Breaking Legal News
On April 8, 2011, Johnson & Johnson (“J&J”) entered into a settlement agreement with the U.S. Securities and Exchange Commission (“SEC”) as well as the U.S. Department of Justice for bribing European doctors and paying kickbacks for contracts to Iraq under the United Nations’ Oil-for-Food Program. According to the SEC, J&J’s actions violated the Foreign Corrupt Practices Act.
A South Carolina jury will determine whether drug manufacturer Johnson & Johnson deceived state doctors about the safety of Risperdal. Risperdal is an antipsychotic drug often prescribed to mental-health patients.
On February 24, 2011, the U.S. Food and Drug Administration (“FDA”) granted Genentech’s request for a hearing to review the safety and effectiveness of Avastin, a drug used to treat various forms of cancer. Genentech, the manufacturer of Avastin, is a subsidiary of Roche.
On April 30, 2010, the FDA recalled children’s Tylenol and other liquid over-the-counter drugs, after receiving consumer complaints. Consumers complained of “tiny particles” in versions of children’s Tylenol, Motrin, Zyrtec, and Benadryl. The drugs included in the Tylenol recall were manufactured in the same factory located in Fort Washington, Pennsylvania, operated by McNeil Consumer Healthcare, a subsidiary of Johnson and Johnson. The Tylenol recall was issued due to quality control issues. Investigations revealed that some of these products may contain a higher concentration of an active ingredient and others may contain inactive ingredients that may not comply with internal testing requirements. The FDA has instructed parents and caregivers not to administer these products to children and to switch to generic brands, which were not affected by the recall. If you or a loved one used children’s Tylenol and suffered an injury, contact one of our Tylenol injury lawyers immediately to discuss your legal rights and options.
March 30, 2010
California Superior Court rejected Mentor Corporation’s motion to dismiss four Mentor ObTape Vaginal lawsuits. These cases will now be permitted to proceed to discovery.
March 11, 2010
On March 2, 2010, the FDA announced a growing number of hardware and software problems with certain insulin pumps. The problems span different manufacturers and products, and include pumps made by Medtronic and Johnson & Johnson. Many of these insulin pumps have been recalled by the FDA and have been the focus of numerous lawsuits.
February 23, 2010
After a two year inquiry, the U.S. Senate released a report on February 20, 2010 stating that GlaxoSmithKline knew of possible heart attack risks tied to Avandia, a popular medication manufactured by GlaxoSmithKline to treat Type 2 diabetes, years before such evidence became public.
February 19, 2010
On February 18, 2010, GlaxoSmithKline announced that it would voluntary stop the manufacture and distribution of denture cream products that contain zinc after becoming aware of potential health problems associated with the long-term excessive use of their zinc-containing denture adhesive products.
October 20, 2009
Bernstein Liebhard LLP filed a Master Complaint in the Philadelphia, Pennsylvania In re Denture Adhesive Cream Mass Tort Program, June Term, 2009, No. 4534. The complaint alleges twelve separate counts against six defendants, including various GlaxoSmithKline (“GSK”) and Procter & Gamble entities. The filing follows GSK’s addition of a zinc-related warning label to Super Poligrip, and the publication of two journal articles, which confirm plaintiffs’ claim that the defendants have known or should have known for many years” that Super Poligrip and Fixodent can cause the serious injuries alleged in the denture cream lawsuits.
October 19, 2009
Bernstein Liebhard LLP filed a lawsuit in federal court in New York on October 7, 2009 against Bayer, the manufacturer of Yasmin and YAZ birth control pills, on behalf of a California couple, Scott and Heather Crawford, Crawford v. Bayer et. al 7:09-cv-8550 (S.D.N.Y.)
September 29, 2009
The FDA this week announced that sitagliptin, an ingredient contained in the type 2 diabetes drugs Januvia and Janumet, may be linked to an increased risk of pancreatitis. According to the agency, 88 cases of acute pancreatitis with people taking Januvia and Janumet were reported to the FDA’s Adverse Event Reporting System between October 2006 and February 2009.
