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Category : Drug Injury Lawsuits
Fresenius Medical Care, the German-based company responsible for treating over one third of American dialysis patients, is under scrutiny after information came to light linking their dialysis products GranuFlo and NaturaLyte to an increased risk of cardiac arrest. More troubling than the up to six-fold increase in risk of cardiac arrest over competing products is that Fresenius appears to have hid the information from the public, as evidenced by an internal memo that was released in November 2011. The memo, titled “Dialysate Bicarbonate, Alkalosis and Patient Safety,” was distributed to doctors operating in Fresenius-owned medical care centers in the United States, and warned that their products could be linked to an increased risk of patients dying through sudden cardiac arrest. It wasn’t until the memo was anonymously leaked in March of 2012 that the problem became public knowledge.
Of particular import in a case such as this are the dates in which the situation unfolded, e.g., there was over a four months between the date of the initial memo and the release of the leaked version. Therefore, to help make the case clearer, we have outlined the most crucial developments in the case in the timeline below.
January 1st – December 31st, 2010 – First Information Concerning Risks Emerges
Research carried out by Fresenius Medical Care (FMC) discovers that 941 patients from 667 facilities suffered from cardiopulmonary arrest. This figure is over six times higher than that of competing products.
September 15th, 2011 – FDA Sends Warning Letter to Fresenius
The FDA sends a warning letter to the Fresenius CEO after their investigation reveals FMC is inadequately addressing complaints filed by patients using the company’s products. The letter addresses five major areas of fault, including “Failure to establish procedures for investigating the cause of nonconformities stemming from incidents pertaining to NaturaLyte Acid Concentrate” and “Failure to establish and maintain an adequate preventative action to ensure identification of actions needed to corrects and prevent problems.”
November 4th, 2011 – Internal Memo Circulated
The internal memo, “Dialysate Bicarbonate, Alkalosis and Patient Safety,” is sent out to Fresenius doctors warning of the risks associated with their GranuFlo and NaturaLyte products. In the document it is written that “[the] issue needs to be addressed urgently.”
March, 2012 – Memo is Leaked to the FDA
Over four months after the original internal memo was circulated, the memo is anonymously leaked to the Food and Drug Administration (FDA).
March 29th, 2012 – Fresenius Issues Warning to Doctors
On March 29th, 2012, Fresenius releases a modified update to the original memo, warning doctors of the dangers associated with its products. The same day, the FDA issues a statement informing the public of the notice. In the statement, the FDA writes, “The manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in Fresenius’ Naturalyte Liquid and Granuflo Dry Acid Concentrate…This product may cause serious adverse health consequences, including death.” The recall is listed as “voluntary.”
May 25th, 2012 – FDA Issues Update Warning Doctors of Dosing Dangers
The FDA releases an update warning doctors of “alkali dosing errors that occurred during hemodialysis using dialysate concentrates containing acetic acid and acetate.” The press release recommends that doctors exercise more caution when prescribing these products to patients and urges doctors to “be aware that metabolic alkalosis (pre-dialysis serum bicarbonate levels greater than or equal to 27 mEq/L) has been associated with a higher risk of death in hemodialysis patients.
June 14th, 2012 – New York Times Reports that FDA is Investigating Fresenius Medical Care
An article released on June 14th raises the public profile of the Fresenius case by reporting that the FDA is investigating the company to determine if Fresenius “violated federal regulations by failing to inform customers of a potentially lethal risk connected to one of its products.” The report gives a brief summary of the case until that date, and includes a statement from Steven Silverman, the director of compliance for the FDA’s medical device division, in which he states, “Personally, I’m troubled by the fact that Fresenius on its own initiative didn’t notify its entire customer base of this particular concern.”
June 27thth, 2012 – FDA Issues a Class I Recall of GranuFlo and NaturaLyte Products
FDA releases a statement announcing a Class I recall of GranuFlo and NaturaLyte, citing that “Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis.” Class I recalls are the most serious recalls of their kind and the move is considered one of the most important developments in the ongoing case against Fresenius.
For more information, visit www.seegerweiss.com/granuflo-lawsuit.
