May 8, 2008

Insulin Pump Dangers

Federal regulators are sounding a warning about dangers associated with the use of insulin pumps by children and teenagers. Insulin pumps are used by tens of thousands of young people worldwide with Type 1 diabetes.

The Food and Drug Administration is warning parents to be vigilant in watching their children's use of the pumps. They are not advising against using the pumps, but suggested further study to address safety concerns in teens and even younger children who use the popular pumps.

Researchers found that in the last ten years there have been 13 deaths and more than 1,500 injuries connected with the pumps. Some of these were the result malfunctioning pumps, but at other times, teenagers were careless or took risks..

The researchers found that some teenagers were not instructed how to use the pumps correctly, dropped them or didn't take good care of them.
The insulin pumps are popular because they allow young people to live more normal lives. They account for $1.3 billion in annual sales around the world, and demand is growing.The pumps are used for those with Type 1 diabetes, which accounts for about 5 to 10 percent of all diabetes cases and used to be called "juvenile diabetes." The more common form is Type 2, which is often linked to obesity and more often affects adults.

Insulin pumps are the size of a cell phone and worn on a belt or pocket. They send insulin into the body through a plastic tube with a small tip that inserts under the skin and is taped in place. They cost about $6,000 and supplies run $250 a month. Most health insurers cover much of the cost.

April 30, 2008

Medical Group Fights Industry Influence

The Association of American Medical Colleges has proposed that drug and medical device companies should be banned from offering free food, gifts, travel and ghost-writing services to doctors, staff members and students in nation’s medical colleges. The Association has begun to write a model policy governing relationships between the schools and industry. While medical schools can ignore the association’s advice, most follow its recommendations.

The rules would apply only to medical schools, but they could have enormous influence across medicine, according to medical educators.
Drug companies spend billions of dollars each year trying to influence doctors. Medical schools, with prominent professors and new trainees are attractive marketing targets.

For decades companies have provided faculty and students free food and gifts, offered lucrative consulting arrangements to teachers and even ghost-wrote research papers for busy professors.

A group of doctors criticized these practices in a 2006 article in The Journal of the American Medical Association, and said that medical schools should ban them.

The proposed rules would require that schools set up centralized systems for accepting free drug samples and suggest that schools audit independently accredited medical education seminars given by faculty. The rules would apply to faculty even when off-duty or away from school.

Speakers’ fees and drug samples are a major part of the drug and device industry’s marketing operations, and many medical school professors have resisted efforts to restrict them.

These efforts to remove the influence of industry marketing from medical decision making shoiuld be applauded.

April 15, 2008

Heparin Concerns Grow

This Tuesday federal regulators from the FDA urged makers of many kinds of medical devices that contain heparin to test their supplies. These concerns arise from previously discovered supplies of Chinese made heparin contaminated with a look-alike ingredient that mimicked heparin in standard tests of drug potency and purity.

The FDA announced last month that it had identified the contaminant as a modified form of a common nutritional supplement. That substance is cheaper to produce than heparin, leading to suspicions that it may have been intentionally added somewhere along a complex and lightly regulated supply chain in China.

China is the world's leading supplier of heparin, a blood thinner often made from a substance in the intestines of pigs. It is commonly given to prevent blood clots in heart surgery and dialysis patients

The products to be tested cover a spectrum of equipment and uses. They include kits that flush out intravenous lines, drug-coated stents for opening clogged arteries and certain diagnostic tests that use heparin and could deliver inaccurate results if contaminated.

Separately, the FDA released statistics on deaths linked to intravenous heparin, the form of the drug in which problems were first detected. The numbers showed an increase in fatalities from November 2007 through February 2008, with problems rapidly abating last month after Baxter Healthcare Corp. issued a recall.

April 3, 2008

Federal Agencies Join Forces Against Consumers

If you think the prescription drug you took for headaches caused your heart attack, the Food and Drug Administration says you can't sue the maker for injury if it met agency standards. The Consumer Product Safety Commission (CPSC) says you can't sue a mattress maker if your mattress bursts into flame despite meeting CPSC standards. Companies making sport utility vehicles would get similar protection from suits brought by people injured or the families of those killed in rollovers under National Highway Traffic Safety Administration (NHTSA) proposals for stronger roofs.

