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Dec
27
2011
Blog, Products Liability By Alexandra | No comments yet

FDA Warned PIP of Defects In Breast Implants, Patients At Risk

Today Reuters reports that since 2000, the Food and Drug Administration (FDA) raised concerns about the French breast implant maker at the heart of a scandal affecting hundreds of thousands of women worldwide. More than ten years later, the company has come under scrutiny from European regulators.
The FDA sent an investigator to inspect a plant run by the manufacturer, Poly Implant Prothese (PIP), at La Seyne Sur Mer in southeastern France in May 2000. Shortly afterwards, the FDA sent the company’s founder, Jean-Claude Mas, a warning letter saying the implants were “adulterated” and citing at least 11 deviations from good manufacturing practices.
The problems had to do with PIP’s saline implants, a different line from the silicone implants that French authorities ordered off the market in 2010 for using industrial-grade silicone instead of medical-grade silicone, leading to the French firm’s bankruptcy. Still, the plant inspected by the FDA was used to manufacture the silicone implants for PIP.

The French government last week recommended that women in France who have PIP’s silicone gel-filled implants get them removed by their surgeons after the implants appeared to have an unusually high rupture rate. Other countries, including Britain and Brazil, said women should visit their surgeons for checks.

A critical question is why the FDA’s warning didn’t trigger greater scrutiny of PIP’s activities by regulators in France and elsewhere. Officials at the FDA and France’s health regulator were not available for comment on Monday on whether the FDA shared information about its inspection of the PIP plant, though the warning letter was made public in 2000.

While no one has been criminally charged in this case, a French court may be pressing fraud charges against 4-6 ex-PIP employees.

As for the patients, they may have a viable case to sue the manufacturer for the cost of a second surgery to remove the implants as well as the pain and suffering and emotional distress associated with such a procedure  For those less fortunate, who actually experienced poisoning from the implant (some say cancer is a risk), they may have a cause of action for serious personal injuries.

If you have or recently had a PIP breast implant and have questions about your consumer rights, contact attorney Alexandra Filutowski.

Copyright © 2012 The Filutowski Law Firm, PLLC.   Disclaimer: This page is intended for general information purposes only and should not be construed as legal advice or legal opinions on any specific facts or circumstances.  An attorney-client relationship is not created or continued.

 

Dec
10
2011
Blog By Alexandra | No comments yet

Deck The Roads Without Drunk Drivers

‘Tis the season to be merry. Office parties, social parties, ugly Christmas sweater parties – you name it, there is a lot of socializing…and drinking in the month of December.  In fact, December is National Drunk and Drugged Driving Prevention Month.

First started in 1982 by President Ronald Reagan, this national holiday has experienced increased community support and continues to promote safer streets on a daily basis.

With your Santa hat, elf costume, or perfect holiday cocktail dress, inhibitions are lost with a drink or two…and risks of injury increase.

 

National Commission Against Drunk Driving Statistics

  • 41 percent of all traffic crashes are alcohol-related.
  • Nearly 600,000 Americans are injured in alcohol-related traffic crashes each year.
  • Someone dies in an alcohol-related traffic crash every 30 minutes. Every two minutes someone is hurt (nonfatally injured) in an alcohol-related accident.
  • Three out of every 10 Americans face the possibility of being directly involved in an alcohol-related traffic crash during their lifetime.

Tips to Stay Merry & Avoid Legal Trouble Here are a couple tips for party hosts and party-goers to stay safe and out of trouble this season:

Continue reading Deck The Roads Without Drunk Drivers →

Nov
24
2011
Blog, Consumer Protection By Alexandra | No comments yet

Black Friday’s Stampede On No One’s Wish List

The day after-Thanksgiving is no longer a fun family outing to the mall to see the new holiday decorations, enjoy a cup of cocoa and slowly ease into the holiday spirit. Instead, the 21st century’s “Black Friday” has evolved into a hairy beast of desperation, manipulation and risk. In a year of continued economic recession and unemployment, the retailer marketing is attracting the extreme bargain-hunters from all socio-economic backgrounds, to stand in their pajamas, sleep-deprived at 3AM in the cold outside the store, adrenaline pumping, scheming how they will be the one to get their hands on the XBOX or laptop, or whatever prized product is the “it” gift this season.

