After more than 50 product recalls in 15 months, including for artificial hips and Tylenol, the $60 billion company is fighting to clear its once-trusted name.

The recalls — voluntary and otherwise — reads like your family medicine cabinet: Tylenol and St. Joseph Aspirin were recalled for foul odors people said made them sick; Benadryl and Zyrtec were recalled for botched amounts of ingredients; Rolaids were recalled for containing bits of wood and metal.

Over the last 15 months, the company has recalled contact lenses, syringes filled with prescription medications, hernia devices, and other products made by subsidiaries around the world.

In the year ended Mar. 8, 2011, J&J was involved in at least 11 major recalls, as defined by the FDA, almost twice as many as Pfizer (PFE), the world’s largest health-care-products company by revenue, or Procter & Gamble (PG), the world’s largest consumer-products company.

J&J’s woes aren’t confined to the last couple of years. During the last decade, the company has been repeatedly confronted with claims that it sold a product that was defective, or that carried risks J&J downplayed in its marketing. It has been accused of paying kickbacks and using other financial incentives to promote off-label use of drugs and devices. It has been cited by federal authorities for trying to avoid the publicity of a recall by quietly buying up tainted products. And it frustrated FDA regulators who were urging the company to strengthen quality control at the factories that produced many of the recalled over-the-counter products.

J&J has steadfastly denied these claims, but its own annual report for 2010 contains eight pages detailing government criminal and civil investigations and thousands of private lawsuits covering a wide range of drugs, devices, and business practices.

If you’ve haven’t been keeping up, here is a recap of the recalls in just the last couple of years.

Johnson & Johnson’s recall rap sheet:

• AUG 2008: Consultants to J&J buy defective Motrin from stores. The FDA says it wasn’t notified of this “phantom recall.”
• NOV 2009: McNeil pulls about 6.3 million bottles of tainted Tylenol Arthritis Pain caplets made in Puerto Rico.
• JAN 2010: McNeil expands withdrawal to include Benadryl Allergy, Tylenol, Children’s Tylenol Meltaway, and Rolaids.
• APR 2010: J&J recalls 135 million bottles of meds made in Fort Washington, Pa., and closes the plant.
• MAY 2010: The FDA says the U.S. may pursue criminal charges against J&J.
• JUNE 2010: McNeil expands the recall from its Puerto Rico plant to include five more lots of Benadryl and Tylenol.
• JULY 2010: Yet more recalls; company submits remediation plan for McNeil plants to FDA.
• AUG 2010: Company appoints quality-control czar, announces corporation-wide standards.
• AUG 2010: J&J pulls 100,000 boxes of 1-Day Acuvue TruEye contact lenses; days later, DePuy recalls ASR hips.
• DEC 2010: 13 million packages of Rolaids softchews are recalled after customers find wood and metal particles in them.
• JAN 2011: J&J withdraws 43 million bottles of Rolaids, Tylenol, Benadryl, and Sinutab.
• JAN 2011: J&J announces 2010 earnings, puts lost sales from recalls and plant slowdowns at $900 million.
• FEB 2011: J&J units announce recalls of 70,000 potentially cracked syringes preloaded with the antipsychotic Invega.
• MAR 2011: J&J withdraws 585,000 surgical sutures due to concerns about compromised sterile packaging.
• MAR 2011: J&J’s Animas unit announces recall of 384,000 insulin-pump cartridges that may leak.
• MAR 2011: FDA and McNeil announce consent decree that will give agency expanded oversight of three plants.

Topiramate (brand name: Topamax) is used to treat epileptic seizures and prevent migraines. However, the drug presents a risk of  birth defects in children born to mothers taking the drug.

As a result, the FDA has required that Topamax carry a stronger warning to alert pregnant women of the risks regarding taking the drug while pregnant.

According to the research, infants who were exposed to Topamax during pregnancy, specifically the first trimester, had an increased risk of developing cleft lips or cleft palates. If you took topiramate during pregnancy and delivered a child with an oral birth defect, you may be entitled to monetary damages.