July 16, 2009
The Judicial Panel on Multidistrict Litigation (JPML) issued an order centralizing In re: Denture Cream Product Liability Litigation, MDL-2051, in the Southern District of Florida before Judge Cecilia M. Altonaga, who the JPML said “has the time and experience to steer this litigation on a prudent course.”
June 25, 2009
On June 17, 2009, the Environmental Protection Agency (EPA) declared a public health emergency in Libby, Montana because of decades of asbestos exposure from a nearby vermiculite mine. It is the first public health emergency to be declared under the 1980 Superfund law, which governs sites contaminated by hazardous substances.
June 25, 2009
An investigation into the cancer unit at Veterans Affairs Medical Center, a Veterans’ Affairs hospital in Philadelphia, found that doctors botched treatments for many prostate cancer patients. The New York Times reported that during a six year period, 92 of 116 surgeries to treat prostate cancer were performed incorrectly.
June 22, 2009
Clarcon Biological Chemistry Lab Inc., of Roy, Utah, voluntarily recalled several of its skin care products due to bacterial contamination uncovered during a routine FDA inspection. The skin care company, which promises its users naturally safe and beautiful skin, was forced to recall its skin sanitizer and skin protectant products that are marketed under different brand names. FDA inspections uncovered high levels of bacteria within these products which are capable of causing infectious disease. The U.S. Food and Drug Administration is now warning consumers not to use any products made by Clarcon.
June 16, 2009
The New York Times reported that the U.S. Department of Justice has begun an investigation into possible medical research fraud by a former surgeon at Walter Reed Army Medical Center, Dr. Timothy Kuklo, following an Army investigation into the matter. Kuklo is accused of fabricating the results of a study comparing bone grafts to Medtronic Infuse, a bone-growth product, and forging the signatures of other Army doctors on the study. Senator Charles E. Grassley of Iowa has also been looking into the issue.
June 16, 2009
Millions of Americans take various forms of vitamin, herbal or other dietary supplements daily. Such supplements make up more than 40,000 products on the market, accounting for annual sales exceeding $23 billion. However, recent studies and reports show that many of these supplements have quality problems, such as containing contaminants or having ingredients not matching what the labels listed.
June 16, 2009
On May 13, 2009, another lawsuit against C.R. Bard, the maker of Avaulta brand vaginal mesh products, was filed in West Virginia federal court. The suit is similar to eight other transvaginal mesh lawsuits filed against Bard in West Virginia this year, claiming that the plaintiff suffered complications after having surgery to implant an Avaulta Anterior and Posterior Biosynthetic Support System to treat her pelvic organ prolapse.
May 29, 2009
In an effort to create more transparency in the medical world, hospitals across the nation are pushing for full disclosure of their doctors’ financial ties to the pharmaceutical industry. After the Cleveland Clinic, one of the nation’s most prominent medical research centers, became the first to mandate that all of its doctors publicly report their business relationships to pharmaceutical companies and medical device makers in December 2008, many other medical centers have followed suit. Failure to disclose conflicts of interest are often the subject of whistleblower lawsuits.
May 29, 2009
Recent figures show that health care fraud continued to comprise the majority of federal False Claims Act (FCA) recoveries in 2008. The Act allows federal officials to prosecute fraudulent billing of government programs. In the 2008 fiscal year, enforcement officials recouped $1.12 billion in settlements and judgments from health care entities, 84% of the year’s $1.34 billion total recovery from all FCA prosecution and settlements.
May 26, 2009
An article published in the Journal of the American Medical Association (“JAMA”) on May 19, 2009 supports the U.S. Supreme Court’s ruling in Wyeth v. Levine, which held that FDA-approved labeling of pharmaceutical drugs does not preempt state law product liability claims for injuries caused by the drugs. JAMA concluded that the benefits to patient welfare resulting from tort litigation outweigh the pharmaceutical industry’s calls for FDA preemption of state tort liability lawsuits.
May 13, 2009
An investigation conducted at the Walter Reed Army Medical Center found that Dr. Timothy Kuklo, a former surgeon at Walter Reed, made false claims and exaggerated the benefits of the Medtronic Bone Infuse Implant, a bone-growth product manufactured by Medtronic Inc. (“Medtronic”). Doctors at Walter Reed treated injured soldiers with Infuse. Kuklo’s study claimed to be a review of those soldiers who were given Infuse to treat lower-leg wounds with open fractures caused by explosions in the Iraq war from March 2003 to March 2005.
