Drug Products

FDA Offers Metal-on-Metal Hip Replacement Patients More Information

In responding to the growing number of complaints concerning metal-on-metal hip replacements, the FDA has responded in a two-fold manner. A few months ago, the governmental agency ordered all metal-on-metal hip replacement manufacturers to provide them with failure data and required them to contact patients who’ve received such hip replacements. Now, the FDA has published new information on its website concerning symptoms and signs of metallosis, a condition where metal fragments from the hip device enter the bloodstream. These metal fragments are loosened and fragment due to the wear and tear of the metal-on-metal friction caused by joint motion.
The new information should prove very helpful for patients who have a metal-on-metal hip replacement but don’t know if they are susceptible to metallosis or hip failure. In publishing the new information and making it accessible to the general public, the FDA has provided a real benefit to those who are concerned about their hip replacement. Here’s what they say in a nutshell:
Among the warning signs of such systemic reactions, according to the FDA:
• Chest pain
• Shortness of breath
• Neuropathies
• Visual or hearing disturbance
• Fatigue
• Weight gain
• Abnormal feelings of cold
• Urinary trouble
Patients with suspected adverse reactions should receive blood tests — to check for cobalt or chromium ions.
If you have a metal-on-metal hip replacement or aren’t sure what type of hip you have and are experiencing any of the symptoms or conditions mentioned above, check with your doctor and refer him to the FDA website.

$55 Million Chinese Drywall Settlement Reached with One Manufacturer

If US District Judge Eldon Fallon of New Orleans approves, Florida homeowners who’ve been plagued with the contaminated Chinese drywall will by paid $55 million by Banner Supply Company. The proposed settlement won’t be final until the Judge approves it and will only settle claims against Banner Supply, not the other Chinese Drywall manufacturers.
According to the Associated Press, “As many as 36,000 homes in Florida may have the Chinese-made drywall. Nationwide, the number may be as high as 60,000 to 100,000. The Environmental Protection Agency released a report in May 2009 confirming health risks in the drywall.”
It’s not clear how many citizens would be eligible to share in the settlement funds. Chinese drywall litigation will continue against the other manufacturers but this is perhaps a hopeful sign.

US Catholic Bishops Head to Seattle to Discuss Sex Abuse

The US Catholic bishops will gather in Seattle this Wednesday for their three day summer gathering. The summer conference is usually shorter than the one held in November with a correspondingly lighter agenda. However, what makes this year’s summer gathering noteworthy is one particular item on the episcopal agenda. In the wake of the Philadelphia Grand Jury report and the Diocese of Kansas City-St. Joseph mishandling of a current abusive priest, the bishops will discuss how to rejuvenate the Dallas Charter originally passed and implemented in 2002. Because of this agenda item, media will likely converge on the meeting and hopefully ask the prelates some tough questions.
In my opinion, not much will come from the meeting. Those who are doing the talking are the same ones largely responsible for the priest abuse scandal in the first place. In nearly a decade of priest abuse cases surfacing all over the country, the bishops themselves have shown little resolve to fix the problem. They are essentially the problem.
In secular society, a community that is confronted with a high crime rate doesn’t look toward the criminals to fix the problem. An outside group must come in and re-establish order and the rule of law. Truthfully, that’s what needs to happen in the Catholic Church. But, don’t hold your breath.

Diocese of Venice Priest Arrested for Lewd Conduct

A Diocese of Venice Catholic priest was arrested yesterday for exposure of sexual organs and battery. Rev. Bernard Chojnacki, stationed at St. Charles Borromeo Catholic Church in Port Charlotte was arrested in Caspersen Beach in Englewood.
Chojnacki, a native of Poland who studied for the priesthood at Orchard Park in Michigan, has been ordained since 2009. The priest will appear in court in July on the sex and battery charges.
This has been a difficult year for priests in the Diocese of Venice. In February, Carmelite priest William Wert, who had been living at a Carmelite retirement center in Venice, FL was arrested and charged with several counts of sex abuse of minors.

Topamax Cleft Palate Cases May Lead to Other Medical Issues

Pregnant women who were prescribed Topamax or one of its generic equivalents may find that their newborn children experience more than cleft palates. These children may be susceptible to dental problems requiring braces and/or surgery as well as nasal/sinus issues. Additionally, there may be an increased risk of hearing loss in children who’ve been harmed by the drug.
Children born with a cleft palate normally require surgery to correct the problem within 12 to 18 months of birth. However, the secondary issues may require surgical intervention even earlier. However, it may be difficult for doctors to spot these secondary issues because they’re often hard to detect.
I spoke with one woman whose child was experiencing difficulty developmentally because the child was malnourished. The issue was caused by the baby’s inability to suck properly. It took some time for doctors to detect the problem causing the malnourishment and this may lead to further developmental delays.
According to the North American Antiepileptic Drug Pregnancy Registry women who’ve taken Topamax during pregnancy are at an increased risk of giving birth to children with an oral cleft. Prompt medical attention is required.

