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Brake Issues Prompt BMW Recall

downloadAccording to the National Highway Traffic and Safety Administration, BMW is set to recall 76,000 of its vehicles. This recall pertains to the years 2012 through 2014 and includes various models.

What is the recall for?

The recall on BMWs has to due with a loss of power brake assist caused by an interruption of the oil supply to the vacuum pump, which operates the brake booster. The brake booster is what makes the power assist work.

What does this problem mean?

According to Matthew Russell, who is a spokesman for BMW, the brakes on the BMWs in question will still function. Matthew says the problem will only make it harder for the driver to press the brake pedal. However, this problem can cause stopping distances to grow as it will take more effort to stop the car.

What models are affected by the recall?

  • 2012 to 2014 328i and 320i and the 320i and 328i xDrive Sedan.

  • 2013-2014 328i xDrive Sports Wagon.

  • 2012-2013 528i and 528i xDrive Sedan.

  • 2013-2014 Xi sDrive28i and X1 xDrive28i.

  • 2013-2014 X3 xDrive28i.

  • 2012-2014 Z4 sDrive 2.81i.

How many vehicles has BMW had to recall of late?

Since 2010, there have been 306,000 vehicles recalled by BMW for various brake booster issues. They recalled around 30,000 of their X5 sport utility vehicles in February. This recall was issued due to the risk of oil contamination in the brake booster.

What type of BMW recall was this?

According to BMW, these recalls were voluntary and are only precautionary. However, it is stated that once a manufacturer is aware of an issue, it must inform the National Highway Traffic and Safety Administration within five business days or face fines.

What can we learn from recalls?

BMW is a luxury brand. However, even BMW has to issue recalls on their vehicles on occasion. These recalls just point out that there is no perfect vehicle design and virtually every vehicle will have its share of problems. Therefore, as consumers, it is wise to stay informed about recalls when they are issued.

 

 

Court Orders New Jury For $30 Million Tobacco Death Case

tobacco lawsuit updateThe ongoing case of a big tobacco manufacturer and a frail older woman continues as a Florida appeals court ordered that a second trial be conducted for the tobacco wrongful death lawsuit.

About the Case

The plaintiff in the case is an 80-year-old resident of Hollywood. She says that her husband started smoking when he was 13. In testimony and interviews, she also says that he could barely breathe for the final thirteen years of his life. He finally died at the age of 80 of chronic obstructive pulmonary disease in 2008. She sued R.J. Reynolds, the second largest tobacco company in the United States.

The Award

The woman originally won the case. The jury awarded her punitive damages in the amount of $25 million, along with $405,000 for medical and funeral expenses, and $4.83 million for pain and suffering.

Challenges to the Ruling

The Fourth District Court of Appeals made decisions regarding multiple matters. First it ruled that the Broward circuit court judge erred when he refused to allow the tobacco company to present part of its defense. In particular, the court ruled that the next jury should have an opportunity to hear the tobacco company’s defense regarding fraudulent concealment and conspiracy claims that were made against it.

The tobacco company says that the widow cannot prove that her husband relied on tobacco company fraudulent statements, which would keep the case within the 12-year statute of limitations against fraud. However, the court of appeals also ruled that the judge erred when he lowered part of the widow’s award. The circuit court judge had cut the punitive damages down to $15.7 million in a move that the court of appeals said was wrong because the amount was not “so excessive as to violate due process.”

What Next?

Because the case is going back for a new trial, the process essentially starts all over. The next jury may rule in favor of the window and award a larger or smaller verdict. It could also rule against the mother, and she could lose her chance at the verdict she received the first time around.

Vaginal Mesh Lawsuit Nearing Settlement

vaginal mesh discomfortManufacturers of Vaginal Mesh-Implants in Negotiations with Plaintiffs

Lawsuits relating to alleged injuries caused by vaginal mesh implants may be approaching settlement.

The manufacturers facing vaginal mesh lawsuits include C.R. Bard Inc., Endo Health Solutions Inc. (ENDP), Boston Scientific Corp. (BSX), Coloplast A/S (COLOB) and Cook Medical Inc. The products in question are vaginal mesh- implants which are inserted in order to support the muscles surrounding the pelvis to help prevent incontinence.  Reports indicate that one other company, Johnson & Johnson, is also facing similar legal problems but does not seem drawn in into the negotiations.

U.S. District Judge Joseph Goodwin Overseeing Vaginal Mesh Lawsuit

The federal-suits filed against the companies are under U.S. District Judge Joseph Goodwin in Charleston.  The plaintiffs have apparently requested for a settlement commission to be appointed. Goodwin has been reported to say that all parties involved are following settlement-protocols and want the issue settled as soon as possible.

The negotiations are intended to resolve about 30,000 implant-related suits set before Goodwin for discussion and settlement prior seeing to trial.

