$1,000,000 Settlement Involving Toxic Tort

posted on:
August 26, 2008

author:
Staff

category:
Environmental | Landmark Verdict

$1,000,000 toxic tort settlement on behalf of the client.

January, 2006 

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New, contradictory evidence from Xarelto makers could lead to retrial for plaintiff

posted on:
September 21, 2017

author:
Staff

xarelto New, contradictory evidence from Xarelto makers could lead to retrial for plaintiff There is an effective lab test to protect patients taking Xarelto, but that isn’t what jurors heard during last month’s trial against Johnson & Johnson’s Janssen Pharmaceuticals and Bayer – the makers of Xarelto. In fact, jurors heard the exact opposite information from witnesses testifying for the defendant companies. Attorneys who represented Dora Mingo in the third Xaretlo bellwether trial have asked the court for a retrial based on the discovery of the new evidence that contradicts the defendants’ testimony.

Near the end of the trial a new study was released that had been conducted and co-authored by Bayer’s own leading scientists and was published by the Journal of Thrombosis and Haemostasis. The study showed that prothrombin time or PT, which is a standard lab test, “may be used to assess anticoagulant activity” and is sensitive to rivaroxaban – the name of the drug marketed as Xarelto. Yet, defense witnesses testified at trial that PT is “dangerous, useless and meaningless” to use with Xarelto, Law360 reports.

“Had jurors known this, it would have changed the outcome of the trial,” said Andy Birchfield, Beasley Allen lawyer and co-lead attorney for Ms. Mingo. “These jurors were told no measuring or monitoring of any kind was required, or even possible. That is simply not true. The study by the Bayer scientists is just the latest example that they knew otherwise.”

Xarelto is an anticoagulant. The Food and Drug Administration (FDA) approved Xarelto to prevent strokes for patients with atrial fibrillation (A-fib), to prevent blood clots forming in post-orthopedic surgery patients, and to treat or prevent deep vein thrombosis and pulmonary embolism. The drugmakers marketed Xarelto as a more convenient alternative to the decades-old warfarin and one that did not require coagulation monitoring.

However, as Beasley Allen has previously explained, patients taking Xarelto have a higher bleeding risk than patients using other oral anticoagulants, and there is no reversal agent for Xarelto. Therefore, the monitoring is essential to determine if the patient will benefit from the drug or if the drug will exacerbate the already high risk of internal bleeding.

Dora’s claim is one of 18,561 claims in the Xarelto multidistrict litigation (MDL), according to the U.S. Judicial Panel on Multidistrict Litigation. The claims are consolidated in the United States District Court for the Eastern District for Louisiana with Judge Eldon E. Fallon presiding. Plaintiffs are suing over the drugmakers’ failure to warn consumers about the potential for Xarelto to increase a patient’s risk of internal bleeding.

Ms. Mingo experienced gastrointestinal bleeding after taking Xarelto for deep vein thrombosis, which she developed after hip replacement surgery in 2015. She had to be hospitalized and was placed in the Intensive Care Unit until doctors could stabilize her condition. If Janssen and Bayer had instructed the doctors caring for Ms. Mingo to monitor her while she was taking Xarelto, she may never have been put through the life-threatening experience, her lawsuit alleges.

* * *

Lawyers in Beasley Allen’s Mass Torts Section continue to investigate injuries suffered by patients who took Xarelto. Injuries include gastrointestinal, rectal and brain bleeds, and deaths caused by major bleeding events. If you would like more information, contact Joseph VanZandt, a lawyer in the Mass Torts Section. You can reach him at 800-898-2034 or by email at Joseph.Vanzandt@beasleyallen.com.

Sources:
Journal of Thrombosis and Haemostasis
Law360
Beasley Allen
U.S. Judicial Panel on Multidistrict Litigation

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At Beasley Allen, there is never a fee for legal services, unless we collect for you. Contact us today by filling out a brief questionnaire, or by calling our toll free number, 1-800-898-2034, for a free, no-cost no-obligation evaluation of your case.

