Philadelphia Personal Injury Lawyer

NY Times: Courts Dismissing Cases Involving Generic Drugs

Jamie Sheller — Wed, 21 Mar 2012 11:39:39 GMT

If you buy a generic drug, you might save money on the purchase. But if a generic drug harms or kills you because it is dangerous, buying a generic drug could cost you your legal rights to hold the drug manufacturer responsible for your injuries.

An article in The New York Times article is highlighting how courts are dismissing cases of people who have been catastrophically injured by dangerous drugs based on the U.S. Supreme Court’s 5-4 decision in Pilva v. Mensing, which held that generic drug manufactures are not responsible for updating drug labels -- even to warn of known dangers -- as brand-name drug manufacturers are. To date, at least 40 judges across the country have dismissed cases against generic drug manufacturers since June.

Consider the story of Debbie Schork, an Indiana supermarket worker, who had to have her hand amputated after she was injected with an anti-nausea drug, which caused gangrene. She sued the manufacturer of the generic drug promethazine. An Indiana court dismissed her case, according to the Times article, “Generic Drugs Prove Resistant to Damage Claims.”

But when Vermont musician Diana Levine was forced to have her hand and forearm amputated because a drug with the same chemical makeup caused gangrene, she sued the manufacturer Wyeth and won $6.8 million.

What was the difference between Ms. Levine receiving fair compensation for her loss and Ms. Schork, who was turned away from the court with nothing? Ms. Levine was given the brand name drug Phenergran, and Ms. Schork was given the generic version of the same drug. Now what most patients view as an insignificant question – whether or not to take a generic or name brand – is the deciding factor in whether a person has a right to bring suit for injury caused by the dangerous drug or not. Frequently, pharmacists and doctors make those decisions without discussing with the patient.

According to the Times’ investigation, dozens of cases brought by people injured by generic versions of drugs have been dismissed across the country in light of the Pilva decision. The Supreme Court’s 5-4 decision was split down ideological lines, with conservative justices making up the majority.

The Court’s analysis was based on a 1980s law that brought generic drugs onto the market. Generally, the law required that generics use the same label as the brand-name drug it copied. The court held that generic manufacturers should not be held liable for a warning label they are required to follow.

But Justice Sonya Sotomayor, writing for the dissenting justices, argued generic companies still have a responsibility to report dangers to the FDA and should not be let off the hook for failing to warn patients about those dangers, the Times notes.

Originally posted at InjuryBoard by Jamie Sheller

Wharton Journal Asks: Is Johnson & Johnson Putting Patients over Profits?

Jamie Sheller — Mon, 20 Feb 2012 10:30:32 GMT

A publication of the nation’s leading business school is raising questions about whether Johnson & Johnson has reversed its reputation for putting patient safety over profits.

A recent article in the online business journal for The Wharton School of the University of Pennsylvania, “Knowledge @ Wharton” cites “stunning setbacks” at J&J, including a “seemingly endless stream of product recalls” to lawsuits brought by numerous states over off-label marketing of the anti-psychotic drug, Risperdal.

In the 1980s, J&J gained a reputation as a patient-centered company following a laudable voluntary recall of Tylenol, when cyanide-laced Tylenol was linked to seven deaths. The company’s crisis management resulted in tamper-proof packaging and a written credo to place patients over profits.

The article “Patients versus Profits at Johnson & Johnson: Has the Company Lost its Way?” suggests that company managers have lost sight of the credo and are putting profits over patients.

The journal cites leading academics, including Erik Gordon, a professor at the University of Michigan’s Ross School of Business, who say that the company’s “relentless focus” on profitability is the reason for the reversal, as well as the company’s current woes.

While its profits have gone up, J&J’s image in the public has gone down. YouGov’s BrandIndex service, has noted a decline in J&J’s public perception rating between 2009 and the present. On a scale ranging from -100 (most negative) to +100 (most positive) J&J’s image fell from 70.7 to 52.6 over the past three years, according to the “Knowledge @ Wharton” article.

The attorneys at Sheller, P.C. currently are litigating cases involving patients who have been injured by taking Risperdal. At this time, Sheller, P.C. attorneys are specifically investigating gynecomastia -- a condition that causes boys and adolescents to grow breasts and has been linked with Risperdal®. If your son or a young boy or adolescent you know has experienced abnormal breast development or has been diagnosed with gynecomastia, contact us at toll free 800-883-2299, or in Pennsylvania at 215-790-7300, now to learn your rights and protect the health of your child.