May 5, 2009
Today, ABC’s Good Morning America (GMA) aired a nationally televised segment about consumers allegedly injured from zinc in denture cream. The GMA coverage is available online by going to our GMA Denture Cream page.
May 1, 2009
There has been a Hyroxycut recall. After the FDA received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, to liver damage requiring liver transplant, the FDA has advised consumers to stopy using Hydroxycut diet pills and the manufacturer has agreed to recall the Hydroxycut products. One Hydroxycut recall related death related to liver failure has been reported to the FDA. Other Hydroxycut health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.
April 10, 2009
The Food and Drug Administration (“FDA”) announced its plan to review 25 types of medical devices marketed prior to 1976. Manufacturers of these devices are required to submit information within 120 days on safety and effectiveness to the FDA so that it can evaluate the risk level posed for each device type. Those found to be of high risk to consumers will be required to undergo the FDA’s most stringent premarket review process.
April 9, 2009
Genentech, manufacturer of the psoriasis drug, Raptiva, announced that it is recalling Raptiva from the U.S. market because the drug poses an increased risk of progressive multifocal leukoencephalopathy (“PML”), a rare and serious fatal disease of the central nervous system. PML is a progressive neurologic disease caused by a virus. It typically occurs in people with weakened immune systems because the virus can attack the myelin, or white matter, that surrounds and protects brain cells. There is no known treatment. PML is the same disease that has been linked to the multiple sclerosis drug Tysabri, sold by Biogen Idec Inc. and Elan Corp.
April 6, 2009
Caraco Pharmaceutical Laboratories Ltd (“Caraco”) announced a voluntary recall of batches of Digoxin tablets. The recall includes batches of Digoxin distributed before March 31, 3009, which are not expired and are within the expiration date of September, 2011. Digoxin is a generic version of GlaxoSmithKline’s Plc’s drug Lanoxin, and is used to treat heart failure and abnormal heart rhythms.
April 3, 2009
The Peanut Corporation of America (“PCA”) announced a nationwide recall of peanut butter produced in its Blakely, Georgia processing facility because of potential salmonella contamination. Since that time, 3,235 peanut products have been recalled as the outbreak continues to spread.
April 2, 2009
After years of litigation over the safety of Yamaha Rhinos, Yamaha has issued a nationwide Yamaha Rhino recall so that repairs can be made to improve the vehicle’s stability and reduce the risk that it may roll over. All Yamaha Rhinos sold since 2003, including Rhino models 450, 660, and 700, are affected by the recall.
April 1, 2009
Philip Morris USA Inc. lost its last chance to overturn a $79.5 million punitive-damages award over an Oregon smoker’s death Tuesday after the U.S. Supreme Court dismissed the tobacco company’s appeal. Now, ten years and a day after a jury awarded Mayola Williams nearly $80 million in punitive damages, she can collect her share.
March 31, 2009
The Food and Drug Administration (“FDA”) advised consumers to avoid eating all pistachio products following a voluntary recall of more than 2 million pounds of roasted pistachio nuts from Setton Pistachio of Terra Bella, Inc. (“Setton”), a California based pistachio processor. The plant is the nation’s second largest pistachio processor and is thought to have shipped pistachios nationwide that are possibly contaminated with salmonella. Last week, the pistachio plant shut down its operation after discovering that four different strains of salmonella were identified on roasted pistachios shipped nationwide for processing. Salmonella can cause serious and sometimes fatal infections in young children, the elderly, and those with weakened immune systems.
March 25, 2009
Leading specialty pharmaceutical company Watson Pharmaceuticals has announced that one lot of Propafenone HCL 225 mg tablets is being voluntarily recalled from consumers. The Propafenone HCL tablets are being recalled because some tablets may be oversized, and as a result, may contain higher-than-normal levels of the active ingredient. While no adverse events have been reported to date, Watson says it is issuing the recall as a precautionary measure.
March 20, 2009
The U.S. Consumer Product Safety Commission (CPSC), in cooperation with Maytag, has announced a voluntary recall of about 1.6 million refrigerators made by Maytag under a variety of brand names. Apparently, an electrical failure in the relay, which is the component that turns on the refrigerator’s compressor, can cause overheating and pose a serious fire hazard.
