Drug Research Company Caught Red-Handed. Now What?

Angel Reyes III Dangerous Drugs

drugs-blog-post-april20131-300x199Cetero Research, a Houston-based firm that researched safety and effectiveness for drug companies throughout the world got busted.  On May 3, 2010, agents from the FDA (Food and Drug Administration) visited the firm to investigate a former employee’s claim that the company fraudulently manipulated records and test data. The lead agent, Patrick Stone, explained the severity of the situation to Cetero’s president, Chinna Pamidi, who admitted to Stone that the allegations were correct.  According to Stone, Pamidi literally said, “You got us.”

File boxes containting five years of data from approximately 1,400 drug trials were evaluated. Based on these records and other tell-tale evidence, the FDA announced that the lab’s violations were so blatantly “egragious” and of a “pervasive nature,” the research conducted between April 2005 and August 2009 was most likely worthless.

So what does this mean to consumers?  It means that around 100 drugs, including chemotherapy compounds and addictive prescription painkillers were approved for sale in this country based partly on Cetero’s fraudulent tests.  Most of these drugs were generics of name-brand drugs.  Astoundingly, Cetero scientists had not even run tests on whether the ingredients in the generics were the same as the originals.  These drug tests included ones for seemingly harmless generics such as ibuprofen gelatin capsules, which were sold by one of the country’s largest grocery store chains for months before the FDA was assured they were safe.

Agent Stone expected the FDA to rapidly alert patients and doctors. However, in its usual fashion, the agency was not only slow to act, it didn’t publicly announce anything. Instead, it quietly “handled” the matter. No drugs were pulled off the market.  What’s more amazing is that even now, some of these drugs are still on the market even though the FDA has absolutely no idea of their safety or effectiveness.

But wait, there’s more!  On two separate occasions, the FDA announced it was making drug makers reanalyze, repeat or audit Cetero’s research.  They even gave them deadlines to report their findings back to the agency.  However, both times, the agency allowed some of these manufacturers to extend their deadlines, while other companies simply removed their drugs from the market.

It is now April 2013 – three years after the initial “drug bust,” (so to speak).  The FDA has finished reviewing only 21 of the 53 submissions.  This means that many consumers of over-the-counter drugs or patients prescribed more serious drugs are taking them to this very day.

Believe it or not, the FDA is refusing to disclose the names of the drugs it’s evaluating, claiming that in doing so, it would expose “confidential commercial information.  The agency defended its handling of the situation.  In fact, Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research, said “It is non-trivial to have to redo all this, to withdraw drugs, to alarm the public and the providers for a large range of drugs.  “There are consequences. To repeat the studies requires human experimentation, and that is not totally without risk.”  She also said that the potential for harm from drugs tested by Cetera was “quite low” as confirmed by the fact that there were no problems with drugs the agency had reviewed.  (Remember, the number of drugs reviewed was less than half of those submitted.)

Woodcock added that an agency risk assessment found the potential for harm from drugs tested by Cetero to be “quite low,” as “confirmed” by the fact that no problems have been found in the drugs the agency has finished reviewing.

Many experts say the FDA is refusing to meet its public obligations by not disclosing its findings of the 21 completed reviews.  David Kessler, who headed the FDA from 1990 to 1997 and is now a professor at the University of California said,  “If there are problems with the scientific studies, as there have been in this case, then the FDA’s review of those problems needs to be transparent.  FDA may be right here, but if it wants public confidence, they should be transparent. Otherwise it’s just a black box.”

So what does Stone, the former FDA investigator have to say?  “They could have done more.  They should have done more.”  That’s an understatement, to say the least.  He also said that there are thousands of bioequivalence studies done each year, each generating thousands of pages of paper records.  According to Stone, “Do you really think we’re going to look at 100 percent of them? We’re going to look at maybe 5 percent if we’re lucky.  Sometimes 1 percent.”  I admire his candor, but am abhorred by this and so many other blatant mishaps involving dangerous drugs and medical devices by the FDA.  Is it incompetence or is the FDA in bed with the drug companies?  That’s another story.  All I know is that it’s time for some real changes to how Big Pharma and the FDA conduct their business.

Bus Accident Should Cause Awareness For Better Safety

Angel Reyes III Auto Accidents

buscrash-300x225Around 9 a.m. this morning, there was a bus accident on Bush Turnpike in Irving, Texas.  The bus hit a rubber crash barrier on the east side of the tollway, swerved across two lanes of traffic, crashed into the middle concrete barrier, and finally flipped over onto the grassy area in the middle of the turnpike.  The flipped bus ended up on it’s right side (where the exit doors were located) and many passengers tried to climb out through the emergency hatches on the roof, or through the windows.  The reason for the crash is still under investigation.