Stampedes of Past Black Fridays




As the hour of the doors opening approaches, the anticipation builds and people stand, stretch their limbs, and push as if that extra few inches will give them an advantage. Then seconds before the doors are open, pressure builds against and breaks down the doors….causing a stampede of madness.

Injuries are all too common in these situations.   At least a few deaths have been reported to have directly been caused by a Black Friday stampede.  

 

Continue reading Black Friday’s Stampede On No One’s Wish List →

Oct
26
2011
Blog By Alexandra | No comments yet

Obama’s Student Loan Debt Solution Coming in 2012

In the wake of Occupy Wall Street, a stagnant economic recession, and the announcement of yet another ex-Goldman Sachs executive being charged with the most egregious insider trading violations in U.S. insider trading history, one may wonder what future is there for U.S. high school and college graduates?

Most young adults, despite the recession, still follow their dream of earning a college degree that will open doors of opportunity for them, hoping for a better economy upon graduation.  Pursuing this dream, in light of the continual increase in college tuition, results in students taking out significant loans to finance their education.  Upon graduation, millions of hard working graduates are burdened with the unattainable responsibility of making monthly student loan payments that are beyond what they can afford when looking for employment or earning a wage that barely cover the cost of living.

Today, there are 23 million borrowers with $490 billion in loans under the Federal Family Education Loan Program. Last year, the Education Department made $102.2 billion in direct loans to 11.5 million recipients.

Despite the grave situation, there is hope:  student loan relief is on its way!  Today President Obama will be announcing his Plan to enact a Congress bill next year that would  forgive student debt after 20 years on the condition that students pay 10% of their discretionary income towards repaying the debt.  Nearly 6 millions borrowers will be affected by the Plan.  Obama is pushing to have the Plan enacted sooner than the 2014 original start date, require 5% less of income paid towards the debt and forgive the debt five years earlier than the original 25 year cut-off.   This push may be in large part as a response to the more than 30,000 signatures on a petition in the last month at the  We the People platform at whitehouse.gov, asking for relief on student debt.

Congress has been moving towards helping students, realizing that student debt is the second cause of the U.S.’s economic recession; secondary to the mortgage-backed securities crisis.  Last year Congress passed a bill that weeded out the scamming middleman that got the nation in this bind: the banks.  Prior to the 2010 bill passing, student borrowers were taking out loans directly from the federal government or from federal government-insured loans in the Family Education Loan Program that were issued by private lenders.

Continue reading Obama’s Student Loan Debt Solution Coming in 2012 →

Oct
14
2011
Blog, Consumer Protection By Alexandra | 1 comment

Students For Justice: For-Profit Colleges Deceive Students Into Crushing Student Loan Debt

The multi-billion enterprise of for-profit colleges continue to make headlines for deceptively burdening thousands of students with unbearable student loans and “degrees” with no value in the job market.   Today, The Huffington Post’s Chris Kirkham has a 5-page feature on Education Management Corporation, Inc.’s (“EDMC”) deceptive recruitment practices, With Goldman’s Foray Into Higher Education, A Predatory Pursuit of Students and Revenues.  At the time of writing this entry, over 2,800 people (mostly students and educators) have posted comments to the news article about the preying  business model of for-profit colleges.

EDMC, owned by Goldman Sachs, profited over $2.5 billion last year.  EDMC operates several for-profit colleges throughout the U.S., including Argosy University, The Art Institute and South University, among others.  On its homepage, EDMC proclaims to be:

dedicated to giving students the skills, tools and confidence they need for a lifetime of success.  From preparing graduates for their first, exciting foray into the business world to helping busy professionals broaden their career possibilities, we provide flexible curriculum and scheduling, smaller classes with hands-on instruction and abundant personal attention and, most importantly, a practical education.”

