St. Louis Pharmaceutical Products Attorney Blog

Thousands of women report negative side effects of vaginal mesh

2013-05-14T18:50:03Z

Hundreds of thousands of American women suffer from problems associated with incontinence or pelvic organ prolapse. In many cases such medical conditions develop after women have given birth or naturally with age. For years, women were forced to deal with the discomfort and embarrassment and suffer in silence. In recent years, however, advances in medical products led to the development of a medical device known as transvaginal mesh.

In 2008, thousands of patients who underwent surgical procedures to implant vaginal surgical mesh began notifying the Food and Drug Administration of problems. These women were experiencing painful side effects which were largely attributed to the erosion or hardening of the vaginal mesh material.

]]> Similar mesh material was previously used in patients to correct hernia injuries. The material, however, was never tested to determine how it would react and hold up when placed within a woman's sensitive vaginal and uterine area. Since the first side effects were reported thousands more women have notified doctors with problems such as pain, infection, incontinence and scarring.

Some women report having excruciating pain which they equate to being stabbed every time they walk or move. While doctors were quick to perform thousands of surgeries to implant the vaginal mesh, many are hesitant to remove the mesh material. In essence the material becomes embedded into the uterine and vaginal tissues making the removal of the mesh difficult and potentially dangerous.

The myriad of problems suffered by many women who have vaginal mesh implants have resulted in some doctors refusing to perform vaginal mesh procedures. Some doctors, however, continue to readily perform procedures using vaginal mesh.

Individuals who have suffered pain and injury as a result of a vaginal mesh procedure may choose to take legal action. The first lawsuit against vaginal mesh maker Johnson & Johnson settled earlier this year for $11 million. This settlement sets precedent for other women suffering similar injuries.

Source: KFOR, "Oklahoma women injured by surgical mesh," Ali Meyer, April 26, 2013

Patients taking SSRIs more prone to post-operative complications

2013-05-08T11:48:00Z

Millions of Americans struggle with chronic depression. Those with depression often experience prolonged periods of extreme sadness which impacts nearly every aspect of their lives. Today, many individuals who suffer from depression have been prescribed drugs known as SSRIs to treat chronic depression. Marketed under brand names like Zoloft, Prozac and Lexapro, for a growing number of Americans these drugs provide much-needed relief from the cripling symptoms commonly associated with depression.

There are many known adverse side effects associated with SSRIs including headache, nausea, decreased sex drive, diarrhea and weight gain. Results of a new study also indicate that patients taking SSRIs who undergo surgery may experience more serious complications including death.

]]> For the study, which appears in this month's issue of JAMA, researchers looked at more than 530,000 adults who underwent major surgical procedures. Researchers found that adults taking SSRIs prior to surgery were 22 percent more likely to experience post-operative complications that required readmission. Additionally, individuals taking SSRIs were 20 percent more likely to die from post-operative complications.

The results of the study are noteworthy and may prompt medical providers to perform additional diagnostic tests on SSRI patients prior to surgery. Some doctors may even advise patients taking SSRI antidepressants cease taking such drugs prior to certain surgical procedures.

Patients who have experienced adverse side-effects as a result of taking an SSRI antidepressant such as Zoloft, Paxil or Lexapro may want to consult with an attorney. A legal professional who handles matters related to pharmaceutical litigation can provide advise and help determine appropriate next steps.

Source: The Washington Post, "Antidepressants linked to increased risk of complications after surgery," Linda Searling, May 6, 2013

Troublesome side effects reported by statin patients

2013-04-30T14:30:02Z

Millions of Americans with heart disease or at risk for developing heart disease have been prescribed a type of statin drug. While cholesterol-lowering statin drugs have been proven effective in helping preventing heart attacks, 17 percent of patients report experiencing adverse side effects as a result of taking such drugs.

