The Injury Lawyer Blog

In February, the U.S. Supreme Court ruled 8-1 that a patient injured by a balloon catheter manufactured by Medtronic Inc. was not entitled to damages because Medtronic was shielded from liability. The Supreme Court ruled in Medtronic's favor because the device in question met the specifications of the Food and Drug Administration (FDA). Early last week, former U.S. Solicitor General Paul Clement spoke to the Philadelphia chapter of the Federalist Society that this ruling may be a precursor of "sweeping protections for pharmaceutical makers." Clement served as solicitor general from June 2005 until June of this year.

Clement stated that a case involving a pharmaceutical is up for review this fall and bears a striking resemblance to the Medtronic case last February. In the case coming up, a patient sued Wyeth, alleging the anti-nausea drug Phenergan injured her. She contends Wyeth, the drug's maker is liable, while Wyeth contends the patient violated FDA rules and administered the drug in an unsafe way. Wyeth is based in Madison, N.J. and employs 5,300 people at its pharmaceutical headquarters.

As solicitor general, Clement filed a brief in favor of liability protection for manufacturers of pharmaceuticals. He believes that because the Supreme Court relied on the finding that the FDA extensively tested medical devices in the Medtronic ruling, they will apply the same kind of protections for drug makers. This principle is known as preemption.

Perhaps in a related note, both Chief Justice John Roberts and Justice Samuel A. Alito Jr. were once active members of the Federalist Society, a conservative legal group that leans toward siding with pro-business concerns, and has been the source for many of the Bush administration's judicial nominees and the top executive branch. However, Clement notes that the assumption of the Roberts court being pro-business many not be correct because they have ruled against corporate defendants in many employment cases.

As has been noted elsewhere, the FDA may not be the best judge of what is ready for the market. They are admittedly understaffed and underfunded, and we can assume this will affect all aspects of the agency's oversight, including what medical devices and pharmaceuticals are used by consumers.

If you or a loved one has been injured by a defective pharmaceutical or medical device, please contact an experienced injury lawyer in your area to find out if you have a claim.

The Food and Drug Administration issued a black box warning, the most "urgent" warning they can give, on a class of antibacterials called flouroquinolone drugs. This includes Cipro and other antibiotics. The FDA cites evidence that using these drugs can lead to tendon ruptures, which can leave patients in need of extensive surgery.

Cipro is made by Bayer, while Ortho-McNeil markets the drug under the name Levaquin. Cipro is an effective drug against the effects of the anthrax bacteria, and is stockpiled by local governments in case of a biological terrorist attack. It became well-known in the media during the fall of 2001 during the anthrax scare. It is also used to treat urinary tract infections. Levaquin is used to treat respiratory infections.

Two Years Late

Public Citizen, a consumer group, petitioned the FDA two years ago to ask for this kind of warning. FDA action came only after Public Citizen sued. However, Sidney Wolfe, head of Public Citizen's health section believes that action came too late and that many of the tendon rupture injuries could have been avoided had the FDA acted sooner. The FDA counters that there is already a warning in the prescription literature about tendon rupture, but acted due to doctors and patients not getting the message. Wolfe believes that, in addition to issuing a warning, the FDA should require the makers of the drugs to send letters to the doctors about the risks. The FDA thinks this should be voluntary and that the manufacturers can send them on their own.

Wolfe claims that 407 tendon ruptures had been reported by the end of 2007, and that there were an additional 341 reports of tendonitis after using the drugs. The FDA says they have received "several hundred" reports of ruptures but have not cited a specific number.

Tendon ruptures are more common with sports injuries occurring to men in their mid-30s. Scientists are unsure why the tendon ruptures occur while taking the antibacterials, and believe the link is "highly unusual." Those patients who have the highest risk of tendon ruptures include people over 60-years-old, those with heart and lung, and kidney transplants, as well as those taking steroids. Some of the ruptures also came without warning. There was simply a snap or pop after the patient started using the drugs. The FDA believes that flouroquinolone may be toxic to some individuals.

While the FDA believes that the injuries are probably preventable if patients stop taking them and switch to another medication at the first sign of pain or swelling, there are many who have already suffered injuries. There may even be some who are unaware that their injury is drug-related.

