The man's family sued both the company that makes the robotic system and the doctor for his wrongful death and settled a claim with the doctor out of court. The trial that is pending now is over the possible negligence of the company that makes the device, Intuitive Surgical Inc.
]]> Among the many things that the family's attorney told the jury the company did wrong was providing only one day of training for surgeons who want to use the system. After that they are required to perform only two supervised surgeries before being permitted to use the system alone. This standard appears to have been established by an executive at Intuitive Surgical who had business experience as a wine salesman but no medical training or background in the medical device industry.Ultimately a company is responsible for the actions of their employees and for hiring appropriately qualified individuals to make essential decisions like this. If the jury agrees that the company inadequately trained surgeons and failed to take an appropriate level of care in protecting patient safety, then the company will be liable for the wrongful death. The family of the deceased man is asking for $8.45 million in damages for the expenses related to his injuries from the surgery and for the pain and suffering caused by his illness and death.
Source: Bloomberg, "Intuitive Robotic Surgery Case Goes to Seattle-Area Jury," Patricia Guthrie & Joel Rosenblatt, May 22, 2013.
]]>The drug, known as Depakote, is very effective in treating migranes but as a side effect for pregnant women would lead to a variety of injuries for their babies. The drug has been linked to lower IQs for babies born to mothers who used the drug while they were in utero.
]]> It is not clear if the drug is harmful at all stages of the pregnancy or when a woman should stop taking it if she is planning to become pregnant, but FDA regulators say that the evidence shows that the risks associating with taking the drug far outweigh the benefits at this point.Doctors say that there are alternative drugs available to patients that have similar benefits but do not have the same documented risks for pregnant patients. Patients should also be aware that Depakote is sold in several generic equivalents, so it is important to check with a healthcare provider if there are concerns about the safety of a migrane medication.
Unfortunately, families may have already been injured by the side effects of this dangerous medication. If that is the case, it is possible for affected parents or children to pursue an action against a pharmaceutical company. Now that a warning about this drug has been issued, there will be signficant questions about whether the company knew or these risks but failed to inform or warn patients.
Source: KMSP TV, “FDA warns migraine medicine Depakote may lower child’s IQ,” Bill Keller, May 7, 2013.
]]>The guilty plea comes after years of investigation by federal safety officials who took a highly unusual step of temporarily baring the company from importing drugs for a period of time in 2008 when quality concerns arose. Various other concerns by regulators lead to other restrictions over the past several years and then in 2012 the company had to recall 41 lots of their generic version of Lipitor when glass particles were found in the capsules.
]]> Despite this, American patients may still be at risk from the defective pharmaceuticals. A recent contract to provide Lipitor to the Department of Veterans Affairs is of particular concern, since it is not clear that the contract will be cancelled as a result of the guilty plea.Patients who are injured from taking improperly formulated or tainted medications have a right to seek justice and compensation from the negligent pharmaceutical company. In this case, since the company has been show to have acted knowingly in distributing tainted and dangerous medications to the American public, there may be some additional damages available to patients who were victims of the dangerous drugs.
In addition to the criminal penalties, the company is also subject to civil allegations in a whistleblower case. Between the criminal and civil cases, the drug maker will pay a total of $500 million in damages.
Source: CNN Money, “Maker of generic Lipitor pleads guilty to selling ‘adulterated drugs,’” Katherine Eban, May 13, 2013
]]>The tragic outbreak brought attention to the fact that compounding pharmacies may ship large quantities of drugs to hospitals and clinics around the country without signficant oversight from state or federal governments, putting patients at serious risk of harm from contaminated drugs or improperly formulated medications.
]]> Under the new bill that lawmakers are working to finalize, larger scale compounding facilities who ship across state lines and create large batches of medication would be re-categorized and subject to FDA oversight. Facilities that produce medications to fill an individual prescription or that do not ship out-of-state would remain under state authority.Typically the federal government can only regulate interstate commerce, but the courts have allowed Congress to extend its reach to commercial activity that does not cross state lines but that does have a substantial impact on interstate commerce. since the major concern in this case is public safety, lawmakers are considering extending the reach of the FDA to cover compounding facilities that do not ship across state lines but that do produce a large quantity of medications for use within one state.
One industry spokesperson told the committee that the volume of medications produced and the associated risks can be just as large for facilities that operate within a single state as those that ship regionally or nationwide. Some worry that carving out an exception will encourage pharmacies to structure themselves to intentionally avoid government oversight.
Lawmakers and safety advocates have expressed concern about under-funded and under-staffed state pharmaceutical licensing authorities, which typically have about 5 employees to inspect all facilities within the state. There are also relatively lax reporting standards, meaning that many states do not have a comprehensive list of all compounding pharmacies operating within its borders.