A new study was recently published which proves that the number of statin patients who experience negative side effects may in fact be much greater than previously reported. For the study, researchers examined more than 100,000 patients who were taking statin drugs over the course of eight years. Of those patients polled, 75 percent reported experiencing negative side effects. What's more, 50 percent of those patient who experienced side effects quit taking the drugs at least temporarily.

]]> Side effects commonly reported by statin-drug patients include muscle weakness and pain, nausea and liver problems. For many patients, such side effects negatively impact their lives and ability to both participate in and enjoy life. As such, many decide to cease taking the drugs which can be dangerous.

In recent years, the safeness of cholesterol-lowering statin drugs has been called into questions are such drugs have also been linked to causing nerve damage in patients. Thousands of other patients also reported developing diabetes as a result of taking statin drugs.

All prescription drugs have side effects. For patients taking statin drugs, the choice of whether to continue to take such drugs despite experiencing adverse side effects can be a matter of life and death. Patients, therefore, would be wise to consult with their doctor prior to starting or stopping any prescription medication.

Patients who have experienced pain, harm and injury as a direct result of taking a prescription drug may choose to take legal action. In many cases, drug companies often have knowledge that such side effects or conditions may develop and fail to adequately warn members of the pubic.

Source: NPR, "Side Effects Prompt Patients To Stop Cholesterol Drugs," Nancy Shute, April 3, 2013

The hidden dangers associated with dietary supplements

2013-04-25T17:04:41Z

In recent years, a record number of dietary supplements have hit the American marketplace. Promises related to decreasing weight or increasing sexual prowess are common as these teas, tablets and powders are sold to and consumed by millions of individuals across the United States throughout states like Missouri.

There are, however, several cases in which such so-called "safe" dietary supplements have been recalled. The problem, many safety advocates argue, often stems from lax and ineffective regulation and oversight of such dietary supplements. In fact, while the regulation and approval of such products typically falls to the Food and Drug Administration, supplements are often categorized as food rather than actual drugs. As such, the regulatory rules and regulations are much less stringent.

]]> As a result, many so-called supplements contain ingredients that are potentially dangerous. Take for example a product called Pai You Guo. Marketed prior to 2009 as a safe and effective "weight-loss tea", the product was recalled after it was found to contain cancer-causing agents as well as an appetite suppressant which had been linked to causing increased blood pressure and heart rate.

While thankfully Pai You Guo was recalled prior to any deaths or serious injuries occurring, there are likely thousands of dietary supplements on the market that pose similar health risks. In fact, an estimated 65,000 such supplements have flooded the U.S. market, many of which were approved with little to no oversight or testing.

Individuals who have suffered adverse health effects as a result of taking a dietary supplement should immediately seek medical attention. People often wrongly believe that such supplements are safe because they are marketed as all natural and sold without a prescription. The immediate and lingering impact on an individual's overall health and wellbeing may warrant taking legal action.

Source: North County Public Radio, "Recalls Of Dietary Supplements Highlight Mystery Ingredients," Audrey Carlsen, April 23, 2013

Another compounding pharmacy facing FDA recall

2013-04-15T16:29:51Z

Readers of this blog may recall the controversy late last year over a New England compounding pharmacy whose unsafe practices led to the contamination of their medications and a nationwide outbreak of fungal meningitis. All told, more than 17,000 potentially-contaminated doses of injectable steroids were sent out to practitioners in 23 states.

Now, it looks like the problem may be repeating itself. A Nevada-based compounding pharmacy called Green Valley Drugs recently recalled nearly all of its products after an FDA investigation revealed that they might not be sterile.

]]> After the meningitis outbreak, the FDA launched an investigation into the nation's compounding pharmacies to be sure that they were following safe practices. Green Valley's investigation revealed problems with drug sterility. Although no injuries have been recorded, all of the company's sterile products were recalled in an effort to avoid another national health scare.

Green Valley was not the only pharmacy to have problems. A pharmacy in Florida had to be taken to court after it refused FDA inspectors access to its records. A pharmacy in Memphis came under fire after the FDA discovered that its workers were potentially contaminating sterile products by resting their hands on surfaces and then going back to work without re-sanitizing. Even worse, the FDA found that the pharmacy did not adequately test its products to be sure they were not contaminated.

