Pharmaceutical Drugs

RICO-PHARMACEUTICAL DRUG MARKETING-AVANDIA

RICO-PHARMACEUTICAL DRUG MARKETING-AVANDIA- In re Avandia Marketing, Sales and Products Liability Litigation, 2019 U.S. App. LEXIS 37485 (3d Cir. December 17, 2019) Restrepo, C.J.  Health care plan sued manufacturer of Avandia claiming RICO violation, violation under state law and Unfair Trade Practices and Consumer Protection Act.  The district court granted the motion to dismiss and the Third Circuit reversed and remanded.  The plans claimed that Avandia concealed data with respect to potential cardiovascular risks and side effects, violating RICO and various consumer-protection laws.  GSK failed to demonstrate that the Plans’ state-law consumer protection claims are preempted by the FTCA.  The district court erred in granting summary judgment on the plans’ RICO claims without giving plans the benefit of discovery on those claims.  Presumably, these claims may be brought by an individual that would even have more direct standing.

Do Sleep Aids Impair Driving Performance?

People who cannot sleep become desperate, so it is not surprising that sleep aids are used by approximately 60 million Americans each year. In addition to prescription drugs, there are many over-the-counter medications used for treating insomnia.

Most common sleep aids help people fall asleep easier and potentially remain asleep for longer. Unfortunately, sometimes the sedative effects last too long and impair functions during the night and the morning after. People can be harmed by nocturnal activities such as sleep-walking and sleep-eating when they do not know what they are doing, and lingering drowsiness during the day can make activities which require alertness, like driving, very hazardous.

If you or a loved one has suffered harm from a vehicle collision or other side effect from sleep-inducing drugs, you may be entitled to compensation for your medical and hospital bills, rehabilitation expenses, lost wages, lost future wage horizon, disfigurement, pain and suffering, and loss of life’s pleasure.  However, your case must be handled correctly and competently, or you may never collect the compensation you are entitled to.

Problems With Sleep Aids

While many people are helped by sleeping pills, there can be side effects to taking them, and some are serious. Among the most commonly prescribed drugs that may cause problems are Zolpidem tartrate, the generic name for best-selling Ambien, and Trazodone.

1) Zolpidem

Zolpidem is in the class of medications called sedative-hypnotics and is a common ingredient in the most widely prescribed sleep medications, including Ambien, Edluar, and the oral spray Zolpimist.

Side Effects of Zolpidem include:

• Parasomnia — unusual behaviors during sleep, including sleep walking, sleep eating, sleep driving, sleep sex, and sleep violence, with no recollection of the behavior upon awakening
• Depression and a suspected factor in suicide attempts
• Hallucinations and dissociation or detachment from physical and emotional experiences
• Addiction if taken too often
• Worsening of insomnia
• Increased risk of next-day car accidents.

Some zolpidem drugs, sold as generic or the brand name Ambien CR, contain an extended-release form of zolpidem that stays in the body longer. Studies have shown many people, especially women, who take extended-release zolpidem have drug levels that are high enough to impair driving and other activities the next morning.

As a result of these problems, on January 10, 2013, the U.S. Food and Drug Administration (FDA) warned the public of the dangers associated with zolpidem and lowered the recommended dose from 10 to 5 milligrams and to 6.25 milligrams for Ambien CR. The FDA’s Adverse Event Reporting System has approximately 700 reports of zolpidem use and impaired driving ability and/or traffic accidents. Although those incidents have not been conclusively linked to zolpidem, a number of lawsuits have been filed for personal injury the plaintiffs believe were the result of taking the drug.

2) Trazodone

Trazodone, another drug commonly prescribed for sleep, is even more likely to leave you feeling drowsy the next day, increasing the chance of accidents while driving.

Trazodone was actually approved as an antidepressant by the FDA in 1981. It has never been approved to treat insomnia; and while some studies have shown that trazodone may improve sleep during the first two weeks of treatment, little is known about how well it works or how safe it is past that point for treating chronic insomnia. Still, it is widely prescribed because it is inexpensive and it is not a controlled substance.