Source: Reuters, "Senators Finalizing Drug Compounding Regulation Bill," Toni Clark, May 13, 2013.
]]>Doctors always have a responsibility to inform patients of the risks associated with a particular device or procedure, particularly when there have been documented incidents of death or serious injury associated with a device. At the same time, the device manufacturer and the FDA may be in a better position to assess the overall safety of a medical device because they have a bigger picture of uses in a variety of contexts.
]]> This particular device has one of the lowest rates of serious complications according to FDA statistics. There are still always concerns, though, even with the most common devices, about potential malfunctions or a singular incident of a defective product.A weight loss surgeon recently told reporters that the Lap Band is not always the best choice for very overweight patients and said that he removes about four Lap Bands from patients each month.
When a medical device is known to be dangerous or simply malfunctions for a particular patient, the pharmaceutical company has an obligation to take responsibility for the injuries that result. This may mean compensation for the medical bills for the additional surgeries required to remedy the harm, but can also extend to other economic and personal costs to injured patients.
Source: Philadelphia Inquirer, "Christie's stomach procedure has fans, skeptics," Stacey Burling, May 9, 2013.
]]>If you have taken an atorvastatin such as Lipitor or Crestor in the past, or if you are currently on any of these medications and you are experiencing any of these symptoms of Type 2 diabetes, please see a doctor immediately:
•- Increased thirst and hunger, especially being hungry right after a meal
•- Dry mouth
•- Frequent urination and unusually dark urine
•- Questionable weight loss regardless of your eating habits, especially if you have lost weight but are eating much more than usual
•- Muscle fatigue and general tiredness
•- Blurry vision, headaches, and nausea
In 2012, a study was released that statins such as Lipitor can increase the risk of diabetes in women by as much as 48%. In early 2012, the Food and Drug Administration began requiring warnings about possible diabetes-related side-effects on labels of drugs like Lipitor, Crestor and Zocor. Shortly after, the Women's Health Initiative conducted a study of 150,000 women who had already experienced menopause and found that if they were taking cholesterol-lowering drugs such as Lipitor, the chances of being diagnosed with Type 2 diabetes increased by as much as 48%.
Many health experts agree that the risk of statin drugs like Lipitor are just one of the latest lies that "Big Pharmaceutical" has fed to doctors and patients that are adversely affecting women's health. Some agree that pharmaceutical companies have been particularly negligent when it comes to women because women are bigger consumers when it comes to health care. Thus, women are highly profitable marketing targets who account for the billions of dollars with which pharmaceutical executives line their pockets.
Arguments have also been made that manufacturers of drugs like Lipitor are aware of the side effects, but sell the product regardless and make so much money before connections to diseases are made that they have enough to pay legal settlements and still make a hefty profit-many are even reported to include settlement payment in their overhead.
It is important that women consult a trusted physician and do their own research if they are ever interested in one of the many drugs out there like Lipitor that are marketed as a "fountain of youth" medicine. Remember, if something seems too good to be true, then it likely is, and while drugs like Lipitor may seem to be your saving grace they are often temporary patches that can lead to detrimental health problems down the road.
Links to more articles to read that may be of interest are listed below.
http://www.reuters.com/article/2012/02/28/us-fda-statins-idUSTRE81R1O220120228
http://www.reuters.com/article/2012/01/09/us-statin-diabetes-idUSTRE80826K20120109
]]>Botox has been approved by the Food and Drug Administration for primarily cosmetic uses such as reducing the appearence of lines between the eyes. It is also used for some therapeutic medical reasons but is not specifically approved for treatment of spasticity.
]]> An off-label use is one that was not specifically approved by the FDA when assessing the safety of the drug. Doctors can prescribe medications for off-label uses after an evaluation of the patient's specific needs, but drug companies may not promote these alternative uses to either doctors or patients.The parents of the teenage boy say that the drug company Allergan, which makes Botox, actively promoted the use of the drug for a wide range of ailments and that in doing so they also failed to warn patients of potential dangerous side effects. The company sells the injection using words like "safe" and "miracle drug", leading patients to believe that there is a low or nonexistent possibility of detrimental side effects and certainly creating the expectation that it would not lead to death.
Patients who are injured or who die when a drug has an unexpected dangerous side effect have a right to seek compensation from drug companies who failed to adequately warn of the risks of using the medication.
Source: Courthouse News Service, "Parents Claim Botox Killed Their Son," Elizabeth Warmerdam, May 6, 2013.
]]>The chemical is part of the billion-dollar anti-bacterial industry: tricolsan. Tricolsan is used in several antibacterial products - many of which are probably in your home. It might be in your hand soap, toothpaste and children's toys. In fact, sources suggest that approximately 75 percent of antibacterial liquid soaps and body washes sold in the U.S. include this potentially dangerous agent. The concern surrounds the potential side effects.
