Byetta Recall - Possible Lawsuit Information

The authors would like to report that a widely used diabetes drug has been linked to severe pancreatic problems in dozens of patients, according the Food and Drug Administration. In an announcement Monday, the FDA warned patients taking Byetta, marketed by Amylin Pharmaceuticals Inc. and Eli Lilly & Co., to discontinue use if they develop symptoms of the disorder and said doctors should consider other prescription options for patients with a history of pancreas problems. More than 700,000 patients have used the drug since it was released in 2005.

If you believe you have been injured as a result of Byetta, please call Ed Wallis today at (901) 527-4673, or send an e-mail by clicking HERE.

Pharmaceutical Business Review cites FDA settlement

A staff writer with the Pharmaceutical Business Review cited the recent FDA settlement between the FDA and Advanced Bionics. As noted within that article:

The FDA asserted that Advanced Bionics should have made a formal submission five years ago before using a second vendor for a particular component in its cochlear implant system.

The component, called a feedthru, contained a hidden weakness that allowed a very slow leak of water molecules into the implanted devices containing this vendor’s feedthru’s while blocking the passage of much smaller helium and nitrogen gases.

Until this situation, such a condition was universally believed to be impossible. After an extended period of one year or more, the slow leakage led to device failures, a product recall, and a termination of the second vendor.

Advanced Bionics responded to FDA’s complaint asserting that it had tested the component with state-of-the-art processes and equipment, which demonstrated that gas molecules much smaller than water molecules were completely blocked from passage; until this hidden weakness was observed, the industry standard testing was considered sufficient to ensure hermeticity.

Although the FDA did not accept these arguments, Advanced Bionics believes them to be true and denies that it violated the law. Nevertheless, rather than continuing a protracted and costly legal process that would likely harm its relationship with the FDA, Advanced Bionics has decided to settle this issue and move on.

In doing so, Advanced Bionics has agreed to pay the FDA $1.1 million and the CEO has agreed to pay $75,000.

For more information, read HERE.

If you believe you have been injured as a result of a defective Advanced Bionics HiResolution 90k (HiRes 90k) cochlear implant, and would like more interest in filing a lawsuit on your behalf or on behalf of a loved one, please call Ed Wallis at (901) 527-4673, or send an e-mail by clicking HERE.

Class action filed against Time Warner

According to the Kansas City Star and a recently filed class action lawsuit, Time Warner Cable Inc. unfairly limits its customers’ ability to access premium cable channels by forcing them to rent a cable box from the company, a potential class-action lawsuit filed Tuesday claims. An attorney for the plaintiff compared the practice to those used by AT&T years ago when it forced customers to rent telephones. Time Warner is the nation’s second-largest cable company, providing service to 14.7 million customers.

An interesting lawsuit. I’d expect others to follow suit against the remaining large cable companies if this lawsuit is successful.

You can read more HERE.

Last Settlement Reached in Nightclub Fire Case

The last major defendants in a sweeping lawsuit stemming from a 2003 Rhode Island night club fire that killed 100 patrons have agreed to settle. Under the settlement, the state of Rhode Island and the town of West Warwick will each pay $10 million to survivors and the relatives of victims. Total settlements in the case total approximately $175 million.

For more information, read HERE.

New England Journal of Medicine Amicus Brief in Wyeth v. Levine

The following amicus brief has been filed in the preemption case, Wyeth v. Levine:

BRIEF OF NEW ENGLAND JOURNAL OF
MEDICINE EDITORS AND AUTHORS AS
AMICI CURIAE IN SUPPORT OF RESPONDENT

You can read the brief HERE.

MySpace and Facebook used in jury selection

The popularity of social networking sites such as MySpace and Facebook has become a valuable tool for attorneys and jury consultants seeking to vet jurors. Information gleaned from personal Web sites, blogs and other Internet sources can reveal important information that jurors may not divulge on jury questionnaires or during voir dire. I guess the only problem is being able to google information during the middle of voir fire for short trials.

For longer, multi-day voir dire sessions, this could be very helpful.

Read more HERE.

BMW recalls 150,000 vehicles

The front passenger air bags in more than 200,000 BMW vehicles may not deploy during a crash, the German automaker said Wednesday in announcing a recall. Recalled vehicles include the 2006 BMW 3 Series, the 2004-2005 BMW 5 Series and 2004-2006 X3 SUV. A malfunction in the seat detection mat that could potentially lead to air bag failure prompted the recall, according the National Highway Traffic Safety Administration Web site.

Read more HERE.

If you believe you have been injured, and for a free case evaluation, please call Ed Wallis at (901) 527-4673, or send Ed an e-mail today by clicking HERE.

