Drug Injury Attorney Blog

As a dangerous medical device lawyer, I was extremely disappointed by the U.S. Supreme Court’s 2008 ruling in Riegel v. Medtronic. That decision said injured people may not bring medical device lawsuits because of a loophole in federal law. The federal law on medical devices expressly preempts state laws; thus, any state-law claim that the manufacturer was negligent must be dismissed, no matter how badly injured victims may be or how clear the manufacturer’s negligence was. That was the fate of Degelmann et al. v. Advanced Medical Optics. Alexis Degelmann brought a proposed class action on behalf of a group of contact lens wearers, alleging false advertising by AMO after one of its products was associated with a breakout of serious eye infections. The Ninth U.S. Circuit Court of Appeals upheld dismissal of their claim, but on a different basis from the one the trial court cited.

In 2007, the CDC reported that AMO’s Moisture Plus contact lens solution was associated with an amoebic eye infection called Acanthamoeba keratitis. AMO recalled Moisture Plus and refunded the money of purchasers; various people who had contracted the infections filed suit. Degelmann and the proposed class did not get the infection, but had used Moisture Plus. Their complaint alleged that AMO falsely advertised Moisture Plus as an effective disinfectant and cleaner even though users were seven times more likely to develop an infection than users of other brands. AMO misled consumers, they alleged. The trial court invited AMO to file for summary judgment and then granted that motion, finding the plaintiffs did not have standing to sue because they had suffered no eye infections or financial losses. AMO’s motion mentioned federal preemption, but the trial court did not reach it. The plaintiffs appealed.

The Ninth Circuit agreed that the suit should be dismissed, but found a different basis than the one the trial court used. In fact, the appeals court disagreed that the plaintiffs suffered no injury in fact under California’s Unfair Competition Law. While the law does require injury in fact, the court said, a claim that they were misled into purchasing Moisture Plus is sufficient to show an economic injury. However, the Ninth Circuit went on to dismiss the claim based on federal preemption, noting that appeals courts may uphold trial courts based on anything in the record. AMO’s contact lens products are regulated by the Medical Device Amendments of the Food, Drug and Cosmetic Act. AMO has shown that it met FDA regulatory requirements, the Ninth said. But those amendments say state and local governments may not further regulate already-regulated devices. And in order to win their lawsuit, the court said, the plaintiffs would have to be able to show that California law requires something different from what the Medical Device Amendments require. Thus, the lawsuit cannot stand, the court said, and the district court was correct in dismissing it.

I cannot argue with the Ninth Circuit’s legal logic. But as a defective medical device attorney, I believe the legal situation that created this ruling is dangerous for American patients. By removing patients’ ability to file any lawsuit at all against medical device makers, the Supreme Court has absolved those manufacturers of responsibility for their actions. Thus, while the lawsuits over the Acanthamoeba keratitis infections may have prevailed in 2005, the same lawsuits cannot prevail today. That’s true no matter how clear it is that the manufacturer’s negligence caused the injury. This is undoubtedly advantageous for manufacturers, but it leaves Americans at the mercy of FDA regulations, which are frequently disinterested (and often declawed when the presidency changes). As a pharmaceutical liability lawyer, I hope Congress passes a law to correct this situation before their hand is forced by a widespread health emergency.

Continue reading "Ninth Circuit Upholds Dismissal of Contact Lens Case Based on Medical Device Preemption – Degelmann v. Advanced Medical Optics" »

As a dangerous medical device attorney, I’ve written several posts in this space about the dangers posed by Triad products. The alcohol wipes, prep pads and other disposable items are intended to be sterile so they can be used to clean and prepare the body for injections, surgery or other actions that increases the risk of infection. Tragically, Triad’s products were not sterile; they turned out to be infected with a bacterium called Bacillus cereus. Before the problem was caught, the ensuing infections killed a little boy in Texas and caused life-threatening illnesses to at least two other people. Worse, investigation showed that the FDA had known about gross safety violations at Triad’s Wisconsin plant for quite a while, but failed to address them. So I was sobered and disappointed to see an MSNBC article suggesting that a second alcohol prep wipes company has recalled potentially infected products.

Professional Disposables International, or PDI, shares a supplier with Triad, the now-defunct Wisconsin company. PDI has recalled all lots of five of its alcohol prep pad products because of positive test results for Bacillus cereus — the same organism in the Triad pads. Both companies bought their pads from Tudor Converted Products Inc. In fact, a Triad company has claimed in litigation that the pads from Tudor were the source of the Bacillus infection, though both Tudor and a spokesperson for PDI deny this. The article did not note whether the FDA has found any problems at PDI’s New York plant. Much of the media attention on Triad focused on gross violations at its plant, including the use of products known not to be sterile, insufficient radiation for sterilization, failure to adequately clean equipment and more. To make matters worse, the FDA let these violations slide, resuming inspections only after a Colorado hospital traced infections back to Triad and notified the agency.

Perhaps the most frightening part of this story is that alcohol prep pads are used to sterilize people’s skin where wounds are or soon will be. By introducing a bacterium into that area, the un-sterile pads do the exact opposite of what they are supposed to do, putting patients at risk of developing a life-threatening infection. That’s exactly what happened to Peyton Armstrong, who was 10 years old and being treated for leukemia when he developed a life-threatening Bacillus infection. It’s also what happened to two-year-old Harrison Kothari, who died of his infection after undergoing what was supposed to be minor surgery. More than 100 others have contacted the Kothari family’s attorney — and in fact, the true number of affected people may be much higher, because the problem extends across many Triad products distributed under multiple brand names across the U.S. As a defective drug lawyer, I hope the FDA is working hard to avoid repeating this terrible experience.

At Carey, Danis & Lowe, we focus our practice on the complex, serious and avoidable injuries caused by defective drugs and medical devices. Patients use the drugs and devices their doctors give them with the belief that their health will improve. When the product is dangerous by design, or contains a major manufacturing flaw like an infection, the product can actually be responsible for making things worse. A lawsuit cannot reverse the injury or illness, unfortunately — but it can help victims deal with the results of their injuries. Our pharmaceutical liability attorneys help victims pass the financial responsibility for the injuries back to the people whose carelessness or greed caused them. Victims can claim all of their financial losses, including lost wages and medical costs, as well as compensation for permanent disability, a loss in the family or more.