Originally posted at InjuryBoard by Jamie Sheller

Energy Star Appliances: Some Are Not Efficient As They Claim

Jamie Sheller — Thu, 16 Feb 2012 09:54:11 GMT

Some consumers who have purchased home appliances with the “Energy Star” efficiency rating may not have received the appliance they bargained for.

Sheller, P.C. is investigating a potential class action lawsuit involving appliances that were labeled to sell with an "Energy Star" efficiency rating, but in fact did not qualify. Energy Star appliances are generally required to use 10% to 35% less energy than standard models, depending on the type of appliance. Manufacturers of Energy Star appliances typically charge a premium above the price of standard models.

If you purchased any of the appliances listed below, and you would like to discuss your legal rights, please contact us at 800-833-2299, or visit us online at www.sheller.com

Government regulators determined that the appliances listed below did not qualify for an Energy Star rating, despite being sold with an Energy Star label:

Product Type	Organization Name	Product Model Number	Date Disqualified
Clothes Washers	Equator Appliances	EZ 3720 CEE	10/22/10
Commercial Refrigerators	Perlick	HP48RO-S	7/13/11
Dishwashers	ASKO	D5122ADA	6/30/10
Dishwashers	ASKO	D5122XXLB	6/1/10
Dishwashers	ASKO	D5122XXLS	6/30/10
Dishwashers	ASKO	D5122XXLW	6/30/10
Dishwashers	ASKO	D5122XXLAD	6/30/10
Refrigerators and Freezers	Electrolux	FFTR1817L	6/25/10
Refrigerators and Freezers	Electrolux	EW26SS70I	8/26/11
Refrigerators and Freezers	Frigidaire	FFN09M5HW	12/16/10
Refrigerators and Freezers	LG Electronics	LFX21975ST	1/20/10
Refrigerators and Freezers	LG Electronics	LFX25975SB	1/20/10
Refrigerators and Freezers	LG Electronics	LFX25975ST	1/20/10
Refrigerators and Freezers	LG Electronics	LFX25975SW	1/20/10
Refrigerators and Freezers	LG Electronics	LFX28977SB	1/20/10
Refrigerators and Freezers	LG Electronics	LFX28977ST	1/20/10
Refrigerators and Freezers	LG Electronics	LFX28977SW	1/20/10
Refrigerators and Freezers	LG Electronics	LMX25985SB	1/20/10
Refrigerators and Freezers	LG Electronics	LFX28977ST	1/20/10
Refrigerators and Freezers	LG Electronics	LFX28977SW	1/20/10
Refrigerators and Freezers	LG Electronics	FFTR1817L	6/25/10
Refrigerators and Freezers	Perlick	HP72R00-S	7/14/11
Refrigerators and Freezers	Samsung	RF26VAB	3/22/10
Refrigerators and Freezers	Sears/Kenmore	79732	1/20/10
Refrigerators and Freezers	Sears/Kenmore	79733	1/20/10
Refrigerators and Freezers	Sears/Kenmore	79737	1/20/10
Refrigerators and Freezers	Sears/Kenmore	79752	1/20/10
Refrigerators and Freezers	Sears/Kenmore	79753	1/20/10
Refrigerators and Freezers	Sears/Kenmore	79754	1/20/10
Refrigerators and Freezers	Sears/Kenmore	79757	1/20/10
Refrigerators and Freezers	Sears/Kenmore	79759	1/20/10
Refrigerators and Freezers	Sears/Kenmore	79782	1/20/10
Refrigerators and Freezers	Sears/Kenmore	79783	1/20/10
Refrigerators and Freezers	Sears/Kenmore	79789	1/20/10
Refrigerators and Freezers	KitchenAid	KSRG25FVMS	9/27/11
Refrigerators and Freezers	KitchenAid	KSRS25RV	9/27/11
Refrigerators and Freezers	Summit Appliances	CF11ES	11/8/11
Room Air Conditioners	Electrolux	FRA256ST2	7/13/11
Room Air Conditioners	Friedrich	US10C30	8/26/11
Room Air Conditioners	Friedrich	CP15F10	8/26/11
Room Air Conditioners	Friedrich	US12C10	8/26/11
Room Air Conditioners	Friedrich	SM24M30	1/03/12
Room Air Conditioners	Midea USA Inc.	MWF08CR	3/9/11
Central Air Conditioner Equipment and Air Source Heat	Thermo Products, LLC	OPB24-80	8/19/11
Ventilating Fans	National HVAC	Zonex GM-80	4/27/11
Dehumidifier	Friedrich	D70D	1/10/12
Geothermal Heat Pump	GeoSystems, LLC	MG069	12/20/11
Stereo Amplifier	Nigel B. Design Inc.	NB-50050	7/21/11
Stereo Amplifier	Nigel B. Design Inc.	NB-50050PL	7/21/11
Stereo Amplifier	Nigel B. Design Inc.	NB-50090	7/21/11
Stereo Amplifier	Nigel B. Design Inc.	NB-50090PL	7/21/11
Stereo Amplifier	Nigel B. Design Inc.	NB-70050	7/21/11
Stereo Amplifier	Nigel B. Design Inc.	NB-70050PL	7/21/11
Stereo Amplifier	Nigel B. Design Inc.	NB-70090	7/21/11
Stereo Amplifier	Nigel B. Design Inc.	NB-70090PL	7/21/11

