TOV Injury and Safety Blog

Consumer group argues that power windows are an unrecognized hazard to children

On November 2, the KidsAndCars.org group challenged the National Highway Traffic Safety Administration to account more accurately for children injuries and deaths associated with power auto windows.  It called for the universal application of an "auto reverse" feature on car windows to protect children. NHTSA responded that the risk to children is a "small, but persistent problem," not requiring government action.  It estimates that car windows cause 1995 injuries to children annually, which it claims are "mostly minor," and six deaths.  A 2003-4 study documented similar numbers, annually.  Making the changes requested by KidsAndCars would cost about $6 per window.

Still wondering if its safe to eat ground beef?

This was another bad week for the American meat industry, in terms of public relations.  First, a New Hampshire resident died after consuming meat infected with E.coli bacteria.  The source was apparently the same meat that sickened Rhode Island school children in October.  This contamination event resulted in the recall of a half-million pounds of ground beef from the New York Fairbanks Farms.  It is thought that the primary risk associated with this beef is meat stored in freezers by consumers unaware of the recall.

Then South Shore Meats Co. of Brockton, Massachusetts initiated a recall after making 20 additional Rhode Island children and adults ill at a camp in Plymouth. Purchases of the meat in each case were made at large chain grocers.

The news became slightly less worrisome, but infinitely more disgusting, when the beef industry announced it would fight attempts to ban meat producers from feeding cows chicken feces.  The Consumers Union, McDonald's Corp., and others have asked the FDA to ban the practice of feeding this chicken waste to cattle. (We wonder why McDonald's doesn't just refuse to contract with suppliers who refuse to avoid the practice:  is that asking too much?)  The FDA estimates that farmers feed between one and two million pounds of chicken litter/feces to cattle, annually.

The practice isn't just disgusting, however.  It is also unsafe:  chicken "litter" includes tissue from other ruminants which had been fed to chickens--thus following the precise practice which is responsible for bovine spongiform encephalopathy, or "mad cow disease." The National Cattlemen's Beef Association, which will cry for help when beef consumption falls with the next report of "mad cow" or the next resulting foreign ban on American beef, objected to such a ban because the risk is "too remote".  The Consumers Union scientists interviewed noted that the practice is also objectionable because the litter contains "disease-causing bacteria, antibiotics and foreign objects such as dead rodents, rocks, nails and glass."

A food safety expert from Cal Davis said that while the practice sounds gross, it is as old as agriculture, with "anything that falls to the ground being fair game."  On the other hand, the practice was probably safer before the onset of industrial, chemical-laced food production practices when animals were not slaughtered by a stranger on an assembly line.

Stryker Corporation, in Kalamazoo, indicted for fraud in illegal sales and promotion of bone-growth product

Yesterday, a grand jury indicted the Kalamazoo medical product company and its CEO from 2004 through 2008, for fraud.  The defendants are accused of promoting the use of its bone growth "OP-1 putty" [called Calstrux] and OP-1 implant for uses not approved by the FDA.  Use of the mixture caused "serious medical problems" for some patients, according to the federal prosecutor.  The product was originally approved under a "humanitarian device exception" to treat a condition affecting fewer than 4,000 patients.

One million window blinds are recalled

IKEA, Bed Bath & Beyond and Hanover Direct recalled almost a million roller blinds and Roman shades because they pose a serious stangulation risk to small children.  The AP reported on October 27 that the recall includes a half million ISDANS, TUPPLUR and ENJE roller blinds made in Taiwan and France and sold by IKEA between 2005 and 2009, as well as nearly 400,000 blinds made in CHina by Dublin Energy Solution, and 90,000 Chinese-made faux suede shades sold by Domestications.  IKEA had recalled blinds in August of this year, as well.  The recalls followed one death and three entanglement reports.  Merely recalling defective products is not a safe solution, however.  Sadly, statistics show that fewer than twenty percent of recalled items will actually be returned, repaired, or taken out of the stream of commerce.