Laser Eye Surgery Injury and Complication Lawsuit Information

LASER EYE SURGERY INJURY OR COMPLICATION?

LASIK: Injuries from the Procedure

Each year there are over 700,000 LASIK surgeries across the country. Of those, statistics show 5% of procedures result in complications. That’s 35,000 possible injuries every year in the United States alone. Common problems post-LASIK are:

• Blurry vision
• Warping or scarring of the cornea
• Dry or painful eyes
• Halo or starburst effects that interfere with clear vision or safe driving
• Sensitivity to light
• Loss of visual acuity, even with the best possible correction with eyeglasses

LASIK injuries can occur because of improper screening/testing, improper surgical techniques, lack of adequate equipment, improper use of equipment, inadequate post-surgery treatment and general negligence. Naturally, LASIK injuries can be quite devastating, resulting in blindness in some cases.

These problems can result from numerous causes. During a surgery, a physician may cut the cornea too shallow or too deep or may improperly use medical equipment and devices. Some injuries may result because of the failure of the physician to follow the “standard of care.” The standard of care differs by state, as for example in Tennessee, the “standard of care” is what a reasonable physician would have done in the same or a similar community.

LASIK problems, however, can also occur because the surgery should have never occurred in the first place. For example, some persons are not proper candidates. For example, some candidates have corneas that are too think to support the LASIK cutting. Others possess a feature known as keratoconus, which means a person has a cornea improperly shaped that will not support LASIK procedures.

LASIK: Unfair and Deceptive Advertising

Unlike some other forms of health care, LASIK is a cash business, meaning that those choosing to undergo LASIK have agreed to pay 100% of the cost to the provider. This has, in a sense, lead to the creation of large corporate LASIK providers, including the Laser Vision Institute (LVI) and The Laser Center (TLC). These, and other, corporations spare no expense at advertising to lure consumers into their clinics and to their surgeons. In a sense, this has resulted in the FDA imposing fines against some LASIK providers for false and deceptive advertising.

Despite fines and warnings, mass-LASIK advertising continues today, in print, on the Internet and on the radio around the globe.

LASIK: Damages

Some damages you may be entitled to include:

• Past medical and pharmacy bills
• Future medical and pharmacy bills
• Mental distress
• Permanent injury
• Loss of enjoyment of life
• Pain and suffering
• Mental distress
• Loss of consortium
• Punitive damages in some instances

LASIK: Do I have a case?

If you have suffered complications following LASIK, you may be entitled to pursue a cause of action against physicians and/or the LASIK provider. Whether or not you are a candidate to pursue an action depends on whether there was a violation of the standard of care by the surgeon and/or the clinic. It may also depend on whether you relied upon false or deceptive advertising before going forward with your treatment.

The first step in determining if you have a possible case is to contact us. Both Tim Edwards and Ed Wallis have handled LASIK malpractice cases and are prepared to review the specific facts of your case today. Please call us today at (901) 527-4673 or SEND US AN E-MAIL today.

For More Information

Tim Edwards
Ed Wallis
Glassman, Edwards, Wade & Wyatt, P.C.
26 N. 2nd Street
Memphis, TN 38103
Telephone: (901) 527-4673
E-Mail: CLICK HERE

The authors practice in the Mid South and Metropolitan Memphis area, an area encompassing Western Tennessee, Eastern Arkansas and Northern Mississippi. Some cities covered in our wide range of practice include Memphis (TN), Cordova (TN), Bartlett (TN), Collerville (TN), Millington (TN), Covington (TN), Somerville (TN), Ripley (TN), Dyersburg (TN), Tiptonville (TN), Union City (TN), Dresden (TN), Humboldt (TN), Milan (TN), Trenton (TN), Alamo (TN), Brownsville (TN), Jackson (TN), Bolivar (TN), Henderson (TN), Lexington (TN), Selmer (TN), Savannah (TN), Parsons (TN), McKenzie (TN), Huntingdon (TN), Paris (TN), West Memphis (AR), Marion (AR), Southhaven (MS), Olive Branch (MS), Hernando (MS), Horn Lake (MS), and Senatobia (MS). This also includes the following counties: SHelby (TN), Tipton (TN), Lauderdale (TN), Dyer (TN_, Lake (TN), Obion (TN), Gibson (TN) Crockett (TN), Haywood (TN), Fayette (TN), Hardeman (TN), Madison (TN) Henderson (TN), Carroll (TN), HHenry (TN), Benton (TN), Chester (TN), Decatur (TN), McNairy (TN), Hardin (TN) Perry (TN), Tunica (MS), Desoto (MS), Tate (MS), Marshall (MS), Lafayette (MS), Crittendon (AR), Mississippi (AR), Poinsett (AR), Craighead (AR), Cross (AR), St. Francis (AR), Lee (AR), Phillips (AR). Even if you are outside of these areas, we may still be able to help, so please contact us today, as our attorneys are licensed in numerous state courts and federal courts, and can still assist in finding you an attorney to help you with your needs.

