Thursday, January 30, 2014

Risperdal lawsuit documents could be sealed

Risperdal lawsuit documents could be sealed


Important Risperdal lawsuit risperdal-johnson-johnsondocuments could be sealed if the manufacturer of the drug has its way with the Philadelphia County Court of Common Pleas.
One of Johnson & Johnson’s latest moves in the company’s ongoing fight to defend its research and promotion of Risperdal is to hide its research and promotion. The company is claiming – in the Philadelphia County Court of Common Pleas where 275 Risperdal cases now sit ready for trial – that it has proprietary rights which allow it to keep its Risperdal research sealed from the public. Because this information concerns the very same public targeted by J & J to use Risperdal, this argument seems of dubious merit at best.
Johnson & Johnson has already paid billions of dollars to settle federal and state allegations that it illegally marketed its drug Risperdal. More than 420 lawsuits have been filed in state courts against Johnson & Johnson over Risperdal. The suits allege that the drug stimulates breast growth and milk production in boys and young men.
Johnson & Johnson’s response to the lawsuits, claiming it has the right to keep the research behind Risperdal from the public and from plaintiffs’ lawyers, comes from a company statement which says, the research “materials are generated for scientists, researchers and regulatory authorities – not the general public. Simply stated, no legitimate purpose would be served by declassifying the documents identified by plaintiffs.”
Lawyers for plaintiffs, meanwhile, have argued to the court that the documents J & J seeks to hide are too vital to the public interest not to be released to the public, “and the data and materials being hidden by Janssen (a division of J & J) outweighs defendants’ claims to secrecy.’ The lawyers argue they cannot be hidden as they are safety documents requiring full disclosure for the well being of the public, as well as “full and unfettered review by regulatory authorities and the education of healthcare providers who are prescribing this powerful drug.”
Plaintiffs further argue that Risperdal’s maker has repeatedly misrepresented the drug’s safety to regulatory authorities, healthcare providers and the public. “Janssen systematically under-reported or misrepresented clinically important study results” relating to the chances of children and adolescents developing gynecomastia from Risperdal. However, says plaintiffs’ lawyers, this misrepresentation is currently “protected behind the shield of the protective order entered in this case.”
A hearing was held on Dec. 16, but so far no decision has been made on the matter.

Contact a Risperdal Lawyer Today

Risperdal lawsuit documents could be sealed

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Important Risperdal lawsuit risperdal-johnson-johnsondocuments could be sealed if the manufacturer of the drug has its way with the Philadelphia County Court of Common Pleas.
One of Johnson & Johnson’s latest moves in the company’s ongoing fight to defend its research and promotion of Risperdal is to hide its research and promotion. The company is claiming – in the Philadelphia County Court of Common Pleas where 275 Risperdal cases now sit ready for trial – that it has proprietary rights which allow it to keep its Risperdal research sealed from the public. Because this information concerns the very same public targeted by J & J to use Risperdal, this argument seems of dubious merit at best.
Johnson & Johnson has already paid billions of dollars to settle federal and state allegations that it illegally marketed its drug Risperdal. More than 420 lawsuits have been filed in state courts against Johnson & Johnson over Risperdal. The suits allege that the drug stimulates breast growth and milk production in boys and young men.
Johnson & Johnson’s response to the lawsuits, claiming it has the right to keep the research behind Risperdal from the public and from plaintiffs’ lawyers, comes from a company statement which says, the research “materials are generated for scientists, researchers and regulatory authorities – not the general public. Simply stated, no legitimate purpose would be served by declassifying the documents identified by plaintiffs.”
Lawyers for plaintiffs, meanwhile, have argued to the court that the documents J & J seeks to hide are too vital to the public interest not to be released to the public, “and the data and materials being hidden by Janssen (a division of J & J) outweighs defendants’ claims to secrecy.’ The lawyers argue they cannot be hidden as they are safety documents requiring full disclosure for the well being of the public, as well as “full and unfettered review by regulatory authorities and the education of healthcare providers who are prescribing this powerful drug.”
Plaintiffs further argue that Risperdal’s maker has repeatedly misrepresented the drug’s safety to regulatory authorities, healthcare providers and the public. “Janssen systematically under-reported or misrepresented clinically important study results” relating to the chances of children and adolescents developing gynecomastia from Risperdal. However, says plaintiffs’ lawyers, this misrepresentation is currently “protected behind the shield of the protective order entered in this case.”
A hearing was held on Dec. 16, but so far no decision has been made on the matter.

Contact a Risperdal Lawyer Today

If you have been injured by a Risperdal schedule your free initial consultation online or call us at 508-499-3366

Tuesday, January 28, 2014

Topamax Verdicts for Plaintiffs

Topamax Verdicts for Plaintiffs


Two Topamax verdicts topamax_lawsuitfor plaintiffs came last year. Johnson & Johnson’s Janssen Pharmaceuticals was ordered by a Philadelphia jury in November 2013 to pay $11 million for a case involving the anti-seizure drug Topamax and birth defects; and in a case the month before, a jury ordered the company to pay $4.02 million for a similar Topamax birth defects case.
Jurors in November found Janssen failed to properly warn doctors for Haley Powell, who took Topamax in the first trimester of a pregnancy which resulted in her son’s being born with a cleft lip.
An attorney for Ms. Powell said that Janssen had long known that the epilepsy drug Topamax causes debilitating birth defects, yet the company, “intentionally kept this information from physicians and patients.”
The Powell verdict likely surprised defendants, as the case was hand-selected by them to go to trial. It was the second of more than 130 cases pending in Philadelphia over Topamax.
Janssen lost a $4.02 million verdict the month before in a lawsuit brought by a Virginia woman, April Czimmer, for birth injuries suffered by her son. Ms. Czimmer and other plaintiffs are blaming Janssen for failing to adequately warn expectant mothers of Topamax’ risk of causing birth defects that include cleft lip and cleft palate.
Janssen’s attorneys argued that both women were adequately warned of Topamax’ dangers.
The next Topamax trial is scheduled in Feb. 2014 in the same Philadelphia state court.
If you have been injured by a Topamax schedule your free initial consultation online or call us at 508-499-3366.

