immunity

Published on: March 21, 2009

Georgia Governor Purdue’s Tort Reform Express Losing Steam?

It looks like Governor Sonny Purdue’s plans for tort reform in Georgia have hit the speed breakers sooner than he had anticipated.On March 10^th, the senate approved a substantially tamer version of a bill that would have made plaintiffs pay in the case of a losing lawsuit. The original bill had language approved by Governor Purdue, and would have made the state only the second in the country to make plaintiffs responsible for defendant’s legal fees if a lawsuit was dismissed in the early stages. That “loser pays” language has fortunately been deleted from the bill that has now been approved.

It’s not just the removal of the “loser pays” clause from his pet bill that must be giving the honorable governor heartburn.Earlier in 2009, another tort reform bill, this one too a pet project of Mr. Purdue died an early death in the Senate Economic Development Committee.This one related to the granting of civil lawsuit immunity to biotechnology companies who set up shop in Georgia.The governor announced at a meeting of the Georgia Chamber of Commerce earlier this year that biotechnology companies who wanted to invest in the state would be granted civil immunity from lawsuits in the event of an injury, if their products had been approved by the Food and Drug Administration.That bill, which had been soundly criticized by citizens’ justice advocates and Georgia personal injury attorneys as being detrimental to consumer interests, seems well and truly dead, and deservedly so.To contemplate removing citizens’ rights to justice and compensation in the event of an injury caused by a pharmaceutical drug or product simply because the drug has FDA approval, is a line of thinking that has just been quashed by the Supreme Court in its recent Wyeth vs. Levine verdict.

Purdue’s insistence that such immunity would open the doors of investment and prosperity to Georgians also rings hollow when you consider that Michigan, which is currently the only state that has such civil lawsuit immunity for pharmaceutical companies, has seen both civil justice and pharmaceutical investment fly out the window, since the bill was passed in that state.To pass a bill like the immunity bill that Purdue was touting, and that too during a recession when citizens need more protection from powerful interests than ever before, would have been a mockery of citizens’ rights.

Published on: March 17, 2009

Judges Uphold Right to Sue Drug Makers in Wyeth vs. Levine

by Robert N. Katz, Esq.

Earlier this month, justices of the Supreme Court ruled that patients injured through use of a drug can sue the drug maker even when the drug has been approved by the Food and Drug Administration. It’s a landmark judgment, and it promises to offer patients who suffer when a pharmaceutical company is negligent, the right to seek civil justice. .

The ruling upheld the $7 million awarded to musician Diane Levine who lost her arm to gangrene after being injected with Wyeth’s Phenargan medicine.Levine had been prescribed the drug for nausea, and was administered the drug through a method called "IV push."Phenargan is not meant to be administered though this method. Levine filed a product liability lawsuit alleging that the warnings against the IV push method specified on the box, weren’t strong enough. At the time, the drug’s warning label did not include specific warnings against using the IV push method. Levine was awarded damages of $6.7 million, but Wyeth argued that FDA approval should give the company immunity against product liability lawsuits.The SC decision had been eagerly waited by Georgia product liability attorneys and patients who have filed or are in the process of filing personal injury lawsuits against pharmaceutical companies for injuries caused by their drugs. The court in a 6-3 ruling has now ruled in favor of Levine, and the larger patient community.

The decision is one product liability lawyers had hoped for.In the past, the SC has shown a slant towards big business interests, and recent attempts in Georgia to grant immunity to pharmaceutical companies in case of injuries caused by drugs approved by the FDA, had many of us very worried. As expected, pharmaceutical companies aren’t too pleased with the Supreme Court decision, and we don’t blame them.After all, this means that these companies will not be able to use FDA approval for their drugs as a screen to shield them form lawsuits. For thousands of patients around the country who have been waiting for the Wyeth vs. Levine decision to proceed with their lawsuits against pharmaceutical companies, much uncertainty has been lifted with the Supreme Court ruling.

