Reno Personal Injury Lawyer - FDA & Prescription Drugs

FDA Announces Safe Use Initiative

Steve Klearman — Wed, 18 Nov 2009 10:00:00 GMT

On November 4, 2009, the FDA introduced its "Safe Use Initiative," an effort to collaborate with the health care field to reduce the preventable harm resulting from medication use and misuse.

The Initiative is in response to the millions of consumers who are harmed each year because of the misuse of medications. The inappropriate use of medications can be a result of several factors, including (1) incomplete access to information, (2) unintentional misuse of medications, medication abuse, and attempts by people to harm themselves with medications, or (3) taking prescription drugs prescribed for other people.

Taking prescription drugs prescribed for other people is a serious abuse, as even one single dose of certain medications, such as opioid drugs, can cause severe harm or death to the person not prescribed the medication.

Through the Initiative, the FDA will work alongside health care professionals to identify drugs that are linked to preventable harm. The FDA intends to collaborate with health care professionals to (1) evaluate consumer medication information, (2) communicate about the risk of inadvertent overexposure to acetaminophen, (3) apply safeguards against surgery fires caused by alcohol-based surgical preparations, and (4) avoid contamination of multiple-use medication vials.

Originally posted at InjuryBoard by Steve Klearman

Exposing Myths About Medical Malpractice

Steve Klearman — Tue, 17 Nov 2009 11:15:58 GMT

The American Association for Justice, in its efforts to promote health care reform, has attacked health care reform opponents' arguments that reform will be a heavy financial burden on the health care system.

“All the facts and evidence show that tort law changes will do practically nothing to lower costs or cover the uninsured,” said AAJ President Anthony Tarricone. “It’s no wonder the tort reformers, insurance lobby, and other corporate front groups have to gin up lies and phony stats, since no legitimate data or research supports their claims. Our focus should be on reducing the 98,000 deaths by medical error that occurs every year, not limiting patients’ legal rights.”

The American Association for Justice takes a look at the misconceptions behind the most common positions of health care reform opponents in its Five Myths About Medical Negligence:

Myth #1: There are too many “frivolous” malpractice lawsuits.

Fact: There’s an epidemic of medical negligence, not lawsuits. Only one in eight people injured by medical negligence ever file suit. Civil filings have declined eight percent over the last decade, and are less than one percent of the whole civil docket. A 2006 Harvard study found that 97 percent of claims were meritorious, stating, “portraits of a malpractice system that is stricken with frivolous litigation are overblown.”

Myth #2: Malpractice claims drive up health care costs.

Fact: According to the National Association of Insurance Commissioners, the total spent defending claims and compensating victims of medical negligence was just 0.3% of health care costs, and the Congressional Budget Office and Government Accountability Office have made similar findings.

Myth #3: Doctors are fleeing.

Fact: Then where are they going? According to the American Medical Association’s own data, the number of practicing physicians in the United States has been growing steadily for decades. Not only are there more doctors, but the number of doctors is increasing faster than population growth. Despite the cries of physicians fleeing multiple states, the number of physicians increased in every state, and only four states saw growth slower than population growth; these four states all have medical malpractice caps.

Myth #4: Malpractice claims drive up doctors’ premiums.

Fact: Empirical research has found that there is little correlation between malpractice payouts and malpractice premiums paid by doctors. A study of the leading medical malpractice insurance companies’ financial statements by former Missouri Insurance Commissioner Jay Angoff found that these insurers artificially raised doctors’ premiums and misled the public about the nature of medical negligence claims. A previous AAJ report on malpractice insurers found they had earnings higher than 99% of Fortune 500 companies.

Myth #5: Tort reform will lower insurance rates.

Fact: Tort reforms are passed under the guise that they will lower physicians’ liability premiums. This does not happen. While insurers do pay out less money when damages awards are capped, they do not pass the savings along to doctors by lowering premiums. Even the most ardent tort reformers have been caught stating that tort reform will have no effect on insurance rates.

For Five Myths About Medical Negligence in its entirety, click here

Originally posted at InjuryBoard by Steve Klearman

Contaminated Peanut Butter Suit Includes Kellogg Co.

