FDA Alert – Specialty Compounding Products
Friday, August 9th the US Food and Drug Administration (FDA) sent out an alert informing health care professionals not to use any sterile products supplied by Specialty Compounding, Cedar Park, TX. Bacterial infections had been potentially associated with contaminated calcium gluconate infusions produced by the company. FDA had received reports of 15 adverse events experienced by patients in two hospitals; the patients had developed bacterial bloodstream infections caused by Rhodococcus equi, an organism commonly found in dry soil. Cultures from an intact sample of calcium gluconate compounded by Specialty Compounding show growth of bacteria that are consistent withRhodococcus species.
As of Monday, August 11th the FDA announced nationwide voluntary recall of all products for sterile use from Specialty Compounding. The recall applies to all unexpired sterile compounded products dispensed since May 9, 2013, including all strengths and dosage forms.
According to information provided by the firm, the recalled products were distributed directly to patients nationwide, with the exception of North Carolina. Recalled products were also distributed directly to hospitals and physicians’ offices in Texas.
Please call The Meyerson Law Firm today to discuss any case. 512-330-9001
I would like to express my sincere gratitude and thanks for everything your firm and especially Mr. Daniel Orocu have done in assisting with my case. Let it be known that Daniel has gone above and beyond to resolve an issue I thought would never end and exceeded my expectations with respect to the settlement received. These efforts are recognized and greatly appreciated and I felt the need to express that I have been totally impressed by the level of dedication, commitment and professionalism in dealing with Daniel and your staff.
Again, thank you for your time and assistance in this matter. I will highly recommend your firm and seek your assistance in any future legal matters.
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St. Jude Medical has recalled certain models of Eon and Eon Mini implantable pulse generators (IPGs). IPGs are battery powered devices that are implanted into a patient’s spinal area and provide stimulation in order to reduce chronic pain.
IPGs require the implanted internal battery to be recharged. However, these devices suffer from significant problems. In certain models, the battery fails which then prevents the device from providing pain relief. In other cases, IPGs have severely burned patients while recharging the battery. Once a problem is detected, the devices must be surgically removed from the spinal area, subjecting the patient to a host of other risks and problems such as infection, pain and scarring.
St. Jude Medical (which is sometimes confused with St. Jude’s Children’s Hospital) has announced that the battery failure problems stem from weld failures within the internal batteries of the units, sometimes allowing fluid to spill out. The battery is fully contained in the titanium shell of the unit, however, and is not at risk of leaking into the body.
If you are having problems with your St. Jude Stimulator, please contact us to discuss how our firm can help you.
The Meyerson Law Firm, P.C. is currently investigating victims of a counterfeit version of the chemotherapy drug Avastin. A fly-by-the-night distributor going by the names Quality Specialty Products and Montana Health Care Solutions sold and distributed the counterfeit drug—which was nothing more than saline solution—to cancer patients across Texas. Our client subsequently died after his lung cancer returned following the administration of the counterfeit drug at South Texas Comprehensive Cancer Center in Corpus Christi. The drug company was not licensed as required by the Texas Department of State Health Services. Although the company has shut down and it appears its owners have fled to the Caribbean, there are potential claims against the facilities who purchased and administered the drug. Our firm has already retained experts to discuss how the Center breached its duties to its patients by purchasing and administering drugs from this unlicensed company. If you or a loved one is a victim of this counterfeit chemotherapy drug, call us for a free consultation.
Recent case law has expanded the definition of what would be considered medical malpractice. In addition to traditional malpractice by doctors or nurses, any injury at a medical facility may fall under the requirements of the Civil Practice and Remedies Code Ch. 74. This chapter, that was created under tort reform, requires that a special report be provided by the Plaintiff within 120 days of filing suit. It also provides for the possibility of an interlocutory appeal by the doctor or facility. The end result can be delays in reaching any resolution or trial of any malpractice case. The Meyerson Law Firm has tactics to reduce some of the risks and delays associated with malpractice claims.
The Meyerson Law Firm is currently litigating an oil fraud case in federal court in Detroit. The allegations of fraud asserted by our client discuss an elaborate scheme involving taking deposits for millions of dollars worth of oil and then refusing to provide the product. Depositions for this case will take us from Houston to San Francisco with the trial being held in Detroit.
The Meyerson Law Firm recently settled on behalf of a client with Verticor, Ltd., the manufacturer of a spherical spinal implant called an Eclipse Sphere as well as Dr. James Hansen. This device was cleared via the FDA’s 510k process using the predicate of Medtronic’s Satellite Sphere. When used in an off-label manner, the device subsides into the vertebrae causing intense pain and typically requiring removal. Over several years, Dr. James Hansen installed the device in numerous patients in Central Texas. At the same time, he was being paid by Verticor as a consultant. When asked whether he received additional payments each time he used the sphere, Dr. Hansen asserted the 5th amendment. The Meyerson Law Firm continues to help his former patients recover for their pain, disability, and medical bills.
The FLSA prohibits restaurants from requiring tip pooling amongst staff. Voluntary tip pooling is legal, but only waiters, bartenders, and restaurant employees making less than minimum wage and who have direct interaction with patrons may participate in tip collection. Managers, cooks, dishwashers, etc. are not permitted to receive tips on a mandatory basis.
Many restaurants and bars violate the FLSA by mandating tip pooling. Successful tip pooling lawsuits have recently been brought against Starbucks, Hard Rock Café, Luby’s, and Outback Steakhouse. If you work in a restaurant or bar and are required to share your tips with staff members who are not legally entitled to receive tips, contact The Meyerson Law Firm today for a free consultation. You may be entitled to financial compensation.