Federal auditors: nursing home abuse and neglect significantly underreported

posted on:
September 21, 2017

author:
Chris Boutwell

 Federal auditors: nursing home abuse and neglect significantly underreportedAs Beasley Allen previously reported, a recent report from the Office of Inspector General (OIG) at the U.S. Department of Health and Human Services (HHS) revealed a gross underreporting of nursing home abuse and neglect incidents throughout the country. After discovering a number of cases had never been reported to local law enforcement as required by law, OIG auditors realized a pattern that indicated a breakdown in the system designed to protect nursing home residents. Without waiting for the conclusion of the audit, the agency issued an “early alert” taking to task HHS and the Centers for Medicare and Medicaid Services (CMS), which oversees nursing homes, for deficient procedures and reporting shortfalls.

Further, the OIG report explained that CMS had taken no enforcement actions since 2011 when federal law triggered a set of sanctions to correct the underreporting. The agency failed to update the State Operations Manual (SOM) with the new regulations until six years after the law became effective.

The SOM is part of the CMS Online Manual System that offers guidance on day-to-day operating instructions, policies and procedures to State Survey Agencies (Survey Agencies). Survey Agencies are state level governing bodies that are delegated certain CMS oversight duties including conducting investigations to determine how nursing homes and other health care providers comply with their Conditions of Participation in the Medicare and Medicaid programs including the reporting of potential abuse or neglect.

In 2011, Section 1150B of the Social Security Act became effective, requiring “covered individuals in federally funded long-term care facilities” to report potential crime, such as abuse and neglect, committed against a resident at the facility. If such incidents were not reported to appropriate authorities, CMS had several enforcement actions at its disposal to ensure compliance with the reporting requirements. These actions included “civil monetary penalties of up $300,000 and possible exclusion from participation in any federal health care program.”

While CMS confirmed that it had not taken enforcement actions, it argued that, as of this summer, the Secretary of HHS had not officially conferred such authority upon the agency. Nonetheless, the agency also said it had not identified anyone who had failed to report an incident of potential abuse or neglect.

The OIG early alert report described the inexcusable experiences of two nursing home residents uncovered during the audit. A female resident was allegedly sexually assaulted and had “two silver-dollar-sized bruises” on one of her breasts following the encounter. The emergency room report noted that nursing home staff helped the female resident bathe and change clothing before taking her to the emergency room. The nursing home did not report the attack. Instead, facility personnel informed the resident’s family the following day and the family contacted law enforcement, which then began investigating the incident.

Similarly, a male resident who “suffered from several medical conditions that affected his mental acuity,” was admitted to the emergency room where medical professional noticed “multiple bruises in various stages of healing.” The emergency room staff noted that some of the bruises were on areas of the body “not easily banged” and that “a deep healing scratch on the right flank” raised the staffs’ concern about possible abuse or neglect. The resident talked to emergency room personnel about “being beaten with feet, hands and a broomstick,” yet because of his mental status, it was difficult for those assisting in him in the emergency room to gain a clear picture of what caused his injuries.

Sadly, incidents like these have become a common occurrence in nursing homes across the country. When they go unreported, perpetrators of appalling abusive or neglectful acts are not held accountable. The OIG report included several recommended steps CMS must take immediately including: continuing to work with HHS to receive the appropriate enforcement authority; updating the SOM and working with Survey Agencies and nursing homes to ensure compliance; and fully enforcing Section 1150B – including all penalties.

* * *

If you need more information on nursing home litigation contact Chris Boutwell, at 800-898-2034 or by email at Chris.Boutwell@beasleyallen.com. Chris handles nursing home litigation for our firm, and he will be glad to talk with you.

Visit BeasleyAllen.com Sept. 28 for another installment in our Nursing Home Series.

Sources:
Beasley Allen
U.S. Department of Health and Human Services/Office of Inspector General

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At Beasley Allen, there is never a fee for legal services, unless we collect for you. Contact us today by filling out a brief questionnaire, or by calling our toll free number, 1-800-898-2034, for a free, no-cost no-obligation evaluation of your case.