Consumer advocates call this "silent tort reform." It is part of the tension between state and federal law that has existed since the nation's founding. If there is a conflict, state laws must yield under Article 6 of the Constitution. But where there is no federal law, federal courts must defer to laws of the state where a lawsuit is heard. Big business and insurance companies are now using this to avoid responsibility for negligent actions and omissions at the expense of innocent consumers.

Under the Bush administration, a developing body of judicial opinion could place new limits on the rights of those who buy or use products. It also could mean the savings of billions of dollars by companies insulated from lawsuits.

Federal agencies are increasingly promulgating rules favorable to big business and insurance companies at the expense of ordinary citizens. They then assert their rules override state tort and product-liability laws. In a novel approach, these agencies are claiming that the preemptive effect is based on statements in the introductions to their rules, not the rules themselves.

The practice varies by agency but is spreading. It delights corporate defense lawyers. The argument is that federal agencies are the absolute rule-makers.

Actor Dennis Quaid and his wife are preparing to fight such a contention — this one made by the FDA — in a suit accusing Deerfield, Ill.-based Baxter Healthcare Corp. of putting vastly different doses of a blood-thinner into confusingly similar packages. The Quaids went to court in November 2007, after their infant twins were given 1,000 times more heparin than babies should get. Their suit contends Baxter should have changed the packaging after three babies died in 2006 at an Indianapolis hospital.

March 17, 2008

Contaminated Chinese Heparin

At least19 people have died, and hundreds became ill after being given heparin, a blood-thinning drug sold by drug manufacturer Baxter International. Baxter obtained the drug’s active ingredient from a Chinese manufacturer.

A belated inspection of the Chinese plant found substandard conditions. Recent lab tests revealed an unknown contaminant in batches of the drug, but researchers have not identified what precisely caused the allergic reactions which caused the deaths.

The Food and Drug Administration is required to inspect plants such as the one in China which supplied the heparin ingredient. However, under the Bush Administration, it has failed to follow this mandate.

Currently, 80 percent of all active drug ingredients come from abroad, but the FDA doesn't know what percentage of foreign manufacturing facilities it has inspected. Many of these plants are in developing countries that don't have infrastructure that meets U.S. safety standards.

Critics of the FDA argue that the FDA doesn't have the resources to meet its statutory mandate to inspect domestic plants every two years, let alone inspect plants abroad. A recent Government Accountability Office report estimated that the FDA can inspect foreign firms on average once every 13 years. They point out that the agency uses antiquated, incomplete databases which led officials to believe they'd already inspected the heparin plant in China when actually they'd been to one with a similar name.

These critics argue that the FDA needs more money, either through Congressional appropriations or user fees. But, they also point out that last year Congress gave the FDA more money than the Bush administration had asked for.

February 28, 2008

New Supreme Court Decision Makes It More Diffcult For Georgia Lawyers To Sue Medical Device And Drug Companies In Product-Injury Claims

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.

February 25, 2008

Dangerous Drugs--Who Is The FDA Trying To Protect?

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.

February 21, 2008

Trasylol Heart Drug Dangers Hidden By Manufacturer

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.

"I just don't know how much further evidence you need," said Dr. Sidney Wolfe of Public Citizen's Health Research Group. Federal health officials should pursue criminal charges against Bayer for withholding information from its own study from the FDA panel in 2006, Wolfe said.

Trasylol was used in heart bypass surgeries to control bleeding. The FDA approved it in 1993 after studies showed its clotting powers clearly reduced the need for blood transfusions, and it became a top choice for surgeons.

Bayer officials still say they believe Trasylol's benefits outweigh its risks when used properly. The company said it's waiting for the final results of the Canadian study before deciding whether to permanently suspend the drug's sales.

February 21, 2008

Trasylol Heart Drug Dangers Hidden By Manufacturer

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.

"I just don't know how much further evidence you need," said Dr. Sidney Wolfe of Public Citizen's Health Research Group. Federal health officials should pursue criminal charges against Bayer for withholding information from its own study from the FDA panel in 2006, Wolfe said.

Trasylol was used in heart bypass surgeries to control bleeding. The FDA approved it in 1993 after studies showed its clotting powers clearly reduced the need for blood transfusions, and it became a top choice for surgeons.

