In Ontario, Canada, Big Tobacco is currently under attack. Ontario claims that, among other things, Big Tobacco misrepresented the dangers of smoking and the addictiveness of nicotine to the public for decades. Ontario also claims that Big Tobacco caused or contributed to an additional $50 billion in health care costs.

Sounding familiar? No one should be surprised that Big Tobacco has felt at liberty to conduct themselves in other countries as they have in the United States. In fact, the findings in Ontario sound very much like the findings by courts and juries across Florida and in other parts of this country:

• Manufacturing, selling and promoting the sale of cigarettes while knowing that cigarettes are addictive, cause serious diseases and that second hand smoke also causes diseases;
• Manipulating the level of nicotine in cigarettes;
• Suppressing information, scientific information and medical data about the risks of smoking and of second hand smoke;
• Misrepresenting to the public and government that filters reduce the risks of smoking and that “light” cigarettes were safer than other cigarettes;
• Misrepresenting that the defendants were aware of no credible research establishing a link between smoking or exposure to second-hand smoke to disease;
• Failing to adequately warn the public that cigarettes are addictive and cause disease;
• Promotional activities with the primary intent to neutralize the effectiveness of the warnings on cigarette packaging;
• Targeting children and adolescents in advertising, promotional and marketing activities for the purpose of inducing them to start or continue to smoke.
• Orchestrate public relations programs with the objects of promoting cigarettes, protecting cigarettes from attack based on health risks and reassuring the public that smoking was not hazardous.

My guess is that the tone of arguments will become increasingly severe as our brethren to the north continue their review of the documents generated by the tobacco industry in previous litigation.

In the United States, one judge who has been perhaps the most exposed to the tobacco documents is United States District Court Judge Gladys Kessler. Judge Kessler has issued a few scathing findings against the tobacco companies and disclosed startling information she found in her review of evidence presented to her.

Her findings and comments have included:

“The evidence spelled out above is simply overwhelming that Defendants knew that smoking is addictive and knew that nicotine is the agent creating and sustaining that addiction. There is also overwhelming evidence that even though Defendants have known internally about addiction for decades, they have endeavored to keep the extensive research and data they had accumulated out of the public domain and out of the hands of the public health community by denying that such data existed, by refusing to disclose it, and by shutting down or censoring laboratories and research projects which were investigating the mechanisms of nicotine.

If, in fact, “everybody knew” that smoking and nicotine were addictive, then why were Defendants publicly, vehemently, and repeatedly denying it?

In short, after reassuring the smoker that smoking was not bad for her health, and was not addictive, Defendants then blamed her for being unable to stop using the product they had so successfully marketed with false information.

Based on the extensive individual Findings of Fact set forth in this Section, the Court finds that Defendants have known for decades that cigarette smoking was addictive, and that nicotine is the addicting element in smoking behavior. Defendants’ false and misleading statements relating to addiction continue even today.

Moreover, Defendants deliberately and intentionally hid this information from the public and closed down research laboratories and on-going projects in order to ensure secrecy. Time and time again, Defendants falsely denied these facts to smokers and potential smokers, to government regulatory authorities, to the public health community and to the American public.”

Our own Florida Supreme Court has found:

• That cigarettes cause a whole bunch of diseases, including: aortic aneurysm, bladder cancer, cerebrovascular disease, cervical cancer, chronic obstructive pulmonary disease, coronary heart disease, esophageal cancer, kidney cancer, laryngeal cancer, lung cancer (specifically, adenocarinoma, large cell carcinoma, small cell carcinoma, and squamous cell carcinoma), complications of pregnancy, oral cavity/tongue cancer, pancreatic cancer, peripheral vascular disease, pharyngeal cancer, and stomach cancer).
• That cigarettes are addictive.
• That the Tobacco Companies knowingly marketed cigarettes that were defective and unreasonably dangerous.
• That the Tobacco Companies concealed or failed to disclose important information about cigarettes that was not able to be known by the public.
• That Tobacco Companies misled the public about the dangers of smoking cigarettes.
• That the Tobacco Companies, acting together, concealed information regarding the negative health effects of cigarettes.
• That the Tobacco Companies, acting together, concealed the addictive nature of nicotine in cigarettes.
• That the Cigarette Companies sold products that were defective.
• That all the Tobacco Companies were negligent.

