The tale of Diane Levin is truly disturbing and highlights the massive loopholes created by the FDA regulations that the drug companies have driven countless profits through. In 2007, Levin, a professional musician, went to the hospital to treat a migraine headache. After being injected with a drug manufactured by Wyeth, she left with injuries that led quickly and irreversibly to the loss of her right arm. Specifically, Levin’s arm was amputated because Wyeth’s drug Phenergan, prescribed to alleviate nausea associated with a migraine headache reached her arteries. Phenergan was given to Levin using a method of administration that was permissible under Wyeth’s labeling instructions, even though Wyeth knew this method increased the risk of contact with arteries and serious injuries.

The drug was administered intravenously through a technique known as an “IV push.” In this method, a syringe pushes medication directly into the patient’s veins. Wyeth had known for decades that if Phenergan is administered by the “IV push” method, even by experienced clinicians, inadvertent arterial contact can result. This is in contrast to administration through a free flow IV bag, which reduces the risk of inadvertent arterial injection because the nurse or physician can be more certain that the needle has been placed in the vein.

Wyeth had known that when Phenergan comes into contact with an artery, the artery dies, necrosis, gangrene and amputation will result. Four experts testified at the state court level that if Phenergan is used intravenously it should be done only through a hanging IV bag and the labels should have warned against the use of IV push. However, Phenergan’s label did not contain any such warning regarding using of the IV push method. The Vermont Supreme Court held that the FDA never made any determination as to whether the label should have warned against the IV push method.

Because the IV push method was used to administer Phenergan to Levin, the drug penetrated her artery. For seven weeks after the injection, she suffered unimaginable physical and emotional pain as she watched her right hand turn black and die. In short as a result of being subjected to an unsafe and unnecessary method of administration of a drug to curb nausea, Levin endured two amputations. First, she lost her right hand and then her right arm up to the elbow harming her profession and life-long passion to be musician and play the guitar.

Background of FDA Labeling

The FDA’s labeling rules require a prescription drug or medical device manufacturer to make any changes to its label and to add or strengthen a warning about a possible adverse reaction as soon as it has reasonable evidence that the drug or device causes an adverse reaction. The importance of this rule was underscored in congressional debate regarding the passage of the Food and Drug Administration’s Amendments Act of 2007, which gave the agency additional authority to better regulate prescription drug approvals. When Congress passed this law, it understood the FDA’s rules to impose a duty on drug manufacturers to update their labels when they became aware of potential hazards.

Consumers who have been hurt by drugs and other dangerous products will now have more latitude since the Supreme Court has ruled that Federal Regulations do not always preempt state law. It is clear and the Supreme Court reaffirmed that Congress never intended to give the FDA full and total authority over drug labeling. Rather, state courts have had the right to hear cases in which people have been injured by drugs. And further, drug companies have the responsibility to fix their labels and keep them current with the latest warning information. Drug companies, the Court said, must also inform the doctors of dangers of drugs through their ubiquitous sales forces or by sending out letters to physicians. In this technology driven market economy this is certainly a simple endeavor. Wyeth, backed by the Bush administration, argued that once drug warning labels get FDA approval, the label does not need to be changed unless the FDA expressly asks for it. Part of Wyeth’s argument was that it was more efficient for Federal Regulations to take precedence because state laws vary so much. Anyone who has had any experience with these regulatory agencies knows that they move at a glacial pace. Science and technology are quickly evolving and it makes sense for drug companies to disseminate new information as soon as its available.

The Court also rejected Wyeth’s claim that allowing juries to entertain such claims would hamper the broader objectives of the Federal Statute. Indeed, the Court noted that the FDA had always welcomed state common law actions right up until it recently changed its position in 2006. Throughout its opinion, the Court stressed that the manufacturer bears responsibility for the contents of its label at all times. In our civil justice system, the Court noted, innocent people generally have recourse in state courts to hold companies accountable when they shirk their legal responsibilities. Drug companies are no different.

In his dissent, Justice Alito, who was joined by Chief Justice Roberts and Justice Scalia, started by writing “this case illustrates that tragic facts make bad law. The Court holds that a state tort jury, rather than the FDA is ultimately responsible for regulating warning labels for prescription drugs.” To the contrary, the state tort system picks up when federal regulators fall down on the job. Can anyone really say with a straight face that they have complete and total confidence in the job the federal regulators are doing? If so, countless defective drugs and consumer products would never make it to market. We all know that is not the case.

In fact, serious data has found that side effects regarding prescription drugs are at a near epidemic rate. Consumer Reports recently reported that one in six Americans who have ever taken a prescription drug experiences side effects serious enough to send them to a doctor or hospital, but the majority of consumers don’t know that they can report these side effects to the FDA which are responsible for tracking drug safety problems.

