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The data that links Zofran and birth defects keeps piling up. Lawsuits have been filed against the drug’s manufacturer, GlaxoSmithKline, because they failed to warn pregnant women that the drug can cause injuries to their unborn children when taken during pregnancy.

What is Zofran and what does it do?

sickwomanZofran is an excellent nausea drug that was originally approved for use in individuals who were undergoing surgery or chemotherapy. The nausea associated with these surgeries is unbearable, and Zofran does a wonderful job of helping people deal with the pain.

But the organizations that make drugs like Zofran are corporations, and what do corporations like to rake in? Profits. So naturally, GlaxoSmithKline tried to figure out other ways to increase their market share for Zofran. One of the ways it did this was to push the drug “off label” on pregnant women suffering from morning sickness. Given the effectiveness of the drug in fighting nausea, this seemed like a good idea. However, the FDA did not and has not approved the drug for such usage, which comes as no surprise given the threat of birth defects to unborn children of mothers on the drug.

Purposefully pushing a drug on those who might be injured by it for the sole purpose of raking in cash seems like a corporate conspiracy theory, right? But the fact that the government levied a $3,000,000,000 (that’s three billion) fine against GlaxoSmithKline for fraud, failing to report safety data, and peddling drugs “off label” supports the claim.

What kind of damage does the drug cause?

Zofran taken during the first trimester of pregnancy has been linked to various birth defects including: cleft lips, cleft palates, and now heart defects. A recent Swedish study now shows that there is a significant correlation between heart malformations and Zofran taken during pregnancy. Specifically, the study looked at infants born between 1998 and 2012, and determined that those who were exposed to Zofran were 62% more likely to experience heart problems, with that group being twice as likely to experience septum defects. These defects were serious and included atrial septal defects (ASD) and ventricular septal defects (VSD). The study did come to a conclusion that GlaxoSmithKline probably does not want to hear: Zofran should not be proscribed to pregnant women because the drug is unsafe for their unborn children.

It is not like this study is an outlier or anomaly either. Studies in 2012 and 2013 showed that children born to mothers who were proscribed Zofran were twice as likely to experience defects. Another 2013 study said that the risk of defects could increase as much as four times for an unborn child.

Zofran Lawsuits

Lawsuits against GlaxoSmithKline alleging birth defects are grounded in the claim that the corporation knew about these defects, yet failed to properly inform women about them in the name of corporate greed. At minimum, women should have been given a choice between other drugs. Remember, Zofran was not approved by the FDA for this type of use, plus the federal government levied a massive fine against Glaxo, meaning the government is not too high on the drug or its manufacturer.

If you think your child was harmed by Zofran while they were in the womb, we can help.  Taking on the big boys requires skill and resources, both of which we have. Call us at 800-553-8082 or visit our website for a free online consultation.

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I think sample settlements and verdicts are a useful tool in conjunction with other tools to help victims better understand at least the range of values in a medical malpractice case.  Clearly, no two cases are the same and you cannot summarizes a case in a paragraph.  Sometimes, I have tried or settled cases where there is no way I could summarize the case in a way that would explain why the plaintiff won or why the verdict was as high or low as it was.  Said differently,reading these is important and education in understanding the value of medical malpractice claims in Illinois but you can only learn so much from these.  If you have what appears to be an exactly identical case, the results could be very different.

All of these verdicts are from 2014.  Illinois is a big state  A lot of cases go to trial here.