Nine different judges. Three different parts of North America. It seems time to believe that the tobacco industry has been lying and deceiving people all over the world about the dangers of cigarettes. The deception started in the early 20^th century while Big Tobacco was literally handing out cigarettes on street corners.

Of course, when tobacco needs to defend itself in court, they like to argue that “everybody” knew about how addictive and dangerous cigarettes were by the 1930’s and 1940’s.

Yet, as late as 1994, the CEO’s of all the Big Tobacco companies swore under oath that cigarettes were not dangerous and nicotine was not addictive:

http://www.youtube.com/watch?v=jQUNk5meJHs

All of those ads you’ve seen on television warning about the dangers of transvaginal mesh do not appear to be scaring away women from the controversial procedure.

Presented at the recent American Urological Association meeting in San Diego, of a survey of 99 women taken at Louisiana State University and Medical University of South Carolina urology clinics, three-quarters of women  said they would still consider mesh as an option to treat stress urinary incontinence (SUI) or pelvic organ prolapse (POP).

Dr. Michelle Koski presented the findings to the May gathering of the American Urological Association meeting in San Diego. She says most of the women cited personal injury law firms as their source of information about surgical mesh.

“It’s a vulnerable population and they are getting all of this misinformation.”

Misinformation? It is sad, but true, that consumers often receive information about product defects from the field of lawyers and usually it is, sadly, after hundreds or thousands of consumers are injured or killed. But, the fact is what trial lawyers frequently convey in those ads is nothing that the Food and Drug Administration hasn’t said.

In 2008, the FDA issued a Safety Communication that mesh complications such as mesh erosion, infection and debilitating pain are complications that are “rare.”  By July 2011, the FDA revisited the issue saying, “serious complications associated with surgical mesh for transvaginal repair of pelvic organ prolapse are not rare.”

The FDA added that “transvaginally placed mesh in pelvic organ prolapse repair does not conclusively improve clinical outcomes over traditional nonmesh repair.”

Doesn’t exactly sound like a rousing endorsement for treatments using mesh.  Yet, polypropylene mesh implants are still being permanently implanted in women despite the fact that there are nearly 22-thousand lawsuits consolidated in one court in the Southern District of West Virginia and thousands more filed in state courts around the country by women with life-altering injuries, some of them permanent.

These are product liability lawsuits that claim synthetic mesh is defectively designed and should never be implanted in anyone.

Fortunately there are law firms that are getting the word out to women because the media seems to be largely absent from the controversy, unless there is a major win by a plaintiff in court.

There have been two to date – one $5.5 million jury award naming C.R. Bard in a California state court. That action on behalf of Christine Scott and her husband also named her implanting doctor accusing him of medical malpractice. The other case that received headlines was the February jury award of $11.1 million to South Dakota resident Linda Gross, who remains disabled and bedridden after hundreds of procedures to try and remove the pelvic floor mesh or mitigate the severe pain, erosion and complications she continues to suffer.

Both Johnson & Johnson (Linda Gross case) and Bard have announced they will appeal the jury verdicts.

The information concerning complications of mesh use in patients has increasingly developed over the years, but one must wonder where physicians are in the chain of information. Shouldn’t physicians have been giving patients information about ALL the potential complications; rather than, in some cases, downplaying the complications and characterizing the use of mesh as some sort of magic bullet for the patient? What does it say about physician-patient communication if Dr. K’s statistics are to be believed and 57% of patients heard about problems with surgical mesh from legal advertising and only 9% from the medical community?

Perhaps with a relatively miniscule 99 patient interview group, Dr. K should rethink her statement about “misinformation” or direct it to the actual parties that are responsible for the misinformation being disseminated about this risky and controversial procedure. In the alternative, perhaps she should interview the thousands of patients in varying degrees of what people like Linda Gross have endured.

They are called “legal” drugs, but for the thousands of fatalities that result from their use the comparison with illegal drugs is a distinction without a difference.

The federal Centers for Disease Control and Prevention (CDC) reports that the number of deaths attributed to prescription painkillers now exceeds those attributed to illegal street drugs such as heroin and cocaine.