Continue reading "Second Maker of Supposedly Sterile Wipes Recalls Products for Possible Contamination" »

In cases of defective medical devices, I rely heavily as a pharmaceutical liability lawyer on the testimony of experts who can explain the medical events and causes behind my clients’ injuries. So I was interested to see an 11th U.S. Circuit Court of Appeals ruling excluding certain testimony from one victim’s treating doctors, which ended her case. In Williams v. Mast Biosurgery USA, Wanda Williams of Georgia sued the maker of SurgiWrap, a surgical barrier used on her reproductive system. She alleged that SurgiWrap tore holes in her colon, requiring doctors to remove part of it and giving her a serious infection.

Williams’ gynecologist, Dr. Adcock, wanted to remove adhesions (buildup of tissue between organs, often from surgery) from her abdomen to increase her chances of conceiving. After surgically removing the adhesions, Adcock put SurgiWrap on the area to prevent more adhesions. A month later, Williams came back to the office with pain, fever, diarrhea and other problems. Adcock admitted her to the hospital, where another doctor found hard pieces of plastic inside her colon, some embedded in the walls of the organ. Surgery to repair the damage found more pieces of plastic in her colon, ultimately requiring part of it to be removed and doctors to give Williams a colostomy (opening in the abdomen for removing feces).

Williams sued, alleging SurgiWrap had a manufacturing defect that caused her injuries. She asked all of the doctors who treated the problem to testify as experts, but Mast challenged their testimony. After their depositions, the court ruled that the doctors had offered a mix of lay, expert and inadmissible testimony. Importantly, their testimony that SurgiWrap was the foreign body was ruled inadmissible. Because there was no admitted testimony establishing that SurgiWrap was defective, the court granted summary judgment to Mast.

Williams appealed, arguing first that the court should have admitted testimony that SurgiWrap was defective. The Eleventh disagreed. Treating physicians like these are not always experts, the court wrote. When they offer a hypothesis rather than an account of how they treated the patient, they are experts, and thus subject to the test of Daubert v. Merrill Dow Pharmaceuticals. Because the doctors fail this test, their testimony was correctly excluded, the court wrote. Williams also cannot use lay testimony from Adcock as evidence for her claim, it said. Adcock’s admissible testimony said the only substance left in her body was the SurgiWrap, but the court said it does not necessarily follow that SurgiWrap was defective. No admissible evidence explained whether it was performing as intended or whether it caused the injury. Thus, the Eleventh upheld the trial court’s ruling ending the case.

As a defective medical device attorney, I am disappointed that Williams did not get a chance to present her claim after such a serious injury. Expert witnesses are usually not treating physicians, and this ruling showcases some of the reasons why. These doctors have personal experience with the patient and the problem, but not always the expertise necessary to identify the product and explain how it is supposed to work. As a result, plaintiffs who rely on their treating physicians to be experts can suffer the same fate Williams did — having the case dismissed entirely. Those patients may still call their doctors as witnesses, but as a dangerous medical device lawyer, I prefer to use separate experts to establish vital evidence.

Continue reading "Treating Doctors’ Testimony Insufficient in Medical Device Defect Case – Williams v. Mast Biosurgery USA" »

As a dangerous medical device attorney, I’ve written twice so far about serious contamination problems in supposedly sterile Triad alcohol prep pads and other products. The products attracted attention after the Kothari family of Texas filed a lawsuit against manufacturer H&P Industries, which blamed a contaminated H&P product for the death of their two-year-old son. Products containing the same bacterium are blamed for disabling heart problems in a Tennessee man and a life-threatening infection in a ten-year-old cancer patient in Colorado. The FDA ordered H&P to stop production March 28, but the company apparently did not immediately comply. Possibly as a result, U.S. Marshals visited the plant April 4 to seize potential evidence, triggering a shutdown.

Products manufactured by H&P have been the subjects of multiple recalls since Harrison Kothari’s death in November. In that case and in several other widely publicized cases, products used to prepare patients for surgery were contaminated with a bacterium called Bacillus cereus, which is not a common hospital-borne infection. The media later discovered that serious problems at H&P’s Wisconsin plant had been turned up as early as July of 2009 and again in early 2010, but the FDA took no serious action. Inspections found plumbing products that could cause contamination, employees handling products without gloves, improperly cleaned and sterilized equipment and a medicine being made without its active ingredient.

It wasn’t clear what triggered the FDA’s request that H&P shut down its operations, but as the Milwaukee Journal Sentinel reported, it is unusual for companies not to comply. An H&P spokesperson said the company was “considering its options” last week. The FDA’s next option could have been to get a court order forcing a shutdown. But on April 4, the U.S. Marshals Service arrived to seize materials at the plant, and H&P voluntarily complied with the shutdown order.

It’s good news for patients that the H&P plant has ceased production, but disturbing to me as a defective medical device lawyer that it took so long to address these problems. As I’ve written before, previous problems included the president of the company authorizing shipments of products even though they failed inspections, a clear breach of safety and possible breach of the law. The FDA also didn’t resume inspections until a Colorado children’s hospital had an outbreak of Bacillus cereus and reported possible contamination to the agency. This inaction by the FDA may have come at far too high a price for the families that suffered a death or illness. Several lawsuits have already been filed in addition to the Kotharis’, and more are expected as more families begin to connect their illnesses with the unsanitary products.

Continue reading "US Marshals Force Triad Alcohol Prep Pad Maker to Obey FDA Shutdown Order" »

Last month, I wrote a blog post about allegations that contaminated alcohol wipes were to blame for the death of two-year-old Harrison Kothari in Texas. As a dangerous medical device attorney, I’m disappointed, but not surprised, to see the wipes popping up again in news reports that the same infection triggered an investigation by a Colorado children’s hospital. As MSNBC reported March 7, The Children’s Hospital in Aurora, Colo. began an internal investigation after several children were infected with Bacillus cereus. It eventually found that the problem was contamination in Triad brand alcohol wipes. The discovery was credited with triggering the recall of the wipes, but critics wonder why the agency didn’t take action when it originally discovered problems with the plant in July of 2009.