Following a string of troubling findings concerning the risks involved with the use of GranuFlo and NaturaLyte dialysis products, Seeger Weiss LLP is advising that the Food & Drug Administration (FDA) has opened up an inquiry into the parent company Fresenius Medical Care (FMC), combined with a Class I recall of both products. The inquiry’s goal is to determine whether Fresenius violated federal regulations by omitting critical information concerning the potentially deadly risk associated with use of the products.
FMC, based in Germany, is the largest operator of hemodialysis centers in the United States, and processes more than a third of the nearly 400,000 Americans who receive dialysis treatment each year. A memo that Fresenius issued in November of 2011 warns that the GranuFlo and NaturaLyte products could lead to a greater risk of cardiac arrest and other heart problems.
The issue was first brought to public attention after an internal memo was anonymously leaked to the FDA earlier this year. In the memo dated November 4th, 2011, FMC warned doctors operating in their dialysis centers that their products may be causing dangerously high biocarbonate levels that would put their patients at a risk of cardiac arrest up to six times higher than that of patients using competing products. The memo also stressed that “This issue needs to be addressed urgently.”
Despite the findings, it was only after the FDA opened an investigation into the matter that FMC issued a wider warning to other care centers, which it did in March of this year. In June, the FDA issued a Class I recall of all GranuFlo and NaturaLyte products from Fresenius.
As more information becomes public, patients who have suffered injuries are seeking redress and exploring their legal options. Chris Seeger, one of the partners of the law firm Seeger Weiss LLP, said that the decision Fresenius made not to inform the public of potential dangers reflects a failing on behalf of the company. “By not advising the FDA, the medical community and dialysis patients as soon as possible about the dangers of GranuFlo and NaturaLyte, Fresenius made the decision to put profits ahead of patient safety. They aren’t the first pharmaceutical company to make that decision and, unfortunately, they won’t be the last.”
Additionally, Mr. Seeger says that the error is made all the more egregious due to the fact that much of the damage to patients was preventable if Fresenius had responded quickly and efficiently to initial reports of the problem. “You would not expect a company that makes millions of dollars a year from dialysis patients to knowingly put those patients at risk for serious injuries, including death, but that’s exactly what Fresenius did. Fresenius was in position to prevent these injuries but chose not to do so. They must be held accountable.”
Seeger Weiss LLP is offering free consultations to those that might have been affected by the products. If you suspect that you or someone you know has been injured after using GranuFlo and NaturaLyte products in dialysis, contact Seeger Weiss by visiting http://www.seegerweiss.com/ or by calling directly at 888.584.0411.
On Friday, June 29, 2012, counsel for the plaintiff in yet another Hoffman La-Roche Accutane trial, led by Seeger Weiss partner David Buchanan and Troy Rafferty of Levin Papantonio, PA were able to secure an $18 million verdict. The plaintiffs in the drug injury lawsuit were Katie Rossitto and Riley Wilkinson, two former Accutane users who took the prescription acne medication in the 1990s and developed ulcerative colitis as a result. Ulcerative colitis, a debilitating, permanent gastrointestinal disease, is among the reported side effects of Accutane use. The New Jersey jury ultimately sided with Mr. Buchanan and the plaintiffs, finding that Hoffman La-Roche, the defendants and makers of Accutane, withheld its knowledge and conclusions about the risk of ulcerative colitis from doctors and patients. In response to the verdict, Mr. Buchanan, of Seeger Weiss LLP stated: “We’re extremely pleased for Katie and Riley. They’ve suffered greatly at the hands of Roche’s drug, and the jury’s verdict provides a measure of justice for each of them.” Learn more about the verdict here.
The lawyers of the drug injury practice of Seeger Weiss LLP announced a new investigation this week into a potential lawsuit against the manufacturers of several different sleeping pills. Dozens of recent studies of sleeping pills have indicated that popular sleeping pills like Ambien, Benadryl and Barbiturates carry high mortality risks that put the patients who use them to get to sleep in danger of never waking up. Among other disturbing figures, these sleep studies have uncovered the fact that patients who take sleeping pills die 4.6 times as often within 2.5 years as those who don’t. Additional data has demonstrated that sleeping pills are associated with several types of cancer. In fact, people who take over 132 sleeping pills per year have a 35% increased risk of developing cancer within the next 2.5 years.