Topamax Pregnancy Guidelines
Topiramate (brand name: Topamax) presents a risk of birth defects in children born to mothers taking the drug. As a result of this risk, the FDA released new Topamax pregnancy guidelines:

• Women of childbearing age should speak with their doctors about alternate treatment options, to limit the use of Topiramate during pregnancy
• Women of childbearing age who continue treatment with Topamax should use an effective birth control method
• Before beginning Topamax, women should speak with their doctor if they are pregnant or plan to become pregnant
• Women who become pregnant while taking Topamax should speak with their doctor immediately
• Women, even those who are pregnant, should not stop treatment with the drug before speaking with their health care professional

Due to the recent information regarding Topamax and pregnancy, women who took Topiramate during pregnancy and delivered a child with a cleft palate or cleft lip may have legal recourse. A Topamax lawsuit would allow women the opportunity to recover the cost of medical bills and other damages resulting from their child’s Topamax birth defects. To find out if you can participate in a Topamax lawsuit, complete our no cost case review form with details of your Topamax pregnancy side effects.

Each year hundreds of thousands of Americans undergo elective hip replacement surgery. For the most part, few patients regret undergoing this surgery which reduces pain and increases their mobility.

Most of the prosthetic devices used are safe, however, through the years various orthopedic medical devices, such as prosthetic knees and prosthetic hips have been associated with complications.

DePuy Orthopaedics, a subsidiary of Johnson & Johnson is the latest manufacturer to recall a defective medical device.

On August 24, 2010 DePuy voluntarily recalled ASR XL Acetabular Hip System and DePuy ASR Hip Resurfacing System Implant products sold after 2006. It is estimated that 1 in 8 patients will suffer from complications. As a result medical monitoring including blood tests and X-rays may be necessary especially if a patient is experiencing pain or difficulty walking.

DePuy customers should avoid any discussions with company representatives since it may compromise their legal rights. There are many complex issues pertaining to the valuation of past, present and future pain and suffering; issues regarding the cost of ongoing medical monitoring and future revision surgery; as well as the potential reimbursement of medical claims by Medicare and other insurance company interests.

Before speaking with any representative it is advised to contact a lawyer skilled in medical device litigation.

All DePuy implant customers should speak to a lawyer to gain a full understanding of their rights concerning a problem which may last decades and should be leery of signing any documents or authorizations before consulting with lawyers.

An earlier Class I recall of saline flush syringes has now prompted a secondary FDA recall of venous catheter trays that included the defective syringes.

Cook Inc., of Bloomington, Ind., has issued an urgent recall for a series of defective central venous catheter trays, including single, double, triple, and five-lumen trays as well as single and double lumen PICC peripheral inserted central venous catheter trays.

The original Class I recall, announced in October 2010, involved certain lots of 6-mL prefilled saline flush syringes (0.9 percent sodium chloride) manufactured by Excelsior Medical Inc.

Leaks in the plunger luer were detected during a routine syringe leak test. The potential exists for leakage and possible loss of sterility.

After learning of the problem with this defective medical device, Cook initiated its own Class I recall. This class of recall means the affected products pose a risk of serious injury or death.

The recalled defective medical devices include 123 individual catheter products, which come packaged in trays containing different sizes. The catheters are used to monitor a patient’s pressure in a vein, for blood sampling, and administration of drugs and fluids.

Source: John Gever, Senior Editor, MedPage Today

The U.S. Food and Drug Administration (FDA) has been allowing tens of millions of relatively untested, unsafe medical devices to be marketed and sold in the U.S. and used in patients, according to an analysis published online by the Archives of Internal Medicine.

“We think patients will be shocked to learn how often new medical products using different materials, made by a different manufacturers, are not scientifically tested in humans to see how well they work,” said study authors in a statement released with the report.

Researchers examined the FDA’s list of high-risk device recalls issued between January 2005 and December 2009 to determine whether the devices had been approved using the rigorous premarket approval (PMA) process or the less-rigorous, less-expensive 510(k) process that does not require clinical testing or inspections of the manufacturing process.

