South Florida Injury Lawyer Blog

A Palm Beach County woman is suing Medtronic Inc. for products liability. English says she developed uncontrolled bone growth in her spine after she received an Infuse Bone Graft implant during spine surgery.

The Infuse Bone Graft, which is bioengineered, is not FDA-approved for posterior-approach lumbar spine surgery. In her Florida defective medical device complaint, English claims that Medtronic misrepresented the risks involved with getting an Infuse implant and improperly marketed the device for uses not approved by the FDA.

English says that the extra bone growth she experienced has caused her to experience nerve compression, which has resulted in ongoing, chronic, and serious pain. Her products liability lawyer says that research had shown that use of Infuse in off-label surgeries can lead to this type of bone growth around and into the spine.

Already, English has had to undergo two surgeries to get rid of the additional bone growth. Daily activities (standing or sitting for a length of time) can lead to leg and back pain.

Infuse Lawsuits
English is not the first person to sue Medtronic over her Infuse implant and more Infuse lawsuits are likely. In June, Spine Journal reported that physicians who had been given millions of dollars by the medical device maker systematically did not reveal the serious complications linked to Infuse. Researchers noted that the rates of complications is 10 to 50 times more than what is actually noted as an estimate in medical literature.

Manufacturers are supposed to make sure patients know of the risks involved in using one of their medical devices. If, in fact, Medtronic took steps to conceal the risks involved and a patient that had Infuse implanted sustained serious complications that he/she was never warned about, that person may have reason for filing a Florida products liability lawsuit. If a doctor purposely neglected to warn the patient of these risks, he/she could be sued for Palm Beach, Florida medical malpractice.

Infuse lawsuits pile up for Medtronic, Mass Device, September 20, 2011

Spine Journal Takes Aim At Infuse Research, MedPageToday, June 28, 2011

Senators Seek Information on Side Effects of Medtronic Bone-Growth Product, NY Times, June 22, 2011

More Blog Posts:
Florida Products Liability Lawsuit Seeks Damages from Manufacturer of ShoulderFlex Deep Kneading Shiatsu Massager For Parkland Woman’s Wrongful Death, South Florida Injury Lawyer Blog, September 6, 2011

Florida Products Liability: Senate Passes Tort Reform Legislation That Could Limit Payouts from Manufacturers of Defective Autos, South Florida Injury Lawyer Blog, March 4, 2011

Defective Medical Device: DePuy ASR Hip Lawsuits To Be Presided Over by One Judge, South Florida Injury Lawyer Blog, December 8, 2010

In South Florida, state regulators have discovered a sobering trend: at least 41 South Florida doctors treat both drug addicts and pain patients. Experts worry that this combination of medical specialties could be dangerous, because it puts potentially addictive drugs to treat pain alongside a population that may already have drug dependencies.

According to an article in the Miami Herald, many of the doctors dispensing painkillers at South Florida pain clinics do not have special certification in addiction or pain management.

New Jersey requires doctors to be board certified in pain management before they can prescribe painkillers, but Florida doctors are allowed to dispense painkillers provided they have completed an eight-hour training course, have a valid medical license, and have approval from the Drug Enforcement Administration (DEA).

Many of these doctors have reportedly been disciplined for recklessly prescribing addictive drugs, but they can continue prescribing the drugs after they return from suspension.

Source: South Florida pain-clinic doctors also treat drug addicts, Miami Herald, December 29, 2009

Continue reading "Experts Worry Over South Florida Doctors Who Treat Pain and Drug Addicts " »

While methadone is prescribed by doctors, nurse practitioners, and osteopaths as a painkiller to treat conditions resulting in severe pain, the drug is implicated in two times as many painkiller-related fatalities as the drugs Vicodin and OxyContin. According to Dr. Howard Heit, a pain medication specialist, many patients that take the drug as prescribed can suffer adverse side effects, including death.

Federal regulators admit that it took them awhile to recognize physician ignorance related to the drug and the dangers that could arise when doctors prescribe methadone as a painkiller. The government cites “imperfect” systems as a cause for the oversight. As late as 2006, the Food and Drug Administration-approved package insert was still recommending a dangerously high dosage.

The number of deaths citing methadone as a contributing cause between 1999 and 2005 was 4,462, which federal officials say may be an underestimation. In 2007, the state of Florida alone reported 785 deaths caused by methadone. Between 1998 and 2006, the number of methadone prescriptions grew by 700%, says the DEA.

One main problem is that many doctors don’t fully comprehend the way methadone metabolizes and how patients can have different responses.

Causes for error include:

• Prescribing too much methadone too quickly.
• Failing to warn patients that it is dangerous to mix methadone with sedatives or alcohol.
• Failing to follow up during the first week a patient is taking the drug.

The FDA is considering mandating that doctors take classes that focus on prescribing narcotics.

Federal regulators and drug manufacturers are supposed to make sure that any medications that are recommended, manufactured, and placed out in the market are safe for use. Allowing a dangerous drug into the marketplace or failing to warn of a drug's potential side effects can be grounds for a drug litigation lawsuit if someone gets sick or dies as a result. A doctor may be subject to a medical malpractice lawsuit if he or she prescribes a drug to a patient but fails to warn of dangers or doesn't prescribe the correct dosage.

Methadone is successful as painkiller, but can be deadly, Boston.com, August 17, 2008

Painkiller more available for abuse, USA Today, July 13, 2008

Related Web Resources:

Methadone, Drugs.com

Methadone, NIH

Continue reading "Methadone as A Painkiller Can Be Fatal For Some Users" »

According to British researchers, the use of Topiramate, an anti-epilepsy drug, increases the chances of pregnant women giving birth to babies with birth defects by up to 14-fold—especially when the drug is taken along with the drug Valproate. The study involved 203 women that became pregnant while taking Topiramate (Topamax is the brand name sold by Johnson & Johnson) alone or with other epilepsy medication.

Findings from the study included:

• 18 spontaneous abortions
• 5 induced abortions
• 2 stillbirths
• 178 births
• 16 infants were born with major birth defects
• 4 infants were born with cleft lips or palates
• 4 babies had genital birth defects

However, because the study involved only 203 women, experts have said that there is still statistical uncertainty related to this new data.

Topiramate has caused similar birth defects in animals. The fact that studies of other epilepsy drugs have revealed an increase in birth defect risks indicates that all of these drugs may affect the reproductive process.

Of the approximately 2.7 million Americans with epilepsy, Topamax makes up 1 out of every 5 prescriptions. Doctors say that even though there are risks involved with taking anti-epilepsy drugs, preventing epileptic seizures that would otherwise harm unborn babies—perhaps even more severely than the side effects that use of the drug can cause—is essential.

If you or someone you love was injured because of a dangerous pharmaceutical drug, you may be entitled to personal injury or wrongful death compensation. Drug manufacturers are supposed to test their medications before making them available to users and warn of any adverse side effects.

Our South Florida drug litigation law firm can determine whether you have grounds for a claim. If a drug maker or seller knowingly concealed risks, failed to conduct the proper and full product tests, or neglect to warn doctors and consumers of potential dangers, we know how to investigate any of these factors and prove your case.

Epilepsy drug Topamax linked to birth defects, Los Angeles Times, July 22, 2008

Study links epilepsy drug to increased birth-defect risk, USA Today, July 21, 2008

Related Web Resources:

Topamax

Epilepsy and Pregnant Women, MayoClinic.com

Continue reading "Report Links Topamax to Birth Defects" »