Articles Posted in Defective Products

While the Food and Drug Administration has done extensive study on psychiatric drugs to see whether they increase the risk of suicide, they are now taking a look at whether other medications, such as drugs to treat seizures, smoking, and asthma, also pose a similar risk.

Drugs that experts are worried could lead to suicidal thoughts if ingested included:

• Paxil, Zoloft, and all other antidepressants • Neurontin, Lyrica, and other anti-convulsives • Chantix, which is used to help people quit smoking • Asthma and allergy drug Singulair • Accutane, for acne

The family of Fernando Vargas, an East Boston teenager who died after his ventilator turned off during a power shortage last week, wants to know if his death occurred because the medical device was defective.

A preliminary police probe found that the ventilator’s backup battery failed during the two-hour power failure that occurred last week. The ventilator will be tested to find out what caused the malfunction. New England Home Therapies, the MassHealth Contractor that supplied Vargas with the ventilator, says it will send the device back to manufacturer Pulmonetic Systems for testing.

While Vargas’s ventilator has the same model number as one of four models included in the 2004 recall of about 10,000 Pulmonetic Systems ventilators, it is not clear whether the ventilator’s serial number is also a match. The recall occurred following approximately 30 reports of the backup battery malfunctioning during a power outage.

Pulmonetic also had voluntarily recalled 1,129 cable adapters that were supposed to fix the defect that led to the ventilator recall after it received reports that the new device was not letting the ventilator repower after the internal battery had been drained.

Medical devices that have been the source of products liability lawsuits include:

• Guidant Pacemakers • Dialysis Machines • Hernia Patches • Hip Prosthetics • Cosmetic Implants • Stents • Orthopedic Implants
Late teen’s stopped ventilator sent for tests, July Boston.com, July 21, 2008

Related Web Resources:

Pulmonetic Systems

Frequency, Causes, and Outcome of Home Ventilator Failure, ChestJournal.com Continue reading

A recent WCBV report discussed the possibility that there could be over 30 million defective tire valve stems on motor vehicles currently in use. A valve stem is a rubber part that is inserted into a tire so that air can be pumped into it. If there is a flaw in the rubber, however, a tire can rupture or deflate, and a flat tire or an auto crash can result.

One man, 31-year-old Robert Monk, died last November when his SUV flipped over. The cause of the rollover, according to investigators, was tire failure due to loss of air pressure. As a result, Monk lost control of the vehicle. His family has filed a wrongful death lawsuit against Discount Tire Co. and Dill Air Controls Products, LLC.

Following the deadly crash, Dill Air Controls Products told service centers that the cracked valve stems had come from a factory in China. Motor vehicle drivers, however, were not notified of the problem. Another company that also obtained valves from the same Chinese factory recalled six million cracked valves. Dill says there could be 30 million defective valves out on the roads.

While the initial hazard was thought to involve only replacement tires, WCBV found that the tires on some brand new cars may also come with the same defect. Several weeks ago, the National Highway Transportation Safety Administration demanded that Dill turn over its list of customers.

Tire defects can result in flat tires, tread separation, tire blowouts, and vehicle rollovers that can lead to serious injuries if the vehicles becomes involved in an auto accident. Injuries can include broken bones, paralysis, anoxic brain damage, closed head injuries, spinal cord injuries, and death.

Potential Defect Threatens More Than 30 Million Tires, TheBostonChannel.com, June 23, 2008
Fatal Rollover Prompts Probe into Chinese-Made Tire Valve Stems Safety, Forbes.com, June 12, 2008

Related Web Resources:

Read the Wrongful Death Action (PDF)

Read the Summary of the NHTSA’s Investigation (PDF)
Continue reading

In Norfolk Superior Court, the Roman Catholic Archdiocese of Boston filed a products liability lawsuit against Whirlpool seeking $10 million for compensation related to a seven-alarm refrigerator-caused fire that destroyed the Sacred Heart Church in Weymouth on June 9, 2005.

The lawsuit accuses Whirlpool of negligence and knowing that it was placing the 134-year-old church under unreasonable risk of harm. The Archdiocese is alleging that the company breached its implied warranty because the refrigerator was in a defective state and therefore hazardous and that the home appliance manufacturer should have known or knew that it had subjected the church to unreasonable risk.The complaint also accuses Whirlpool of violating the Massachusetts Consumer Protection Act.

It cost over $10 million to rebuild the church, which was burned to the ground. The Weymouth Fire Department, Weymouth Police Department, the Office of the State Fire Marshall, and the federal Bureau of Alcohol, Tobacco, Firearms, and Explosives conducted a joint investigation. A malfunction in an old refrigerator in the church basement was determined to be the cause of the fire.

The US Supreme Court heard oral arguments this week in a case that could determine whether drug makers should receive a similar protection from lawsuits to the one the court granted to medical device makers last week.

The main issue, according to Justice Stephen Breyer, is whether a drug, “on balance,” will save people or hurt people. Breyer says he believes that the Food and Drug Administration, and not a jury, is solely responsible for policing the pharmaceutical industry. He expressed concern over allowing a jury of 12 people randomly selected to rule on such lawsuits.

If the Supreme Court rules along with Breyer, thousands of personal injury lawsuits filed against drug manufacturers could be thrown out.

The issue in this case, Warner-Lambert v. Kent, is restricted to examining a Michigan statute that prevents personal injury lawsuits against drug manufacturers unless the injured person can prove that the company purposely kept information from the FDA that would have then barred the drug from the marketplace. A majority of the arguments on Monday centered on whether (and how much) of the Michigan law should be struck down.

The Supreme Court, however, is also scheduled to hear arguments in Levine v. Wyeth. It is during this case that the will be asked to rule on whether FDA approval bars personal injury lawsuits.

Last week, the Supreme Court ruled 8-1 in favor of medical device maker Medtronic Inc. The court said that FDA approval of a medical device trumps state tort lawsuits filed against medical device makers for products that have already passed a rigorous FDA approval process.

The ruling may benefit other medical device manufacturers that have been named in products liability and wrongful death cases by injured patients.

U.S. Supreme Court considers extending protections to drug makers, International Herald Tribune, February 26, 2008
Top court rules for Medtronic in devices case, Washington Post, February 20, 2008

Related Web Resources:

Warner-Lambert Co. v. Kent, Oyez.org
Riegel v. Medtronic, Justia US Supreme Court Center Continue reading

A Texas woman has filed a products liability lawsuit against Advanced Medical Optics Inc. for its contact lens disinfectant Complete Moisture Plus Multi-Purpose solution’s failure to properly disinfect her contact lenses.

Kimlyn Cline, a contact lense wearer for 35 years, says she always cleans and disinfects her contact lenses properly and that the infection in her left eye occurred because she used the solution. The damages she is seeking include medical costs, loss of income, pain, vision problems, mental and emotional trauma, disfigurement, and legal fees.

A corneal specialist diagnosed Cline’s condition as Acanthamoeba Keratitis. She must now undergo corneal transplant surgery, but she cannot do this until her infection clears.