Originally posted at InjuryBoard by Jamie Sheller

DePuy ASR Hip Implant Failure Rates Continue to Rise

Jamie Sheller — Tue, 03 Jan 2012 10:52:07 GMT

Reports indicate that problems associated with the DePuy ASR metal-on-metal hip implants are on the rise.

According to recent report, the Food and Drug Administration ("FDA") received more complaints related to failure of metal-on-metal hips in the first six months of 2011 than the prior four years combined. And the National Joint Registry for England and Wales is reporting that nearly one out of three ASR hip systems implanted in patients six years ago have failed.

The reports follow a spate of lawsuits challenging metal-on-metal devices manufactured and marketed by DePuy Orthopedics. The lawsuits allege that the metal-on-metal devices can shed tiny particles damaging to bone, muscle, and nerve, complicating revision surgeries.

The FDA is now reviewing the risk-benefit profile and revision surgery rates of hip prostheses by 21 manufacturers. The metal-on-metal devices include a metal ball and socket parts. Other designs are plastic or ceramic, to avoid metal-on-metal contact and wear.

Metal-on-metal hip systems were marketed in the U.S. prior to 1976 legislation that gave the FDA premarket authority over medical devices. These so-called “pre-amendment devices” were automatically designated as Class III (higher risk)devices, but they were regulated under the less rigorous 510(k) premarket notification program.

In August 2010, DePuy Orthopedics recalled its ASR™ XL Acetabular hip system after researchers found 13 percent of patients required a revision surgery to fix problems within five years of the surgery. The New York Times characterized the rate of failure as “unusually high.”

Any patient with a hip replacement should contact their orthopedic surgeon to determine whether they received a DePuy device.

Sheller, P.C. represents clients nationwide with the recalled hip implant. If you or someone you know has been injured by one of these products, see www.hiprecallhelp.com, or call 1(800)883-2299.

Originally posted at InjuryBoard by Jamie Sheller

Risperdal: Boys at risk of growing breasts (gynecomastia) requiring surgery

Jamie Sheller — Fri, 30 Dec 2011 16:09:12 GMT

The attorneys of Sheller, P.C. continue to investigate the use of the antipsychotic drug Risperdal® and its dangerous side effects, particularly for children. Boys who have taken Risperdal® ay be at risk of developing potentially irreversible condition gynecomastia (breast development).

Sheller, P.C. has filed numerous lawsuits across the country on behalf of children harmed by this drug. We are actively litigating these cases in New Jersey and Pennsylvania. The initial cases involving Risperdal® and gynecomastia are expected to go to trial in the Philadelphia Court of Common Pleas in July.

Research indicates that use of Risperdal® elevates the hormone prolactin, which is one of the reasons why the drug causes boys and male adolescents to grow breasts. Prolactin is the same hormone that causes new mothers to produce breast milk after they give birth. In some cases, a mastectomy may be required to remove the breast(s).

Though approved for adults, until recently the use of Risperdal® in children was not approved by the FDA. Even now, it is approved for very limited use in pediatric patients. Unfortunately, the drug continues to be prescribed as a behavior restraint for children who are considered disruptive or hard to control, some with the diagnoses of ADD, autism, and other conditions. There continues to be controversy over the use of antipsychotics in children over safety and efficacy.

If your son or a young boy or adolescent you know has experienced abnormal breast development or has been diagnosed with gynecomastia, contact us at (800) 883-2299 now to learn your rights and protect the health of your child.

Originally posted at InjuryBoard by Jamie Sheller

Federal Actos Cases Moving to Multidistrict Litigation

Jamie Sheller — Fri, 30 Dec 2011 15:15:23 GMT

The Judicial Panel on Multidistrict Litigation is streamlining litigation for all federal cases alleging injury caused by the diabetes drug ACTOS®, a diabetes drug that has been linked with incidents of bladder cancer. These cases will now be brought under MDL No. 2299.