Consumer Product Safety Commission eyes standards for 4-wheel ORVs

The CPSC recently rejected voluntary safety standards suggested by manufacturers of 4-wheel ORVs, finding them inadequate.  Instead, it will take testimony from the industry and the public and compose independent standards.  It noted that the side-by-side off-road vehicles, capable of speeds in excess of 35 miles per hour, are involved in a disproportionate number of deaths and injuries.  In March, Yamaha recalled 100,000 of its Rhino models for repairs, after two models were linked with 46 deaths in six years.  The vehicles pose a substantial roll-over risk and have been associated with 116 deaths and many serious injuries since 2003.  Many of the victims have been children.  Industry spokesman suggest that the deaths are merely the result of owners' unsafe use.

Pfizer hit with 1.3 billion dollar penalty for illegal practices: no big deal if your annual revenue is 48 billion

The U.S. government began investigating Pfizer's illegal activities in promoting Bextra--a pain killer since removed from the market--in a criminal action arising out of the government's payment of medical expenses for its beneficiaries.  Ultimately, the U.S. Attorney concluded that Pfizer was illegally promoting Bextra and other drugs to doctors through kickbacks and other illegal practices that included marketing the drugs for uses not approved by the FDA.  The claim was recently resolved by agreement of Pfizer to pay $1.3 BILLION dollars in civil and criminal fines.  Given that Pfizer reported revenues of $48.3 billion dollars in 2008, this kind of punishment is unlikely to phase the company's executives or deter future illegal activity of this nature.   Bextra was removed from the market because it was implicated in an unreasonble number of heart attacks and strokes among pain-relief users.

Investigation documents the risk of eating ground beef in the U.S.

22-year old Stephanie Smith is a paraplegiac.  She suffered severe kidney and neurological injury after eating a frozen Cargill hamburger her family purchased from Sam's Club.  Tracing the E. coli contamination of the burger allows a disturbing view into the game of Russian Roulette that is involved in eating an American burger.  The frozen patty Smith ate was labeled "American Chef's Selection Angus Beef Patties" but Cargill records show that it was derived from slaughtershouses in Nebraska, Texas and Uruguay, along with trimmings from a South Dakota company that processes trimmings and treats them with ammonia.  Cargill tested none of these components for E.coli bacteria and does not require that its suppliers test, either.

Target penalized for selling toys with lead paint surfaces

The Consumer Product Safety Commission announced this week that Target Corp. had agreed to pay a $600,000.00 civil penalty for importing and selling a variety of toys with surface lead paint.   The CPSC maintained that Target knowingly imported and sold the illegal toys from China in 2006 and 2007.  They include Kool Toyz play sets, Anima Bamboo Collection games, Happy Giddy Gardening Tools, and Sunny Patch chairs. The CPSC says the company did not take any of the appropriate steps to assure that the toys complied with restrictions on lead levels.  Sadly, if Michigan kids were injured by these unsafe toys, they would have an extremely difficult time recovering from Target, since Michigan legislators eliminated retailer liability for defectively manufactured products several years ago.

Expert not allowed to offer opinion on poor design of surgical table

Pontiac Osteopathic Hospital hired an expert to criticize its "shoulder chair," after the chair collapsed during surgery on Michael Pagano.  The Hospital, Allen Medical Systems, manufacturer of the chair, and Hillenbrand Industries had all been sued by Pagano after he fell to the floor while unconscious, injuring his neck and back.  The Defendants settled Pagano's claim and then continued the case among themselves to apportion fault.  Ultimately, the trial court excluded the Hospital's expert testimony regarding flaws in the design of the "shoulder chair," leaving the Hospital to bear the entire cost of the settlement because it could not prove fault by the manufacturer.

Significant recall of Children's Tylenol products

The AP on September 25, 2009, reported that Johnson & Johnson had recalled a number of children's Tylenol products, including Tylenol Suspension 4 oz. Grape, Infant's Tylenol Grape Suspension Drops, 1/4 oz. and Children's Tylenol Plus Cold/Allergy 4 oz. Bubble Gum.  57 lots of these medications were recalled over concern regarding potential bacterial contamination.  Consumers with questions were directed to McNeil's Consumer Call Center at 1-800-962-5357.