50,000 Claims Expected to be Filed

Reports indicate that the number of plaintiffs can still increase.  More people with similar complaints are allegedly set to file their claims too.  According to Carl Tobias, a professor of product liability law at University of Richmond, settlement seems the way to go as there seems to be no contest as to accountability.  The damages seem grave, the injured numerous, so the settlement may be in the multibillion dollar range.

Settlement Committee

The women who have filed the vaginal mesh lawsuits are reported to have requested Goodwin to include plaintiff counsels Garrard, Rice, Aylstock, and Clark so that negotiations with all the mesh –manufacturers can drawn up and finalized without delay.  The plaintiffs legal counsels face the difficulty of having to contend with more than fifty various implants made by six different manufacturers.  Some of these implants are no longer in the market while others still are.

 

Tobinco Recall Issued by the FDA for 100 Imported Drugs

tobinco recallThe FDA has issued a Tobinco recall. The Tobinco recall was ordered by the FDA because of 100 drugs distributed and imported by the company lacked proper authorization. While waiting for the recall, the authorities have started their investigations into how these drugs were imported into the country without approval and proper documentation.

James Lartey, the PR Officer of the FDA, said that the only places for the proper importation of drugs into the country were in Tema Port and Kotoka International Airport. The authorities have wondered how these assorted drugs got into the country without approval or documentation in the first place.

Tobinco Recall Updates

Aside from the lack of documentation and approval, it is more alarming that Tobinco’s drugs have been in the market for some time now. Mr. Lartey said that the authorities have already told its officials to do what it can to find, confiscate, and destroy the undocumented drugs that can harm public safety. The officials of the FDA would meet to make a decision and mete out sanctions on the company that is responsible for the importation and distribution of the undocumented drugs.

The Daily Graphic has reached out to the Western Regional Officer of the Food and Drug Administration, Solomon Agampim. Mr. Agampim told the Daily Graphic that the Drug Enforcement Department of the FDA has conducted surveillance on the surroundings of Tobinco Pharmaceuticals. The surveillance has revealed that Tobinco has 48 products that were not registered and approved by the FDA, while another 41 products had expired registrations. Upon further investigation, the FDA revealed that Tobinco’s 16 other drugs had pending registration and only two drugs were registered with the FDA.

The Decision of the FDA

Mr. Agampim has released a statement saying that it was unlawful for Tobinco to import and distribute drugs that are unregistered. It is not only a direct violation of the law, but it can potentially harm or kill innocent people. Tobinco was compelled to comply with the laws and regulations of the FDA regarding drugs. Also, Tobinco was compelled to dispose of the unregistered drugs safely at the expense of the company.

Mr. Agampim has also stated that the regional office of the FDA has been to the premises of Tobinco in Takoradi, and would move the consignment of the unregistered drugs to a landfill for proper and safe destruction. Tobinco has declined comment or interviews when contacted by the Daily Graphic.

 

 

Yet Another Stryker Recall Announced

stryker hip implant recallThe US FDA has posted a safety alert last August 29, 2013 informing the public of the class 1 recall of Stryker’s Oasys Midline Occiput Plate.

Reasons for recall

Stryker’s Oasys Midline Occiput Plate has been used in for cervical spinal fusion surgery. It has been used to stabilize the junction between the occipital bone and the vertebrae in the spinal cord.

However, Stryker has been receiving reports of post-operative problems with the said device. After orthopedic surgery, the pin that connects the tulip head to the plate body has a tendency to break.

Breakage of the pin can lead to destabilization of the plate and corrective surgery may be required to remove the fractured pin. The fracture of the pin may also lead to serious health hazards to patients including nerve injury and even blood loss.

Class 1 recall

Class 1 recall are the most serious type of recall that a product or device can receive. A class 1 recall means that a product has the probability of causing serious adverse health effects or even death to consumers and patients.

Recommendations to patients

The company is advising patients who have received the Oasys Midline Occiput Plate to observe for symptoms such as weakness, pain, or numbness. And if they do experience any of these symptoms, they should visit their doctor for urgent evaluation.

Meanwhile, patients who have already undergone revision surgery are advised to routinely receive post-operative care and follow-ups.

The FDA also encourages patients and healthcare professionals to immediately report any adverse effects connected to the product to FDA’s MedWatch Safety Information.

Background on the recall

Prior to the Class 1 recall issued by the FDA, Stryker already issued an Urgent Medical Device recall last May 2013 on its Oasys Midline Occiput Plate, advising medical facilities and healthcare institutions to immediately stop the use of the recalled lots.

Then by June 2013, Stryker had already alerted orthopedic surgeons to perform routine clinical and post-operative evaluation on patients implanted with the Oasys Midline Plate. They also recommended urgent evaluation for patients already experiencing symptoms such as pain or weakness.

Third Stryker recall

This has already been the third recall issued by Stryker on its medical devices. In 2007, the company recalled the Trident hip. While in 2012, Stryker also issued a recall of the Rejuvenate and ABG II models.

The recalls were issued following reports from patients of symptoms like pain, swelling, and even metal poisoning from the components after they were implanted with the devices.