Legislation on the Horizon

Recently, Democrats in Congress just introduced a measure to allow consumers harmed by medical devices approved by the FDA to sue the device manufacturer in state court. This is in response to the Supreme Court in Reigal v. Medronic. In Medronic, the Supreme Court allowed the dismissal of a lawsuit involving a ruptured catheter. In that case, the Supreme Court ruled that the FDA approval preempts state courts from hearing liability suits against the makers because such suits could minimize devices FDA determined benefits and risks. Medronic and the Bush administration asserted that “allowing state personal injury lawsuits against the makers of defective medical devices amounts to a state court requirement” different from the FDA requirements because such complaints are based on state laws. There is now legislation being funneled through Congress, that tries to further even the playing field with regard to making sure defective medical devices are also subject to state tort laws. Congress should act quickly to close up these loopholes as well.

It has often been said that the role of government is to fill the void when citizens acting individually cannot bridge the gap. This is the reason we have regulatory agencies that try to ensure that our roads are safe, the environment is protected and the food we eat is safe to name just a few. However, our government is under a tremendous amount of pressure and cannot meet the demands to ensure that the public is safe from defective products. That is why the avenue to the Court’s must remain open so injured citizens can seek redress against companies that manufacture, market, sell and , of course, profit from defective and unsafe products. If this important constitutional right is abrogated, the onslaught of dangerous and defective products hitting the market will have no limitation.

Can anyone really say that they purchased an American car because it's safer than other foreign cars? Until being acquired by Ford, Volvo has centered its marketing campaign around safety. Volvo had countless commercials and promotions extolling passenger safety in accidents. Before being acquired by Ford, Volvo did tremendously well with that campaign. Of course, Ford's influence on Volvo squelched their focus on safety and their profitability suffered.

Every since the National Highway Traffic Safety Administration (NHTSA) was charged with regulating the safety of automobiles over 40 years ago, Detroit has been kicking and screaming at every turn. For the past decades, the automobile industry has been fighting seatbelts and then airbags which, now, are uniformly embraced by the automobile insurance industry and consumer groups alike.

In 1971, when Lee Iacocca was President of Ford Motor Company, he so strongly opposed automobile airbags that he personally appealed to then President Richard Nixon and persuaded the President to kill a pending federal regulation mandating airbags for U.S. cars. Of course, Iacocca did not know that Nixon was taping the conversation. At the time, automakers predicted that a single driver's side airbag would add $1,000 to the cost of a new car. The industry predicted that benefits would be marginal and that the consumers would not want or pay for them. Now, airbags are standard in every vehicle and it's hard to imagine buying a new car without this safety feature.

Not only did the Big Three oppose airbags, but if you go back even farther, their track records against safety have been consistently wrong. The automobile industry even opposed seatbelts years ago. The U.S. government started studying seatbelt use in the 1960's, but the auto industry believed that safety would not sell and instead emphasized the cars comfort, style, and performance. In 1970, NHTSA proposed Federal Motor Vehicle Safety Standards that all vehicles have passive restraint, i.e. seatbelts, by January 1973. Over the next ten years, the standard was debated, delayed, altered and eventually rescinded by NHTSA in 1981. Finally, in 1984 NHTSA proposed that all vehicles have seatbelts by 1989.

It is undisputed that seatbelts and airbags have improved vehicles and enumerable studies have shown that these features save lives. Despite this fact, the automobile industry refuses to get ahead of the curve a make a safer car.

Despite these mandates, Detroit continues to refuse to prioritize designing and building a safer car. For example, the automobile industry is confronted with autos that are prone to rollover, roof crushes and tires that are defective due to tread separation. In addition, the rise of defective airbag cases has seen steady growth over the past ten years. One of the biggest reasons is because Detroit continues to scrimp and cut corners wherever and whenever it can and these decisions are affecting safety. For example, there are numerous cases being filed due to the airbags’ failure to deploy. Upon further review of these cases, it has become clear that the auto makers have cut corners by having inadequate sensors that detect the forces of an accident and make the airbag deploy. The Big Three’s attitude is that more sensors cost more money and are not needed. This is the exact same approach to business that got them in trouble in the first place.

The Bush administration’s lax rules and regulations over the automobile industry probably only rivals its abysmal regulation over the oil companies. However, since taxpayers are funding part of the bailout, not only should we insist on greener technology but we should also demand that NHTSA do its job and ensure that these vehicles are safer for consumers.

What’s next? It still remains to be seen if the Big Three can meet the challenges ahead and make the kind of cars that Americans want and deserve—because safer cars will sell better. Or, will the bailout just be a band aid so they can go back to their business as usual approach to technology and safety. Undoubtedly, if they go down that latter road – we can stop calling them Big Three because they won’t be so big and there sure won’t be three viable American automobile manufactures.