Risks of trazodone include:

• Abnormally low blood pressure, dizziness or fainting, particularly in seniors
• Heart-rhythm disorders
• Priapism, or persistent erection, which may require surgery
• Increased risk of suicidal thoughts and behavior in children and adolescents
• Next day drowsiness, which increases the chance of having an accident while driving.

Sleeping Pill Lawsuits

The FDA has warned that patients who take zolpidem extended-release should not drive or engage in other activities that require complete mental alertness the day after taking the drug. This is because zolpidem levels can remain high enough the next day to impair these activities.

If you or a loved one has suffered personal injury from taking sleeping pills or from a vehicle crash caused by sleep medication, you may have the right to file a lawsuit for compensation for your damages. Some plaintiffs have already been awarded damages as a result of sleeping pill side effects which were not adequately addressed on drug warning labels. However, proving that damages were linked to sleep aids is difficult; to be successful, you need the help of an experienced personal injury attorney.

The seasoned Pennsylvania personal injury attorney Cliff Rieders of Rieders, Travis, Dohrmann, Mowrey, Humphrey & Waters, is a Past President of the Pennsylvania Association for Justice, formerly Pennsylvania Trial Lawyers Association.  Rieders has won numerous awards and recognition from the Pennsylvania Association for Justice, and he received the Pennsylvania Patient Safety Authority recognition award.  He was a founder of the Pennsylvania Patient Safety Authority and served on its Board for 15 years.

Rieders was a Law Clerk in the federal court system for one of the most well-known and longest serving federal judges in the country, the Honorable Malcolm Muir.  Cliff has received the George F. Douglas Amicus Curiae Award, as well as the Milton D. Rosenberg Award from the Pennsylvania Trial Lawyers. He is on committees and organizations that write the law in many fields of practice and was involved in the writing of the Mcare Act, which governs medical liability actions in Pennsylvania.

Cliff Rieders wrote the book on medical malpractice that lawyers use in the state.  Cliff teaches the subject of medical malpractice at seminars attended by the leading lawyers in the state.  Cliff Rieders is recognized as an outstanding authority in the medical malpractice field.  Cliff has even testified before the legislature on medical malpractice laws. Rieders is a Nationally Board certified specialist for Civil Trial and Civil Practice and Procedure, a cum laude Phi Beta Kappa graduate of New York University as well as Georgetown University Law Center.  Rieders is admitted in Pennsylvania, New York State, District of Columbia and numerous federal courts including the Supreme Court of the United States and is a life member of the American Law Institute which publishes recommended legal principles utilized throughout the United States.

Cliff Rieders is the lawyer that other lawyers call for counsel and advice in the medical and hospital malpractice and pharmaceutical/vitamin supplement fields.  He does substantial work in multi-district litigation in connection with pharmaceutical products and medical devices.

Based in Williamsport, Cliff Rieders and the other trial lawyers at Rieders, Travis, Dohrmann, Mowrey, Humphrey & Waters serve clients throughout Pennsylvania, offering a free consultation on all personal injury matters. More than that, we offer you experience, knowledge, compassion, and a long history of results.