Possible reasons for the multiple recalls

The multiple recalls on Stryker’s implants are, according to reports, due to the lack of proper testing of the devices. Stryker hip implants were only laboratory-tested before the implants were made available to the public.

Actos Lawsuit Update: Bellweather Pilot Programs (BPP)

biomet logoArtificial hip implant maker Biomet is facing a lawsuit against lead plaintiffs Leslie and Allison Caccia, who claim that the company’s M2A-Magnum artificial hip implant is defective. According to the plaintiffs, Mr. Caccia’s implant prematurely failed, produced metal poisoning, and forced him to undergo revision surgeries after the M2A-Magnum metal on-metal hip replacement system and ReCap Femoral Resurfacing System failed to take effect in his body.

This Actos lawsuit involves the BioMet M2A-Magnum hip implant, which is actually a metal-on-metal artificial hip replacement system that prevents premature hip failure. This is usually implanted to anyone that has developed metallosis or metal poisoning. Metallosis occurs when microscopic debris is released into the soft tissues of the body from these parts grinding upon one another; this can occur in daily activities such as standing, sitting, or walking. The

All product liability claims of the Biomet’s M2A-Magnum metal-on-metal hip replacement system have been requested by the company’s lawyers to be dismissed by the Caccias’ and other plaintiffs. Such a development in the Actos lawsuit has arisen according to the legal theory of federal preemption, which claims that implant makers are free from being sued for their design defects since the product is FDA approved.

But presiding Judge Robert L. Miller has denied this motion by Biomet’s lawyers despite the FDA approval using the investigational device exemption or IDE. IDE enables the testing f approved products in order to properly vouch for its safety and effectiveness. The IDE process show that the plaintiff’s ReCap System was done outside the proper controlled study and did not even include record keeping, FDA oversight or proper monitoring.

Judge Miller asserts his conviction on this matter, stating that he is not persuaded by Biomet obtaining the proper IDE status for the device; thus they are not exempt from the liability of using the device outside the necessary clinical trial.

Biomet is currently facing 600 cases under Judge Miller, which includes lawsuits pertaining to the Actos bellwether pilot programs. Injuries from the BioMet hip replacement system cover numerous victims from different parts of the country. Injury lawyers represent these individuals from various states, most of whom are experienced and knowledgeable on the action that needs to be done against medical issues. As more and more victims are coming forward, the awareness on the defect of Biomet’s products will eventually aid these people in moving forward and prevent others from making the same mistake when seeking treatment.

Consumer Reports Tests Popular Joint Supplements, Finds Them Wanting

glucosamine chondroitinAccording to a recent study by Consumer Reports, some of the most popular joint supplements on the market are considerably less effective than most consumers may realize.

Arthritis

Degenerative joint disease is a common disease for the middle aged. It can cause a person to cease its normal physical activities because it is quite a painful illness. Around 27 million people in the US suffer from osteoarthritis. Because of this huge (and ever increasing number) of sufferers, there’s a wide opportunity for pharmaceutical companies to come up with health aids that can relieve arthritic pain and restore physical their activities.

Glucosamine

The body produces glucosamine for the joints. Though over time, the body decreases its glucosamine production, so drug companies made a glucosamine supplement for cartilage tissues. It is extracted from seafood (mainly from shrimp and crabs). Glucosamine sulfate is more effective against glucosamine hydrochloride because it is closer to the glucosamine produced by the body.

In a Consumer Reports’ joint supplements study, glucosamine was found to have a slight effect on the overall health of joints and cartilages. But this effect is the same as placebo. Even with prolonged use, the participants in the trial experienced no significant reduction in pain and inflammation.

Chondroitin

Chondroitin is also a major component of cartilage. It is derived from cow, pig or shark cartilage, and it can also be made synthetically. Theoretically, it positively slows the breakdown of cartilages and can increase the production of new cartilages.

But actual research claims that taking chondroitin does not alleviate pain and inflammation of the joints. Usually, this drug is taken along with aspirin or other pain killers, so its real efficacy is questionable. Some studies show that prolonged intake of this supplement might have positive effects on the overall musculoskeletal health. Though this is true, taking chondroitin can also induce hair loss and minor gut discomfort.

Combination

Glucosamine and chondroitin are sometimes taken together to gain a more desirable result. But alternative medical experts recommend taking glucosamine alone. Their effectiveness looks good on paper, but this remains unviable because chondroitin may act against glucosamine. Chondroitin decreases its absorption in the body.

Conclusion of the Consumer Reports Joint Supplement Study

Because the manufacturers of these drugs file them under therapeutic substances and not under pharmaceutical drugs, there they don’t have definite standardizations to follow. Each drug manufacturer may only include a small amount of these substances; one can never know which is effective for a person unless they try it themselves.

More over, scientific claims for glucosamine, chondroitin and MSM’s efficacy on the joints sound contradictory. Some experts refute their effectiveness on cartilage and ligament’s overall health, and compare their effect as similar to placebo. But therapeutic drugs are really helpful to many, even though they have little or no scientific basis.