Taxotere MDL trial dates set

posted on:
September 20, 2017

author:
Beau Darley

beau darley Taxotere MDL trial dates setAccording to the U.S. Judicial Panel on Multidistrict Litigation there are 1,624 lawsuits in the Taxotere multidistrict litigation (MDL) pending against the drug’s manufacturer and French drugmaker Sanofi Aventis (Sanofi). The cases are consolidated in the U.S. District Court of the Eastern District for Louisiana with Judge Kurt D. Engelhardt presiding.

Last month, Judge Engelhardt issued an order establishing the dates of four bellwether trials for the MDL, beginning in January 2019. The initial dates for the other three trials are set for April 8, July 15, and Nov. 4, 2019.

The MDL is moving ahead despite Sanofi’s continued attempts, Reuters reports, to get the claims tossed out of court.

Taxotere is a chemotherapy drug approved by the Food and Drug Administration (FDA) to treat breast cancer and other forms of cancer, the Jere Beasley Report explains. And, as Beasley Allen previously reported, it is two times as potent as its safer and just as effective alternative, Taxol. Many patients who took the drug are now experiencing permanent hair loss, but were never warned of the risk. Unlike Taxol, Taxotere can destroy hair follicles, preventing hair from growing back after treatment.

Although Sanofi knew about the risk and warned patients outside of the U.S. as early as 2005, it refused to warn U.S. patients until 2013 when the FDA demanded the drugmaker change its label and warn patients of the risk of permanent hair loss. Patients suffering from the unnecessary side effect have a permanent physical reminder of their cancer and its impact on their lives.

* * *

Lawyers at Beasley Allen are currently investigating potential cases involving individuals who have suffered permanent hair loss following chemotherapy with Taxotere. For more information on this subject, contact Beau Darley or Melissa Prickett, lawyers in our firm’s Mass Torts Section, at 800-898-2034 or by email at Beau.Darley@beasleyallen.com or Melissa.Prickett@beasleyallen.com.

Sources:
U.S. Judicial Panel on Multidistrict Litigation
U.S. District Court Eastern District of Louisiana
Reuters
Jere Beasley Report (March 2017)
Beasley Allen

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At Beasley Allen, there is never a fee for legal services, unless we collect for you. Contact us today by filling out a brief questionnaire, or by calling our toll free number, 1-800-898-2034, for a free, no-cost no-obligation evaluation of your case.

Whistleblower action recovers $1.4 million from national dental chain

posted on:
September 15, 2017

author:
Archie Grubb

archie grubb1 Whistleblower action recovers $1.4 million from national dental chainNational dentistry chain Dental Dreams has agreed to pay the U.S. nearly $1.4 million to settle a whistleblower’s claims that it improperly billed the Massachusetts Medicaid program, MassHealth, for “unnecessary and unjustifiable dental procedures.”

The $1.375 million settlement resolves allegations brought by a former Dental Dreams employee under the whistleblower provisions of the False Claims Act (FCA), which allows private parties to sue on behalf of the U.S. government when witness to apparent fraud and other wrongdoing.

According to the U.S. Department of Justice (DOJ) the whistleblower lawsuit alleged that Dental Dreams overbilled the Massachusetts Medicaid program for surgical extractions of teeth and for a certain type of oral examination that was not specified.

“This dental chain’s extensive improper billing violated state regulations and cost our state’s Medicaid program more than a million dollars,” said Massachusetts Attorney General Maura Healey. “As a result of this joint investigation, today’s settlement provides restitution to MassHealth and ensures that these funds are properly used to benefit its members.”

Harold Shaw, Special Agent in Charge of the FBI’s Boston Field Division said that Dental Dreams “took advantage of a vulnerable patient population when it submitted claims to MassHealth for medically unnecessary and unreasonable dental procedures.”

“Today’s settlement underscores the FBI’s commitment to investigate health care providers who overbill federal and private health insurance programs to maximize profits,” he added. “We urge anyone with information regarding overbilling practices to contact us.”