First Transvaginal Mesh Trial against J & J

First Transvaginal Mesh Trial against J & J


Johnson & Johnson TVT Case set for W. Va. MDL
The first transvaginal mesh trial against J & J for a suburethral sling product will be jointly tried by Matthews & Associates and Freese & Goss. The trial is set to begin Feb. 10, 2014 in the multi-district litigation court (MDL) in Charleston, West Virginia.
The case involves a Texas woman who was implanted with J & J’s Gynecare TVT mesh sling, a transvaginally implanted polypropylene tape used as a suburethral sling for stress urinary incontinence (SUI).
Shortly after the mesh was implanted in 2009, the woman experienced severe pelvic pain and dyspareunia (painful intercourse). An MRI of her pelvis revealed abnormal tissue between the posterior urethra and anterior vaginal wall, which was reportedly either granulation tissue from the body’s reaction to, or its rejection of, the mesh, or sling placement. She also reported urinary frequency and urgency issues, as well as a weak stream.
The woman later underwent surgery to remove the transvaginal suburethral tape, at which time it was discovered that clear plastic along with blue mesh-like material was embedded throughout her natural body tissues.
The difficulty removing the synthetic plastic material when problems arise can cause serious problems. The result can be a lifetime of pain for the unlucky woman in whom the material was implanted.
Matthews & Associates and Freese & Goss charge that Johnson & Johnson failed to properly warn the woman of the difficulty of having the mesh removed in the event that the body rejects it, or in the event that the product causes more problems than it solves, including the chronic pain which she now experiences daily.
The trial is expected to last at least two weeks.
If you have been injured by a mesh implant schedule your free initial consultation online or call us at 508-499-3366.

Thursday, January 23, 2014

Testosterone Injuries examined by FDA

Testosterone Injuries examined by FDA


The FDA made a Safety androgel pictureAnnouncement today regarding Testosterone Therapy. FDA is evaluating the risk of stroke, heart attack and death regarding FDA-approved testosterone products.
The agency announced that it is has been monitoring the risk and has decided to reassess the safety issue of testosterone supplementation based on two studies which suggested an increased risk of cardiovascular events in groups of men who took testosterone therapy.
The FDA said it has not concluded that testosterone therapy increases the risk of cardio events, but that it will give its final conclusion and recommendations after a review of the current research literature.
The agency also pointed out in the alert that testosterone therapy products are approved only for men with low testosterone levels who also have an associated medical condition. These conditions can include testicular failure in producing testosterone due to genetic problems or chemotherapy. Brain structures such as the hypothalamus and pituitary can also affect testosterone output, controlling the testicles’ testosterone production.
The first publication the FDA mentions in the alert is the U.S. Veterans Affairs health system study published in Nov. 2013 in the Journal of the American Medical Association (JAMA). That study found a 30 percent increased risk of stroke, heart attack, and death in the men who had taken testosterone therapy.
The second study referenced by FDA found increased risk of heart attack in older men taking testosterone therapy, as well as in younger men with pre-existing heart disease. This study found a two-fold increase in heart attack risk among men 65 years and older in the first 90 days after the first prescription. Men under 65 who had a pre-existing history of heart disease had a two- to three-fold increased heart attack risk in the first 90 days after their first prescription. Younger men who took testosterone therapy but had no history of heart disease had no increased risk of heart attack.
PI Law Group is investigating “Low T” or Testosterone Injury Claims. schedule your free consultation on line for a potential Testosterone Lawsuit or call: 508-499-3366.