There were 45 people on the passenger list at the time of the incident.  Most of them were reported to be elderly.  Two of these people didn’t survive this tragedy and 41 were injured.  When the emergency vehicles arrived, people were rushed to nearby hospitals.  Victims experienced everything from cuts and scrapes to severe internal injuries.  Sixteen of the patients are in critical condition.

Most of the bus passengers were not wearing seatbelts during the time of the crash.  As a result, when this crash occurred, many people ended up crushing each other in a pile.

Sadly, this is just one of many bus accidents reported annually.  A 2010 national report stated that there were 13,000 buses involved in crashes that year, resulting in 226 fatalities and countless injuries.  In Texas alone, there were 2,358 school bus accidents that occurred during the 2011-2012 school year (Texas Eduaction Agency report).

Safety should be taken very seriously.  Although we can’t completely avoid accidents like this because they’re unforeseen and can occur spontaneously, we can help save lives by enforcing safety rules.  Had passenger involved in this accident been wearing their seatbelts there would have been far less injuries.  It is crucial to follow safety rules and guidelines for any type of transportation.  Remember that buckling up can help save both your life and the lives of those around you.  Perhaps stricter laws should be enforced to ensure that all bus safety rules are followed.

Contact Reyes | Browne | Reilley today if you or someone you care about has been injured in a bus accident. Our Dallas auto accident lawyers will help you get the compensation you deserve.  Call us at 214-526-7900 or submit the short Case Review form on the right.

18-Wheeler Accidents in Texas

Angel Reyes III Truck Accidents

reyes-blog-040113-300x200Driving next to 18-wheelers can be both scary and dangerous. The large and powerful force of a semi-truck roaring down the road is intimidating to drivers of smaller vehicles, trucks, and motorcycles. 18-wheelers are involved in some of the biggest and deadliest accidents across America. Although 18-wheeler truck drivers are licensed professionals, trucking accidents still occur quite frequently.

Every year in the US there are approximately 400,000 trucking accidents, which comprise about 8% of all motor accidents – 4,500 of which are fatal. Although that may seem like a small number, when you consider that there are far fewer 18-wheelers than any other vehicles on the road, this figure is astounding.

I-35 in Texas is ranked as #5 in top deadliest highways across America. With all the 18-wheelers zooming across the state, there’s good reason for concern. In Texas alone, there were over 16,401 crashes involving semi-trucks in a 2011 report, 299 of which resulted in death.

The common cause for 18-wheeler accidents is driver fatigue. Although there are laws limiting how much time can be spent driving on the road, many drivers exceed that limit. When traveling those long stretches of lonely Texas roads, driving can be especially tiring. Other causes of 18-wheeler accidents include tire blowouts, faulty equipment, and sideswiping other vehicles when changing lanes because of blind spots.

Contact Angel Reyes and Associates today if you or someone you care about has been injured in an 18-wheeler accident. Our expert DFW truck accident attorneys will help you get the compensation you deserve.

Motorcycle Accidents in Texas

Angel Reyes III Auto Accidents

reyes-blog-032513-300x310Texas is one of the most beautiful states for driving a motorcycle. With almost every kind of terrain and weather, wide open spaces, and long stretches of highway, you can pick and choose your riding scenery without ever having to cross the state. This is probably one reason that Texas has over 400,000 registered motorcycles.

Motorcycle accidents are a threat to bikers and passengers alike. If the bike slides on the road during bad weather, skids off the road during an evasive maneuver, or is hit by a car whose driver isn’t paying attention, head injuries and spinal damage can lead to expensive hospital bills, lifelong challenges and even death.

Although motorcycles may be fun to drive, they are extremely dangerous. In a 2011 report by the Texas Department of Transportation (TXDOT), there were 211,006 injured in motorcycle accidents in the last year. There were 5,970 serious injuries, and 479 fatalities caused by motorcycle accidents.

Over two-thirds of all Texas motorcycle accidents result in serious injury or death. Despite the high rates of accident fatalities caused by motorcycles, people still refuse to obey the law. 2,375 of the serious injuries, and 246 of the fatalities were not wearing helmets. 51% of the motorcyclists killed were not wearing helmets at the time of the crash.

If you or a someone you care about has been injured in a motorcycle accident, you may be eligible for compensation. Contact Angel Reyes today for a free consultation regarding your case.

Spanish Speakers Are Fastest Growing Demographic In USA

Angel Reyes III Aside

reyes-blog-0318131-300x200Currently the Hispanic population in the US is approximately 50,500,000. Latinos represent 16% of the US population, and are expected to grow to 27.8% by 2050. They accounted for more than half of the 2.3 million persons increase in the last year. More than 60% of Hispanics in America were born in the US. Mexico makes up 36.1% of those Hispanics that are foreign-born.

