San Antonio Personal Injury Lawyer - Medical Malpractice

Medical Malpractice Insurers’ Profits Higher than 99% of All Fortune 500 Companies

Beth Janicek — Sat, 31 Oct 2009 17:58:31 GMT

The American Association for Justice (AAJ) recently released a statistic claiming that medical malpractice insurance companies’ average profits are higher than 99 percent of all Fortune 500 companies. AAJ points out that medical malpractice lawsuits only account for a small percentage of unnecessary costs. The bigger problem is medical errors and the profits of malpractice insurers.

The report released by the AAJ also states that the average profit of medical malpractice insurance companies is 35 time higher than the Fortune 500 average for the same time period, and that malpractice insurers have seen their profit margins range from 5.9 percent to 74.8 percent, with an average of 31.2 percent. In addition, the report finds that malpractice insurers have publicly overestimated their losses and underestimated their profits in an attempt to suggest that insurance business and medical practices face a crisis that must be resolved by tort reform. This report released by the AAJ shows that insurance companies profit the most, and obviously need Tort Reform the least.

AAJ President Anthony Tarricone said,

Insurance companies are gouging doctors on their premiums to mislead lawmakers…And today, injured patients are often left with no avenue to pursue justice, while health care costs continue to skyrocket.”

Originally posted at InjuryBoard by Beth Janicek

Bill Would Allow Military Personnel to Sue for Medical Malpractice

Beth Janicek — Wed, 20 May 2009 11:10:18 GMT

Legislation that would enable military service members to sue the government for medical malpractice is moving closer to becoming law. The House Judiciary Subcommittee approved Carmelo Rodriguez Military Medical Accountability Act. The legal precedence barring negligence lawsuits for military service members goes back to a 1950 Supreme Court ruling known as the Feres Doctrine.

The Feres ruling came from the Federal Tort Claims Act of 1946, which waived the common law doctrine of sovereign immunity in certain circumstances to allow lawsuits against the government for negligent acts. The law was initially interpreted to forbid lawsuits by military personnel only for combat-related injuries. The Feres decision extended the law to include any lawsuits for injuries “incident to military service.”

Over the years cases applying the Feres Doctrine have include incidents such as leaving foreign objects inside patients, misdiagnosing, failure to notify patients about potentially deadly health problems, and failure to treat patients with easily treatable illnesses.

The Feres Doctrine has received criticism all across the board. Attempts to revoke the doctrine have surfaced periodically in Congress for over 20 years, but all have failed. In 1987, a 5-4 Supreme Court decision reaffirmed the Doctrine. The decision drew dissents from Justices John Paul Stevens and Antonin Scalia.

Scalia wrote that the Feres Doctrine “was wrongly decided and heartily deserves the widespread, almost universal criticism it has received.”

The latest attempt to amend the Feres Doctrine is H.R. 1478, the “Carmelo Rodriguez Military Medical Accountability Act of 2009”, introduced by U.S. Representative Maurice Hinchey (D-N.Y). The Act would allow lawsuits on behalf of military personnel who are killed or injured by medical malpractice but would contain an exception for combat-related injuries. It also requires that any paid claim be reduced by the amount of any other government compensation resulting from the injury.

U.S. Rep. Hinchey said, “I think military personnel should be treated in normal ways. Their medical issues should be dealt with responsively and attentively, the way we anticipate and expect the medical problems of ordinary citizens should be dealt with. We see far too much negligence in military medical care.”

Jonathan Turley, a law professor at George Washington University, has been a leading critic of the Feres Doctrine for years.

He said, “We see cases in the military involving conduct that would be viewed as perfectly medieval in the civilian world. Decades ago civilian doctors were sued over the practice of leaving sponges in patients. It used to be very common.”

Now, he says, it is rare to see that type of malpractice in civilian medicine, due to the fear of lawsuits. But since there is no fear of a lawsuit in military medicine, it keeps occurring.

Turley said, “I consider the Feres Doctrine to be one of the most grotesque rules created in the history of this republic. It has done untold damage to thousands of military personnel and their families.”

Let’s hope for the sake of our military that the Carmelo Rodriguez Military Accountability Act of 2009 has a better outcome than other bills written to overturn the Feres Doctrine. Rep. Hinchey admits that this bill is going to face a tough fight, but as far as he is concerned it is simply a matter of fairness.