Physician group seeks new warnings on prescriptions

According to the Los Angeles Times, the American College of Physicians has gone on record criticizing the Food and Drug Administration for its passive lack of supervision of prescription labeling.  The nation's primary association of Internal Medicine physicians, the ACP made a number of concrete suggestions and recommendations.  These included placing limits on the advertising of newly-approved medicines, identifying them as "new" through appropriate consumer labeling, creating a better system of tracking complications in newly-approved drugs and better identifying drugs formulated abroad.  The organization documented its concerns and justified these recommendations by reference to recent medical product recall and patient injury history.

Kohl's fined for selling childrens' sweatshirts with drawstrings at neck

It is well established that neck drawstrings are a safety hazard in childrens' clothing.  Nevertheless, Kohl's Department Stores were selling imported sweatshirts with a drawstring at the neck, even though it had been fined $35,000.00 for the same violation in 2008.  This year, the Consumer Product Safety Commission fined it $425,000.00 for the violation which resulted in a recall in March of 2009.  Despite the earlier violation and fine, Kohl's maintains that it did not knowingly violate the law.

Pfizer admits fraud in marketing drugs and is fined $2.3 billion dollars

If you are wondering why pharmaceuticals are adding so much to the cost of health care, take a look at Pfizer.  For the fourth time since 2002, the company or one of its subsidiaries has agreed to settle criminal or civil charges arising out of its improper marketing of a drug.  Previously it was Lipitor, Neurontin and Genotropin.  This time it is Bextra and three other medications which Pfizer was promoting to doctors for uses not authorized by the Food and Drug Administration.  Bextra has since been pulled off the market by Pfizer after serious safety concerns were raised.

Death of three kids results in major window blind recall

The Associated Press reported today that the Consumer Product Safety Commission had ordered the recall of millions of window blinds and shades, after the strangulation death of three children who became entangled in the window covering cords.  The window treatments were sold at Target, IKEA and Pottery Barn Kids, among other retail outlets.  The deaths, dating back to 2006, involved manufacturers Vertical Land Inc., and Lewis Hyman Inc.  Free retrofit kits are available for the Vertical Land blinds and free repair kits are offered by Lewis Hyman for its products. 

Simplicity bassinet recall is emphasized after two more deaths

The Consumer Product Safety Commission reemphasized its August 2008 recall of some 900,000 Simplicity bassinets after four more entrapment incidents resulted in two fatalities.  Sadly, research shows that recalls result in less than twenty percent of recalled products being removed from the stream of commerce, and only a small percentage of products being repaired or improved.

This recall involves Simplicity 3-in-1 and 4-in-1 convertible bassinets sold under the Simplicty name or by Graco between 2001 and 2008.  The deaths and injuries have typically resulted from entrapment between metal bars or in pockets of fabric where velcro-attached fabric is not attached to the bars or is attached improperly.

Tanning beds cause cancer

The highly respected English medical journal Lancet Oncology published an analysis this week, documenting the cancer risk of tanning beds.  The authors evaluated 20 existing studies and concluded that the risk of skin cancer increases by 75 percent among young people who visit tanning beds before the age of 30.    The scientists concluded that all types of ultraviolet radiation contribute to cellular mutations and render radiation carcinogenic.  The Associated Press noted that as tanning bed use has increased in the U.K., melanoma, the deadliest form of skin cancer, is now the leading cancer diagnosed among women in their 20s.  Previous studies have suggested that younger people who regularly use tanning beds increase their risk of melanoma to eight times the average among the population in general.

More on crib safety

What is it with the crib industry that it cannot build a safe product?  Numerous blog entries on this site have addressed the multiple crib recalls over the past three years.  The Atlanta Journal-Constitution published a column in the July 13 edition summarizing the problem. 

Darvon to carry stronger warning

As the Food and Drug Administration has become more active under President Obama, new issues have arisen, almost weekly, regarding the use and mis-use of various pain medications.  Last week, a panel of the FDA  recommended that percocet and vicodin be managed differently, in order to guard against liver damage potentially resulting form over-use of the medications. 

Chelation study criticized by research physicians

Chelation is the periodic infusion of a drug in an attempt to flush arteries.  It is used in cases of lead poisoning, and is currently being tested as a potential method of clearing calcium deposits in coronary arteries, through the infusion of disodium EDTA.  Critics say that heart attack survivors who have enrolled in the study have not been adequately warned of the dangers of chelation and that the "alternative medicine" research is unethical. 