Steve Klearman — Thu, 19 Mar 2009 10:00:00 GMT

Since August 2008, about 550 people have gotten sick and eight people have died from the salmonella outbreak. Thousands of peanut butter products have been recalled. The law firm that filed the first lawsuit over the recent salmonella outbreak in certain brands of peanut butter products has added the Kellogg Co. as a defendant.

The suit was filed last month on behalf of a Vermont couple, Gabrielle and Daryl Meunier, whose 7-year-old son became sick after eating peanut butter cracker sandwiches made by Kellogg from products of the Peanut Corp. of America, whose Georgia plant has been identified as the source of the contamination that led to the outbreak. Meunier v. Peanut Corp. of America, No. 1:09-cv-00012 (M.D. Ga.).

Marler Clark, the plaintiffs' firm, added punitive damages to the case in recent weeks after the U.S. Food and Drug Administration concluded that the Peanut Corp. of America knowingly released a product that could have been contaminated.

For the full article, please click here.

Bill Marler, a partner at Seattle's Marler Clark, said that Kellogg was added as a defendant because the company manufactured the peanut butter cracker sandwiches and conducted at least two of its own inspections, through a third party, of the Peanut Corp. of America's Georgia plant in 2008. Kellogg spokesperson Kris Charles said the company does not comment on litigation. Peanut Corp. of America has denied wrongdoing.

Originally posted at InjuryBoard by Steve Klearman

AAJ Supports US Supreme Court's Wyeth v. Levine Decision

Steve Klearman — Mon, 16 Mar 2009 10:00:00 GMT

The full article can be found here.

The U.S. Supreme Court in a 6-3 decision upheld a Vermont jury’s decision that Diana Levine, the plaintiff in the Supreme Court case Wyeth v. Levine could hold the drug manufacturer accountable for the injuries she suffered—which included the loss of her arm—after taking one of Wyeth’s medicines.

Writing the Supreme Court’s majority opinion, Justice John Paul Stevens said Food and Drug Administration oversight of drug labeling doesn’t prevent the filing of state-level consumer liability lawsuits against drug companies. Joining Stevens in the majority were Supreme Court Justices Anthony Kennedy, David Souter, Ruth Bader Ginsburg, Stephen Breyer and Clarence Thomas.

The following is the statement from American Association for Justice President Les Weisbrod.

"The Supreme Court reaffirmed the principle that state lawsuits perform a valuable and important function in ensuring accountability in uncovering drug hazards. Also, the Supreme Court rejected the FDA’s attempts to use the preamble in drug regulations to provide complete immunity to drug manufacturers.

It is clear consumers retained their remedy under law when drug companies have failed to provide adequate warnings for the safe use of their drugs.

Today’s decision in favor of Diana Levine proved that even if you are just one person, you can fight for justice and hold your wrongdoer accountable."

Originally posted at InjuryBoard by Steve Klearman

Nevada Supreme Court to Decide on Pharmacy Liability

Steve Klearman — Thu, 12 Mar 2009 15:14:40 GMT

A recent editorial in Modern Medicine reported that the Nevada Supreme Court will be deciding whether or not pharmacies can be held liable for death or injuries caused by a customer under the influence of prescription medication. In June of 2004, Patricia Copening, while under the influence of hydrocodone, drove her car into two men who had pulled over to fix a flat tire. Robert Martinez was severely injured and Gregory Sanchez Jr died as a result of the accident.

Under Nevada law, prescriptions are tracked in an effort to reduce drug abuse. A year before the accident, the Prescription Controlled Substance Abuse Prevention Task Force informed the doctors and pharmacists who supplied Copening with hydrocodone that she could be a drug abuser. The task force urged them to "use their professional expertise to assist patients who may be abusing controlled substances." Because the pharmacies were adequately warned, the victims' attorneys argue that they are liable for continuing to fill the prescriptions.

Judge Douglas Hernon, for the Eighth Judicial District, dismissed the pharmacies from the lawsuit arguing that Nevada law does not provide for a legal duty to refuse to refill a prescription even if there does exist an ethical duty to protect the public.

Senior Editor, Alania Scott, opined that if the Supreme Court rules in favor of the plaintiffs, it will mean that any pharmacist who is aware that a customer could be a potential drug abuser "must call the doctor, or stand on the legal duty to refuse to fill the prescription."

