Posts Tagged ‘Law’

Supreme Court reverses Zimmer win in $20m knee implant lawsuit

Reported by: Irina Robu, PhD

The Pennsylvania Supreme Court yesterday reversed a state appeals court’s decision to overturn a $20 million verdict against in a knee implant lawsuit. Margo Pollet had a double knee replacement procedure in 2006 using Zimmer’s Gender Solutions devices but after making a Zimmer promotional video which included riding a bicycle and running on treadmill, she claimed that it damaged her knees. She sued for negligence saying the injuries occured during filming the video. A jury awarded Polett millions in damages after finding that Zimmer was 34% culpable. The jury also put 30% of the blame on Polett herself and 36% on the marketing firm Public Communications for its involvement with the ad.

The Pennsylvania Superior Court last October ruled that the lower court incorrectly shifted the burden of proof onto Zimmer by asking the company to provide alternative explanations for Polett’s revisions surgeries, thus leading the jury to a potentially false conclusion, and ordered a new trial. 

“In sum, the trial court’s ruling that Dr. Booth’s expert testimony as to causation was not barred by [Pennsylvania law] was amply supported by the evidence of record, and thus was reasonable. Consequently, we conclude that the trial court did not abuse its discretion in allowing Dr. Booth to render an expert opinion at trial, and that the  Superior Court erred by reassessing the evidence relied upon by the trial court in making its ruling, and by supplanting the trial court’s findings with its own evaluation of that evidence. We, therefore, reverse the order of the Superior Court as to this issue,” McCloskey Todd wrote.

The Supreme Court ordered the Superior Court to review whether the trial court was wrong to deny the defendants’ bid to overturn the verdict.



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Author: Dr Anayo Unachukwu, MBBS, LLM


Modern society is built on the twin pillars of Judaeo-Christian jurisprudence and Graeco-Roman civilisation. The jurisprudence has provided us with the moral[1], ethical and legal system that has sustained the civilisation. The civilisation prides itself with the legacy it bequeathed modern society-science. Revolution in science has often been preceded by revolution in measurement. The scientific endeavours have led to delineating, characterising, validating and reliably predicting and identifying the origin of concepts, phenomena, etc encountered by mankind and seeking remedies for these with some degree of certainty and accuracy. The prodigious advances in science and technology within the ethico-legal framework that stemmed from it have brought with it advantages in medical science and related fields. These pervade our every day environment; and we are all witnesses to the consequences of its innovation and creativity. Given the new found confidence in these fields, there have been attempts by medical and behavioural scientists to stretch its research frontiers further in providing succinct explanation to often complex human behaviour and interaction within social spheres. The science behind these quests usually has aural of purity-value free and bereft of ideology. However as Rose puts it: “It may well be that it is only in the periods of social and intellectual crisis that we can glimpse the interconnections between science and social system.[2]

One of the preoccupations of prehistoric man has been attempts at classification and categorisation; this heuristic pursuit-through generalisation-is a way of navigating the complex environment he finds himself. Attempts at generalisation by extrapolating from medical model to account for mental disorders[3] have not altogether been helpful. This could be due to lack of clarity in understanding the aetiological underpinnings; stigma and labeling intrinsic to the sufferers and skepticisms that surround the practice of psychiatry.

The mentally disordered offender raises questions which have troubled theologians, moral philosophers and lawyers throughout the Christian era.[4] It is not only these professions that grapple with this group of offenders; as Eastman puts it psychopaths[5] are the moral and scientific junctional case between the mad and the bad, both in terms of treatment and of punishment.[6]

Psychopathy[7] as a construct throws up more questions than answers-origin, remedial attempts[8] and heuristic generalisation as regards prognostic inferences. There is larger debate on whether psychopathy and personality disorder[9] are primarily legal or diagnostic categories, or neither.[10] Given that psychopathy straddles interpersonal and social domain in everyday human endeavours which impacts on both clinical and legal settings; one would have thought that a complete delineation and categorisation would have been understood by relevant practitioners[11] involved, but this appears not to be the case. Some researchers both clinical and non clinical strongly disagree on the nosological certainty of psychopathy and its inclusion in the medical classificatory system.