New Jersey treats Levaquin claims as class action

Lawsuits against Levaquin's manufacturer filed in New Jersey will be treated as a "mass tort" under the July, 2009, ruling of New Jersey's Supreme Court.  The plaintiffs argue that they suffered tendon injuries, frequently achilles' tendon tears, as a side-effect of treatment with the Johnson & Johnson antibiotic.  The FDA warned of the risk of tendon injuries associated with fluoroquinolone class antibiotics in 2008, some dozen years after the antibiotics were approved for sale. 

CPSC expected to recall one million Kolcraft "play yards" after 21 injuries

The Wall Street Journal announced the Consumer Product Safety Commission's anticipated action on July 8, noting that collpasing sides on the Chinese-made play pens have resulted in "hundreds of complaints" and 21 injured children.  The Journal indicated that there have been 347 reports of the play yard's side rail failing to latch properly.

400,000 Simplicity cribs recalled, July 2009

The Consumer Product Safety Commission recalled about 400,000 cribs today, due to a defect in the hardware that allows a crib side to detach, creating a potentially fatal gap allowing entrapment or suffocation.    In September of 2008, the manufacturer recalled 600,000 similar cribs.  In 2007 it recalled a million older, similar cribs.  This new recall comes after at least one reported suffocation death.  How hard can it be to get this right, if this is your business?

FDA panel recommends ban on Percocet and Vicodin

On June 30, 2009, a panel created by the Food and Drug Administration recommended that the agency ban Percocet (a combination of acetaminophen and oxycodone) and Vicodin (acetaminophen and hydrocodone).  The panel also voted almost unanimously to limit children's medicines containing acetaminophen to a single formulation in order to avoid confusion among doctors and patients over appropriate dosing.  The panel acted out of concern over the effects of these medications on the liver. 

Defective Chinese drywall brings to prominence concerns about inability to hold Chinese manufacturers accountable

The Kansas City Star pointed out on June 30, 2009, that the enormous problems associated with defective Chinese drywall have brought to the surface the compounding problems associated with holding Chinese manufacturers accountable.  The paper reminded readers that in recent months the list of faulty Chinese products identified in the media have included:

    "highchairs whose seat backs failed, steam cleaners that burned their users, bikes whose front-wheel forks broke, saunas that overheated, illuminated exit signs that stopped working when commercial power failed, dune buggies whose seat belts broke on impact and coffee makers that overheated and started fire...a soccer goal net that entrapped and stangled a child and a toy chest whose poorly supported lid fell on a toddler's neck and killed him."

During 2007, fully 69 percent of products recalled in the U.S. were manufactured in China, and previously recalled products continue to be imported, including "breakable toys on which infants can choke, lead toys, toys painted in lead-based colors and cribs whose slats are far enough apart to trap babies' heads."

Roche Holding AG removes Accutane acne medicine from market after verdicts.

On June 26, Bloomberg.com reported that Roche would take Accutane off the market following a reevaluation of personal injury verdicts and generic competition.  Roche has "vigorously" defended claims that the drug causes bowel disease, but jurors have awarded a total of $33 million dollars in damagesin several cases, and there are as many as 5,000 claims still pending.  One of the attorneys who attained a successful verdict claims that six cases have gone to trial and that all have been losses for the manufacturer.

G. M. agrees to maintain legal liabilty for future claims involving defective products after bankruptcy

As it was initially envisioned, the bankruptcy process involving General Motors would have resulted in the elimination of any liability for injuries caused by defective products, whether filed currently or in the future.  That would have closed the doors on a number of pending claims alleging death or serious injury resulting from a defective product.  After several state Attorneys General protested on behalf of injury victims, the company  and the Obama Administration have agreed to continue to recognize G.M.'s pre-existing product liability obligations, but apparently only with respect to unfiled claims. 