If you or a loved one has been injured by pharmaceuticals, such as Cipro or Levaquin, please contact an experienced injury lawyer in your area. If you are taking Cipro or Levaquin, contact your physician immediately to discuss changing medication.

The outbreak of Salmonella Saintpaul which has sickened 869 people, and put 107 in the hospital, may have as much to do with the types of food eaten with suspected tomatoes as the tomatoes themselves. The reason is due to the longevity of this outbreak, which began in April. The latest case tied to this particular outbreak was reported on June 20. Over half of the cases have been in Arizona, New Mexico, and Texas. What may be as disconcerting as the fact the outbreak may involve more foods than tomatoes is that Salmonella Saintpaul is an uncommon, and even rare, form of the bacteria.

Dr. David Acheson, associate commissioner for foods at the FDA, says that ten of the 100 laboratories that comprise the country's Food Emergency Response Network have expanded their testing of other foods. However, he won't say what those foods are. Another disconcerting fact, though Acheson says it would be "irresponsible" to say what the foods they are looking at are. Because tomatoes are used in several kinds of recipes and with different foods, it can be left to consumers' collective imagination as to what could possibly be tainted.

The FDA continues to stress that cherry, grape, and on-the-vine tomatoes are not part of the investigation, and that raw tomatoes from many countries and states are not associated with the outbreak. However, the investigation seems to be going slow enough that Michael Leavitt, Secretary of Health and Human Services, acknowledged there was frustration. Furthermore, the United Fresh Produce Association has asked for federal safety regulations in an attempt to allay the fears of consumers.

According to the Centers for Disease Control and Prevention (CDC), there are nearly 1.4 million cases of salmonella poisoning annually in the US. There are approximately 600 deaths each year as a result of these infections, accounting for 31% of all food-related deaths. Symptoms include:

• Diarrhea
  
• Fever
  
• Abdominal cramps
  
• Nausea
  
• Vomiting
  

These symptoms can last anywhere from 24 hours to seven days or more. Due to diarrhea and vomiting, dehydration is a serious concern.

If you or a loved one has become sickened due to a food borne bacteria, please contact an experienced injury lawyer in your area to see if you have a claim.

In 2007, the Food and Drug Administration (FDA) approved 19 new drugs. This was the fewest number of new medicines approved in 24 years. At the same time, they announced nearly 75 new or revised black-box warnings about the risks of side-effects. Furthermore, approvable letters the FDA sends out when they believe more data is necessary, increased 40%. According to drug makers the FDA's focus on safety is delaying new drugs, and many of these drugs are potentially life-saving. So what's with the delay?

In 2004, the drug maker Merck, withdrew the painkiller called Vioxx after it was reportedly linked to heart attacks and strokes. As a result, Merck was flooded with criticism and 28,000 lawsuits. Accusations about the drug maker putting profits ahead of customers' safety and the FDA allowing the drug onto the market were made very public. While the FDA may hold some of the responsibility, the drug industry has allegedly manipulated data, concealed dangerous side-effects, and promoted products it knows are dangerous. Evidence points to this episode beginning a sea-change in policy at the FDA. According to Kenneth Kaitlin, director of the Tufts Center for the Study of Drug Development, the FDA is "viewed as an agency that is supposed to keep unsafe drugs off the market, not to speed access to life-saving drugs." Either situation is not likely to gain the government agency points with an already wary public.

While Vioxx is one of the most widely publicized drug recalls, others, such as GlaxoSmithKline's diabetes drug, Avandia, Pfizer Inc.'s smoking-cessation drug, Chantrix, and the recent contaminated heparin debacle have all become part of the public record. As a result, several senators have taken the FDA to task for not being vigilant enough.

Matter of Balance

Though the FDA has approved drugs whose side-effects have led to devastating injuries and death, one of the central parts of this story is that of balancing risks that may affect only a small percentage of users against the possibility of improving quality of life, or even saving lives of hundreds of people. However, the problem certainly goes beyond this. According to the FDA, they have 500 vacancies for its staff of reviewers, and claim that having to train new hires delays the reviewing drug applications. They also claim that the low number of approved drugs is simply because fewer new drugs were proposed. According to Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, 33% fewer applications were submitted in 2006. Still, is this an industry response to fears of lawsuits when side-effects do harm users? Or is it that research showed the drugs had problems, and would never be green-lighted by the FDA? Dr. Woodcock denies that the FDA has become more conservative in its approvals, so it's unclear.

