Medical Malpractice

Darvon and Darvocet Recall Has Serious Health, Legal Implications

Published on: January 19, 2011 | By Berniard Law Firm

Two of the most highly prescribed painkillers, Darvon and Darvocet, have recently been pulled off the market as a result of the health risk they pose to individuals. Dangerous heart side effects plagued the painkiller for years; however, it was not until November of 2010 that the FDA recommended the painkillers be withdrawn from the market completely. The estimated amount of individuals who have been prescribed such medications is in the millions, especially since Darvocet has been prescribed for over sixty years. The actual amount of people who have been prescribed or have taken either or both of these painkillers may lead to an astounding number, which no one can quite quantify as of yet. While it is sad that a prescription that is supposed to ease the pain of individuals may lead to a person suffering fatal consequences, the legal ramifications of the drug causing these problems is important to understand.

Both types of painkillers have been criticized heavily for over thirty years, without any change or modification until now by the FDA. The common dangers element that exists in both Darvocet and Darvon is the fact they both contain propoxyphene. In fact, the Public Citizen group petitioned the FDA to ban the drug in 1978 and again in 2006. Within that time period, millions of individuals every year were being newly prescribed the painkillers or were continuing to take them, relying on their physicians assurance that the drug was safe and would help ease their pain and discomfort. Yet, in July 2009, an FDA expert advisory committee voted 14-12 to ban the drug as a result of its dangerous side effect.

The FDA overruled the panel, instead conducting more research on the prescriptions dangerous effects. The director of the FDA’s office of new drugs at the Center for Drug Evaluation and Research, John Jenkins, MD, stated, “The drug puts patients at risk of abnormal or even fatal heart rhythm abnormalities.” Further, Jenkins admitted that it is hard to determine exactly how many individuals have passed away due to taking these painkillers, yet, the FDA study shows that more deaths are linked to the drug than to either of two alterative opioid painkillers, tramadol and hydrocodone.

DePuy Had Time to Recall Device, Chose to Not Notify Public

Published on: January 13, 2011 | By Berniard Law Firm

This blog has noted several times that DePuy knew of the likely failure rates of its ASR hip implants several years before the medical device manufacturer issued its 2010 recall of the product. In light of this knowledge, DePuy nevertheless waited years before it decided to remedy the dangerous situation caused by its defective hip implants. Instead, it chose to shift the blame for reported problems elsewhere before finally initiating the recall.

New evidence has been uncovered showing that DePuy had received credible notification of its ASR hip implant failure rates as far back as 2007. According to The Independent, the Australian joint registry, the second largest registry of its kind in the world, informed DePuy of identified problems in seven separate reports. One of the most striking findings made by the registry was the higher than usual amount of revision surgeries needed to replace previously-implanted ASR hip units. DePuy sat on this knowledge until 2009, when the company finally withdrew the ASR hip implants from the Australian marketplace, citing “commercial reasons.” DePuy initially blamed the Australian joint registry findings on “imprecise surgical techniques” by doctors, but was forced to retreat from that position in response to the multiple reports of problems sent the company’s way.

Director of the Australian joint registry, Stephen Graves, has since stated DePuy behaved “irresponsibly and very badly.” Graves warns, “This is why regulators should not rely so heavily on manufacturer data. It is a complete untruth that DePuy did not have reason to withdraw the ASR before now; we have been telling them since 2007, but they allowed it to be used on thousands of people.”

Artificial Hip Recall Shows Dangers of a Broken Medical Implant System

Published on: January 11, 2011 | By Berniard Law Firm

The A.S.R., or Aritcular Surface Replacement, artificial hip was promoted by Johnson and Johnson as a breakthrough in design that would last 15 years or more and provide patients with more natural movement. Now, the device has been recalled due to patients developing inexplicable pain and surgeons discovering mysterious masses of dead tissue in patients who are having the device replaced. DePuy Orthopedics, the Johnson and Johnson unit responsible for the hip and the largest maker of replacement hips worldwide, maintained that the hip was working for a long time despite warnings that it was a failure.