PBS recently talked to the family of Oklahoma Sooners Linebacker, Austin Box, who died in 2011 from a combination of five pain medications and an anti-anxiety drug that stopped his heart at the age of 22. No one had any idea that this young man was addicted to prescription painkillers.

The CDC reports the number of deaths attributed to prescription drugs had quadrupled in the U.S rising from 4,030 fatalities in 1999 to 16,651 in 2010. OxyContin, Vicodin, Opana and methadone are believed to be responsible for about 125,000 U.S. lives over the last decade and the CDC reports that is just part of the picture.

For every fatality there are 32 emergency room visits, 10 drug treatment admissions and 130 other users who are addicted.

The CDC reports on the Top 10 things you should know about Prescription Drug Abuse:

1. More Americans are killed by drug overdoses than car crashes – about 105 deaths every day.
2. There were enough painkillers prescribed in 2010 to medicate all U.S. adults every four hours for one month.
3. Prescription drugs deaths increased four times from 1999 to 2010.
4. Non-medical use of painkillers for a “high” is sought by one in 20 Americans.
5. It is suggested you hide or lock up prescription painkillers or dispose of them properly.
6. Community and state policies are being employed to prevent painkiller drug overdoses.
7. The Patient Review and Restriction Program and Prescription Drug Monitoring Programs can coordinate care for patients.
8. State laws can address doctor shopping and pill mills.
9. Substance abuse programs can intervene and help save lives by reducing overdoses among addicts. 
10. Prescribers should turn to painkillers as a last resort, prescribe only what is necessary and monitor patients for substance abuse.

The problem isn’t just with teenagers but of adult Americans as well. The CDC estimates about 12 million adults and teens used prescription painkillers to get a “high” while emergency room visits have doubled to nearly a half million.

Even if you are not a statistic, the CDC estimates the painkiller epidemic is costing all Americans more than $72.5 billion annually in related healthcare costs.

The U.S. Food and Drug Administration (FDA) has proposed tightening regulations over heart defibrillators after dozens of recalls, failures and deaths attributed to the malfunctioning medical device. There are about 2.4 million automated external defibrillators (AED) in public places in the U.S. They are found in newsrooms, airports, casinos, even churches.  Using paddles that deliver an electrical jolt to the chest, an AED can re-establish a normal heart beat during a potentially fatal cardiac arrhythmia which, according to the American Heart Association, kills about 400,000 a year.

No one knows how many patients have died due to the malfunctioning devices, but the New York Times reports in one case a nurse was trying to help a patient in cardiac arrest when the defibrillator read “memory full” and it shut down. The patient died. In another instance the software showed an “equipment disabled” message. That patient also died.

The FDA reports that there have been 45,000 failures of defibrillator hardware and software since 2005, and manufacturers have had to recall AEDs 88 times. In order to improve that dismal record, the proposed order will require manufacturers to make available designs of the AEDs. The agency would also be given tighter controls on buying defibrillator components overseas.  Dr. William Maisel with the Center for Devices and Radiological Health (CDRH) announced plants could also be inspected, although historically the FDA has not had the personnel to inspect plants overseas.
The FDA could have downgraded AEDs to a lower or moderate risk device (Class I or II), but an expert panel convened in October 2011 recommended AEDs remain Class III (highest-risk medical device) and required pre-market approval (PMA),  higher degree of scrutiny than the current notification process.

One application for PMA approval would cost about $248,000 according to Dr. Maisel, but that would cover all models of AEDs made by the company. Dr. Maisel says the safety data has already been conducted by the companies so most will not have to do any additional clinical studies.   The revamp of FDA safety oversight should be completed by 2014.

AEDs are known as “pre-amendment devices” which means that they were already in the marketplace before 1976 when the FDA began regulating medical devices.  At that time there were 170 devices called Class III that were approved through the 510(k) notification process that were never required to submit PMAs.  The FDA’s website says 19 medical devices are still waiting to be reclassified, including the high-risk metal hip joints with uncemented acetabular components as well as cemented acetabular components.

How do we know they are safe and effective?

