Drugs & Medical Devices

Please visit our Drugs & Medical Devices Practice Center for more information.

First, Do No Harm...

All pharmaceutical products, prescription drugs and medical devices must adhere to strict state and Federal guidelines regarding safe use and be approved by the Food & Drug Administration (FDA). We use these products everyday assuming that they have been properly manufactured, tested and approved. They are, after all, intended to help alleviate serious medical conditions so when these drugs or devices are found to cause harm, the injured parties and their families have the legal right to seek compensation for their injuries.

At Bailey & Galyen, our Texas personal injury attorneys have assisted clients nationwide in the successful negotiation and litigation of defective pharmaceutical and medical devices lawsuits. We understand the emotional, as well as legal component of these cases and offer a compassionate, client-focused practice for injuries related to:

Dangerous Drugs / Pharmaceuticals – VIOXX, Celebrex, Zyprexa, Prempro (Hormone Replacement Therapy - HRT), Seroquel, Propulsid, Ephedra, Baycol, Rezulin, PhenFen, Digitek (Digoxin tablets) and many others
Defective Medical Devices – Hip / Joint Replacement, Heart Valves, Zeiss Opthalmic System, Bypass Connectors, Patient Lifts
Unrevealed side-effects
Misrepresentation
Negligence

A Note About “Medical Devices”

It should be noted that a defective medical device need not be a product used to directly address a medical condition; rather it can also include items used to assist sick people during treatment, including wheelchairs, lifts, heating pads and other products.

In an effort to speed up the process of testing and approving drugs for waiting consumers, the FDA has released many pharmaceuticals that are only now being shown to cause serious side effects and medical conditions, sometimes many years after the individual used the product. Negligence need not be willful in these cases – if a drug is found to do damage, the manufacturer, prescribing doctor and others may be held responsible under statutes of “strict liability” and be compelled to deliver compensation.

No Risk - No Obligation

If you have suffered a serious medical condition while taking a prescription pharmaceutical or been injured by a defective medical device, you have legal rights that must be protected and a limited time to report the injury and file a claim. CONTACT the Dallas / Houston dangerous drug litigation lawyers at Bailey & Galyen today for a FREE consultation and assessment of your injuries. All cases are taken on contingency, meaning there is never a fee until we recover the maximum settlement for your very real injuries.

CLICK HERE for more information on specific areas of personal injury / wrongful death practice at Bailey & Galyen, including motor vehicle accidents, birth injuries and product liability.

FDA Announces Class I Recall of Baxter Healthcare's Colleague Volumetric Infusion Pumps

The U.S. Food and Drug Administration (FDA) is announcing that Baxter Healthcare Corporation of Deerfield, Ill., has initiated a worldwide recall of all models of its Colleague Volumetric Infusion Pumps because they can shut down while delivering critical medication and fluids to patients. Baxter has received six reports of serious injury and three reports of death associated with this shut-down problem. The affected are: Models 2M8151, 2M8151R, 2M8161, 2M8161R, 2M8153, 2M8153R, 2M8163, 2M8163R.

Based on information from a current FDA inspection and independent analysis of the failure modes by FDA's Office of Science and Engineering Laboratories, as well as a comprehensive review of adverse event reports in FDA's database, FDA has determined that this action is a I recall. I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the affected product will cause serious injury or death.

"Given the widespread use of these pumps and the multiple failure modes, FDA is quickly informing users of this important safety issue," said Daniel Schultz, M.D., Director of FDA's Center for Devices and Radiological Health. "We will continue to monitor the situation closely and inform the public immediately of any new developments."

The firm notified customers today that it has voluntarily stopped shipping Colleague Volumetric Infusion Pumps until the problems are resolved. Baxter also advised customers on March 15, 2005, to stop using any pumps that exhibit a failure code beginning with 402, 403, 533, 535, and 599, related to these electronic problems. Additionally, Baxter advised customers to take out of service any pumps that exhibit failure codes 810:04 and 810:11 related to air-in-line sensor problems, until they are inspected by authorized service personnel.

In addition to the shut-down problem, the device may exhibit two additional failure modes:

Users may inadvertently press the on/off key instead of the start key when attempting to start an infusion.
Disconnecting or connecting the pump from the hospital monitoring system while the pump is powered "on" can result in a failure code, requiring the infusion to be restarted.

Also, these failures may occur during the infusion of therapy, so it is imperative that health care institutions have a contingency plan to mitigate any disruptions of infusions of life-sustaining drugs or fluids.

Approximately 255,000 Colleague Volumetric Infusion Pumps are currently in use, including 206,000 distributed in the United States.

Guidant Corp. Recalls 50,000 Heart Defibrillators

June 17, 2005: Guidant Corp. announced the recall of nearly 50,000 heart defibrillators that could short circuit without warning. As a result of the short circuit, the device can fail to deliver the necessary shock to the heart.

Less than a week later, Guidant issued a second safety advisory about its implantable defibrillators. The announcements continued on July 18, 2005, when Guidant Corp. revealed problems with an additional 28,000 implanted pacemakers and recommends that physicians consider replacing the devices.

What You Should Know

Guidant is reported to have discovered the design flaws in early 2002 after receiving two reports of failures. However, instead of immediately recalling the devices, Guidant chose not to notify patients with the original defective device -- or their doctors -- of the potential problem. Instead, they merely rectified the problem in new devices.

The matter recently came to light in March 2005 after the sudden death of a 21-year-old college student who had received the Guidant defibrillator due to a genetic heart disease. It was later determined that the student's defibrillator had short circuited. After investigation, Guidant informed the student's doctors that it was aware of 25 other cases in which the defibrillator had been affected by the same flaw.

Guidant has indicated that of the 78,000 suspect devices, up to 21,000 can be corrected by external reprogramming. The following models are included in the recall:

June 17, 2005:
- Ventak Prizm 2 DR (Model 1861) ICDs manufactured on or before April 16, 2002
- Contak Renewal (Model H135) and Contak Renewal 2 (Model H155) CRT-Ds manufactured on or before August 26, 2004
- Ventak Prizm AVT; Vitality AVT; Renewal 3 AVT; and Renewal 4 AVT ICDs (all series numbers)
June 24, 2005
- Contak Renewal 3 and 4; Renewal 3 and 4 AVT; and Renewal RF
July 18, 2005 - devices manufactured between November 25, 1997 and October 26, 2000
- Pulsar MAX; Pulsar; Discovery; Meridian; Pulsar MAX II; Discovery II; Virtus Plus II; Intelis II and Contak TR

The FDA has classified some of the devices subject to recall under the 'highest priority' designation. Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, said, "Malfunctions of these devices can lead to serious consequences and it's important for patients to call their doctor for additional information and personalized advice."

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