  • 2014, Illinois: $3,000,000, Settlement: A 35 year-old woman goes to the emergency room, complaining of double vision and fatigue. After a negative CT scan, she is discharged and follows-up with her personal doctor. After a diagnosis of Gillian-Barre syndrome, the physician proscribes medication for the patient, only for her to become hypoxic 24 hours later. Believing her to be suffering from COPD and ascending paralysis, the doctors performed a tracheostomy. Afterwards, a nurse attempted to bathe the patient, resulting in her trachea tube becoming dislodged, causing acidosis, brain damage, and cardiac arrest. The patient later died as a result of the botched bed-bath. Her two adult children alleged that the nurse should have asked for help when performing the by bath by having another nurse secure her airway. The parties entered into mediation, eventually settling for $3,000,000. Craig v. Advocate Health and Hospitals Corp.Illinois medial malpractice settlement
  • 2014, Illinois: $935,600, Settlement: After suffering from joint pain, a 53 year-old woman seeks treatment from a foot treatment specialist. The doctor completes a full examination of her feet and recommends fusion treatment in both feet, even claiming it would be a “win-win” situation. She experiences pain almost immediately after surgery and follows up with the doctor, who determines that the patient is suffering from a hematoma. Her toe was necrotic within two weeks, and the patient has to undergo amputation of her big toe. She sues the foot treatment center and doctor; however the center is dismissed from the case early on. She then alleges that the doctor should have realized that her toe was experiencing complications, and treated it accordingly in addition to warning her about the potential risk of surgery. The doctor disputes both claims, but a jury eventually awards $935,600 to the patient, $850,00 of which included past and future disability, disfigurement, and pain and suffering. Neiderkorn v. Weil
  • 2014, Illinois: $2,747,768, Verdict: The patient undergoes a hysterectomy and suffers a fatal pulmonary embolism the day after a post-op visit to her OB-GYN. The patient’s family sues, claiming that the doctor failed to recognize the onset of the embolism and failed to take proper preventive measures. The defense argues that the patient was a Jehovah’s Witness, who would not accept a blood-transfusion. This being the case a dosage of blood-thinner (which would have reduced the chance of embolism) would have made the hysterectomy more risky. Still, the jury awarded the patient’s family $2,747,768, with $1,500,000 stemming from the family’s loss of companionship. Mitchell v. Majumdar.
  • 2014, Illinois: $85,000, Settlement: A book keeper, 56, receives a dental implant. The dentist completes the procedure, but the patient suffered a sliced nerve resulting in pain. She receives corrective surgery a month later and sues the original dentist. The patient alleges that the injury resulted from the dentist placing the implant too low in her jaw, which resulted from sloppy pre-operation prep. The dentist argued that this type of pain was unpredictable and could happen even if a doctor takes every precaution. The parties settled, and the patient received $85,000. Anasenes v. Silc.
  • 2014, Illinois: $4,804,457, Verdict: A 38 year-old physical therapist (with Crohn’s disease) undergoes bowel resection surgery. After surgery, she suffers severe abdominal pain, prompting the doctor to perform exploratory surgery. He removes part of the patient’s bowel, while also repairing an abscess. The patient then develops severe sepsis, and remains hospitalized for six weeks, while also recovering from an ileostomy caused by the doctor’s extra surgery. Over the next 11 months, the patient has lengthy medical visits to manage her condition, while also undergoing another surgery to repair the damage caused by the extra surgery. The patient sues the original doctor and hospital. After settling with the hospital, she alleges that the doctor should have told her that he had never performed the operation on someone with Crohn’s before and that the initial surgery was unnecessary. The doctor claims that the surgery was needed and that there was no reason to disclose that he had not performed the surgery on anyone with Crohn’s. The patient further alleges lasting pain, diarrhea, and an addiction to painkillers that forced her to attend rehab. A jury awards her a total of $4,804,457, which includes $909,457 in medical costs and $2,000,000 in pain and suffering. Walters v. Adajar.
  • 2014, Illinois: $1,269,926, Verdict: A 34 year-old waitress gets surgery to remove a bunion on her big toe and to get an implant in her ankle. The surgery fails, and the patient’s condition worsens, leading to a nonunion of the bone in her big toe. A few months after surgery, the patient goes to the emergency room with severe foot pain, and eventually has to get corrective surgery. However, this time, she develops MRSA in her right foot, along with continuing pain. The patient sues the doctor alleging that the surgery was performed negligently. She claims that the doctors inserted a screw in her big toe improperly, leading to the nonunion. Despite the doctor’s denials, the jury awards the patient $1,269,926. Doedtman v. Borreggine
  • 2014, Illinois: $415,090, Verdict: A financial consultant, 29, goes to the doctor for allergy treatment and is proscribed L-Glutamine powder. However, a mix-up resulted in the doctor’s office giving the patient Selenium power instead. The patient later takes a toxic dose (thinking it was L-Glutamine), which sends her to the hospital. Only making things worse, the patient is pregnant, and her child is born with cognitive defects. Her family sues the doctor, claiming that she suffered PTSD from the poisoning and that her child’s cognitive defects resulted from it as well. The doctor argued that the injuries from the poisoning did not last long, and it was uncertain whether the medication mix-up caused the child’s birth defects. The plaintiff sought $5,000,000 but was awarded $415,090 by the jury. Brucker v. Mercola
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medicationwarningBenicar, a commonly prescribed medication used to treat hypertension or high blood pressure, has been prescribed over 58 million times since its introduction in 2002.  With numbers like that, amounting to more than $4 billion in sales, it’s a surprise Benicar manufacturer Daiichi Sankyo, isn’t facing more lawsuits – yet.  Yet being the key word here as more lawsuits are expected to come down the pipeline.