What is clear is that there are several drugs being held up that may, or may not, benefit users. Recently, Novartis quit trying to gain US approval for the diabetes drug Galvus and the painkiller Prexige even though Galvus is already on the market in Europe and Prexige has been approved in 50 countries. Glaxo's cancer vaccine Cervarix, Schering-Plough's sugammadex, a post-surgical drug designed to negate muscle relaxants, and Merck's pain medicine Arcoxia, were either delayed or rejected outright. These drugs are also on the market in Europe.

The outcome between balancing drugs to help people and drug safety is important, and this is part of the FDA's job. However, we, as current and potential future users need to know that we have access to them. And the drug makers and doctors need to rest assured that they will not encounter lawsuits for putting them on the market or prescribing the dosage.

Still, if you or a loved one has been harmed in anyway by a defective drug, please contact an experienced personal injury lawyer in your area.

In a report to be released this Monday, May 5, by the Journal of the American Medical Association (JAMA), experimental blood substitute tests allowed by US regulators raised the risk of heart attack and death. The report is written by scientists with the National Institutes of Health Clinical Center and advocates from the watchdog organization Public Citizen.

Biomedical companies and the government have been looking for a way to substitute the need for blood for several years. If a blood substitute is found, it will become a financial boon to companies that market it, as well as save lives in such places as battlefields. Theoretically it could be stored for years without the need for refrigeration, as well as not run the risk of carrying infections such as hepatitis or HIV. According to JAMA, the FDA had completed a dozen studies of blood substitutes by the end of 2000, and the risks were well known at that time. Dr. Charles Natanson of the NIH Clinical Center states that the FDA used their data to look at each product and each use (trauma, surgery, and in stroke patients) separately rather than pooling it to see the whole picture.

Ethical Concerns

After Public Citizen filed a lawsuit in 2006 to protest closed-door hearings, the FDA halted a planned test by the Navy to use the substitute on civilians without their knowledge or consent. While this raises certain ethical questions, American companies are testing products on people in South Africa and in some European countries. Cambridge, Mass.-based Biopure Corp. is using their blood substitute, Hemopure, on anemic surgery patients in South Africa. Study co-author Sidney Wolfe of Public Citizen states it is highly unlikely or even impossible, that these countries are aware of the risks, even though the governments have approved the tests.

Findings

The report shows 16 random control studies of five different blood substitutes with 3,700 patients involved. These patients include trauma, elective surgery, and victims of stroke. The findings show:

• A 30 percent higher risk of death for those who received blood substitute transfusions. 164 patients died compared to 123 who received ordinary blood or saline transfusions.
  
• Risk of heart attack tripled with blood substitutes. 59 patients suffered heart attacks with the new product compared to 16 who did not. Experts speculate that hemoglobin in the blood substitute removes nitric oxide from the blood, which causes blood vessels to constrict and a buildup of sticky platelets
  

Perhaps predictably, two of the companies whose products were included in the study call the analysis "flawed." Biopure vice president, Dr. A.G. Greenburg states, "There are vast differences among these products that make any pooling of data flawed, especially across different clinical experiences." Evanston, Ill.-based Northfield Laboratories Inc.'s CEO, Dr. Steven Gould explains that though pooled data can be useful to raise questions, it does not "provide answers about specific products or to examine fully the risk-benefit ratio of any particular product."

Defending the FDA's decision, Dr. Jay Epstein, the director of the FDA's office of blood research and review, says there are enough differences among the blood substitute products and their intended uses to allow some of the studies to continue. Dr. Natanson does give the FDA some credit, but says that while the agency may know more than any one individual at any of the companies, "they may not know the whole story" and there may be information being withheld from the FDA by these companies.

Dr. Natanson's theory seems to be backed up by Dr. William Hoffman, former chief medical officer at Biopure. He left in 2000 because management there wouldn't let him tell the FDA that he believed one of the studies should be halted. However, he states that management at Biopure has changed since then.