As pointed out in a recent New York Times article, the trouble with the hip is an indicator of a bigger problem: a piecemeal, broken medical implant system. Critical implants are sold without going through medical trials and testing or gaining FDA approval if the device resembles an implant that has already been approved. Theoretically, this allows manufacturers to make small changes to devices without having to jump through approval hoops; however, according to experts, it has also created a loophole that allows manufacturers to bundle an unapproved component into an existing design and sell it with minimal testing.

This is what happened with the A.S.R. as DePuy announced late last year that it was phasing the device out. However, the company blamed lagging sales rather than safety issues. In a recent statement an official stated that, “We believe we made the appropriate decision to recall at the appropriate time given the available information.”

Louisiana Residents With Personal Injury Questions

Published on: April 18, 2010 | By Berniard Law Firm

For those Louisiana residents, whether you live in Lake Charles, Shreveport, Baton Rouge, New Orleans, Kentwood or any other of the great cities across this state, looking for more information on their possible personal injury claim, check out our blog dedicated to these legal matters:

Louisiana Personal Injury Blog

This blog discusses the legal issues relating to Admiralty/Maritime law, Animal/Dog Bites, Car Accidents, Chemical/Industrial Spills, the intricacies of Expert Testimony, Insurance Disputes, employee rights under the Jones Act, Legal Duty, Civil Lawsuits, Criminal prosecution, Medical Malpractice, Mesothelioma/Asbestos, Motorcycle Injury, Negligence, Offshore Accidents, Product Defects, Chinese Drywall, Strict Liability, Workers’ Compensation and Wrongful Death. All of these issues are crucial to citizens rights and residents of Louisiana.

Louisiana law regarding embryo care

Published on: October 3, 2009 | By Berniard Law Firm

When handling frozen embryos, as previously discussed, there is a specific duty of care owed by the hospital to the parents to maintain the embryos properly and sufficiently so as to preserve them from harm and maintain them for usage by the donor couple. In Louisiana, lawyers have been filing lawsuits regarding a mixup at Ochsner Hospital Elmwood in which a mislabeling matter led to what may end up being a complete disposal of a number of embryos because of a lack of screening that also occurred.

ABC recently profiled a series of mishaps, including that in Louisiana, occurring in the world of in vitro fertilization. With loose regulations, there is a huge possibility of error, as is the case here.

Louisiana law clearly stipulate facets involved in the adoption or change of possession regarding frozen embryos. It does this to try to protect families from the improper transfer of an embryo to another individual, among other reasons. The law states

Name mixup possible reason for wrong embryo implantation

Published on: October 1, 2009 | By Berniard Law Firm

The news has widely covered the story of how one woman, Carolyn Savage, of Toledo, Ohio, found out during her pregnancy that the embryo she had been impregnated with was, in fact, from another couple. Mrs. Savage gave birth to that child and, in an act of extreme charity and kindness, turned it over to its biological parents, Shannon and Paul Morell. The story, found here, has received so much attention because of the extreme amount of compassion it would take for a couple like the Savages, who are themselves looking to have their own child, to give birth to a child that is not theirs, let alone readily hand that child over upon birth. It also shows the possibility for mistakes that recently occurred in New Orleans most recently.

In the case of the Morells and Savages, a name-error may have caused the mislabeling, or incorrect usage, of the embryo that was used to impregnate Mrs. Savage. The American Chronicle reports

In an interview with The Blade yesterday afternoon, Carolyn’s husband, Sean Savage, said it’s possible the error occurred because the mothers share a name, and when it was mentioned that it seems to be a very odd coincidence, he commented “which makes it probably not a coincidence.”