Everyone deserves to have access to safe medicines. When pharmacies cut corners on safety, everyone is at risk. Hopefully, the FDA will continue its campaign to hold pharmacies accountable.

Source: The Tennessean, "TN drug supplier recalls all product," Tom Wilemon, April 12, 2013.

Our law firm represents people who have been injured by dangerous pharmaceuticals. For more information, please visit our website.

Commonalities found among patients with transvaginal mesh complications

2013-04-09T14:20:15Z

After thousands of transvaginal mesh surgeries were performed - often to resolve problems caused by pelvic organ prolapse - problems caused by the mesh were revealed. Consequently, many women have suffered serious and painful complications, sometimes requiring additional surgeries.

]]> Researchers recently announced specific factors they found to be more likely to lead to complications following transvaginal mesh implantation at the European Association of Urology Congress. According to the Russian researchers, the factors that often result in transvaginal mesh complications include:

The patient's age
Seriousness of the pelvic organ prolapse
Whether the patient had a hysterectomy in the past

Although contrary to what some may imagine, the patients who suffered the most following transvaginal mesh operations were younger, had a less serious kind of pelvic organ prolapse or had previously undergone a hysterectomy.

The researchers reviewed data from over 675 patients who had transvaginal mesh implanted to treat pelvic organ prolapse between 2006 and 2010. Of those, over 150 of the patients suffered from complications during or after the procedure.

The study revealed that the most common problem experienced by the patients was vaginal and pelvic hematomas. Other common complications included:

Perineal hematomas
Bladder injuries
Rectal damage
Mesh erosion

Due to the severity of the complications experienced by many women who have undergone transvaginal mesh implantation surgery, lengthy continuing medical care is often needed. In one case, a woman received 18 additional surgeries following the initial implantation, but continues to suffer from severe pain.

When someone has suffered complications due to transvaginal mesh implantation, seeking the advice of a qualified attorney can ensure the injured party's rights are protected.

Source: Injury Lawyer News, "New Study Reveals Risk Factors for Vaginal Mesh Complications," Ava Lawson, March 27, 2013.

Bayer to settle lawsuits related to oral contraceptives

2013-03-26T19:44:55Z

Millions of American women rely upon birth control pills as an effective means of contraception. While birth control pills have several known mild side effects, they are typically considered safe and effective. For thousands of women who took the birth control pills known as Yaz and Yasmin, the adverse side effects were serious and include reported cases of blood clots, strokes, heart attacks and gallbladder disease.

]]> Bayer AG is the company that manufacturers and markets the oral contraceptives sold as Yaz and Yasmin. After legal action was taken thousands of women reported suffering gallbladder injuries after taking the drugs, Bayer has agreed to pay plaintiffs. The company has agreed to a $24 million settlement which equates to $3,000 for plaintiffs who were forced to have their gallbladders removed and $2,000 for plaintiff's who suffered gallbladder injuries.

While the drug manufacturer still publically contends that both Yaz and Yasmin are as safe as any other oral contraceptive on the market, the company contends they decided to settle the claims to avoid additional legal costs. In addition to the claims related to gallbladder injuries, thousands more women have filed lawsuits related to blood clot injuries after taking Yaz or Yasmin.

Many of those plaintiffs, who suffered blood clots and the resulting injuries, may also have suffered gallbladder injuries. Legal experts, however, caution these women from accepting settlement funds related to a gallbladder injury as doing so could potentially prevent them from collecting damages related to a more serious blood clot injury.

Source: Reuters, "Bayer agrees to settle Yasmin, Yaz gallbladder lawsuits," Terry Baynes, March 20, 2013

Compounding pharmacy recalls drug after reports of infection

2013-03-22T20:46:39Z

Missouri residents are likely familiar with the meningitis outbreaks that occurred last year. To date, more than 700 individuals have been impacted and 50 died, after they used contaminated steroid medication that was manufactured at a compounding pharmacy. Recently, after receiving news of adverse side effects, another compounding drug was recalled over contamination concerns.