Of the 113 high-risk device recalls issued in the four-year period, 71 percent of the devices had been cleared by the FDA using only the 510(k) process, a process typically intended for low-risk devices to speed along the approval process.

Only 19 percent of the recalled devices had been approved through the PMA process, which requires testing in actual patients as well as post-marketing safety studies. The remaining 7 percent of the recalled devices were exempt from regulation by the FDA.

“Our findings reveal critical flaws in the current FDA device review system and its implementation that will require either congressional action or major changes in regulatory policy,” wrote study authors Diana M. Zuckerman of the National Research Center for Women & Families in Washington, D.C., and Steven E. Nissen of the Cleveland Clinic in Cleveland.

About half of the studied device recalls involved cardiovascular devices such as automatic external defibrillators (AEDs) and implantable defibrillators.

The issue of untested, unapproved medical devices is an ongoing concern in connection with last year’s recall of two popular DePuy hip replacement systems in the U.S. The hip device has since been connected to numerous health complications, as the manufacturer was allowed to sell and market the defective hip replacements without having received FDA approval due to a loophole in the device approval process.

Certain uses could lead to maternal heart problems and death

The U.S. Food and Drug Administration is warning that terbutaline administered by injection or through an infusion pump should not be used in pregnant women for prevention or prolonged (beyond 48-72 hours) treatment of preterm labor due to the potential for serious maternal heart problems and death. In addition, oral terbutaline tablets should not be used for prevention or treatment of preterm labor. The FDA is requiring the addition of a Boxed Warning and Contraindication to the drug prescribing information (labeling) to warn against these uses.

Terbutaline is FDA-approved to prevent and treat narrowing of the airways (bronchospasm) associated with asthma, bronchitis, and emphysema. The drug is used off-label for obstetric purposes, including treating preterm labor and treating uterine hyperstimulation. Terbutaline has also been used in an attempt to prevent recurrent preterm labor. There is no evidence, however, that use of terbutaline to prevent preterm labor improves infant outcomes. Serious adverse events, including maternal deaths, have been reported with such use in pregnant patients.

“Women should be aware that serious and sometimes fatal side effects have been reported after prolonged use of terbutaline in pregnant women,” said Scott Monroe, M.D., director of FDA’s Division of Reproductive and Urologic Products. “It is important for patients and health care professionals to consider all the potential risks and known benefits of any drug before deciding on its use.”

The FDA is aware that administration of terbutaline by injection to pregnant women is used in hospital settings in certain urgent situations. The FDA warning relates to safety concerns about the prolonged use of terbutaline injection beyond 48-72 hours, and against any use of oral terbutaline in pregnant women for prevention or treatment of preterm labor.

The decision to require a Boxed Warning and Contraindication is based on the FDA’s review of post-market safety reports of heart problems and even death associated with terbutaline use for obstetric indications, as well as data from medical literature documenting the lack of safety and effectiveness of terbutaline for preventing preterm labor, and animal data suggesting potential risks. Based on this information, the FDA concluded that the risk of serious adverse events outweighs any potential benefit to pregnant patients for either prolonged use of terbutaline injection beyond 48-72 hours or use of oral terbutaline for prevention or treatment of preterm labor.

These changes to the drug labeling are consistent with statements from the American College of Obstetricians and Gynecologists discouraging use of terbutaline for preventing preterm labor.

There are multiple generic versions of terbutaline oral tablets and injectable formulations available. The brand name products were previously discontinued by the companies that made them.

The FDA encourages patients to talk to their health care professional if they have concerns about any treatment they are receiving. Patients and health care professionals should report any side effects from the use of terbutaline to the FDA’s MedWatch adverse event reporting program at www.fda.gov/MedWatch¹.

For more information:

• Drug Safety Communication: Use of Terbutaline for Preterm Labor
  ²
• FDA Citizen Petition Response: Terbutaline Sulfate, Docket No. FDA-2008-P-0358

A judge accepted a guilty plea by a division of Boston Scientific on charges that it hid defects in heart defibrillators. In addition, the judge  placed the company on three years’ probation.

Posted on behalf of Cappolino Dodd Krebs LLP.