Examples of Commonly Prescribed Sleeping Pills with Risks of Cancer and Death:
- Zolpidem (Ambien, Stilnox)
- Temazepam (Restoril)
- Eszopiclone (Lunesta)
- Zaleplon (Sonata)
- Triazolam (Halcion)
- Flurazepam (Dalmane, Dalmadorm)
- Estazolam (ProSom)
- Quazepam (Doral)
- Barbiturates (especially Luminal)
- Antihistamines, mainly diphenhydramine (Benadryl)
Seeger Weiss LLP, an award-winning, national plantiffs’ firm, is offering to review the case of anyone who has been harmed by a prescription sleeping pill. Visit their investigation page for more information.
If you were one of the 111.3 million people watching the Super Bowl this past Sunday, you may have noticed that one of the big game’s much-anticipated commercials actually came from the National Football League itself. In the clip below, which originally aired during the Giants-Patriots match, the NFL describes the history of football in the United States. Using the tagline “evolution”, the League emphasizes developments in the rules to promote player health and safety. The website advertised at the end of the commercial, titled “NFL Evolution | Health & Safety” includes an interactive feature that details these improvements more fully.
The release of the multimillion dollar advertisement comes in the midst of much heated criticism of the medical supervision of players. As CNN reported just hours before the Super Bowl, the discussion was sparked as a result of hundreds of former players filing lawsuits against the NFL for a host of ailments (mostly related to brain damage) they say they developed because of inadequate treatment of injuries. One of the most notable cases was brought in early December on behalf of 11 former players by Seeger Weiss LLP, a national plaintiff’s law firm based in New York City. With extensive experience in drug injury, personal injury and medical malpractice, Seeger Weiss offers to review the case of anyone who has been harmed by a sports injury at no cost. Learn more here.
With Super Bowl XLVI around the corner, sports pages are abuzz with predictions for both contenders. One topic on many fans’ minds specifically, is the fate of New England Patriots tight end Rob Gronkowski. After sustaining a high ankle injury during last Sunday’s AFC Championship Game, Gronkowski will almost certainly not be playing at his best this Sunday, doctors and players who have dealt with the injury in the past say. Doctors also expect that Gronkowski will be given the drug Toradol to manage the pain. However, even with the help of the anti-inflammatory, many in the league still have reservations about the effectiveness of Gronkowski’s playing and the long-term damage the big game could do to his ligaments. The Boston Herald reports, ”‘It’s not a miracle drug,’ said former Patriots fullback Heath Evans, who indicated he used Toradol for neck trouble last season. ‘It’s not, “Oh I can’t play, and now I can.” This is just something that takes the edge off. That’s it.’”
The article also notes that the NFL has recently come under scrutiny for its excessive use of Toradol. While the drug helps to numb pain, it also makes it harder for players to recognize injuries – a side effect especially dangerous in a contact sport as rough as football. At least part of the heat on the NFL has come from Seeger Weiss LLP. In December, the law firm used its expertise in drug injury to file a lawsuit against the NFL on behalf of 11 former professional players, who say they have suffered brain damage after being given Toradol to treat concussions. Those who have been harmed after receiving Toradol for a sports injury can contact Seeger Weiss LLP by phone or online. The firm’s drug injury lawyers will review any claim for free.
Last week, the Washington Post reported the story of a Washington state couple suing Tylenol manufacturers, Johnson & Johnson. According to the Post, Daniel and Katy Moore claim that their 2-year-old son River Moore died as a result of consuming a Children’s Tylenol product. The specific package in question had been recalled due to high levels of the active ingredient acetaminophen. Shortly after taking the over-the-counter medication for a slight fever, the young boy died of liver failure, a known effect of an acetaminophen overdose. “The lawsuit, filed…in Philadelphia’s Court of Common Pleas, accuses Johnson & Johnson of recklessness, negligence, breach of warranty, infliction of emotional distress, conspiracy and other offenses,” the story explains.