]]> The injection drug Avastin, was recalled after five people reported suffering eye infections after injecting the drug into their eyes. Avastin is used to treat an eye condition known as macular degeneration. An injection drug that is typically used in the treatment of cancer, the drug is manufactured by compounding pharmacies that mix the drug in smaller batches for alternative uses. Doing so allows patients access to the drug for roughly $50 per dose as compared to the approved drug, Lucentis, which costs nearly $2,000 per dose.

While few can argue over the importance of compounded drugs' cost savings benefits, these pharmacies remain largely unregulated. The news of the most-recent Avastin recall shocked one woman whose husband died last summer after using the drug. The Avastin injection which the man received was tainted with bacteria. He suffered an eye infection which spread to his brain.

While some safety advocates are calling on officials at the Food and Drug Administration to step in and provide more oversight of such compounding pharmacies, the FDA has been slow to act. While efforts have been stepped up to increase inspections, compounding pharmacies seem to fall into a gray area leading state and federal regulators confused over how best to deal with the problem.

Individuals who have received an Avastin injection would be wise to consult with their doctor and immediately report any adverse side effects. Additionally, it may be wise for impacted individuals to consult with a legal professional who can help determine if legal action is appropriate.

Source: The Tennessean, "Avastin compounder recalls eye drugs in another sterility scare," Tom Wilemon, March 20, 2013

Scientists turn to Internet to identify dangerous drug side effects

2013-03-15T14:29:13Z

In recent years, the process by which a prescription drug gains approval by the Food and Drug Administration has come under scrutiny. In most cases, to control costs and outcome, clinical drug trails are conducted on a relatively small and controlled group of individuals. How such trials are conducted, often results in many negative side effects going unnoticed until a prescription drug is released into the U.S. market.

]]> Today, when an individual feels ill or is experiencing an odd side effect, they are likely to use the Internet to conduct research prior to calling or visiting a doctor. Scientists and researchers are hoping they can gain more insight into a drug's potential side effects through the analysis and compilation of users' Internet searches.

During 2010, several scientists from esteemed businesses and universities assessed Internet searches performed by 6 million study participants. Looking at the types of searches these individuals made helped scientists uncover a previously unreported and potentially dangerous side effect experienced by individuals taking a certain antidepressant and statin drug.

The goal of the automated system is to detect potential side effects prior to unnecessary injuries and deaths occurring. While there is certainly a great need for additional oversight of prescription drugs and their potentially harmful side effects, the system's creators have yet to determine exactly how they would go about mining the data.

Each year, thousands of individuals die as a result of taking dangerous prescription drugs. In many cases, these deaths could have been prevented had drug companies engaged in more detailed clinical trials or responded more urgently to initial reports of injuries and side effects.

Source: Chemistry World, "Googling for new drug side effects," Anthony King, March 12, 2013

Patient deaths and injuries prompt recall of anemia drug

2013-03-07T20:26:33Z

Patients who suffer from chronic illnesses must often undergo a variety of medical treatments and therapies. In many cases, such treatments have adverse side effects which doctors try to combat by administering certain prescription drugs. In some cases, such drugs that are meant to alleviate side effects instead cause more serious or even fatal side effects.

]]> Patients who have chronic kidney disease must often undergo routine kidney dialysis treatments. While necessary to rid a patient's body of waste and water, such treatments often result in a patient having a low red blood cell count or a condition commonly referred to as anemia.

The prescription drug Omontys was recently recalled after numerous reports of severe side effects which resulted in at least five patient deaths. The drug is manufactured by Affymax Inc. and Takeda Pharmaceutical Co. The drug companies issued an immediate recall of Omontys after at least 50 patients reported experiencing a severe allergic reaction to the drug upon first use.