Dental Dreams is a full-service chain of dentistry clinics that operate in ten states and the District of Columbia.

* * *

Are you aware of fraud being committed against the federal government, or a state government? If so, you may be protected and rewarded for doing the right thing by reporting the fraud. If you have any questions about whether you qualify as a whistleblower, please contact an attorney at Beasley Allen for a free and confidential evaluation of your claim. There is a contact form on this website, or you may email one of the lawyers on our whistleblower litigation team: Archie Grubb, Larry Golston, Lance Gould or Andrew Brashier.

Source: U.S. Department of Justice

Free Legal Consultation
At Beasley Allen, there is never a fee for legal services, unless we collect for you. Contact us today by filling out a brief questionnaire, or by calling our toll free number, 1-800-898-2034, for a free, no-cost no-obligation evaluation of your case.

U.S. nursing home industry fails to protect residents as aging population demand grows

posted on:
September 14, 2017

author:
Chris Boutwell

 U.S. nursing home industry fails to protect residents as aging population demand growsA new study from the RAND Center for the Study on Aging shows that more than half the U.S. population will require nursing home care at some point during their lives. The number is much higher than the 35 percent previously estimated by the U.S. Department of Health and Human Services (HHS).

The needs can range from weeks of temporary care for rehabilitation to longer term care. These findings come on the heels of a recently released report by the Office of Inspector General (OIG) at HHS. When combined, the information from the two reports is very troubling for our country’s aging population and their loved ones regarding the abuse and neglect running rampant in nursing homes across the country.

Auditors for the OIG found that skilled nursing facilities or nursing homes failed or refused to report more than one-quarter of severe incidents of abuse as required by law.

In an ongoing review of potential abuse and neglect of Medicare beneficiaries, auditors uncovered 134 such incidents and learned that 28 percent of the cases showed no evidence they were reported to local law enforcement “despite State mandatory reporting laws requiring the hospitals’ medical staff to do so,” the report noted. While the audit continues, OIG officials believed it was critical to issue an “early alert” insisting the Centers for Medicare and Medicaid Services (CMS), which oversees nursing homes, immediately address the significant underreporting problem.

The auditors discovered the grave problem while sifting through and comparing reports for services paid to beneficiaries who obtained emergency room treatment in addition to the treatment and care they were already receiving at their nursing home. Auditors learned that CMS does not conduct the same type of comparison of beneficiaries’ records. This finding was key to alerting auditors that CMS procedures to identify and report abuse and neglect incidents were deficient.

As federal regulators and consumer advocates work to combat nursing home abuse and neglect and make nursing homes safer for residents, others are working to block these efforts, including the nursing home industry. In the coming weeks, we will highlight the shortfalls within the industry and the challenges facing nursing home residents and their families and caregivers in this Nursing Home Series of stories.

* * *

If you need more information on nursing home litigation contact Chris Boutwell at 800-898-2034 or by email at Chris.Boutwell@beasleyallen.com. Chris handles nursing home litigation for our firm, and he will be glad to talk with you.

Visit BeasleyAllen.com on Thursday, Sept. 21 for another installment in the Nursing Home Series.

Sources:
RAND Center for the Study on Aging
U.S. Department of Health and Human Services/Office of Inspector General

Free Legal Consultation
At Beasley Allen, there is never a fee for legal services, unless we collect for you. Contact us today by filling out a brief questionnaire, or by calling our toll free number, 1-800-898-2034, for a free, no-cost no-obligation evaluation of your case.

New trial for testosterone litigation starts next week

posted on:
September 13, 2017

author:
Matt Teague

matt teague New trial for testosterone litigation starts next weekIn June, the first bellwether trial for the Testosterone Replacement Therapy (TRT) multidistrict litigation (MDL) ended in a mistrial when the lead plaintiff’s lawyer suffered from heart problems. The new trial for the case is slated to begin next week in the U.S. District Court for Northern Illinois in Chicago, Law.com reported.