The simple answer, which would surprise most patients and physicians, is that we do not know if the medical devices are safe and effective. A study published in the Archives of Internal Medicine in 2011 found nearly three-quarters of medical devices that caused injury or death from 2005 to 2009 had entered the market through the 510(k) process.   Any changes in the 510(k) process, however, would also need to address the false notion that the PMA process leads to safer medical devices.  That is not necessarily the case, with the Birmingham metal-on-metal hip implant marketed by Smith & Nephew being a prime example of a PMA-approved medical devices that has injured untold thousands of patients who have had to undergo revision surgeries and suffered other bone and tissue damage and disability as a result of cobalt and chromium poisoning and premature failure of the devices.

For a diabetic, accurately monitoring his blood sugar level can mean a matter of life or a diabetic coma.

So this latest warning from healthcare giant Johnson & Johnson is especially troublesome.

Its popular OneTouch Verio IQ blood glucose meters have been found to be faulty when the blood sugar is especially high. Instead of providing a warning, they turn off.

J&J is recalling almost 1.9 million units following the death of a patient in Europe.

About 900,000 units were sold to U.S. consumers. The problem was detected when a high blood sugar of 1,024 milligrams per deciliter caused the device to trip off.

The company says the likelihood of reaching that level of blood glucose is remote but the failure to deliver an accurate reading could delay treatment that can result in serious complications including death or a diabetic coma.

Just for comparison, a diabetic wants to keep his blood sugars in the range of 160 milligrams per deciliter or below. Any higher and the sugar travelling through the body can damage the heart, eyes, blood vessels and other organs. Amputations, blindness, kidney failure and heart attack can result when blood sugar goes unchecked.

These meters were sold in the U.S. and in other countries. J&J’s LifeScan unit says it will replace them for free. Those recalled include the OneTouch VerioIQ, OneTouch VerioPro, and the OneTouch VerioPro+.

The VerioIQ meter can be used until replacement meters come in.

The problem was detected by internal company testing soon after the patient died following an inaccurate reading which may or may not have been linked to the medical device.

Over the last couple of years, J&J has issued about a dozen recalls for faulty medications, contact lenses and hip implants. You’ll recall the children’s Tylenol and Motrin recalls, the DePuy ASR metal-on-metal hip recall, a bone putty to stop bleeding and the complete overhaul of a nonprescription medicine factory that was taken over by the FDA after an inspection found contaminated products and dirty conditions.

Bloomberg reports 2012 sales of LifeScan diabetes care products at $2.6 billion.

Visit the company’s website www.onetouch.com or contact customer service at (800) 717-0276 to return the meter.

The Food and Drug Administration (FDA) is cracking down on compounding pharmacies after a nationwide fatal outbreak of fungal meningitis was found in contaminated steroid injections made at the New England Compounding Center (NECC).

Now a Georgia compounding pharmacy, Clinical Specialties Compounding Pharmacy (CSCP) of Augusta, has voluntarily recalled all lots of sterile syringes loaded with the cancer drug Avastin. The recall was undertaken after an FDA inspection revealed sterility concerns.

At least five people have serious eye infections associated with the Avastin drug that was repackaged from vials into syringes by CSCP. The condition is called endophthalmitis, which the FDA reports occurs inside the eyeball and can lead to permanent blindness. The link to the syringes was brought to the federal agency’s attention by the Centers for Disease Control and Prevention (CDC).

The FDA is playing catch-up after 48 people died from a contaminated epidural steroid injection. Over 700 patients continue to be treated for fungal infections and hundreds of lawsuits have been filed against NECC, which has filed for bankruptcy.

Historically, compounding pharmacy regulation has fallen outside of FDA radar and states have not been picking up the slack. There is a move to increase the FDA’s authority over compounders and the surprise plant visits are part of the plan.

Meanwhile the voluntary recalls continue with three announced during one week in March.

Med Prep Consulting of Tinton Falls, New Jersey voluntarily recalled 83 types of antibiotics and drugs used during surgery because of a possible mold contamination, which was visible to the eye. Regional hospitals in New Jersey, Connecticut, Delaware and Pennsylvania received the infusion bags, glass vials and plastic syringes linked to the mold.

An inspection at Pallimed Compounding Pharmacy of Massachusetts led to the recall of all sterile products made at the plant in an “abundance of caution” even though there had been no injuries reported. The FDA inspectors indicated there were “deficiencies” but the recall does not include the facility’s non-sterile products.

