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Novartis Recalls over 5 Million Bottles of Potentially Contaminated Drugs

Novartis has recalled over 5 million bottles of antihypersentives, statins and other drugs following concerns that the drugs may have been contaminated by a chemical used in the company’s packaging process.

About the Novartis Recall

According to Medscape, the U.S. Food and Drug Administration has confirmed a class-2 recall for a total of 127 drug lots distributed by Novartis to physicians as free samples.

Novartis is currently unsure how many samples may have reached customers, but has sent letters to physicians who received the samples and is working with them to return the recalled products.

The company has also confirmed that they will no longer be using an ink component produced by a third party to mark sample sleeves and, over time, migrated through the sleeve and bottle and into the drugs.

Products Affected by the Medicine Recall

Drugs affected by the recall include:

  • Exforge (amlodipine and valsartan)
  • Exforge HCT (w/ hydrochlorothiazide)
  • Diovan (valsartan)
  • Tekturna (aliskiren)
  • Tekturna HCT (w/ hydrochlorothiazide)
  • Lexcol XL (fluvastatin)
  • Stalevo (carbidopa, levodopa, and entacopone)
Contact an Experienced Drug Recall Attorney

Thomas J. Henry are leaders in the area of drug and product liability litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. The Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/or defective pharmaceuticals.

If you or a loved one have been injured by or have developed serious side-effects from the use of recalled medications or pharmaceuticals, contact Thomas J. Henry immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.

Feds Investigate Brilinta Clinical Trials

The U.S. Department of Justice as launched a probe investigating possible data manipulation in AstraZeneca’s Brilinta clinical trials, particularly the Plato trial.

Discrepancies and Possible Manipulation in Brilinta Clinical Trials

Brilinta is a blood thinner that was approved by the U.S. Food and Drug Administration in July 2011 as a preventive treatment for stroke, heart attack and blood problems.

Pharmalot reports that the data presented to the FDA in order to gain approval is now the subject of a federal investigation as an estimated 23 possible cardiovascular events or deaths were omitted or mitigated upon submission of the trial data to the FDA.

Further, while Brilinta subjects were more likely to be hospitalized after index events than patients on a competitor’s drug, Plavix, researchers failed to report the hospitalizations as primary events.

The FDA has stated that there “appears to be multiple serious deficiencies” in the clinical trial data, and that clinicians should “carefully reconsider their practice of (Brilinta) prescription for this indication.”