Since the Food and Drug Administration (FDA) in June 2011 issued a Drug Safety Communication Update for Actos, Sheller, P.C. has continued to investigate the link between ACTOS® and bladder cancer.

The FDA warns that patients using ACTOS® (pioglitazone) for a year or longer have a substantially increased risk of bladder cancer. (Read announcement here). ACTOS® is the brand name of a drug developed by Takeda Pharmaceuticals in conjunction with Eli Lilly and Company. The drug is designed to help control blood sugar levels in patients with Type 2 Diabetes.

An FDA September 17, 2010, Safety Communication revealed that patients taking Actos over several years had an increased risk of bladder cancer. That Safety Communication was based on a planned five-year interim analysis of an ongoing, ten-year study that found as patients’ bladder cancer risks increased with patients’ exposure.

The FDA referred to a French Study which found a statistically significant increase in the risk of bladder cancer in Actos patients as compared to patients using other diabetic medications. The most significant increase in risk was observed in males.

Based on the results of this study, France has suspended the use of pioglitazone and Germany has recommended not to start pioglitazone in new patients. If you or anyone you know takes ACTOS® and has experienced these symptoms, you should consult your health care provider immediately to check for bladder cancer:

Blood in the urine
Urgent need to urinate
Pain while urinating
Frequent urination, or feeling the need to urinate but with no results
Pain in the abdominal (stomach) area or in the back

If you or someone you know has taken Actos and developed bladder cancer, please call Sheller, P.C. at 1-800-833-2299.

Originally posted at InjuryBoard by Jamie Sheller

FDA : Patients With Permanent AF Should Not Take Multaq®

Jamie Sheller — Fri, 23 Dec 2011 09:41:16 GMT

The heart-drug Multaq® , which an FDA report has linked to severe liver injuries , is now being cited for additional safety issues.

On the heels of the independent Institute for Safe Medicine Practices report that Multaq (dronedarone) was associated with more cases of slow heart beat; a rapid heart beat in the heart’s main chamber, and an uncontrolled arrhythmia in the atria than all other drugs the institute monitors, the

The Food and Drug Administration has taken action to keep people with permanent atrial fibrillation from taking Multaq®. The drug, sold by Sanofi-Aventis, is designed to prevent potentially deadly arrhythmia and make the heart beat normally.

The safety agency's latest advisory said that patients with a "permanent" version of the abnormal heartbeat called atrial fibrillation shouldn't get the medicine, generically called dronedarone. The FDA's said the drug "doubles the rate of cardiovascular death, stroke, and heart failure" in patients with permanent atrial fibrillation.

Sheller, P.C. is investigating potential claims for injuries related to the drug. If you or someone you know with permanent AF who has suffered heart failure, stroke, or cardiovascular-related death after taking Multaq®, contact us by e-mail at info@sheller.com, or call toll free 800-883-2299.

Originally posted at InjuryBoard by Jamie Sheller

Patient Safety Alert: Blood Pressure Drugs Pose Dangers

Jamie Sheller — Fri, 23 Dec 2011 09:22:46 GMT

Drug maker Novartis has suspended promotion of five high blood pressure drugs after researchers saw an increased number of adverse events.

Sheller, P.C. attorneys are investigating potential claims for serious injury and possibly life-threatening side effects associated with the following high blood pressure drugs:

Tekturna®
TekturnaHCT®
Valturna®
Tekamlo®
Amturnide®

An increased number of adverse events potentially caused by the drugs were discovered in a drug trial that was terminated, according to Novartis and other sources, on December 20, 2011.

These adverse events increased when the drugs were given in combination with the heart/cardiovascular treatment ACE (angiotensin converting enzyme) and ARB (angiotensin receptor blocker) drugs. Patients with Type 2 diabetes are particularly at risk.

Potential side effects include:

cardiac injury (heart injury, stroke, and other)
renal (kidney injury or failure)
hyperkalemia (increased blood potassium that may present as irregular heartbeat, nausea, slow or weak pulse, muscle weakness )
hypotension (low blood pressure)

If you or anyone you know takes or has taken these drugs and has experienced cardiac (heart) or renal (kidney) injury, or other side effects listed above, contact the attorneys of the Sheller, P.C. law firm immediately to learn your legal rights and protect your health.

