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Saturday, September 13, 2014
FDA Warns of NuVision Contamination!
Connecticut health care providers are being urged by the FDA to cease using sterile products from NuVision Pharmacy. The FDA discovered poor sterilization practices being used by NuVision Pharmacy during an inspection that took place in April. Due to the findings of the inspection, the FDA has called upon the pharmaceutical manufacturer to issue a recall for all their sterile products that have not yet passed their expiration dates.
The FDA believes the products made by NuVision Pharmacy may be dangerous and defective drugs due to their possible lack of sterility. According to the FDA, if drugs that are marketed as sterile actually contain a microbial contamination, patients who are given the drugs may be at risk of infection, which can be life-threatening in some cases. The drug manufacturer has repeatedly declined to issue a recall for their sterile products.
Since the FDA does not have the authority to demand a recall of products from NuVision Pharmacy, the manufacturer is not required to do so. However, to deal with the issue, the FDA has called upon health care providers to stop using products labeled sterile by the company. So far, NuVision Pharmacy is not aware of any adverse events related to their sterilized products, but they did end up recalling two other drugs earlier in the year due to sterility concerns. Individuals who have been injected with products made by the company should contact their health care provider if they have any concerns.
The FDA believes the products made by NuVision Pharmacy may be dangerous and defective drugs due to their possible lack of sterility. According to the FDA, if drugs that are marketed as sterile actually contain a microbial contamination, patients who are given the drugs may be at risk of infection, which can be life-threatening in some cases. The drug manufacturer has repeatedly declined to issue a recall for their sterile products.
Since the FDA does not have the authority to demand a recall of products from NuVision Pharmacy, the manufacturer is not required to do so. However, to deal with the issue, the FDA has called upon health care providers to stop using products labeled sterile by the company. So far, NuVision Pharmacy is not aware of any adverse events related to their sterilized products, but they did end up recalling two other drugs earlier in the year due to sterility concerns. Individuals who have been injected with products made by the company should contact their health care provider if they have any concerns.
Wednesday, September 10, 2014
Boston Scientific Mesh Case hit with $73.5 million jury verdict
How the mesh case verdict was decided!
A jury hit Boston Scientific with $73.5 million in damages this week in one of thousands of suits the device maker faces over an implant intended to treat incontinence.
The verdict in a Dallas court is part of a recent overload of product-defect and failure-to-warn litigation the device industry faces over similar products. Boston Scientific, which had won two similar suits in Massachusetts, has 23,000 more pending against it.
The plaintiff in the Texas case, 42-year-old Martha Salazar, is the first to win an award against the company over alleged defects with its Obtryx sling. Salazar said she suffered nerve damage and persistent pain and infections from the vaginal implant.
“I think it’s a really big case,” said David Matthews, the Houston personal-injury lawyer who represented her in the two-week trial. “A woman’s life was turned upside down because of a device she was using for a minor issue of urinary incontinence.”
Boston Scientific, which has a large workforce in the Twin Cities, said in an e-mailed statement that it was disappointed in Monday’s ruling and vowed to appeal.
The company argued at trial that doctors’ continued widespread use of the devices shows that they understand the benefits and risks.
“Devices like the Obtryx serve an important public medical need,” company attorneys wrote in legal filings.
“The prevalence of their usage in the medical community demonstrates that mesh slings are beneficial to patients.”
Seven companies are sued
A total of seven companies are facing lawsuits over alleged defects in vaginal mesh devices, including C.R. Bard and Johnson & Johnson’s Ethicon subsidiary, Reuters reported. Last April, a subsidiary of Dublin-based Endo International agreed to pay $830 million to settle about 20,000 defect lawsuits without admitting wrongdoing.
The devices are designed to treat incontinence and the shifting of organs from pelvic-floor prolapse, which can occur with age and after childbirth. Mesh slings are supposed to support weakened or damaged internal tissues, and may be removable or permanent.
Salazar accused Boston Scientific of negligence for designing and marketing the flawed Obtryx device even though it had a safer alternative design before January 2011, when her doctor implanted her device. The jury agreed, and awarded Salazar and her husband, Felix, $23.5 million in compensatory damages and an additional $50 million in punitive damages.
The jury verdict form said the Dallas jurors decided that the company’s actions amounted to gross negligence because executives knew of the risk from the product and sold it “with conscious indifference to the rights, safety or welfare of others.”
Company lawyers strongly dispute the strength of Salazar’s evidence at trial. They said she failed to show the device was “unreasonably dangerous” and never proved that the company failed to warn doctors of the risks inherent in the device.
“As explained by Ms. Salazar’s treating surgeon, Dr. Lopez, the Obtryx is recognized by the medical community as the standard of care,” company lawyers wrote in court filings before the verdict, referring to stress urinary incontinence.
Monday, September 8, 2014
Whistleblower Special Meeting for Your Rights!
BREAKING NEWS
Whistleblower Special Meeting
Tomorrow, Tuesday September 9th at 2:00 pm ET, the House Oversight Government Reform Committee’s Federal Workforce, US Postal Service and Census Subcommittee will hold the following hearing, “Examining the Administration’s Treatment of Whistleblowers”. It will explore whistleblower retaliation since passage of the Whistleblower Protection Enhancement Act.