Lab tech responsible for embryo mixup may not have been certified

Published on: October 1, 2009 | By Berniard Law Firm

A recent twist to Ochsner Elmwood’s recent embryonic disaster regarding the mislabeling and invalidation of an unknown number of frozen embryos complicates the matter even further. It is now alleged that the individual responsible for the mixup may not have even been an employee of the hospital and, further, even certified to be working in the professional capacity he was working in.

While contracting out medical specialists is not new for hospitals, this new kink adds fuel to the fire of the argument some have regarding the lack of concrete regulation in regards to fertilization and embryonic storage.

The Times-Picayune reports

Louisiana embryo law clear on patient rights

Published on: September 30, 2009 | By Berniard Law Firm

In order to help readers understand more about the embryo debacle and ensuing lawsuits that recently occurred at Ochsner Hospital Elmwood, outside New Orleans, an explanation of relevant Louisiana statutory law is a helpful tool. The Louisiana law provides a specific comprehension for lawyers and citizens to understand regarding embryos frozen at facilities and does not fail to mention the proprietary rights that go with the storage. While a couple may freeze embryos and store them with a hospital, they do not give up any of their rights over those embryos and they are handled as if they were never removed from the woman.

Louisiana law states

La. Rev. Stat. Ann. § 9:126 An in vitro fertilized human ovum is a biological human being which is not the property of the physician which acts as an agent of fertilization, or the facility which employs him or the donors of the sperm and ovum. If the in vitro fertilization patients express their identity, then their rights as parents as provided under the Louisiana Civil Code will be preserved. If the in vitro fertilization patients fail to express their identity, then the physician shall be deemed to be temporary guardian of the in vitro fertilized human ovum until adoptive implantation can occur. A court in the parish where the in vitro fertilized ovum is located may appoint a curator, upon motion of the in vitro fertilization patients, their heirs, or physicians who caused in vitro fertilization to be performed, to protect the in vitro fertilized human ovum’s rights.

Ochsner embryo mixup develops as government investigates

Published on: September 28, 2009 | By Berniard Law Firm

While the embryo mixup that occurred in the Louisiana hospital outside New Orleans was bad news for families who had stored there, recent news makes the situation worse. The unfortunate reality, it appears, for those couples whose embryos were kept at Ochsner Hospital Elmwood is that, even if they could be identified after being mislabeled, a failure to screen them for sexually transmitted diseases when freezing took place makes them inviable to implant. The suit filed a couple earlier this month is the second filed against the hospital after another couple found that the embryos they had frozen at Ochsner Hospital Elmwood went missing. That the mislabeled embryos are not even viable even if identified is a harsh addendum to an already tragic and sad event.

The hospital has shut down its in vitro program indefinitely so as to attend to the problems that obviously exist before continuing. Ochsner CEO Pat Quinlan has stated the problem and shutdown arrives from a “significant labeling issue, which makes us unable to account for all the frozen embryos in our IVF center.”

What this means to New Orleans residents is simple: any couple or woman who has had embryos frozen at Ochsner Hospital Elmwood needs to contact the hospital immediately to find out the status of their frozen embryos. The hospital has stated any patients concerned with the status of their embryos should call concerns can contact Ochsner by calling 866.631.9783 or send e-mails or questions to questions@ochsner.org. As both of these appear to be public manners of contact, an important next step for patients would be to attain legal counsel.

Ochsner shuts down in vitro after mislabeling of embryos

Published on: September 26, 2009 | By Berniard Law Firm

It is hard to think of something that could be more traumatic or concerning for families looking to in vitro for pregnancy options beyond what seems to now be the reality many are facing today. In New Orleans, Louisiana, Ochsner hospital has shut down their in vitro fertility program after realizing that their Elmwood facility is currently facing a huge mismanagement issue of embryos. As embryos are an integral part of in vitro pregnancy for families looking to have children, the fear for some is that this mismanagement has led to terrifying questions that remain to be sufficiently answered.

The Times-Picayune reports that the facility has shut down its program indefinitely in light of a recent discovery that its embryos have been mislabeled.

In her feature, Michelle Hunter reports