Details of the Plato Clinical Trials

  • The Plato clinical trial enrolled 18,624 patients being treated for blocked arteries or heart attack across 46 countries.
  • During the trials patients were given Plavix (Clopidogrel) or Brilinta (Ticagrelor) as part of a double blind study.
  • While the results presented by researchers suggested  treatment with Brilinta reduced death by stroke, heart attack and cardiovascular problems by 16 percent when compared to Plavix, the FDA and Department of Justice believe the data may not have been accurate or complete.
  • Adverse events associated with Brilinta include:
    • Heart Failure
    • Allergic Reactions
    • Renal Disorders
    • Hemorrhage
    • Coronary Artery Occlusion
    • Death
Plato Clinical Trial Locations
  • Alabama
    • Birmingham
    • Huntsville
    • Mobile
  • Arizona
    • Tucson
  • California
    • Bakersfield
    • Beverly Hills
    • Burbank
    • Healdsburg
    • Los Angeles
    • Roseville
    • Sacramento
    • San Diego
    • Torrance
  • Colorado
    • Fort Collins
  • Connecticut
    • Danbury
    • Hartford
  • Delaware
    • Newark
  • Washington D.C.
  • Florida
    • Atlantis
    • Daytona Beach
    • Ft. Lauderdale
    • Hollywood
    • Jacksonville
    • Jupiter
    • Melbourne
    • Miami Beach
    • Ocala
    • Orlando
    • Ormond Beach
    • Pensacola
    • Sarasota
    • St Petersburg
  • Illinois
    • Chicago
    • Park Ridge
    • Rock Island
    • Rockford
  • Indiana
    • Indianapolis
    • Muncie
    • Valparaiso
    • Iowa
    • Iowa City
    • West Des Moines
  • Kansas
    • Kansas City
    • Olathe
  • Kentucky
    • Ashland
    • Louisville
  • Louisiana
    • Shreveport
  • Maine
    • Auburn
    • Bangor
  • Maryland
    • Baltimore
    • Bethesda
    • Salisbury
  • Massachusetts
    • Boston
    • Springfield
  • Michigan
    • Ann Arbor
    • Kalamazoo
    • Lansing
    • Laper
    • Pontiac
    • Royal Oak
    • Saginaw
    • Troy
    • Ypsilanti
  • Minnesota
    • Duluth
    • Minneapolis
    • St Paul
  • Mississippi
    • Tupelo
  • Missouri
    • Columbia
    • Joplin
    • Kansas City
    • St Louis
  • Nebraska
    • Lincoln
    • Omaha
    • Papillion
  • New Jersey
    • Newark
    • Oakland
    • Paterson
  • New Mexico
    • Albuquerque
  • New York
    • Brooklyn
    • Buffalo
    • Johnson City
    • Kingston
    • New Hartford
    • New York
    • Rochester
    • Syracuse
    • Williamsville
  • North Carolina
    • Chapel Hill
    • Charlotte
    • Greensboro
    • High Point
    • Raleigh
    • Winston-Salem
  • Ohio
    • Cleveland
    • Columbus
    • Kettering
    • Zanesville
  • Oklahoma
    • Oklahoma City
    • Tulsa
  • Oregon
    • Bend
  • Pennsylvania
    • Camp Hill
    • Danville
    • Doylestown
    • Harrisburg
    • Lancaster
    • Langhorne
    • Philadelphia
    • Pittsburgh
    • Sayre
    • Sellersville
    • Wormleysburg
    • York
  • Rhode Island
    • Providence
    • Wakefield
  • South Carolina
    • Anderson
    • Charleston
    • Columbia
    • Greenville
  • South Dakota
    • Rapid City
  • Tennessee
    • Jackson
    • Knoxville
    • Memphis
  • Texas
    • Amarillo
    • Austin
    • Dallas
    • Houston
    • Lubbock
    • San Antonio
    • San Marcos
    • Tyler
    • Victoria
  • Vermont
    • Burlington
  • Virginia
    • Falls Church
    • Fredericksburg
    • Norfolk
    • Winchester
  • Washington
    • Everett
    • Tacoma
  • West Virginia
    • Morgantown
  • Wisconsin
    • Green Bay
Contact an Experienced Clinical Trial Attorney

Thomas J. Henry are leaders in the area clinical trial litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. Our Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/or defective pharmaceuticals.

If you or a loved one have been injured by or have developed serious side-effects while participating in a clinical trial, contact Thomas J. Henry immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.

Essure Faces Criticism after Hundreds of Reported Adverse Events

According to ABC News, Erin Brockovich, who led the 1993 case against Pacific Gas and Electric Co., is now focusing her attention on the popular birth control, Essure.

How Essure Works

  • Approved by the U.S. Food and Drug Safety Administration (FDA) in 2002, Essure is an irreversible birth control system in which two small metal coils are place inside the fallopian tubes.
  • The system relies on the body creating scar tissue around the metal inserts which, after about three months, should block sperm from reaching the egg.
  • As Essure does not take effect immediately; women are encouraged to use other forms of birth control until an x-ray confirms the scar tissue building process is complete.