However, all agrees that the disorder generates a lot of controversy; and the emotive[12] issue that it provokes-social, psychological, economic and legal-reverberates further afield way beyond the field of clinical sciences.

From social policy perspective, other characteristics of psychopathy notwithstanding, criminal and violent behaviours are the main hallmarks of the disorder.[13] Psychopaths are high risk offenders with many criminogenic needs (i.e., personal characteristics correlated with recidivism).[14] In fact, recent research efforts have shown that there is a relationship between psychopathy and both general and violent crimes.[15] The criminogenic derivative that stem from the disorder had a legal ringing endorsement.[16]

In contrast to the relationship between psychopathy and rate of recidivism; Gibbens et al[17] eight-year comparative follow-up study on criminal psychopaths (diagnosed as ‘severe cases’) and criminal non psychopaths as regards their reconviction rates showed insignificant differences in the reconviction rate for both groups. The conclusion from this study was broadly similar to a two year follow-up study by Walker et al[18] which compared the rates of reconviction amongst psychopaths and non psychopaths who were diagnosed with severe mental illness, schizophrenia and those diagnosed as subnormal (learning disability); the rate of recidivism for both groups were not statistically significant.

Without making an extraordinary reading of the follow-up studies, Cooke et al[19] had argued that criminal behaviour should not play a central role in the diagnosis of psychopathy; instead such behaviour is best viewed as a secondary feature; or sequel of the disorder. This view is consistent with Cleckley’s original classical description of psychopathy where criminal behaviour was not intrinsic to the disorder; the motivation of the behaviour when it is present is usually obscure.[20] Criminality and psychopathy are not the same construct; the core features of the disorder-glib charm, callousness, arrogance, shallow affect, deceitfulness, and lack of empathy do not necessarily involve or imply criminal behaviour.[21] Why then is there such a great emphasis in diagnosis of this disorder? The answer partly lies in the society we live. There appears to be an inverse relationship between the tolerance of risk[22] in a given society and its level of affluence. There is a political imperative driven by popular lay press for a ‘risk free’ society; such an unrealistic expectation has led to the bourgeoning of research in risk instruments for assessment and management of risks. The trend in the wider society, technological advances and rise in consumerism has all further fueled this gusto-risk intolerance. Risk assessment as a concept is not a legal issue per se as competence to stand trial or criminal responsibility; however, it forms important part of different decision making in law. As Fennell puts it, there is a role redefinition whereby risk management has assumed increasing centrality in the role of psychiatrists and other mental health professionals, and philosophies of risk management now permeate decision-making in both the psychiatric system and penal system.[23] It is a given that psychopaths are involved in violent crimes and they recidivate for both violent and non violent crime compared to non psychopath; hence violence risk is an “indirect” legal issue often relevant to ultimate decisions but rarely defining the ultimate issue specifically.[24] Therapeutic jurisprudence[25] partly relies on risk assessment and management in deciding on disposal options available when dealing with mentally disordered offenders. As Leacock and Sparks remarked; Risk…is a fashionable idea—one whose moment would appears to have arrived.[26] Risk is now so integral to every day discourse given the high profile homicides; most notable was the killing of Jonathan Zito (in England) by a stranger, Christopher Clunis, who suffered from schizophrenia. As a result, the risk management/public protection agenda is now prominent-in England and Wales-and since 1992, health authorities have a duty to carry out an independent inquiry in any case of homicide or suicide by a mentally disordered person in their care.[27]



Mentally disordered offenders-like the poor-will always be in our midst. Labelling and stigmatising this group as a whole may be unhelpful at best and amounts to discrimination. Managing risk out every day discourse is naivete to the extreme, given that in any society a trade-off has to be made as far as risk goes. Criminality as a construct should not be synonymous with psychopathy, given that not all psychopaths offend and not all criminals are psychopaths.