RISPERDAL

W.C. v. Janssen Pharms., Inc., 2017 Pa. Super. 356 (November 13, 2017) Panella, J.  Appellant W.C. appealed from the judgment entered following a jury trial in the Philadelphia County Court of Common Pleas in favor of Appellees, Janssen Pharmaceuticals, Inc., Johnson & Johnson and Janssen Research and Development. A new trial was granted to the issues of causation and damages.  Risperidone was developed for treatment of schizophrenia in adult patients, but the claim was that it caused breast enlargement.  Claims for punitive damages were dismissed.  The patient offered expert testimony through Mark Solomon, MD.  He said that the plaintiff suffered from gynecomastia solely due to the Risperdal ingestion during childhood.  The jury returned a verdict in favor of the pharmaceutical companies.  The jury did find the pharmaceutical companies negligent for failing to provide adequate warnings to prescribing physicians concerning the risk of gynecomastia associated with Risperdal use.  However, they failed to find that this negligence caused the gynecomastia.  The trial court did not abuse its discretion by permitting pharmaceutical companies’ counsel to display two tennis balls during his closing.  The trial court did not abuse its discretion by permitting pharmaceutical counsel to use in closing a 75-slide pre-prepared PowerPoint presentation that was not introduced into evidence during their case-in-chief and was not even authenticated.  The court also found that there was nothing wrong with expert testifying about matters that came up at trial even if they were not in the expert report.  However, a physician assistant who was offered by the pharmaceutical companies for the opinion that weight gain was the cause of the gynecomastia was improper and should not have gone into evidence and therefore a new trial was granted as to causation and damages.  The PA was not designated as an expert prior to trial.  The trial court erred in determining that the PA’s testimony did not constitute expert testimony.  The court failed to determine if the PA was qualified as an expert.  The court did not ensure that the jury was able to separate the PA’s testimony from lay testimony.

PHARMACEUTICALS-RISPERDAL

Stange v. Janssen Pharmaceuticals, 2018 Pa. Super. LEXIS 11 (January 8, 2018) Ford Elliott, P.J.E.  Timothy Stange was the plaintiff against Janssen Pharmaceuticals, Johnson & Johnson, and others.  The jury returned a verdict of $500,000 plus delay damages.  Janssen raised Frye issues.  The case at issue was Frye v. United States, 293 F. 1013 (D.C. Cir. 1923).  As Pennsylvania held in Trach v. Fellin, 817 A.2d 1102 (Pa. Super. 2003) en banc appeal denied, 847 A.2d 1288 (2004), Frye excludes evidence when a party wishes to introduce novel scientific evidence.  Under Frye, the relevant scientific community must have reached general acceptance of principles and methodology employed by expert witnesses before the trial court will allow the expert witness to testify about his conclusions.  However, the conclusions reached by the expert witness from generally accepted principles and methodologies need not also be generally accepted.  Thus, the court’s inquiry into whether a particular scientific process is “generally accepted” is an effort to ensure that the result of the scientific process, i.e., the proffered evidence, stems from “scientific research which has been conducted in a fashion that is generally recognized as being sound, and is not the fanciful creation of a renegade researcher.”  As Grady v. Frito-Lay, Inc., 839 A.2d 1038, 1046 (Pa. 2003) noted, the proponent of expert scientific evidence bears the burden of establishing all the admissions under Pennsylvania Rule of Evidence 702.  The methodology must be accepted but not the conclusions.  So in Straub, for example, epidemiology and biological papers are accepted methodology and there is no Frye issue because the conclusions may differ with the conclusions of the defendants.  There is nothing novel about using differential diagnosis to include that the gynecomastia was caused by Risperdal.  Likely, the doctors at Geisinger and Hershey in Straub used differential diagnosis.  Frye does not apply where the methodology employed by the plaintiff’s medical experts is generally accepted in the medical community for diagnosis and treatment.  The expert witnesses in Straub testified that methodology they utilized to say that the problem was caused by aegeline and the liver failure was what they used for diagnosis and treatment.  This knocks out all the Frye motions defendants seek to file in Straub.

This case also deals with failure to warn.  Under Learned Intermediary Doctrine, a manufacturer is liable only where it fails to exercise reasonable care to inform a physician of facts which make the drug likely to be dangerous.  There was ample evidence in this case that the warning labels were inaccurate and misleading and intentionally downplayed the risk of gynecomastia for adolescent boys using Risperdal.  Further, a doctor testified that if he knew the truth he would not have prescribed Risperdal.  The rest of the case is decided under Wisconsin law.  The court sent back for individual determination concerning application of punitive damages, however.  The court also found emotional distress because the boy suffered for so many years, being made fun of and bullied by kids because of his breasts.