Plaintiff Jeffrey Konrad contends that his heart attack seven years ago was linked to the TRT drug AndroGel he started to use 65 days earlier. His is one of more than 7,000 claims pending against TRT manufacturers, including AndroGel maker AbbVie, Besins, Eli Lily and GlaxoSmithKline, as Beasley Allen previously reported. The claims are seeking to hold the manufacturers accountable for failing to warn users of potential cardiovascular side effects.

The Food and Drug Administration (FDA) approved TRT to treat hypogonadism, which occurs when the body does not produce enough of the male hormone.

Plaintiffs maintain that despite not being designed to treat symptoms of age-related testosterone decline, manufacturers marketed the products as “fountain of youth” drugs to lure men who did not need the treatment to ask for it by name. They claim TRT manufacturers concocted a fictitious condition called “Low T,” which includes symptoms such as low libido, weight gain and muscle loss – all age-related symptoms.

The off-label use is ineffective and even puts men at increased risk of life-threatening events such as heart attacks, strokes and blood clots, the litigation alleges. A jury in July agreed and awarded another plaintiff in the MDL $150 million in punitive damages. It found that AbbVie’s aggressive marketing scheme targeting aging men was fraudulent, Beasley Allen Reported.

Jeffrey’s case is one of seven cases in the class action selected as bellwethers – six of the claims are against AbbVie. The remaining bellwethers are scheduled through next April.

* * *

If you or a loved one has suffered a heart attack or stroke while taking testosterone supplements, or if someone you love has died, you can contact Matt Teague, a lawyer in the firm’s Personal Injury and Product Liability Section at 800-898-2034 or by email at Matt.Teague@beasleyallen.com. More information about testosterone replacement drugs or replacement therapy can be found at http://www.lowt-lawyer.com/.

Sources:
Law.com
Beasley Allen

Free Legal Consultation
At Beasley Allen, there is never a fee for legal services, unless we collect for you. Contact us today by filling out a brief questionnaire, or by calling our toll free number, 1-800-898-2034, for a free, no-cost no-obligation evaluation of your case.

Beware: Experts say Equifax data breach ‘free’ monitoring offer raises red flags

posted on:
September 8, 2017

author:
Staff

category:
Fraud

data breach Beware: Experts say Equifax data breach ‘free’ monitoring offer raises red flagsAs Americans come to grips with the gravity of yet another corporate data breach, they are also learning that the offer to monitor their credit free of charge for a year comes at a high price. CBS News reported that the offer by Equifax, the credit reporting agency at the center of the latest compromise of consumers’ personal data, is contingent upon consumers’ agreeing to mandatory arbitration – waiving their Constitutional right to take the company to court.

The breach appears to have occurred months ago, but Equifax only learned about it July 29 and still waited more than a month to publicly disclose the incident. In the meantime, the company was creating a website, www.equifaxsecurity2017.com, which allows consumers to check and see if their personal information could have been impacted by the breach, according to the Washington Post. Regardless of whether a consumer was one of the 143 million people affected or not, they can opt to enroll in a free credit monitoring service through TrustedID Premier.

The process sounds simple, but it isn’t, and consumer groups warn that red flag issues should make consumers proceed with caution.

First, after a consumer verifies whether their information was potentially impacted, they have the option to click “Enroll.” An auto generated message gives them a date in the future to return to the site and complete the enrollment. So, while their data was compromised months ago, and they have waited to even learn of the breach, they still must wait days to activate the monitoring.

Parsing through the fine print, consumers will note they agree to mandatory arbitration if they opt to use the service. The terms of service appeared to have changed Friday, CBS News noted, and it may be possible to opt-out of arbitration. Even so, the responsibility to opt out will be on customers.

Arbitration clauses, or “rip-off clauses” as consumer rights activist call them, forced on consumers involved in financial transactions may soon be a thing of the past thanks to the Consumer Financial Protection Bureau (CFPB). The CFPB announced rules in July that will block companies “that extend credit or collect debt” from “contractually obligating customers to binding arbitration agreements,” CBS News reported.