On appeal to the Pennsylvania Supreme Court in Bogush, Defendants are arguing for the wholesale rejection of product liability law and the standards of Section 402 (a) which have been uniformly adopted throughout almost every jurisdiction. Instead, Appellants are pushing for the Restatement (Third) of Torts regarding product liability. The Restatement (Third) addresses, among other things, the failure to provide an adequate warning for products. Under the revised Restatement, a product is defective when, at the time of sale or distribution, it has inadequate instructions or warnings when a foreseeable risk of harm that is posed by the product could have been reduced or avoided by reasonable instructions or warnings by the seller or other persons in the chain of distribution. Restatement (Third) of Torts - Product Liability §2 ( c).

The plain meaning of the Restatement (Third) clearly mandates that if there was a foreseeable risk to anyone, all persons in the chain of distribution would bear responsibility. However, in Bogush, Defendants are trying to argue that foreseeable risk means foreseeable to them, only. This is not what the Restatement provides and the Pennsylvania Supreme Court must reject that broad interpretation.

This proposed interpretation and application of §2 of the Restatement (Third) will result in a fundamental shift in Pennsylvania law which is not justified by any change in policy rationale. Pennsylvania product liability law is deeply rooted in the concept that the manufacturer who places a product in the commercial stream is in a better position than the consumer to take steps to reduce the risk of injury from its product or the accept the costs of injuries that result from its product. The axis of product of liability law has always been a cost shifting analysis. Pennsylvania law has long required a manufacturer/seller/distributor to be liable although it may not have been at fault. Of course, Plaintiff was not at fault either since contributory negligence is inapplicable in a product liability action. The roots of strict liability require that if that there is a split between two faultless entities, the party who caused the injury, who designed the product, who manufactured the product, who sold it and who profited from it, should pay for the injuries caused by the defective product.

The Appellants argument in Bogush for an expanded application of §2 of the Restatement (Third) will change strict liability for design defects in warning cases for a broad “foreseeability test.” As commentators and Courts have pointed out, a foreseeability test effectively eradicates the distinction between strict liability and negligence. A return to a negligence based system is clearly contrary to the law as it has developed in Pennsylvania since the adoption of §402(a). As the Pennsylvania Supreme Court has long recognized, negligence concepts have no place in strict liability. Azzarello v. Black Brothers Company, 391 A.2d 1020 (Pa. 1978) and this separation of negligence concepts from strict liability actions was reaffirmed recently Pennsylvania Supreme Court. Phillips v. Cricket Lighters, 841 A.2d 1000 (Pa. 2003). Such a division between negligence and strict liability is not a senseless exercise in semantics; rather, it is dictated by the very underpinnings of a strict liability action. The adoption of these broad foreseeability concepts for all parties across the chain of distribution, would inject impermissible negligence concepts that have been routinely rejected by the Pennsylvania Courts. The abandonment of current strict liability law would present a reversion to a society that no longer protects the innocent consumer but rather the responsible manufacturer/ supplier of the defective product. Certainly, the latter is more able to bear the burden in our society. As such, the Pennsylvania Supreme Court must reject the proposed changes of the Third Restatement because a foreseeability test will not protect innocent parties injured by defective products.

A few days earlier, you received some bank records via your subpoena, and you are not sure your opponent has reviewed them with his client. As you pull them out of your file, you see your opponent and the witness start to fidget, and you think you might be on to something. The next line of questioning goes like this:

Answer: No. I haven’t seen these.

Question: Here, why don’t you take a look at these 15 pages of records, and I’ve even made a copy for your attorney to look at while we go through these bank statements.

Answer: Okay.

Question: You see that deposit for $12,500 on August 20, 2008?

(The witness and his attorney are now shuffling through all the bank records, and you can tell that there is concern about what is in these bank statements)

Answer: I see that deposit. Yes.

Question: Where did those funds come from?

Opposing attorney: Objection. I’m not going to let him answer that question until I review these records with the witness.

Plaintiff’s attorney: No. You can’t do that. This deposition is to find out what your client saw, heard and what he thinks and knows. There’s no reason that you need to act as an intermediary.

Opposing attorney: It doesn’t matter because anything I talk to him about is protected by attorney-client privilege anyway.

Plaintiff’s attorney: That’s not the point, and I’m not asking that he divulge any privileged conversations anyway. I just don’t want the witness to have an opportunity to confer with you to perhaps learn how to best answer the questions about these bank statements.