Bacillus cereus is best known for causing food poisoning; it’s not an infection that typically gets passed around a hospital. So doctors at The Children’s Hospital were alarmed when they diagnosed it as a blood infection in several patients in late November. Those included Peyton Armstrong, 10, who was there for a medical port to start chemotherapy for leukemia, but developed an infection that nearly killed him and delayed his treatment. The wipes were used to sterilize children’s skin, and Triad was the only supplier; a spokeswoman said the hospital used about 2,500 a day.

After the hospital reported the problem, the FDA sent an inspector to the plant on the next business day, which eventually led to a Jan. 6 recall. But the FDA’s own documents show that it found problems in the plant as early as July of 2009, more than a year before the Colorado outbreak, and didn’t launch a recall or penalties because it did not believe the problems posed an imminent health hazard.

Clearly, that has turned out not to be true — certainly not for the Armstrong and Kothari families, and as many as 100 others who have contacted the Kothari family’s attorney. As a defective medical device lawyer, I know this could be extremely widespread and extremely serious. Alcohol prep pads, swabs and swabsticks are used as disinfectants before an injection or surgery, which is important because bacteria can cause an infection when the skin is cut. These contaminated pads don’t just fail to protect patients — they actually introduce the infection into some of the most vulnerable populations. Hundreds of millions of pads and swabs have been recalled, many of them packaged with injectable prescription medications or sold under a store brand name. We may only be seeing the beginning of a flood of complaints and lawsuits from people who were seriously hurt by contaminated Triad products.

Continue reading "FDA Resumed Triad Inspections Only After Colorado Hospital Found Contamination" »

As a defective medical device attorney, I was interested to see a growing number of stories about contaminated alcohol wipes blamed for the death of a little boy in Texas. MSNBC originally reported Feb. 15 on the lawsuit by Shanoop and Sandra Kothari of Houston, who lost their two-year-old, Harrison, in December. Harrison Kothari was supposed to have surgery to remove a benign cyst from his brain and spinal cord. But as he recovered at a children’s hospital, he was treated with Triad alcohol wipes that were supposed to be sterile. A few days later, he died of bacterial meningitis that was later determined to be caused by the bacterium Bacillus cereus. The Triad wipes were later recalled for possible contamination by Bacillus cereus, and the Kothari family is now suing the manufacturer Triad Group of Wisconsin.

Bacillus cereus is typically found in cases of food poisomning and is an unusual bacterium to find in a hospital. However, MSNBC followed up with a Feb. 22 report showing that the FDA knew there was a problem with the wipes as long ago as July of 2009. Plant visits by FDA inspectors in that month, and later in the spring of 2010, found that Triad couldn’t show that its sterilization process was working, but was continuing to sell its products as sterile anyway. Documents sent to MSNBC anonymously showed that the FDA was concerned about the low levels of radiation used in the sterilization of products, as well as Triad’s failure to address high levels of microbes found in a supposedly sterile lubricating jelly.

The reports show that the president of the company even authorized the shipment of a product that failed tests, only to recall it after some had already been sold. Triad also failed to evaluate and investigate a complaint by a hospital that one of its jellies was not sterile — one of six such complaints. Nonetheless, the FDA took no action to penalize the company or incentivize it to correct its problems. A note in the papers says only that Triad promised to correct the mistakes. In the week since the report, 50 people have contacted the Kothari family’s attorney to report their own health problems blamed on the Triad wipes, which range from skin infections to another death. And Joe Postich of Tennessee has also sued, alleging that contaminated wipes caused him to develop a heart infection that left him too disabled to work.

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As a dangerous medical device lawyer, I’m pleased that these reports have focused public attention on the regulatory lapses at the FDA. The FDA exists to protect us from contaminated, ineffective or otherwise dangerous foods, drugs and medical devices. But when it cannot or will not do that job carefully, Americans can be lulled into a false sense of security that products offered for sale are guaranteed to be safe, and seriously hurt or even killed. The pharmaceutical industry has been complaining in the past months about the FDA’s choice to increase regulatory actions — but this case shows that the agency may not be going far enough.

Continue reading "Complaints About Contaminated Alcohol Wipes Growing After MSNBC Investigation" »

As a defective medical device attorney, I was interested to see news reports about a second FDA warning for a company that makes artificial joints. As Reuters reported Dec. 29, Smith & Nephew, a British medical device company, received an FDA warning letter Dec. 21 saying the FDA was not satisfied with the company’s quality control. Smith & Nephew’s regulatory problems date from the summer of 2010, when the FDA inspected a plant in Germany and found problems with the way artificial hips were being sterilized. The new warning letter says the FDA feels the steps Smith & Nephew has taken are inadequate. The warning is not expected to make the artificial hips unavailable, as Smith & Nephew also has plants in Tennessee and Britain.

The problem is specifically with the manufacturing of the company’s R3 Ceramic Acetabular Systems, artificial joints used in hip replacement surgery. The FDA inspected the German plant in mid-July of 2010 and found that sanitizing procedures were not up to the legal standards required of all medical device manufacturers. For example, the FDA said Smith & Nephew’s irradiation procedures didn’t meet the specified minimum dose of radiation, which is intended to prevent infection. Despite this, the company also allegedly used those inadequately irradiated products. Smith & Nephew said it addressed those and other issues raised by the FDA, but in the Dec. 21 letter, the agency said those measures were not adequate. The company must contact the FDA within 15 days to explain what steps it is taking to solve the problems.

This back-and-forth between the FDA and the company looks familiar to me, as a dangerous medical device lawyer, because something very similar happened with the McNeil/Johnson & Johnson recall of many over-the-counter medicines. Unlike that case, however, this one involves medical devices that patients receive surgically rather than buying at a drugstore. That limits our ability to protect ourselves from potential health effects by throwing out or returning tainted products. And patients receiving artificial hips must rely on doctors to make sure the products they’re surgically implanting are safe and free of infection. An infection is particularly serious after an artificial joint replacement because the body can only fight off infection of its own tissues -- not of the artificial materials in the false joint. As a result, the artificial hip would most likely need to be removed in the event of infection, a painful and expensive prospect.

Continue reading "Artificial Hip Manufacturer Gets Second FDA Warning Letter for Sterilization Problems" »

If you watch television or browse the Internet, you’ve probably seen advertisements for Invisalign, a product that claims to straighten teeth invisibly and without braces. So I was very interested, as a defective medical device attorney, to see that the product’s manufacturer is in trouble with the U.S. Food and Drug Administration for failing to report potentially life-threatening allergic reactions. Makers of drugs and medical devices are required by law to report “adverse events” to the FDA, meaning injuries or illness to people who used the product correctly. As the San Jose Mercury-News reported Dec. 2, an FDA warning letter sent Nov. 18 faulted Align Technologies for failing to do this. The company must provide more information to the FDA or face fines and other penalties.