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newbornDepression treatment is essential.  This is especially true during pregnancy.  Untreated depression can have harmful effects on both the mother and the baby.  But we are learning more about more about  the use of antidepressants and the increased risk of problems for the baby.  We keep wondering: WHY DIDN’T THE DRUG COMPANIES KNOW ABOUT THESE RISK SOONER?

A recent study supports prior findings that women who use Zoloft during pregnancy are at an increased risk of giving birth to an infant with birth defects that could include severe heart or crainial malformations.  According to findings published last month in the American Journal of Obstetrics & Gynecology, use of Zoloft may increase the risk of atrial and ventricular defects by more than 30%, and more than double the risk of craniosynostosis.

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As the fight against Bayer and Johnson & Johnson over the controversial drug, Xarelto, wages on, Pennsylvania has organized claims floating around state courts into a mass tort. The anticoagulant (blood thinner), which has already been linked to bleeding and in some cases death, has prompted at least 70 individual suits in Pennsylvania, each claiming that the drug’s manufacturers didn’t warn users about the risks associated with the drug. While Xarelto does its job as a blood thinner, the main concern is that this drug never stops doing that job, and there is no antidote on the market to reverse the effects should a user ever need that to happen. Considering the sheer volume of cases piling up on Pennsylvania’s dockets, the Administrative Judge (judge in charge) of the Court of Common Pleas of Philadelphia, streamlined proceedings into a “mass tort.”

Mass Tort? What About a Class Action?

Similar claims and similar plaintiffs? Isn’t that a class action? Not always. In order for a case to be considered a class action, it has to meet certain procedural requirements, and the plaintiffs’ injuries have to be essentially the same. Plus, the verdict and recovery are going to be the same for every plaintiff in a class action. The problem with this is that each individual plaintiff may have suffered a different type of injury or their injuries may have varied in severity. Mass tort actions take that into account by consolidating only the pre-trial proceedings, as opposed to the actual trial and verdict. The most important pre-trial proceeding is, of course, discovery, so consolidation allows for plaintiffs’ attorneys to work together during the discovery phase to streamline and avoid wasted time for the plaintiffs, defendants, and courts.

A good way to tell these two apart is to think about this situation: your 20 year-old son, your 80 year-old aunt, and your 2 year-old nephew each purchase a bottle of soda. Let’s say the soda is tainted and causes each of you to contract pneumonia (all the more reason to drink water). Pneumonia is going to effect each family member differently, so each should be entitled to a recovery against the soda company that aligns with the severity of their injury. That’s where a mass tort comes in. On the other hand, lets say each family member bought a soda, and a year later the company was found to be guilty of price-fixing, meaning each of your family members paid $1 more than they should have for the soda. Each of their injuries is the same here ($1 loss), so a class action is the way to go.

What does this mean for Pennsylvania?

The decision to consider this a mass tort is similar to the Feds’ decision to establish “multi-district litigation” for the Xarelto suits in Federal Court. This, once again, is a fancy way of saying that different courts in different jurisdictions are getting the same cases, so let’s not waste everyone’s time and money doing the same discovery and ruling on the same pretrial motions over and over. A federal judge in Louisiana currently has the 86 pending Xarelto cases on his docket. In spite of Xarelto defense counsel’s unwillingness to do so (based upon their argument that most plaintiffs were from out of state), the PA cases will be transferred to the state’s Complex Litigation Center. Granted, a few cases will be selected for early trial dates, allowing plaintiff’s attorneys to dip their toes into the water, assessing jurors’ initial response. But still, they’re not binding on other trials.

Xarelto litigation keeps pouring in, yet Bayer and Johnson & Johnson are only pushing the drug harder and seeking more ways for people to buy it. Of course, millions of dollars in settlements and litigation seems like a drop in the bucket when the drug is already raking in almost $1,000,000,000 per year, with that number likely to only go up if the FDA approves the drug for more types of usage.

 

 

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missouriAfter a divided Supreme Court of Missouri found the legislature’s $350,000 statutory cap unconstitutional 2 year ago, opponents of letting juries decide just how victims should be compensated said the sky was going to fall in Missouri. Last September, Missouri Supreme Court nixed a statutory limit on the amount of punitive damages that can be awarded against defendants.  Tort reformers screamed doctors would flee, malpractice rates would skyrocket, and no one would want to do business in Missouri.  This never happened. But now, some in the Missouri legislature want to pretend that never happened and want to take another shot at caps.