The state took the next step and issued a “limited Cease and Desist Order” to prevent the sale of 16 sterile compounded products. Last December, the Boston Globe reports the company had been ordered to stop compounding Viagra because of “improper components.”

Originally, compounding pharmacies were developed to mix small batches of custom ordered drugs. Depending on the individual state’s regulations, they were not intended to become full-blown mini-pharmaceutical manufacturing facilities, but that is the role many have undertaken.

State laws vary and the FDA is seeking additional authority over the growing industry, however, as we’ve seen so many times, the agency does not have enough funding to oversee about one-quarter of the consumer products used by Americans.

One proposal has the compounding companies pay a user fee to cover the cost of FDA inspections.

Bottom line – inspect the products coming from a compounding facility. In the case of the mold, a nurse, not FDA regulators, noticed the contamination problem which led to the recall.

Consumers are being warned to stop using the Imaginarium Activity Walkers for children after the government received five reports of the wheels detaching. No children were injured.

The product is sold by Toys R Us which has issued a recall for 9,000 units of the walkers, used to help babies take their first steps. The walker has a wooden push handle at the top of the walker and the base has four wheels.  A small bolt and spacer attached to the front wheel can potentially detach and cause the child to fall and/or choke on the parts.

Consumers are encouraged to take the walkers back to the store for a full refund.

The Imaginarium Activity Walker was sold exclusively at Toys R Us stores from August 2011 through January of this year at a cost of about $30. The walker was made in China and imported by Toys R. Us Inc of Wayne, New Jersey.

Health Canada has issued a similar Consumer Product Recall.

The U.S. Consumer Product Safety Commission (CPSC) and its CPSC Safer Products site will continue to take consumer calls and complaints regarding this recalled product.

Federal law prohibits anyone from selling or re-selling a defective product on the retail or second-hand market where many children’s products end up.

The CPSC protects the public from thousands of consumer products that pose an unreasonable risk of injury or death. The cost to the nation for defective consumer products? More than $900 billion annually.

That may include baby products and children’s bedding with carcinogenic flame retardant chemicals, which were removed from the market in California beginning in January; defective baby furniture and cribs which can trap and suffocate infants; and defective child products containing lead, among many other products that have been recalled over the years.

The agency has been criticized for working too closely with manufacturers. In August 1995, the CPSC initiated a fast-track recall program to get defective products off of store shelves.

In a concession to manufacturers, the CPSC eliminated the preliminary determination to establish whether or not a product is defective in its design, its manufacturing or in its instructions for use. In return, manufacturers agreed to comply with a recall and to notify distributors, wholesaler and retailers within 20 days. This saves years of litigation and gets defective products off the store shelves quicker.

Under law, manufacturers must report any risks of serious injury or death to the CPSC and the agency receives about 300 a year. A failure to report a defective product can result in a civil penalty of up to $1.5 million.

In this case, the loss of the product itself will cost Toys R Us around $270,000; plus the overhead and costs involved in announcing and running the recall process. Why can’t we reach a program in which manufacturers actually test their products before placing them on the market; to, for example, determine whether the wheels will fall off before they go on the shelves for sale to unwary consumers.

The company can be reached at (800) 869-7787 from 9 a.m. to 11 p.m. ET Monday through Saturday and 11 a.m. to 7 p.m. Sunday.

Attorney Cal Warriner was interviewed by the Palm Beach Post as set forth in an article published in Sunday’s paper. Mr. Warriner raised as number of valid points, but two dealt with short cuts to FDA approval and a national joint registry:

Would any patients have been harmed by the Stryker Rejuvenate and the ABG II hip implants if short cuts to approval through the Food & drug Administration were prohibited?

Would less patients have been harmed by the Stryker Rejuvenate and the ABG II hip implants if the United States had an effective joint replacement registry in place similar to the one in Australia?

The FDA permits orthopedic device manufacturers to short cut the approval process if a manufacturer can demonstrate that a product for which they seek approval is “equivalent to a device” already approved by the FDA. If the manufacturer can demonstrate the substantial equivalence of their device, they may bypass the lengthy and expensive clinical trial and scientific scrutiny that new devices are put through.