Complications Experienced while on Essure

“The pain was incredible. It was like fire inside your body… It felt like child delivery for days, and days, and days.” – Essure patient Shelly Towndrow to ABC

  • Since its approval in 2002, over 700,000 women have undergone the Essure procedure.
  • Since 2004 the FDA has received 838 adverse event reports including:
    • 150 reports of coils which have broke or misfired.
    • 91 patients have undergone hysterectomies in order to remove the coils.
    • 80 women have become pregnant after undergoing the Essure procedure.
    • Hundreds more have reported the inserts moving or puncturing the fallopian tubes.
  • According to Brockovich, thousands of women have experienced problems with the procedure beyond those events reported to the FDA.
  • Brockovich further argues that the two years of clinical trials that Essure underwent before being granted approval were not enough to adequately determine the efficacy of the Essure system.
Other Side Effects and Heath Risks of Essure

Following information provided by MayoClinic:

  • Pain
  • Cramping
  • Infection
  • Perforation of the uterus or fallopian tubes
  • Tubular blockage
  • Increased risk of ectopic pregnancy
Contact an Experienced Product Liability Attorney

Thomas J. Henry are leaders in the area of drug and product liability litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. The Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/ or defective pharmaceuticals.

If you or a loved one have been injured by or have developed serious side-effects from the use of defective medications or medical devices, contact Thomas J. Henry immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.

Toyota Recalls Roll-Away Sienna Minivans

Toyota has issued a recall on 615,000 of its Sienna Minivans in the United States.The issue lies in the transmission shifting gears out of the park position without the driver’s doing, causing the vehicle to roll away.

Description of the Faulty Transmission

  • The shift lock solenoid is an electrical component and could be damaged.
  • If so, it is possible that the shift lever could move out of the “P” position without the brake pedal ever being employed.
  • When shifted out of ‘park,’ the vehicle can roll away.

Information on the Toyota Sienna Recall

  • This recall only covers Toyota Sienna model vehicles.
  • Model years 2004, 2005, and 2007-2009 are possibly affected.
  • Twenty-one accidents have been tied to problems with the faulty transmission, two incidents have resulted in minor injuries; no deaths have been reported.
Contact an Experienced Auto Recall Attorney

Thomas J. Henry are leaders in the area of product liability litigation. Our Defective Drug and Products Division has extensive knowledge and resources in order to represent our clients efficiently and aggressively. We represent a multitude of people who are battling against manufacturers of defective vehicles and auto parts.

Your choice does matter. If you or a loved one has suffered serious injuries because of a recalled vehicle or defective auto part, call Thomas J. Henry immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.

How to Identify Tire Defects and Prevent Tire Tread Separation

Tire tread separation is a potentially dangerous even in which the tread of a tire separates from the casing or the body of a tire. When traveling at highway speeds, tire separation can lead to loss of vehicle control, rollovers, accidents and death.

Tire Tread Separation and Manufacturer Defect

  • While tire abuse and neglect can lead to tire tread separation, one of the most common causes is actually manufacturer defect.
  • The vast majority of tires manufactured for cars, pickups, minivans and sports utility vehicles are steel belted radial tires. The most common defect associated with these types of tires is tire tread separation.
  • When these types of tires are manufactured, specialized rubber compounds are reinforced by fabric cords and steel wires.
  • Defect occurs when a problem in the chemical process causes the tread and steel belting to not properly bond to the tire casing. With long-term use, the tread and belting begin to separate from the casing until complete separation occurs.

Identifying Tire Tread Separation

As provided by Texas Tire Sales:

  • A common sign of tire tread separation is that the car will begin shaking at a certain speed (most often between 10 mph to 40 mph).
  • This may begin as a small vibration, but as the problem worsens, it may feel as though the whole wheel is shaking side-to-side as though the wheel is not tightly fastened.
  • The first visual indication will be a bubble along the tread or the sidewall of the tire. The bubble will continue to expand and a larger section becomes separated from the tire’s casing.
  • Drivers may also notice a wavy pattern in the tread. The treads of a tire should always align straight and remain parallel. Misaligned tread patterns are an indication that the tread is not properly bonded or is losing hold.
  • If tire tread separation is identified, repair should not be attempted. The only remedy is to replace the tire completely.
Contact an Experienced Tire Recall Attorney

Thomas J. Henry are leaders in the area of product liability litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. We represent a multitude of people who are battling against manufacturers of defective tires and tire parts.