Wednesday, January 22, 2014

** HE SAID / SHE SAID **: ** How to Keep Liars Out of Court ** by Jonathan Marin

** HE SAID / SHE SAID **:

Overview
In recent years, frequent exposure of wrongful criminal convictions and mistaken verdicts in prominent civil cases have attracted media attention, and become a matter of public concern. Together with widespread accusations of domestic violence associated with matrimonial litigation, they have reinforced the belief that attorneys, including prosecuting attorneys, often willingly and even eagerly make use of highly suspect testimony. The Ramparts police perjury scandals in Los Angeles, and similar scandals in Illinois, West Virginia, and other states, have heightened public awareness of the untrustworthiness of testimony by police and informants, especially jailhouse informants and accomplices testifying under plea agreement. Corrolary to the public awareness of official misconduct has been a high volume of accusations against law enforcement officers, and public skepticism when, as usually happens, the officers are cleared.  While the accusations are pending, however, they are a source of anxiety and distraction for innocent officers. The volume of accusations, together with the "he said /she said" nature of most cases and the presumed credibility of an officer vis a vis an accused criminal, create a screen behind which the occasional rogue cop can successfully hide, sometimes for years. This article looks at how a novel, limited use of polygraph results might be used to address the problems.
Whenever a question has been debated for a long time, where champions of both sides are intelligent, in good faith, and fully informed as to the facts, there is a high probablility that it is the wrong question. The polygraph debate has centered on the question of whether polygraph results should be admitted as evidence in court. This article sidesteps the traditional positions of both proponents and opponents of this use of the polygraph and instead asks the question: "In light of what is known about its validity and reliability, how can the polygraph best be used?".  A strong case emerges for an innovative, but sound, "third way."  Some constituencies of both groups may perceive the proposal as a threat to their interests. Nevertheless, I think this "third way" is a reform worth fighting for, in order to restore public confidence in testimony by police officers and cooperating witnesses and to prevent miscarriages of justice.
The article addresses the issues and problems--scientific, legal, and social--that surround the use of polygraph evidence in court and suggests an approach to its use that I think safely navigates the minefield they present. It presents the idea that paired polygraph results should be used to screen out or impeach untrustworthy testimony.
Courts should exclude testimony from a witness who has tested "deceptive" where--and only where--that result is corroborated by a "nondeceptive" result on the opposing side ("paired results"). Using only paired results resolves the unquantifiable uncertainties and reduces by a factor of at least 5 the quantifiable uncertainties that underlie most legitimate resistance to the polygraph. If individual examination results are incorrect 15% of the time, then after correction for inconclusive results the probability that two together will be in error is less than 4.0%. Examinations should be conducted by examiners who have personally proven their proficiency at 85% of conclusive results or better, with no more than 20% inconclusive.
Juries make mistakes. Evidence that has at most a 4.0% likelihood of being true is too untrustworthy to warrant submitting it for their consideration. Excluding it will reduce the incidence of perjury and the number of mistaken verdicts. It will discourage frivolous claims and frivolous defenses, thereby reducing court caseloads and backlogs. Wherever possible, the decision to exclude should be made before trial.
The article addresses broad problems of admissibility, impeachment, and exclusion of evidence affecting both civil and criminal cases. In respect to criminal cases, it considers the constitutional implications of the approach, particularly those having to do with the right against self-incrimination. It also analyzes alternative approaches and their drawbacks.
HE SAID / SHE SAID: Polygraph Evidence in Court
INTRODUCTION
In many court cases, civil as well as criminal, the two sides present witnesses whose factual claims clash. Both cannot be telling the truth. A woman swears she was raped; the defendant swears it was consensual. An arrested suspect charges that police used excessive force; the officers deny it. A jailhouse "informant" swears that the defendant confessed a murder to him; the defendant swears it isn't so. In these situations, polygraph results may prove invaluable, if used correctly.
Polygraph results are no longer barred from the courtroom. The Supreme Court has left it to the courts of each jurisdiction to determine how and when to allow it, or to exclude it altogether [United States v. Scheffer, 523 U.S. 303 (1998)]. I believe that the courts' safest, simplest, and most productive use of the polygraph is to exclude testimony about a fact from any witness who has tested "deceptive" about that fact whenever a witness from the opposing side has tested "nondeceptive" about that fact. No jury would ever hear, or hear of, the polygraph results themselves. A witness's refusal to submit to a polygraph examination on any factual claim would be treated as a "deceptive" result in regard to that claim in civil cases; it would be treated similarly in criminal cases except where the refusing witness is a defendant.
A defendant would have the right to demand that a jailhouse informant be polygraphed concerning an alleged confession and to be polygraphed himself. If the informant refused to take the test, his testimony would be inadmissible. If the informant tested positive for deception, and the defendant negative, then the informant's testimony would be inadmissible. If the defendant did not demand that the informant be tested, or the test produced any other combination of results, the informant's testimony would be admissible, and, except that neither side would be allowed to make any reference to the polygraph, he would be subject to cross-examination as any other witness.
Polygraph results are unreliable to some degree. How a polygraph chart is interpreted can depend on the thresholds of physiological variance above which a response will be called "deceptive" and below which it will be called "nondeceptive." (Responses falling between the thresholds are called "inconclusive.") It will be the court's responsibility to determine that the thresholds and the conditions under which tests have been given are in accordance with the standards enforced by federal agencies or ASTM.  Results should be accompanied by an unedited beginning-to-end videotape of the examination. Determination of examiners' competence should not be based on their academic credentials, their years of experience, or the number of tests they have conducted, but on their proven accuracy in studies where the protocol and number of subjects are comparable to those in the published peer-reviewed literature.
RELIABILITY, VALIDITY, AND THE POWER OF PAIRING