Pharmaceuticals: Risperdal Causation and Damages

W.C. v. Janssen Pharms., Inc., 2017 Pa. Super. LEXIS 909 (November 13, 2017) Panella, J.  Appellant, W.C., appeals from the judgment entered following a jury trial in the Philadelphia County Court of Common Pleas in favor of Appellees, Janssen Pharmaceuticals, Inc., Johnson & Johnson Company and Janssen Research and Development, LLC. Appellant argues the trial court abused its discretion in denying his request for a new trial due to erroneous evidentiary rulings at trial. We reverse and remand for a new trial limited to the issues of causation and damages. Appellees developed and manufactured risperidone, an atypical antipsychotic, for the treatment of schizophrenia in adult patients. In 1993, the Food and Drug Administration granted approval to Appellees to market risperidone for this purpose. Appellees brought their product to market under the brand name Risperdal.  At some time between 2006 and 2008, when Appellant was ten to twelve years old, Appellant’s mother, M.C. (“Mrs. C”), alleged she observed Appellant suffering from unexplained weight gain and gynecomastia. However, at that time, neither Appellant nor Mrs. C informed Appellant’s medical providers of his condition.

The complaint claimed that Risperdal caused the gynecomastia.  The trial court granted the motion of the pharmaceutical company and dismissed all plaintiff’s claims for punitive damages.  The trial court also granted in part pharmaceutical’s motion for summary judgment dismissing all claims with the exception of a negligence claim.  Trial was held on the gynecomastia claim under the negligence theory.  The jury returned a verdict in favor of the pharmaceutical company.  They found the company negligent for failing to provide adequate warnings to the prescribing physicians concerning the risk of gynecomastia associated with Risperdal use.  However, the jury failed to find that the negligence caused the gynecomastia.

The court permitted the physician assistant who treated the patient to testify as to the cause of the gynecomastia.  The company did not designate the physician assistant as an expert or disclose any expert reports from her prior to trial.  The Superior Court found the trial court erred in determining that the PA’s testimony did not constitute expert testimony.  The licensed physician assistant could have met the standard for an expert witness, but the court erroneously believed that her testimony was that of facts only.  The court did not ensure that the jury was able to separate the physician assistant’s expert testimony from lay testimony.  The defense in this case was that it was weight gain rather than Risperdal which caused the appearance of gynecomastia.  The physician assistant opined that the weight gain, rather than Risperdal use, caused him to appear to have gynecomastia.  That was the only causation testimony offered by a witness who personally treated the patient.  Hence the reversal.