Your choice does matter. If you or a loved one has been injured in an auto accident caused by a defective or recalled tire, call Thomas J. Henry immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.

Vitamix Blenders Recalled – Laceration Hazard

Vitamix Corporation has issued a voluntary recall for the Vitamix 64-Ounce Low Profile Container, which is sold at major retailers nationwide, at show demonstrations, and online. According to the United States Consumer Product Safety Commission, 165,000 units of this product have been circulated in the U.S. and 4,300 more in Canada from April 2013 to August 2013.

About the Blender Recall

  • The blade can break and may potentially pose a laceration hazard.
  • There have been 18 reports of the blade breaking.
  • At this time, there are no reports of injury.
  • Consumers should immediately stop using this product.

VitamixConatiner Recall Description

The following information has been provided by the US Consumer Product Safety Commission:

  • The recall involves Vitamix 64-ounce Low-Profile containers with blade part number 103208 A and blade date codes 03-12 (March 2012) through 07-13 (July 2013).
  • The blade part number and date code are laser etched onto the top of the blade at the bottom of the container.
  • The clear, plastic, 64-ounce container with black plastic handle and lid was sold with Vitamix blender models 7500, Professional Series 300, Professional Series 750 and individually.
  • Replacement blades with part number 104602 A are not affected.
Contact an Experienced Product Liability Attorney

Thomas J. Henry are leaders in the area of product liability litigation. We represent a multitude of people who are battling against manufacturers of defective drugs and/or products.

Your choice does matter. If you or a loved one has suffered serious injuries because of a recalled product, call Thomas J. Henry immediately. We are available 24/7, nights and weekends.

Philips LED Bulbs Recalled from Home Depot

According to a release by the Consumer Product Safety Commission, Philips Lighting has issued a recall for its Endura and Ambient LED bulbs.

About The LED Bulb Recall

  • According to the release, the entire lamp can become electrified due to a lead wire in the bulb’s housing having an improper fitting.
  • The recall affects about 99,000 units sold at Home Depot stores and home center stores nationwide. The bulbs were also available through online retailers including Amazon.
  • The bulbs were sold between October 2012 and May 2013 for between $15 and $30.

Details on the Philips Lighting LED Bulbs

Information Provided by CPSC.gov

  • The recall includes the Endura 12-watt LED dimmable light bulb and the Ambient 12-watt LED dimmable light bulb.
  • The bulbs are orange and have model numbers and “Made in China” printed on the neck. Date codes are printed on the metal screw portion of the bulbs.
  • Endura LED 12W A19 2700k Dimmable 120V bulb
    • Model Number: 9290001829
    • Ordering Code: 12A19/END/2700-800 DIM
    • UPC: 4667740994
    • Date Code: 2L
  • Ambient LED 12.5W A19 2700K Dimmable 120V bulb
    • Model Number: 9290001829
    • Ordering Code BC-12.5A19/AMB/2700-800 DIM
    • UPC: 4667742215
    • Date Code: 2K and 2L
Contact an Experienced Product Liability Attorney

Thomas J. Henry are leaders in the area of product liability litigation. Our Defective Drug and Products Division has extensive knowledge and resources in order to represent our clients efficiently and aggressively. We represent a multitude of people who are battling against manufacturers of defective drugs and/or products.

Your choice does matter. If you or a loved one has suffered serious injuries because of a recalled product, call Thomas J. Henry immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.

Char-Broil Recalling Patio Bistro Gas Grills

The Consumer Product Safety Commission has issued a release stating that Char-Broil is recalling 69,300 units of two models of their Patio Bistro Gas Grills.

About the Char-Broil Grill Recalls

  • According to the CPSC release, there have been 26 reports of the grills igniting unexpectedly.
  • Several of the incidents have resulted in burns.
  • The grills were sold at hardware shops including Home Depot, Target, Ace Hardware, and Sears between September 2010 and June 2013.
  • The CPSC recommends consumers stop using the grill and contact the manufacturer.

