Defective Drug and Medical Device Blog

Bayer Fights Against Federal Multi-District Litigation Consolidation

24February
2013

Although Bayer petitioned the New Jersey courts to consolidate Mirena IUD cases, Bayer is now opposing consolidation in the federal courts.

This latest battle began when plaintiff’s counsel filed a motion with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate the federal cases in the Northern District of Ohio. However, soon after this Bayer argued that MDL will prejudice the company. Bayer contends that one lawsuit is already scheduled for trial in May of this year. Bayer says that it has spent significant resources defending the case. If the JPML orders consolidation in federal court Bayer believes that it will be forced to start over and duplicate the time consuming process of discovery.

Further, Bayer argues that an MDL will encourage plaintiffs to file meritless claims. Additionally, the company says that the cases currently filed do not meet the commonality requirement because there are no injuries in common in every of the 8 pending federal cases. The most common injury, uterine perforation, has only been plead in 6 of the 8 cases. Further, Bayer argues that it has warned of the risk of uterine perforation and that there will be no need for pervasive discovery on the issue.

Although Bayer had originally requested consolidation in New Jersey courts in August, the corporation says that procedural irregularities in New Jersey made adjudication of the claims in separate state districts impossible. With the federal cases, on the other hand, Bayer argues that each federal court could just as easily handle the claims as any other federal court.

The plaintiffs took issue with Bayer’s assertions. The plaintiffs argue that Mirena labels did not actually warn against uterine perforation. Plaintiffs also believe that once consolidated hundreds of similar lawsuits will be filed.

Posted in Multidistrict Litigation |

Forecasting Lawsuits for Medtronic Medical Devices

14February
2013

Serious complaints are stemming from Medtronic Infuse bone graft patients. Although Medtronic sales spiked at $800 million as recently as 2011, it appears a litany of Medtronic lawsuits are poised to launch.

Complications tied to Medtronic products are deadly. They’ve ranged from difficulty swallowing to even death. A variety of patients are enduring so much pain it literally requires them to be on other precarious forms of medication such as Oxycontin.

One Californian woman in 2008 suffered respiratory arrest and died after receiving a Medtronic device following surgery. The family was quick to file suit against the medical device manufacturer, believing her death was caused by the faulty graft.

A completely separate study also indicated Medtronic devices could cause sterility among men. It’s an equally serious claim, that despite not carrying quite the same consequences of wrongful death, is placing immense scrutiny toward one of the largest medical supply companies currently operating.

Medtronic may be placed in a position where they distribute high sums over several lawsuits. It remains to be seen whether or not the amount of cases being filed will warrant a joint lawsuit that carries a significant penalty.

Posted in Lawsuits |

Companies to Pay $688 from Cholesterol Drug Lawsuits

10February
2013

The third largest drug company, Merck, and fellow pharmaceutical partner, Scherling-Plough had agreed to pay out $688 million dollars to their investors after not coming forward with an unfavorable study of their top selling cholesterol drugs, Zetia and Vytorin.

Upon the drugs conception, Merck paid a research team to provide evidence that Zetia and Vytorin were the best in the industry at reducing cholesterol. Unfortunately for the company, the study suggested that the drugs were no better than a cheap generic statin drug for reducing plaque in arteries. The company did not want the results of the study to interfere with the sales of the pricey drug, and delayed releasing the unflattering results until 2008. After the news was released, the stocks plummeted, and the sale of the drugs also started declining rapidly.

Scherling-Plough will be ordered to pay $473 million while Merck will pay $215 million, a settlement which is widely seen as a triumph for private civil litigation. This is not the first time that the company has paid out over the concern of the two drugs, in 2009, both companies paid just over $40 million dollars to settle lawsuits from consumers and insurers, then $5.4 million from a civil protection suit.

Since the study was released, the two companies have been trying to get Zetia back in demand by combining it with Pfyzer drug, Lipitor, but were quickly rejected by the FDA.  Although many people have stopped taking the pricey cholesterol reducing-drugs, they are still one of the most popular brands on the market. If you have been the victim of a drug company’s wrongdoings, make sure you contact an experienced attorney to get you the compensation you deserve.

Posted in Lawsuits |

Yaz Lawsuits Increase after FDA enforces new label

6February
2013

The number of lawsuits leveled against the PMDD medication company Yaz has risen significantly after the Federal Drug Administration ordered the company to place a stronger warning label on their product in April of 2012.

The stronger warning label states that ““some epidemiological studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products…whereas other epidemiological studies found no additional risk.”