Yet, in reality, the quality of the education is sub-par.  According to Frontline’s investigation into the for-profit college industry in College, Inc., the for-profit business model attracts corporate investors and a target of the most vulnerable consumer – the homeless, the poor, the desperate.  College “degree” programs are created within a day or two, whereas at state-owned and private, accredited and alumni supported universities and colleges, it can take up to several months for a faculty board to scrutinize and approve the  curriculum for a proposed new degree offering.

Continue reading Students For Justice: For-Profit Colleges Deceive Students Into Crushing Student Loan Debt →

Oct
1
2011
Blog By Alexandra | No comments yet

Students Sue For-Profit School and Settle

Students who attended the San Francisco California Culinary Academy filed a class action lawsuit alleging deceptive admissions practices and misrepresentation of job placement statistics.  This week the hundreds of students received news that they will be refunded their tuition thanks to a $40 million settlement.

The academy’s tuition and fees range from $21,000 for a certificate in pastry and baking arts to $43,000 for an associate’s degree in culinary arts. Those costs don’t include books, supplies, or room and board.

The school’s website says 48 to 100 percent of graduates find work in their field of study or a related field, depending on the program or methodology.  A false statement of fact.  Reality is that the certificate offered no value to students.

In 2004 student Journey enrolled in a 7-month, $30,000.00 program in pastry and baking arts at the San Francisco school. Recruiters convinced her it was a worthwhile investment and helped her secure loans.  Upon graduation, the only job Journey could find paid $8 an hour to work the night shift at an Oregon bakery.

The Filutowski Law Firm represents students who have been deceived or ripped off by for-profit colleges, including Education Management Corporation owned Argosy and Art Institute.  If you were or are currently enrolled in Argosy University, or any of the other universities or colleges owned by Education Management Corporation, you may have a legal claim.  Contact attorney Alexandra Filutowski with the facts of your situation to learn if you have a case.

Copyright © 2011 The Filutowski Law Firm, PLLC.   Disclaimer: This page is intended for general information purposes only and should not be construed as legal advice or legal opinions on any specific facts or circumstances.  An attorney-client relationship is not created or continued.

 

Oct
1
2011
Blog, Products Liability By Alexandra | No comments yet

All-Metal Hip Replacements Causing Serious Injuries

In August, we shared with readers that defectively designed all-metal hip devices are failing and causing serious personal injury.  According to today’s New York Times,  the problem with defective all-metal hip devices is affecting more and more patients.   The defective metal hip “socket” grinds with the metal ball, creating a fine metal debris that is absorbed by the patient’s body, causing problems.  The chart below illustrates the problem.

One of the most problematic all-metal hip devices, is Johnson & Johnson’s Articular Surface Replacement (A.S.R.), which was recalled last year.

If you are suffering pain following an implant of an all-metal hip device, you may have a products liability case.

Contact attorney Alexandra Filutowski with the facts of your situation to learn if you have a case.

Copyright © 2011 The Filutowski Law Firm, PLLC.   Disclaimer: This page is intended for general information purposes only and should not be construed as legal advice or legal opinions on any specific facts or circumstances.  An attorney-client relationship is not created or continued.

Aug
31
2011
Blog By Alexandra | No comments yet

Argosy University Student Complaints

Argosy University students who were either deceived by recruiters into enrolling at the school or prevented from graduating due to arbitrary “grading” criteria, may have a legal claim for violations of the Consumer Protection Act.

Argosy University’s parent company, Education Management Corporation, is already being sued for $11 billion by the Federal Justice Department and some U.S. Assistant Attorney Generals for deceiving the government into giving federal loans to students who were lied to.  This violates the False Claims Act.

Recruiters were working under an incentive-based program to get students enrolled and take out significant government loans. Empty promises were made to students – such as intimate class size, national accreditation within the field of study,  guaranteed job placement, etc.

Such fraudulent actions has resulted in over 150,000 students in several billions of dollars in debt, collectively (the government is suing Education Management Corporation for $11 billion dollars), many without jobs in their area of studies.

