Articles Tagged with FDA

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Blood Monitor Device Tainted Xarelto Clinical Trials

A new drug’s effectiveness and safety are tested and verified by studies and clinical trials conducted by independent third parties such as universities and scientific labs. From a drug company’s perspective, receiving the endorsement of a successful clinical trial is essential to successfully marketing a new drug. Drug companies and their salesman use the results of these studies and trials as sales tools to market the drug to doctors. A pharmaceutical company can make billions of dollars by developing a drug that is more effective than another, providing doctors with an incentive to buy one to replace the other. In 2015 alone, Johnson and Johnson made $1.9 billion dollars selling Xarelto, an anti-clotting drug used to treat patients who are in danger of having a stroke. The future of this drug is now in question, however, because one of the testing devices used in the clinical trial has been deemed to be defective.

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Mesh warnings from the U.S. Food and Drug Administration (FDA) are nothing new, but last week the FDA announced that surgical mesh to treat pelvic organ prolapse (POP) will be reclassified as a Class III (or high risk) medical device. Part of the FDA press release also indicated that manufacturers will need to receive premarket approval (PMA) for their safety and effectiveness in order to keep selling their product.

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Yesterday, a Philadelphia jury ruled Johnson & Johnson (J&J) must pay an injured woman $5.5 million in compensatory damages for its negligence over the defectively designed Prolift pelvic mesh. Today, the jury also awarded her $7 million in punitive damages – a sum intended to punish Johnson & Johnson for having marketed an unsafe product.

This was the second product liability trial involving Prolift mesh, one of the most widely used pelvic meshes produced. The first Prolift trial of Linda Gross in 2013 resulted in a $11.1 million ruling for Ms. Gross but did not find the mesh was defective in its design. That verdict is still under appeal.

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08192014The Food and Drug Administration (FDA) has announced a recall of all units of Expression 1.5cc gel used in intranasal splint procedures. The gel, manufactured by Enhancement Medical, may have been manufactured without proper monitoring of the concentration of hyaluronic acid. Improper concentrations of active ingredients can cause adverse reactions in patients.

An initial recall of certain lots of Expression gel was issued in August 2013 after Enhancement Medical received 68 complaints of patients experiencing the following adverse effects after use.

  • swelling.
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hemodialysis-patient-300x200With more than 650 cases filed against Fresnius Medical Care the stakes are growing ever higher in what may soon become the Fresnius Dialysis Multi-District Litigation. These cases—all of which allege patients suffered cardiac arrest or death as a direct result of the problems with Granuflo or NaturaLyte dialysate systems—have been filed in federal courts throughout the U.S., which may initiate a “bellwether” trial program in order to streamline claims pursuant to a more efficient resolution of the proceedings.

The cases are not particularly diverse insofar as they all allege similar failures by Fresnius to warn patients of Granuflo and NaturaLyte acid concentrates used during hemodialysis treatment. That lack of diversity in their legal claims renders the cases more susceptible to consolidation before a single Multi-District Litigation panel, which can address the issues raised in one proceeding so that the same issues need not be addressed for the first time by various judges throughout the country. While the decisions of the first “bellwether” cases are not binding upon later cases (meaning the outcome does not have to be the same), they are instructive. Furthermore, the earlier bellwether cases can lead to global settlements that will avoid the costs of additional litigation. The MDL process also reduces the likelihood that similar cases will have different outcomes, a situation that can result in discord among the various decisions of the federal courts and forum shopping by litigants.

The circumstances surrounding the litigation are suspect at best. The allegations surrounding the Fresnius dialysis solutions were encouraged, if not initiated, by an internal Fresnius memorandum that was leaked to the Food and Drug Administration (FDA). In 2011 Fresnius conducted an internal review of the products at their own clinics in an effort to determine if and to what extent there were negative effects associated with the acid concentrates used in the dialysis systems. Fresnius identified 941 instances of cardiac arrest during dialysis treatment in 2010 alone, but failed to provide that information to non-Fresnius clinics using those products.

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fda-logo1-300x143The Food and Drug Administration sure is busy these days. Currently, it’s out to stop U.S. Sales of almost 24 products claiming to be alternative diabetes treatments. The agency says these treatments are illegal and can be ineffective, counterfeit or even dangerous. Fifteen companies’ dietary supplements and purported natural cures are being targeted.

The agency sent warning letters to these companies, and if they don’t comply, they may seize their products and even prosecute those who don’t take corrective measures. These products stem from an alternative health system that evolved in India and include herbs and special diets. Many of the drugs also include unapproved versions of prescription medications, including metformin and Januvia. Diabetes sufferers can buy these treatments online or at retail stores.

