Personal Injury & Wrongful Death

In 2006, a disabled and brain damaged man, near death, was taken into an operating room at a California hospital in order to harvest his organs for donation. Law enforcement officials contend that what occurred in the operating room was a criminal act. The surgeon, Dr. Hootan Roozrokh has been criminally charged with prescribing excessive and improper doses of drugs, apparently in an attempt to hasten Mr. Navarro’s death to retrieve his organs sooner. The doctor is facing three felony counts relating to his actions

Central to the case is whether Dr. Roozrokh was pursuing organs at any cost or had become entangled in a web of misunderstanding about a lesser-used harvesting technique known as donation after cardiac death. Dr. Roozrokh has pleaded not guilty.

Transplanting organs from patients whose hearts have stopped, or cardiac-death donations, began to go out of vogue in the late 1960s and early ’70s after medical advances like life support and subsequent changes in the legal definition of death made donations from those declared brain dead more efficient. But health officials have encouraged cardiac-death donations in recent years.

Last Wednesday the Supreme Court of the United States made it harder for injury and wrongful death victims to sue manufacturers of federally approved medical devices. This decision will also impact cases involving dangerous drugs. The issue before the Supreme Court was whether the Estate of Charles Riegel could sue a company under state law over a medical device which had previously been cleared for sale by federal regulators. Under federal law, a company must prove the safety and effectiveness of a medical device before the United States Food and Drug Administration will approve it for the marketplace. In an 8 to 1 decision, the Court ruled against the Estate of the injured patient who suffered serious injuries when a catheter burst during a medical procedure. As a result of this Supreme Court decision, state lawsuits are barred to the extent that they might impose requirements that are different from federal requirements. In other words Federal law will prempt state law where the two are in conflict or different. Not surprisingly, the Bush Administration sided with the medical device industry, saying unfavorable state jury verdicts would force companies to alter product designs or product labels that had already gotten FDA approval. This case is bad news for people injured by defective medical devices. The fallout from last week’s Supreme Court decision in this case will no doubt be felt throughout the country. Attorneys with cases pending against device makers such as Medtronic, Stryker and Johnson & Johnson expect these companies to file Motions to Dismiss the lawsuits which are currently pending. Lawyers also are concerned that this ruling may prompt judges to dismiss product-injury lawsuits before injured plaintiffs can gain access to data that might prove that the companies used false or misleading data to get government approval to market the devices.

Atlanta TV stations are reporting that this afternoon, a car veered into a bus stop during a police chase and struck four pedestrians. The incident was near Metropolitan Parkway and University Drive.
According to reports, the Atlanta Police were chasing three juveniles in a stolen vehicle when the car ran into the bus stop. One juvenile was apprehended at the scene while two others escaped.
Four of the people involved were injured, one critically. This is another instance of innocent civilians harmed and/or killed by police chases for non-violent offenses. The victims could have easily been your family members.

In January of this year, the FDA issued a proposed rule which directly contradicts Congress’ expressed intent when it passed the Food and Drug Administration Amendment’s Act of 2007 (FDAAA). Unlike the FDA’s proposed rule, Congress intended the duty to warn customers of a drug’s hazards rests with the drug company, who is in the best position to warn about problems associated with the drug. However, under the FDA rule, drug companies will enjoy more relaxed labeling requirements and will use the rule to claim immunity for failing to warn patients of potential drug hazards. The FDAAA requires a drug company to update its label to include drug hazard warnings as soon as there is reasonable evidence of that risk. This law allows consumers to be aware of a drug’s potential risks at the earliest possible moment and prevents injuries and deaths such as those associated with Avandia and Vioxx. However, under the new FDA rule, drug companies will only have to revise their warning label where they establish “sufficient evidence of a causal association” which could take years. This is a significantly higher standard that drug companies would have to meet before informing consumers of a potential hazard. It is imperative that Congress hold oversight hearings to curb this agency’s abuse of power because the FDA has ignored expressed Congressional intent and this proposed rule will not serve to make drugs safer. Instead the proposed rule will make it more difficult for consumers injured by prescription drugs to hold negligent drug companies accountable.

Two studies have concluded that heart surgery patients are more likely to die if given the anti-bleeding drug Trasylol. The drug has been widely used for the last 14 years to treat hundreds of thousands of heart bypass patients each year. Drug manufacturer Bayer AG ceased sales of the last fall, after a Canadian study was halted because of deaths among patients taking Trasylol.

The new studies are being published this week in the New England Journal of Medicine. Bayer funded one of the two new studies, and had the preliminary results before a September 2006 federal hearing on the drug’s safety. It did not present the results at the hearing.

The company issued a statement this week saying both the new studies are flawed.

This Wednesday the Supreme Court issued a major anti-consumer opinion, making it harder for consumers to sue manufacturers of federally approved medical devices.