History in the Cap in Missouri

In 2005, the Missouri Legislature passed HB 393 which placed  a $350,000 cap on non-economic damages in medical negligence claims.  In Watts v. Lester E. Cox Medical Centers , the Supreme Court of Missouri struck down § 538.210’s — the state’s medical malpractice noneconomic damage caps that became law in 2005 – for violating the Missouri Constitutions’ right to trial by jury.  The Court boldly overruled its own prior opinion in making that tough call.  Then, last September, the court struck down the state’s statutory limit on punitive damages.  This time, there was no debate.  The court was unanimous.

The thinking behind the cap was to avoid frivolous lawsuits largely in medical malpractice case.  Proponents struggle to point out these cases that were filed and not immediately dismissed.  Why?  Missouri, like Maryland, Tennessee, and many other states, requires an affidavit of merit in medical malpractice cases.  This means that within 90 days of filing a claim, the plaintiff must file an affidavit that there is a written opinion of a qualified health care provider maintaining that the “defendant health care provider failed to use such care as a reasonably prudent and careful health care provider would have under similar circumstances and that such failure” was a cause of the plaintiff’s damages.   Who is putting these kind of cases together?  Lawyers that would be out of business in the blink of an eye if they were constantly filing cases without a certificate of merit.

Constitutional Amendment

Some in the Missouri legislature think a state constitutional amendment is necessary.  I think there is pretty much no chance of this happening.   Senate Majority Floor Leader Ron Richard disagrees.  “Missouri will continue to be a judicial hellhole” if caps are not put in place, he said, saying a constitutional amendment at least capping punitive damages is a major goal of his for this legislative session.  I love this line from Jay Atkins, a lobbyist for the Missouri Chamber of Commerce and Industry: “If the trial bar would stop the practice of using punitive damages to line their own pockets, maybe we could find some common ground.”

I predict this effort will go nowhere.

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chiropractor2There are not that many chiropractor malpractice cases.  Is it that chiropractors are particularly competent health care providers?  No. Chiropractors’ negligence usually does not result in serious injury.   Most of the cases we get calls on are negligent manipulation cases where the injury is not particularly serious by viable malpractice case standards and proof of what caused what is usually an exacerbation of a preexisting condition and is a challenge.  That said, there are sometimes great claims to be made against chiropractors and, because they do not have the halo effect that doctors have, there is a very level playing field for plaintiffs filing suit them.  Stunningly, chiropractors are trusted less in most communities than lawyers (but ahead of Congress, of course).  Which really is saying something.

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erMany states are trying to carve out malpractice caps and different standards of care for emergency room doctors in medical malpractice cases.  The thinking starts out okay.  Emergency department doctors should be given the benefit of the doubt because things are happening so quickly.   But ER doctor are always getting the benefit of the doubt from jurors.  There is statistical evidence of this.  More importantly, the standard of care already bakes in the fact that things are sometimes happening at the speed of light in the ER.  That is why reasonableness is always based on all of the facts and circumstances.

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gelWith roughly 300 complaints currently pending before U.S. District Judge Mathew Kennelly, and several thousand expected to be filed before all is said and done, Judge Kennelly of the Northern District of Illinois has appointed four testosterone drug attorneys to serve as liaisons with state courts where dozens of additional cases are pending.  In an effort to increase coordination of the litigation, the role of the state-federal court liaisons will be to promote better coordination for the rapidly accumulating host of testosterone lawsuits  being filed.

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gavelstethescope2The first recorded opinion that I have seen in 2015 is a reminder to medical malpractice victims that there is rarely another option to hiring a lawyer in a medical malpractice case.

In Bagley v. Rochester General Hospital, a woman presented to the renal dialysis unit with complaints of abdominal pain, constipation, and complications from end-stage diabetic renal disease.  This was, regrettably, not a healthy woman.  The hospital did some tests and sent the woman to the emergency room believing that she had bacterial peritonitis as a result of being on dialysis.  The woman’s condition went downhill from there and she died of cardiac arrest.  Plaintiff contends that the real problem was a ruptured acute appendicitis, not peritonitis.

Let me start with a blunt statement: our law firm would never take this case.   Let’s assume it is exactly as the victim’s family says.  The hospital’s doctors screwed up and misdiagnosed the patient.  Even if this is true — I would bet that, although it is just a hunch on these facts —  I don’t think it is a viable medical malpractice action.

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