]]> Research is looking at the chemical's hormone-related problems, which increase the risk of infertility. Moreover, tricolsan predates current laws that require scientific analysis. Therefore, the Food and Drug Administration will only now study the chemical.Can you imagine? You use many of these products for the purpose of preventing harmful disease and side effects (for example, the common cold). However, the very items that are supposed to protect you may be causing harm. This is alarming to consumers.
If you have been experiencing harmful side effects from a medical product, it may be time to see a doctor. Furthermore, if you think the product is connected to your problems, you may be entitled to legal recovery. If you would like to learn more, you can speak to a local pharmaceutical products attorney.
Source: Fox News Radio, "FDA To Study Side Effects Of Popular Germ Killer," May 2, 2013
]]>The device stimulates brain tissue to treat a variety of neuroligical conditions in addition to Parkinson's, including tremors and involuntary muscle contractions. The problem, according to Medtronic, is that the cap used to protect the wires can sometime damage the wires during the surgery to instert them.
]]> Doctors and hospitals have been informed of the recall and Medtronic has submitted an updated designed to the FDA for approval that would eliminate this defect.Replacing the wires or removing the device is no simple matter, requiring an additional invasive surgery for already vulnerable patients. This could put them at serious risk for additional brain damage or surgical complications.
It is these types of complications that result from a defective medical device that can cause patients so much additional pain and suffering. Not only are they harmed by the original defect in the device, but they must also endure costly and painful follow-up procedures to correct the problem.
The company says that if patients are receiving the therapy as expected, that the device that they have implanted may not be defective. However, that is quite a risk to take with something that is implanted in one's brain that sends electrical pulses into the tissue.
Source: Bloomberg News, "FDA: Flaw in Medtronic's brain-stimulation device," Michelle Fay Cortez, May 2, 2013.
]]>The FDA relies on patient complaints and consumer reporting in order to know which devices or medications are causing injuries. Only a fraction of actual injuries from defective devices are actually reported to the FDA, but patients who do take the time to make a complaint help show the FDA where the problem is and contribute to figuring out whether there is a need for a nationwide recall.
]]> In addition to reporting defective devices like malfunctioning hip replacements, the application for smart phones will also allow patients and healthcare professionals to make reports about incidents that occur when they are not certain of the cause. Providing detailed information about an injury or incident and the surrounding circumstances will help the FDA determine whether the device caused the harm or not, and the additional data will help them detect patterns of patient injuries even when the cause is not obvious.Patients can upload photographs, too, to help regulators identify the specific medical device and get detailed information on the problems that it is causing.
Sometimes the symptoms of a defective medical device can start out small and patients think that they are just experiencing routine pain from the surgery or from living with an implant. However, it is important that patients do not ignore the signs of potential trouble and seek medical treatment when a device is causing signficant pain or creating unusual symptoms.
Patients who are suffering from an injury from a defective device can also seek compensation from the manufacturer for their medical bills and other costs associated with recovering from the injury.
Source: Consumer Reports, "Got a complaint about a medical device or drug? There's an app for that," April 29, 2013.
]]>While many consumers might take the label of "supplement" to believe that they are buying and using a product with natural or mild ingredients, the truth is that some supplements, like those for bodybuilding, can contain very real drugs like steroids.
]]> The FDA initiates countless recalls each year, some of which are more urgent for public health and safety than others. Class one recalls are designated as the most urgent and are instituted for drugs that contain ingredients that the FDA says have a "reasonable probability of causing serious adverse health consequences or death."Once the FDA identifies an "adulterated" supplement, like one containing steroids, the recall process begins. Unfortunately, a recent investigation found that the FDA lacks some of the basic tools to complete this task, namely the correct contact information for 20 percent of manufacturers.
This is intentional on the part of the manufacturers, who know that changing a company name or address or slightly altering the formula for the product can throw regulators off of their scent. As a result, many supplements that are in fact subject to recalls by the FDA are still on the market and consumers continue to unknowingly purchase a potentially dangerous product.
While these manufacturers may try to escape regulators, companies can and must be held responsible when their products injure consumers. Harmful supplements should be taken just as seriously as other dangerous drugs and consumers have a right to pursue justice from the responsible party.
Source: Forbes, "Massive Drug Recalls are a Wake-Up Call for Vitamin and Supplement Industry" David DiSalvo, April 18, 2013
]]>The lawsuit was filed by the wife of a man that allegedly died after taking the medication. She claims that representations were made that taking this brand of Tylenol would be safe for users when in fact it could cause damage to the liver. Her husband apparently died of acute liver failure due to what is called acetaminophen poisoning and toxicity.