Class 1 Recall: Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System

For more information contact:
Tim Edwards
(901) 527-4673
tedwards@gewwlaw.com

AUG 14, 2008 (Memphis, TN) – On June 6, 2008, medical device company Boston Scientific® issued a Class 1 recall for its NexStent Monorail®, NexStent Carotid Stent® and Monorail Delivery System®.  The product was manufactured from June 12, 2007 through May 2, 2008 and distributed from June 19, 2007 through May 5, 2008. Read the FDA recall HERE.

This device is used in patients to treat a blockage (stenosis) in the carotid artery, known as carotid artery disease. The two carotid arteries (located on either side of the neck) supply blood to the brain. The device is used in a procedure called carotid artery stenting (CAS), in which the physician places the self-expanding stent in the carotid artery to keep the artery open and to help prevent future narrowing of the artery.

This device has been recalled because the tip of the stent delivery system may detach from the delivery system during the procedure. This could lead to increased procedure time, cause vessel wall injury, stroke and/or emergency surgery to remove the detached tip.

You may have received a letter from Boston Scientific describing the recall and condition.  If you have been physically or emotionally injured as a result of a NexStent Monorail®, NexStent Carotid Stent® and Monorail Delivery System® from Boston Scientific, please contact us for a free case evaluation today: call Tim Edwards at (901) 527-4673 or send an e-mail today by clicking HERE.

Advanced Bionics Cochlear Implants Lawsuit Info

The Recall

In 2004, Advanced Bionics issued a recall for the Clarion HiResolution 90k (HiRes90k) bionic ear system. It appears Advanced Bionics kept shipping these devices across the country, and eventually, the Food and Drug Administration (FDA) approached Advanced Bionics about numerous deficiencies with the development, manufacturing, design, testing, and sale of the HiRes90k cochlear implant. After there was a nearly 20% failure rate for Supplier B HiRes90k implants, Advanced Bionics issued a second nationwide recall for all unimplanted cochlear implants.

The FDA eventually filed a complaint against Advanced Bioncs seeking $2.2 Million in fines, plus additional fines from the company’s CEO. The complaint accused Advanced Bionics of failing to follow pre-market approval procedure, failing to properly test the HiRes90k, supplier B, and failing to comply with numerous other FDA requirements. The HiRes90k cochlear implant was alleged by the FDA to “pose a public health risk due to excessive moisture, exposing patients to the risk of device failure, possible surgery, and the potential for additional hearing loss.”

The Settlement

Advanced Bionics has settled the Complaint with the FDA, agreeing to pay $1.1 Million Dollars in fines for alleged wrongdoing. The company’s CEO has also agreed to pay a $75,000.00 fine.

Why file a lawsuit?

Advanced Bionic’s failure to follow FDA regulations and guidelines shows a conscious disregard for the safety of patients. Causes of action may exist for design defects, breach of warranty, consumer protection, negligence, intentional wrongful and more.

Symptoms

Possible symptoms of injuries include:

• Discomfort
• Ear pain
• Loss of sound
• Cracking, hissing and popping noises
• Sudden loud noises

If you believe you have sustained any injuries, please seek medical help IMMEDIATELY. If your child is not showing proper development advances, and you suspect his or her cochlear implant is malfunctioning, please seek medical help IMMEDIATELY.

The Authors’ Connection

Tim Edwards, an author of this blog, has a personal connection to cochlear implants and this specific allegation of wrongdoing by Advanced Bionics. Tim’s grandson was born completely deaf, and at twelve months of age, he was implanted with an Advanced Bionics HiRes90k cochlear implant. While Tim’s grandson today has experienced no symptoms of a failing device, he is a part of the recalled group, and must live day by day never knowing when his implant might fail.

Tim has a strong, personal connection to these cases, and is passionate about seeing that justice prevails for his clients.

For More Information

Attorneys Tim Edwards and Ed Wallis are currently representing injured persons who received the HiRes90k cochlear implant and stand ready to discuss your case with you. If you were a recipient of an Advanced Bionics HiRes90k Cochlear Implant, and have experienced physical or emotional injuries due to a malfunctioning implant, please call us today at (901) 527-4673 or send an e-mail immediately for a FREE CASE EVALUATION.

If you have already settled with Advanced Bionics, CALL US OR E-MAIL US TODAY as there may be means to address wrongdoing by Advanced Bionics.

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