Bayer officials still say they believe Trasylol's benefits outweigh its risks when used properly. The company said it's waiting for the final results of the Canadian study before deciding whether to permanently suspend the drug's sales.

February 20, 2008

Medical Device Manufacturers Receive Protections

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.

Charles Riegel's family alleged that the catheter produced by Medtronic Inc. of Fridley, Minn., outside Minneapolis had a design defect and an inadequate warning label. Riegel survived the procedure to unclog an artery, though he had permanent disabilities. He died in 2004.

State lawsuits are barred to the extent they would impose requirements that are different from federal requirements, said the ruling by Justice Antonin Scalia. In dissent, Justice Ruth Bader Ginsburg said that Congress never intended "a radical curtailment of state common-law lawsuits seeking compensation for injuries caused by defectively designed or labeled medical devices."

Not surprisingly, the Bush administration sided with industry, saying unfavorable state jury verdicts would compel companies to alter product designs or labels that had already gotten FDA approval.

February 11, 2008

FDA Circumvents Congressional Intent In Favor Of Drug Companies


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.

February 11, 2008

Drug Ads Investigated


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.

According to the House Committee on Energy and Commerce, it is looking into whether the advertisements give the public a false impression. Lipitor is the world’s single best selling drug. It is estimated it generates sales of over $12.7 billion a year. Recently, however, it has come under competition from cheaper generic drugs. Pfizer has used the Jarvik advertisements to help protect its’ market share. Between January 2006 and September 2007, it is reported that Pfizer spent $258 million advertising Lipitor.

February 11, 2008

Botox Danger

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.

Sixteen of the cases reported were fatal, including four involving children under 18, Public Citizen said. Some patients were hospitalized.

Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said such problems can occur if toxin spreads from the injection site to the esophagus, causing partial paralysis. Instructions for Botox and Myobloc mention the issue but it is easy to miss, he said. He called for the increased warnings to physicians and consumers.

February 5, 2008

DANGEROUS MEDICAL DEVICES AND DOCTORS

Lawyers who practice in the field of dangerous medical devices and drugs are never surprised to discover relationships between physicians and pharmaceutical and medical device companies. Recently, questionable ties between supposedly objective researchers and the maker of an artificial spinal disk have come to light. An artificial spinal disk is a device that is used in place of conventional surgery during which patients’ vertebrae are fused.

In a study of nearly 240 patients with lower back pain, physicians reported that the artificial spine disk, manufactured by Prodisc, had worked much better than conventional fusion surgeries. A well-known spine specialist and one of the study’s researchers said in a 2006 news release that “as a surgeon, it is gratifying to see patients recover function more quickly than after fusion and return to their normal activities more easily.”

Discovery in a lawsuit against the manufacturer has disclosed that the surgeon had a large financial interest in the outcome of the study. So did other doctors at about half of the 17 research centers involved in the study. Federal law requires that manufacturers inform the Food and Drug Administration of researchers’ financial interest in a product or drug before the study is used to seek approval of a device. It is unclear whether the disk’s manufacturer made this information available to the FDA.

In the study results submitted to the FDA , an unusually large number of patients were not included. Some of those patients had very poor results. As a result, some doctors are very critical of the research stating that the study may have overstated the value of Prodisc. They point out that clinical researchers with financial conflicts have incentives to overstate the value of a new product.

Dr. Richard A. Deyo, a Professor at Oregon Health and Science University, summed up the matter in this way, “The surgeons themselves are guilty of being insufficiently critical of products and techniques they are developing. More people are more interested in getting on the gravy train than on stopping the gravy train.”

January 20, 2008

Medication Errors In Atlanta Hospitals

We have previously written about the dangers of medication errors in hospitals. Recently another incident made the news because a celebrity was involved. Actor Dennis Quaid’s newborn twins and another child were put in serious danger when they were administered overdoses of a blood thinner. The California Department of Public Health said the Cedars-Sinai Medical Center gave the newborns 1,000 times the intended dosage of heparin. Fortunately, all three children recovered, but two needed a drug that reverses the effects of heparin.

The authorities said the "violations caused, or were likely to cause, serious injury or death to the patients who received the wrong medication," and they faulted the hospital for its "deficient practices" around administrating the drug.