]]> The deceased man had to undergo a number of medical procedures in an attempt to save him. He underwent a liver transplant operation, but his body ultimately rejected the new liver. Apparently, there were no warnings that Tylenol could affect the liver until 1993, and the warnings at that time were specifically aimed only at individuals that consumed three or more alcoholic beverages per day - which presumably did not apply to the deceased man.We will await the outcome of this lawsuit. Without question, such a case will be extremely difficult for the attorney representing the wife of the deceased man to prove. Attorneys trying such cases require extensive understanding of medical technology and the process for producing products like Tylenol, and will also need to be adept at questioning medical experts and doctors on the stand.
Taking on large drug manufacturers such as Johnson & Johnson is a difficult undertaking to begin with. These companies have an endless supply of money to throw towards the defense of such cases. Still, there have been a number of cases such as this that have resulted in large verdicts.
Source: The Pennsylvania Record, "N.Y. Tylenol wrongful death claim transferred to MDL in Philadelphia," by Jon Campisi, April 11, 2013
The lawsuit has actually been brought by Pfizer's shareholders, who are saying that the drug company misrepresented how safe the two medications were. This misrepresentation, they say, along with the fact that the medications have now been associated with some serious health risks, caused the value of shareholder's stock to plummet. Since the concealment of the safety hazards was allegedly intentional, board members and executives may be held liable for shareholder's financial losses.
]]> This is a very different kind of lawsuit from the dangerous drug suits that we normally cover. However, just as class action and individual cases brought against dishonest drug companies help create a financial incentive to do the right thing in the future, this shareholder suit could show drug companies another side of financial loss and civil consequences for misleading labeling of dangerous drugs.The shareholder suit could also lead to the dismissal of board members or other executives who condone or encourage misrepresenting the safety of certain medications, which could in turn lead to more responsible decisions about releasing products.
Questions about the safety of these pain medications began after a very similar competing medication was taken off of the market by a different drug company. Celebrex, a drug that treats arthritis pain, is still on the market despite concerns about its safety for patients. The other drug was pulled from pharmacy shelves after the FDA recommended that Pfizer do so.
Source: Reuters, "Pfizer fails to end lawsuit over Bextra, Celebrex safety," Jonathan Stempel,
Information about what patients can do if they have been injured by Celebrex or Bextra can be found on our dangerous drugs page.
]]>Whether or not manufacturers could produce a generic version of the drug was up for debate as the patent neared its expiration. The company that makes the brand-named version, Purdue Pharma, said that a newer version released in 2010 was safer for patients because it was less prone to tampering and that the old version should be pulled from the marketplace.
]]> The motivations for this are questionable since Purdue stands to profit hugely from the absence of generic versions on the market. However, the truth remains that people who tamper with narcotics and take them either without a prescription or not according to their prescription can be prone to serious consequences such as an overdose.The original version of OxyContin could be crushed fairly easily, while the newer version resists becoming a powder and instead becomes jelly-like and sticks together. This makes it harder or impossible to ingest through the nasal passage or use as an injection, two ways that people who are abusing the drug typically try to use it.
OxyContin has been the subject of controversy before with regards to its harmful properties. When it was originally brought to the market in the mid 1990s, drug companies claimed that the time-release technology limited the potential for abuse, an assertion that turned out to be false and which led to harm for substance abuse-prone patients who were given the drug.
The FDA is supposed to protect patients from harmful pharmaceuticals and to balance the usefulness of a medication with the risks associated with it before approving it for the market. Hopefully the new version of OxyContin will not cause harm to patients in the same profound way that the original version has.
Source: New York Times, "F.D.A. Bars Generic OxyContin," Barry Meier, April 16, 2013.
Patients who have been injured by dangerous drugs can seek a remedy from the drug companies. More information is available on our website.
]]>There are many different companies that make this product and many different iterations have proven to be dangerous for patients. The FDA has issued a warning about the mesh in general, but says that based on the complaints it has received there is no link to a single brand. People who have been injured experience pain in their legs and abdominals and say that it is difficult or impossible to leave the house. Additional surgeries are necessary to remove the defective surgical mesh, but sometimes doctors are unable to remove all of it, leading to years of pain and suffering.
]]> Patients who have had surgical mesh implanted and who have experienced injuries and infections as a result have a right to seek a remedy from the pharmaceutical company that manufactured the defective device. In addition to compensation for the significant medical expenses, injured patients can also pursue compensation for their diminished quality of life and inability to continue to work. Each case is different, so it is important to consult with an experienced professional to find out more about the rights of a specific patient.Source: First Coast News, "Surgical mesh complications tear lives apart," Heather Crawford, March 23, 2013.
More information about the rights of patients who are injured by surgical or transvaginal mesh can be found on our personal injury site.
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