Eight recent studies - four field and four laboratory - that sought to quantify polygraph tests' accuracy found both false positives and false negatives to be less than 10% [Honst, US v Scheffer (Amicus)]. "Accuracy" can be misleading, however, especially where the proportion of subjects who are in fact telling the truth is high. Suppose that from a sample of 100 subjects, of whom only 1 is "deceptive," a test found 2 of the subjects to be "deceptive." It could claim 99% accuracy (if one of them was the deceptive subject). Impressive. But the likelihood that a failing subject had actually been deceptive would be only 50%. The field studies cited in Honst (average false positive rate = 9.5%) imply that the 50% figure probably does approximate the ratio of false positives to true positives in the real world of criminal investigations. That figure is far too high to allow  the results of individual tests, standing alone, to be admitted into evidence.
Drawing correct inferences from stand-alone results requires knowledge about the relevant samples that is rarely possible outside the laboratory and an understanding of statistical inference that is beyond the experience of jurors. Admitting single results can easily clear the guilty and imperil the innocent. When two people dispute a fact within the personal knowledge of both, however, usually one is telling the truth and the other is lying. Pairing results therefore assures the balanced samples necessary to support sensible inferences. Even allowing for a modest percentage of witnesses who are honestly mistaken, and of cases where both are lying, the known accuracy of the test can be safely applied. When results are paired and the second result confirms the first, then according to probability theory the probability of an erroneous conclusion is the product of the two individual probabilities. Since no testimony will be excluded when both subjects pass or when both fail, the procedure operates under an effective base rate of 50%. Conservatively supposing the tests' individual probability of error to be as high as 15%,  the probability that confirmed "deceptive" testimony would be true would be under 4.0% (0.15 x 0.15 = 0.225 * 1.5 (to adjust for inconclusives) < 4.0%), and the probability that it would be false would therefore be >96.0% (100 - 4.0 = 96.0%).
Numerical Examples:
Suppose paired testing were implemented to exclude testimony from any subject found to be "deceptive" regarding facts where a contradicting witness has tested "non-deceptive" about those facts. Here are examples of the numerical consequences that would ensue assuming 80%, 85%, and 90% accuracy respectively, per 100 pairs where a conclusive result is obtained for both subjects.  
+ means exclusion increased the likelihood of a just result
- means exclusion increased the likelihood of an unjust result
= means no exclusion (same as under present system)
Supposing 80% accuracy:
80 Non-deceptive subjects correctly identified
    64 (of deceptives paired to the 80) correctly identified, properly excluded (+)
    16 (of deceptives paired to the 80) incorrectly identified, neither subject excluded (=)
20 Non-deceptive subjects, incorrectly identified
     4 (of deceptives paired to the 20) incorrectly identified, wrong subject excluded (-)
    16 (of deceptives paired to the 20) correctly identified, neither subject excluded (=)
TOTALS (64+, 4-, 32=) or (+) in more than 94% of cases where exclusion applies.
    64 cases where deceptive subject is excluded, non-deceptive subject allowed
    4 cases where deceptive subject allowed
    32 cases where both parties are allowed to testify as they would be now
Supposing 85 % accuracy:
85 Non-deceptive subjects correctly identified
    72 (of deceptives paired to the 85) correctly identified, properly excluded (+)
    13 (of deceptives paired to the 85) incorrectly identified, neither subject excluded (=)
15 Non-deceptives, incorrectly identified
    3 (of deceptives paired to the 20) incorrectly identified, wrong subject excluded (-)
    12 (of deceptives paired to the 20) correctly identified, neither subject excluded (=)
TOTALS : (72+, 3-, 25=) or (+) in 96% of cases where exclusion applies.
    72 cases where deceptive subject excluded, non-deceptive subject allowed
    3 cases where deceptive subject allowed
    25 cases where both parties are allowed to testify as they would be now
Supposing 90 % accuracy:
90 Non-deceptive subjects correctly identified
    81 (of deceptives paired to the 90) correctly identified, properly excluded (+)
     9 (of deceptives paired to the 90) incorrectly identified, neither subject excluded (=)
10 Non-deceptives, incorrectly identified
    1 (of deceptives paired to the 10) incorrectly identified, wrong subject excluded (-)
    9 (of deceptives paired to the 10) correctly identified, neither subject excluded (=)
TOTALS (81+,1-,9=) or (+) in more than 98% of cases where exclusion applies.
    81 cases where deceptive subject is excluded,
     1 case where deceptive subject allowed, non-deceptive subject excluded
     9 cases where both parties are allowed to testify as they would be now
Precedent
Courts continue to agonize over whether to accept polygraph results as "scientific" and admit them into evidence. But information doesn't have to go before a jury (or other finder of fact) in order to be useful. Using the polygraph to exclude testimony that has a ~95% likelihood of being false accords both with common sense and with the Supreme Court's view that "Exclusion . . ., is usually premised on the view that admission would lead to the frequent presentation of perjured testimony to the jury" and that "untrustworthy evidence should not be presented to the triers of fact" [Chambers v Mississippi, 410 U.S. 284 (1973)]. Utilising paired test results to exclude untrustworthty testimony would not require modifying or overturning longstanding precedent against admissibility. Excluding such testimony would not usurp the role of the jury as ultimate fact-finder any more than such time-honored exclusions as the rule against hearsay. Doing so could well prove as valuable as the hearsay rule in steering juries away from mistaken results.
There are at least two quite distinct purposes that polygraph evidence can serve in court. One is to present negative ("nondeceptive") test results in order to bolster the credibility of witnesses. The other is to present positive ("deceptive") results in order to preclude witnesses from testifying or impeach their credibility. Both arise from the same technology, but the scientific and statistical bases for trusting them, and the practical and legal considerations surrounding them, differ greatly.
Through the years, the primary focus of the polygraph debate has been the admissibility of individual "nondeceptive" polygraph results to bolster testimony, especially that of criminal defendants and prisoners whose test results point to their innocence. The points raised by both sides focus on the trustworthiness of polygraph results treated on a stand-alone basis.
The proponents of wider use have argued for admitting test results as trial evidence. Admissibility is a difficult argument to win, and its proponents have rarely been able to win it. Results could be admitted only after an elaborate, tedious, and time-consuming courtroom minuet. They would have to be supported by the examiner, and perhaps other experts, as well as be subjected to challenge by cross-examination and the presentation of contrary evidence, and to a web of instruction, some of it highly technical, by the court. Exclusion based on paired tests circumvents those difficulties. Because of the benefits it offers to police, prosecutors, courts, defense and civil bar, and honest parties, it is the approach that provides proponents of widening the courts' use of the polygraph their best prospect of success.