Richard Cordray, who heads the CFPB, discussed the new rule in a New York Times commentary saying, “Not only do group lawsuits help consumers recover money they otherwise would forfeit, but they also protect many more consumers by halting and deterring harmful behavior.”

Finally, a cyber-security blog, Krebs on Security, noted that the new website had been reported as a possible phishing attack – potentially subjecting consumers to even further damage. Krebs on Security has previously recommended consumers consider alternative measures to protect themselves from cyber crime, including:

  • Place a fraud alert, or security alert, on your credit file, which lasts for 90 days. The law allows them to be renewed as often as the consumer wishes. A longer-term alert can last up to seven years with proper documentation showing fraud has been committed against a person or is likely to be committed against them. Potential creditors are supposed to contact a consumer and obtain permission before opening new lines of credit in their name if they have a fraud alert in place. A consumer only needs to file a fraud alert with one of the major credit bureaus (Equifax, Experian or Trans Union). They are required by law to alert the other two bureaus.
  • Place a security freeze, which locks access to a credit file against anyone trying to open a new account or acquire a line of credit in someone’s name. A credit freeze may be less frustrating than a fraud alert if a consumer needs to apply for credit. A freeze can be lifted temporarily by the consumer if they are applying for credit.
  • Monitor your own credit. Consumers can obtain one free credit report from all three major credit bureaus each year. A free copy is available at www.annualcreditreport.com, or call 877-322-8228 to obtain the free report.
  • Consumers also can reduce their exposure to identity theft by opting out of unsolicited credit card or insurance offers. Doing this, via www.optoutprescreen.com, or 888-5OPT-OUT, should block most unsolicited applications and reduce the incidence of identity theft.

Sources:
CBS News
Washington Post
New York Times
Krebs on Security

Free Legal Consultation
At Beasley Allen, there is never a fee for legal services, unless we collect for you. Contact us today by filling out a brief questionnaire, or by calling our toll free number, 1-800-898-2034, for a free, no-cost no-obligation evaluation of your case.

U.S. intervenes in alleged Los Angeles accessible housing fraud

posted on:
September 8, 2017

author:
Andrew Brashier

category:
Fraud

andew brashier1 U.S. intervenes in alleged Los Angeles accessible housing fraudIn early August, the Department of Justice (DOJ) announced the United States filed a complaint in intervention against the City of Los Angeles and the former Community Redevelopment Agency of the City of Los Angeles (CRA/LA).

The allegation is, together, the CRA/LA and the City of Los Angeles fraudulently obtained millions in housing grants from the U.S. Department of Housing and Urban Development (HUD). These funds were obtained under the false certification they would be spent in compliance with federal accessibility laws. The complaint in intervention replaces a complaint previously filed on behalf of the United States by a whistleblower under the False Claims Act (FCA).

HUD is a Cabinet department of the Executive branch of the federal government. One of HUD’s primary goals is to establish and maintain a suitable living environment for all Americans. Generally, HUD works to improve and develop communities and additionally enforces fair housing laws.

In this case, HUD granted federal funds to the City of Los Angeles for creation of housing for people with disabilities in compliance with federal accessibility laws. CRA/LA and the city are required by law to comply with federal accessibility laws. However, the City of LA authorized the design and construction of inaccessible buildings.

The complaint includes alleged violations of Section 504 of the Rehabilitation Act, the Americans with Disabilities Act, and the Fair Housing Act. Section 504 of the Rehabilitation Act prohibits discrimination of disabled persons under any program or activity receiving federal funds or conducted by any Executive agency. The Americans with Disabilities Act prohibits discrimination against individuals in all areas of public life. The Fair Housing Act protects individuals from discrimination in renting, buying, or securing financing for a home.

In the repeated certification of compliance with federal accessibility laws, the U.S. alleges that the former CRA/LA and the City of LA defrauded the government in direct violation of the FCA.

