Skirt of medical devices after the evaluation of the FDA previously approved

May 4, 2012 /24-7PressRelease / -devices of the defective implant hip and transvaginal mesh devices were placed on the market despite significant concerns about the security of previous models. And thousands of Americans have been injured as a result. Unfortunately, a gap in the Federal Act may be to blame.

By law, the Food and Drug Administration is not required to review or approve medical devices which are "substantially equivalent" previously approved models, as long the previous model was not removed from the market pursuant to an order of the Court or FDA. As previous models of the aircraft have been approved and still available, the Act allowed new devices to skirt past the FDA without evaluation.

However, some regulators require the Congress to change that. Since February, controller of medical-device head of the FDA asked the Congress to fill this gap, indicating that a medical device is five times more likely to be recalled to have security problems if it is based on a previous model that had a known design flaw.

His remarks came only a few weeks after the House Democrats introduced a bill that would allow the FDA to reject medical devices if previous models had been subjected to withdrawals of manufacturer. Bill proponents say that the change will go a long way towards the protection of the safety and health of patients.

Manufacturers of medical devices, however, see the proposal as unnecessary regulation. The Advanced Technology the Medical Association, which is for manufacturers of medical devices, said that the Bill "not help the patient safety."

In addition, most companies choose to issue a voluntary recall before that their products are submitted to the FDA or the Court.

No surprise, as the promoters of the Bills in profound disagreement. Each year, on average, FDA approves 28 medical devices whose design is based on a model already recalled. While not all prove to be dangerous or notorious as the implant hip DePuy or mesh of transvaginal Johnson & Johnson, many have still cause serious injury.

It remains to be seen what Congress will take action. Additional regulations and formalities can impair the ability to move medical devices on the market to help those in need. On the other hand, without proper assessment, defective devices could and prove detrimental to the consumers they are supposed to benefit.

Article provided by Friedman, Hirschen & Miller, LLP
Visit us at the www.friedmanhirschen.com

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US Supreme Court Limits Police Installation of GPS Devices to Track Suspects

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April 28, 2012 /24-7PressRelease/ -- In many criminal cases, including prosecutions of drug crimes or white collar crimes, the police investigations that led to criminal charges often involve surveillance of a suspect. When reviewing the state's case, criminal defense lawyers must assess whether their clients' Fourth Amendment rights were violated based on evidence obtained without a warrant. A successful pretrial challenge of the evidence based on this strategy can result in dismissal or at a least a reduction of the charges faced by the defendant.

Last November, the U.S. Supreme Court heard arguments in U.S. v. Jones, a case involving charges of possession and distribution of drugs. Evidence used by the prosecutors to establish that the defendant was involved in a criminal conspiracy included a record of his whereabouts for several weeks, obtained using an electronic tracking device that police had attached to his car.

This case could have significant implications for future use of technology to establish a suspect's activities or presence at a certain place at a specific time. From smart phones to computer activity and global positioning systems (GPS), law enforcement can potentially compile a wealth of information about a person that could not have been hoped for several decades ago. But a defendant's protection from unreasonable searches and seizures is still the law of the land.

Conviction on Drug Charges Based on GPS Data and Other Evidence

Defendant Antoine Jones was linked by District of Columbia police to a group of defendants involved in acquiring, processing, repackaging and selling large quantities of cocaine. During their investigation, law enforcement agents obtained search warrants to gain access to his cell phone text messaging records. They also obtained a separate court order to affix a GPS device to Jones's Jeep Cherokee, which tracked his movements for four weeks.

Jones moved to suppress multiple categories of evidence after he was charged in federal court, including the GPS tracking data. The trial court denied the motion with respect to virtually all of the evidence, suppressing only the GPS data obtained while the vehicle was in the garage adjoining his home. He was convicted at trial of conspiracy to distribute and possess with intent to distribute more than five kilograms of cocaine.

Jones appealed, arguing in part that his conviction was invalid because the use of the GPS device without a valid warrant had violated his Fourth Amendment right to be free from unreasonable searches. His appeal cited previous Supreme Court holdings regarding a defendant's reasonable expectation of privacy.

Federal prosecutors countered that the evidence was admissible based on a 1983 Supreme Court holding that approved use of a beeper device placed in a five-gallon container of chloroform to track a suspected drug manufacturer from Minneapolis, Minnesota, to a secluded drug lab in Wisconsin.

Drug Conviction Reversed Based on Defendant's Constitutional Rights

The U.S. Court of Appeals, District of Columbia Circuit, agreed that the use of the GPS device was a search that is subject to Fourth Amendment protections. Closely examining the circumstances of the case, including the public nature of many of Jones's movements, the appellate judges unanimously agreed that the GPS device violated his reasonable expectation of privacy.

The court distinguished the case involving tracking of the chloroform container, stressing the prolonged nature of the electronic surveillance of Jones. In the court's own words: "A reasonable person does not expect anyone to monitor and retain a record of every time he drives his car, including his origin, route, destination, and each place he stops and how long he stays there; rather, he expects each of those movements to remain disconnected and anonymous."

The appellate judges concluded that the drug conviction must be reversed because it depended on evidence of a drug conspiracy that had been collected in violation of the Fourth Amendment. Last summer, the Supreme Court agreed to hear the government's appeal of the reversal, focusing on the question of whether the government violated Jones's Fourth Amendment rights by installing the vehicle tracking device without a valid warrant and without his consent.

Supreme Court's Ruling Shies From Addressing New Technology

In the Supreme Court's final ruling, which came out in late January, the justices unanimously found that Jones' Fourth Amendment rights had been violated, but they differed on their reasoning. Many were surprised that the majority opinion, written by Justice Antonin Scalia, did not take issue with the use of GPS technology, but rather focused on the installation of the device. Jones' conviction was overturned because the installation of the GPS invaded Jones' personal property and personal privacy rights.

What was surprising to many was the reluctance of justices to address the use of GPS technology. In a separate concurring opinion, Justice Samuel A. Alito, Jr. expressed his disappointment that the majority failed to address the greater privacy concern of long-term GPS monitoring.

Although the ruling ultimately resulted in Jones' release, it is likely to have frustrated privacy advocates, who have seen an increase in the use of new technologies by law enforcement for surveillance purposes.

Recently the New York Times did an article about frequent and indiscriminate use of cell phone tracking to follow the movements of suspects. A review of police department manuals from across the country make it clear that police are aware they are treading dangerously close to Fourth Amendment violations with their activities and officers are discouraged from talking about cell phone tracking openly. Still, several courts have declined to extend the ruling in Jones to this latest form of police surveillance.

In any criminal case, from charges of DWI to computer crimes and sex crimes, police officers cannot overstep their bounds by ignoring a suspect's constitutional rights. A criminal defense lawyer must closely examine the record to challenge improperly obtained evidence that implicates a client. When pretrial challenges fail, pursuing a just outcome on appeal may be a convicted defendant's best option.

Article provided by Groshek Law
Visit us at www.christagrosheklaw.com

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