Acceptance of paired results can help free many wrongly convicted prisoners, whereas stand-alone results face an insurmountable public acceptance problem. Suppose that 90% of prisoners are guilty of the crimes for which they are incarcerated and that false negatives average about 10%. Then for every 100 prisoners tested, there would be 80 true positives, 10 true negatives, 9 false negatives, and 1 false positive. About half the people that stand-alone tests would release would in fact be guilty. Acting where prisoners test negative and their accusers test positive would reduce that to 10%. Freeing 10 innocent persons, at the price of freeing 1 guilty one, is an objective capable of winning public acceptance.
STAND-ALONE NEGATIVE RESULTS
The case--scientific, legal, and social--against allowing negative ("nondeceptive") results on a stand-alone basis is strong. The statistical underpinning of negative results is problematical because of the difficulty of quantifying the false negatives in the absence of "ground truth"--an external yardstick by which to measure whether subjects are deceptive. In field work, ground truth is notoriously difficult to determine.
There is no straightforward way to ascertain false negative rates--the percentage of subjects testing 'nondeceptive" who were in fact deceptive--in real-world samples. To be a known false negative, a subject must first beat the test and later be found out. That rarely happens. When people beat the test, it usually remains their secret. It is not known how many cases go unsolved because a false negative was excluded from further investigation and how many because the culprit was not among those tested. In laboratory tests, false negative rates are usually about 10%, but extrapolating them to the real world is difficult. The physiological changes the equipment measures are affected by the subjects' fear. The higher the stakes, the greater the fear of being caught in a lie, and the greater the measured response. However expert the examiner and well conducted the test, the high stakes of real-world tests cannot be duplicated in the laboratory.
Allowing stand-alone "nondeceptive" polygraph evidence is fraught with other difficulties. Once it were allowed, litigants would seek to introduce polygraph evidence to buttress many, even most, witnesses. Juries would come to expect them to do so. Since polygraph results cannot be introduced into evidence without the testimony of the examiner or other expert to interpret them, this would mean a de facto return to the archaic voucher system of the Middle Ages, when litigants were expected to produce "voucher witnesses" to vouch for the credibility of their witnesses.
The parade of voucher witnesses would tie up dockets and, by lengthening trials, would add to the cost of litigation for all parties. Moreover, polygraph examinations are expensive, and examiners are well paid for their time in court. In civil cases, the "voucher effect" would tend to raise the price of justice, aggravating the already serious disadvantage faced by parties with limited budgets. It would be especially pernicious in criminal trials, where strategy considerations often preclude defendants' taking the stand. Allowing "nondeceptive" results into evidence in support of prosecution witnesses would practically compel criminal defendants to be polygraphed and testify, giving prosecutors an unacceptable subterfuge around the right against self-incrimination.
Many possible countermeasures that would enable deceptive subjects to fool polygraph examiners have been suggested. Their utility remains unproven, but to the extent they may be or become effective, their use would affect only negative results. Police officers testify frequently, and they are trained to do it effectively. Many are professional witnesses. If effective countermeasures could be mastered, unscrupulous police and other "professional witnesses" would be among the first to learn them. The danger exceeds their numbers of such witnesses because of the number of times each would testify through the course of a career.
If negative results were to be admitted as evidence on behalf of criminal defendants, they would practically guarantee acquittal. To the extent that individuals' false negative results are repeatable, the selectivity bias could create a threat to public safety. Those individuals, knowing themselves to be practically impervious to prosecution, would be enabled to break the law with impunity. The special protections afforded criminal defendants introduce another selectivity bias into the process. If defendants had the option of introducing polygraph evidence, their counsel could be counted on to bury unfavorable results. Defendants would take tests privately--a no-risk option. Most defendants opting for private tests would presumably fail. The court would never know. Only defendants with favorable test results would introduce them. If defendants in, say, 10% of trials presented "nondeceptive" test results, would that mean that 10% of defendants are innocent? That the polygraph is subject to 10% false negatives? This selectivity bias applies primarily to criminal defendants, not to most other witnesses. But no court that allowed stand-alone negative results to bolster the testimony of some witnesses could constitutionally bar criminal defendants as a class from using them. To the extent false negatives occur, the selectivity bias would lead to wrongful acquittals.
James K. Murphy, the former polygraph unit chief at the FBI laboratory in Washington, D.C., has testified (http://truth.boisestate.edu/polygraph/MURPHY1.HTML) that the FBI annually administers polygraph examinations to about 5,000 applicants for sensitive jobs. Each applicant takes two tests. Applicants almost always pass the first test, which focuses on counterintelligence issues: Applicants are asked whether they've ever been in contact with anybody from a foreign intelligence service and whether they were directed to seek FBI employment. The failure rate is about 0.5%.
The applicants' charts from the first test are used for comparison with the charts from their second test, which deals with use of illegal drugs, abuse of legal drugs, and falsification of the application for employment. In accord with ordinary knowledge and common sense, the failure rate on the second test is much higher: More applicants have had undesirable experience with drugs than have an involvement with espionage. More than 70% of applicants failing the second test have validated the examination results through confession or through admission at the time of the test.
The FBI believes that these results support validation, through the correspondence of the results with the known statistical base rates for those two subject areas, and achieve reliability as the test relates to them. They rely heavily on these results, notwithstanding that the test results provide only a weak inference regarding false negatives.
Despite the scientific and statistical difficulties with "nondeceptive" results, federal, state, and local police and prosecutors place great confidence in them and make important decisions based upon them. The methodological argument against their use on a stand-alone basis is not that they are valueless, but that their value is so uncertain. The rub is that the testimony of interested parties, informantes, and plea-bargained accomplices is also uncertain.
STAND-ALONE POSITIVE RESULTS