Howard Sklamberg, director of compliance at the FDA’s center for drug evaluation and research said that if patients have diabetes, they should be treated by a doctor, not a so-called natural cure. He went on to say that the FDA was protecting consumers by its actions, and urged them not to buy these products.

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infuse1-300x207Medtronic Inc’s motion to dismiss a product liability and medical malpractice lawsuit was denied by an Illinois state court judge recently. The lawsuit is over Infuse, an off-label bone graft manufactured by Medtronic Inc. The plaintiff, Karl Sanda, is suing Medtronic for negligence, strict liability, breach of warranty and willful and wanton conduct. Additionally, the lawsuit charges Northwestern Memorial Hospital, Northwestern Orthopedic Institute LLC and Dr. Mark T. Nolden with negligence claims.

Sanda experienced severe complications after initial and additional surgery and is now permanently disabled.

Although the U.S. Food and Drug Administration (FDA) approved Infuse for use in spinal fusion on the lower spine and for specific dental procedures, it was not approved for use in the cervical spine, which was where Sanda’s surgery occurred. In 2008, the FDA warned that the product could cause serious side effects and injures when used in cervical spine fusion surgeries, including swelling of the neck, difficulty breathing, constricted airways, swallowing difficulties and even nerve damage. Recent studies indicate that Infuse has even been linked to more severe injuries, including male sterility, infections and cancer.

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shutterstock_116910856-300x225Since 2006, Intuitive Surgical Inc., the manufacturer of the controversial da Vinci Robotic Surgical System, has experienced 20 or more percent growth in revenue each year. In 2012, its revenue grew to a whopping $2.18 billion. However, in February of this year, U.S. regulators began surveying surgeons due to reports of up to 70 deaths since 2009. In fact, FDA records show that injuries involving robotic surgery procedures doubled in the first six months of 2013 alone.

Since the FDA inquiry news broke, Intuitive Surgical’s value has dropped a staggering $7 billion. Earlier this month, the FDA issued a warning letter based on it’s provider surveys. On July 18th, Intuitive admitted it had received an FDA warning letter, and afterward, cut its 2013 revenue projections by half!

Last week, Intuitive’s shares fell by 6.8 percent to $392.67. The company has lost 32 percent of its market value since February 27, the day before Bloomberg News reported that the FDA was surveying surgeons about the product’s safety.

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rbr-davinci-robot2.jpg-300x300Most of us have experienced the anxiety and frustration of a computer, smartphone, iPad or other device malfunctioning. But what would we do if our lives depended on an electronic device performing perfectly?

That’s not an exact analogy to a robotic surgery machine, but since most of us don’t own robots, it’s close enough. There are literally hundreds of thousands of robotic surgeries performed in the United States, and most are done safely. However, the more these machines are used, the more injuries are reported.

Since 2007, the U.S. Food and Drug Administration has received over 200 reports of burns, cuts, infections and close to 100 deaths after robotic surgeries. Further, prompted by a recent study that found doctors using expensive robots to perform surgeries produced no better results for patients than regular, less expensive procedures, the American Congress of Obstetricians and Gynecologists spoke out against the use of robots for surgeries, which are often hysterectomies.

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shutterstock_1107829731-300x207In a recent federal court ruling, pharmaceutical drug manufacturers may now defend themselves against product liability lawsuits through preemption, which means that the FDA’s approval of a drug outweighs any state law claims questioning safety, effectiveness or labeling.

In 2009, the US Supreme Court allowed a Vermont woman to sue Wyeth (now owned by Pfizer) because the drug manufacturer didn’t include adequate warnings on the nausea drug Phenergan, which was administered to her by IV and caused her to lose part of her arm. She won the suit because there was no evidence the FDA would have disallowed a stronger warning had Wyeth chosen to put one on its label. But the court also said that if a drug manufacturer can prove the FDA would not have approved a labeling change, it would be impossible to adhere to both the agency’s requirements and a state law’s finding for a stronger warning.

Believe it or not, Merck won just such a case when a federal court judge determined that the drug manufacturer had tried to include a stronger warning on the drug Fosamax, used to treat osteoporosis. Merck claimed it had attempted to update its label to include a potential link between Fosamax and femur fractures, but the FDA didn’t approve the warning. Bernadette Glynn, a 58-year-old school teacher in upstate New York had taken Fosamax and suffered a fracture the following year. But there’s the catch: Merck’s attempt to update its warning occurred just prior to Glynn’s claims against the manufacturer, and she lost her case in court.

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