[1] Psychopathy which under the Mental Health Act 1983 is classified as a mental disorder is seen by some philosophers, lawyers, clinicians and the society at large as essentially a moral disorder. See Maibon, H.L. The Mad, the Bad, and the Psychopath. Neuroethics (2008) 1:167-184. DOI 10.1007/s12152-008-9013-9.

[2] Rose, S., Rose, H. (1971). The myth of the neutrality of science. In Watson Fuller (ed). The SOCIAL IMPACT OF MODERN BIOLOGY.Routledge & Keegan Paul. London. p.233

[3] The adoption of this term was recommended in the Report of the Royal Commission on the law relating to Mental Illness and Mental deficiency 1954-1957 (Cmnd 169 (1957)) Pt 3 paras 146-198. The Commission recommended its use as a general term covering all forms of mental ill-health or disability. S (1) of the amended Mental Health Act 2007 gives a broader description of mental disorder-any disorder of the mind; ‘mentally disordered’ shall be construed accordingly.

[4] Walker, N. (1968) Crime and Insanity in England. vol. I. Edinburgh University Press. p. 6

[5] Psychopathy is a personality disorder defined by a cluster of interpersonal, affective, and lifestyle characteristics that results in serious, negative consequences for society.

[6] Eastman, N (2002). The Ethics of Clinical Risk Assessment and Management:Developing Law and the Role of Mental Health Professionals. In Gray, N,  Lain, J,  Noaks, L. (Eds.). Criminal Justice, Mental Health and the Politics of Risk.(pp. 49-66). Cavendish Publishing Limited.

[7] The adverb psychopathic means literally ‘psychically damaged’ and was introduced in the 19th century Germany to cover all forms of psychopathology. From the outset it should be distinguished from psychopathic disorder which is a legal concept. Authors disagree on its definition; sometimes the usage is in vernacular, and this paints a derogatory picture. See Gunn, J. and Robertson G. (1976b) Psychopathic Personality: a conceptual problem. Psychological Medicine, 6, 63-4 (386).

[8] Cleckley, H. (1941). The mask of insanity. St. Louis, MO: Mosby. The present day conceptualisation of psychopathy is credited to the systematic writings and observation of Cleckley. He expressed concerns about the progressive nature of the disorder, social malady it posed to the society and therapeutic nihilism associated with it.

[9] The defining characteristic of personality disorder more than any symptom is the incomprehensibility and inaccessibility that the sufferer provokes in other people. It is classified as a mental disorder by both two international classificatory systems- World Health Organisation. (1992) International Classification of Disease and Related Health Problems: ICD-10. Geneva: WHO; and American Psychiatric Association. (1994) Diagnostic and Statistical Manual of Mental Disorders. DSM-IV. WashingtonDC: Mental Health Service.

[10] Ogloff, J.R.P., & Lyon, D.R. (1998). Legal issues associated with the concept of psychopathy. In D.J. Cooke, A.E. Forth, & R. D. Hare (Eds) Psychopathy: theory, research, and implications for society (pp. 401-422). Dordrecht, The Netherlands: Kluwer.

[11] Unfortunately among various practitioners not just legal practitioners, but most clinicians the conceptual cousins of psychopathy-sociopathy, dissocial personality and antisocial personality have been mistaken for psychopathy. See Gacono, C.B., Nieberding, R., Owen, A., Rubel, J., & Bodholdt, R. (2000). Treating juvenile and adult offenders with conduct disorder, antisocial and psychopathic personalities. In J. Ashford, B. Sales, & W.Reid (Eds.), Treating clients with special needs. WashingtonDC: American Psychological Association.