PHARMACEUTICALS-ZOLOFT

In re Zoloft Products Liability Litigation, No. 16-2247 (3^rd Cir. Op. Filed June 2, 2017) Roth, C.J.  This case involves allegations that the anti-depressant drug Zoloft, manufactured by Pfizer, causes cardiac birth defects when taken during early pregnancy. In support of their position, plaintiffs, through a Plaintiffs’ Steering Committee (PSC), depended upon the testimony of Dr. Nicholas Jewell, Ph.D. Dr. Jewell used the “Bradford Hill” criteria  to analyze existing literature on the causal connection between Zoloft and birth defects. The District Court excluded this testimony and granted summary judgment to defendants. The PSC now appeals these orders, alleging that 1) the District Court erroneously held that an expert opinion on general causation must be supported by replicated observational studies reporting a statistically significant association between the drug and the adverse effect, and 2) it was an abuse of discretion to exclude Dr. Jewell’s testimony. Because we find that the District Court did not establish such a legal standard and did not abuse its discretion in excluding Dr. Jewell’s testimony, we will affirm the District Court’s orders.  Central to this case is the question of whether statistical significance is necessary to prove causality. We decline to state a bright-line rule. Instead, we reiterate that plaintiffs ultimately must prove a causal connection between Zoloft and birth defects. A causal connection may exist despite the lack of significant findings, due to issues such as random misclassification or insufficient power.  Conversely, a causal connection may not exist despite the presence of significant findings. If a causal connection does not actually exist, significant findings can still occur due to, inter alia, inability to control for a confounding effect or detection bias. A standard based on replication of statistically significant findings obscures the essential issue: a causal connection. Given this, the requisite proof necessary to establish causation will vary greatly case by case. This is not to suggest, however, that statistical significance is irrelevant. Despite the problems with treating statistical significance as a magic criterion, it remains an important metric to distinguish between results supporting a true association and those resulting from mere chance. Discussions of statistical significance should thus not understate or overstate its importance. In short, despite the fact that both the Bradford Hill and the weight of the evidence analyses are generally reliable, the “techniques” used to implement the analysis must be 1) reliable and 2) reliably applied. In discussing the conclusions produced by such techniques in light of the Bradford Hill criteria, an expert must explain 1) how conclusions are drawn for each Bradford Hill criterion and 2) how the criteria are weighed relative to one another. Here, we accept that the Bradford Hill and weight of the evidence analyses are generally reliable. We also assume that the “techniques” used to implement the analysis (here, meta-analysis, trend analysis, and reanalysis) are themselves reliable. However, we find that Dr. Jewell did not 1) reliably apply the “techniques” to the body of evidence or 2) adequately explain how this analysis supports specified Bradford Hill criteria. Because “any step that renders the analysis unreliable under the Daubert factors renders the expert’s testimony inadmissible,” this is sufficient to show that the District Court did not abuse its discretion in excluding Dr. Jewell’s testimony. This case involves complicated facts, statistical methodology, and competing claims of appropriate standards for assessing causality from observational epidemiological studies. Ultimately, however, the issue is quite clear. As a gatekeeper, courts are supposed to ensure that the testimony given to the jury is reliable and will be more informative than confusing. Dr. Jewell’s application of his purported methods does not satisfy this standard. By applying different techniques to subsets of the data and inconsistently discussing statistical significance, Dr. Jewell does not reliably analyze the weight of the evidence. Selecting these conclusions to discuss certain Bradford Hill factors also contributes to the unreliability. While the District Court may have flagged a few issues that are not necessarily indicative of an unreliable application of methods, there is certainly sufficient evidence on the record to suggest that the court did not abuse its discretion in excluding Dr. Jewell as an expert on the basis of the unreliability of his methods. For these reasons, we will affirm the orders of the District Court, excluding the testimony of Dr. Jewell and granting summary judgment in favor of Pfizer.

Dangerous Drug Combinations

What happens when you become extremely ill after taking medicine your doctor ordered? Patients have every expectation that the medications prescribed for them will be beneficial and help get them well; but all too often, drugs — and their interactions with other medications the patients are taking — wind up making them more sick.

According to the Centers for Disease Control and Prevention (CDC), pharmaceutical drugs kill over 40,000 people each and every year. Studies highlighted by the CDC estimate that more than 50% of all the drugs marketed to the American consumer have side effects that injure people, in spite of testing and FDA regulation.

Sometimes, it is a new drug that ultimately proves defective or dangerous, but also there are times doctors or pharmacies fail to recognize that drugs which may be safe when prescribed on their own can become dangerous or even deadly in combination with other medications.

Consider what happened when a Chicago Tribune reporter walked into an Evanston CVS pharmacy with two prescriptions: one for clarithromycin, a common antibiotic, the other for simvastatin, an anti-cholesterol drug. Each drug is relatively safe when taken alone, but taken together they can cause a severe breakdown in muscle tissue and lead to kidney failure and death.

The pharmacist never warned him of the dangerous interaction of these drugs. Neither did the pharmacist when a reporter presented prescriptions for a different pair of drugs that dangerously interact.