Originally posted at InjuryBoard by Beth Janicek

FDA Adds Warning of Celgene’s Risks for Elderly

Beth Janicek — Mon, 12 Jan 2009 12:54:03 GMT

Celgene Corp. added an additional warning to its blood-clot drug Innohep stating that it could increase the risk of death in elderly patients with kidney problems. Innohep (tinzaparin) is a low-molecular weight heparin used as a blood thinner or anti-coagulant approved in 2000 by the FDA to treat blood clots in patients with pulmonary embolism (PE) and deep vein thrombosis (DVT).

As of October 15, 2008, the FDA had received 383 reports of side effects and complications worldwide, including 96 deaths. The company stated that the risk only appeared for elderly patients age 90 and older, but the FDA asked Celgene to further revise the warning to include elderly patients 70 and older. Celgene posted a letter that says,

“We now regard the risks for Innohep as applying to all elderly patients with renal insufficiency and have further revised the label to include this information as a warning.”

Preliminary data does not appear to indicate a manufacturing problem with Innohep, but the FDA cannot categorically rule out this possibility until a thorough analysis of the manufacturing data is completed. Information surrounding the side effects will be evaluated to determine whether Celgene will be held liable for failing to provide adequate warnings about the risk of death.

If you or a loved one have had complications or have experienced any negative side effects due to the mistaken subscription of medicine such as Innohep contact a personal injury attorney.

Originally posted at InjuryBoard by Beth Janicek

Lawsuits Consolidated against Manufacturer of Defective Urinary Device

Beth Janicek — Wed, 07 Jan 2009 10:03:56 GMT

I wrote a blog last month about the FDA’s quick review of certain medical devices and I referenced a “fast-track” approved device meant to help women with urinary issues but the device ended up being recalled. Similar urinary devices have made the news again due to recent lawsuits against a device manufacturer. The problematic device is a sling that is surgically implanted to treat stress urinary incontinence, which often is brought on by coughing, sneezing or exercise, and is common in women after childbirth. The product was removed from the market in 2006.

Now there are 32 pending lawsuits against Mentor Corp., a Santa Barbara, Calif.-based cosmetic surgery device manufacturer. The Plaintiffs claim Mentor was negligent in their design of the ObTape device and that they failed to properly warn patients of the risks of injury created by the device. The FDA issued a general warning to doctors about potential risks connected to these slings but the FDA did not specifically name the ObTape device.

A recent California jury verdict came down in favor of Mentor because the jury concluded the doctors knew of the risks involved when they implanted the ObTape. But, the litigation does not end there; a U.S. District Court in Georgia recently consolidated 22 lawsuits against Mentor regarding the ObTape device. Gary Blasingame, a lawyer handling some of the women’s cases said, “What they’re claiming is that because of the defective device, this ObTape, these women have experienced serious medical injuries and problems. We think it's a significant series of cases, and we think this product is one that we have alleged in our complaint and anticipate will be proven is defective."

Originally posted at InjuryBoard by Beth Janicek

Lack of State Investigations into Nursing Homes

Beth Janicek — Thu, 11 Dec 2008 12:24:24 GMT

I am continually amazed when I read the TDADS investigations into nursing home complaints. TDADS is the regulatory agency that regulates nursing homes. I have been handling cases against nursing homes for many years and have been reviewing these investigations. I have noticed a lack of any true investigations by the agency. It is a rare occasion that I ever find an investigation that substantiates the complaint.

Recently I reviewed a group of investigations by TDADS of incidents including one that I am litigating now. My client was injured when the ropes to the Hoyer lift slipped and she fell face forward and fractured her neck. See the video of how to use a Hoyer lift. Hoyer lift.

The TDADS investigation determined the claim of negligence was unsubstantiated (unfounded). The State investigator talked to the nurse aids involved with the transfer. They told the State investigator that the ropes were secure prior to them transferring with the Hoyer lift and that the disabled resident must have untied the ropes herself. Although it would be very difficult for this woman, who was dependent on the staff for all of her needs, to be capable of untying the ropes since she has no use of her right arm as the result of a stroke. Regardless, the staff should have been present during the whole transfer and would have seen this disabled woman untying the ropes! The state investigator never even references this very obvious point! Not any of the investigations were substantiated including another where the resident had choked to death.