Nestle denied FDA information related to contaminated cookie dough

USA Today reported on June 29, 2009, that Nestle repeatedly  (from 2004 thorough 2007) refused to provide Food and Drug Administration inspectors with data including complaint logs, pest-control records and other pertinent information.   Perhaps if the information had been produced, or if the FDA had reacted more vigorously, Nestle Toll House cookie dough would not be implicated in the poisoning of 69 people with E.coli.  The Center for Disease Control has now become involved in the investigation.  An FDA spokesperson suggested that Nestle was within its rights in refusing to provide the information, however critics point out that the FDA could have insisted on access if public health is at stake.  FDA inspectors would have been obligated to secure an administrative warrant, which they did not do.

420,000 pounds of beef recalled in Michigan and other states

In a further indictment of the safety of our food supply, the Marler Blog reported this morning that the JBS Swift Beef Company had expanded its beef recall on June 24 from the original 40,000 pounds to more than 400,000 pounds.  E.coli contamination was alleged. The recall results from the investigation of 24 illnesses in multiple states.  Additional information can be obtained at the reporting website (www.marlerblog.com) or through FSIS.

FDA shuts down Detroit-area drug manufacturer Caraco Pharmaceuticals

Bloomberg.com reported on June 25 that U.S. authorities seized generic drugs produced by Caraco Pharmaceutical Laboratories, Ltd., citing multiple violations of manufacturing standards.  Inspectors found "serious violations" of manufacturing standards and "serious deficiencies" in quality control when they inspected the facility in May of 2009.  

Nestle cookie dough recalled

On Friday, Toll House refrigerated cookie dough was recalled after E-coli contamination was traced to the dough.  As many as 66 people in 28 states may have been afflicted with E.coli O157 which causes severe cramping, vomiting and bloody diarrhea and which may damage kidneys.  E. coli O157 is associated with contaminated meat and a Nestle spokeswoman could not explain how cookie dough became contaminated with this particular pathogen. 

Nestle suggests that it is not responsible for the illnesses because its label proclaims "Bake before consuming."   Most of the victims were young women, and 25 have been hospitalized, including seven who suffered a severe complication called hemolytic uremic syndrome.

Newly assertive FDA warns about use of Zicam and loss of smell

The Food and Drug Administration has been roundly criticized for its failure to act in numerous matters over the past 8 years and for the consequent deaths, illnesses and corporate fraud that have resulted.  The FDA has become more proactive under the Obama administration, despite its inadquate resources and funding, and on June 17 it issued a warning about the use of Zicam, a popular homeopathic cold remedy that can permanently damage or even eliminate a consumer's sense of smell.  The FDA has received 130 reports of olfactory injury resulting from the use of Zicam nasal products, dating back to 1999.  The manufacturer has received more than 800 reports of Zicam users losing their sense of smell, but failed to provide those complaints to the FDA.

Concern expressed over asthma drug Singulair

U.S. regulators concluded that Merck & Co.'s top-sulling asthma drug, Singulair, should come with a caution about psychiatric problems.  The caution would also apply to Accolate, manufactured by AstraZeneca, Zyflo and Zyflo CR, made by Cornerstone Therapeutics.  A "caution" is less serious than a warning, according to Reuters News Service, and applies to problems incluidng agitation, aggression, suicidal ideation, depression, insomnia and irritability, which may be associated with the medications in some patients.  Singulair is prescribed to tens of millions of patients since approval in 1998 and has annual sales of $4.5 billion dollars.

Deadly consequences of FDA's failure to shutdown tainted syringe manufacturer

The June 7, 2009 edition of the Chicago Tribune carried a long article discussing the consequences of the Food and Drug Administration's failure to shut down a contaminated plant operated by a syringe manufacturer now associated with four deaths and hundreds of illnesses.   The plant in North Carolina was inspected in July of 2007 by the FDA in response to reports of contamination with "red, brown and black particles."  She reported that the plant had a plan to respond to  the "rust contamination" and took no action beyond reporting that the plant had "switched to an unreliable sterilization method."

Mattel fined $2.3 million over lead in toys

On June 5, Bloomberg reported that Mattel and Fisher-Price (a subsidiary) have agreed with the U.S. Consumer Product Safety Commission to resolve pending complaints over selling Chinese-made toys with hazardous levels of lead.  The settlement relates to the sale of 95 tainted toys, including Barbie accessories.  Mattel imported about 900,000 illegal toys from September 2006 to August 2007.  Fisher-Price reportedly imported another 1.1 million during the same period.  Ultimately Mattel recalled almost 21 million toys.  Unfortunately, the current statistics suggest that only a small proportion of recalled toys are actually removed from circulation.