Originally posted at InjuryBoard by Steve Klearman

Reactions to Wyeth v. Levine

Steve Klearman — Tue, 10 Mar 2009 15:22:51 GMT

A USA Today editorial opined that the Wyeth v. Levine decision opened a new door for plaintiff's rights. During the Bush administration manufacturers were able to avoid lawsuits for defective products as long as the product met federal regulations. The Wyeth decision, however, opens the door for plaintiffs to sue manufacturers despite compliance with federal standards. The editorial argues that the courts will have to strike a balance to protect the interests of both consumers and companies. "States should allow suits but set a high burden of proof on the plaintiffs."

Bert Rein's article in USA Today sets forth an opposing view. He argues that the decision actually creates uncertainty for patients and doctors. He emphasizes that the FDA was created because decisions regarding the risks and benefits of prescription drugs and medical devices should be left up to the experts. Allowing a jury to make these decisions based on an isolated catastrophic event places the interests of one individual over the health interests of the public as a whole.

Originally posted at InjuryBoard by Steve Klearman

Wyeth v. Levine: Supreme Court Rules On Adequacy Of Drug Labels

Steve Klearman — Tue, 10 Mar 2009 15:19:50 GMT

The Supreme Court's March 4th decision in Wyeth v. Levine could mean increased responsibility for drug companies to adequately warn clinicians and consumers of a drug's risks. Affirming a jury verdict in favor of a plaintiff injured as a result of inadequate drug label warnings, the Supreme Court held that the drug label's warnings were inadequate, rejecting the argument that FDA approval of a label is sufficient to shield a drug manufacturer from state law liability.

The plaintiff, Diana Levine, received the drug Phenergan, an antinausea drug manufactured by Wyeth, by the "IV-push" method (as opposed to the safer "IV-drip" method). The drug was injected directly into her vein, after which it escaped into her artery, caused irreversable gangrene, and resulted in the amputation of her forearm.

Levine brought suit alleging that Wyeth had failed to provide adequate warnings on its label of the risks associated with administering Phenergan by the IV-push method. The jury found in favor of Levine, determining that Levine would not have suffered her injury had Wyeth provided an appropriate warning. Wyeth argued in return that Levine's state law claims were preempted by federal law because Phenergan's labeling had been approved by the FDA. The Supreme Court granted certiorari to determine whether the FDA's approval of drug labels "preempt[s] state law product liability claims premised on the theory that different labeling judgments were necessary to make drugs reasonably safe for use."

Wyeth argued that it was impossible to comply with the state-law duties underlying Levine's claims and federal labeling requirements at the same time. The Court rejected the argument pointing out that under the FDA's "changes being effected" (CBE) regulation, a drug company may make certain changes to a label upon filing a supplemental application with the FDA but need not wait for FDA approval. "The CBE regulation permitted Wyeth to unilaterally strengthen its warning, and the mere fact that the FDA approved Phenergan's label does not establish that it would have prohibited such a change."

Wyeth also argued that Levine's tort claims were preempted because they interfered with "Congress's purpose to entrust an expert agency to make drug labeling decisions that strike a balance between competing objectives." The Court also rejected this argument, finding that Congress, being well aware of state-law suits, would have enacted a preemption provision if it determined that state law claims were an obstacle to its objectives. to see full opinion, click here

Originally posted at InjuryBoard by Steve Klearman

FDA Globalization Act to Increase Nation's Food Safety

Steve Klearman — Thu, 05 Mar 2009 01:36:08 GMT

Congressman John Dingell introduced the Food and Drug Administration's Globalization Act in late January 2009, legislation that if passed would help would help ensure the safety of the nation’s food, drugs, medical devices and cosmetics and help restore confidence in the safety of the nation’s products, according to the American Association for Justice.

The Act adds registration fees for processing plants to provide increased funding for food safety, increases inspections of manufacturing facilities to every four years, including unannounced inspections, increases penalties for noncompliance and increases food-testing for imported products among other safety provisions. The legislation also gives the Food and Drug Administration increased authority to recall products believed to pose a risk to consumers.

