Articles Posted in Pharmaceutical Litigation/Dangerous Drugs

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The Alabama Supreme Court recently sided with a plaintiff seeking damages against a grocery store pharmacy for injuries she suffered after she was given the wrong prescription.
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Defense counsel in Morgan v. Publix Super Markets Inc. argued in their motion for summary judgment before the Jefferson Circuit Court that the plaintiff failed to make her case because she hadn’t produced an expert witness that would have established a breach of the applicable standard of care under the Alabama Medical Liability Act.

However, in reversing the trial court’s earlier decision to grant that motion, the Alabama Supreme Court found that a pharmacy’s negligence in dispensing the wrong medication is so straightforward that the plaintiff didn’t need the testimony of an expert witness to prove it.

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Our Tuscaloosa defective medical device lawyers know transvaginal mesh products were sold by manufacturers with lots of promises to doctors and patients that the surgical mesh would make it easier to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). For thousands of women who began to experience complications after their TVM surgeries, however, the surgical mesh turned out not to live up to its promises. 1088940_2_annual_reports__3.jpg

Now, a new study has demonstrated that transvaginal mesh is not only unsafe but also that it is ineffective. The study was conducted by Georgetown University and published in the September issue of Obstetrics and Gynecology. The results are alarming and every patient who has had a mesh procedure or who is considering one should be aware of what the research showed.

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The first case in a series of multidistrict transvaginal mesh lawsuits against the manufacturer C.R. Bard did not go as the company had hoped.
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As a result, the health care products manufacturer intends to appeal, knowing full well that such a judgment sets the tone for the flood of future cases that are waiting in the pipeline. However, a federal judge has denied a motion from the defendant Bard to stay or hold the other pending cases while this one works its way through the appellate process.

In the case of Cisson v. C.R. Bard, the jury sided with the plaintiff, awarding her $250,000 in compensatory damages and $1.75 million in punitive damages.

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It’s been several months since compounding pharmacies in New England came under severe scrutiny by health officials, following a fatal outbreak of fungal meningitis that affected patients nationwide.
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Our Alabama pharmaceutical litigation attorneys predicted that, given the lack of oversight, such hazards were sure to repeat. Sure enough, they have – this time at a Texas compounding facility called NuVision Pharmacy.

The U.S. Food and Drug Administration has issued a second warning regarding the facility’s supposedly sterile products, which the company has refused to recall, despite the FDA’s mandate. The first warning about the company’s products was issued back in mid-May.

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Contaminated steroid injections blamed for at least 32 deaths in 19 states have led federal investigators to sterility problems at a second New England drugmaking facility. Ameridose is one of the leading suppliers of pre-filled syringes and is now under fire in a widening probe into dangerous drugs that have put thousands of patients at risk.

Alabama pharmaceutical attorneys understand the widening probe into activities at Ameridose means the risks may be far from over. Ameridose agreed to shut down for inspection in October after its sister company, the New England Compounding Center, was blamed for distributing steroid injections containing fungal meningitis to health clinics nationwide. 250621_injection_time_-_syringe_with.jpg

USA Today reported this week that the head of the Food and Drug Administration will ask lawmakers to grant the agency more authority to oversee such compounding facilities. Congress is racing through hearings and calling for legislation so there is now little doubt reforms will be enacted. However, as Reuter News reports, Congress has known about the risks posed to consumers by such facilities for a number of years. In 2007, it killed the Safe Drug Compounding Act sponsored by the late Senator Ted Kennedy amid heavy lobbying from the pharmaceutical industry.

In the report given to Congress, 10 of 29 drugs provided by compounding facilities failed one or more quality-control test. Including nine that failed potency tests — some testing less than 70 percent of dosage. That compares to just four failures of more than 3,000 tested samples provided by drug manufacturers. Because of Congressional inaction, licensing and inspection of such facilities largely relies upon state agencies.

Problems at the New England Compounding Facility were reported as far back as 1998 — just one year after it opened and was granted a license to operate by the Massachusetts Board of Pharmacy. The head of the state’s pharmacy board has since been fired. The Centers for Disease Control and Prevention reports more than 400 have now been sickened. The company’s entire product line is under recall. The Alabama Department of Public Health reports 44 health care facilities received products from the NECC that are now under recall, including injectable drugs, epidurals, and medications used in eye and heart surgeries.

Now the problems at Ameridose have the potential to exacerbate the crisis. The Montgomery Advertiser reports federal inspectors have found a host of problems at the facility, including ineffective drugs meant to be administered to children and women, leaky ceilings, insects, non-sterile conditions and even a bird flying around the facility. While no deaths have yet been reported, problems at the facility date to 2008, according to a 20-page report released by the FDA.

In at least 58 separate incidences, Ameridose staff is accused of not investigating contamination of bacetia or fungi found in sterile liquid used in pain relief and anesthetic injections. Ameridose provides medications in prefilled syringes to hospitals nationwide.

These are tragically preventable cases that illustrate the dangers medical patients face every day. These companies are operating as for-profit enterprises. Too often, clinics, hospitals and other medical establishments are cutting corners and ordering medication from such compounding or mixing facilities as a way to cut costs. And, as we see again in this case, consumers cannot count on the FDA to be anything more than reactionary.

If you believe you have been injured by a dangerous pharmaceutical or defective medical product, speak to an experienced Alabama law firm today.

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Drug maker GlaxoSmithKline PLC said Thursday that it has agreed in principle with the United States government on a $3 billion settlement of investigations of the company’s sales and marketing practices.

The agreement is expected to be completed next year, and the settlement will be paid through the company’s cash resources, it said.

The case dates from 2004, and included investigations of possible price irregularities and the development and marketing of the diabetes drug Avandia.

The company said the tentative settlement covers both civil and criminal liabilities.

In June, Glaxo’s U.S. subsidiary agreed to pay more than $40 million to 37 U.S. states and Washington, D.C., to settle complaints about manufacturing processes at a plant in Puerto Rico, which has been closed.

The company also paid a $750 million fine in 2010 in the U.S. related to the Puerto Rico plant.

Source: The Associated Press