Lawsuits claim zinc in denture cream builds up in body causing health problems

A dozen claims are pending around the country, alleging that PoliGrip and Fixodent contain unsafe levels of zinc. The lawsuits allege that zinc competes with copper in the body to bind to certain receptors, and a build up over time negatively affects neurological function.  The manufacturers claim the amount of zinc ingested is safe and comparable to eating six ounces of beef.

Fiat can take Chrysler assets without its responsibilities

Bankruptcy judge Arthur J. Gonzalez held last week that Fiat need not assume Chrysler's product liability defect responsibilities along with its assets.  A bankruptcy judge has broad discretion in deciding whether a successor entity must stand behind its predecessor's liabilities for personal injuries.  Many judges, and most common law decisions outside bankruptcy, hold that a successor entity that takes over the valuable assets of a company must also assume its existing duties to injury victims.

Michigan Senate Republicans reject pharmaceutical liability

On June 2, 2009, the State Senate majority voted on a straight party line to maintain immunity for drug company negligence.  After several years of disclosures evidencing the inability of the FDA to adequately monitor drug safety, and the U.S. Supreme Court's rejection of pharmaceutical immunity, State legislators attempted to revoke Michigan's one-of-a-kind immunity for FDA-approved drugs.  The immunity had been granted as part of "tort reform" during the Engler era, even for drugs that were approved as a result of fraud by the manufacturer.

Recent developments in cancer therapy, including hormone replacement and use of anti-depressants

It has long been understood that hormone therapy to mediate the symptoms of menopause probably has a deleterious impact on cancer treatment.  Nearly twenty years ago, we prevailed in a malpractice claim against a General Surgeon who continued estrogen therapy throughout a woman's treatment for breast cancer.  Our claim was supported by an oncologist from the National Cancer Institute, and even the Defendant's expert was forced to concede the connection.  Even at that time, the medical research showed a likely negative impact, and continuing estrogen therapy was not recommended.  A new study out of the UCLA Medical Center adds weight to the argument and also suggests a tie between hormone replacement therapy, smoking and an enhanced cancer risk.

Controversy over lead and toxic chemicals in common products

The Campaign for Safe Cosmetics (CSC) has brought national attention to the fact that lead and other known carcinogens are found in a number of daily-use consumer products.  Manufacturers of the products and some authorities argue that the chemicals are present in such small quantities that they do not pose a health risk.  The New York Times has published several columns on the issue, including potential sources of further information.

JAMA article relates increased risk of pneumonia to acid-reflux drugs

The Journal of the American Medical Association today published an article disclosing research that ties the routine, prophylactic use of acid-reflux drugs to an increased risk of pneumonia in hospitalized patients.  The study followed more than 63,000 patients at Beth Israel Deaconess Hospital for three years.  The drugs involved, so-called proton pump inhibitors, including Nexium, Prilosec and Prevacid, are given to an estimated 40-70 percent of hospitalized patients, with about one-half receiving them for the first time.  They are intended to prevent the development of stress ulcers, but are not currently recommended for patients who are not at high risk.

Profile of an autism "expert"

Perhaps looking at the record of Dr. Mayer Eisenstein from Chicago will shed some light on why courts have recently refused to allow testimony from some of the doctors who are willing to testify that mercury  preservative formerly used in childhoon vaccines caused autism.  Large European and American studies involving literally hundreds of thousands of children have failed to show any causal link between mercury preservatives and autism, yet some physicians continue to suggest there is a link.  If Dr. Eisenstein is typical of these "scientists," we may have a little better understanding of why the courts have been reluctant to allow them to offer expert testimony.

Vermont requires publication of drug company payments to doctors; Medtronic rebuked

In the absence of meaningful regulation at the federal level, states have begun to act to achieve greater transparency in the relationship between medical manufacturers and doctors.   Vermont took the most meaningful step thus far, with the Vermont legislature adopting a statute that requires drug and medical device manufacturers to publicly disclose all payments to physicians or health care providers.  It also bans all free meals.  While a drug industry spokesman claimed the legislation would be "onerous" for doctors, it was supported by the Vermont Medical Association, which represents 65 percent of the state's doctors.  It is explected that the Governor will sign the act into law next month.