Thankfully, there are state laws that provide remedies for such injustice.  Each state has its own Consumer Protection Act (“CPA”).  Each CPA protects consumers from businesses’  fraudulent misrepresentation that the consumers relied upon.   In the instant case, the Washington State CPA provides a legal remedy for students who were deceived by recruiters to enroll into the university.

Several students have vented about the deceitful actions of Argosy University Recruiters on College Board Complaints.

If you were or are currently enrolled in Argosy University, or any of the other universities or colleges owned by Education Management Corporation, you may have a legal claim.  Contact attorney Alexandra Filutowski with the facts of your situation to learn if you have a case.

Copyright © 2011 The Filutowski Law Firm, PLLC.   Disclaimer: This page is intended for general information purposes only and should not be construed as legal advice or legal opinions on any specific facts or circumstances.  An attorney-client relationship is not created or continued.

Aug
30
2011
Consumer Protection, Products Liability By Alexandra | No comments yet

Transvaginal Mesh Products Should Be Recalled

Transvaginal mesh products are causing serious injury to thousands of women nationally.  Surgical mesh products made by Johnson & Johnson (JNJ) and Boston Scientific Corp. (BSX) to correct falling pelvic organs in women should be immediately recalled because of painful side effects, a watchdog group said.

Transvaginal placement of surgical mesh to treat pelvic organ prolapse may carry more risks than other surgical options, without any evidence of greater benefit, the FDA said.

Mesh products made of non-absorbable synthetic material can erode and cause pain, bleeding and urinary incontinence, Public Citizen, based in Washington, said in a statement today.  One woman, of the 300 or so who have filed a lawsuit against the mesh manufacturer, describes the pain as if barbed wire is in her pelvic region.

The mesh is implanted through incisions made in the wall of the vagina to reinforce the tissues around the pelvic organs.

The watchdog group, founded by Ralph Nader, estimates that 67,500 women had the non-absorbable mesh implanted last year. The Food and Drug Administration received 1,503 reports of complications associated with the material from January 2008 to December 2010 when used to repair pelvic organ prolapse, the agency said in a safety warning July 13.

Continue reading Transvaginal Mesh Products Should Be Recalled →

Aug
26
2011
Blog, Medical Care, Products Liability By Alexandra | No comments yet

Hip Implants Injuring Thousands, FDA Reports

A sports related injury, age or poor genes are all reasons why hundreds of thousands of Americans are receiving hip replacements.   The average metal hip replacement should last 15 years without problem.   Yet, since January 2011, the Food and Drug Administration (FDA) has received over 5,000 complaints of defective metal hip replacements. The number of complaints is more than the number of complaints received by the FDA in the past four years, combined.  Thankfully, most complaints are not life-threatening.  The injuries typically involve from crippling injuries caused by small particles of cobalt and chromium shed from the metal devices.

Approximately 250,000 individuals receive hip replacements annually, 1/3 a total hip replacement.   An all-metal hip replacement is where both the artificial ball and cup (hip socket) are made of metal.

Some experts fear that these all-metal replacement hips may become the biggest and most expensive implant recall since Medtronic’s recall in 2007 of its popular heart device component.  About 7,700 complaints have been filed in connection with that recall.

Johnson & Johnson’s Articular Surface Replacement (“ASR”) hip implants, the “Depuy” were recalled in 2010.  Since the Depuy Hip Implant recall, Johnson & Johnson is strategizing how to minimize its liability.

The New York Times offers a lot of helpful information, media and links to additional information on hip replacements and the Johnson & Johnson recall.

 

If you, or a family member or friend are considering a partial or full hip replacement, ask your physician questions on the product that will be implanted.  Do your research.  If you, or someone you know, has undergone an implant surgery and is experiencing pain, squeaking that won’t go away, or rashes, then there may be a defective metal implant.

Copyright © 2011 The Filutowski Law Firm, PLLC.   Disclaimer: This page is intended for general information purposes only and should not be construed as legal advice or legal opinions on any specific facts or circumstances.  An attorney-client relationship is not created or continued.

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