Invisalign uses a clear plastic casing to “train” teeth straight. That material apparently has caused an allergic reaction in at least three users, which in some cases led to hospitalization. However, the FDA said Align Technologies failed to report these, even though some cases date back as far as 2007 and could lead to serious injury or death. The FDA’s warning letter cited at least three cases of patients with swollen and irritated lips, swollen lymph nodes, burning sensations on the tongue, sore throat and mouth ulcers. One patient received steroids to treat an unspecified reaction. In all cases, Align failed to report the problem within 30 days as required by law. The letter also faulted the company for not responding with documentation adequate to show it’s taking corrective action. Align said it had responded.

As a pharmaceutical liability attorney, I wonder how many more of these Invisalign allergic reaction cases are out there but have not been reported. If Align has not been meeting its legal requirement to disclose allergic reactions, it’s hard to know whether this is a widespread problem or a few isolated incidents. However, the company says 1.3 million people have used devices in the Invisalign family. Even if 5 percent of those people had any kind of reaction, that would still be 65,000 people hurt by Invisalign. To make matters worse, Align has known since at least 2007 that its product can cause life-threatening allergic reactions, but failed in its duty to warn customers and the FDA. That failure to warn makes the company liable for any legal actions filed by people who were hurt by Invisalign products that they trusted -- but that the company knew could send them to the hospital.

Continue reading "Invisalign Maker Gets FDA Warning Letter for Failing to Report Allergic Reactions" »

Several months ago, I wrote about the discovery of an increased risk of cancer for patients who undergo CT scans. As a defective medical device attorney, I am particularly concerned to hear about the discovery of new risks from medical technologies that were thought to be safe. The radiation to which patients are exposed in CT scans -- in many cases unnecessarily, since many patients do not even benefit from them -- turned out to be at a much higher level than previously thought. According to a National Cancer Institute study, the radiation from CT scans performed in 2007 was likely to cause 14,500 fatal cancers.

This is a frightening figure. It becomes even more so in light of a recent St. Louis Post-Dispatch article about the effects of CT scans on children. Children are even more endangered by CT scan radiation than adults are, and about 19,000 children undergo CT scans each day in the U.S. Because their bodies are smaller, their organs are closer together than adults', so a CT scan of particular tissues or organs of the body is more likely to expose other tissues or organs to the radiation as well. Cancer can develop slowly, and since kids have more years of their lives ahead of them than adults do, they have more years during which cancer can grow from damaged cells. And while children's bodies are more sensitive to radiation, they are often scanned at adult levels.

Despite all of this, studies of children arriving in emergency rooms have found that up to a third of CT scans are performed unnecessarily, or even repetitively. Children with head trauma, but with mild symptoms that did not indicate serious injury, were sent for CT scans even though they did not need them. Variation in how CT scans are performed, within and across institutions, also increases the amount of radiation to which patients are exposed, according to a University of California at San Francisco study. Different machines use different doses, and technicians are not always able to understand the machines' manuals or keep up with new technologies. The machines could be programmed incorrectly as well, exposing patients to even higher levels of radiation than planned, as a recent New York Times article about radiation therapy for cancer reports. In fact, a California CT scan facility encountered a problem like this in 2009, when more than 200 patients were exposed to eight times the proper level of radiation, resulting in hair loss and skin problems.

While CT scans are an important diagnostic technology, clearly there is work to be done to ensure patients' safety. Dr. Steven Don, a pediatric radiologist at St. Louis Children's Hospital, advises parents to discuss with their pediatricians why any recommended CT scan is necessary, and to ask the CT scan technician what they are doing to make sure the radiation is at the proper dose.

As a dangerous medical device lawyer, I feel that parents without any special medical knowledge should not bear all of the responsibility for making sure that their children are not injured by unnecessary radiation. A parent whose child is in the emergency room is unlikely to be in a state of mind to have a careful discussion with his or her child's doctors in order to evaluate the risks of CT scan radiation. Rather, the machine's manufacturer has a legal responsibility to ensure that the machine is safe for patients, and that the machine's manual is comprehensible to technicians. (Decision-makers at a hospital may also share some blame.) If the manufacturer fails to ensure that its product is safe, people who have been seriously harmed by the product can sue to recover money for their medical costs and financial losses, as well as compensation for their physical and emotional injuries.

Continue reading "Radiation From CT Scans Poses a Special Cancer Risk to Children" »

Over the past two years, Baxter International Inc. has received reports of serious injuries and one death linked to its dialysis machines, and as of January 8, 2010, the company initiated a recall of the machines. These automated peritoneal dialysis (PD) systems, marketed as Home Choice and Home Choice PRO, treat both adults and children with severe chronic kidney failure by removing waste products and extra fluid from their blood. The defective machines have put too much of the dialysis solution used for this process into the patients, leading to increased intraperitoneal volume (IIPV), or overfill of the abdominal cavity. Unfortunately, this has led to at least one death, and serious injuries such as heart failure, hernias, and breathing problems. Children and nonverbal patients are at particular risk from these machines because they are unable to clearly communicate when something's wrong. Patients who already suffer from heart or lung problems also face special risk, since the defective machines can further damage these organs.

As a dangerous medical device attorney, I am concerned that Baxter International Inc. has chosen to continue marketing these machines in the face of this Class I Recall. According to the FDA, a Class I Recall is "the most serious type of recall" that involves "situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death." Baxter says that it will add alarms, messages, and software modifications to the device so that patients and caregivers will be able to stop fluid accumulation in time. Patients and caregivers who continue using the machines, as Baxter suggests, should be aware of danger signs such as vomiting, difficulty breathing, or feeling bloated. Children treated with this machine should be monitored as well, and danger signs for them include crying during therapy or reporting a "funny feeling" in the abdomen.