The methodological, scientific, and statistical grounds for confidence in estimates of the rate of false positives are stronger. The FBI, OSI, and CIA have administered polygraph examinations to tens of thousands of past, present, and prospective government employees and armed forces personnel. The 0.5% failure rate cited by Mr. Murphy of the FBI indicates that when tests are given under proper conditions by competent examiners, and interpreted using a high threshold of physiological variance, false positives, taken as a percentage of tests administered, can be extremely low. This low occurrence of positive results occurs in a real-world setting where the stakes for the examinees are not only their jobs, but also the unpleasantness of becoming the subject an espionage investigation. Since there obviously cannot be more false positives than there are positives, the percentage of positive results establishes a rigorous limit for those thresholds. But for purposes of evaluating the significance of an individual positive result, it is the ratio of false positives to all positives that matters. If there is one spy among a population of subjects, and two (including the culprit) fail the test, then that ratio is 50%, irrespective of the number of subjects in the sample.
In testing conducted by police for the purpose of eliminating possible suspects, where the subjects are people who have an appreciable likelihood of being involved in a crime, positives occur more often. Many subjects who get positive results confess and provide independent evidence that supports their confession or are convicted by juries with no knowledge of the polygraph results, thereby reducing the number of positives that might be false positives and helping scientists further refine their estimates of the trustworthiness of positive test results.
Nevertheless, I believe that no testimony from a witness who has tested "deceptive" should be excluded unless a contradicting witness has tested "nondeceptive." The second result increases confidence, by a factor of 5 or more, that the excluded testimony is really untrustworthy. Both witnesses may be untruthful, and no advantage should accrue to the one who has refused to be tested. In criminal cases, defendants would be freed from the Hobson's choice of having to testify before the jury in order to contradict testimony they know to be false.
POLICE AND PROSECUTION ISSUES
Police and prosecutors have consistently opposed allowing polygraph results into court. The polygraph is an extremely useful investigative tool that enables them to screen possible suspects and focus their resources effectively. Police cannot compel suspects to take polygraph tests, due to the rule against self-incrimination. If failing results could be introduced into court, even many innocent people would be reluctant to risk consent, and the police would lose an invaluable time-saver. If, in order to keep the tool, they were to promise not to use results in court, their relation to the technology would remain exactly as it is now. Only defendants would stand to benefit from admissibility. Even if acknowledging a refusal to take the police polygraph became a condition of defendants' introducing "nondeceptive" results, such refusals would be credibly explainable, in light of the favorable test result, as due to an innocent person's distrust of the police.
By limiting prosecutors' use of a positive result to exclusion, the subjects' risk is reduced and the legitimate police concern addressed. Their stated concerns no doubt mask the unwillingness of some law enforcement people to forgo the advantage they gain from police perjury and other dubious testimony. To the extent that the polygraph removes that advantage, it removes a blight. The Ramparts scandals in Los Angeles, and similar scandals elsewhere, come into an atmosphere of increasing public awareness of wrongful convictions. Together, they threaten to foster a deep and long-lasting suspicion against testimony by police and informants, especially jailhouse informants and accomplices testifying under plea agreement.
It is no mere public relations problem. It is a serious cloud, and it will require concrete measures to dispel it. Apart from problems arising from a generalized negative attitude toward police, there is the specific danger of lost convictions due to excessive juror skepticism. I think the use of polygraph results suggested here is a reform that will help to restore public confidence in testimony by police officers and cooperating witnesses. Departments that opt for the idea will find allies among the media and among groups that are opposed to prosecutorial misconduct and wrongful convictions, whatever their attitude toward police image problems.
CONCLUSION
Police departments hold classes and workshops to teach officers how to testify effectively. Consequently, the persuasive impact of officers' testimony, whether honest or not,  is greater than that of most other witnesses. And it is often false. Indeed, perjured testimony by police is so common that there is a word for it, "Testilying", that is used and understood in every station house and D.A. office. In civil litigation, false statements, oral and written, enable parties asserting an invalid claim (or defense) to exact a penalty from opponents with worthy cases. Especially where the party in the wrong is financially stronger, this frequently compels the honest party to agree to an unconscionable settlement, or even abandon the case altogether.
In both civil and criminal litigation, fact-finders evaluate witness credibility using a host of spurious factors such as age, ethnicity, physical attractiveness, speaking voice, clothes, and occupational status. When litigation attorneys assess whether a person will make a "good" witness, it is those factors rather than the truthfulness of the person's testimony they are usually talking about.
Imagine that a couple of King Arthur's knights arrived here in a time machine, and happened upon a refrigerator. One of them suggests using the unfamiliar object as a boat, while the other says no, let's fill it with dirt and grow vegetables. To me, the debate over the use polygraph results in court feels much the same. One side wants to bar them altogether, while the other wants the results of single stand-alone tests to be admitted before juries. They are equally incorrect. It is a third course--using paired results to screen testimony-- that I believe is the right one.
Paired polygraph results can streamline court proceedings, lighten prosecution and legal assistance caseloads, reduce litigation costs, and move the docket along. Countless laborious cross-examinations will never take place. Many witnesses will not appear at all. Many fraudulent and frivolous cases will never be brought, and many others will never reach trial.
Ensuring that the utilization is proper is nontrivial but straightforward. Judges need to know about proper polygraph examination procedure and interpretation of results. They need to be able to reject unqualified and "bought" examiners, and conclusions based on unreasonable thresholds. Judges are capable of learning this and applying the knowledge on an ongoing basis. Unlike juries, whose secret deliberations give few clues as to the weight given to admitted evidence, judges' decisions are open, would apply to specific testimony, and would be based on examination charts and videotapes that will become part of the record, making their decisions subject to review.
The approach offers the prospect of reducing the number of wrongful criminal convictions, and of wrongful outcomes of civil cases, in a way that skirts a potential minefield of technical uncertainties as well as legal and social complications. The courts of every jurisdiction would do well to consider it.