“Despite the federal government investing hundreds of millions of dollars in Los Angeles to create housing for everyone, the City of Los Angeles instead created housing only for some,” said Acting U.S. Attorney Sandra R. Brown for the Central District of California. “For 17 years, the city falsely certified that it had complied with federal law and covered up its repeated disregard of historic and important civil rights laws.”

The complaint in intervention is indicative of HUD’s mission to ensure equal access to federally funded public housing. The initial lawsuit was filed in U.S. District court by whistleblowers Mei Ling, a Los Angeles inhabitant who uses a wheelchair, and the Fair Housing Council of San Fernando Valley, a nonprofit civil rights advocacy group. The U.S. Government elected to intervene in the lawsuit and take over the case, unsealing the whistleblowers’ complaint.

The case against the City of Los Angeles was brought under the qui tam or whistleblower provision of the FCA. This provision allows private parties to sue on behalf of the United States when they believe a party has submitted false claims for government funds. Incentives for blowing the whistle include governmental protection from retaliation and 15 to 25 percent of the recovered funds. This particular case is still pending in District Court.

* * *

Are you aware of fraud being committed against the federal government, or a state government? If so, the FCA can protect and reward you for doing the right thing by reporting the fraud. If you have any questions about whether you qualify as a whistleblower, please contact an attorney at Beasley Allen for a free and confidential evaluation of your claim. There is a contact form on this website, or you may email one of the lawyers on our whistleblower litigation team: Archie Grubb, Larry Golston, Lance Gould or Andrew Brashier.

Sources:
U.S. Department of Justice
U.S. Department of Housing and Urban Development
29 U.S.C. § 701
42 U.S.C. § 3604

Free Legal Consultation
At Beasley Allen, there is never a fee for legal services, unless we collect for you. Contact us today by filling out a brief questionnaire, or by calling our toll free number, 1-800-898-2034, for a free, no-cost no-obligation evaluation of your case.

FMSCA hosts meeting on trucking safety performance scoring program

posted on:
September 7, 2017

author:
Chris Glover

chris glover FMSCA hosts meeting on trucking safety performance scoring programThe Federal Motor Carrier Safety Administration (FMSCA) will host a meeting this week for stakeholders and the public to weigh in on the agency’s Compliance, Safety, Accountability (CSA) initiative, Transport Topic News reports. The FMSCA launched the CSA initiative in December 2010 to reduce crashes, injuries and fatalities that are related to commercial motor vehicles, or CMVs, such as heavy trucks and busses operating across the country.

As Safety and Health Magazine notes, the CSA is used to rank CMVs’ safety records. In 2015, Congress mandated an analysis of the CSA because of the trucking industry’s outcry that it is flawed and unfairly assesses a CMV’s risk potential.

The National Academies of Sciences, Engineering, and Medicine (NAS) analyzed the CSA and announced its findings earlier this summer. The NAS concluded that the Safety Measurement System is “conceptually sound,” but advised the agency that it could improve the implementation aspect by developing “a more statistically principled approach.” It suggested the agency consider using an item response theory (IRT) model on a limited basis for two years with full implementation if the model is effective.

The NAS report emphasizes CMVs’ responsibility to maintain the highest level of safety compliance – noting that “[a]bout 100,000 fatality- or injury-causing crashes involving large trucks and busses occur in the United States each year.” It also stresses the importance of the specially trained inspectors that conduct about 3.5 million roadside inspections each year, looking for safety violations that fall under six categories including: unsafe driving, hours of service compliance, vehicle maintenance, controlled substances/alcohol use, hazardous materials compliance, and driver fitness.

Beasley Allen has previously underscored the importance of safety regulations governing the trucking industry and the need for better oversight to ensure the safety of all those who share the roads. Input from the public as well as industry insiders may provide some helpful guidance, but public safety should remain a top priority for any changes to the CSA or other safety regulations intended to keep all road warriors safe.