This is not the first time Baxter's products have been under scrutiny as dangerous medical devices or dangerous drugs. Most recently, in 2008, Baxter came under fire for failing to make obvious the difference between adult and children's doses of its anticoagulant drug heparin, resulting in overdose and death for a number of babies in several states. This included the newborn twins of actor Dennis Quaid, who eventually sued Baxter. The company did make the adult and children's labels more distinct from one another, but not before these terrible tragedies occurred. And in 2001, Baxter's dialysis machine caused several deaths.

Continue reading "Dialysis Machine Recalled for Potential for Death or Serious Injury" »

The hot medical news story of this week is one that interests me greatly as a defective medical device attorney. According to a Dec. 14 article from HealthDay News, two studies published this week in the Archives of Internal Medicine say CT scans, the commonly used diagnostic tool, may cause as many as tens of thousands of cancers each year. Doctors have always known that CT scans expose patients to radiation, but the studies found that patients who undergo them are exposed to more radiation than originally though. The authors of the study believe the risk is so serious that they asked doctors to carefully consider whether each CT scan is worthwhile and inform patients of the risk beforehand.

CT scans (formerly called CAT scans) use computer technology and X-rays to create detailed pictures of the inside of patients’ bodies. Dr. Rebecca Smith-Bindman, a lead author on one study, said doctors have lowered their thresholds for using CT scans so much that some patients get no real benefit from them. In fact, her team’s study said the use of the scans has grown dramatically in the past 30 years, from 3 million a year in 1980 to nearly 70 million in 2007. That’s a problem because the dose of radiation a patient receives during an abdominal scan can be as high as 90 millisieverts, which the article said was equivalent to thousands of X-rays. Radiation doses vary according to the type of scan, and tolerance varies across patients. One doctor quoted said that patients could expect to be exposed to that amount of background radiation over 30 years -- but with a CT scan, it comes all at once and focused on the body.

And this, the two studies said, can cause cancers. Smith-Bindman’s team found that one in 270 women and one in 600 men who undergo a coronary angiography CT scan at age 40 will develop cancer. That risk was doubled for 20-year-old patients and halved for 60-year-olds. The other study, headed by Amy Berrington de Gonzalez of the National Cancer Institute, broke down cancer risks according to gender, age and the type of scan. They predicted that CT scans performed in 2007 alone would result in 29,000 cancers, 14,500 of which would be fatal. The highest risks came from chest, head, abdominal and pelvis scans -- all of the most commonly performed. Women bore the greatest risk because they get the scans more often and are more likely to develop breast and abdominal cancers. In addition to warning patients and considering whether CT scans are truly necessary, study authors suggested tracking radiation exposure through a searchable database of medical records.

Radiologists stressed that fear of cancer should not stop patients from getting CT scans that help doctors address other major health issues, like heart disease. But as a dangerous medical device lawyer, I wonder how many patients have already developed life-threatening cancers because they submitted to a scan their doctors recommended. As a rule, patients trust that treatments and diagnostics their doctors recommend are safe and effective, or at least worth the risk. However, the oldest CT equipment, which tends to deliver the highest doses of radiation, is still in use, and patients are unlikely to be told how old the equipment is. That’s true even though the cancer risk from radiation is well understood and has been for decades. Going forward, patients can ask careful questions and give informed consent to CT scans. But for those already exposed, it may be too late to do anything more than assign responsibility after the disease develops.

Continue reading "New Studies Show CT Scans Cause Tens of Thousands of Cancers Each Year" »

As a St. Louis defective drug attorney, I was disturbed to read about a new Food and Drug Administration warning of potential irreversible cartilage damage from certain anesthetics and medical devices. According to a Nov. 17 article from the Wall Street Journal, the FDA has called for stronger warnings on the labels of pain pumps and certain anesthetics after 35 reports that they caused permanent cartilage damage (chondrolysis) in patients who received continuous infusions after surgery. In more than half the cases, patients needed additional surgery, including joint replacements for otherwise healthy young adults. The FDA required pain pump and anesthetic makers to update their labels within 30 days to include warnings about the destruction of cartilage.

The drugs in the FDA’s announcement include bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine and ropivacaine, all widely used local anesthetics. The FDA’s announcement noted that these drugs have been used safely for years or decades, but in smaller, short-term doses. They are not approved for continuous use or use in pain pumps, which deliver constant flows of medication over two or three days. In fact, the pain pumps themselves are not approved for use in joint (intra-articular) areas, the uses that generated the cartilage damage reports. Dr. Constance Chu, a cartilage restoration specialist the University of Pittsburgh, told the Wall Street Journal that local anesthetics are toxic to tissues at high doses and not intended for continuous use. The Canadian version of the FDA issued a warning about cartilage damage in January, following studies and reports on the issue.

Almost all (97%) of the surgeries the FDA reviewed were shoulder joint surgeries. Patients reported stiffness, loss of motion and joint pain as soon as the second month after their surgeries. About half needed additional surgeries to relieve the pain and symptoms, including joint replacements (arthroscopy). Cartilage damage and loss is not life-threatening, but it has an immense effect on the patient’s quality of life. Without cartilage, the bones in joints grind against one another, causing pain, swelling, loss of mobility and thus severe restrictions on the patient’s movement. Osteoarthritis, a common complaint among older Americans, is a form of cartilage loss with similar symptoms. A newer treatment called articular cartilage repair can mend some of the damage to cartilage, but this cannot restore cartilage. Expensive joint replacement surgery may be necessary to restore patients’ normal movements.

The Wall Street Journal noted that pain pump manufacturers are already facing hundreds of lawsuits around the United States over post-operative cartilage damage. As a southern Illinois pharmaceutical liability attorney, I expect the FDA’s warning to add to that number. If the FDA is correct, both the pain pumps and the anesthetics are apparently being widely used for off-label, unintended purposes. This report makes it explicit that the FDA does not approve of those uses, and is even taking steps to warn doctors and patients against them. In fact, medical studies turned up these problems as early as 2006, but manufacturers failed to warn patients about them -- and doctors continued to prescribe pain pumps full of anesthesia.

Continue reading "FDA Calls for New Labeling for Anesthetics Used in Post-Surgery Pain Pumps" »

The U.S. Food and Drug Administration is investigating possible defects in power cords used with medical devices from at least two companies, Reuters reported Oct. 19. Abbott Nutrition, a division of Abbott Laboratories Inc., and Hospira Inc., have reported 122 incidents of fires, sparks or charring from power cords used with their devices, which include infusion pumps and adult feeding tubes. This can expose users and health care professionals to injury or even death from shocks, fires, and failure of the device while in use. The FDA is warning hospitals and home users of devices to keep an eye on wear and tear on power cords, and stop using cords with visible damage. It also asked users to report any incidents of sparking, charring or fires.