While it would be a huge break though to have a blood substitute, especially in times of crisis, there seems to be little doubt that the products being tested are far from ready. Clinical tests on people are an important step, but the individuals should be able to give their consent, and know the risks.

If you or a loved one has been injured due to a product risk you were not made aware of, please contact an experienced injury lawyer in your area.

As the Chinese government continues to insist that it had nothing to do with the tainted anti-coagulant heparin supplies found in stocks in the U.S. supply, officials have found contaminated heparin in 11 other countries. Meanwhile, the tainted heparin is now suspected in 81 deaths here. The Food and Drug Administration has identified 12 Chinese plants that have supplied tainted heparin to Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands, New Zealand, and the U.S. However, the origin of the contaminant is still being investigated. It is suspected that the added ingredient, hypersulfated chondroitin sulfate, is the culprit and that it was fraudulently added into the supply chain at some point.

The U.S.-China heparin row has taken on a new dimension with the Chinese government insisting that it be allowed to inspect the New Jersey plant where finished heparin vials are made. The plant is run by Illinois-based Baxter International. Ning Chen, second secretary at the Chinese Embassy states, "We don't have strong evidence to show that it is heparin or its contaminant that caused the problem." He states further that the problem has only been in the U.S., and refutes the finding that other nations were affected.

This seems to add to the fuel already on the fire regarding the safety of products from China. Lately products as diverse as tainted fish, toxins in pet food, lead in toys, and poisonous toothpaste have created problems between China and the U.S. This week has already seen the FDA send a warning letter to Changzhou SPL, the plant in China tracked down as the probable source of contaminated heparin. The letter states that the plant is unclean, the ingredients to make heparin, pig intestines, were received from an unacceptable vendor, and that the plant has no way to remove the impurities.

China has promised reforming the way products imported into the U.S. are created, going as far as executing the top Chinese food and drug regulator for taking bribes, but they also accuse "foreign forces" of making something out of nothing.

Another part of this issue that has come to light is that the FDA is badly underfunded. It is believed that, at the current pace, it will take the FDA over 25 years to inspect every foreign plant that exports medicines to the U.S., 13 years for every foreign drug plant, and almost 2,000 years to check out every foreign food plant. The Bush administration has acknowledged the problem, but Bush's current budget does not provide funds for the FDA to hire more inspectors. Should we get used to hearing more about substandard products from places like China?

If you or a loved one has been sickened by tainted heparin, please contact an experienced injury lawyer in your area.

Members of both political parties believe that the Food and Drug Administration needs further funding if it is to continue to protect American lives. As it stands now, a report sent out last year by a panel of outside advisers stated the FDA does not have the staff, scientific expertise, or the money to do all it can. The Appropriations subcommittee, which oversees the agency's funding, met with Dr. Andrew C. von Eschenbach yesterday to decide just how much money the FDA needs. All in attendance believe the White House suggestion of an increase of three percent in next year's allocated budget is not nearly enough. Dr. von Eschenbach said the agency wanted to hire an additional 700 people this year, but the proposed White House budget won't even cover expected increased costs.

Citing the heparin controversy, Dr. von Eschenbach said the FDA wants to open three new offices in Beijing, Shanghai, and Guangzhou, China. They will increase their Chinese staff to 13 with five native Chinese hired locally. This will hopefully lessen the chances that tainted products, such as the blood-thinner heparin, will make it to American markets.

It isn't only tainted heparin, but a plethora of other items, that are investigated by the FDA. Pharmaceuticals, food, medical devices, and even cosmetics are OK'd by the agency. Without the necessary funding, we may see an increase in the numbers of people injured and killed by products that had no business being sold, or given, to consumers.

If you or a loved one has been injured or sickened by a defective product or pharmaceutical that could have been removed from the market by the FDA, please contact an experienced injury lawyer in your area.