Witnesses have not yet been publicly announced, but GAP legal director Tom Devine, Federal Air Marshal whistleblower Robert MacLean, and VA whistleblower Dr. Van Boven will be testifying, among others.
The hearing is open to the public and will be held at 2154 Rayburn House Office Building.
Elderly Overmedicated--When Will This Abuse Stop
Elderly pay the price once again for someone's greed!
NPR (9/5, Jaffe, 519K) reported in its "Shots" blog that a Federal lawsuit against two California nursing homes accused of overmedicating patients may offer a new approach to dealing with the persistent problem of such facilities overmedicating their residents."
The US Attorney for Northern California "claims that the two nursing homes provided 'grossly inadequate, materially substandard and/or worthless services,'" while they "received about $20 million from Medicare and Medicaid for those services."
Kelly Bagby, a senior attorney with the AARP Foundation, said, "Under the False Claims Act, the government can ask for triple damages."
Halliburton Settles With Plaintiff Claims
Halliburton has agreed to “settle a substantial portion of plaintiff claims” from the 2010 Deepwater Horizon spill for $1.1 billion. The settlement is still “subject to court approval.” The settlement pertains to claims Halliburton was assigned as a result of BP’s 2012 settlement.
The Washington Post notes that the settlement covers “two classes of plaintiffs, including new punitive damages for those who suffered property damage or were in the commercial fishing business” as well as “BP claims against Halliburton that were assigned to the plaintiffs as part of BP’s earlier settlement.” Judge Barbier must still approve the settlement.
The New York Times reports that in a Tuesday statement Halliburton said that it “denies all allegations of any wrongdoing, fault, noncompliance, liability; denies that it acted improperly in any way; and denies that it caused any damage or loss arising out of, due to, resulting from, or relating in any way to, directly or indirectly, the Deepwater Horizon incident.”
Bloomberg News reports that Halliburton’s settlement “refocuses attention” on the ongoing BP trial, as spill victims asserted Halliburton’s work on BP’s Macondo well “was defective.” A BP spokesman on Tuesday said Halliburton’s settlement emphasizes “that the fire and explosion aboard the Deepwater Horizon was an accident resulting from multiple causes, involving multiple parties” and marks “the very first time” that Halliburton has said “that it played a role in the accident.”
The Hill reports that “in its own statement,” the company “did not take any responsibility” for the Deepwater Horizon accident. However, plaintiffs attorney Joe Rice called the agreement “a reasonable compromise of a highly contested issue – the level of responsibility of Halliburton and the degree of the alleged failures of Halliburton’s conduct.”
The Wall Street Journal notes that the $1.1 billion settlement is slightly less than the $1.3 billion that Halliburton put aside for costs related to the spill. Transocean, BP, and Halliburton are still awaiting a verdict from US District Judge Carl Barbier on the degree of negligence for each party. Tuesday’s settlement allows Halliburton to avoid risking a higher damages ruling if Judge Barbier finds it was grossly negligent.
TIME (9/2, Kedmey, 24.1M) notes that the $1.1 billion settlement will be placed “into a trust in three installment.” That trust will be used to award “damage claims from property holders and commercial fisheries” affected by the Deepwater Horizon spill.
BBC News (9/2, 1.17M) notes that Deepwater Horizon rig owner Transocean previously entered a $1.4 billion settlement in the case, and thus far BP has paid an estimated $28 billion.
Bass Pro Ordered To Pay $6 Million To Settle Recorded Call Lawsuit
Bass Pro LLC, the outdoor sporting goods company, will pay more than $6 million to settle a class action accusing the retailer of illegally recording customer calls without their consent. U.S. District Judge Cynthia Bashant, sitting in California, has approved the settlement agreement. The preliminary approval of the agreement resolves a suit filed by a customer who alleged the retailer recorded a conversation between him and a Bass Pro customer service representative. It was contended that the employee divulged financial information, including the customer’s credit card information. In addition to the $6 million cash award, under the agreement the retailer will stop recording calls without customer consent.
Lead Plaintiff Geoffrey McDonald claims Bass Pro recorded at least one conversation where he told a customer service representative sensitive information, without being informed that his conversation would be recorded. The suit, which was removed to federal court in April 2013, alleged that the outdoor retailer, in the year prior to the filing of the complaint, had a regular practice of recording incoming and outgoing telephone communications with customers without notifying the customers that the communications would be recorded, in violation of California privacy laws. McDonald filed the suit on behalf of all California residents who have had a least one phone conversation with a live Bass Pro customer service representative that was recorded without notification. In the order granting preliminary approval to the settlement, Judge Bashant also granted conditional class certification.
According to the court’s order, the settlement agreement applies to California residents who had at least one Bass Pro phone call recorded between March 14, 2012, and April 3, 2013. Approximately 94,600 improperly recorded calls were found during discovery, of which 30,000 individuals could be identified, according to the order. The $6 million settlement will be broken down into $1.8 million in attorneys’ fees, $150,000 in litigation costs and $20,000 in service-payment deductions, leaving $4 million to be paid to class members.
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