Lawsuit filed, claims baby shampoo and other products contaminated with formaldehyde

Bloomberg.com reported on Tuesday that Johnson & Johnson, Procter & Gamble and other personal-care product retailers were selling items contaminated with known carcinogens.  Bloomberg only identified the contaminated products as "shampoos and soaps," although a spokesperson for the firm involved suggested that Johnson's Baby Shampoo was one of the contaminated products.

Experts who connect autism to mercury-based vaccines are struck by court

Many parents sincerely believe that their children suffer from autism as a result of mercury used as a preservative in childhood vaccines.  We have addressed that issue previously in this web log.  Their arguments have consistently been undercut, however, by major studies, involving hundreds of thousands of vaccinated children, that have not supported any causal relationship.  The Centers for Disease Control now concludes that "the weight of the evidence indicates that vaccines are not associated with autism."

Trial demonstrates Merck's Vioxx liability

An Australian class-action lawsuit against Merck over its painkiller Vioxx should be causing the large pharmaceutical company embarrassment.  Evidence has shown that the company circulated its own marketing publication touting the drug, which it passed off to doctors as an independent medical journal. It created an "independent" board of doctors, whom it groomed to market the drug, without informing them of the safety risk, and it prepared sales staff with a "training manual" of talking points to address safety concerns as early as 2001.

Medtronic, Inc., implicated in doctor's fraudulent study supporting bone-growth product, Infuse.

Dr. Timothy Kuklo, a West Point graduate, attorney and surgeon specialist who recently retired from the Army, is alleged to have falsified information used in an article he wrote supporting the effectiveness of Medtronic's "Infuse" to assist bone-growth after trauma.  His article was originally published in a British medical journal, which retracted the article after one of the three physicians whom Kuklo listed as co-authors challenged his claims. 

FDA warns of contamination in Olay cosmetics plant

Reuters reported on May 5 that the FDA had warned Procter & Gamble that it had not adequately addressed contamination and other manufacturing problems at its Puerto Rico manufacturing plant.  The plant produces over-the-counter drugs such as Vicks Sinex nasal spray, and Olay cosmetics such as Revitalizing Daily Foam and Foaming Face Wash.  The FDA's previous inspection report pointed out that products were packaged or prepared in "unsanitary conditions" and that they may have been "contaminated by filth...or... rendered injurious to health." 

Boy, there's an endorsement for your next "Face Wash."  The warning letter is posted on the FDA's website.

FDA alerts doctors to heightened suicide warnings on anti-seizure drugs

On May 5, the FDA reminded doctors that new warnings are being placed on 20 medications used to control seizures, psychiatric disorders and nerve pain.   The warnings point out the "risk of suicidal thoughts or behavior" in patients taking the medications, including Lamictal, Topamax and Lyrica and applies to all medicines in the antiepileptic class.  These medications were the fourth-best-selling class of drugs in the U.S. last year, with total sales of more than 11 billion dollars, according to the Associated Press. 

ProDisc maker settles conflict of interest allegations

The Synthes company makes an artificial device, the ProDisc, which is surgically implanted between spinal vertebrae in a high-risk, expensive procedure that remains controversial.  The company did not disclose for several years that the very doctors who were recommending use of the device were being compensated with shares in the company.  In a negotiated settlement with the New Jersey Attorney General, the company agreed to pay $236,000.00 to the State for the cost of its investigation and to disclose all financial arrangements with medical "researchers."  It also agreed to stop paying with stock or stock options doctors who conduct clinical trials of its products.   

Injury claim dismissed where victim cannot document product failure

Ron Paquin filed suit against Control Chief Corporation after he was injured by a 15-ton mandrel which he was re-locating by crane.  He had no memory of the injury, but claimed that the remote controller malfunctioned, causing the mandrel to strike him.  He offered the evidence of a mechanical engineer who claimed that the remote controller showed evidence of contact welds on the control pads which would have caused an unintended movement of the crane.