict*
Venue: Carroll County
Court: Carroll County, Circuit Court
Case Type: Medical Malpractice – OB-GYN, Surgical Error
Case Name: Stella Mae Richardson v. Steven Miller, M.D., No. 06C12061714
Date: November 19, 2013
Stella M. Richardson (Female, 73 Years)
Mark E. Rosasco; Hyatt & Weber; Annapolis, MD, for Stella M. Richardson
Adam G. Smith; Hyatt & Weber; Annapolis, MD, for Stella M. Richardson
Robert Lobel; M.D.; Urology-Female; Albany, NY called by Mark E. Rosasco, Adam G. Smith
Steven Frank; M.D.; Critical Care; Macon, GA called by Mark E. Rosasco, Adam G. Smith
Steven Miller, M.D.
Conrad W. Varner; Varner & Goundry PC; Frederick, MD, for Steven Miller, M.D.
Joel Bowers; Radiology; Silver Spring, MD called by Conrad W. VarnerPaul Lin; General Surgery; Washington, DC called by Conrad W. VarnerDonovan Dietrick; OB-GYN; Baltimore, MD called by Conrad W. Varner
Insurer(s): Medical Mutual for Miller
Plaintiff Stella Mae Richardson, 73, a store clerk, was referred to defendant OB/GYN, Steven Miller, M.D., for removal of a pelvic mass. Dr. Miller performed the surgery, following which Richardson experienced complications, including peritonitis. She claimed permanent residuals as a result of the complications.
Richardson sued Dr. Miller for medical malpractice. She alleged that Dr. Miller perforated her bowel during the surgery, resulting in serious complications. Plaintiff asserted that perforation of the bowel was a trocar injury, which she argued was a violation in the standard of care.
Defendant contended that the plaintiff did not suffer a trocar injury and that the surgery was performed according to the accepted standards of care. Defendant argued that peritonitis is a known risk of the surgery.
Plaintiff suffered complications following the removal of a pelvic mass, including peritonitis, and cardiac and respiratory difficulties.
Defendant did not dispute that the plaintiff suffered complications, but argued that the complications were not caused by negligence.
The jury returned a defense verdict.
Judge: Lawrence Daniels
Trial Deliberations: 6 hours
This report is based on information that was provided by defense counsel. Plaintiff’s counsel did not respond to a request for comment.
Leave a Comment March 27, 2014SHOW LESS..........
Saranac Hale Spencer, The Legal Intelligencer
Two expert witnesses, one for a coal-fired power plant and one for the people who allege that it polluted the surrounding area, will be allowed to testify about their air modeling reports, a federal judge has ruled.
Three related cases were consolidated for discovery after dozens of people who live near the Bruce Mansfield Power Plant in Shippingport, Pa., filed suit against the plant when white and black rain fell on the area, allegedly causing property damage and health problems.
“Two of the key issues in these cases are the extent of the area affected by the white rain and the two black rain events and the amount of material deposited by those events,” said U.S. District Chief Judge Joy Flowers Conti of the Western District of Pennsylvania in Hartle v. FirstEnergy Generation. “The parties seek to introduce air modeling experts to opine about these issues,” she said.
FirstEnergy Generation owns the Bruce Mansfield plant and the lead plaintiffs in the other two cases are David and Rikki Patrick and Robert and Carol Price.
The two experts each used a different model as a method for assessing the level and range of pollutants contributed by the plant to the white rain. Each side argued that the other’s expert used the wrong model.
The judge held that neither model is perfect, but that doesn’t preclude either expert from testifying.
“Which of the competing models better reflects the facts of these cases is a matter for the jury to decide,” Conti said.
The third expert witness, who had been offered by the plaintiffs and was challenged by the power plant, will be excluded from testifying, though.
Nicholas Cheremisinoff, a chemical engineer with expertise in fluid dynamics, didn’t do his own air modeling but, rather, reviewed the reports submitted by Ronald Petersen, the plaintiffs’ main expert, and Peter J. Drivas, the defendant’s expert.
“Cheremisinoff’s evaluation of Petersen’s white rain opinions amounts to vouching for Petersen and is cumulative to Petersen’s testimony. Cheremisinoff is not an air modeler,” Conti said.
“Because Cheremisinoff’s opinions are unnecessarily cumulative and would not help the trier of fact, defendant’s motions to preclude his expert testimony will be granted,” the judge ruled.
Both Petersen and Drivas will be allowed to testify, though.
Petersen, for the plaintiffs, used a model called AERMOD to examine the range of the white rain. That model is preferred by the U.S. Environmental Protection Agency for regulatory air dispersion modeling, Conti said.
“To predict white rain deposition, Petersen entered inputs for emission rates, droplet size, stack flow rate and temperature, and meteorological conditions,” according to the opinion. “Petersen ran the model under three different operating scenarios to reflect changes to the plant over time. For each of the three scenarios, Petersen produced maps with contour lines outlining areas where white rain was deposited at a given level. Petersen mapped deposition for several time periods: total annual deposition, maximum 24-hour deposition, and maximum one-hour deposition.”
However, the power plant’s expert, Drivas, argued that AERMOD is the wrong model to use in this case because it is meant for dry particulates gases and doesn’t take into account the evaporation for the wet droplets in this case.
Petersen made some adjustments to the model to account for evaporation, which the judge found to be satisfactory.
“While defendant may quarrel with the accuracy of Petersen’s handling of evaporation, this goes to credibility or weight, not admissibility,” Conti said.
Drivas, on the other hand, used a model called AGDISP that was made to model airborne spray pesticides, according to the opinion.
“Using AGDISP, Drivas calculated that over 95 percent of water droplets released from the Bruce Mansfield stacks will evaporate in the air and that almost all droplet deposition occurs within 1,500 feet of the stack,” Conti said. “At a distance of one-half mile from the stacks, less than 2 percent of released water droplets remain aloft. AGDISP predicted that these remaining droplets evaporate in less than 10 seconds, leading to no deposition beyond one-half mile from the stacks.”
The plaintiffs discredit Drivas’ use of the AGDISP model by arguing that it isn’t a reliable method for measuring raindrops and that the EPA recommends the AERMOD model for predicting dispersion of air and pollution from power plants, according to the opinion.
“Since these cases do not directly involve regulatory action and since AERMOD is less appropriate for measuring wet droplets than criteria air pollutants, the EPA guideline does not justify the exclusion of AGDISP as scientifically unreliable,” Conti said.
Neither method is perfect in this situation, Conti held, saying that it isn’t up to the court to decide which is superior.
(Copies of the 23-page opinion in Hartle v. FirstEnergy Generation, PICS No. 14-0409, are available from The Legal Intelligencer. Please call the Pennsylvania Instant Case Service at 800-276-PICS to order or for information.) •
Leave a Comment March 19, 2014SHOW LESS..........