In an 8-1 decision, the court ruled against the estate of a patient who suffered serious injuries when a catheter burst during a medical procedure. The case has significant implications for the $75 billion-a-year health care technology industry, whose products range from heart valves to toothbrushes.

At issue before the Supreme Court was whether the estate of Charles Riegel could sue a company under state law over a device previously cleared for sale by federal regulators. Under federal law, a company must substantiate the safety and effectiveness of a medical device before the U.S. Food and Drug Administration will approve it for the marketplace.

Our police chase injury lawyers have handled many cases involving the deaths of innocent civilians due to police chasing suspects for minor crimes. We have previously written about police departments that have adopted restrictive policies limiting chases and decreasing the chances that innocent civilians and police officers can be seriously injured or killed.

On May 30, 2007, in Forestville, Maryland, a police officer was chasing a motorcyclist for speeding. During the chase, the police officer tried to position his car to stop the speeding motorcyclist, but instead hit a civilian car that rolled down an embankment into oncoming traffic. This caused a seven car pile up injuring 15 and killing two innocent civilians. Among the injured were two police officers. The police car camera revealed that the officer was driving at times more than 120 m.p.h. as he drove onto the shoulder and back onto the highway.

Today, the police officer, Scott Campbell, was indicted by a Grand Jury on two counts of vehicular manslaughter for the May 30th crash. The indictment charges that Campbell, started the chase in violation of department policy. The police department policy permits officers to engage in high speed pursuits only if there is probable cause that the suspect used or threatened physical force or is involved in a hit and run accident resulting in serious injury or death.

Last year, the Food and Drug Administration (FDA) issued a proposed rule which directly contradicts Congress’ expressed intent when it passed the Food and Drug Administration Amendments Act of 2007 (FDAAA), an Act which encompasses the Prescription Drug and User Fee Act. As a result, drug companies will enjoy more relaxed labeling requirements and will surely use the rule to claim immunity for failing to warn patients of potential drug hazards. When Congress passed the FDAAA it included language confirming the responsibility of the drug manufacturer to promptly update its drug label when they become aware of new safety information. Congress was clear that it intended to keep the burden squarely on the drug companies to update warning labels. Nonetheless, the FDA had promulgated this new rule against Congress’ expressed wishes. Congress explicitedly stated that it did not intend to ease the requirements on drug companies to inform consumers of potential drug hazards. It reiterated the need for drug companies to change its label if the drug company learns of reasonable evidence of that risk. In fact, the drug companies fought and lobbied hard to include language to loosen warning label obligations that the Congress specifically left out of the final Bill. But since the drug companies could not get Congress to agree to lessen their responsibilities towards consumers, they turned to the Bush Administration. Unfortunately, the FDA’s tactics are not new to Bush Administration bureaucrats. Unelected federal agencies have been ignoring congressional directives in a number of other cases. The Environmental Protection Agency (EPA), National Highway Traffic Safety Administration (NHTSA), Consumer Product Safety Commission (CPSC), and others are also engaging in this tactic of bureaucratic activism.

We have previously written about controversial drug advertising that takes place in the United States. Once again, this practice has come to the forefront through Dr. Robert Jarvik, who is best known as the developer of an artificial heart. About two years ago, Dr. Jarvik began appearing in television ads for the drug Lipitor, manufactured by Pfizer.

In the ads, Dr. Jarvik is depicted in various athletic pursuits, such as rowing and running, and tells viewers that Lipitor significantly lowers cholesterol when diet and exercise are not sufficient.

Now, a Congressional Committee has become concerned and is taking preliminary steps to investigate drug advertising, particularly the Lipitor ads. Some critics point out that even though Dr. Jarvik is an M.D., he is not a cardiologist and is not licensed to practice medicine. In fact, people who know Dr. Jarvik have reported that he does not even row. Apparently, a stunt double was hired to portray him in rowing scenes shown in the advertisements.

The U.S. consumer advocacy group, Public Citizen, has called upon authorities to require that Botox and a similar injections come with strong warnings following reports of 16 deaths and other serious problems after the botulinum toxin spread inside the body. Public Citizen asked U.S. authorities to require the strongest possible warning, highlighted in a “black box,” on Allergan Inc’s Botox and Solstice Neuroscience Inc’s Myobloc.

Botox is used widely to decrease facial wrinkles but also has approved medical uses such as treating cervical dystonia, or rigid neck muscles. Myobloc is cleared only for the neck condition. Both are made with forms of the botulinum toxin, which can paralyze muscles.

Public Citizen reviewed 180 reports submitted to the Food and Drug Administration by manufacturers involving patients injected with Botox or Myobloc. The reports detailed cases of muscle weakness, difficulty swallowing or aspiration pneumonia, a serious condition caused by breathing a foreign material into the lungs.