Published on: March 6, 2009

Democratic Lawmakers Introducing Legislation to Overturn Immunity for Medical Device Companies

by Robert N. Katz, Esq.

Democratic lawmakers are planning to introduce legislation that would overturn a Supreme Court decision in February 2008 barring injured patients from suing a medical device company if the device had already received Food and Drug Administration FDA approval. In effect, the legislation promises to return patients their right to sue medical device makers for injuries sustained after using their products.

In February 2008, the Supreme Court ruled that injured patients or their survivors could not sue companies that manufactured medical devices that had FDA approval. Since the ruling was passed, judges around the country have thrown out several hundreds of lawsuits that were filed by patients and their families against manufacturers of defective medical devices. Now Henry A Waxman, Democrat from California and Frank Pallone Junior Democrat from New Jersey, have plans to introduce legislation that would overturn the Supreme Court decision. The Supreme Court ruling was based on the premise that approval by the FDA took preemption or precedence over product liability laws in individual states. Judges around the country have cited the Supreme Court decision as the reason for their dismissal of several medical device product liability lawsuits.

Since the Supreme Court ruling was passed, Atlanta product liability attorneys, pharmaceutical injury experts and patients’ advocates have been vocal in their opposition to the law which essentially cuts off individual rights to justice in the event of an injury. It is important to understand how serious some of these injuries are. Defective Medtronic defibrillators have resulted in a massive shock being delivered to patients’ heart, and there have been other serious injuries including burning and scarring injuries caused by malfunctioning joints and other devices. These injured victims used devices that were approved by the FDA, but can hope for little justice as long as the Supreme Court decision rules. The FDA has time and again failed in its duty to make sure that medical devices entering the market are free of defects. It has severe critics both within and outside the organization who are concerned about botched approval procedures, and even corruption at the agency. If the new Democrat-sponsored legislation passes, patients can hope for justice again.

Published on: February 19, 2009

Georgia Introduces Pharmaceutical Immunity Bill

by Robert N. Katz, Esq.

Earlier this month, we reported on Governor Sonny Perdue’s proposed legislation granting immunity from civil liability to pharmaceutical companies and medical device makers if their products had already received FDA approval. Earlier this month, a bill was introduced outlining many of the same proposals that the governor mentioned, and underscoring the fears of patients, civil justice advocate and Georgia product liability attorneys.

The Bill, Senate Bill 101 grants immunity to these companies from any injury lawsuit brought by Georgia residents if the injury was caused by a pharmaceutical drug or medical device that had FDA approval. It’s clearly aimed at attracting Big Pharma investment into the state with civil liability immunity being the Unique Selling Proposition (USP). What it essentially does, however, is sacrifice patients’ rights to hold these companies accountable for injuries or deaths caused by their products. At the risk of sounding dramatic, we believe victims of device and pharmaceutical injury will be at the mercy of these companies.

The bill relies on a foundation that has been found to be increasingly fragile in recent years. FDA approval of drugs and devices has come under the scanner after several drugs and devices were forced off the market when injuries and risks associated with their use came to light. Do the names Vioxx, Heparin and Medtronic defibrillator leads ring a bell?

Published on: January 14, 2009

Governor Considers Tort Reform Again

by Robert N. Katz, Esq.

Governor Sonny Purdue is at it again – he has proposed legislation aimed at reducing the number of "frivolous" lawsuits," including measures that are clearly aimed at making it harder for plaintiffs to initiate civil litigation against companies.Purdue’s proposals, which he unveiled at a breakfast meeting of the Georgia Chamber of Commerce, will mean that plaintiffs have to pay the legal fees of the defendant, in case the lawsuit is dismissed at the earliest stages.Even more disturbing, the legislation will virtually grant immunity to biotechnology companies who have a "significant presence" in the state.That’s political speak for giving big name pharmaceutical companies carte blanche, without the drag of accountability to the consumer. Under the proposed laws, a citizen of Georgia cannot sue a company for a defective or dangerous medical device or drug that has received approval of the FDA.