Now at the same nursing home a resident was beaten to death by another resident. I have not seen the state investigation into this incident but I am curious as to what they will find. Perhaps if the state would put forth genuine effort in investigating these incidents the safety in nursing homes would increase due to fear of punishment by the state. But for now Texas nursing homes can rest easy because they do not have to fear lawsuits due to state caps on damages and they have no fear of TDADS doing a sincere investigation.

Originally posted at InjuryBoard by Beth Janicek

Off-label Drugs Not Researched for Safety

Beth Janicek — Thu, 27 Nov 2008 12:55:00 GMT

There is a recent study which has identified 14 drugs which needed the most pressing research into off-label use. The study says that physicians and patients should be most concerned about the antidepressants and the antipsychotic drugs on the list. The FDA only requires that the drug companies test the drugs for the use that they are seeking approval. For example on the list is Seroquel which has been approved by the FDA to treat schizophrenia and short term episodes of bipolar disease but the drug is more commonly prescribed as maintenance therapy for bipolar disease and yet there has not been ample research by the drug company for the FDA to approve the drug for this purpose. Therefore, it has not been proven to be safe for this treatment or effective.

Once a drug is approved by the FDA then according to PLoS Medicine, industry-paid "nationally known, influential academic physicians" help create "buzz" about off-label uses by writing about them for publication or presentation at scientific meetings.

This is of concern because many of these drugs have serious side effects. For example, Seroquel had added to its label the risk of diabetes and hyperglycemia. There may be other safety risks with these drugs that are unknown because there has not been sufficient testing.

Off-label use is legal and accounts for roughly half of all prescriptions written. I think the most important part is that patients need to be made aware that the drug they are being prescribed is for an off-label use so that they can make an informed decision on whether they want to use the drug. In a recent article in PLoS Medicine, the authors argued that the doctors had an ethical duty and an extension of informed consent to tell the patients about the off-label use. I could not agree more!

Originally posted at InjuryBoard by Beth Janicek

FDA’s Quick Review of Medical Devices

Beth Janicek — Mon, 17 Nov 2008 18:55:32 GMT

The New York Times recently reported on a way medical device manufactures can get their products on the market quickly, even without proving the effectiveness of the product. When the FDA began regulating medical devices in 1976, they created a type of review process known as a 510(k) review. Since the new medical device regulations would not apply retroactively (to devices already in the market), Congress created the 510(k) review to help disadvantaged manufactures of newer products get their products on the market faster. Basically, the quick review process applies to any new product deemed “substantially equivalent” to something already on the market.

While the 510(k) review process works for devices like band aids or crutches, the review process is also being used for more complex and invasive devices that have a greater impact on patients than just a band aid. For example, the MammoSite system, which is used to treat women with breast cancer by sending radioactive “seeds” into the tumor site, was approved by the FDA after a fast-track review.

The problem is under the 510(k) review, manufactures do not have to prove the products effectiveness for treating patients. With the MammoSite, the manufacturer provided only a 25-patient, four-year clinical trial to the FDA, and while a long-term study is currently in progress, at this point there is no long-term data on the effectiveness of the device.

Critics of the 510(k) review process argue patients need to be told when devices their doctors recommend have not been proven as long-term treatments for the patient’s specific condition. On the other hand, FDA officials point to Mammosite label which warns doctors the treatment is unproved and urge doctors to inform their patients. The 510(k) review has back fired in the past. In 1996, the FDA cleared Protegen, a device to prevent bladder stress incontinence, through the fast review process, but the Protegen was ultimately recalled in 1999 due to a high rate of complications.

In the end, it is important that patients become fully informed about the devices doctors recommend they use.

“Nobody is looking to see whether they help patients,” said Diane C. Robertson, an executive with the ECRI Institute, a nonprofit group in Plymouth Meeting, Pa., that evaluates new devices for insurers and hospitals. “We’re never going to wisely allocate resources in health care unless we start to focus on what’s best for patients.”