* * *

Beasley Allen attorney Chris Glover handles cases of personal injury involving heavy trucks, log trucks, 18-wheelers and other commercial vehicles. He is practicing in Beasley Allen’s new Atlanta office. For more information about these types of claims, contact him by email at Chris.Glover@BeasleyAllen.com. To get your free copy of “An Introduction to Truck Accident Claims: A Guide to Getting Started,” visit Chris Glover’s website at www.ChrisGlover-Law.com.

Sources:
Transport Topics News
Safety and Health Magazine
National Academies of Sciences, Engineering, and Medicine
Federal Motor Carrier Safety Administration

Free Legal Consultation
At Beasley Allen, there is never a fee for legal services, unless we collect for you. Contact us today by filling out a brief questionnaire, or by calling our toll free number, 1-800-898-2034, for a free, no-cost no-obligation evaluation of your case.

More than 800 Physiomesh incidents filed with FDA report pain, suffering

posted on:
September 6, 2017

author:
Matt Munson

matt munson More than 800 Physiomesh incidents filed with FDA report pain, sufferingAs Beasley Allen previously reported, the U.S. Judicial Panel on Multidistrict Litigation (JPML) created a multidistrict litigation (MDL) for Physiomesh plaintiffs earlier this summer. The JPML reports the number of pending lawsuits has climbed to 92 since the MDL was created. And, with information collected by the U.S. Food and Drug Administration’s (FDA’s) MAUDE reporting system about adverse events involving the product, there is no doubt the claims will continue to rise.

Physiomesh is manufactured by Ethicon, a subsidiary of Johnson & Johnson. According to Righting Injustice, more than 800 negative incidents involving the mesh have been reported to the FDA’s MAUDE. The system allows doctors and hospitals to provide details about adverse events related to medical devices. Since Physiomesh was first approved by the FDA in 2010, medical professionals have reported 839 such events, including injuries and at least nine deaths, naming the mesh device as the culprit.

Physiomesh, considered a medical device, is made of a flexible plastic called polypropylene and is used to repair weak abdominal muscles, called hernias. It is intended to reinforce the weakened area and prevent the hernia from reopening. Yet, once implanted, Physiomesh begins to erode. It has a higher rate of hernia recurrence and re-opening in patients using the device as compared to patients using similar devices.

Two of the more recent lawsuits, consistent with previous lawsuit claims, provide a glaring backdrop of the pain and suffering patients report is associated with the mesh.

Righting Injustice describes Kathy Edward’s plight as she watched her husband suffer numerous surgeries and countless hours of pain after surgeons used Physiomesh to repair a hernia. The device failed to incorporate into William Edwards’ tissue, which resulted in an infection and required a wound vac to prevent the infection from growing worse. The wound never healed and William died from septic shock, respiratory failure and acute renal failure on January 31, 2017 – 19 months after the initial surgery.

An Alabama man’s lawsuit recounts his own torture from the device and explains how it left him with permanent scarring and other injuries, the Daily Hornet explains. Bill Tedford had a hernia repaired in December 2013 with a Physiomesh patch implant. The device was marketed as a hernia repair device that would prevent or minimize the risk of inflammation and adhesions. The device’s design was also purported to incorporate better into the body’s tissues. However, Ted’s lawsuit explains that it “caused or contributed to an intense inflammatory and chronic foreign body response.” Like William and many others, Ted endured a number of surgeries in order to repair the damage caused by the failed Physiomesh patch.

The embattled mesh maker has settled approximately 3,000 lawsuits due to similar problems with a related product – the company’s Proceed polypropylene transvaginal mesh. The settlement came in January 2016 as part of an MDL. It occurred just months before Ethicon issued a Field Safety Notice and quietly withdrew Physiomesh from markets in the U.S., Europe and Australia because of the product’s high failure rate.

If you or a loved one has received hernia treatment that included Physiomesh and have experienced complications, contact Matt Munson by calling 800-898-2034 or by email at Matt.Munson@BeasleyAllen.com.

Sources:
Beasley Allen
U.S. Judicial Panel on Multidistrict Litigation
Righting Injustice
Daily Hornet

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