Cliff Rieders, of Rieders, Travis, Dohrmann, Mowrey, Humphrey & Waters, has handled cases against pharmacies and doctors where a prescription or the dosage was wrong or inappropriate, causing harm to patients. Cliff Rieders wrote the book on medical malpractice utilized in Pennsylvania. Cliff teaches a course on medical malpractice to lawyers throughout the state, and is a founding member of Pennsylvania’s Patient Safety Authority. Rieders is a nationally Board Certified Trial Advocate.

Reasons for Pharmaceutical Problems

Unfortunately, pharmacists are often rushed and under pressure to make profits, and drug manufacturers sometimes rush drugs to market without adequate testing. Driven by the profit-motive, companies have even hidden clinical evidence that a drug may have problems in order to gain the U.S. Food and Drug Administration (FDA)’s approval. Side effects may sometimes take years to emerge, so people may be injured or die before the FDA recognizes dangerous side effects that outweigh benefits and finally pull drugs from the shelves. Since drug companies often offer perks to doctors who prescribe their medications, especially new ones, patients may be prescribed a more expensive drug or one that has more risks just because the doctor receives a payment for promoting that medication.

If you or a loved one has been injured from side effects of medications or their interactions, you may be entitled to compensation for injuries and other losses. Unfortunately, people who suffer serious side effects may not realize the medication or combinations of medications are causing the problems. As a result, they often are not aware they may have a pharmacy malpractice case until the time limits for filing have passed. So if you even suspect you have a pharmacy medical malpractice case, you should contact an attorney immediately.

The seasoned Pennsylvania pharmaceutical medical malpractice attorneys at Rieders, Travis, Dohrmann, Mowrey, Humphrey & Waters, are leaders in the field and are known for settling cases efficiently and litigating cases to obtain maximum compensation. If you have suffered any type of drug injuries, including product liability or medical malpractice lawsuits against drug companies, prescribing doctors, or pharmacies, we are here to help. We offer a free consultation on personal injury cases, so contact our product liability lawyer today to learn your legal options.

Common Medications Involved in Lawsuits

Drug manufacturers have certain immunities in connection with the sale and promotion of drugs. Pharmaceutical manufacturers often cannot be sued under state law because of a doctrine called “preemption.” The pharmaceutical manufacturers may be sued for failure to warn, warranty problems, and, in rare occasions, because a drug is dangerous for any reasonable purpose. Generally speaking, design flaws or the fact that drugs and pharmaceuticals could have been made better, are not a reason to bring a claim. Many of the cases that can be brought involve multi-district litigation, which can have very complicated rules.

Vitamin and dietary supplements are different. The regulation of the FDA is much less. Manufacturers of those products, which can also be very dangerous alone or in combination, can be sued in products liability actions under a variety of theories.

Doctors and pharmacists are held to professional standards and may be liable for negligence in prescribing and dispensing medications and combinations of medications.

Some drugs and pharmaceuticals have caused so many injuries that thousands of lawsuits, sometimes called mass tort litigation, but commonly known as multi-district litigation, have been filed against manufacturers. Examples include:

• Abilify
• AccutaneActos
• Crestor
• Dostinex
• Paxil
• Pradaxa
• Seroquel
• Topamax
• Vioxx
• Yaz Yasmin

If You Have Suffered Serious Side Effects or Injuries From Unsafe Medicines and Their Combinations, Our Attorneys Are Here to Help

Dangerous drug cases are very complicated, so it is essential to have experienced attorneys and legal staff on your side. Whether in settlement negotiations or pursuing a favorable trial verdict, the seasoned Pennsylvania personal injury attorneys of Rieders, Travis, Dohrmann, Mowrey, Humphrey & Waters are familiar with the law regarding dangerous drugs and their combinations, and we are thoroughly prepared and committed to achieving a just outcome. With our sizeable staff, we offer strength in numbers to do research and to pursue your interests in court, while providing top-notch personal service.