A December 2011 FDA study found that women who take the birth control pills, which contain the active ingredient drospirenone , are at an increased risk of developing blood clots compared with women who take a contraceptive without drospirenone.

Despite the study, an FDA panel voted 15 to 11 to keep the controversial contraceptives on the shelves, deciding that the benefits of Yaz and drugs like it outweigh the risks. However, the panel did vote in a near unanimous decision to add stronger warning labels that specifically address the risk of blood clot.

Yaz has also been accused of dishonestly representing their product in television advertisements which has prompted the FDA to conduct a ‘corrective advertising’ study. The study will help to “answer questions about their recall and understanding of the benefit and risk information, their perceptions of the benefits and risks of the drug, and their intent to ask a doctor about the medication,”

In 2008 Bayer, which operates Yaz, was reprimanded by the FDA for minimizing the serious risks associated with the drug as well as broadening the drug’s indication to include PMS. The TV ads for the product were deemed to be in violation with federal statutes and regulation.

Posted in Lawsuits |

Stryker Recall Costly for the Orthopedic Manufacturer

1February
2013

Stryker Corporation said on Wednesday that a hip implant recall that began in June of 2012 will cost up to $390 million for treatment, new surgeries, lawsuits and insurance payments.

The company said that is has raised the low end of its expectations for these unforeseen costs and have also raised their related financial reserves. This will result in a 35 cent charge per share for shareholders or an estimated $174 million before taxes.

Stryker, a manufacturer of power tools, surgical accessories, and hospital beds, recalled its ABG II and Rejuvenate modular-neck hip devices in June after discovering there was a risk of corrosion, which may result in local tissue damage as well as pain and swelling. The recall came after other orthopedic device manufacturers, including Johnson & Johnson, took similar action sparking the largest hip replacement recall ever. Stryker provided the new cost information early January after projecting their finances for the next quarter and full year.

Broadspire Services was hired as a third-party claims administrator to help the company deal with patients who need to have their recalled hip implants replaced.

The final price tag for the recall depends on the number of patients who require testing and follow-up procedures as well as the cost of lawsuits.

Stryker has released a statement advising anybody who currently has either the Rejuvenate or ABG II modular-neck hip implants to consult a doctor.

The company said that blood tests, X-rays, MRIs or ultrasound evaluations may be needed to examine the device. Replacements that are made of exclusively metal, known as metal on metal, are particularly troublesome. In addition to high failure rates, these models may release metals into the blood stream over time.

Researchers are unsure of the long term effects of high levels of metal in the blood stream.

Posted in Lawsuits |

Painkillers Increase Risk of Car Crash

15January
2013

Individuals who take a daily does of painkillers have a 20-40 percent higher risk of being involved in a car crash, a Canadian study shows.

While significantly less dangerous than driving under the influence of alcohol, patients and doctors should be aware of the effects opiate based prescriptions have on their safety, researchers say. The Toronto-based Institute for Clinical Evaluative Studies, which conducted the study, says that the most important message from the study is that doctors need to be more proactive about explaining the risks of driving while on painkillers.

Dr. David Juurlink, who co-authored the study, warns that painkillers affect attentiveness and alertness and that pain patients should be aware of these risks. Taking the proper precautions such as minimizing driving are the best way to avoid accidents.

“We’re not proposing draconian measures like don’t drive or licence suspensions. We’re just saying: ‘Be aware,’ because these drugs are very commonly prescribed.” Said Juurlink.

More than 200 million prescriptions are written for opioids  in the United States every year. Opioids include medications such as Percocet, Morphine, Oxycontin, and codeine. The study postulates that patients on a low daily painkiller regimen, approximately 20 mg of morphine, are at a 20% higher risk of being involved in a car crash. Additionally, individuals on a high daily regimen, approximately 100 mg of morphine, see their risk jump up 42%.

There is no easy way of measuring levels of intoxication caused by opioids and other prescription drugs, like there is with alcohol.

Original Article

 

Posted in Uncategorized |

FDA Issues New Warnings for Ambien Users

6January
2013

Sleep aid, Ambien, and its generic form, Zolpidem, are said to contain inaccurate information about the side effects, particularly in women, according to the Food and Drug Administration (FDA). The drugs have been hailed as a non-habit forming sleep aid, sold by Bayer Drugs and have gained popularity for their ability to make even the most tense of people fall asleep with ease.

Issues involving sleep walking, sleep eating, and other activities in which the person is not awake have been associated with the drug. Although these side effects are relatively uncommon, there is a fairly widespread problem with morning drowsiness.