An estimated 25,000 patients have been prescribed and given Omontys. The good news is that the severe allergic reaction to the drug seems to manifest quickly after the initial dose is administered. Therefore, patients who have been exposed to and tolerated the drug will most likely not suffer any harm.

The drug companies are working with the U.S. Food and Drug Administration to ensure that the use and administration of Omontys cease at all dialysis centers. At least five patients have reportedly died as a result of taking the defective drug.

Patients or loved ones of patients who have been adversely impacted by a recalled drug may want to seek legal advice. In many cases legal action may be an appropriate means to resolving matter involving injuries that result from exposure to defective and dangerous drugs.

Source: NBC News, "5 deaths, allergic reactions prompt anemia drug recall," The Associated Press, Feb. 25, 2013

Vital hormone absent from defective hypothyroid drug

2013-02-28T21:01:10Z

Many Americans have been diagnosed as having the medical condition known as hypothyroidism. Classified as a medical condition in which the thyroid gland does not produce enough of the thyroid hormone, individuals impacted by hypothyroidism often experience feelings of tiredness and weakness. If left untreated, those who suffer from hypothyroidism are at an increased risk of developing serious health problems and suffering a heart attack or stroke.

]]> The drug manufacturer AbbVie Inc. recently announced a drug recall of nearly 30,000 bottles of its thyroid-hormone replacement drug Synthroid. Only roughly a year old, AbbVie, Inc. is owned by drug manufacturing giant Abbott Laboratories and the most-recent recall of Synthroid marks the second such recall in the young company's existence.

Citing a "manufacturing line clearance error" officials at AbbVie believe the effected lot of the prescription medication may contain lower doses of the drug's vital hormone. As a result, patients who take the drug would not get the adequate or prescribed amount of medication necessary to counteract the adverse side effects of having hypothyroidism.

Currently AbbVie officials assert they have received no complaints related to any patients who are currently taking Synthroid suffering harm due to the defective drug. Now that an official recall has been issued, however, patients who rely upon Synthroid to control symptoms of their hypothyroidism are encouraged to report any negative side effects they've experienced to their doctor.

Individuals who have suffered harm or injury as a result of a defective drug may be entitled to compensatory damages. A legal professional who is experienced in handling matters related to dangerous and defective drugs can provide advice and guidance.

Source: Nasdaq, "Former Abbott Drug Unit Issues 2^nd Recall of Synthroid in 6 Months," Peter Loftus, Jan. 11, 2013

Pradaxa Lawsuits filed in federal court are consolidated into Multidistrict Litigation (MDL)

2013-02-28T16:36:29Z

Pradaxa® lawsuits filed in federal court are consolidated into a Multidistrict Litigation (MDL) in the US District Court for the Southern District of Illinois. District Judge David Herndon is the Judge presiding over the MDL. As reported by The Madison-St. Clair Record on October 5, 2012 Judge Herndon set a schedule for four "bellwether" trials that would start in August 2014 and end in early 2015. Also reported by The Madison-St. Clair Record on January 10, 2013 Judge Herndon said attorney's are well into the Discovery Phase with each side producing various documents "by the tens of thousands" and that they will begin to take depositions of people with Boehringer Ingelheim Pharmaceuticals. There have been over 200 cases filed within the MDL and there are also cases pending in State Courts throughout the Nation

Pradaxa® may be more likely to cause life threatening bleeding than other drugs for this same purpose.

2013-02-27T16:30:02Z

Pradaxa®, manufactured by Boehringer Ingelheim Pharmaceuticals, was first approved by the FDA on October 29, 2010 for the treatment of people with atrial fibrillation, or an irregular heartbeat. This anticoagulant (blood thinning drug) is prescribed to lower the risk of blood clots that could result in a stroke. Doctors wrote more than 3.7 million prescriptions for this new blood thinner after the FDA approved it in October 2010.Pradaxa® has the usual side effects and health risks of other blood thinners, which include excessive bleeding. However Pradaxa® has two important differences 1) there is no known reversal agent or antidote; and 2) there is no standard method with which to measure the anticoagulant effects. A 2011 FDA Safety Communication stated that Pradaxa® may be more likely to cause life threatening bleeding than other drugs for this same purpose.