Federal officials have announced that a fairly common ingredient in nutritional supplements has been identified as the contaminant in heparin, a blood thinner used in surgery and kidney dialysis. Heparin helps to prevent blood clots that may cause heart attacks and strokes. The contaminant known as hypersulfated chondroitin sulfate, or chondroitin sulfate, is made from animal cartilage and is an ingredient in several nutritional supplements used to promote healthy joints. However, the hypersulfated chondroitin sulfate is not approved for use in the U.S. Levels of the contaminant ranged from 2% to 50% in lots of heparin tested.

Unknown Origin

It is believed that this substance is the culprit that sickened and killed hundreds of patients across the U.S. How it got into heparin is a question authorities are still investigating. The contaminant originated in China, and there are several theories about how it made its way into the drug. There may have been some kind of "mishap." Or perhaps it was an experiment gone awry. However, it may have also been deliberately added to the heparin to boost profits of middlemen. FDA officials may never find out due to difficulties in back-checking.

Sen. Edward Kennedy, chairman of a panel overseeing the FDA, stated, "it is unacceptable that Americans have died and been seriously injured by what appears to be deliberate tampering." He went on to say that those responsible must be brought to justice. Independent experts tend to agree that this is deliberate tampering, and akin to the pet food case in which thousands of cats and dogs were sickened by food ingredients from China last year.

Heparin manufacturer, Illinois-based Baxter Healthcare Corp., believes the contaminant was introduced before raw heparin ingredients reached its supplier, Scientific Protein Laboratories. Scientific Protein Laboratories is a joint venture partner with the Chinese facility that supplied the heparin in question.

Chinese Cooperation

It is hoped that this case will lead to better cooperation between the U.S. and China regarding imports. The last year has seen several high profile examples of the poor monitoring of products from China, including tainted pet food and lead in children's toys, as well as this case. But Chinese officials expedited the visas of FDA investigators. Their Chinese counterparts seem to have been more helpful with this case than others.

Rep. John Dingell wants a more stringent system that will oversee imports from other countries. It is unknown if the Bush Administration will go for it because the system would need to be financed by new industry fees.

If you, or a loved one, have been sickened by tainted heparin, please contact an experienced injury lawyer in your area.

Imports of heparin, a blood thinner used in surgery and kidney dialysis to prevent clotting, have been stopped at the border by the FDA to test for a contaminant. The contaminant was found in the drug thinner's raw ingredient, pig intestines, and is linked to hundreds of allergic reactions and 19 deaths.

The contaminant was found in 20 of 28 samples of raw heparin tested by the FDA. The raw ingredient is supplied by a Chinese factory, which is owned by Scientific Protein Laboratories in Wisconsin. Illinois-based Baxter International Inc. then supplies heparin to hospitals around the country. They are one of the main suppliers of heparin in the U.S.

This latest news stems from an earlier suspension and recall of heparin announced in February by the FDA. At the time that story broke, almost 450 allergic reactions and 21 deaths had been linked to contaminated heparin. The deaths have apparently been revised down to 19. No additional deaths and only two allergic reactions have been reported since last month's recall. Allergic side effects include increased heart rate and lower blood pressure.

Prime Suspect

When the FDA and Baxter announced the recall, the link between the contaminant and the allergic reactions and deaths was "tenuous." And because scientists have yet to identify what the contaminant is, there is still some uncertainty as to whether it caused the reactions and deaths. The uncertainty is due to the contaminant closely mimicking heparin's structure so it is not caught by standard drug-purity tests. FDA drug chief, Dr. Janet Woodcock, believes they are close to identifying the substance, as well as determining if it got into the heparin accidentally or through fraud.

The pig intestines used in heparin come from small family-run workshops in China. These are located near slaughterhouses, where the ingredients are then given to middlemen before they reach larger factories. The FDA hasn't inspected these workshops, so it isn't clear exactly where the contaminant might be. It has been surmised that due to pig diseases that depleted the stock of healthy animals used, the Chinese were buying sick pigs in the market. This forced Chinese producers to look for alternative sources, which often are located in villages with unsanitary conditions.

While worldwide testing has begun to make sure heparin is contaminant-free, five of the nation's leading heparin manufacturers will perform the testing on imports. The FDA will not name these five companies and do not plan on spot checking the quality of the tests.

If you, or a family member, believe you have suffered an allergic reaction due to contaminated heparin, please contact a personal injury lawyer with experience in pharmaceutical liability.