Purdue’s proposals, not surprisingly were cheered by the 2500 members of the Chamber at the meeting.The initiatives, the Governor believes, will make the state "even more attractive" to biotechnology companies.The last time Georgia attempted to introduce tort reform in medical malpractice, the resulting storm was intense.That move resulted in senate Bill 3, which severely limits the amount of compensation thata patient who has been injured due to the fault of doctors, or hospitals to $350,000 even in the event of death of the patient due to negligence.Many of the provisions of the Georgia Tort Reform Act of 2005 have been removed as violations of a citizen’s constitutional rights.That doesn’t seem to have deterred Purdue, who this time around, intends to protect the pharmaceutical industry. Needless to say, the Georgia Trial Lawyers Association has already voiced strong opposition to any such new legislation.

As we’ve seen last week in Minnesota, where a judge has thrown out dozens of lawsuits relating to the Medtronic defibrillator leads, device or drug approval from the FDA cannot and shouldn’t be allowed to come in the way of a person’s right to sue if these approved devices result in injuries.The Sprint Fidelis leads were approved by the FDA, and yet, have caused several deaths and heart injuries, because of fractures or broken wires that caused the defibrillator to malfunction.Now, dozens of injured patients or families of those who died have had their lawsuits dismissed, and their hopes for justice becoming bleaker because of the pre emption doctrine.

Published on: March 4, 2008

Medical Malpractice Rights Denied by Tort Reform

by Robert N. Katz, Esq.

The Tort Reform Act of 2005 may be going up on appeal. In 2005 Georgia legislators saw fit to pass a Tort Reform Act that, among other things, gave emergency room doctors virtual immunity from negligence suits.

That bill provided that the ER staff cannot be held liable for damages unless it is shown by clear and convincing evidence that the doctor or health care provider’s actions showed “gross negligence.”Gross negligence is defined as the absence of that degree of care that every man of common sense, however inattentive he may be, exercises under the same or similar circumstances.Another common definition of “gross negligence” is “reckless disregard for the safety of the patient.”

In addition to this standard of care change, pain and suffering damages in a medical malpractice case were capped at $350,000.Thus, if you are injured as a result of medical malpractice, your right to recover has been greatly diminished.

Published on: December 3, 2007

Wrongful Death Lawsuit Gets Family Crosswise

by Robert N. Katz, Esq.

December 3, 2007

Last week the Atlanta Journal Constitution’s front-page article examined the complex legal issues that arise when two family members are involved in a single car collision.Sisters Yvonne Woods and Janice Carroll were traveling cross-country in Janice’s SUV.While driving her sister’s vehicle, Yvonne fell asleep.The SUV left the road and crashed.Yvonne was killed in the accident and Janice was injured.

The AJC article focused on the outrage from Yvonne’s family when Yvonne’ eldest daughter (probably the executor of the estate) was served with a personal injury lawsuit filed by Aunt Janice.Apparently, the family had no idea that Aunt Janice was suing the estate for her injuries.Further, the family was shocked that Aunt Janice would sue when her sister had been doing her a favor (helping her drive cross-country) when she was killed.

Published on: November 20, 2007

Stand Your Ground Laws Allowed In Georgia

by Robert N. Katz, Esq.

November 20, 2007

ABC News recently reported on an incident in Pasadena, Texas last week and captured on a 911 tape where zealous gun owner, Joe Horn, noticed his neighbor’s home was being burglarized.Relying on the Texas “Stand Your Ground” law, the neighbor ran next door, shot and killed the two burglars despite pleas for patience from the 911 operator.

In 2006, the Georgia legislature with Senate Bill 396 enacted a “Stand Your Ground” law similar to the one in Texas. O.C.G.A. sections 16-3-2 and 51-11-1 provide that a person has the right to meet force with force, including deadly force, in defense of one’s self, one’s home or other property.These laws provide immunity from both prosecution and civil tort actions.Sixteen other states have enacted similar legislation, expanding the legal boundaries of self-defense that previously required a duty to retreat.