[12] Hare, R.D. (1996a). Psychopathy: A construct whose time has come. Criminal Justice Behavior. 23, 25-54.

[13] Patrick, C.J. (2006). Handbook of Psychopathy The Guilford Press. p.555

[14] Zinger, I., & Forth, A.E. (1998). Psychopathy and Canadian criminal proceedings: The potential for human right abuses. Canadian Journal of Criminology, 40, 237-276.

[15] Salekin, R.T., Rogers, R., & Sewell, K. W. (1996). A review and meta-analysis of the Psychopathy Checklist and Psychopathy checklist-Revised. Clinical Psychology: Science and Practice, 3, 203-215

[16] Carraher v HM Advocate 1946 JC 108 at 117, per Lord Normand: it is to my mind descriptive rather of a typical criminal than a person…regarded as being possessed of diminished responsibility.

[17] Gibbens, T.C.N., Pond, D.A. and Stafford-Clark, ‘A Follow-up Study of Criminal Psychopaths’ in (1959) 105, Journal of Mental Science, 108 ff.

[18] Walker, N., McCabe, S. (1973) Crime and Insanity in England. Vol. II. p.212. Edinburgh University Press.

[19] Cooke, D. J., Michie, C., Hart, S. D., et al (2004) Reconstructing psychopathy: Clarifying the significance of antisocial and socially deviant behavior in the diagnosis of psychopathic personality disorder. Journal of Personality Disorders, 18, 337-357.

[20] Cleckley,H. (1988) The Mask of Sanity (5th edn). Mosby. p.279

[21] Hare, R.D. (1998). Psychopathy, affect, and behaviour. In D.J. Cooke, A.E.Forth, & R.D. (Eds.), Psychopathy, theory, research, and implication for society (pp104-137). Dordrecht, the Netherlands: Kluwer.

[22] Risk is defined as the uncertainty of outcome whether opportunity or negative threat, of actions and event

[23] P, Fennell (2002) .The Ethics of Clinical Risk Assessment and Management:Developing Law and the Role of Mental Health Professionals. In Gray, N,  Lain, J,  Noaks, L. (Eds.). Criminal Justice, Mental Health and the Politics of Risk.(pp. 49-66). Cavendish Publishing Limited.

[24] Roesch, R., & McLachlan, K. (2007). Clinical Forensic Psychology and Law. Ashgate Publishing Ltd.

[25] Wexler, D., & Winck, B. (Eds.) (1996). Law in a therapeutic key. Durham, NC: Carolina Academic Press. At p. 32 describe it as a concept that addresses the issue of how knowledge, theories and insight of the mental health disciplines can help shape the development of law.

[26] R.D. Mackay (2002). Criminal Justice, Mental Health and the Politics of Risk. Crim. L.R. 2002, Sep, 765-767.

[27] Fennell, P (2010). HISTORY AND CONTEXT OF MENTAL HEALTH LAW AND POLICY. In Gostin, L., Bartlett, P., McHale, J., Mackay, R. (eds). PRINCIPLE OF MENTAL HEALTH POLICY AND LAW. Oxford University Press. p.53.


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Reporter: Aviva Lev-Ari, PhD, RN

this post was reblogged on 9/28/2012 by


September 27, 2012 08:30 AM Eastern Daylight Time

Oral Arguments in the UCSF Appeal of United States Patent and Trademark Office Judgment in Favor of InSite Vision Are Scheduled for November 6, 2012

InSite Vision Along with Merck Will Vigorously Defend AzaSite® Patents

ALAMEDA, Calif.–(BUSINESS WIRE)–InSite Vision Incorporated (OTCBB: INSV) today announced that oral arguments are scheduled for November 6, 2012, in Washington, D.C. in connection with the University of California, San Francisco’s (UCSF) appeal of the November 2011 favorable judgment of the United States Patent and Trademark Office (USPTO). The USPTO panel of judges ruled in favor of InSite Vision and confirmed the inventorship of InSite Vision’s U.S. Patent Nos. 6,239,113 and 6,569,443 protecting AzaSite® (azithromycin ophthalmic solution) 1%. The appeal was filed by UCSF with the U.S. Court of Appeals for the Federal Circuit in Washington, D.C. on December 23, 2011, and a cross appeal was filed by InSite Vision on January 4, 2012. Merck, which markets AzaSite in the U.S. for the treatment of bacterial conjunctivitis, is collaborating with InSite on the continued vigorous defense of the AzaSite patents.