If you or your loved one has suffered injury from pharmaceuticals or any other type of medical malpractice, time is of the essence, so don’t delay.

Remember, there are major differences between pharmaceutical cases involving FDA approved drugs, medical device cases, and vitamin supplement or dietary supplement litigation. Each of these has very particular and specific rules.

The following is an example of some of the multi-district litigation that we are accepting cases on now:

• IVC Filters
• Talcum powder / ovarian cancer
• Bair Hugger warming devices
• Invokana
• AbbVie’s AndroGel, Auxilium’s Testim, Eli Lilly’s Axiron, and Actavis’s AndroDerm (Testosterone drugs)
• Power morcellators

Based in Williamsport, we serve clients throughout the state of Pennsylvania, offering a free consultation on all medical malpractice matters. We are dedicated to providing the legal support you need to have a successful case, and we offer you experience, knowledge, compassion, and a long history of results.

Pharmaceutical Pre-Emption

In re Fosamax Alendronate Sodium Prods. Liability Litigation, 2017 U.S. App. LEXIS 5075 (March 22, 2017) Fuentes, J.  Beginning in 2010, hundreds of plaintiffs filed personal-injury suits against the drug manufacturer Merck Sharp & Dohme, alleging that the osteoporosis drug Fosamax caused them to suffer serious thigh bone fractures. Each Plaintiff brought a state-law tort claim alleging that Merck failed to add an adequate warning of the risk of thigh fractures to Fosamax’s FDA-approved drug label. Many Plaintiffs also brought a variety of additional claims including defective design, negligence, and breach of warranty.

Plaintiffs’ suits were consolidated for pretrial administration in a multi-district litigation in the District of New Jersey. Following discovery and a bellwether trial, the District Court granted Merck’s motion for summary judgment and dismissed all of Plaintiffs’ claims on the ground that they were preempted by federal law. The District Court based its ruling on the Supreme Court’s decision in Wyeth v. Levine,¹ which holds that state-law failure-to-warn claims are preempted when there is “clear evidence” that the FDA would not have approved the warning that a plaintiff claims was necessary.

We will vacate and remand. Preemption is an affirmative defense, and Merck has not carried its burden to prove that it is entitled to that defense as a matter of law. The Wyeth “clear evidence” standard is demanding and fact-sensitive. It requires the factfinder to predict a highly probable outcome in a counterfactual world and, therefore, requires a court sitting in summary judgment to anticipate both the range of conclusions that a reasonable juror might reach and the certainty with which the juror would reach them. Here, Plaintiffs have produced sufficient evidence for a reasonable jury to conclude that the FDA would have approved a properly-worded warning about the risk of thigh fractures—or at the very least, to conclude that the odds of FDA rejection were less than highly probable. Under Wyeth and Rule 56, that is enough for Plaintiffs to defeat summary judgment and proceed to trial.

Adverse Drug Events

Pharmaceutical drugs, and medical devices, are highly risky and dangerous instrumentalities. Some drugs and medical devices should not be on the market at all, and others may cause an adverse event, which is an injury resulting from use of the drug or medical device. The law concerning pharmaceutical drugs is not the same as that relating to medical devices. There are important distinctions. The involvement of the Food and Drug Administration causes many complexities because of a legal doctrine called preemption.

If you or someone you love has been injured by a pharmaceutical drug or medical device, you may have the option of filing a lawsuit for damages in connection with the injuries and compensable losses. Cliff Rieders at the law firm of Rieders, Travis, Dohrmann, Mowrey, Humphrey & Waters is one of the leading lawyers in this field of practice. Rieders has written “the book” that Pennsylvania attorneys use in medical liability areas, including cases concerning medical devices and pharmaceutical drugs. Rieders is a Board Certified attorney, Past President of the Pennsylvania Trial Lawyers, and lectures widely to other attorneys on the subject.