Spanish speakers are America’s fastest growing demographic. Of the 50+ million Latinos, almost 37 million are Spanish-language dominant. 24% of Hispanics live in homes where only English is spoken, but 68% of Hispanics live in homes where both English and Spanish are spoken. Although there are over 100 languages spoken in the US, a 2012 US Census reported that Spanish is the most common secondary language used by non-native English speakers.

The US Department of Labor reports that there are currently about 23 million people of Hispanic/Latino ethnicity. That is almost 15% of the current labor force, and it’s a growing number. By 2020 it is expected to grow to 19%. Neilson data reports that Latino buying power will increase from approximately 1 trillion dollars in 2010, to 1.5 trillion by 2015.

Hispanics (specifically Spanish speakers) watch more television than their English-speaking counterparts. In a 2011 report, Univision beat all other networks in the evenings for the 18-34 age demographic among all Americans.

Fun Fact: The last name Garcia is the #8 most popular name in the US. There are 1,114,559 Hispanics with this name.

Deadly Statistics For Auto Accidents In Texas

Angel Reyes III Auto Accidents

reyes-blog-031113-300x225According to the National Highway Traffic Safety Administration’s (NHTSA) FARS Data, Texas is the most dangerous state for drivers in the US with over 3,000 traffic related fatalities reported in 2011. Most of these drivers were between the ages of 25-34.

These are the top 4 causes of accidents in Texas:


Speeding is the #1 cause of auto accidents in Texas. This is a common statistic around the country. Although almost everybody exceeds the speed limit every once in awhile, driving while speeding reduces the drivers ability to react in time to stop an accident from occurring.

Driving Inattention:

This includes everything from texting while driving, to talking on the phone, eating, looking at a map or just not paying attention. Even if it’s just for a second, not paying attention to the road can cause serious and even fatal accidents.

Failure to drive in a single lane:

Sometimes it can be difficult to see the line on the road in bad weather conditions, or if the road markings are worn, however swaying in and out of your lane while driving can cause very serious accidents, especially if you are crossing out of your lane into oncoming traffic.

Failure to yield while turning left:

It is difficult to judge the distance and speed of oncoming traffic during a yield on left turn. Driver error that occurs when the driver is turning into oncoming traffic can lead to very dangerous situations. The drivers that are making the turn typically get the worst end of the deal with the full force of the impact into the side of their vehicles.

The Texas Department of Transportation has compiled a list of traffic crash highlights with some shocking statistics on traffic fatalities that occurred.

Deadliest month to drive:

April is the month with the most fatal traffic accidents in Texas. The weather has a lot to do with this. April showers bring May flowers, but it also brings slippery dangerous roads. Be especially careful driving during this time of the year.

Driving without Restraint:

Texas has established the “Click It or Ticket” campaign, however out of all the fatalities that were reported 46% of the people were not restrained.

Driving Intoxicated:

1,039 fatalities occurred because of the driver being intoxicated. This was 34.5% of the people killed in traffic accidents.

If you or a loved one has been injured in a traffic accident, contact Angel Reyes and Associates today!

Mastering the Art of Driving on Icy Roads

Angel Reyes III Safe Driving

Icy-roadIcy conditions around Dallas are causing a series of traffic accidents. Although major roadways are considered passable, many side streets are still considered dangerous. Texas is not known for frequent snowstorms, so it is important drivers of the Lone Star state follow a few simple tips practiced by their cousins from the north.

1) First, slow down – Nothing is more likely than excessive speed to cause an accident. Don’t feel like you have to maintain the maximum speed limit in icy conditions.

2) Give yourself plenty of time to stop, and turn – It can be challenging to make turns when roads are covered in ice. Start braking well before you need to come to a stop, especially when approaching an intersection.

3) Always use your directional signals – When roads are covered in ice, the last thing you want is to take drivers around you by surprise. Let them know your intentions well ahead of time.

4) See and be seen – Replace your windshield wipers when they become worn, and check that all your lights are working correctly. In any kind of wet conditions, visibility can become an issue.

5) Keep your tires properly inflated – Traction between your car and the road is increased by properly inflating your tires. Keep them at the optimum pressure recommended by the manufacturer. They should also have good treads – don’t travel on ice driving using bald tires.

Winter is almost over, but each of these ideas are also useful in the spring, especially in heavy rain. Drive safely out there!

Johnson & Johnson Lawsuits Over Transvaginal Mesh Implants

Angel Reyes III Medical Devices

reyes-blog-022613-300x300Transvaginal mesh implants used in surgery – not a fun subject by any means. But worst of all, these implants have been a living hell for the women who suffered the horrible symptoms associated with them.

Yesterday an Atlantic City, New Jersey jury awarded $3.35 million to Linda Gross. The Johnson & Johnson subsidiary, Ethicon, must pay this substantial amount in what is the first of 2,100 lawsuits over the transvaginal mesh implant. Now, punitive damages in this case may amount to as much as $16.75 million.