“We are highly confident that the UCSF claims are entirely without merit as confirmed by the USPTO judgment last November and we will continue to collaborate actively with Merck to vigorously defend our position”

“We are highly confident that the UCSF claims are entirely without merit as confirmed by the USPTO judgment last November and we will continue to collaborate actively with Merck to vigorously defend our position,” said Timothy Ruane, InSite Vision’s Chief Executive Officer. “We anticipate results of the appeal will be announced in 2013, but we could get a verdict before the end of 2012.”

In 2009, the Regents of the University of California claimed that the inventions contained in the patents were made by a former employee of the University alone and without collaboration with InSite Vision, the assignee of all the named inventors.

About InSite Vision

InSite Vision is advancing new ophthalmic products for unmet eye care needs based on its innovative DuraSite® and DuraSite 2® platform technologies. The DuraSite and DuraSite 2 drug delivery systems extend the duration of drug retention on the surface of the eye, thereby reducing frequency of treatment and improving the efficacy of topical drugs. DuraSite is currently leveraged in two commercial products for the treatment of bacterial eye infections, AzaSite® (azithromycin ophthalmic solution) 1%, marketed in the U.S. by Merck, and Besivance® (besifloxacin ophthalmic suspension) 0.6%, marketed by Bausch + Lomb. InSite Vision is also advancing three novel ophthalmic therapeutics through Phase 3 clinical studies: AzaSite Plus and DexaSite for the treatment of eye infections, and BromSite for pain and swelling associated with ocular surgery. DuraSite 2 incorporates InSite’s proprietary bioadhesive core technology with a cationic polymer to achieve sustained and enhanced ocular delivery of drugs. The DuraSite 2 platform will be applied to InSite’s future pipeline product candidates and available through a broad licensing program for advanced ophthalmic drug development. For further information on InSite Vision, please visit www.insitevision.com.

Forward-looking Statements

This news release contains certain statements of a forward looking nature relating to future events, including InSite Vision’s expectations of a successful outcome in the appeal, the expected timing of a decision by the court, and other plans and expectations with respect to the litigation described above. Such statements entail a number of risks and uncertainties, including but not limited to: that the court may not rule in favor of InSite Vision, the inherent uncertainty of any litigation matter including the court’s decision and the timing of same; InSite Vision’s ability to continue to adequately protect its intellectual property and to be free to operate with regard to the intellectual property of others. Reference is made to the discussion of these and other risk factors detailed in InSite Vision’s filings with the Securities and Exchange Commission, including its annual report on Form 10-K and its quarterly reports on Form 10-Q, under the caption “Risk Factors” and elsewhere in such reports. Any forward-looking statements or projections are based on the limited information currently available to InSite Vision, which is subject to change. Although any such forward-looking statements or projections and the factors influencing them will likely change, InSite Vision undertakes no obligation to update the information. Such information speaks only as of the date of its release. Actual events or results could differ materially and one should not assume that the information provided in this release is still valid at any later date.

AzaSite® and DuraSite® are registered trademarks of InSite Vision Incorporated.

BESIVANCE® is a registered trademark of Bausch + Lomb Incorporated.


InSite Vision
Louis Drapeau, 510-747-1220
Chief Financial Officer
Media and Investor inquiries
BCC Partners
Michelle Corral, 415-794-8662
Karen L. Bergman, 650-575-1509



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