The regulators' found that the hospital did not adequately educate staff about safe use of heparin, which it described as a "high alert, high risk" blood thinner, and that nurses sometimes failed to adequately read labels on vials of the drug.

The hospital has apologized to the patients' families and said it made changes to prevent a recurrence, including providing more training and requiring four pharmacy workers to verify a high-alert medication before putting it in a patient care unit.

Quaid and his wife, have sued Baxter Healthcare Corp., the makers of heparin, accusing the firm of negligence in packaging different doses of the product in similar vials with blue backgrounds.
A similar dosage error killed three premature infants at an Indianapolis hospital in 2006. Three others survived overdoses.

January 7, 2008

Antibiotics Cause Tendon Ruptures

The consumer group, Public Citizen filed a lawsuit in the U.S. District Court for the District of Columbia, asking the court to force the Food and Drug Administration to act upon a petition the consumer group filed with the agency 16 months ago. According to the lawsuit, despite long-standing evidence that fluoroquinolone antibiotics can cause tendon ruptures, the FDA has failed to increase its warnings to patients and physicians about the dangers of the medicines.

The FDA failed to respond to the Public Citizen asked the agency to put a “black box” warning on fluoroquinolone antibiotics (such as Cipro, Levaquin and others) to make doctors and patients more aware of the risk of serious tendon injury before tendons actually rupture. The petition also urged the FDA to send a warning letter to physicians, as well as require an FDA-approved medication guide to be dispensed when prescriptions are filled. According to the lawsuit, the FDA is violating the Administrative Procedure Act by not acting upon the petition.

From November 1997 through December 2005, the FDA received 262 reports of tendon ruptures, mainly of the Achilles tendon, 258 cases of tendinitis and 274 cases of other tendon disorders in patients using fluoroquinolone antibiotics. An additional 74 tendon ruptures have subsequently been reported to the FDA for a total of 336. Because only a small fraction of cases are typically reported to the FDA, the actual number of ruptures and other tendon injuries attributable to the antibiotic is much higher.

January 2, 2008

Drug Patch Injuries and Deaths Reported

The Food and Drug Administration has issued a warning about fentanyl pain patches. The fentanyl skin patch contains fentanyl, a potent narcotic. The skin patch was approved by FDA in 1990 for use in patients with persistent, moderate-to-severe pain who have become opioid tolerant – meaning that they have been using another strong opioid narcotic pain medicine around-the-clock, and have been using the medicine regularly for a week or longer. The skin patch is most commonly prescribed for patients with cancer.

The FDA has continued to receive reports of deaths and life-threatening side effects after doctors have inappropriately prescribed the patch or patients have incorrectly used it.

In addition, the agency is asking manufacturers of all fentanyl patches to update their product information and to develop a medication guide for patients.

The FDA has received recent reports describing deaths and life-threatening side effects after doctors and other health care professionals inappropriately prescribed the patch to relieve pain after surgery, for headaches, or for occasional or mild pain in patients who were not opioid tolerant. In other cases, patients used the patch incorrectly: The patients replaced it more frequently than directed in the instructions, applied more patches than prescribed, or applied heat to the patch – all resulting in dangerously high fentanyl levels in the blood.

December 28, 2007

Drug Manufacturer Called To Task

Drug manufacturer Genentech has been involved in a dispute with physicians over the use of its drug Avastin. Ophthalmologists became concerned last October when Genentech announced it was changing the distribution channels for Avastin, which would make it much more difficult for patients to receive the drug. Doctors accused the company of making the change to force the use of its more expensive drug, Lucentis.

Lucentis is approved to treat macular degeneration, a condition that causes blindness and is encountered frequently in elderly patients. It costs approximately $2,000 per injection. Most patients require monthly injections.

Many ophthalmologists have been Avastin, which is approved only to treat cancer, but works in the same way as Lucentis. Compounding pharmacies divide a vial of Avastin into small portions for use in the eye. In small doses, Avastin costs between $20 to $100 per injection.
Genentech announced in October that it would no longer sell Avastin to compounding pharmacies.

However, after an inquiry by Senator Herb Kohl of Wisconsin, Genentech and two announced that doctors would be able to purchase Avastin themselves and have the drug delivered to compounding pharmacies.