March 11, 2009
Written complaints from senior FDA staff members regarding the handling of Menaflex, a new medical device for treating knee injuries, are calling into question the validity of the FDA’s approval process. Specifically, U.S. Food and Drug Administration (FDA) documents show that the recent approval of Menaflex followed a lobbying campaign that overcame multiple rejections by FDA scientists.
March 9, 2009
The Medical Technology Learning Institute and Compliance-Alliance is offering a course to help drug and medical device companies cut down on expensive legal settlements.
The one-day $995 course, called “Dangerous Documents: Avoiding Land Mines in Your FDA Records and Emails,” is designed to educate drug and medical device company employees on how to avoid writing internal and external communications that may attract the attention of prosecutors and product liability lawyers. For example, the course teaches its students that instead of writing “We’ll meet on Thursday to destroy the documents,” it is better to say, “We’ll meet on Thursday to implement our document retention policy.”
March 4, 2009
A new surgically implanted electrical device that stimulates the sacral nerve may be an alternative to transvaginal placement of surgical mesh to treat urinary incontinence. The device is called InterStim and is sold by medical device manufacturing giant Medtronic Inc. It is implanted during a half-hour surgery, which can be done using local anesthetic with a sedative or under general anesthesia. The cost, generally from $20,000 to $30,000, is covered by most insurers. InterStim is meant to be left on continuously, but patients can use a remote control to turn it on and off and adjust intensity. When the device is on, it feels like a slight vibration or tingling. There are two available models, and the newer one offers four preset programs.
March 3, 2009
Multiple news sources reported compressor antitrust probes by the European Union, the Brazilian Ministry of Justice, and the United States Department of Justice for antitrust violations by: Whirlpool Corporation; Empresa Brasileira de Compressores S.A.- Embraco; Danfoss A/S; Danfoss North America Refrigeration & Air Conditioning; Tecumseh Products Company; and Tecumseh do Brasil Ltda. As a result, Bernstein Liebhard LLP is investigating these compressor companies for violations of United States antitrust laws to direct compressor purchasers.
Consumers Union, a nonprofit consumer activist group, has initiated a “Stop Hospital Infections” campaign, which is pushing for legislation to create a national hospital infection-reporting law. The proposed federal law would require hospitals to report the rate at which patients develop infections during treatment at their facilities and, according to Consumers Union, would dramatically reduce hospital infection rates.
February 27, 2009
The U.S. Food and Drug Administration (FDA) announced that California medical device manufacturer Cardinal Health 303 Inc., formerly known as Alaris Medical Systems Inc., and three of its top executives have signed an amended consent decree to correct violations of current Good Manufacturing Practice (cGMP) requirements in the company’s infusion pumps.
February 26, 2009
Because denture creams, such as Fixodent and Poligrip, have been linked to serious and life-threatening side effects, such as zinc poisoning and neuropathy, the denture cream lawyers at Bernstein Liebhard LLP are currently investigating denture cream-related injuries for potential denture cream lawsuits. If you or a loved one uses denture cream and has suffered from zinc poisoning or neuropathy, a denture cream lawyer may be able to help you file a denture cream lawsuit, including a Fixodent lawsuit or Poligrip lawsuit, seeking compensation for physical injury, pain, suffering, lost compensation, and more.
February 24, 2009
Opening statements began in the case of U.S. v. W.R. Grace & Co. (“Grace”) and five former company executives, who were charged with knowingly exposing the residents of Libby, Montana to asbestos, which causes asbestos cancer. During the opening statements, the prosecution alleged that Grace exposed its workers and the town residents to asbestos during Grace’s mining operations. The vermiculite mine, operated by Grace, produced bags of puffy white granules that were marketed throughout the United States and used to insulate attics, aerating gardens and potting soil.
February 23, 2009
The U.S. Food and Drug Administration issued an FDA Warning regarding serious complications associated with transvaginal placement of surgical mesh, including Bard Avaulta surgical mesh. The Bard Avaulta FDA Warning stated that, over the last three years, it has received more than 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair Pelvic Organ Prolapse and Stress Urinary Incontinence. Among the surgical mesh products associated with complications are the Avaulta Biosynthetic Support System and Avaulta Plus Biosynthetic Support System, both of which are manufactured by Bard.