All of the incident reports the FDA has received are about cords manufactured by Electri-Cord Manufacturing Corp. All of the implicated cords use a black plastic “bridge” connecting the plug’s prongs. The two medical device manufacturers, Abbott and Hospira, found that the prongs may fail or crack, either outside the cord or just inside the plastic covering of the plug. The cords have been supplied to other manufacturers of medical devices as well, and the FDA is tracing the cords to determine where else they may be. The problem has already sparked a recall from Hospira; the company initiated a voluntary recall in August, the same month it received a letter from the FDA criticizing its response to the power cord problem. A spokesman for Electri-Cord denied that defects are the problem, suggesting that most cords involved in reported incidents showed signs of “significant abuse.”

I don’t doubt that cords involved in fires, sparking or charring might look abused. However, as a defective medical device attorney, I applaud the FDA’s recall effort, which I hope will prevent further incidents that could seriously hurt someone. Defective cords on any device can be very dangerous because they can electrocute their users or start a fire. (In fact, defective wiring is among the most common causes of house fires.) This may be especially true in hospitals, where doctors routinely use highly flammable pure oxygen during surgery. But on a medical device that patients depend on for nutrition, medicine or other essential needs, faulty wiring can also have serious medical consequences unrelated to a fire or shock. If the device fails, temporarily or permanently, the patient can be deprived of its life-saving effects -- which can be at least as deadly as a fire.

Continue reading "Suspected Defects in Power Cords for Medical Devices Spark FDA Investigation" »

As a defective medical device attorney, I was alarmed to read a detailed article on medical device recall problems from the Associated Press Oct. 5. In short, the article exposes the federal government’s dangerous lack of a centralized system to track down people using medical devices that have been recalled for safety reasons. When a device is recalled, the FDA and manufacturers send out press releases and may make it into the news -- but only certain devices are registered and tracked so that patients may be personally notified. As a result, health care providers, medical professionals and patients may continue to use the recalled products for months or years before realizing the problem.

The FDA currently requires comprehensive registries for 14 medical devices, including pacemakers and breast implants, and a registry for artificial joints is in the works. However, thousands of devices are excluded from these registries, meaning patients must rely on medical providers to keep track of which devices have been recalled. Most hospitals note the serial number of a device in paper records, which can be time-consuming to sift through; some health insurers and nonprofit medical organizations are building their own databases. A comprehensive national medical device registry is part of the health care legislation that Congress is currently considering, but the medical device industry says it would be too costly and unnecessary. However, a study of 2,200 hospitals by a hospital umbrella group found that even after one device was recalled, doctors continued to implant it in at least 50 patients.

The article focuses on the sad story of married couple Michael and ShellyAnn King of New York. Michael King agreed to donate a kidney to his dialysis-dependent wife, but after the surgery to remove the kidney, a Hem-o-lock brand surgical clip popped off his renal artery. Before the problem was discovered, he bled to death in the hospital at the age of 29. After the incident, the King family discovered that the Hem-o-lock clips had been recalled about two years earlier out of concerns that they could dislodge from the renal artery and cause deadly uncontrolled bleeding -- precisely what happened to Michael King. The family’s dangerous medical device lawyer said the hospital had been notified of the recall but never took action. They are suing the hospital, the medical center and the surgeon involved.

This is disturbing news. Patients rely on medical devices to sustain or save their lives, or help them live normal, healthy lives. If our doctors and regulatory agencies don’t have the information they need to stay up to date on which devices have safety problems, they can’t give us the information and the excellent care that we deserve -- and that they want to provide. As a defective medical device lawyer and a longtime observer of the pharmaceutical and device industries, I know that both the use of medical devices and the number of medical device recalls have grown rapidly; the article notes a 164% increase in medical device recalls since 2000. Millions of patients are using devices in an industry with a spotty safety record. If even 1% of those devices slip through the cracks, that still leaves thousands of patients with potentially life-altering or fatal problems from devices implanted in their own bodies.

Continue reading "FDA System for Tracking and Announcing Medical Device Recalls Faulted as Recalls Soar" »

Last year’s Supreme Court ruling in Riegel v. Medtronic took away patients’ right to sue makers of defective medical devices that seriously harmed them or their loved ones. The court said in the 2008 ruling that patients may not file these legal claims because they are explicitly preempted by language in federal law. In response, Congress introduced the Medical Device Safety Act of 2009, which would correct that decision with language that explicitly says federal law does not preempt state-court lawsuits against makers of dangerous medical devices. On April 9, the New England Journal of Medicine published an editorial supporting the legislation, on the belief that it would make patients safer.

The editorial noted that thousands of medical device lawsuits have been thrown out of court since Riegel, regardless of how deserving the injured patients might be. In particular, it cited dismissal of more than 1,000 lawsuits filed by victims of the defective Medtronic Sprint Fidelis defibrillator, which is surgically implanted directly into the patient’s chest. The device has a defective wire that’s unreasonably likely to break, causing it to stop working or shock the patient internally at random times until it can be surgically removed. As the New York Times noted April 7, that surgery is very risky and should ideally be performed by a doctor who specializes in removing the wires. Medtronic itself notes that there have been 13 related deaths so far -- but thanks to Riegel, victims and their families have no legal recourse.

The editorial called for the Medical Device Safety Act’s passage for two major reasons, most importantly, patient safety. The decision shielded medical device makers from the potential consequences of not disclosing risks -- and as a defective medical device lawyer, I know all too well that some pharmaceutical companies are willing to hide risks in order to protect their profits. Restoring the right to sue would remove that risk and improve safety. It would also bring the law on dangerous medical devices in line with the law on defective drugs, the editorial said. The Supreme Court recently ruled in Wyeth v. Levine that federal law does not preempt state-court claims that a medication is defective, a decision the writers find inconsistent with Riegel. The proposed bill would level the playing field between drugs and devices, they wrote.