Liability with respect to pharmaceutical drugs and medical devices may be predicated upon a number of different bases. It is important to have an attorney who is experienced in connection with these cases. Some of the cases are brought directly, and others as class actions or multi-district litigation. Sometimes consolidating actions in state court are the way these claims are made.

Many lawyers advertise over the internet or on TV, but they do not actually handle these cases — they refer them to someone else. Call the attorney that other attorneys call: Cliff Rieders.

The Federal Food and Drug Administration defines a serious event as one in which the patient outcome is one of the following:

• Death
• Life-threatening condition
• Hospitalization (initial or prolonged)
• Disability – significant, persistent or permanent change, impairment, damage or disruption in the patient’s body function/structure, physical activities or quality of life
• Congenital anomaly
• Requires intervention to prevent permanent impairment or damage.

In 2011, the Food and Drug Administration received 179,855 reports of serious or fatal adverse drug reactions.

How are medical device and pharmaceutical drug cases handled?

It must be proven either that a pharmaceutical drug does not have a legitimate and proper purpose, given its serious side effects, or that there was a failure to warn about the risks of the drug. Also, there may be liability where there has been a misrepresentation or fraud to the Federal Food and Drug Administration by the manufacturer in seeking approval to market the product. Generic drugs are handled differently. The law of medical devices is somewhat different, because a medical device may malfunction or may be accompanied by advice given to the health care provider by manufacturer representatives. Needless to say, there are other possible bases of liability as well.

There are two major types of adverse drug reactions:

1. Type A reactions are most common and are usually a consequence of the drug’s primary pharmacological effect (e.g., bleeding when using the anticoagulant warfarin).
2. Type B reactions are not related to the pharmacological action of the drug and are typically unpredictable.

Sometimes drug manufacturers do not provide information about possible drug reactions to federal approving authorities, or information may even be false or misleading. There may be claims based upon the safety of the drug, the nature of the warnings, or possibly even the marketing of the drug. Manufacturers are required to report serious events within 15 days of becoming aware, but they do not always do so.

Each adverse drug event case is different and must be individually considered as to facts and the basis of liability. The seriousness of the adverse drug event is also an issue.

What drugs cause most problems?

By the end of 2015, the 10 drugs with the largest numbers of reports to the FDA by healthcare practitioners and consumers, in order of frequency, were:  Pradaxa, Coumadin, Levaquin, Carboplatin, Zestril, Cisplatin, Zocor, Cymbalta, Cipro and Bactrim.

Cliff Rieders and Sasha Coffiner are concentrating on the following drugs:

• Testosterone: Replacement therapies such as AndroGel, Axiron, Testim or AndroDerm can potentially be linked to heart attack, stroke and pulmonary embolism.
• Byetta: This is an injectable drug that is prescribed to lower blood glucose levels in Type II diabetes. Recent studies have linked Byetta to conditions such as pancreatitis and pancreatic cancer.
• Januvia: A medication commonly prescribed for Type II diabetes, Januvia has recently been linked to pancreatitis and pancreatic cancer.
• Victoza: Another injectable drug for Type II diabetes, it has been linked by recent studies to serious conditions such as acute pancreatitis and pancreatic cancer.
• Mirena: Some individuals using the Mirena IUD for birth control have suffered serious injuries such as a perforation of the uterine wall, sepsis or pelvic inflammatory disease.
• Lipitor: Women have developed diabetes while taking Lipitor to lower their blood cholesterol, and this is a possible case against Pfizer.

Seek Legal Assistance.

If you or a loved one have been injured as a result of a drug or pharmaceutical, you may be entitled to financial restitution. We offer an authoritative knowledge of the law and of the scientific underpinnings of medical malpractice cases. We utilize a network of experts who provide consultation on specific medical topics, including ADEs, and we also employ nurses to help us evaluate cases.

We understand what you are going through and can help. Do not delay.

CALL FOR A FREE CONSULT. Contact Cliff Rieders, Pharmaceutical/Drug/Medical Device Attorney at (570) 323-8711.