Friday, January 17, 2014

Transvaginal Mesh Doctors’ Conflicts of Interest

Transvaginal Mesh Doctors’ Conflicts of Interest


Transvaginal Mesh doctors’ conflicts of interest could be dramatically impacting women’s healthcare.
We start with a simple premise: If a urogynecologist has a potential conflict of interest regarding the use of synthetic mesh as a treatment option for stress urinary incontinence (SUI), that doctor’s patients have a right to know about that potential conflict. Unfortunately, these conflicts are seldom, if ever, disclosed to the women they can affect.

A Few speak for All?

The American Urogynecologic Society (AUGS) – or, more accurately, a small percentage of its members who purport to speak for the whole organization – has gone out of its way more than once to promote the use of transvaginal mesh slings for stress urinary incontinence (SUI). It is more than a little unusual that the AUGS board has stated publicly how much AUGS supports and approves of the use of synthetic mesh to treat a condition which was treated surgically with sutures just as effectively as the mesh for more than 40 years.

Sutures vs. Polypropylene Mesh

One indisputable advantage simple suturing holds over the implantation of permanent synthetic mesh into a woman’s pelvic floor is that the former can be easily and safely removed, while a failure of the latter can result in lifelong scarring and permanent pain. It is usually impossible to retrieve all of the synthetic material once it enters the body and irrevocably begins binding to tissue. In the rare event that sutures cause more problems than they solve, the suture procedure can be reversed or repaired, at the very least to the point of returning the woman to the condition she was in prior to her surgery for SUI. The same cannot always be said for the synthetic mesh, which could result in nerve damage, permanent pain, permanent dyspareunia (painful sex), other organ damage, and the need for multiple explant surgeries.

AUGS Board Statement

Nevertheless, AUGS Board of Directors released a statement on Monday, Jan. 6 which claims: “The polypropylene mesh midurethral sling is the recognized worldwide standard of care for the surgical treatment of stress urinary incontinence. The procedure is safe, effective, and has improved the quality of life for millions of women.”

AUGS Fails to Disclose

This statement fails to disclose its authors’ financial ties to the synthetic mesh industry or the fact that a small percentage of AUGS members cannot be said to speak for all. Many urogynecologist members of AUGS disagree with this assessment, which also fails to explain how nearly three dozen different midurethral sling products on the market can all be said to represent a single “standard of care.” Given that each manufacturer stresses the differences between its sling and all the others, it is difficult to grasp the notion that ALL and ANY midurethral slings can be said to represent “the recognized worldwide standard of care.” Johnson & Johnson alone pulled four of its mesh products off the market in summer 2012, including mesh sling products which had been used for SUI, though the company claimed it did not remove the products for safety reasons.

Conflicts of Interest

AUGS web site reports that the organization represents some 1,700 members. AUGS also invites corporations to become members, such as those which make and market transvaginal mesh slings.  AUGS thanks its “corporate members,” which include  Allergan (the maker of Botox and the synthetic Lap band) and mesh sling makers such as American Medical Systems, Bard Urological Division, Boston Scientific, Coloplast and Ethicon (of Johnson & Johnson).

Corporate “Members” Undisclosed

AUGS fails to report this corporate support in its very public promotion of mesh for SUI. More importantly, it fails in its press releases – such as the Jan. 3, 2013 statement drafted by Charles Nager, Paul Tulikangas and Dennis Miller from AUGS – to disclose the conflicts of interests of at least five of its 13 board members. Conflicts of interest include arrangements where these doctors work as consultants, sit on advisory boards, accept research grants, work as speakers for, or even have proprietary interest in these companies. Dennis Miller has been a paid speaker for Johnson & Johnson, American Medical Systems (AMS), Boston Scientific, and has received substantial payments from each of those mesh-producing companies.