Research: Sleep mechanism enables brain to consolidate emotional memory

The many dimensions of sleep

The chemicals, especially in the delayed release drugs, are said to stay in a person’s system even after the user has woken up. This could lead to serious problems when it comes to activities which require alertness, such as driving, operating machinery, or tasks at the workplace. Women are said to be more susceptible to the prolonged side effects since the body metabolizes Ambien and Zolpidem slower than in men.

The FDA now recommends that people using Ambien should talk to their doctor about taking less of their prescribed amount. This is one of many allegations against Bayer regarding inaccurate warnings. If you have suffered because of improper warnings, side effects, or an over-prescription, make sure you contact an attorney right away who can fight for your well-being.

Posted in Side Effects |

Birth Control Mirena Facing Lawsuit

6January
2013

Bayer’s hormonal intrauterine device (IUD) birth control, Mirena has been under hot water, due to claims of serious side effects. Women have claimed that they suffered perforation of the uterus, expulsion of the device, pelvic inflammatory disease, cysts, pain, ectopic pregnancies and miscarriages. The IUD was marketed towards women who have already had children as a long term-term birth control which could last five years, without requiring pills or patches.

Thousands of complaints have been submitted to the FDA, stating that the warnings were insufficient. Bayer marketed the product as a safe and effective way to prevent pregnancy, even insinuating that it could help with intimacy issues, which is a completely unfounded claim, according to the FDA. Some of the common side effects are weight gain, acne, and back pain which is contrary to any claims that Bayer had issued about the device.

A lawsuit against Bayer alleges that they jeopardized public safety by failing to address these serious complications. Numerous claims site the IUD as “defective and unreasonably dangerous,” and insinuates that Bayer was negligent, and is accused of deceptively advertising their product.

If you or someone you love has suffered from a Mirena IUD, contact an experienced attorney immediately. There is no reason you should have to suffer due to the negligence of a multi-billion dollar company. Contact a firm that specializes in defective drug and medical devices so you can get the specialized attention and expertise for your unique case.

Posted in Uncategorized |

FDA Warns against WOW Dietary Supplement

20December
2012

The U.S. Food and Drug Administration has issued a warning regarding the dietary supplement Reumofan Plus which has been relabeled and sold as WOW. The product is marketed to treat arthritis pain, muscle pain, osteoporosis, bone cancer and other ailments.

A FDA drug analysis of the product has revealed that the substance being marketed as WOW contains the same active ingredients are Reumofan Plus including dexamethasone, diclofenac sodium, and methocrabamol. These ingredients have the potential to affect liver function and cause serious injury.

Melind Plasier of the FDA made a statement saying, ” “These dangerous products should simply not be sold or distributed. ”The FDA is prepared to take aggressive enforcement action to protect consumers from these dangerous products, including seizure, injunction, and pursuit of criminal prosecution.”

Anyone who is currently taking or has taken Reumofan plus or WOW should discontinue use immediately and consult a physician. Consumers should not buy or use either of these products. The FDA is concerned that the company Riger Naturals might be relabeling the product with other names besides WOW; the public is advise to avoid all products produced by this company.

The FDA launched it’s investigation in early 2012 after receiving reports of liver injury, severe bleeding, corticosteroid withdrawal syndrome, adrenal supression, stroke and even death.

Original Article

Posted in Uncategorized |

Antibiotic Prescriptions Rise With Flu Season

4December
2012

With the current reported cases of flu on the rise, all indications point to yet another breakout epidemic for the dreaded debilitating illness. If you’ve personally been holding off on acquiring a flu shot, now is the time to have yourself treated to avoid a serious headache down the line.

Medical reports are now suggesting people are building a higher resistance to antibiotics throughout the flu season, in some cases rendering them highly ineffective in treating the individual. Simple statistics would point that a higher tolerance can mostly be attributed to the increased amount of registered prescriptions for antibiotics during the seasonal flu period.

It has long been known that doctors should not prescribe their patients antibiotics outside of situations that call for them specifically, the fear being antibiotics becoming essentially irrelevant to the user in treatment. The cases have prompted a series of lawsuits that have placed further scrutiny upon the use of antibiotics as a form of treatment.

The excessive amount of antibiotics used throughout the flu season raises other concerns. A certain line of antibiotics, fluoroquinolones, is raising red flags on its own. Some patients have reported retina detachment as well as an even more alarming overall blindness.

Such reports stress the importance of doctors following the important regimen for prescribed medicines throughout the season ahead. Talk with your doctor about your line of treatment should you find yourself under the weather this year.

Posted in Lawsuits |