I strongly agree, and not just because this issue affects my practice as a defective drug and medical device attorney. Medical device safety, effectiveness and disclosure are literally life-or-death situations for many patients. The high-profile cases of drugs like Vioxx and Seroquel make it clear that not all manufacturers are putting safety ahead of profits, and mistakes or lax regulation by the FDA show that we can’t rely on that agency as our only safeguard. Allowing litigation in the cases that slip through the regulatory cracks would give medical device companies the accountability that American patients deserve. As the editorial said, “lawsuits by injured patients... have been an important part of the regulatory framework and very effective in keeping medical devices safe.”

Based in St. Louis, the Lowe Law Firm represents clients throughout the United States who have been seriously harmed or lost a loved one because of a defective prescription drug or medical device. If you or a loved one was hurt after taking a drug, and you believe the manufacturer failed to disclose important safety information about it, our Missouri defective pharmaceutical lawyers can help. To speak to us about your situation and your legal rights, please contact us online as soon as possible or call toll-free from anywhere in America at 1-877-678-3400.

Political lobbying may have trumped FDA scientists’ opinions during the approval process for the medical device Menaflex, the Wall Street Journal reported March 6. According to the newspaper, internal documents and emails show that FDA scientists twice rejected an application for controversial “fast-track” approval by Menaflex maker ReGenBiologics Inc. before the agency later approved the device. Agency emails show that officials later removed language from a draft letter because it documented special treatment for ReGen.

Menaflex is an implant used to treat tears to the meniscus, the most commonly injured part of the knee. Millions of people undergo surgery to correct a torn meniscus every year, and some need to repeat the surgery later. This device is unique, according to Dr. Jay Mabrey, an orthopedic surgeon who chaired the FDA advisory committee that considered Menaflex. For that reason, Mabrey told the Wall Street Journal, he believes it should not have been fast-tracked. Mabrey said he now suspects that the FDA packed the committee with friendly members to secure approval for Menaflex.

The ordinary approval process was not working out well for Menaflex. According to the article, ReGen started a clinical trial required under the conventional approval process, only to be rebuked by the FDA for recordkeeping violations and a conflict of interests on its independent oversight panel. ReGen then applies fast-track approval process -- which doesn’t require a clinical trial -- even though devices must be substantially similar to an approved device to qualify. After the FDA rejected its request twice, ReGen enlisted lobbying help from elected officials and sent letters pressuring the FDA to remove officials who had rejected their requests before. The agency did what ReGen asked, even after FDA scientists disputed ReGen’s favorable analysis of the results in its clinical trial.

The agency is already under fire for its handling of medical device approvals. An anonymous group of FDA staffers wrote to the Obama transition team in January calling for the removal of top medical device officials, saying the process was “corrupted and distorted by current FDA managers.” Also in January, the watchdog General Accountability Office said the FDA was too quick to allow fast-track approval. If all of these allegations are true, they point to severe corruption of the regulatory process -- and the science behind that regulation. And that would put patients who use and trust Menaflex in potential danger from an untested, unproven device.

As a defective medical device lawyer practicing in Missouri and around the nation, I have seen multiple cases of medical devices with serious flaws that cause real harm to patients. If improper pressure from ReGen contributes to another, victims could have a strong case against the company for knowingly bypassing safety regulations and selling an untested, unproven product. In a dangerous medical device claim, patients can win back all of the costs related to the injury, plus compensation for physical pain, emotional suffering and any permanent disability. The Lowe Law Firm handles these claims throughout the United States for a variety of unsafe medical devices, along with defective prescription drugs.

If you or someone you love has been hurt by Menaflex or any other flawed medical device and you’d like to learn more about your legal options, please contact the Lowe Law Firm online or call us at 1-877-678-3400.

Federal legislators are introducing new bills that would allow patients to once again file lawsuits over injuries from flawed or unsafe medical devices, the New York Times reported Feb. 19. The bills are necessary because of a February 2008 Supreme Court decision in Riegel v. Medtronic Inc. (PDF), which found that defective medical device lawsuits based on state claims are preempted by explicit language in federal law. The decision barred most, if not all, medical device claims, leaving patients at the mercy of a flawed FDA approval process.

The article starts with the story of the Turnidge family, which lost father Mark Turnidge in January. Turnidge, 33, had an internal defibrillator implanted into his heart, which was intended to regulate his heartbeat. Because of a break in the device that could have caused random, repeated electric shocks to his heart, Turnidge decided to have it surgically removed -- but the surgery went wrong. Turnidge died, leaving wife Wendy and two young boys behind. Wendy Turnidge is considering a medical malpractice lawsuit as well as a dangerous medical device lawsuit against Medtronic, the maker of the flawed defibrillator that made the surgery necessary. But thanks to the Riegel decision, a Medtronic lawsuit would almost certainly be dismissed unless Congress takes action.

Preemption is a legal doctrine that says federal law trumps the laws of states and local governments. If a federal law preempts a state law, following that federal law should protect individuals and businesses from criminal or civil liability for not following state laws on the same subject, including state negligence claims. The Riegel decision found that language in the Medical Devices Amendments of 1976 explicitly preempted state claims. (This makes it distinct from the court’s more recent decision in Wyeth v. Levine, in which the pharmaceutical company argued that the law implied, but did not outright specify, preemption.)

As the Times reported, this decision left medical device patients to rely wholly on FDA regulators to prevent serious injuries or even deaths from medical device defects. That would be more reassuring if so many medications and medical devices had not been recalled in recent years due to serious safety flaws, and if we had not seen so many reports of political and industry influence trumping science at the agency. As a pharmaceutical liability attorney, I have seen patients killed, disabled or diagnosed with lifelong serious health conditions because of injuries from FDA-approved medicines and devices. I do not believe FDA approval is enough to ensure safety, at least at the moment.

Based in St. Louis, The Lowe Law Firm represents clients in Missouri and throughout the nation in defective medical device litigation and dangerous prescription drug claims. If you or someone you love has been hurt by a pharmaceutical product and you’d like to talk with us about legal action, please contact us online or call us toll-free at 1-877-678-3400.

A federal judge has dismissed with prejudice lawsuits filed over lead wires to an implantable defibrillator made by Medtronic, the Associated Press reports.

The court concluded that the Food and Drug Administration’s approval of the device protected Medtronic from lawsuits under the legal doctrine of preemption. The lawsuit involved the Sprint Fidelis defibrillator wires. In 2007, the wires were pulled off the market after it was discovered that broken wires may have played a role in several patient deaths.