February 20, 2009
The European Medicines Agency (EMA) has recommended that sales of Merck KGaA’s psoriasis drug Raptiva be suspended in Europe in light of serious brain infections confirmed in three Raptiva patients. According to the EMA, a committee has concluded that “the benefits of Raptiva no longer outweigh its risks, because of safety concerns” following the three confirmed instances of progressive multifocal leukoencephalopathy, or PML. The European Commission will consider the EMA’s advice and will likely suspend Raptiva sales, as it usually follows EMA recommendations.
February 13, 2009
The FDA recently issued a health alert stating that transvaginal placement of surgical mesh has been linked to several serious side effects. Transvaginal placement of surgical mesh is used to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). Many companies, including large medical device companies like Bard and Mentor, manufacture this type of surgical mesh.
January 28, 2009
Pfizer’s acquisition of Wyeth for $68 million overshadowed two other newsworthy items connected with its business dealings. Pfizer not only announced that its earnings were down 90 percent as a result of a settlement with the Department of Justice concerning the off-label promotion of Cox-2 painkiller Bextra, which was leading to heart attacks and deaths in patients, but they also announced that it was laying off 19,000 employees. The layoffs are reported to allow Pfizer to proceed with the Wyeth acquisition.
January 21, 2009
The Peanut Butter Corporation of America (PCA) recalled various lots of peanut butter because of potential salmonella contamination. Since that time, the list of peanut butter products potentially contaminated with salmonella has morphed into an outbreak throughout the peanut butter industry.
January 5, 2009
PriCara, a division of Johnson & Johnson, announced that is recalling one lot of the Duragesic pain patch and one lot of the generic Sandoz fentanyl pain patch. The recall, conducted in conjunction with the Food and Drug Administration (“FDA”), was issued after the manufacturer became aware of tears in the products that could allow the fentanyl gel to leak from the patches. There is a serious risk of respiratory problems and fentanyl overdose, which could be fatal if the gel makes direct contact with skin.
December 22, 2008
U.S. District Judge Dan Polster entered a Case Management Order (CMO) delaying the discovery and trial schedule for consolidated gadolinium MRI contrast agent lawsuits in the multi-district litigation (MDL) filed by individuals diagnosed with Nephrogenic System Fibrosis (NSF) by 90 days.
December 19, 2008
A new study shows that women who take diabetes drugs Avandia and Acots are at higher risk of bone fractures. For these drugs, it is the latest in a series of side effects discovered. Avandia and Acots have also been shown to result in a higher risk of heart problems for female users.
December 18, 2008
The U.S. Food and Drug Administration (“FDA”) announced a recommendation that manufacturers developing type 2 diabetes drugs offer evidence that new therapies will not increase the risk of cardiovascular episodes such as heart attacks. The guidance applies to all diabetes drugs currently in development. Until now, companies were generally only required to show that treatments lower blood sugar.
December 17, 2008
Medtronic, Inc. (MDT) announced that it will inform the U.S. Food and Drug Administration (“FDA”) about the death of a patient who underwent spinal surgery and was treated with its Infuse Bone Graft (“INFUSE”) product. Medtronic claims that it was unaware of the death of Shirley Nesbit for three months and was only notified when her family filed a wrongful death lawsuit. The suit alleges that the surgery to her neck used INFUSE even though the product had not been approved by the FDA for this type of procedure.
December 16, 2008
Amylin Pharmaceuticals Inc., Eli Lilly and Co., and Alkermes Inc. are developing a long-acting release (“LAR”) version of the diabetes drug Byetta (exenatide). First introduced by Amylin and Eli Lilly in 2005, Byetta is an injectable drug used in the treatment of type 2 diabetes that must be taken twice a day. The Byetta LAR, however, can be taken once a week. In a statement released by Amylin, the company announced that the U.S. Food and Drug Administration (“FDA”) will accept data from an ongoing clinical study of Byetta LAR instead of requiring a new study. Further, the companies expect to seek FDA approval of the drug during the first half of 2009.