Originally posted at InjuryBoard by Beth Janicek

Tainted Heparin Seized by Federal Marshals

Beth Janicek — Fri, 07 Nov 2008 15:20:35 GMT

I have blogged in the past on contaminated heparin and found this recent article very interesting as a follow up to the contaminated heparin issue.

The Food and Drug Administration (FDA) sent federal marshals into a Cincinnati based manufacturer, Celsus Laboratories, to seize 11 lots of heparin, a blood-thinning drug. The FDA had asked the manufacturer twice to recall the contaminated heparin but received no cooperation.

Large amounts of Chinese raw heparin imported into the United States were contaminated with oversulfated chondroitin sulfate. The tainted blood thinner which is given during heart surgery and kidney dialysis was blamed for nearly 250 deaths and hundreds of allergic reactions.

Heparin sodium is given to patients as a blood thinner and heparin lithium is used to coat medical devices. Two pounds of heparin sodium and 31 pounds of heparin lithium were seized. The heparin that was seized was worth $112,000.00 which represented a portion of the 11 lots which had already been shipped to other manufacturers.

FDA said in a release that it has also advised manufacturers who might have bought heparin from the company to contact the agency to make sure they don't have any of the contaminated heparin. "The product does not meet acceptable quality standards," the agency said.

If you or a loved one has been injured by contaminated heparin or had an allergic reaction to heparin, contact my office as we are currently litigating several cases regarding heparin.

Originally posted at InjuryBoard by Beth Janicek

Avandia – Too Toxic to Be On The Market

Beth Janicek — Thu, 06 Nov 2008 15:35:43 GMT

Avandia (rosiglitazone maleate) prescribed to diabetics helps improve blood sugar control in adults with type 2 diabetes.

On October 30^th, Public Citizen petitioned the Food and Drug Administration (FDA) to immediately ban the drug. Avandia causes liver failure, including 12 deaths and has been linked to other serious problems including heart attacks, heart failure, bone fractures, anemia and macular (retinal) edema.

Public Citizen has a website on drug safety and has been warning against this drug for almost four years. The informational website is WorstPill.org and includes their full petition to ban Avandia. The American Diabetes Association (ADA) and the European Association for the Safety of Diabetes has advised against using Avandia.

If you are using Avandia, ask your doctor for a safer drug, including metformin, a sulfonylurea, glipizide or possibly insulin. Actos ( pioglitazone) is in the family of Avandia and is therefore not recommended.

If you have been prescribed Avandia and have suffered dangerous side effects, contact my office.

Originally posted at InjuryBoard by Beth Janicek

Doctors Prescribing Medical Devices for Uanpproved Uses?

Beth Janicek — Tue, 07 Oct 2008 16:39:37 GMT

Pharmaceutical and medical device companies should develop high-quality, innovative products which assist Doctors in providing the best possible care for their patients. Instead it seems there are some companies using kickbacks such as money and trips to entice Doctors to prescribe their products—even if the product is not approved for a particular use. One such company is Medtronic, the world’s largest device maker, which has attracted the attention of two Senators, Charles Grassley, R-Iowa and Herb Kohl, D-Wis., who have asked Medtronic to provide details about physicians who receive company payments for consulting services. In attempt to prevent, or at least expose, such unethical practices, Sen. Grassley and Sen. Kohl have written a bill which would require companies to disclose all payments to physicians over $500.

This isn’t the first time Medtronic has been questioned about their physician-payment practices. In 2006 they reached a $40 million settlement with the U.S. Department of justices to settles charges that Medtronic paid doctors millions in kickbacks to use its spinal repair products. As a part of the settlement, the government agreed to seek dismissal of two law suits brought by former employees.

A recent Wall Street Journal Law Blog discussed one of these law suits, which includes such allegations that Medtronic sales staff took physicians to strip clubs and picked up the tab. The problem is even greater because there is widespread off-label use of Medtronic Infuse, a bone graft device, and some believe these non-approved uses stem from doctors who received kickbacks. This situation worsens because serious complications have been reported, and the Food and Drug Administration has warned doctors that using Infuse for off-label procedures, such as neck surgeries, has led to problems swallowing, breathing, and speaking which in some cases required additional surgery.

Originally posted at InjuryBoard by Beth Janicek