Last year, the U.S. Supreme Court ruled that Medtronic was protected from a similar lawsuit involving FDA approval of a balloon catheter that could burst during angioplasty.

With the democrats controlling the United States House, Senate and Presidency, this protection of medical device manufactures under the guise of preemption may be overturned legislatively.

If you believe you have been injured by a defective medical product, we can help. Contact The Lowe Law Firm headquartered in St. Louis, Missouri to discuss your case.

The Minneapolis Star-Tribune reported that a doctor from the Minneapolis Heart Institute Foundation expressed grave doubts this week about the safety standards for a new breed of defibrillators. In the Dec. 11 edition of the New England Journal of Medicine, Dr. Robert Hauser (writing with Dr. Adrian Almquist of the Heart Institute) warned that FDA regulations for the medical devices must be strict -- or patients could suffer lethal consequences.

The defibrillators at issue are an improved version of existing implanted defibrillators (ICDs), which are implanted directly into patents’ chests. The devices work by monitoring patients’ heartbeats and sending electric shocks to the heart if they detect missing or irregular heartbeats. Unfortunately, some existing models of ICDs had to be recalled after a lead -- the wire that leads from the device to the patient’s heart -- turned out to be likely to break. This has caused at least five deaths and sent other patients to emergency rooms with uncontrolled and random electric shocks.

Dr. Hauser was among the first to blow the whistle on past ICDs; he and a colleague went public with concerns in 2005 after a patient died due to a defective implanted defibrillator. His current concern, according to the Star-Tribune, stems from the fact that new devices can be approved by the FDA with little testing or review if they’re similar to existing devices. He writes that the new design, which features more leads attached to the patient’s heart, is different enough to require new studies before the FDA can safely approve it. A representative from the FDA wrote that no final decision has been made.

A representative from the medical device industry also told the newspaper that the manufacturers themselves test the devices thoroughly before they reach market. Unfortunately, this is cold comfort for victims of defective medical devices and unsafe prescription drugs. As a Missouri medical device defect lawyer, I have seen many situations in which pharmaceutical companies know all about problems with a device or medication, but intentionally do not disclose them to the public in an effort to keep profits high.

When this irresponsible behavior kills or seriously hurts patients, victims and their families have the right to sue the manufacturer over their physical, financial and emotional injuries. My law firm represents victims of several defective medical devices, including the defective Guidant defibrillator Dr. Hauser warned of in 2005. If you believe you’ve been hurt by a defective implanted defibrillator and you’d like to learn more about defending your rights, please contact the Lowe Law Firm for a free initial consultation.

Thoratec Corp. last month issued a worldwide recall of the HeartMate II Left Ventricular Assist Systems device.

According to the company’s press release, wear and fatigue of the percutaneous lead can cause the pump to stop working. At least five people have died while using the device and the company has received 27 reports of wear and fatigue to the electrical wire.

The mishaps occurred over the past five years with 1,972 implants. The pumps were distributed to 153 hospitals in throughout the U.S., Canada, Europe and other countries.

The recall affects devices with catalog numbers 1355 and 102139. The Lowe Law firm has experience with with defective medical devices and in particular the Thoratec Heartmate LVAD's. We are currently representing the family of a man who died due to the failure of the Thoratec Heartmate II.

If your life has been affected by a defective medical product, we can help. Contact The Lowe Law Firm in St. Louis, Missouri to discuss your case.

Transvaginal mesh has resulted in over 1,000 Reports of Complications in 3 Years. That number should be multiplied because epidemiologist in the medical field acknowledge that adverse events are under reported usually by a factor of ten. Consequently there may have been an additional 9,000 complications which were not reported.

FDA has issued a public health notification concerning serious complications associated with transvaginal placement of surgical mesh used in the repair of pelvic organ prolapse (POP) and urinary Stress Urinary Incontinence.

Over the past 3 years, FDA has received more than 1,000 reports from 9 surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI. These mesh devices are usually placed transvaginally utilizing tools for minimally invasive placement.

The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia.

Treatment of the various types of complications included additional surgical procedures (some of them to remove the mesh), IV therapy, blood transfusions, and drainage of hematomas or abscesses.

My law firm currently is handling cases for the defective Kugel Mesh and we are investigating cases involving other defective mesh products. The lawyers of The Lowe Law Firm are experienced in helping people injured by Defective Mesh Products. We will seek compensation for past and future medical expenses, past and future wages, pain and suffering, disability and other damages.

We offer a free initial consultation for victims harmed medical products. If you cannot make it to our office, we will come to you where ever you are.

Medtronic and the Food and Drug Administration (FDA) issued a Class I Recall of the Medtronic Neuromodulation INDURA IP. The recall of the Medtronic device was prompted by potential for life-threatening blockages.

A Class I Recall is the most serious of type of product recall issued by the FDA, and involves situations in which there is a reasonable probability that use of the product will cause serious injury or death.

The pain pumps are often used in patients who have spasticity related to cystic fibrosis, traumatic brain injury, multiple sclerosis and chronic pain. About 25,000 devices have been sold since May 2007.

This recall was prompted by potential misconnections of the Medtronic sutureless connector ("SC") catheters from the catheter port on the pump. These misconnections have resulted in a blockage between the sutureless pump connector and the catheter port on the pump and disconnection from the pump connector.

The Medtronic Neuromodulation INDURA IP consists of 2 models of intrathecal catheter, the sutureless pump, and the intrathecal catheter pump segment revision kit.

The intrathecal catheter or intrathecal catheter revision kits use a sutureless connector for the final connection to the implanted Medtronic SyncroMed II, SynchroMed EL, and IsoMed infusion pumps. The catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space.

The product models included in the recall are: Intrathecal Catheter, Model 8709SC; Intrathecal Catheter, Model 8731SC; Sutureless Pump; Connector Revision Kit, Model 8678; and Intrathecal Catheter Pump Segment Revision Kit, Model 8596SC.

My law firm currently represents numerous victims and their families in lawsuits against Medtronic. The lawyers of The Lowe Law Firm are experienced in helping people injured by Medtronic. We will seek compensation for past and future medical expenses, past and future wages, pain and suffering, disability and other damages. We also represent family members in wrongful death cases.

We offer a free initial consultation for victims harmed pharmaceutical products. If you cannot make it to our office, we will come to you.