But, what if the “new device” differs from the already approved device in ways that might create problems? The FDA is largely funded by the same device and drug manufacturers they regulate and they have little funding or staff to conduct independent device evaluation. If the manufacturer represents “substantial equivalence”, the device is likely to get approved if it appears to be a similar device.

The “short cut” process is great for device manufacturers, but reasonable suspicion exists as to its benefit for consumers.

The Australian Orthopaedic Association National Joint Registry has proved successful in repeated instances. Long before the FDA has recalled problem medical devices in the United States, Australia and the European Union (who also maintains a device database) have alerted to problems in devices such as Stryker’s Rejuvenate, Depuy and other joint replacement devices.

Does the United States maintain a device database? Yes. It has only a year ago begun to accumulate data; so, in fairness, it will be several years before we really can gauge its success. There does seem to be some differences between the AJRR (American Joint Replacement Registry) and the Australian registry.

The United States Registry includes, as contributors, manufacturers including:

• Aesculap Implant Systems, Inc.
• DePuy Orthopedics, Inc.
• Exactech, Inc.
• Stryker
• Zimmer, Inc.
• Biomet, Inc.
• Consensus Orthopedics
• DJO Surgical
• Smith & Nephew plc
• Wright Medical Technology, Inc.

So, of the 17 listed financial contributors to the American registry, 10 of them are some of the largest manufacturers of medical devices in the world. In contrast, the Australian registry is funded by the departments in the Australian government charged with regulating the medical device industry.

In all fairness, the FDA’s “short cut” to medical device approval seems like a process to benefit manufacturers more than consumers. But, an oversight organization, such as the American registry funded largely by the medical device manufacturers seems like a classic case of the fox guarding the hen house!

Stryker is finally acknowledging that their Rejuvenate and ABG II modular hip product line can cause serious problems in patients – even if they aren’t yet feeling symptoms of metal poisoning or tissue destruction.

Since the Rejuvenate product recall on July 4th, Stryker has been telling patients that if you aren’t feeling any symptoms, you should not return to your orthopedic specialist unless it’s part of your individual treatment plan.

Since June, we have been warning patients of heavy metal toxicity, tissue necrosis, and irreversible skeletal damage.

Now, (6) months after our warnings and (5) months after the Stryker recall, Stryker has a different message: “It is important that you follow-up with your surgeon, even if you are not experiencing symptoms such as pain and/or swelling at or around your hip” and even recommending that if you are unsure if you have the Rejuvenate or ABG II, to find out immediately.

Stryker’s about-face in this situation is predictable given the obvious problems with Rejuvenate and ABGII hip systems. It is inexcusable, however, for Stryker to tell patients that failure rates are so low that they need not be concerned, when “heavy metal toxicity, tissue necrosis, and irreversible skeletal damage” was medically predictable at the time of the recall.

Why did Stryker delay these recommendations for so long; when we at Searcy Denney have been asking Stryker since their voluntary recall this summer to acknowledge that their device is causing serious harm to patients? For now, we are left to guess, until we discover in the process of litigating lawsuits on behalf of victims.

According to Reuters, Stryker has now employed a company called Broadspire to administrate the claims process for future incurred medical expenses. Although it is not clear what expenses Stryker may cover, we hope they intend to compensate for at least replacement of faulty hips to prevent continued injury to patients.

But, as we have warned before, you should always speak with a lawyer before negotiating or dealing with a third-party claims administrator like Broadspire. Whether you hire a lawyer or not is a different issue, but at least speak with one.

Do not be misled. These companies often portray themselves as wanting to help patients and they really may want to help patients; but at the end of the day, they work for, their loyalty is to Stryker and not the patient. If they can secure a full release for their employer by paying pennies on the dollar of a victim’s actual losses, they will because that is their job.

When might a legal case involve extensive discovery, including electronic discovery (e-discovery)?

Suppose you sue a corporation and want to obtain documents/data (Request to Produce), information from the corporation itself (Interrogatories) and information from employees of the corporation (depositions). What might the subject matter of the lawsuit involve:

• Breach of contract or agreement
• Trademark or patent infringement
• Shareholder derivative action
• Product defect
• Defective drugs

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