December 15, 2008
The United States Judicial Panel on Multidistrict Litigation (JPML) has consolidated 22 federal lawsuits against Mentor Corp, the creator of the Mentor ObTape Vaginal Sling, in the U.S. District Court for the Middle District of Georgia. Actions consolidated by the JPML are commonly referred to as multi-district litigations (MDLs).
December 12, 2008
After receiving reports linking oral sodium phosphate products (OSP) to kidney injuries, the U.S. Food and Drug Administration (“FDA”) mandated that its manufacturer, Salix Pharmaceuticals Ltd, add a Boxed Warning to the prescription drugs Visicol and OsmoPrep. Additionally, the FDA expressed concern about the use of related over-the-counter (OTC) laxatives (e.g., Fleet Phospho-soda). OSPs are commonly used by patients preparing to undergo a colonoscopy (colon examination to detect precancerous growths) because OSP products cleanse the bowels.
December 8, 2008
In November 2007, health officials, including the Food and Drug Administration (“FDA”), began receiving a spike in adverse event reports describing allergic-type reactions associated with the use of Heparin, an anticoagulant (blood thinner). Heparin is commonly used in surgical procedures and dialysis treatment to prevent blood clots.
December 4, 2008
A pain pump is a medical device implanted into the shoulder during arthroscopic surgery to alleviate post-operative shoulder (or knee or ankle) joint pain. It works by infusing pain medication directly into the shoulder through a catheter. If placed into the joint, the pain pump can destroy cartilage, leading to a condition referred to as PAGCL. This is particularly a problem because pain pumps used in surgeries more recently used higher volumes of anesthetics, which can destroy shoulder cartilage.
December 3, 2008
A recent study suggests that excessive use of denture creams, such as PoliGrip and Fixodent, may cause copper deficiency, nerve damage and a serious nerve disorder called neuropathy. The study, which was published in the medical journal Neurology, was conducted by researchers at the University of Texas Southwestern Medical Center in Dallas and reported on four denture-wearing patients who developed nerve damage.
December 2, 2008
For Bayer Healthcare LLC, November was a busy month with a near $100 million settlement and a new class action in New Jersey brought by consumers. Bayer’s settlement with the Department of Justice (DOJ) ended a federal investigation into whether Bayer paid kickbacks to medical equipment suppliers who deal with diabetes patients.
December 2, 2008
Genentech Inc. and OSI Pharmaceuticals Inc. have disclosed that a late-stage trial showed that adding the cancer drug Avastin to the cancer drug Tarceva did not prolong the lives of patients with advanced lung cancer. Lung cancer can be caused from, among other things, exposure to asbestos.
November 25, 2008
An article in today’s edition of the Wall Street Journal reported that internal company emails produced in a lawsuit against Johnson & Johnson suggest that Johnson & Johnson planned funding for a research institute to focus on use of the antipsychotic drug Risperdal by children well before the FDA approved Risperdal for patients that young.
November 14, 2008
A new study suggests that Nexium and other heartburn medications may keep the blood-thinner Plavix from working effectively. Consequently, mixing the two drugs may significantly increase the risk of heart attack and stroke. The study, conducted by Medco Health Solutions, followed 16,690 people and found the risk of heart attack or other cardiac trouble to be 50 percent higher in patients taking some combination of Plavix and a heartburn medicine than in those taking Plavix alone. Two additional studies conducted within the past year found similar problems.
November 14, 2008
An FDA update released yesterday says clinical trial data from four drug makers shows little overall risk of heart problems in patients taking bisphosphonates, a class of drugs prescribed to prevent and treat osteoporosis. The agency reviewed studies on the following bisphosphonates: Merck & Co.’s Fosamax; Roche Holding AG’s Boniva; Novartis AG’s Reclast; Procter & Gamble Co.’s Actonel
November 14, 2008
Mineola Middle School, located on Long Island in Nassau County, New York, is reopening this week after the school was temporarily closed to remove asbestos from the roof of its technology and shop rooms. The asbestos was initially found when construction workers began renovating a ventilation system used by the technology and shop rooms. The school district immediately notified the students’ parents about the issue after the discovery of the asbestos was made.
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