Medical negligence news In Product liability

Pfizer on regulatory compliance pitfalls experienced by pharmaceutical companies in a multijurisdictional world

Created: 25/04/2012
Categories: Product liability

BBC News - AstraZeneca 'suppressed' drug test data

Michelmores' clinical negligence team provide a link to this BBC News online article - click here

Created: 26/01/2010
Categories: Product liability

Government apology for thalidomide survivors

Michelmores' clinical negligence team provide a link to this BBC News online article - click here

Created: 14/01/2010
Categories: Product liability

Government to pay £20m and apologise to victims of thalidomide

MIchelmores' clinical negligence team provide a link to the TimesOnline news item - click here

Created: 21/12/2009
Categories: Product liability

Omniscan: GE Healthcare uses libel law to gag doctor

Michelmores' clinical negligence team provide a link to the Times report - click here

Created: 20/12/2009
Categories: Product liability

US court's Vioxx forum non conveniens ruling over foreign plaintiffs

Michelmores' clinical negligence team provide a link to the Law360 webservice - click here

Created: 09/12/2009
Categories: Product liability

US judge requests mass tort status for Yasmin birth control pill claims

With the growing numbers of claims in the US alleging an increased risk of pulmonary embolism and other severe side-effects from the oral contraceptive Yasmin, a court in New Jersey has requested that the actions be centralised and given mass tort status. The US litigation includes three "fourth generation" oral contraceptives Yasmin and Yaz products manufactured by Bayer Healthcare Pharmaceuticals and Ocella manufactured by Barr Pharmaceutical Companies. Women who have filed claims in various States allege that they have suffered strokes, DVTs and other problems including raised potassium levels which may increase the risk of complications for women with a range of conditions including obesity, renal problems, diabetes, chronic high blood pressure or a history of stroke and DVT. The claims allege that the drugs contain oestrogen and progesterone, which suppress ovulation and prevent pregnancy. It is alleged that they also contain drospirenone, an ingredient not found in other oral contraceptives which is alleged to differ from other progesterones in the US and not previously marketed in this country before its use in these 3 drugs. Drospirenone has been associated with health risks not seen in other forms of the hormone. In August 2009 the British Medical Journal published two studies identifying an increased risk of venous blood clots for women taking drospirenone when compared with women who had taken other oral contraceptives. The BMJ referred to 40 cases in which women had suffered venous thrombosis, including one involving the death of a 17 year old. The BMJ reports that the Dutch College of General Practitioners has recommended that its members prescribe the older forms of second generation birth control pills rather than Yasmin and Yaz. Between 2004 and 2008 in excess of 50 deaths associated with the use of Yasmin and Yaz have been reported to the US FDA. On 5 August 2009 the US Food & Drug Administration issued a warning letter to Bayer after it was alleged to have used low-quality batches of drospirenone from a plant in Germany. Michelmores' clinical negligence team provide a link to the netdoctor website setting out information on Yasmin, its active ingredients, guidance for use and warnings. Click here http://www.netdoctor.co.uk/medicines/100004704.html

Created: 12/11/2009
Categories: Product liability

US article highlights concerns for patients in wake of failures of Medtronic Fidelis defibrillator implanted device

On October 15, 2007, after 38 months on the U.S. market and 268,000 implantations worldwide, Medtronic issued a "voluntary market suspension" in the US to remove its line of Medtronic Sprint Fidelis defibrillation leads from the market because of their propensity to fracture. Dr. William Maisel writes in the New England Journal of Medicine that the controversy highlights the shortcomings of the regulatory system in the US for medical devices and underscores the urgent need for legislation that will ensure adequate protection for patients.

Created: 06/03/2008
Categories: Product liability

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