Details on the Char-Broil Grills and Patio Bistro Gas Grills

  • The recall concerns two models produced by Char-Broil:
    • The model 240 Full Size Grill
      • Model Numbers (11601558, 11601558-A1, 12601558, 12601558-A2)
      • Sold for approximately $175
    • The model 180 Table Top Grill
      • Model Number (12601713)
      • Sold for approximately $135
  • The products are single burner propane grills with a battery operated electronic ignition.
  • The products are black with round bodies and an aluminum trim.
  • “Char Broil” and “Patio Bistro” can be found printed near the thermometer and on the near the control knob on the front of the grill.
  • The model number is on a label located on the bottom support on the back of the unit.
Contact an Experienced Product Liability Attorney

Thomas J. Henry are leaders in the area of product liability litigation. Our Defective Drug and Products Division has extensive knowledge and resources in order to represent our clients efficiently and aggressively. We represent a multitude of people who are battling against manufacturers of defective drugs and/or products

Your choice does matter. If you or a loved one has suffered serious injuries because of a recalled product, call Thomas J. Henry immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.

Ford Hit with $53 Million Verdict for Seatbelt Failure

A Florida school teacher has been awarded $53 million after a jury found that Ford was liable for the injuries she sustained when her seat belt allegedly failed during an automobile accident.

The plaintiff claimed the 1997 Ford Explorer her husband was driving hydroplaned before crashing into a guardrail at which point her seat belt and seat back failed ejecting her through the rear windshield of the vehicle.

About the Ford Seatbelt Trial

  • The plaintiff was riding in the backseat with her 5-month-old son when the car crash occurred. The infant was in a car seat and was uninjured. The husband who was driving also reported no injuries.
  • The plaintiff’s biomechanical and seat belt experts testified that back loading of the seat belt resulted in the seat belt becoming “inertially unlatched.”
  • The experts also testified that the seat’s back was not properly secured to the vehicle.
  • An accident reconstruction expert testified that the vehicle’s center of gravity was too far forward, leading to it being unstable.

Injuries and Damages Sustained in the Accident

  • Traumatic Head Injuries
  • Traumatic Axonal Injury
  • Brain Stem Trauma
  • Intra Cranial Hemorrhages
  • Vision Impairment
  • Speech Difficulty
  • Hearing Loss
  • Accelerated Neurological Deterioration

The plaintiff can no longer teach due to her condition.

Verdict of the Ford Lawsuit

The jury found in favor of the plaintiff and found Ford to be liable for all damages and injuries resulting from the accident. The plaintiff was awarded $53 million for past and future damages and injuries.

Contact an Experienced Defective Vehicle Attorney

Thomas J. Henry are leaders in the area of product liability litigation. Our Defective Drug and Products Division has extensive knowledge and resources in order to represent our clients efficiently and aggressively. We represent a multitude of people who are battling against manufacturers of defective vehicles and auto parts.

Your choice does matter. If you or a loved one has suffered serious injuries because of a recalled vehicle or defective auto part, call Thomas J. Henry immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.

Michelin Recalls 100,000 Tires

Michelin has issued a recall of 100,000 tires after a retailer discovered that some of the tires had holes in them and were prone to deflating rapidly.

Michelin Tires Being Recalled

  • The tires were sold between September 2012 and early June 2013
  • Models being recalled include:
    • MICHELIN LTX M/S 2: P275/55R20 111T RBL, P265/65R18 112T, and P265/60R18 109T ORWL
    • MICHELIN X Radial LT2: P265/65R18 112T and P275/55R20 111T
    • MICHELIN Latitude Tour: P255/60R19 1085 and 9255/70R18 112T

Affected tires may have a partial or full sidewall aperture that could cause them to experience loss of air pressure.

Contact an Experienced Tire Recall Attorney

Thomas J. Henry are leaders in the area of product liability litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. We represent a multitude of people who are battling against manufacturers of defective tires and tire parts.

Your choice does matter. If you or a loved one has been injured in an auto accident caused by a defective or recalled tire, call Thomas J. Henry immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.

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