Originally posted at InjuryBoard by Jamie Sheller

Consumer Watchdog Asks FDA to Withdraw Brain Stent Approval

Jamie Sheller — Thu, 22 Dec 2011 19:20:54 GMT

A prominent national watchdog group and a former Food and Drug Adminstration official are calling on drug regulators to withdraw approval for a medical device designed to prevent strokes, but which has been shown to increase strokes and stroke-related deaths.

The watchdog, Public Citizen, and former FDA official Dr. Larry Kessler are petitioning the FDA to pull its approval of the Wingspan Stent System as a humanitarian use device (HDE), because "when combined with aggressive medical treatment, they provide no additional benefit but cause significantly more harm than safer aggressive medical treatment alone," Public Citizen said.

Approximately 700,000 patients experience an ischemic stroke, and 240,000 have a transient ischemic attack (which cause stroke-like symptoms) in the United States each year. The Wingspan system has been prescribed to these patients -- at risk of future strokes. In 2005, the FDA approved the device -- which is a mesh tube implanted in the narrowed arteries that supply blood to the brain.

Public Citizen and Dr. Kessler charge that, because the FDA’s rules for approval of a HDE are less stringent than those for other medical devices, the manufacturer Boston Scientific did not have to provide evidence that the Wingspan Stent System was effective prior to its approval.

However, a recent study, funded by the National Institutes of Health (NIH), "proves that some of the key conditions upon which the Wingspan Stent System was approved as a humanitarian use device cannot be met," Public Citizen said in a media release.

The NIH-funded study, published in September 2011 in the New England Journal of Medicine, showed a more than 2.5-fold increase in strokes or death caused by the Wingspan system.

Sheller, P.C. is investigating cases of patients who have suffered additional strokes or died after receiving a stent. If you or someone you know has suffered additional strokes or died after receiving a stent please contact us at 1-800-833-2299.

Originally posted at InjuryBoard by Jamie Sheller

Consumer Alert: Check Snow Thrower Tires Before Inflating

Jamie Sheller — Thu, 15 Dec 2011 17:23:46 GMT

As winter temperatures drop, many people bring out the snow blower and snow throwers for seasonal maintenance.

But beware before pumping up flat tires: Defective wheel-rims may explode and turn routine maintenance into a trip to the emergency room for a serious injury.

In 2006, MTD Product Inc. recalled a series of 130,000 snow blowers with wheel-rims made from a dangerous plastic composite that easily exploded and fragmented. Years after the recall, consumers are still suffering severe injuries. Even as winter just begins, Sheller, P.C. has already begun receiving calls from unsuspecting consumers who say they have been hurt by the exploding tires.

The snow throwers have two wheels and come in red, green, gray or black. They are sold under the Troy-Bilt, Yard Machines or Craftsman brands. The recalled models include the following:

Brand	Model	Snow Thrower
Troy-Bilt	31AS3BB2766	5.5 HP 24-inch Two Stage
Yard Machines	31A-3AAD700	5 HP 22-inch Two Stage
	31A-3BAD700	5.5 HP 22-inch Two Stage
	31A-3BAD729	5.5 HP 22-inch Two Stage
	31A-3BAD752	5.5 HP 22-inch Two Stage
	31A-3BAD762	5.5 HP 22-inch Two Stage
	31AS3DDE729	7 HP 24-inch Two Stage
Craftsman	247.88255	5.5 HP 24-inch Two Stage
Craftsman	247.88700	5 HP 22-inch Two Stage

MTD, a manufacturer of lawn machines, by and the Consumer Products Safety Commission recalled the machines due to hundreds of injuries inflicted on consumers when they filled the defective tires on these snow blowers, and the tires exploded with extreme force – sending plastic shrapnel flying with extreme force and causing severe fractures and lacerations.

This tire rim exploded after inflation. The hunk of plastic fired off at a high rate of speed and fractured the thumb of a bystander so severely it required surgery and pinning to repair

The snow blowers were sold at Home Depot and Sears and many other local hardware stores. Despite the recall five years ago, many recalled machines with the defective tires remain in use, posing a threat to unknowing consumers.

If you have an MTD snow blower, please contact Sheller, P.C. in determining whether it is among the recalled machines and do not attempt to fill the tires. Sheller, P.C. continues to investigate and monitor the recall status.

If you did fill the tires and it exploded causing an injury we can assist you in getting compensation for your injuries. We have resolved dozens of cases for injured consumers. Please contact Sheller, P.C. at 1-800-883-2299.

Originally posted at InjuryBoard by Jamie Sheller