"With the onslaught of reports of contaminated spinach, tomatoes, beef, pet food, and now peanut butter, it is clear increased funding and authority is needed at the FDA like Congressman Dingell’s legislation provides," said Bill Marler, a food safety attorney and member of the American Association for Justice’s Foodborne Illness Litigation Group.

Find the full AAJ article here.

Originally posted at InjuryBoard by Steve Klearman

No duty for pharmacy to cut off drug abuser's prescriptions, says Nevada District Court

Steve Klearman — Thu, 25 Sep 2008 19:56:22 GMT

The Las Vegas Sun reports an interesting facet to the continuing problem with prescription drug abuse in Nevada.

Patricia Copening served nine months in jail after driving under the influence of hydrocodone, hitting two victims who were changing a flat tire at the side of the road.

Copening's doctors and pharmacies are now being sued by the victims' families.

The pharmacies were recently dismissed from the case.

The victims' theory was that the pharmacies are liable for the victims' damages after continuing to fill Copening's prescriptions after being notified of her drug abuse. Copening's doctors and pharmacies had been notified about a year prior to the accident of her potential drug abuse, by the Prescription Controlled Substance Abuse Prevention Task Force. (Recall from a previous blog that Nevada was the first to implement a drug tracking program to prevent "doctor shopping.")

However, the District Court Judge said that Nevada’s law doesn't impose a legal duty for pharmacists to take specific action after being notified that a particular patient is a suspected drug user.

Originally posted at InjuryBoard by Steve Klearman

Prescription tracking: Too invasive?

Steve Klearman — Sun, 07 Sep 2008 22:35:04 GMT

With prescription drug use at its highest in Nevada, and with overdoses from painkillers, including methadone, on the rise, prescription tracking programs are emerging all over the country.

Nevada was the first to implement such a program. The Nevada Pharmacy Board has developed a database listing every prescription written in Nevada for certain medications. The listing includes the provider and the patient, and is designed to prevent drug-seeking patients from obtaining prescriptions from multiple doctors.

To some, the potential privacy invasion from such programs is too invasive.

The Concord Monitor published an editorial on August 24 detailing concerns with the programs:

Some abused drugs are stolen, but most are obtained by filling prescriptions from doctors. Abusers go from doctor to doctor and, since a physician has no way of knowing whether another doctor has just written a prescription for the same drug, get multiple prescriptions. Drug monitoring programs, proponents say, greatly reduce doctor shopping. And they allow doctors, who, when they punch in a security code, see the patient's prescription history, to see when potential harmful or fatal interactions could occur between drugs prescribed by different physicians.

Though more than 30 states have sanctioned the creation of a prescription monitoring system, most are too new to judge their effectiveness. The oldest programs were adopted by Nevada in 1997 and Kentucky in 1999. Studies cited by the National Conference of State Legislatures suggest that the monitoring programs dramatically reduce prescription forgery and doctor shopping, but they also push abusers to states lacking a program and to the internet.

Every New England state but New Hampshire has now approved a monitoring program, so attempts to procure drugs illegally here will likely increase. That means greater vigilance on the part of the local medical community and increased scrutiny by law enforcement will be necessary.

The push for monitoring is coming not just from doctors and public health officials but the attorney general's office. And it would likely be a useful tool. But it's easy to imagine a time when lobbyists could convince lawmakers that the drug problem has become severe enough to grant law enforcement agencies unfettered access to everyone's prescription history without a warrant. Then, agents would view the private medical information of hordes of innocent people in hopes of nabbing a small number of abusers.

Even more troubling is the thought that computer hackers or bribed employees could obtain the records and sell them. The information would be very valuable to pharmaceutical companies, and to insurers and employers who want to avoid both abusers and people in need of expensive health care.

Banks, major retail chains, communications systems and federal agencies including the Department of Veterans Affairs, FEMA, the nation's nuclear laboratories, companies working for the Department of Homeland Security, the CIA and the FBI have all been breached with some degree of success by hackers or had information stolen or lost.

Privacy concerns have trumped the potential value of establishing a prescription monitoring program three times in the past.

Not enough has changed to recommend that lawmakers change course.

You can see the full article here

Originally posted at InjuryBoard by Steve Klearman