Women impacted by recalled birth control face uphill legal battle

2013-02-22T21:29:50Z

It's been said that every child is a blessing. While many parents would agree, there is no doubt that raising a child is a huge responsibility. In a perfect world, a woman who becomes pregnant is in a loving and committed relationship, has the financial and emotional means to provide for a child and planned for the child's arrival. For some women who became pregnant after taking recalled birth control, the circumstances surrounding their child's conception was much different.

]]> One 33-year-old woman recalled her disbelief upon learning she was pregnant. The single woman, who worked two jobs and loved to travel, faithfully took her birth control. Soon after learning she was pregnant she received a letter informing her that her birth control pills were being recalled due to a packaging error. Outraged, she decided to take legal action and file a lawsuit.

Most birth control pill packs contain pills that are essentially placebos. In the case of the recalled birth control pills, these placebo pills were incorrectly placed during a time when a woman should have been taking an active pill. For an unknown number of women, this "mistake" resulted in a pregnancy and child.

The packaging errors have been traced back to the manufacturing plants where the pills were packaged. Many are blaming officials at the Food and Drug Administration for failing to conduct routine inspections of such plants. Critics of the FDA raise additional concerns related to the fact that many of the drugs that are sold and distributed in the U.S. are manufactured and packaged in other countries. In fact, the last three out of four recalls involving faulty birth control pills were linked to errors at foreign plants.

For the women who found themselves faced with motherhood due to these faulty birth control pills, legal action seems appropriate. In many similar cases, however, judges are quick to dismiss such lawsuits under provisions such as the so-called "blessing doctrine". While it's true that every child is a blessing, raising a child also completely changes a woman's life.

Source: The Kansas City Star, "After birth-control pills recalled, babies and lawsuits - arrive," Alan Bavley, Feb. 18, 2013

Recent verdict marks second win for plaintiffs in Fosamax cases

2013-02-15T21:01:16Z

Osteoporosis is a disease that impacts an individual's bones and bone density. Individuals diagnosed with osteoporosis are at an increased risk for suffering bone fractures and other health problems that may result from necessary surgeries to repair such fractures. In an effort to slow or prevent additional bone density loss associated with osteoporosis, many individuals take prescription medications.

]]> The prescription drug Fosamax is one such drug commonly prescribed to combat the ill-effects associated with osteoporosis. For years, patients have reported possible dangerous side effects associated with use of Fosamax and there are currently more than 4,000 lawsuits pending against the drug's maker Merck & Co. Inc.

The lawsuits contend the drug maker failed to adequately warn patients of potential dangerous side effects and risks associated with taking Fosamax. As a result, thousands of patients have suffered permanent injury and harm including jaw-related bone disease and injury.

In an attempt to aid in the stipulation and swiftness of settlement negotiations, judges overseeing the Fosamax cases have ordered that some initial cases be considered as "bellwether" cases. The outcomes of such cases help judges and attorneys when deciding or settling similar future cases.

In the most-recent case, a judge ruled in favor of the plaintiff and ordered Merck to pay a settlement in the amount of $285,000. The 69-year-old plaintiff filed a lawsuit against Merck after suffering bone disease of the jaw as well as delayed healing as a result of taking Fosamax. In this case, a jury agreed that Merck was negligent in contributing to the woman's injuries.

The case marks the second win for plaintiffs out of seven cases that have gone to trial. Individuals who have been harmed as a result of a defective or dangerous drug may want to seek legal advice. Drug makers are responsible for informing patients of a drug's potential side effects and failure to do so proves negligence.

Source: Reuters, "Merck hit with $285,000 verdict in Fosamax trial," Nate Raymond, Feb. 5, 2013