Apparently, the South Dakota woman’s surgeon wasn’t warned of the dangers associated with its Gynecare Prolift transvaginal mesh implant. What’s more, it is claimed that Ethicon misled her. Linda Gross, a 47-year-old nurse was experiencing constant pain and 18 operations after the device was implanted. So along with her husband, she sued Ethicon. According to Gross’s attorney Adam Slater, “This verdict establishes that Johnson & Johnson and Ethicon failed to tell physicians and women the truth about the catastrophic complications that can result from the Prolift.”

Punitive damages could be awarded today. Compensatory damages pay victims for losses and injuries. Punitive damages actually punish the defendants for “willful and wanton behavior.”

In January, 2012, the FDA (Food and Drug Administration) ordered Johnson & Johnson, C.R. Bard Inc. and 31 other manufacturers to study rates of organ damage and complications from transvaginal mesh implants. In 2010, doctors implanted over 70,000 of these devices in women to secure their pelvic muscles. Slater, the attorney for Gross, told jurors that company communications proved Ethicon knew their mesh product would harm women.

The Prolift is made of a polypropylene mesh and was inserted vaginally by incision. In August, Johnson & Johnson discontinued selling four of these mesh products in the U.S., including Prolift. However, they claimed this move was based on a lack of commercial sales, and not due to the risks or effectiveness of the products. But Slater said Ethicon knew of the dangers as early as 2005.

Mrs. Gross said that since the mesh was implanted, she experiences severe and constant pain. She has prescriptions for 20 different medications to help the pelvic problems. Gross has had over 400 visits to both doctors and physical therapists, and these experiences were horrific.

Once again, Big Pharma got away with damaging the lives of numerous women forever. Fortunately in this case, they have to pay for their crimes. If you or someone you care about has had a surgery in which a transvaginal mesh product was used, call our team of expert DFW medical device attorneys now at 1.877.308.7900. Or email me: Angel@ReyesLaw.com.

Top Car Wreck Causes In USA

Angel Reyes III Auto Accidents

reyes-blog-022513-200x299Although automobile manufactures are always coming out with new and improved safety features, car accidents remain a leading cause of death and injury in the United States.

According to the NHTSA (National Highway Traffic-Safety Administration), the amount of traffic accidents has slowly decreased in Texas, but on average there are about still about 3,300 fatalities a year in the Lone Star State alone. Surprisingly, at least 10% of those accidents involve drivers who are 16-20 years of age.

The main causes of most automobile accidents are drunk or distracted drivers. Despite all the public service announcements and growing awareness of the dangers of using cellular phones while driving, recent surveys show that most drivers are willing to risk others’ lives and their own to answer a call or text while behind the wheel. Texting increases the risk of having a car crash by a whopping 23%! For more information about distracted driving visit www.Distraction.gov.

The highest price we pay for these car crashes is the loss of human lives, but there are many non-fatal accidents that also incur huge costs. The CDC (Center for Disease Control) statistics for 2010 show that the cost of medical and productivity losses associated with car crashes was over $99 billion, or $500 per licensed driver in the US.

Our law firm has helped thousands of people recover millions of dollars they were owed for their injuries from car crashes. If you or someone you care about has been injured in a car crash, call Dallas’s premier auto wreck attorneys today at 1.877.308.7900 or email me: angel@reyeslaw.com.

Recalled Kidney Dialysis Products Cause Heart Injuries

Angel Reyes III Defects

reyes-blog-0205131-300x199Chronic kidney failure may be due to diabetes or low blood sugar, and affects approximately 2 million people. In the US, kidney disease affects over 2 out of every 1,000 people. In kidney dialysis, a machine called a dialyzer uses a solution to clean the blood. Products used in this process were GranuFlo and NaturaLyte, which may produce an excess of bicarbonate leading to a condition known as metabolic alkalosis in which pH levels in the body are elevated. This condition can cause low blood pressure, heart attacks, serious heart injuries and sudden cardiac-related deaths.

GranuFlo and NaturaLyte are manufactured and marketed by Fresenius Medical Care (FMC). IN 2011, Fresenius had a whopping net revenue of $12.8 billion and is the US leader in the dialysis market. FMC also owns over 1,800 U.S. Dialysis clinics that perform these treatments with GranuFlo. Additionally, approximately 125,000 patients are treated with GranuFlo at other clinics.

At the present time, Fresenius Medical Care has numerous suits against it since 941 patients suffered from cardiac arrest in 2010 after being treated with GranuFlo products. In March of 2012, the FDA recalled both GranuFlo and NaturaLyte. Unfortunately, this recall came far too late to save countless patients who experienced severe symptoms or died from these products. Worst of all, patients or survivors of loved ones who died say they were not informed of the dangers of using GranuFlo or NaturaLyte.