Topamax Birth Injury Lawsuit

It’s a sad situation when an adult is injured by a defective product or a bad drug, it’s tragic when an infant is hurt. That’s the case with Topamax, a drug touted to treat migraines and epilepsy. Unfortunately, besides treating these conditions pregnant women have exposed their unborn children to a devastating birth defect-cleft palate.
As a birth injury lawyer, I believe the manufacturer of Topamax along with its generic equivalents, knew about these devastating side effects. Topamax is manufactured by Ortho-McNeil Neurologics. Since the drug has been on the market so long, there are generic equivalents of Topamax (topiramate) made by pharmaceutical companies such as Apotex Corporation, Aurobindo Pharma, Mylan Pharmaceuticals, Ranbaxy Pharmaceuticals, Inc., Roxane Laboratories, Inc., and Teva Pharmaceutical Industries, Ltd.
Soon after its introduction to the marketplace in 1998, the FDA became concerned that Topamax was being marketed for uses not specifically approved by the federal regulatory agency. This concern led to a criminal probe and Johnson and Johnson paid $81 million in fines and pled guilty to misdemeanor criminal conduct for “misbranding” Topamax.
Criminal behavior that hurts adults, that’s one thing but when criminal behavior injures innocent babies, that’s quite another, that’s unforgivable.

Are Diocesan Review Boards Effective?

Sounds like a loaded question, right? Actually, the answer depends upon the diocese or archdiocese, more specifically, the bishop or the archbishop in charge. After the Dallas Charter was adopted some nine years ago to deal with the priest abuse crisis in this country, each bishop was asked to form an independent review board within their own diocese to ensure priest sex abuse allegations were investigated and handled properly as well as avoid future occurrences. Most of the US bishops have complied and have active review boards. I can think of two who have refused to comply with the audits mandated by the Dallas Charter-Fabian Bruskewitz and Robert Vasa, the newly appointed bishop of Santa Rosa CA.
Yet, there are problems within the archdioceses and dioceses that have review boards. Some prime examples are the Archdiocese of Philadelphia, the Diocese of Kansas City-St. Joseph, and the Diocese of Gallup. There are others, but these three serve as prime examples of the inherent problems faced by these review boards. They are only as effective as the bishop allows them to be. In the three instances I’ve cited the bishop in charge didn’t bother communicating everything to the board, rendering their opinions and ability to make decisions ineffective.
In the end, the problem lies with the bishops since they are selective in what information they are allowing their own boards to see. This may be an insurmountable problem for the US Conference of Catholic Bishops when they gather to discuss this in June in Seattle. Each bishop acts as a sovereign in his own diocese. No other bishop can tell him what to do with his review board. Now, the Pope can intervene but no one truly believes he has such inclinations. Perhaps some bishops think it’s easier to ask for forgiveness once they’re caught rather than comply with the Dallas Charter. At least, that’s what the bishops in Philadelphia and Kansas City-St. Joseph have done.

Fosamax Lawsuits Consolidatedin MDL

Fosamax lawsuits have been consolidated into a multidistrict litigation for purposes of streamlining discovery and judicial proceedings in the US District Court for the District of New Jersey. Fosamax, Merck’s osteoporosis drug is already facing numerous lawsuits in an MDL in New York for jaw necrosis. However, the new consolidated Fosamax lawsuits are concentrating on femur fractures in those who’ve taken Fosamax for osteoporosis.
Last year, the FDA asked all bisphosphonate drug makers to include an additional warning about atypical femur fractures associated with these drugs, including Fosamax.
The new MDL in New Jersey was requested because the drug’s manufacturer has its headquarters in the Garden State.

DePuy Pinnacle Hip Lawsuits Consolidated

DePuy Pinnacle hip replacement lawsuits will be consolidated in a multidistrict litigation in a Texas federal court. The MDL allows all claims to share discovery and streamline the discovery process as the lawsuits proceed through federal court.
Presently, there are about 57 DePuy Pinnacle hip lawsuits to be consolidated. Like the DePuy ASR XL lawsuits which are consolidated in federal court in northern Ohio, the Pinnacle hip replacements are failing at a higher than acceptable rate. As a metal-on-metal hip replacement similar to the DePuy ASR XL, the Pinnacle replacement hips may shed metal particles that flow into the bloodstream causing a potentially dangerous situation known as metallosis.
Recently, the FDA called on hip medical device manufacturers to submit data to the FDA as well as contact all hip implant patients in order to obtain information about failure rates, symptoms and problems with the hips, as well as information about which hips are failing and the causes relating to the failures.

Bishop Finn and Child Safety

It all began last December when Fr. Shawn Ratigan had a technician work on his laptop. The technician found image of child pornography on the laptop and promptly turned the computer over to officials at the Diocese of Kansas City-St. Joseph where Ratigan was incardinated. Ratigan’s bishop, Robert Finn acknowledged that he knew back in December about the images but he was told they weren’t pornographic. (This in spite of the fact that media reports note the image include “up skirt” photos of young girls under the age of 12 and one nude photo of a young girl’s genitalia).
Diocesan officials copied the images and returned the laptop to Ratigan’s family. Ratigan attempted suicide after he found out the Diocese knew about the images. At this time, it’s not clear who contacted a police officer. The officer was not shown the images but they were described to him. During this entire time, the Diocesan Review Board was never told about Ratigan or the images found on his laptop. Review Board members found out when Ratigan was arrested and charged with possessing child pornography.
Bishop Finn, who has promised transparency in all abuse matters, failed to tell his own Review Board about the pornography and appears to have been less than forthcoming with law enforcement about Ratigan. His inaction could have endangered more children since Ratigan continued to be around children until his arrest last week. Finn defended his actions by stating that he spoke with Ratigan and ordered him to stay away from children. That’s not good enough. Children could have been harmed and some may have been harmed by Shawn Ratigan because of Finn’s desire to keep it quiet.