That pharmaceutical companies occasionally manufacture a dangerous drug or that a defective drug slips through the system isn’t really news.

We’ve known for some time that there were serious problems with dangerous drugs like Paxil and Avandia.

Now, we’re learning that GlaxoSmithKline, a British drug giant, has agreed to pay $750 million to settle criminal and civil complaints that the company for years knowingly sold contaminated baby ointment and an ineffective antidepressant made in their Puerto Rico plant, despite warnings from their own quality control manager that the plant had problems.

Cheryl D. Eckard, GlaxoSmithKline’s quality manager, asserted in her whistle-blower suit that she had warned of the problems but the company fired her instead of addressing them. Among the drugs affected were Paxil, an antidepressant; Bactroban, an ointment; Avandia, a troubled diabetes drug; Coreg, a heart drug; and Tagamet, an acid reflux drug. No patients were known to have been sickened, although such cases would be difficult to trace.

In a rising wave, recent lawsuits have asserted that drug makers misled patients and defrauded federal and state governments that, through Medicare and Medicaid, pay for much of health care.

Ms. Eckard’s role in the case began in August 2002 when GlaxoSmithKline sent her to Cidra, south of San Juan, to lead a team of 100 quality experts to fix problems cited by an F.D.A. warning letter a month earlier.

This was GlaxoSmithKline’s premier manufacturing facility, producing $5.5 billion of product each year. But Ms. Eckard soon discovered that quality control was a mess: the water system was contaminated; the air system allowed for cross-contamination between products; the warehouse was so overcrowded that rented vans were used for storage; the plant could not ensure the sterility of intravenous drugs for cancer; and pills of differing strengths were sometimes mixed in the same bottles.

Although F.D.A. inspectors had spotted some problems, most were missed. And the company abandoned even the limited fixes it promised to conduct, the unsealed lawsuit says. Ms. Eckard complained repeatedly to senior managers; little was done. She recommended recalls of defective products; recalls were not authorized. In May 2003, she was terminated as a “redundancy.”

She complained to top company executives, but she was ignored even after warning that she would call the F.D.A. So she called the F.D.A. and sued. The agency began a criminal investigation and used armed federal marshals in 2005 to seize nearly $2 billion worth of products, the largest such seizure in history. Unable to fix the plant, GlaxoSmithKline closed it in 2009.

If you or someone you love has been harmed by one of these defective drugs, you may be entitled to financial compensation. Please contact an experienced defective drugs attorney for professional insight.

Source: GARDINER HARRIS and DUFF WILSON of The New York Times.

After reviewing reports on 31 overdoses of the prescription cough medication benzonatate (Tessalon) — including the deaths of five toddlers — the FDA said it was beefing up the drug’s label warnings and urging parents to keep it out of reach of children.

The product is sold in colored gelcaps with a “candy-like” appearance, the agency indicated in a press release.

“Benzonatate should be kept in a child-resistant container and stored out of reach of children,” said Carol Holquist, RPh, director of the agency’s Division of Medication Error Prevention and Analysis. “The FDA encourages healthcare professionals to talk with their patients and those caring for children about the risk of accidental ingestion or overdose.”

The product will remain on the market, but new label information will be added about risks of accidental ingestion resulting in overdose and death in children younger than 10.

Benzonatate was approved in 1958 for treatment of coughs in patients 10 and older. It is available in 100- and 200-mg dosage forms.

An FDA review of adverse event reports disclosed 31 cases of overdose in children and adults, ranging in age from 1 to 66. The overdoses involved as many as 30 gelcaps and as few as one.

Most of these appeared deliberate. However, seven were ruled accidental, all of which occurred in children younger than 10.

Five of these — all involving children younger than two — ended in death.

Cardiac arrest, coma, and convulsions were common in the overdose cases.

In six cases where the event report included information on time course of events, the FDA said, symptoms developed within an hour of ingestion, much faster in some cases.

The agency recommended that healthcare professionals prescribe the minimum number of capsules needed to treat an episode.

Providers should also advise parents to keep the capsules in childproof containers out of reach of children, the FDA said.

Source: John Gever, MedPage Today