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Latest News & Updates

Following on from medical device alerts from the Medicines and Healthcare products Regulatory Agency (MHRA), CareFusion has made updates and replacements to the MDA/2016/023 Alaris syringe pumps that were at risk of having uncontrolled bolus i.e. chewed up amounts of substances from the medicine.
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Anaphylaxis is a life-threatening reaction to certain allergens which can be found in foods, drugs, and even venom like in a wasp sting. Depending on the sufferer’s sensitivity to the allergens, anaphylactic shock can be caused by ingestion or even mere contact on skin.

Otherwise more commonly known as an allergic reaction, without the simple treatment, the consequences can be serious and even fatal. Anaphylactic shock can come on immediately, and in severe cases, symptoms can develop just as quickly. Some symptoms include swelling of the throat and face; wheezing; dizziness and fainting spells. If left untreated, individuals may have difficulty breathing to a point where they may stop doing so.

For these reasons, any life saving EpiPen recall is always a major concern.
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The Medicines and Healthcare products Regulatory Agency (MHRA) has recommended recalling instant pain relief tablets due to an issue with some batches.

Bayer plc is a pharmaceutical company who manufactured the pain relief tablets in question; Alka-Seltzer Original & Alka-Seltzer XS. Bayer noticed an issue with the blister foil and as a result, are voluntarily recalling them as a precautionary measure.
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Drager has issued a ‘risk of failure’ alert to all users after multiple reports were made complaining that ventilation devices had stopped working.

This is reportedly not the first time the company has received these complaints. Dräger has now issued a second Field Safety Notice for the Oxylog 3000 and Oxylog 3000 plus ventilators.
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Thousands of women worldwide have experienced catastrophic injuries as a result of having a synthetic transvaginal mesh, transvaginal tape, or a bladder sling implanted.

The net-like implant is commonly used to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI).

Common side effects reported from the use of the vaginal mesh implants include continuing urinary incontinence; recurrent bladder infections; erosion; haematomas; nerve damage; inability to have sexual intercourse; pain during sexual intercourse; auto immune reactions; and life-long disabilities and even death.
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Pharmaceutical company Biogen Inc has recently received a scare from its big-selling oral multiple sclerosis drug, Tecfidera.

Tecfidera has been well-known to treat relapsing multiple sclerosis, and although, Tecfidera’s historic side effects have been linked with serious viral infections to the brain, which could lead to disability or death, more recently, the medicine has been linked to liver injuries.

Of the 230,000 patients treated with Biogen’s Tecfidera, there have been 14 reported cases of liver injury, according to a Biogen spokeswoman.
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A medical device manufacturer has stopped the production and use of a heart pump device following the death of a patient.

Abbott Laboratories, an American-based worldwide healthcare company, has halted the use of the HeartMate PHP catheter following a patient death and several malfunctions in the U.S. and in Europe.

The device was initially thought to be commercially promising, but the problems identified are serious.
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Bayer plc, a global pharmaceutical company, has received two complaints with regards to its Mirena inserters. The complaints detail that the insertion tube was mounted inversely to the handle, and this has led to an inversion of the insertion depth scale, which may lead to incorrect insertion depth; consequently reducing the efficacy and/or causing injuries.

An investigation has shown that both complaints involve one batch of inserters and a Mirena batch number TU01BPE. The affected batch was first distributed on 29^th August 2016, with an expiry in June 2019.
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The Medicines and Healthcare products Regulatory Agency (MHRA) recently issued a caution relating to a drug that treats adult patients with active rheumatoid arthritis or active psoriatic arthritis.

Global pharmaceutical company Sanofi informed the medical agency of the error on the Braille on the packaging of some batches of the Arava 10mg film-coated tablets. The affected batches were distributed in May 2016, August 2016,  September 2016 and October 2016 with batch numbers 5JK2A, 5JK3A, 5JK6G and 6EV2A accordingly.
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J&J has had a rough time of late with the J&J talcum-powder lawsuit in which victims argued the use of such powder was a strong cause for ovarian cancer. On top of that we have the ongoing cases for hip replacement products that have been pursued across the world for several years now.

A $1 billion (£813 million) fine was slapped on both J&J and its subsidiary, Depuy Orthopaedics, after a Texas jury found that the metal-on-metal Pinnacle hip implants were defectively designed, and that no warnings were given to consumers to highlight the risk.
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There is a reported risk with the use of non-recommended syringes in Alaris syringe pumps, manufactured by CareFusion.

The non-recommended syringes are reported to have a broken spring in the plunger which may cause unintended bolus (usually chewed up mass in the mouth) of medication.
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Teva U.K. Limited – a global pharmaceutical company – has recalled a batch of class 2 medicines due to a possible metal contamination.

The pharmaceutical company has recently made a precautionary batch recall for a ‘small number’ of Evacal D3 chewable tablets. The tablets are a calcium-vitamin D supplement used to treat a lack of calcium and vitamin D, predominantly in the elderly.
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