Who’s right? Are private conferences allowed? What if it is privileged communications? Can interrogating counsel ask the witness what was discussed, if not privileged? As in many cases, it mostly depends on whether you’re in federal court or state court. In the Eastern District of Pennsylvania, Judge Gawthrop authored the opinion in Hall v. Clifton Precision, 150 F.R.D. 525 (ED. Pa 1992), that is still widely considered as authoritative. Hall holds that counsel and their witness-client shall not engage in any private, off the record conferences during depositions or during breaks or recesses, except for the purpose of deciding whether to assert a privilege. Any conference which occurs pursuant to, or in violation of those guidelines are proper subjects or inquiry by deposing counsel to ascertain whether there has been any witness coaching and, if so, what kind of coaching was made. Such a conference shall be noted on the record by the counsel who participated in the conference and the purpose of the conference shall also be noted on the record.

State Court practice, however, does not precisely follow Hall, and until December 2007, no Pennsylvania Appellate Court or court rule addressed the issue of the conduct of attorneys and clients during depositions. Then, in AmerisourceBergen Drug Corporation v. Curascript, Inc, No. 690 EDA 2007 (unpublished), the Superior Court set forth guidelines on such conduct, and acknowledged that there was no such precedent yet in state court. Amerisource, an appeal from the Philadelphia Commerce Court, does not preclude off the record conversations, but allows deposing counsel to ask only whether a private conversation took place on the relevant subject matter. The Court suggested that the following type of questions could be asked “At any time during the breaks of this deposition, did you discuss [what I just asked you about] with your lawyer?”. If the witness responded that no such conversation took place, then the deposition shall move on without further inquiry. If the answer is yes, however, that line of questioning would similarly be concluded because there is no authority to permit the attorney to continue the questioning about the content of such a privileged communication.

In short, Federal Court practice holds that you can not confer with your witness, but if you do, it’s fair game to ask if the witness was coached and what he was coached about. In State Court, this recent opinion can be interpreted that you can confer, but interrogating counsel is then limited to the follow-up questions about the content of the conversation. Guidance will be welcome in the form of Rules of Procedure.

It was a hard pill to swallow; $700B to bailout the huge companies that got themselves in this mess. However, when you hear about companies like AIG taking $400,000 junkets after receiving Federal assistance, it just makes your blood boil. However, the chickens need to come home to roost eventually and certainly the banks are beginning to run for cover. Seeing the vulnerability of their position, they are beginning to ask for immunity from lawsuits brought by defrauded investors and shareholders. Congress should do everything to prevent immunity to these lending institutions of investors and shareholders. At Shaffer & Gaier, we have represented consumers who were taken advantage of by these businesses.

The lawyers at Shaffer & Gaier were proud to be poll watchers to ensure that every person, Democrat, Republican or Independent had a clear path to the voting place. All of our attorneys, watched the polling places to ensure our citizens’ rights were not infringed upon and they could exercise their right to vote.

Countless studies have shown that when companies face difficult economic obstacles, one of the first measures to be cut is safety. Unfortunately, companies often believe that since safety is not a money producing venture, it can take a back seat to their employees and consumers well being. At Shaffer & Gaier, we have handled several cases where products did not go through the vigorous testing they should have done because the companies were trying to save money toward their bottom line. When these defective products caused injury, it was clear that if the companies had gone through their normal paces, the defects of the products would have been avoided. In addition, we have also had experiences with construction accidents where construction companies have placed their workers at risk by failing to adhere to basic safety protocols because they were trying to add to their profit. Certainly, in these difficult economic times these dangers rise to consumers and workers.

Too often, clients are faced with mounting medical bills that are only amplified by medical mistakes. One of the most tragic cases we ever had was a bed sore case where a patient was allowed to develop a bed sore that was literally larger than his fist. This individual had heart surgery and due to the nurses’ negligence in turning the patient, he was allowed to develop a huge bedsore on his buttocks. This made his recovery that much more difficult. We were happy to be able to secure a substantial settlement on his behalf.

In a report released just last week, Federal investigators have found that more than 90% of nursing homes were cited for violations of Federal health and safety standards last year. Most troubling, the for-profit nursing homes were more likely to have problems than any other types of nursing homes Federal investigators found. These problems included infected bed sores, medication mix-up, poor nutrition and abuse and neglect of patients. Inspectors received over 37,000 complaints about the conditions in nursing homes last year and they substantiated almost 40% of them. About 20% of the complaints verified by Federal and State authorities involved nursing home abuse or neglect of patients.

It’s often said that the greatness of a country is determined how it cares for people who can’t care for themselves. Certainly, the elderly fall within this category and no one can contest that these people deserve the best care possible. It is clear from this study that many elderly are not receiving the best care available and that they deserve.

Our firm has handled many nursing home cases throughout the years. We employ a full time nurse/paralegal to review these type of cases. She has over a decade of experience in the nursing field reviewing and evaluating our cases. Please contact us at Shaffer & Gaier, LLC if one of your loved ones has not received appropriate care at a nursing home.