Under the Act, if a medical device was approved under the expedited 510(k) process, “which now requires companies only to show their devices are smilar to those already on the market,” the FDA could require post-market studies to determine safety. The FDA could also grant partial device approval for devices approved under the 510(k) process, pending futher saftey studies.

In addition to introducing post-market safety legislation, the Senators have also sent investigative letters to five medical device manufacturers, requesting information on their post-market surveillance of products.

Senator Grassley’s press release states, “Letters were sent to Johnson & Johnson, for its DePuy metal-on-metal hip implant…Medtronic for its Infuse product; Boston Scientific for Guidant’s defibrillators; CR Bard for vaginal and hernia mesh products; and, Zimmer Holdings for its knee replacements.”

Democratic lawmakers believe that examining these two medical devices can provide insight into the regulation of medical devices. The Congressmen write, “Both items are examples of devices that were found to be associated with major health problems after being approved or cleared by the FDA. As such, we believe they could provide important lessons about the device clearance and approval process as well as the adequacy of our postmarketing safety system.” The DePuy metal-on-metal hip implant was approved through the FDA’s 510(k) process, which does not require clinical data and approves new devices deemed substantially equivalent to devices already on the market. The stent was approved “under a humanitarian exemption that lets a maker bypass full premarket approval when the condition affects fewer than 4,000 people.”

After using Simply Thick to feed their premature baby daughter, the Umphress’ infant developed life-threatening necrotizing enterocolitis (NEC), an intestinal condition with a 25% mortality rate and which imposes lifelong injuries on survivors. The Umphress’ daughter, after being airlifted to Children’s Hopsital in Albuquerque and receiving two blood transfusions over a period of twenty days, is now stable but continues to suffer from NEC.

The FDA issued a warning in May 2010 that Simply Thick may cause NEC and that it should not be fed to premature infants. In June 2011, Simply Thick, LLC issued a voluntary recall of Simply Thick thickening gel manufactured at a particular processing plant. By July 2011, the product was released back to the market but is now accompanied by a warning not to feed Simply Thick to premature infants.

Read the full article at Las Cruces Sun-News. Learn more about the Simply Thick recall and victim’s rights.

Transvaginal mesh was approved as a moderate risk device under the FDA’s controversial 510(k) process. The FDA’s 510(k) process allows for a medical device to be approved for market without clinical data if it is deemed “substantially equivalent” to products already on the market. This “substantially equivalent” approval condition has been criticized as overly lax and responsible for public health nightmares such as DePuy’s recalled ASR hip implant.

Transvaginal mesh failures were cited in the U.S. Institute of Medicine’s July review of the FDA’s medical device approval and their recommendation that the process be replaced with a stricter system. Opponents of transvaginal mesh allege that the mesh products, currently classified as moderate risk devices, expose patients to higher risks than non-mesh products, and ask that transvaginal mesh be recalled and reclassified as a high risk device.

Previously reported in Bloomberg, the FDA issued a transvaginal mesh safety warning in July 2011, stating that it has received “1,503 reports of complication associated with the material from January 2008 to December 2010.” It is in response to these widespread reports of complications that the FDA is considering a change in risk classification.

The researchers concluded:

In summary, our findings provide strong evidence that prolonged bisphosphonate therapy is associated with an increased risk of subtrochanteric or femoral shaft fracture, although the absolute risk of these fractures is low. These findings also highlight the need for a thoughtful assessment of individual risk of fracture when considering extended bisphosphonate therapy and that long-term use of these drugs may warrant reconsideration, especially in patients at relatively low risk of fracture. It may be appropriate to consider a drug holiday for selected patients, particularly as the cumulative duration of bisphosphonate therapy surpasses 5 years.

Last year, the Food and Drug Administration warned patients that bisphosphonates approved for osteoporosis treatment may pose the risk of a rare type of thigh bone (femur) fracture, particularly with patients who have taken Fosamax and/or other bisphosphonates for several years.

The FDA warning applies to:

• oral bisphosphonates such as Actonel, Actonel with Calcium, Atelvia, Boniva, Fosamax, Fosamax Plus D, and their generic products; and
• injectable bisphosphonates such as Boniva and Reclast and their generic products.

Lieff Cabraser represents patients injured by prescription drugs with dangerous undisclosed side effects. Learn more about bone drug (including Fosamax) lawsuits.