Financial Incentives for Doctors

Here is a quick snapshot of five AUGS board members’ names and the corporations with which the doctor has been or is connected by direct financial ties.
• Patrick J. Culligan: CR Bard, Intuitive Surgical, AMS, Boston Scientific, Origami Surgical;
• Roger P. Goldberg: Boston Scientific, Endo Pharmaceuticals, GlaxoSmithKline (GSK);
• Catherine A. Matthews: AMS, Boston Scientific, Pelvalon;
• Karen Noblett: Medtronic, Boston Scientific, Astellas, Allergan, Pfizer, GSK;
• Peter L. Rosenblatt: AMS, Ethicon (J & J), Coloplast, Cook Medical, Boston Scientific, Olympus Gyrus, Allergan, Pfizer.

Increased profits for Surgeons

St. Louis urogynecologist Dr. Wall warned in January 2010 that “powerful commercial interests are reshaping the field of pelvic surgery.” The proliferation of transvaginal mesh “kits,” he said, “hold out the promise of quick, easy, standardized operations; higher surgical volumes; and increased profits for both the surgeon and the device manufacturer.”
Could AUGS ongoing promotion of synthetic mesh and these kits in place of tried-and-true suturing be a result of conflicts of interest between urogynecologists’ bottom lines and the health of their patients?
Conflicts of interest also abound for the self-proclaimed “Midurethral Sling Task Force,” which assembled the Jan. 3 statement. The force  included Eric Rovner and Howard Goldman from the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU). Doctors with conflicts of interest on that “Force” include more industry-connected doctors:
• Dennis Miller: Johnson & Johnson, AMS, Boston Scientific, Allergan, Eli Lilly, Pfizer, AstraZeneca, Merck, Novartis;
• Eric Rovner: Allergan, Merck, Pfizer;
• Howard Goldman: Allergan, Merck, Pfizer, Valeant.

All Urogynecolotists in Agreement?

The 1,700 members of AUGS were not part of a random poll which could, at least in theory, find out whether or not they agree with the declaration of three doctor writers and 13 board of director doctors, nearly half of whom have clear conflicts of interest in promoting the use of a synthetic material as a “worldwide standard of care” for stress urinary incontinence. Are the board members smarter than the 1,700? Do they really speak for all 1,700? When is the last time you could name 70, or even seven, people who agreed about anything? Nevertheless, the “Midurethral Sling Task Force” and 13 members of the AUGS board purport to speak for 1,700 people.
At the very least, such pronouncements should come with caveats explaining how a very tiny percentage of AUGS members cannot be said to speak for all on issues concerning the health of millions of women, and what money, if any, they are receiving from the mesh industry. At the very least, those women deserve disclosures so they can make informed decisions regarding any salient factors that could affect their doctors’ judgment and advice to them. Women about to be implanted with a permanent surgical device deserve to know how (or whether) their very own doctor arrived at his or her own conclusion, and whether their doctor is aware of AUGS conflicts of interest which could unduly influence their own doctor’s judgment.

Check your own Doctor’s Conflicts of Interest

If you would like to check on your own doctor’s potential conflicts of interest regarding any treatment option, check out Propublica.orgDollars for Docs. This site was developed for people who wish to gain what information they can regarding their own doctor’s potential conflicts of interest.

Monday, January 6, 2014

Risperdal lawsuit documents could be sealed

Risperdal lawsuit documents could be sealed


Important Risperdal lawsuit risperdal-johnson-johnsondocuments could be sealed if the manufacturer of the drug has its way with the Philadelphia County Court of Common Pleas.
One of Johnson & Johnson’s latest moves in the company’s ongoing fight to defend its research and promotion of Risperdal is to hide its research and promotion. The company is claiming – in the Philadelphia County Court of Common Pleas where 275 Risperdal cases now sit ready for trial – that it has proprietary rights which allow it to keep its Risperdal research sealed from the public. Because this information concerns the very same public targeted by J & J to use Risperdal, this argument seems of dubious merit at best.
Johnson & Johnson has already paid billions of dollars to settle federal and state allegations that it illegally marketed its drug Risperdal. More than 420 lawsuits have been filed in state courts against Johnson & Johnson over Risperdal. The suits allege that the drug stimulates breast growth and milk production in boys and young men.
Johnson & Johnson’s response to the lawsuits, claiming it has the right to keep the research behind Risperdal from the public and from plaintiffs’ lawyers, comes from a company statement which says, the research “materials are generated for scientists, researchers and regulatory authorities – not the general public. Simply stated, no legitimate purpose would be served by declassifying the documents identified by plaintiffs.”
Lawyers for plaintiffs, meanwhile, have argued to the court that the documents J & J seeks to hide are too vital to the public interest not to be released to the public, “and the data and materials being hidden by Janssen (a division of J & J) outweighs defendants’ claims to secrecy.’ The lawyers argue they cannot be hidden as they are safety documents requiring full disclosure for the well being of the public, as well as “full and unfettered review by regulatory authorities and the education of healthcare providers who are prescribing this powerful drug.”
Plaintiffs further argue that Risperdal’s maker has repeatedly misrepresented the drug’s safety to regulatory authorities, healthcare providers and the public. “Janssen systematically under-reported or misrepresented clinically important study results” relating to the chances of children and adolescents developing gynecomastia from Risperdal. However, says plaintiffs’ lawyers, this misrepresentation is currently “protected behind the shield of the protective order entered in this case.”
A hearing was held on Dec. 16, but so far no decision has been made on the matter.

Contact a Risperdal Lawyer Today

If you or someone you love has developed Gynecomastia (male breasts)  after taking Risperdal schedule your free initial consultation online or call us at 508-499-3366.