The article also notes that Johnson & Johnson’s 2009 recall of the product at the center of this lawsuit is “part of the company’s continuing string of recalls of drugs and medical devices.” In fact, the drug injury practice of Seeger Weiss LLP is currently investigating complaints of liver damage at the hands of Tylenol. If you or someone you know has suffered liver damage as a result of taking Tylenol, let Seeger Weiss help you seek justice. Our experienced drug injury attorneys have won billions of dollars for our clients and will review your Tylenol liver damage case for free.
In a recent piece in TIME, sports columnist Sean Gregory examines the National Football League‘s policies regarding on-field injuries. As Gregory notes, in response to the widely publicized injury of Cleveland Browns quarterback Colt McCoy, the NFL has recently refined its rules on concussions, now requiring an independent trainer to be present at all games. But according to Gregory, this effort isn’t enough to keep players safe. He suggests that the League should place a neurologist in the press box along with the trainer, to ensure that someone with a specialty in concussions is present.
Even prior to the helmet-on-helmet hit involving Colt McCoy, Seeger Weiss LLP has been putting significant pressure on the NFL to improve its treatment of players’ concussions. In early December, the experienced drug injury and medical malpractice attorneys of Seeger Weiss filed a lawsuit against the League on behalf of 11 former players. These athletes now suffer from a host of ailments due to the League’s repeated mistreatment and neglect of concussions.
If you have suffered from a sports related injury or have experienced any of the adverse effects of Toradol, a drug administered by the NFL that is known to decrease the warning signs of a concussion, contact Seeger Weiss today. Our drug injury and medical malpractice attorneys will review your case for free.
Sports media outlets have been abuzz since the Associated Press published the results of an interview with 44 National Football League players on Sunday that seemed to confirm the existence of a league-wide “tough-it-out” attitude. The group of interviewees included at least one representative from each of the 32 teams, 33 starters, 11 reserves, 25 offensive players, and 19 defensive players. Among the questions posed, one asked, “If you get what you think could be a concussion, do you think you would hide it and try to stay in the game or immediately pull yourself out?” 23 of the 44 players admitted that they would attempt to hide their injuries.
While the results of the survey are disturbing, they should not come as a shock to anyone following the recent case against the NFL that Seeger Weiss LLP has brought on behalf of 11 former players. The plaintiffs allege that they were regularly administered the drug Toradol, which can mask the symptoms of a concussion and cause cerebral bleeding. The case, and many others like it, have brought to light a brutal culture in the NFL, in which potentially life-threatening conditions are often left untreated. Another question in the AP’s interview asked if players believed an independent neurologist should be present at games to check for concussions. 31 of the 44 players answered “Yes.”
To learn more about Seeger Weiss’ investigation of the NFL’s use of Toradol, click here.
To read the full results of the Associated Press interview, click here.
Football fans across the nation are weighing in on the National Football League‘s medical practices since Colt McCoy of the Cleveland Browns was permitted to continue playing after enduring a helmet-on-helmet hit last week. McCoy was back in last Thursday’s game a mere two plays after colliding with linebacker James Harrison of the Pittsburgh Steelers; and by the end of the fourth quarter, McCoy was experiencing classic concussion symptoms, including memory problems and sensitivity to light. It has since been revealed that the medical staff of the Cleveland Browns did not conduct a concussion test immediately following the tackle.
This controversial story comes just a few days after Seeger Weiss LLP filed a lawsuit on behalf of 11 former NFL players who say they were given Toradol, a drug that minimized the warning signs of concussions. Many of these players continue to experience symptoms ranging from depression to frequent headaches. If you have been harmed by Toradol or another drug, our experienced drug injury and personal injury lawyers might be able to help you seek retribution. Our attorneys practice in a number of states across the country, and Seeger Weiss LLP was recently named to the top tier of New York City Mass Tort and Class Action firms by U.S. News and World Report.
Click here to learn more about our lawsuit against the NFL.
Click here to learn more about our drug injury practice.