The U.S. Food and Drug Administration states more than 50% of patients do not take over-the-counter medication as directed.  Research confirms that overdosing on over-the-counter painkillers may lead to organ failure, strokes, and even death.

Consumers that frequently and repeatedly take painkillers are urged to reexamine their behavior and talk to a doctor to avoid potential danger.

Lieff Cabraser currently represents patients who have suffered health injuries from popular over-the-counter drugs.  Patients are welcome to contact an attorney to discuss your legal rights at no cost or obligation.

Acetaminophen is a widely used pain reliever found in many popular over-the-counter medicines such as Tylenol and Nyquil, which treat headaches, sore throats, fevers and muscle aches.

The Food & Drug Administration will ask manufacturers to limit acetaminophen used in combination prescription drugs to 325 milligrams per capsule.  The agency is also asking drug makers to strengthen their warnings about severe liver damage on the labels of the prescription medicines.

FDA’s action follows publication of studies showing that acetaminophen is the leading cause of liver failure in the U.S., recording more than 50,000 emergency room visits and 200 deaths.  Regulators estimate that over half of these annual deaths are linked to the prescription drug combinations that use acetaminophen.

GlaxoSmithKline insists that the study was reliable and that it demonstrated that the drug is safe. Critics assert that the study conducted by GlaxoSmithKline was flawed, manipulated and that its findings cannot be trusted.

The nation’s leading medical advisory group, The Institute of Medicine, released a report last week “concluding that Avandia increased the risks of stroke, heart failure and death compared with Actos.”

Beginning today, the FDA will determine in two days of hearings on whether Avandia should be withdrawn from the market.

Read an earlier entry outlining a New York Times report that exposed how Avandia is linked with risks of heart failure.

Patients taking Avandia that suffered serious side effects are welcome to contact a Lieff Cabraser attorney to learn about their legal rights for no charge or obligation.

As published in the Archives of Internal Medicine, one study found that Avandia, as compared with other diabetes medications, increased the risk of heart attacks by 28% to 38%.  The other study, published in the Journal of the American Medical Association, found that Avandia, as compared with another diabetes drug, Actos, increased the risk of stroke by 27%, heart failure by 25%, and death by 13%.

Both studies were released in advance in the Food and Drug Administration hearing that will determine if Avandia should stay on the market.  In the meantime, The American Diabetes Association has recommended doctors to discontinue prescribing Avandia.  The U.S. Senate Committee on Finance called for Avandia’s removal and charged the FDA with knowledge of the drug’s dangerous link to cardiovascular health risks before it was reported to the public.

The manufacturer of Avandia, GlaxoSmithKline, defended the safety of the drug and denied the findings reported by studies.

Read an earlier entry explaining a New York Times report that exposed the heightened heart failure risks of Avandia.

Patients taking Avandia that suffered serious side effects are welcome to contact a Lieff Cabraser attorney to learn about their legal rights for no charge or obligation.

Hundreds of people taking Avandia, a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market. The reports, obtained by The New York Times, say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart.

Avandia, intended to treat Type 2 diabetes, is known as rosiglitazone and was linked to 304 deaths during the third quarter of 2009.  “Rosiglitazone should be removed from the market,” one report, by Dr. David Graham and Dr. Kate Gelperin of the Food and Drug Administration, concludes. Both authors recommended that Avandia be withdrawn.

Millions of diabetics have been prescribed Avandia sold by GlaxoSmithKline PLC since it came on the market in 1999.  In May 2007, Avandia was linked to a 43 percent greater risk of heart attack and death in a scientific analysis published by the New England Journal of Medicine.

Upon the release of the 2007 study, GlaxoSmithKline downplayed the report and encouraged continued use of Avandia.  Dr. Lawson McCartney, who led Glaxo’s diabetes drug development, said, “We remain very confident in the safety and of course in the efficacy of Avandia as an important diabetic medicine.”

Soon thereafter, the U.S. Food and Drug Administration (FDA) asked  Glaxo to carry a more prominent warning, a so-called black box warning, of Avandia’s heart risks because “despite existing warnings, these drugs were being prescribed to patients with significant heart failure.” Glaxo continued to maintain the safety of Avandia, and the drug has remained on the market.

Learn more about the legal rights of patients that suffered serious side effects from Avandia.